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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2024
or
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from ________ to ________
Commission
File Number 001-39678
SANARA
MEDTECH INC.
(Exact
name of Registrant as specified in its charter)
Texas |
|
59-2219994 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
No.) |
1200 Summit Ave, Suite 414, Fort Worth, Texas 76102
(Address
of principal executive offices)
(817)
529-2300
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.001 par value |
|
SMTI |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
Accelerated
filer |
Non-accelerated
filer |
Smaller
reporting company |
Emerging
growth company |
☐ |
☐ |
☒ |
☒ |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 9, 2024, 8,746,976 shares of the Issuer’s common stock, $0.001 par value per share, were outstanding.
SANARA
MEDTECH INC.
Form
10-Q
Quarter
Ended June 30, 2024
Sanara,
Sanara MedTech, our logo and our other trademarks or service marks appearing in this report are the property of Sanara MedTech Inc. Trade
names, trademarks and service marks of other companies appearing in this report are the property of their respective owners. Solely for
convenience, the trademarks, service marks and trade names included in this report are without the ®, ™ or other applicable
symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable
law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names.
Unless
otherwise indicated, “Sanara MedTech,” “Sanara,” the “Company,” “our,” “us,”
or “we,” refer to Sanara MedTech Inc. and its consolidated subsidiaries.
Part
I – Financial Information
ITEM
1. FINANCIAL STATEMENTS
SANARA
MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
| |
(Unaudited) | | |
| |
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Assets | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash | |
$ | 6,150,375 | | |
$ | 5,147,216 | |
Accounts receivable, net | |
| 10,495,742 | | |
| 8,474,965 | |
Accounts receivable – related parties | |
| 111,412 | | |
| 8,400 | |
Accounts receivable | |
| 111,412 | | |
| 8,400 | |
Royalty receivable | |
| - | | |
| 49,344 | |
Inventory, net | |
| 3,564,659 | | |
| 4,717,533 | |
Prepaid and other assets | |
| 489,240 | | |
| 608,411 | |
Total current assets | |
| 20,811,428 | | |
| 19,005,869 | |
| |
| | | |
| | |
Long-term assets | |
| | | |
| | |
Intangible assets, net | |
| 42,977,404 | | |
| 44,926,061 | |
Goodwill | |
| 3,601,781 | | |
| 3,601,781 | |
Investment in equity securities | |
| 3,084,278 | | |
| 3,084,278 | |
Right of use assets – operating leases | |
| 1,792,448 | | |
| 1,995,204 | |
Property and equipment, net | |
| 1,116,266 | | |
| 1,257,956 | |
Total long-term assets | |
| 52,572,177 | | |
| 54,865,280 | |
| |
| | | |
| | |
Total assets | |
$ | 73,383,605 | | |
$ | 73,871,149 | |
| |
| | | |
| | |
Liabilities and shareholders’ equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 750,538 | | |
$ | 1,924,082 | |
Accounts payable – related parties | |
| 145,487 | | |
| 77,805 | |
Accounts payable | |
| 145,487 | | |
| 77,805 | |
Accrued bonuses and commissions | |
| 6,715,062 | | |
| 7,676,770 | |
Accrued royalties and expenses | |
| 2,475,488 | | |
| 2,047,678 | |
Earnout liabilities – current | |
| 1,085,549 | | |
| 1,100,000 | |
Current portion of debt | |
| - | | |
| 580,357 | |
Operating lease liabilities – current | |
| 393,663 | | |
| 361,185 | |
Total current liabilities | |
| 11,565,787 | | |
| 13,767,877 | |
| |
| | | |
| | |
Long-term liabilities | |
| | | |
| | |
Long-term debt, net of current portion | |
| 14,371,485 | | |
| 9,113,123 | |
Earnout liabilities – long-term | |
| 2,654,001 | | |
| 2,723,001 | |
Operating lease liabilities – long-term | |
| 1,512,584 | | |
| 1,737,445 | |
Other long-term liabilities | |
| 1,877,753 | | |
| 1,941,686 | |
Total long-term liabilities | |
| 20,415,823 | | |
| 15,515,255 | |
| |
| | | |
| | |
Total liabilities | |
| 31,981,610 | | |
| 29,283,132 | |
| |
| | | |
| | |
Commitments and contingencies (Note 8) | |
| - | | |
| - | |
| |
| | | |
| | |
Shareholders’ equity | |
| | | |
| | |
Common Stock: $0.001 par value, 20,000,000 shares authorized; 8,746,976 issued and outstanding as of June 30, 2024 and 8,535,239 issued and outstanding as of December 31, 2023 | |
| 8,747 | | |
| 8,535 | |
Additional paid-in capital | |
| 75,085,515 | | |
| 72,860,556 | |
Accumulated deficit | |
| (33,387,960 | ) | |
| (28,036,814 | ) |
Total Sanara MedTech shareholders’ equity | |
| 41,706,302 | | |
| 44,832,277 | |
Equity attributable to noncontrolling interest | |
| (304,307 | ) | |
| (244,260 | ) |
Total shareholders’ equity | |
| 41,401,995 | | |
| 44,588,017 | |
Total liabilities and shareholders’ equity | |
$ | 73,383,605 | | |
$ | 73,871,149 | |
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
SANARA
MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Net Revenue | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | 38,695,461 | | |
$ | 31,275,081 | |
| |
| | | |
| | | |
| | | |
| | |
Cost of goods sold | |
| 2,008,686 | | |
| 2,187,516 | | |
| 3,898,732 | | |
| 4,313,175 | |
| |
| | | |
| | | |
| | | |
| | |
Gross profit | |
| 18,150,137 | | |
| 13,565,648 | | |
| 34,796,729 | | |
| 26,961,906 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative expenses | |
| 18,957,608 | | |
| 13,811,476 | | |
| 35,149,867 | | |
| 26,780,545 | |
Research and development | |
| 985,651 | | |
| 1,177,128 | | |
| 1,931,949 | | |
| 2,494,452 | |
Depreciation and amortization | |
| 1,105,507 | | |
| 803,694 | | |
| 2,210,927 | | |
| 1,582,569 | |
Change in fair value of earnout liabilities | |
| (13,773 | ) | |
| (360,470 | ) | |
| (79,451 | ) | |
| (813,157 | ) |
Total operating expenses | |
| 21,034,993 | | |
| 15,431,828 | | |
| 39,213,292 | | |
| 30,044,409 | |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| (2,884,856 | ) | |
| (1,866,180 | ) | |
| (4,416,563 | ) | |
| (3,082,503 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other expense | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (644,346 | ) | |
| - | | |
| (911,682 | ) | |
| (6 | ) |
Total other expense | |
| (644,346 | ) | |
| - | | |
| (911,682 | ) | |
| (6 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (3,529,202 | ) | |
| (1,866,180 | ) | |
| (5,328,245 | ) | |
| (3,082,509 | ) |
| |
| | | |
| | | |
| | | |
| | |
Less: Net loss attributable to noncontrolling interest | |
| (25,188 | ) | |
| (38,447 | ) | |
| (60,047 | ) | |
| (76,876 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss attributable to Sanara MedTech shareholders | |
$ | (3,504,014 | ) | |
$ | (1,827,733 | ) | |
$ | (5,268,198 | ) | |
$ | (3,005,633 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share of common stock, basic and diluted | |
$ | (0.41 | ) | |
$ | (0.22 | ) | |
$ | (0.62 | ) | |
$ | (0.37 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of common shares outstanding, basic and diluted | |
| 8,468,835 | | |
| 8,226,271 | | |
| 8,444,101 | | |
| 8,200,173 | |
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
SANARA
MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (UNAUDITED)
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Interest | | |
Equity | |
| |
Common Stock | | |
Additional | | |
| | |
| | |
Total | |
| |
$0.001 par value | | |
Paid-In | | |
Accumulated | | |
Noncontrolling | | |
Shareholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Interest | | |
Equity | |
Balance at December 31, 2022 | |
| 8,299,957 | | |
$ | 8,300 | | |
$ | 65,213,987 | | |
$ | (23,394,757 | ) | |
$ | (107,555 | ) | |
$ | 41,719,975 | |
Share-based compensation | |
| 74,781 | | |
| 75 | | |
| 597,230 | | |
| - | | |
| - | | |
| 597,305 | |
Net settlement and retirement of equity-based awards | |
| (15,854 | ) | |
| (16 | ) | |
| (315,572 | ) | |
| (340,354 | ) | |
| - | | |
| (655,942 | ) |
Issuance of common stock in equity offering | |
| 26,143 | | |
| 26 | | |
| 1,033,735 | | |
| - | | |
| - | | |
| 1,033,761 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (1,177,900 | ) | |
| (38,429 | ) | |
| (1,216,329 | ) |
Balance at March 31, 2023 | |
| 8,385,027 | | |
| 8,385 | | |
| 66,529,380 | | |
| (24,913,011 | ) | |
| (145,984 | ) | |
| 41,478,770 | |
Share-based compensation | |
| 33,355 | | |
| 33 | | |
| 1,127,299 | | |
| - | | |
| - | | |
| 1,127,332 | |
Net settlement and retirement of equity-based awards | |
| 21,363 | | |
| 22 | | |
| 224,740 | | |
| (186 | ) | |
| - | | |
| 224,576 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (1,827,733 | ) | |
| (38,447 | ) | |
| (1,866,180 | ) |
Balance at June 30, 2023 | |
| 8,439,745 | | |
$ | 8,440 | | |
$ | 67,881,419 | | |
$ | (26,740,930 | ) | |
$ | (184,431 | ) | |
$ | 40,964,498 | |
| |
Common Stock | | |
Additional | | |
| | |
| | |
Total | |
| |
$0.001 par value | | |
Paid-In | | |
Accumulated | | |
Noncontrolling | | |
Shareholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Interest | | |
Equity | |
Balance at December 31, 2023 | |
| 8,535,239 | | |
$ | 8,535 | | |
$ | 72,860,556 | | |
$ | (28,036,814 | ) | |
$ | (244,260 | ) | |
$ | 44,588,017 | |
Share-based compensation | |
| 100,662 | | |
| 101 | | |
| 803,285 | | |
| - | | |
| - | | |
| 803,386 | |
Net settlement and retirement of equity-based awards | |
| (13,162 | ) | |
| (13 | ) | |
| (483,633 | ) | |
| (97,148 | ) | |
| - | | |
| (580,794 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| (1,764,184 | ) | |
| (34,859 | ) | |
| (1,799,043 | ) |
Balance at March 31, 2024 | |
| 8,622,739 | | |
| 8,623 | | |
| 73,180,208 | | |
| (29,898,146 | ) | |
| (279,119 | ) | |
| 43,011,566 | |
Balance | |
| 8,622,739 | | |
$ | 8,623 | | |
$ | 73,180,208 | | |
$ | (29,898,146 | ) | |
$ | (279,119 | ) | |
$ | 43,011,566 | |
Share-based compensation | |
| 67,294 | | |
| 67 | | |
| 1,411,478 | | |
| - | | |
| - | | |
| 1,411,545 | |
Net settlement and retirement of equity-based awards | |
| 56,943 | | |
| 57 | | |
| 493,829 | | |
| 14,200 | | |
| - | | |
| 508,086 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (3,504,014 | ) | |
| (25,188 | ) | |
| (3,529,202 | ) |
Net income (loss) | |
| - | | |
| - | | |
| - | | |
| (3,504,014 | ) | |
| (25,188 | ) | |
| (3,529,202 | ) |
Balance at June 30, 2024 | |
| 8,746,976 | | |
$ | 8,747 | | |
$ | 75,085,515 | | |
$ | (33,387,960 | ) | |
$ | (304,307 | ) | |
$ | 41,401,995 | |
Balance | |
| 8,746,976 | | |
$ | 8,747 | | |
$ | 75,085,515 | | |
$ | (33,387,960 | ) | |
$ | (304,307 | ) | |
$ | 41,401,995 | |
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
SANARA
MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS (UNAUDITED)
| |
2024 | | |
2023 | |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (5,328,245 | ) | |
$ | (3,082,509 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 2,210,927 | | |
| 1,582,569 | |
Credit loss expense | |
| 155,930 | | |
| 86,000 | |
Inventory obsolescence | |
| 259,577 | | |
| 69,990 | |
Share-based compensation | |
| 2,214,931 | | |
| 1,724,637 | |
Noncash lease expense | |
| 202,756 | | |
| 144,628 | |
Back-end fee | |
| 52,500 | | |
| - | |
Paid-in-kind interest | |
| 161,875 | | |
| - | |
Accretion of finance liabilities | |
| 117,267 | | |
| - | |
Amortization and write-off of debt issuance costs | |
| 100,883 | | |
| - | |
Change in fair value of earnout liabilities | |
| (79,451 | ) | |
| (813,157 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable, net | |
| (2,127,363 | ) | |
| (371,094 | ) |
Accounts receivable – related parties | |
| (103,012 | ) | |
| 77,886 | |
Inventory, net | |
| 893,297 | | |
| (941,854 | ) |
Prepaid and other assets | |
| 119,172 | | |
| 618,877 | |
Accounts payable | |
| (1,173,544 | ) | |
| (376,521 | ) |
Accounts payable – related parties | |
| 67,682 | | |
| 62,620 | |
Accrued royalties and expenses | |
| 402,610 | | |
| (248,769 | ) |
Accrued bonuses and commissions | |
| (961,709 | ) | |
| (1,859,029 | ) |
Operating lease liabilities | |
| (192,383 | ) | |
| (135,436 | ) |
Net cash used in operating activities | |
| (3,006,300 | ) | |
| (3,461,162 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (124,580 | ) | |
| (40,650 | ) |
Proceeds from disposal of property and equipment | |
| - | | |
| 650 | |
Net cash used in investing activities | |
| (124,580 | ) | |
| (40,000 | ) |
Cash flows from financing activities: | |
| | | |
| | |
Loan proceeds, net | |
| 14,112,747 | | |
| - | |
Pay off line of credit | |
| (9,750,000 | ) | |
| - | |
Equity offering net proceeds | |
| - | | |
| 1,033,761 | |
Net settlement of equity-based awards | |
| (72,708 | ) | |
| (431,366 | ) |
Cash payment of finance and earnout liabilities | |
| (156,000 | ) | |
| - | |
Net cash provided by financing activities | |
| 4,134,039 | | |
| 602,395 | |
Net increase (decrease) in cash | |
| 1,003,159 | | |
| (2,898,767 | ) |
Cash, beginning of period | |
| 5,147,216 | | |
| 8,958,995 | |
Cash, end of period | |
$ | 6,150,375 | | |
$ | 6,060,228 | |
| |
| | | |
| | |
Cash paid during the period for: | |
| | | |
| | |
Interest | |
$ | 549,227 | | |
$ | 6 | |
Supplemental noncash investing and financing activities: | |
| | | |
| | |
Right of use assets obtained in exchange for lease obligations | |
| - | | |
| 1,369,164 | |
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
SANARA
MEDTECH INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 – NATURE OF BUSINESS AND BACKGROUND
Sanara
MedTech Inc. (together with its wholly owned and majority owned subsidiaries on a consolidated basis, the “Company”) is a
medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce
healthcare expenditures in the surgical, chronic wound and skincare markets. Each of the Company’s products, services and technologies
are designed to achieve the Company’s goal of providing better clinical outcomes at a lower overall cost for patients regardless
of where they receive care. The Company strives to be one of the most innovative and comprehensive providers of effective surgical, wound
and skincare solutions and is continually seeking to expand its offerings for patients requiring treatments across the entire continuum
of care in the United States.
In
June 2020, the Company formed a subsidiary, United Wound and Skin Solutions, LLC (formerly known as “WounDerm”), to hold
certain investments and operations in wound and skincare virtual consult services. In 2023, WounDerm was renamed and is now doing business
as “Tissue Health Plus” (“THP”). THP is continuing its mission to simplify skin health, starting with
wound care through a refined business plan. Through THP, the Company plans to offer a first of its kind value-based wound care program
to payers and risk-bearing entities such as accountable care organizations and value-based care primary care companies, with Medicare
Advantage payers as the initial target market for this program.
As
further discussed in Note 11, the Company historically managed its business on the basis of one operating and reportable segment. During
the second quarter of 2024, the Company changed its reportable segments to reflect the manner in which the business is currently managed.
Based on the growing importance of the value-based wound care program to the Company’s future outlook and how the Company’s
chief operating decision maker, the Chief Executive Officer, reviews operating results and makes decisions about resource allocation,
the Company now has two reportable segments: Sanara Surgical and THP.
Sanara
Surgical
The
Sanara Surgical segment primarily markets and sells soft tissue repair and bone fusion products for use in the operating room or
other sterile environments. Sanara Surgical’s soft tissue repair products include, among other products, the Company’s
lead product, CellerateRX Surgical Activated Collagen (“CellerateRX Surgical”), and BIASURGE Advanced Surgical Solution, which
is a no-rinse, advanced surgical solution used for wound irrigation. Sanara Surgical’s bone fusion products include, among
other products, BiFORM, which is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site,
and ALLOCYTE Plus, which is a human allograft cellular bone matrix containing bone-derived progenitor cells and conformable bone
fibers.
Sanara
Surgical also includes an in-house research and development team (Rochal Technologies) with an extensive pipeline of innovative products
under development.
Tissue
Health Plus
The
THP segment is focused on value-based wound care services. Through THP, the Company plans to offer a first of its kind
value-based wound care program to payers and risk-bearing entities such as accountable care organizations and value-based care
(“VBC”) primary care companies, with Medicare Advantage payers as the initial target market for this
program.
THP’s
programs are expected to enable payers to divest wound care spend risk, reduce wound related hospitalizations and improve patient
quality of life. THP plans to coordinate delivery of community and home-based wound care for its managed patients. Community-based
care spans a variety of settings including physician offices, skilled nursing facilities, assisted living facilities and senior living
facilities. THP’s programs are intended to integrate science and evidence-based medicine protocols to standardize wound prevention and
treatment.
As
a result of the change in reportable segments, certain prior period amounts have been recast to conform to the current period presentation.
Throughout this Quarterly Report on Form 10-Q, unless otherwise indicated, amounts and activity reflect reclassifications related to
the Company’s change in reportable segments. The change in reportable segments had no impact on the Company’s Consolidated
Balance Sheets, Statements of Operations, Cash Flows and Shareholders’ Equity
previously reported.
NOTE
2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation and Basis of Presentation
The
accompanying unaudited consolidated financial statements include the accounts of Sanara MedTech Inc. and its wholly owned and majority-owned
subsidiaries, as well as other entities in which the Company has a controlling financial interest. All significant intercompany profits,
losses, transactions and balances have been eliminated in consolidation. Certain prior year amounts have been reclassified to conform
to the current year presentation.
The
accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles
for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include
all the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the
opinion of management of the Company, all adjustments (consisting of normal accruals) considered necessary for a fair presentation
have been included. Operating results for interim periods are not necessarily indicative of the results that may be expected for the
full year period. These financial statements and notes should be read in conjunction with the financial statements for each of the two
years ended December 31, 2023 and 2022, which are included in the Company’s most recent Annual Report on Form 10-K.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date
of the consolidated financial statements, and the reported revenue and expenses during the reporting period. However, actual results
could differ from those estimates and there may be changes to the Company’s estimates in future periods.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.
Income/Loss
Per Share
The
Company computes income/loss per share in accordance with Accounting Standards Codification (“ASC”) Topic 260, Earnings per
Share, which requires the Company to present basic and diluted income per share when the effect is dilutive. Basic income per share is
computed by dividing income available to common shareholders by the weighted average number of shares of common stock outstanding. Diluted
income per share is computed similarly to basic income per share, except that the denominator is increased to include the number of additional
shares of common stock that would have been outstanding if the potential shares of common stock had been issued and if the additional
shares of common stock were dilutive. All common stock equivalents were excluded from the calculations for the periods presented as their
inclusion would have been anti-dilutive during the six months ended June 30, 2024 and 2023 due to the Company’s net loss.
The
following table summarizes the shares of common stock that were potentially issuable but were excluded from the computation of diluted
net loss per share for the six months ended June 30, 2024 and 2023 as such shares would have had an anti-dilutive effect:
SCHEDULE
OF COMPUTATION OF DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | |
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Stock options
(a) | |
| 31,013 | | |
| 124,191 | |
Warrants (b) | |
| 16,725 | | |
| 16,725 | |
Unvested restricted stock | |
| 230,277 | | |
| 164,755 | |
Anti-dilutive securities | |
| 230,277 | | |
| 164,755 | |
Revenue
Recognition
The
Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Revenues
are recognized when a purchase order is received from the customer and control of the promised goods or services is transferred to the
customer in an amount that reflects the consideration the Company expects to be entitled to receive in exchange for transferring those
goods or services. Revenue is recognized based on the following five-step model:
-
Identification of the contract with a customer
-
Identification of the performance obligations in the contract
-
Determination of the transaction price
-
Allocation of the transaction price to the performance obligations in the contract
-
Recognition of revenue when, or as, the Company satisfies a performance obligation
Details
of this five-step process are as follows:
Identification
of the contract with a customer
Customer
purchase orders are generally considered to be contracts under ASC 606. Purchase orders typically identify the specific terms of products
to be delivered, create the enforceable rights and obligations of both parties and result in commercial substance. No other forms of
contract revenue recognition, such as the completed contract or percentage of completion methods, were utilized by the Company in either
2024 or 2023.
Performance
obligations
The
Company’s performance obligation is generally limited to delivery of the requested items to its customers at the agreed upon quantities
and prices.
Determination
and allocation of the transaction price
The
Company has established prices for its products. These prices are effectively agreed to when customers place purchase orders with the
Company. Rebates and discounts, if any, are recognized in full at the time of sale as a reduction of net revenue. Allocation of transaction
prices is not necessary where only one performance obligation exists.
Recognition
of revenue as performance obligations are satisfied
Product
revenues are recognized when a purchase order is received from the customer, the products are delivered and control of the goods and
services passes to the customer.
Disaggregation
of Revenue
Revenue
streams from product sales and royalties are summarized below for the three and six months ended June 30, 2024 and 2023.
SCHEDULE
OF REVENUE FROM PRODUCT SALES AND ROYALTIES
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Soft tissue repair products | |
$ | 17,641,318 | | |
$ | 13,249,742 | | |
$ | 33,723,610 | | |
$ | 26,122,223 | |
Bone fusion products | |
| 2,516,599 | | |
| 2,453,172 | | |
| 4,970,945 | | |
| 5,052,358 | |
Royalty revenue | |
| 906 | | |
| 50,250 | | |
| 906 | | |
| 100,500 | |
Total Net Revenue | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | 38,695,461 | | |
$ | 31,275,081 | |
Accounts
Receivable Allowances
Accounts
receivable are typically due within 30 days of invoicing. The Company establishes an allowance for credit losses to provide for an estimate
of accounts receivable which are not expected to be collectible. The Company bases the allowance on an assessment of customer creditworthiness,
historical payment experience, the age of outstanding receivables and other information as applicable and will record its allowance based
on the estimated credit losses. The Company recorded credit loss expense of $90,930 and $50,000 during the three months ended June 30,
2024 and 2023, respectively and $155,930 and $86,000 during the six months ended June 30, 2024 and 2023, respectively. The allowance
for credit losses was $683,960 at June 30, 2024 and $528,030 at December 31, 2023. Credit loss reserves are maintained based on a variety
of factors, including the length of time receivables are past due and a detailed review of certain individual customer accounts. The
Company also establishes other allowances to provide for estimated customer rebates and other expected customer deductions. These allowances
totaled $4,437 at June 30, 2024 and $3,820 at December 31, 2023. If circumstances related to customers change, estimates of the recoverability
of receivables would be further adjusted.
Inventories
Inventories
are stated at the lower of cost or net realizable value, with cost computed on a first-in, first-out basis. Inventories consist primarily
of finished goods, and also include an immaterial amount of raw materials and related packaging components. The Company recorded inventory
obsolescence expense of $164,342 and $39,479 during the three months ended June 30, 2024 and 2023, respectively, and $259,577 and $69,990
during the six months ended June 30, 2024 and 2023, respectively. The allowance for obsolete and slow-moving inventory had a balance
of $467,508 at June 30, 2024, and $446,917 at December 31, 2023.
Property
and Equipment
Property
and equipment are stated at cost, less accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated
useful lives of the related assets, ranging from two to ten years. Below is a summary of property and equipment for the periods presented:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
Useful | |
June 30, | | |
December 31, | |
| |
Life | |
2024 | | |
2023 | |
Computers | |
3-5 years | |
$ | 230,532 | | |
$ | 194,788 | |
Office equipment | |
3-7 years | |
| 214,190 | | |
| 201,785 | |
Furniture and fixtures | |
5-10 years | |
| 346,508 | | |
| 304,338 | |
Leasehold improvements | |
2-5 years | |
| 168,431 | | |
| 134,170 | |
Internal use software | |
5 years | |
| 1,618,999 | | |
| 1,618,999 | |
| |
| |
| | | |
| | |
Property and equipment, gross | |
| |
| 2,578,660 | | |
| 2,454,080 | |
Less accumulated depreciation | |
| |
| (1,462,394 | ) | |
| (1,196,124 | ) |
| |
| |
| | | |
| | |
Property and equipment, net | |
| |
$ | 1,116,266 | | |
$ | 1,257,956 | |
Depreciation
expense related to property and equipment was $133,301 and $108,492 for the three months ended June 30, 2024 and 2023, respectively,
and $266,270 and $216,166 for the six months ended June 30, 2024 and 2023, respectively.
Internal
Use Software
The
Company accounts for costs incurred to develop or acquire computer software for internal use in accordance with ASC Topic 350-40, Intangibles
– Goodwill and Other. The Company capitalizes the costs incurred during the application development stage, which generally includes
third-party developer fees to design the software configuration and interfaces, coding, installation and testing.
The
Company begins capitalization of qualifying costs when both the preliminary project stage is completed and management has authorized
further funding for the completion of the project. Costs incurred during the preliminary project stage along with post implementation
stages of internal-use computer software are expensed as incurred. The Company also capitalizes costs related to specific upgrades and
enhancements when it is probable the expenditures will result in additional functionality. Capitalized development costs are classified
as “Property and equipment, net” in the Consolidated Balance Sheets and are depreciated over the estimated useful life of
the software, which is generally five years.
Goodwill
The
excess of purchase price over the fair value of identifiable net assets acquired in business combinations is recorded as goodwill. As
of June 30, 2024 and December 31, 2023, all of the Company’s goodwill relates to the acquisition of Scendia Biologics, LLC (“Scendia”), which is included in the Sanara Surgical segment. Goodwill has an indefinite useful life and is not amortized. Goodwill is tested annually
as of December 31 for impairment, or more frequently if circumstances indicate impairment may have occurred. The Company may first perform
a qualitative assessment to determine if it is more likely than not that the fair value of the reporting unit is less than the respective
carrying value. If it is determined that it is more likely than not that a reporting unit’s fair value is less than its carrying
value, then the Company will determine the fair value of the reporting unit and record an impairment charge for the difference between
fair value and carrying value (not to exceed the carrying amount of goodwill). No impairment was recorded during the six months ended
June 30, 2024 or 2023.
Intangible
Assets
Intangible
assets are stated at cost of acquisition less accumulated amortization and impairment loss, if any. Cost of acquisition includes the
purchase price and any cost directly attributable to bringing the asset to its working condition for the intended use. The Company amortizes
its finite-lived intangible assets on a straight-line basis over the estimated useful life of the respective assets which is generally
the life of the related patents or licenses, seven years for customer relationships and five years for assembled workforces. See Note
4 for more information on intangible assets.
Impairment
of Long-Lived Assets
Long-lived
assets, including certain identifiable intangibles held and to be used by the Company, are reviewed for impairment whenever events or
changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The Company continuously evaluates
the recoverability of its long-lived assets based on estimated future cash flows and the estimated liquidation value of such long-lived
assets and provides for impairment if such undiscounted cash flows are insufficient to recover the carrying amount of the long-lived
assets. If impairment exists, an adjustment is made to write the asset down to its fair value, and a loss is recorded as the difference
between the carrying value and fair value. Fair values are determined based on quoted market values, undiscounted cash flows or internal
and external appraisals, as applicable. Assets to be disposed of are carried at the lower of carrying value or estimated fair value less
cost to sell. No impairment was recorded during the six months ended June 30, 2024 or 2023.
Investments
in Equity Securities
The
Company’s equity investments consist of nonmarketable equity securities in privately held companies without readily determinable
fair values. Unless accounted for under the equity method of accounting, the investments are reported at cost minus impairment, if any,
plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the
same issuer. The Company did not have any investments which are recorded applying the equity method of accounting as of June 30, 2024.
The
Company has reviewed the carrying value of its investments and has determined there was no impairment or observable price changes as
of or for the six months ended June 30, 2024 and 2023.
Fair
Value Measurement
As
defined in ASC Topic 820, Fair Value Measurement (“ASC 820”), fair value is the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price).
The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including
assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable,
market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to
measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or
liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). This fair value measurement
framework applies at both the initial and subsequent measurement.
The
three levels of the fair value hierarchy defined by ASC 820 are as follows:
Level
1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets
are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on
an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and
listed equities.
Level
2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly
observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies.
These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities,
time value, volatility factors, and current market and contractual prices for the underlying instruments, as well as other relevant economic
measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be
derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments
in this category generally include nonexchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
Level
3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used
with internally developed methodologies that result in management’s best estimate of fair value.
The
carrying amounts of cash, accounts receivable, accounts payable and accrued expenses, other than acquisition-related expenses, approximate
fair value because of the short-term nature of these instruments. The fair value of acquisition-related accrued expenses is categorized
as Level 2 of the fair value hierarchy. The value of these instruments has been estimated using discounted cash flow analysis based on
the Company’s incremental borrowing rate. The carrying value of the Company’s CRG Term Loan (defined below), which has a
fixed interest rate approximates fair value based on instruments with similar terms (Level 2 inputs). The carrying value of the Company’s
Cadence Term Loan (defined below), which had variable interest rates determined each month, approximates fair value based on instruments
with similar terms (Level 2 inputs). The fair value of the contingent earnout consideration and the acquisition date fair value of goodwill
and intangibles related to the acquisitions discussed in Notes 3 and 4 are based on Level 3 inputs.
Liabilities
for contingent consideration for the Precision Healing merger, acquisition of Scendia and Applied Asset Purchase (defined below)
(see Note 3 for more information) are measured at fair value each reporting period, with the acquisition-date fair value included as
part of the consideration transferred. Subsequent changes in fair value for the Precision Healing merger and Scendia acquisition are
reported under the line item captioned “Change in fair value of earnout liabilities” in the Company’s Consolidated
Statements of Operations. Due to the Applied Asset Purchase being accounted for as an asset acquisition and given that the
transaction did not include contingent shares, subsequent revaluations of contingent consideration for the Applied Asset Purchase
results in an adjustment to the contingent consideration liability and the intellectual property intangible asset with a cumulative
catch-up amortization adjustment. The current year changes in fair value of earnout liabilities below are as a result of a net
decrease in the estimated fair value of the earnout liabilities established at the time of the Company’s Precision Healing
merger and Scendia acquisition. The current year revaluation of earnout liability below is a result of a decrease in the estimated
value of the earnout liability established at the time of the Applied Asset Purchase. The following table sets forth a summary of
the changes in fair value for the Level 3 contingent earnout considerations.
SCHEDULE
OF CHANGES IN FAIR VALUE FOR CONTINGENT EARNOUT CONSIDERATION
| |
| | |
Balance at December 31, 2023 | |
$ | 3,823,001 | |
Changes in fair value of earnout liabilities | |
| (79,451 | ) |
Revaluation of earnout liability | |
| (4,000 | ) |
Balance at June 30, 2024 | |
$ | 3,739,550 | |
Income
Taxes
Income
taxes are accounted for under the asset and liability method, whereby deferred income taxes are recorded for temporary differences between
financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax
rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it
is more likely than not that some or all the deferred tax asset will not be realized.
Share-based
Compensation
The
Company accounts for share-based compensation to employees and nonemployees in accordance with ASC Topic 718, Compensation – Share
Compensation. Share-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as expense
over the stipulated vesting period, if any. The Company estimates the fair value of share-based payments using the Black-Scholes option-pricing
model for common stock options and warrants, and the closing price of the Company’s common stock for grants of common stock, including
restricted stock awards.
Research
and Development Costs
Research
and development (“R&D”) expenses consist of personnel-related expenses, including salaries share-based compensation
and benefits for all personnel directly engaged in R&D activities, contracted services, materials, prototype expenses and
allocated overhead which is comprised of compensation and benefits, lease expense and other facilities-related costs. R&D
expenses include costs related to enhancements to the Company’s currently available products and additional investments in the
product and platform development pipeline. The Company expenses R&D costs as incurred.
Recently
Adopted Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”)
2016-13, Financial Instruments - Credit Losses (Topic 326). This update amends the impairment model by requiring entities to use a
forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments
that are not measured at fair value through net income. The Company adopted the new guidance effective January 1, 2023. The adoption
did not have a material impact on the Company’s consolidated financial position, results of operations or cash
flows.
Recently
Issued Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU
2023-07”), which requires disclosure of incremental segment information on an annual and interim basis. ASU 2023-07 is effective
for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective
basis. The Company is currently evaluating the effect of this pronouncement on its disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”),
which expands the disclosure required for income taxes. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024,
with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The
Company is currently evaluating the effect of this pronouncement on its disclosures.
NOTE
3 – APPLIED ASSET PURCHASE
On
August 1, 2023, the Company entered into an Asset Purchase Agreement (the “Applied Purchase Agreement”) by and among the
Company, as guarantor, Sanara MedTech Applied Technologies, LLC, a Texas limited liability company and wholly owned subsidiary of the
Company (“SMAT”), The Hymed Group Corporation, a Delaware corporation (“Hymed”), Applied Nutritionals, LLC, a
Delaware limited liability company (“Applied”, and together with Hymed, the “Sellers”), and Dr. George D. Petito
(the “Owner”), pursuant to which SMAT acquired certain assets of the Sellers and the Owner, including, among others, the
Sellers’ and Owner’s inventory, intellectual property, manufacturing and related equipment, goodwill, rights and claims,
other than certain excluded assets, all as more specifically set forth in the Applied Purchase Agreement (collectively, the “Applied
Purchased Assets”), and assumed certain Assumed Liabilities (as defined in the Applied Purchase Agreement), upon the terms and
subject to the conditions set forth in the Applied Purchase Agreement (such transaction, the “Applied Asset Purchase”). The
Applied Purchased Assets include the underlying intellectual property of, as well as the rights to manufacture and sell, certain hydrolyzed
collagen products, including CellerateRX Surgical, for human wound care use.
The
Applied Purchased Assets were purchased for an initial aggregate purchase price of $15.25 million, consisting of (i) $9.75 million in
cash (the “Cash Closing Consideration”), (ii) 73,809 shares of the Company’s common stock (the “Stock Closing
Consideration”) with an agreed upon value of $3.0 million and (iii) $2.5 million in cash (the “Installment Payments”),
to be paid in four equal installments on each of the next four anniversaries of the closing of the Applied Asset Purchase (the “Closing”).
Prior
to the Closing, the Company licensed certain of its products from Applied through a sublicense agreement (the “Sublicense Agreement”)
with CGI Cellerate RX, LLC (“CGI Cellerate RX”), a related party (see Note 10 for additional information regarding transactions
with related parties). Pursuant to the Sublicense Agreement, the Company has an exclusive, world-wide sublicense to distribute certain
hydrolyzed collagen products, including CellerateRX Surgical, into the surgical and wound care markets. In connection with the Applied
Asset Purchase, Applied assigned its license agreement with CGI Cellerate RX to SMAT.
In
addition to the Cash Closing Consideration, Stock Closing Consideration and Installment Payments, the Applied Purchase Agreement provides
that the Sellers are entitled to receive up to an additional $10.0 million (the “Applied Earnout”), which is payable to the
Sellers in cash, upon the achievement of certain performance thresholds relating to SMAT’s collections from net sales of a collagen-based
product currently under development. Upon expiration of the seventh anniversary of the Closing, to the extent the Sellers have not earned
the entirety of the Applied Earnout, SMAT shall pay the Sellers a pro-rata amount of the Applied Earnout based on collections from net
sales of the product, with such amount to be due credited against any Applied Earnout payments already made by SMAT (the “True-Up
Payment”). The Applied Earnout, minus the True-Up Payment and any Applied Earnout payments already made by SMAT, may be earned
at any point in the future, including after the True-Up Payment is made.
In
connection with the Applied Asset Purchase and pursuant to the Applied Purchase Agreement, effective August 1, 2023, the Company entered
into a professional services agreement (the “Petito Services Agreement”) with the Owner, pursuant to which the Owner, as
an independent contractor, agreed to provide certain services to the Company, including, among other things, assisting with the development
of products already in development and assisting with research, development, formulation, invention and manufacturing of any future products
(the “Petito Services”). As consideration for the Petito Services, the Owner is entitled to receive: (i) a base salary of
$12,000 per month during the term of the Petito Services Agreement, (ii) a royalty payment equal to three percent (3%) of the actual
collections from net sales of certain products the Owner develops or co-develops that reach commercialization, (iii) a royalty payment
equal to five percent (5%) for the first $50.0 million in aggregate collections from net sales of certain future products and a royalty
payment of two and one-half percent (2.5%) on aggregate collections from net sales of certain future products on any amounts exceeding
$50.0 million but up to $100.0 million, (iv) $500,000 in cash in the event that 510(k) clearance is issued for any future product accepted
by the Company and (v) $1.0 million in cash in the event that a U.S. patent is issued for a certain product; provided that with respect
to the incentive payments described in (iv) and (v) of the foregoing, the Owner shall not earn more than $2.5 million.
The
Petito Services Agreement has an initial term of three years and is subject to automatic successive one-month renewals unless earlier
terminated in accordance with its terms. The Petito Services Agreement may be terminated upon the Owner’s death or disability or
by the Company or the Owner “For Cause” (as defined in the Petito Services Agreement); provided, however, that the base salary
described in (i) of the foregoing paragraph shall survive termination through the three-year initial term and the royalty payments and
incentive payments described in (ii)-(v) of the foregoing paragraph shall survive termination of the Petito Services Agreement.
As
the contingent consideration was negotiated as part of the transfer of assets, the contingent obligation was measured at fair value and
included in the total purchase consideration transferred. Accordingly, since the Applied Asset Purchase was accounted for as an asset
acquisition and did not include contingent shares, the contingent consideration is classified as a liability at its estimated fair value
at each reporting period with subsequent revaluations recognized as an adjustment to the intellectual property intangible asset and the
earnout liability with a cumulative catch-up amortization adjustment.
The
total purchase consideration for the Applied Asset Purchase as determined by the Company was as follows:
SCHEDULE
OF ASSET PURCHASE CONSIDERATIONS
Consideration | |
Equity Shares | | |
Dollar Value | |
Cash Closing Consideration | |
| | | |
$ | 9,750,000 | |
Fair value of Stock Closing Consideration | |
| 73,809 | | |
| 3,089,645 | |
Fair value of Installment Payments | |
| | | |
| 2,040,808 | |
Cash paid for inventory | |
| | | |
| 30,007 | |
Fair value of Petito Services Agreement defined payments | |
| | | |
| 825,834 | |
Fair value of Petito Services Agreement contingent consideration | |
| | | |
| 893,000 | |
Direct transaction costs | |
| | | |
| 162,743 | |
Total purchase consideration | |
| | | |
$ | 16,792,037 | |
Based
on guidance provided by ASC 805, Business Combinations (“ASC 805”), the Company recorded the Applied Asset Purchase as
an asset acquisition due to the determination that substantially all the fair value of the assets acquired was concentrated in a
group of similar identifiable assets. The Company believes the “substantially all” criterion was met with respect to the
acquired intellectual property being the only significant asset acquired. Accordingly, the Company accounted for the transaction as
an asset acquisition.
The
purchase consideration, plus transaction costs, was allocated to the individual assets according to their fair values as a percentage
of the total fair value of the assets purchased, with no goodwill recognized. Based on the estimated fair value of the gross assets acquired,
the total fair value of the net assets acquired was primarily attributable to, and classified as, finite-lived intellectual property
in the third quarter of 2023. The total purchase consideration was allocated based on the relative estimated fair value of such assets
as follows:
SCHEDULE
OF PURCHASE CONSIDERATION ON FAIR VALUE OF ASSETS ACQUIRED
Description | |
Amount | |
Inventory | |
$ | 30,007 | |
Equipment | |
| 33,062 | |
Intellectual property | |
| 16,728,968 | |
Net assets acquired | |
$ | 16,792,037 | |
NOTE
4 – GOODWILL AND INTANGIBLES, NET
The
changes in the carrying amount of the Company’s goodwill were as follows:
SCHEDULE
OF CHANGES IN THE CARRYING AMOUNT OF THE GOODWILL
| |
Total | |
Balance as of December 31, 2022 | |
$ | 3,601,781 | |
Acquisitions | |
| - | |
Balance as of December 31, 2023 | |
| 3,601,781 | |
Acquisitions | |
| - | |
Balance as of June 30, 2024 | |
$ | 3,601,781 | |
In connection with the change in reportable operating segments, the Company
reassessed goodwill with respect to the change in reportable operating segments as they are presented in this report. Goodwill was recorded in connection
with the acquisition of Scendia and is included entirely within the Sanara Surgical Segment. The Company’s assessment determined
that these changes, or any other matters noted, did not alter the Company’s conclusion that goodwill is not impaired as of June
30, 2024 or for the periods then ended.
The
carrying values of the Company’s intangible assets were as follows for the periods presented:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
Accumulated | | |
| | |
| | |
Accumulated | | |
| |
| |
Cost | | |
Amortization | | |
Net | | |
Cost | | |
Amortization | | |
Net | |
Amortizable Intangible Assets: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Product Licenses | |
$ | 4,793,879 | | |
$ | (1,535,647 | ) | |
$ | 3,258,232 | | |
$ | 4,793,879 | | |
$ | (1,342,626 | ) | |
$ | 3,451,253 | |
Patents and Other IP | |
| 38,566,549 | | |
| (4,348,964 | ) | |
| 34,217,585 | | |
| 38,570,549 | | |
| (3,181,186 | ) | |
| 35,389,363 | |
Customer relationships and other | |
| 7,947,332 | | |
| (2,445,745 | ) | |
| 5,501,587 | | |
| 7,947,332 | | |
| (1,861,887 | ) | |
| 6,085,445 | |
Total | |
$ | 51,307,760 | | |
$ | (8,330,356 | ) | |
$ | 42,977,404 | | |
$ | 51,311,760 | | |
$ | (6,385,699 | ) | |
$ | 44,926,061 | |
As
of June 30, 2024, the weighted-average amortization period for finite-lived intangible assets was 14.5 years. Amortization expense related
to intangible assets was $972,206 and $695,202 for the three months ended June 30, 2024 and 2023, respectively, and $1,944,657 and $1,366,403
for the six months ended June 30, 2024 and 2023, respectively. The estimated remaining amortization expense as of June 30, 2024 for finite-lived
intangible assets is as follows:
SCHEDULE
OF FUTURE AMORTIZATION EXPENSE
| |
| | |
Remainder of 2024 | |
$ | 1,944,768 | |
2025 | |
| 3,889,537 | |
2026 | |
| 3,872,281 | |
2027 | |
| 3,758,429 | |
2028 | |
| 3,725,187 | |
2029 | |
| 3,725,187 | |
Thereafter | |
| 22,062,015 | |
Total | |
$ | 42,977,404 | |
The
Company has reviewed the carrying value of intangible assets and has determined there was no impairment during the six months ended June
30, 2024 or 2023.
NOTE
5 – INVESTMENTS IN EQUITY SECURITIES
The
Company’s equity investments consist of nonmarketable equity securities in privately held companies without readily determinable
fair values. Unless accounted for under the equity method of accounting, the investments are reported at cost minus impairment, if any,
plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the
same issuer.
In
July 2020, the Company made a $500,000 long-term investment to purchase certain nonmarketable securities consisting of 7,142,857 Series
B-2 Preferred Shares of Direct Dermatology Inc. (“DirectDerm”), representing approximately 2.9% ownership of DirectDerm at
that time. Through this investment, the Company received exclusive rights to utilize DirectDerm’s technology in all acute and post-acute
care settings such as skilled nursing facilities, home health and wound clinics. In 2021, the Company purchased an additional 3,571,430
shares of DirectDerm’s Series B-2 Preferred for $250,000. In March 2022, the Company purchased an additional 3,571,429 shares of
DirectDerm’s Series B-2 Preferred for $250,000. The Company’s ownership of DirectDerm was approximately 8.1% as of June 30,
2024. The Company does not have the ability to exercise significant influence over DirectDerm’s operating and financial activities.
In
June 2021, the Company invested $2,084,278
to purchase 278,587
Class A Preferred Shares (the “Pixalere Shares”) of Canada based Pixalere Healthcare Inc. (“Pixalere”). The
Pixalere Shares are convertible into approximately 27.3%
of the outstanding equity of Pixalere. Pixalere provides a cloud-based wound care software tool that empowers nurses, specialists
and administrators to deliver better care for patients. In connection with the Company’s purchase of the Pixalere Shares,
Pixalere granted Pixalere Healthcare USA, LLC (“Pixalere USA”), a subsidiary of the Company, a royalty-free exclusive
license to use the Pixalere software and platform in the United States. In conjunction with the grant of the license, the Company
issued Pixalere a 27.3%
equity ownership interest in Pixalere USA valued at $93,879.
The
Company has reviewed the characteristics of the Pixalere Shares in accordance with ASC Topic 323, Investments – Equity Method and
Joint Ventures. Due to the substantive liquidation preferences of the Pixalere Shares over Pixalere’s common stock, the Pixalere
Shares are not “in-substance” common stock, and therefore, the Company does not utilize the equity method of accounting for
this investment. In accordance with ASC Topic 321, Investments - Equity Securities, this investment was reported at cost as of June 30,
2024.
The
following summarizes the Company’s investments for the periods presented:
SCHEDULE
OF INVESTMENTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Carrying Amount | | |
Economic Interest | | |
Carrying Amount | | |
Economic Interest | |
Cost Method Investments | |
| | |
| | |
| | |
| |
Direct Dermatology, Inc. | |
$ | 1,000,000 | | |
| | | |
$ | 1,000,000 | | |
| | |
Pixalere Healthcare Inc. | |
| 2,084,278 | | |
| | | |
| 2,084,278 | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Total Cost Method Investments | |
$ | 3,084,278 | | |
| | | |
$ | 3,084,278 | | |
| | |
NOTE
6 – OPERATING LEASES
The
Company periodically enters operating lease contracts for office space and equipment. Arrangements are evaluated at inception to determine
whether such arrangements constitute a lease. Right of use assets (“ROU assets”) represent the right to use an underlying
asset for the lease term, and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease
ROU assets and liabilities were recognized on the transition date based on the present value of lease payments over the respective lease
term, with the office space ROU asset adjusted for deferred rent liability.
The
Company has three material operating leases for office space. In March and September of 2023, the Company amended its primary office
lease to obtain additional space, as well as extend the term. The leases have remaining lease terms of 78, 14 and 31 months as of June
30, 2024. For practical expediency, the Company has elected to not recognize ROU assets and lease liabilities related to short-term
leases.
In
accordance with ASC Topic 842, Leases, the Company has recorded ROU assets of $1,792,448 and a related lease liability of $1,906,247
as of June 30, 2024. The Company recorded lease expense of $277,596 and $184,575 for the six months ended June 30, 2024 and 2023, respectively.
Cash paid for amounts included in the measurement of operating lease liabilities was $267,223 and $175,382 for the six months ended June
30, 2024 and 2023, respectively.
The
present value of the Company’s operating lease liabilities as of June 30, 2024 is shown below.
Maturity
of Operating Lease Liabilities
SCHEDULE OF OPERATING LEASE LIABILITY
| |
June 30, 2024 | |
Remainder of 2024 | |
$ | 237,793 | |
2025 | |
| 532,053 | |
2026 | |
| 379,529 | |
2027 | |
| 297,947 | |
2028 | |
| 295,689 | |
2029 | |
| 300,158 | |
Thereafter | |
| 303,892 | |
| |
| | |
Total lease payments | |
| 2,347,061 | |
Less imputed interest | |
| (440,814 | ) |
Present Value of Lease Liabilities | |
$ | 1,906,247 | |
| |
| | |
Operating lease liabilities – current | |
$ | 393,663 | |
Operating lease liabilities – long-term | |
$ | 1,512,584 | |
As
of June 30, 2024, the Company’s operating leases had a weighted average remaining lease term of 5.5 years and a weighted average
discount rate of 7.64%.
NOTE
7 – DEBT AND CREDIT FACILITIES
CRG
Term Loan Agreement
On
April 17, 2024 (the “Closing Date”), the Company entered into the CRG Term Loan Agreement, by and among the Company, as
borrower, the subsidiary guarantors party thereto from time to time (collectively, the “Guarantors”), CRG Servicing LLC
as administrative agent and collateral agent (the “Agent”), and the lenders party thereto from time to time (the
“CRG Term Loan Agreement”), providing for a senior secured term loan of up to $55.0
million (the “CRG Term Loan”). The CRG Term Loan Agreement provides for (i) $15.0 million
of the CRG Term Loan that was borrowed on the Closing Date (the “First Borrowing”) and (ii) up to an aggregate of
$40.0
million available for borrowing in two subsequent borrowings, provided that each
such borrowing must be at least $5.0 million or a multiple of $5.0 million and occur between the Closing Date and June 30,
2025, subject to the satisfaction of certain conditions, including that the First Borrowing having previously occurred and
the Agent having received certain fees. The Company used part of the initial proceeds under the CRG Term Loan to extinguish the
Cadence Term Loan described further below.
The
CRG Term Loan is due and payable on March 30, 2029 (the “Maturity Date”), absent any acceleration. Pursuant to the CRG Term
Loan Agreement, the proceeds of the CRG Term Loan shall be used to repay the Cadence Term Loan, to pay fees and expenses related to the
CRG Term Loan Agreement, for certain permitted acquisitions and similar investments and for general working capital and corporate purposes.
The
CRG Term Loan bears interest at a per annum rate equal to 13.25%
(subject to a 4.0%
increase during an event of default), of which 8.00%
must be paid in cash and 5.25%
may, at the election of the Company, be deferred through the 19th quarterly Payment Date (defined below) by adding such
amount to the aggregate principal loan amount, so long as no default or event of default under the CRG Term Loan Agreement has
occurred and is continuing. The Company is required to make quarterly interest payments on the final business day of each calendar
quarter following the Closing Date, commencing on the first such date to occur at least 30 days after the Closing Date (each, a
“Payment Date”). Interest is payable on each Payment Date in arrears with respect to the time between each Payment Date
and upon the payment or prepayment of the CRG Term Loan, ending on the Maturity Date. In addition, the Company is required to pay an
upfront fee of 1.50%
of the principal amount of the CRG Term Loan, which is payable as amounts are advanced under the CRG Term Loan on a pro rata basis.
The Company will also be required to pay a back-end fee equal to 7.00%
of the aggregate principal amount advanced under the CRG Term Loan Agreement. For the three and six months ended June 30, 2024, the
Company paid $246,667
of interest in cash and recorded $161,875
of interest paid-in-kind related to the CRG Term Loan. The paid-in-kind interest was applied to the principal balance of the CRG
Term Loan. The Company recorded $52,500
for the three and six months ended June 30, 2024 to interest expense related to the back-end fee. The back-end fee is accreted and
amortized to interest expense over the term of the CRG Term Loan. Paid-in-kind interest and the accreted back-end fee are included
in “Long-term debt, net of current portion” on the Consolidated Balance Sheets.
Subject
to certain exceptions, the Company is required to make mandatory prepayments of the CRG Term Loan with the proceeds of certain
assets sales and in the event of a change of control of the Company. In addition, the Company may make a voluntary prepayment of the
CRG Term Loan, in whole or in part, at any time. All mandatory and voluntary prepayments of the CRG Term Loan are subject to the
payment of prepayment premiums as follows: (i)
if prepayment occurs on or prior to the date that is one year following the applicable borrowing (the “Borrowing Date”),
an amount equal to 10.0% of the aggregate outstanding principal amount of the CRG Term Loan being prepaid and (ii) if prepayment
occurs one year after the applicable Borrowing Date and on or prior to two years following the applicable Borrowing Date, an amount
equal to 5.0% of the aggregate outstanding principal amount of the CRG Term Loan being prepaid. No prepayment premium is due
on any principal prepaid if prepayment occurs two years or more after the applicable Borrowing Date.
Certain
of the Company’s current and future subsidiaries, including the Guarantors, are guaranteeing the obligations of the Company under
the CRG Term Loan Agreement. As security for their obligations under the CRG Term Loan Agreement, on the Closing Date, the Company and
the Guarantors entered into a security agreement with the Agent pursuant to which the Company and the Guarantors granted to the Agent,
as collateral agent for the lenders, a lien on substantially all of the Company’s and the Guarantors’ assets, including intellectual
property (subject to certain exceptions).
The
CRG Term Loan Agreement contains affirmative and negative covenants customary for financings of this type, including limitations on the
Company’s and the Guarantors’ abilities, among other things, to incur additional debt, grant or permit additional liens,
make investments and acquisitions above certain thresholds, merge or consolidate with others, dispose of assets, pay dividends and distributions
and enter into affiliate transactions, in each case, subject to certain exceptions. In addition, the CRG Term Loan Agreement contains
the following financial covenants requiring the Company and the Guarantors in the aggregate to maintain:
|
●
|
liquidity
in an amount which shall exceed the greater of (i) $3.0 million and (ii) to the extent the Company has incurred certain permitted
debt, the minimum cash balance, if any, required of the Company by the creditors of such permitted debt; and |
|
|
|
|
● |
annual
minimum revenue: (i) for the twelve-month period beginning on January 1, 2024 and ending on December 31, 2024, of at least $60.0
million, (ii) for the twelve-month period beginning on January 1, 2025 and ending on December 31, 2025, of at least $75.0 million,
(iii) for the twelve-month period beginning on January 1, 2026 and ending on December 31, 2026, of at least $85.0 million, (iv) for
the twelve-month period beginning on January 1, 2027 and ending on December 31, 2027, of at least $95.0 million and (v) during each
twelve-month period beginning on January 1 of a given year thereafter, of at least $105.0 million. |
The
CRG Term Loan Agreement contains representations and warranties of the Company and the Guarantors customary for financings of this type,
and also includes events of default customary for financings of this type, including, among other things, non-payment, inaccuracy of
representations and warranties, covenant breaches, a material adverse change, bankruptcy and insolvency, material judgments and a change
of control, in certain cases subject to customary periods to cure. The occurrence and continuance of an event of default could result
in the acceleration of the obligations under the CRG Term Loan Agreement.
Cadence
Term Loan
In
connection with the entry into the Applied Purchase Agreement, on August 1, 2023, SMAT, as borrower, and the Company, as guarantor, entered
into a loan agreement (the “Cadence Loan Agreement”) with Cadence Bank (the “Bank”) providing for, among other
things, an advancing term loan in the aggregate principal amount of $12.0 million (the “Cadence Term Loan”), which was evidenced
by an advancing promissory note. Pursuant to the Cadence Loan Agreement, the Bank agreed to make, at any time and from time to time prior
to February 1, 2024, one or more advances to SMAT.
The
proceeds of the advances under the Cadence Loan Agreement were used for working capital and for purposes of financing up to one hundred
percent (100%) of the Cash Closing Consideration and Installment Payments for the Applied Asset Purchase and related fees and expenses,
including any subsequent payments that were due to the Sellers after the Closing. On August 1, 2023, the Bank, at the request of SMAT,
made an advance for $9.75 million. The proceeds from the advance were used to fund the Cash Closing Consideration for the Applied Asset
Purchase.
Advances
under the Cadence Term Loan were scheduled to begin amortizing in monthly installments commencing on August 5, 2024. All remaining unpaid
balances under the Cadence Term Loan were due and payable in full on August 1, 2028 (the “Cadence Loan Maturity Date”). SMAT
was permitted to prepay amounts due under the Cadence Term Loan. All accrued but unpaid interest on the unpaid principal balance of outstanding
advances was due and payable monthly, beginning on September 5, 2023 and continued monthly on the fifth day of each month thereafter
until the Cadence Loan Maturity Date. The unpaid principal balance of outstanding advances bore interest, subject to certain conditions,
at the lesser of the Maximum Rate (as defined in the Cadence Loan Agreement) or the Base Rate, which was for any day, a rate per annum
equal to the term secured overnight financing rate (Term SOFR) (as administered by the Federal Reserve Bank of New York) for a one-month
tenor in effect on such day plus three percent (3.0%).
The
obligations of SMAT under the Cadence Loan Agreement and the other loan documents delivered in connection therewith were guaranteed by
the Company and were secured by a first priority security interest in substantially all of the existing and future assets of SMAT.
The
Cadence Loan Agreement contained customary representations and warranties and certain covenants that limited (subject to certain exceptions)
the ability of SMAT and the Company to, among other things, (i) create, assume or guarantee certain liabilities, (ii) create, assume
or suffer liens securing indebtedness, (iii) make or permit loans and advances, (iv) acquire any assets outside the ordinary course of
business, (v) consolidate, merge or sell all or a material part of its assets, (vi) pay dividends or other distributions on, or redeem
or repurchase, interest in an obligor, including the Company, as guarantor (vii) cease, suspend or materially curtail business operations
or (viii) engage in certain affiliate transactions. In addition, the Cadence Loan Agreement contained financial covenants that required
SMAT to maintain (i) a minimum Debt Services Coverage Ratio of 1.2 to 1.0 as of the last day of each applicable fiscal quarter and (ii)
a maximum Cash Flow Leverage Ratio of not more than (a) 4.5 to 1.0 as of the last day of the fiscal quarter ending on September 30, 2023,
(b) 4.0 to 1.0 as of the last day of each fiscal quarter ending on December 31, 2023 and March 31, 2024, (c) 3.5 to 1.0 as of the last
day of each fiscal quarter ending June 30, 2024 and September 30, 2024 and (d) 3.0 to 1.0 as of the last day of each fiscal quarter thereafter.
Pursuant to the Cadence Loan Agreement, in the event that SMAT failed to comply with the financial covenants described above, the Company
was required to contribute cash to SMAT in an amount equal to the amount required to satisfy the financial covenants.
The
Cadence Loan Agreement contained customary events of default. If such an event of default occurred, the Bank was entitled to take various
actions, including the acceleration of amounts due under the Cadence Loan Agreement and actions permitted to be taken by a secured creditor.
On
the Closing Date, the Cadence Loan Agreement was terminated and all outstanding
amounts under the Cadence Term Loan were repaid in full and all security interest and other liens granted to or held by Cadence were
terminated and released. In addition, unamortized debt issuance costs as of the termination date of $53,438 were included in “Interest
expense” on the Consolidated Statement of Operations.
The
table below presents the components of outstanding debt for the periods presented:
As
of June 30, 2024, the interest rate on the CRG Term Loan was 13.25% per annum and as of December 31, 2023, the interest rate
on the advance under the Cadence Term Loan was 8.3%.
SCHEDULE
OF LONG-TERM DEBT
| |
June 30, 2024 | | |
December 31, 2023 | |
Cadence Term Loan | |
$ | - | | |
$ | 9,750,000 | |
CRG Term Loan | |
| 15,000,000 | | |
| - | |
Paid-in-kind interest | |
| 161,875 | | |
| - | |
Back-end fee | |
| 52,500 | | |
| - | |
Debt | |
| 15,214,375 | | |
| 9,750,000 | |
| |
| | | |
| | |
Less: debt issuance costs | |
| (887,253 | ) | |
| (61,658 | ) |
Accumulated amortization of debt issuance costs | |
| 44,363 | | |
| 5,138 | |
Net debt issuance costs | |
| (842,890 | ) | |
| (56,520 | ) |
| |
| | | |
| | |
Debt, net of debt issuance costs | |
| 14,371,485 | | |
| 9,693,480 | |
| |
| | | |
| | |
Less: Current portion of long-term debt | |
| - | | |
| 580,357 | |
Long-term debt | |
$ | 14,371,485 | | |
$ | 9,113,123 | |
The
table below presents the aggregate maturities of the Company’s outstanding debt as of June 30, 2024:
SCHEDULE
OF MATURITIES OUTSTANDING DEBT
Year | |
Total | |
| |
| |
Remainder of 2024 | |
$ | - | |
2025 | |
| - | |
2026 | |
| - | |
2027 | |
| - | |
2028 | |
| - | |
Thereafter | |
| 15,214,375 | |
Total debt | |
$ | 15,214,375 | |
In
connection with the CRG Term Loan, the Company incurred $887,253 in debt issuance costs during the six months ended June 30, 2024. Debt
issuance costs are amortized to “Interest expense” on the Consolidated Statement of Operations over the life of
the debt to which they pertain. The total unamortized debt issuance costs were $842,890 and $56,520 as of June 30, 2024 and December
31, 2023, respectively. Debt issuance costs are included in “Long-term debt, net of current portion” on the Consolidated
Balance Sheets. Amortization expense related to debt issuance costs was $100,883 and zero for the six months ended June 30, 2024 and
2023, respectively.
NOTE
8 - COMMITMENTS AND CONTINGENCIES
License
Agreements and Royalties
CellerateRX
Surgical
In
August 2018, the Company entered an exclusive, world-wide sublicense agreement with CGI Cellerate RX, LLC (“CGI Cellerate RX”)
to distribute certain hydrolyzed collagen products, including CellerateRX Surgical, into the surgical and wound care markets. Pursuant
to the Sublicense Agreement, the Company paid royalties of 3-5% of annual collected net sales of these products. As amended in January
2021, the term of the sublicense was extended through May 2050, with automatic successive year-to-year renewal terms thereafter so long
as the Company’s Net Sales (as defined in the Sublicense Agreement) each year are equal to or in excess of $1,000,000. If the Company’s
Net Sales fall below $1,000,000 for any year after the expiration date, CGI Cellerate RX has the right to terminate the Sublicense Agreement
upon written notice.
Under
this agreement, royalty expense, which was recorded in “Cost of goods sold” in the accompanying Consolidated Statements of
Operations, totaled zero and $548,430, respectively, for the three months ended June 30, 2024 and 2023 and zero and $1,069,244, respectively,
for the six months ended June 30, 2024 and 2023. Sales of CellerateRX Surgical comprised the substantial majority of the Company’s
sales during the three and six months ended June 30, 2024 and 2023.
As
discussed further in Note 3, on August 1, 2023, the Company purchased certain assets from Applied, including the rights to manufacture
and sell certain hydrolyzed collagen products, including CellerateRX Surgical, for use in the human wound care market. In connection
with the Applied Asset Purchase, Applied assigned its license agreement with CGI Cellerate RX to SMAT.
BIAKŌS
Antimicrobial Wound Gel and BIAKŌS Antimicrobial Skin and Wound Cleanser
In
July 2019, the Company executed a license agreement with Rochal Industries, LLC (“Rochal”), a related party, pursuant to
which the Company acquired an exclusive world-wide license to market, sell and further develop antimicrobial products for the prevention
and treatment of microbes on the human body utilizing certain Rochal patents and pending patent applications (the “BIAKŌS
License Agreement”). Currently, the products covered by the BIAKŌS License Agreement are BIAKŌS Antimicrobial Wound
Gel, BIAKŌS Antimicrobial Skin and Wound Cleanser and BIASURGE Advanced Surgical Solution. All three products are 510(k) cleared.
Future
commitments under the terms of the BIAKŌS License Agreement include:
|
● |
The
Company pays Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal was $133,000 for 2023 and will increase
by 10% each subsequent calendar year up to a maximum amount of $150,000. |
|
● |
The
Company pays additional royalty annually based on specific net profit targets from sales of the licensed products, subject to a maximum
of $1,000,000 during any calendar year. |
Unless
previously terminated by the parties, the BIAKŌS License Agreement expires with the related patents in December 2031.
Under
this agreement, royalty expense, which is recorded in “Cost of goods sold” in the accompanying Consolidated Statements of
Operations, was $42,305 and $32,500 for the three months ended June 30, 2024 and 2023, respectively. For the six months ended June 30,
2024 and 2023, royalty expense under this agreement was $77,305 and $65,000, respectively. The Company’s Executive Chairman and
Chief Executive Officer is a director of Rochal, and indirectly a significant shareholder of Rochal, and through the potential exercise
of warrants, a majority shareholder of Rochal. Another one of the Company’s directors is also a director and significant shareholder
of Rochal.
CuraShield
Antimicrobial Barrier Film and No Sting Skin Protectant
In
October 2019, the Company executed a license agreement with Rochal pursuant to which the Company acquired an exclusive world-wide license
to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care
market utilizing certain Rochal patents and pending patent applications (the “ABF License Agreement”). Currently, the products
covered by the ABF License Agreement are CuraShield Antimicrobial Barrier Film and a no sting skin protectant product.
Future
commitments under the terms of the ABF License Agreement include:
|
● |
The
Company will pay Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal will be $50,000 beginning with the
first full calendar year following the year in which first commercial sales of the products occur. The annual minimum royalty will
increase by 10% each subsequent calendar year up to a maximum amount of $75,000. |
|
● |
The
Company will pay additional royalties annually based on specific net profit targets from sales of the licensed products, subject
to a maximum of $500,000 during any calendar year. |
Unless
previously terminated or extended by the parties, the ABF License Agreement will terminate upon expiration of the last U.S. patent in
October 2033. No commercial sales or royalties have been recognized under this agreement as of June 30, 2024.
Debrider
License Agreement
In
May 2020, the Company executed a product license agreement with Rochal, pursuant to which the Company acquired an exclusive world-wide
license to market, sell and further develop a debrider for human medical use to enhance skin condition or treat or relieve skin disorders,
excluding uses primarily for beauty, cosmetic, or toiletry purposes (the “Debrider License Agreement”).
Future
commitments under the terms of the Debrider License Agreement include:
|
● |
Upon
FDA clearance of the licensed products, the Company will pay Rochal $500,000 in cash and an additional $1,000,000, which at the Company’s
option may be paid in any combination of cash and its common stock. |
|
● |
The
Company will pay Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal will be $100,000 beginning with
the first full calendar year following the year in which first commercial sales of the licensed products occur and increase by 10%
each subsequent calendar year up to a maximum amount of $150,000. |
|
● |
The
Company will pay additional royalty annually based on specific net profit targets from sales of the licensed products, subject to
a maximum of $1,000,000 during any calendar year. |
Unless
previously terminated or extended by the parties, the Debrider License Agreement will expire in October 2034. No commercial sales or
royalties have been recognized under this agreement as of June 30, 2024.
Rochal
Asset Acquisition
The
Company entered into an asset purchase agreement with Rochal effective July 1, 2021, pursuant to which the Company purchased certain
assets of Rochal. Pursuant to the asset purchase agreement, for the three-year period after the effective date, Rochal is entitled to
receive consideration for any new product relating to the business that is directly and primarily based on an invention conceived and
reduced to practice by a member or members of Rochal’s science team. For the three-year period after the effective date, Rochal
is also entitled to receive an amount in cash equal to twenty-five percent of the proceeds received for any Grant (as defined in the
asset purchase agreement) by either the Company or Rochal. In addition, the Company agreed to use commercially reasonable efforts to
perform Minimum Development Efforts (as defined in the asset purchase agreement) with respect to certain products under development,
which if obtained, will entitle the Company to intellectual property rights from Rochal in respect of such products.
Precision
Healing Merger Agreement
In
April 2022, the Company closed a merger transaction with Precision Healing pursuant to which Precision Healing became a wholly owned
subsidiary of the Company. Pursuant to the terms of the merger agreement, holders of Precision Healing common stock and preferred stock,
other than the Company, were entitled to receive closing consideration, consisting of $125,966 in cash consideration, which was paid
to stockholders who were not accredited investors, 165,738 shares of the Company’s common stock, which was paid only to accredited
investors, and the payment in cash of approximately $0.6 million of transaction expenses of Precision Healing. The Company recorded the
issuance of the 165,738 shares to accredited investors and cash payments to nonaccredited investors based on the closing price per share
of the Company’s common stock on April 4, 2022, which was $30.75.
Upon
the closing of the merger, the Precision Healing outstanding options previously granted under the Precision Healing Plan converted, pursuant
to their terms, into options to acquire an aggregate of 144,191 shares of Company common stock with a weighted average exercise price
of $10.71 per share. These options expire between August 2030 and April 2031. In addition, outstanding and unexercised Precision Healing
warrants converted into rights to receive warrants to purchase (i) 4,424 shares of the Company’s common stock with an initial exercise
price of $7.32 per share and an expiration date of April 22, 2031, and (ii) 12,301 shares of the Company’s common stock with an
initial exercise price of $12.05 per share and an expiration date of August 10, 2030. Concurrent with the assumption of the Precision
Healing Plan, the Company terminated the ability to offer future awards under the Precision Healing Plan.
Pursuant
to the merger agreement, upon the achievement of certain performance thresholds, the securityholders of Precision Healing, including
the holders of options and warrants to purchase Precision Healing common stock and certain persons promised options to purchase Precision
Healing common stock, are also entitled to receive payments of up to $10.0 million, which was accounted for as contingent consideration
pursuant to ASC 805. The earnout consideration is payable in cash or, at the Company’s election, is payable to accredited investors
in shares of Company common stock at a price per share equal to the greater of (i) $27.13 or (ii) the average closing price of Company
common stock for the 20 trading days prior to the date such earnout consideration is due and payable. Pursuant to the merger agreement,
a minimum percentage of the earnout consideration may be required to be issued to accredited investors in shares of Company common stock
for tax purposes. The amount and composition of the portion of earnout consideration payable is subject to adjustment and offsets as
set forth in the merger agreement.
Scendia
Purchase Agreement
In
July 2022, the Company closed the Scendia acquisition pursuant to which Scendia became a wholly owned subsidiary of the Company. Pursuant
to the purchase agreement, the aggregate consideration for the acquisition at closing was approximately $7.6 million, subject to customary
post-closing adjustments. The consideration consisted of (i) approximately $1.6 million of cash, subject to certain adjustments, and
(ii) 291,686 shares of common stock of the Company. Pursuant to the purchase agreement, at closing, the Company withheld 94,798 Indemnity
Holdback Shares, which such Indemnity Holdback Shares were withheld to the extent provided in the purchase agreement to satisfy Phillips’
indemnification obligations and subsequently issued and released to Phillips in July 2023.
In
addition to the cash consideration and the stock consideration, the purchase agreement provides that Phillips is entitled to receive
two potential earnout payments, payable on an annual basis, not to exceed $10.0 million in the aggregate, which was accounted for as
contingent consideration pursuant to ASC 805. The earnout consideration is payable to Phillips in cash or, at the Company’s election,
in up to 486,145 shares of the Company’s common stock upon the achievement of certain performance thresholds relating to net revenue
attributable to sales of Scendia products during the two-year period following the closing. The Company made the first earnout payment
of approximately $693,000 in cash in August 2023. The Company expects the final earnout payment to be made in the third quarter of 2024.
Applied
Asset Purchase
On
August 1, 2023, the Company closed the Applied Asset Purchase. The Applied Purchased Assets were purchased for an initial aggregate purchase
price of $15.25 million, consisting of (i) the Cash Closing Consideration, (ii) the Stock Closing Consideration and (iii) the Installment
Payments.
In
addition to the Cash Closing Consideration, Stock Closing Consideration and Installment Payments, the Applied Purchase Agreement provides
that the Sellers are entitled to receive the Applied Earnout, which is payable to the Sellers in cash, upon the achievement of certain
performance thresholds relating to SMAT’s collections from net sales of a collagen-based product currently under development. Upon
expiration of the seventh anniversary of the Closing, to the extent the Sellers have not earned the entirety of the Applied Earnout,
SMAT shall pay the Sellers the True-Up Payment. The Applied Earnout, minus the True-Up Payment and any Applied Earnout payments already
made by SMAT, may be earned at any point in the future, including after the True-Up Payment is made.
In
connection with the Applied Asset Purchase and pursuant to the Applied Purchase Agreement, effective August 1, 2023, the Company entered
into the Petito Services Agreement with the Owner, pursuant to which the Owner, as an independent contractor, agreed to provide the Petito
Services. As consideration for the Petito Services, the Owner is entitled to receive: (i) a base salary of $12,000 per month during the
term of the Petito Services Agreement, (ii) a royalty payment equal to three percent (3%) of the actual collections from net sales of
certain products the Owner develops or codevelops that reach commercialization, (iii) a royalty payment equal to five percent (5%) for
the first $50.0 million in aggregate collections from net sales of certain future products and a royalty payment of two and one-half
percent (2.5%) on aggregate collections from net sales of certain future products on any amounts exceeding $50.0 million but up to $100.0
million, (iv) $500,000 in cash in the event that 510(k) clearance is issued for any future product accepted by the Company and (v) $1.0
million in cash in the event that a U.S. patent is issued for a certain product; provided that with respect to the incentive payments
described in (iv) and (v) of the foregoing, the Owner shall not earn more than $2.5 million.
The
Petito Services Agreement has an initial term of three years and is subject to automatic successive one-month renewals unless earlier
terminated in accordance with its terms. The Petito Services Agreement may be terminated upon the Owner’s death or disability or
by the Company or the Owner “For Cause” (as defined in the Petito Services Agreement); provided, however, that the base salary
described in (i) of the foregoing paragraph shall survive termination through the three-year initial term and the royalty payments and
incentive payments described in (ii)-(v) of the foregoing paragraph shall survive termination of the Petito Services Agreement.
Other
Commitments
On
December 20, 2023, the Company signed an exclusive license agreement with Tufts University (“Tufts”) to develop and commercialize
patented technology covering 18 unique collagen peptides. As part of this agreement, the Company formed a new subsidiary, Sanara Collagen
Peptides, LLC (“SCP”) and 10% of SCP’s outstanding units were issued to Tufts. SCP has exclusive rights to develop
and commercialize new products based on the licensed patents and patents pending. SCP will pay royalties to Tufts based on net sales
of licensed products and technologies. Under the exclusive license agreement, royalties will be calculated at a rate of 1.5% or 3%, depending
on the type of product or technology developed. SCP will pay Tufts a minimum annual royalty of $50,000 on January 1 of the year following
the first anniversary of the first commercial sale of the licensed products or technologies. SCP will pay Tufts a $100,000 minimum annual
royalty on January 1 of each subsequent year during the royalty term specified in the exclusive license agreement. There have been no
material accounting impacts related to this arrangement as of June 30, 2024.
NOTE
9 – SHAREHOLDERS’ EQUITY
Common
Stock
At
the Company’s Annual Meeting of Shareholders held in July 2020, the Company approved the Restated 2014 Omnibus Long Term Incentive
Plan (the “2014 LTIP”) in which the Company’s directors, officers, employees and consultants are eligible to participate.
A total of 748,453 shares had been issued under the 2014 LTIP and 1,251,547 were available for issuance as of June 30, 2024.
In
April 2022, the Company closed a merger transaction with Precision Healing pursuant to which Precision Healing became a wholly owned
subsidiary of the Company. Pursuant to the terms of the merger agreement, holders of Precision Healing common stock and preferred stock,
other than the Company, were entitled to receive closing consideration, consisting of $125,966 in cash consideration, which was paid
to stockholders who were not accredited investors, 165,738 shares of the Company’s common stock, which was paid only to accredited
investors, and the payment in cash of approximately $0.6 million of transaction expenses of Precision Healing. The Company recorded the
issuance of the 165,738 shares to accredited investors and cash payments to nonaccredited investors based on the closing price per share
of the Company’s common stock on April 4, 2022, which was $30.75.
Upon
the closing of the merger, the Precision Healing outstanding options previously granted under the Precision Healing Plan converted, pursuant
to their terms, into options to acquire an aggregate of 144,191 shares of Company common stock with a weighted average exercise price
of $10.71 per share. These options expire between August 2030 and April 2031. In addition, outstanding and unexercised Precision Healing
warrants converted into rights to receive warrants to purchase (i) 4,424 shares of the Company’s common stock with an initial exercise
price of $7.32 per share and an expiration date of April 22, 2031, and (ii) 12,301 shares of the Company’s common stock with an
initial exercise price of $12.05 per share and an expiration date of August 10, 2030. Concurrent with the assumption of the Precision
Healing Plan, the Company terminated the ability to offer future awards under the Precision Healing Plan.
Pursuant
to the merger agreement, upon the achievement of certain performance thresholds, the securityholders of Precision Healing, including
the holders of options and warrants to purchase Precision Healing common stock and certain persons promised options to purchase Precision
Healing common stock, are also entitled to receive payments of up to $10.0 million, which was accounted for as contingent consideration
pursuant to ASC 805. The earnout consideration is payable in cash or, at the Company’s election, is payable to accredited investors
in shares of Company common stock at a price per share equal to the greater of (i) $27.13 or (ii) the average closing price of Company
common stock for the 20 trading days prior to the date such earnout consideration is due and payable. Pursuant to the merger agreement,
a minimum percentage of the earnout consideration may be required to be issued to accredited investors in shares of Company common stock
for tax purposes. The amount and composition of the portion of earnout consideration payable is subject to adjustment and offsets as
set forth in the merger agreement.
In
July 2022, the Company closed the Scendia acquisition pursuant to which Scendia became a wholly owned subsidiary of the Company. Pursuant
to the purchase agreement, the aggregate consideration at closing for the acquisition was approximately $7.6 million, subject to customary
post-closing adjustments. The consideration consisted of (i) approximately $1.6 million of cash, subject to certain adjustments, and
(ii) 291,686 shares of common stock of the Company. Pursuant to the purchase agreement, at closing, the Company withheld 94,798 Indemnity
Holdback Shares, which such Indemnity Holdback Shares were withheld to the extent provided in the purchase agreement to satisfy Phillips’
indemnification obligations and subsequently issued and released to Phillips in July 2023.
In
addition to the cash consideration and the stock consideration, the purchase agreement provides that Phillips is entitled to receive
two potential earnout payments, payable on an annual basis, not to exceed $10.0 million in the aggregate, which was accounted for as
contingent consideration pursuant to ASC 805. The earnout consideration is payable to Phillips in cash or, at the Company’s election,
in up to 486,145 shares of the Company’s common stock upon the achievement of certain performance thresholds relating to net revenue
attributable to sales of Scendia products during the two-year period following the closing. The Company made the first earnout payment
of approximately $693,000 in cash in August 2023.
In
February 2023, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”)
with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which the Company could offer and sell from time
to time, to or through Cantor, shares of the Company’s common stock having an aggregate offering price of up to $75,000,000.
Sales
of the shares were made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under
the Securities Act of 1933, as amended. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement,
Cantor agreed to use commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal
law, rules and regulations and the rules of The Nasdaq Capital Market to sell the shares from time to time based upon the Company’s
instructions, including any price, time period or size limits specified by the Company. The Company had no obligation to sell any of
the shares under the Sales Agreement and could suspend or terminate the offering of its common stock pursuant to the Sales Agreement
upon notice to Cantor and subject to other conditions. Cantor’s obligations to sell the shares under the Sales Agreement were subject
to satisfaction of certain conditions, including customary closing conditions. Pursuant to the Sales Agreement, the Company paid Cantor
a commission of 3.0% of the aggregate gross proceeds from each sale of the shares.
In
2023, the Company sold an aggregate of 26,143 shares of common stock for gross proceeds of approximately $1.1 million and net proceeds
of approximately $0.9 million pursuant to the Sales Agreement. The Company paused the offering at the end of the first quarter of 2023
and did not reactivate it during the remainder of 2023. The Form S-3 registration statement for this offering expired at the beginning
of 2024.
On
August 1, 2023, the Company closed the Applied Asset Purchase. Included in the purchase price was 73,809 shares of the Company’s
common stock. See Note 3 for more information regarding the acquisition of Applied.
On
June 12, 2024, the Company’s shareholders approved the 2024 Omnibus Long-Term Incentive Plan (the “2024 LTIP”), which
went into effect upon shareholder approval. The maximum number of shares of the Company’s common stock that may be delivered pursuant
to awards granted under the 2024 LTIP is 1,000,000, subject to increase by any awards under the 2014 LTIP (i) that were outstanding on
or after June 12, 2024, and that, on or after such date, are forfeited, expire or are canceled, and (ii) any shares subject to awards
relating to common stock under the 2014 LTIP that are settled in cash on or after June 12, 2024 (the “Prior LTIP Awards”).
The 2024 LTIP also provides that, to the extent an award under the 2024 LTIP or a Prior LTIP Award is forfeited, expires or is canceled,
in whole or in part, the shares subject to such forfeited, expired or canceled award may again be awarded under the 2024 LTIP.
Restricted
Stock Awards
During
the six months ended June 30, 2024, the Company issued restricted stock awards under the 2014 LTIP which are subject to certain vesting
provisions and other terms and conditions set forth in each recipient’s respective restricted stock agreement. The Company granted
and issued 167,956 shares, net of forfeitures, of restricted common stock to employees, directors, and certain advisors of the Company
under the 2014 LTIP during the six months ended June 30, 2024. The fair value of these awards was $5,894,731 based on the closing price
of the Company’s common stock on the respective grant dates, which will be recognized as compensation expense on a straight-line
basis over the vesting period of the awards.
Share-based
compensation expense of $1,411,545 and $1,127,332 was recognized in “Selling, general and administrative expenses” and “Research
and development” in the accompanying Consolidated Statements of Operations during the three months ended June 30, 2024 and 2023,
respectively. Share-based compensation expense of $2,214,930 and $1,724,637 was recognized in “Selling, general and administrative
expenses” and “Research and development” in the accompanying Consolidated Statements of Operations during the six months
ended June 30, 2024 and 2023, respectively.
At
June 30, 2024, there was $6,557,465 of total unrecognized share-based compensation expense related to unvested share-based equity awards.
Unrecognized share-based compensation expense is expected to be recognized over a weighted-average period of 1 year.
Below
is a summary of restricted stock activity for the six months ended June 30, 2024:
SCHEDULE
OF RESTRICTED STOCK ACTIVITY
| |
For the Six Months Ended | |
| |
June 30, 2024 | |
| |
| | |
Weighted Average | |
| |
Shares | | |
Grant Date Fair Value | |
Nonvested at beginning of period | |
| 144,211 | | |
$ | 34.07 | |
Granted | |
| 190,240 | | |
| 35.03 | |
Vested | |
| (81,890 | ) | |
| 33.19 | |
Forfeited | |
| (22,284 | ) | |
| 34.53 | |
Nonvested at June 30, 2024 | |
| 230,277 | | |
$ | 35.13 | |
Stock
Options
A
summary of the status of outstanding stock options at June 30, 2024 and changes during the six months then ended is presented below:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
For the Six Months Ended | | |
| |
| |
June 30, 2024 | | |
| |
| |
| | |
Weighted Average | | |
Weighted Average | | |
Aggregate | |
| |
| | |
Exercise | | |
Remaining | | |
Intrinsic | |
| |
Options | | |
Price | | |
Contract Life | | |
Value | |
Outstanding at beginning of period | |
| 93,892 | | |
$ | 10.22 | | |
| | | |
| | |
Granted or assumed | |
| - | | |
| - | | |
| | | |
| | |
Exercised | |
| (62,879 | ) | |
| 10.05 | | |
| | | |
| | |
Forfeited | |
| - | | |
| - | | |
| | | |
| | |
Expired | |
| - | | |
| - | | |
| | | |
| | |
Outstanding at June 30, 2024 | |
| 31,013 | | |
$ | 10.57 | | |
| 6.3 | | |
$ | 547,530.6 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 31,013 | | |
$ | 10.57 | | |
| 6.3 | | |
$ | 547,530.6 | |
Warrants
A
summary of the status of outstanding warrants to purchase common stock at June 30, 2024 and changes during the six months then ended
is presented below:
SCHEDULE OF WARRANTS TO PURCHASE COMMON STOCK
| |
For the Six Months Ended | |
| |
June 30, 2024 | |
| |
| | |
Weighted Average | | |
Weighted Average | |
| |
| | |
Exercise | | |
Remaining | |
| |
Warrants | | |
Price | | |
Contract Life | |
Outstanding at beginning of period | |
| 16,725 | | |
$ | 10.80 | | |
| | |
Granted or assumed | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| | |
Forfeited | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| | |
Outstanding at June 30, 2024 | |
| 16,725 | | |
$ | 10.80 | | |
| 6.3 | |
| |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 16,725 | | |
$ | 10.80 | | |
| 6.3 | |
NOTE
10 – RELATED PARTIES
CellerateRX
Sublicense Agreement
The
Company has an exclusive, world-wide sublicense to distribute certain hydrolyzed collagen products, including CellerateRX Surgical into
the surgical and wound care markets from an affiliate of The Catalyst Group, Inc. (“Catalyst”), CGI Cellerate RX, which licensed
the rights to these products from Applied. Sales of CellerateRX Surgical have comprised the substantial majority of the Company’s
sales during the six months ended June 30, 2024 and 2023. As amended in January 2021, the term of the Sublicense Agreement was extended
through May 2050, with automatic successive one-year renewals so long as annual net sales of the licensed products exceed $1,000,000.
As
discussed further in Note 3, on August 1, 2023, the Company purchased certain assets from Applied, including the underlying intellectual
property of, as well as the rights to manufacture and sell certain hydrolyzed collagen products, including CellerateRX Surgical. In connection
with the Applied Asset Purchase, Applied assigned its license agreement with CGI Cellerate RX to SMAT. Ronald T. Nixon, the Company’s
Chief Executive Officer and Executive Chairman, is the founder and managing partner of Catalyst.
Product
License Agreements
In
July 2019, the Company executed a license agreement with Rochal, a related party, whereby the Company acquired an exclusive world-wide
license to market, sell and further develop antimicrobial products for the prevention and treatment of microbes on the human body utilizing
certain Rochal patents and pending patent applications. Currently, the products covered by the BIAKŌS License Agreement are BIAKŌS
Antimicrobial Wound Gel and BIAKŌS Antimicrobial Skin and Wound Cleanser. Both products are 510(k) cleared. Mr. Nixon is a director
of Rochal, and indirectly a significant shareholder of Rochal, and through the potential exercise of warrants, a majority shareholder
of Rochal. Another one of the Company’s directors is also a director and significant shareholder of Rochal.
In
October 2019, the Company executed the ABF License Agreement with Rochal whereby the Company acquired an exclusive world-wide license
to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care
market utilizing certain Rochal patents and pending patent applications. Currently, the products covered by the ABF License Agreement
are CuraShield Antimicrobial Barrier Film and a no sting skin protectant product.
In
May 2020, the Company executed a product license agreement with Rochal, whereby the Company acquired an exclusive world-wide license
to market, sell and further develop a debrider for human medical use to enhance skin condition or treat or relieve skin disorders, excluding
uses primarily for beauty, cosmetic, or toiletry purposes.
See
Note 8 for more information on these product license agreements.
Consulting
Agreement
Concurrent
with the Rochal asset purchase, in July 2021, the Company entered into a consulting agreement with Ann Beal Salamone pursuant to which
Ms. Salamone agreed to provide the Company with consulting services with respect to, among other things, writing new patents, conducting
patent intelligence, and participating in certain grant and contract reporting. In consideration for the consulting services to be provided
to the Company, Ms. Salamone is entitled to receive an annual consulting fee of $177,697, with payments to be paid once per month. The
consulting agreement has an initial term of three years, unless earlier terminated by the Company, and is subject to renewal. Effective
July 13, 2024, the consulting agreement with Ms. Salamone was amended to provide that the initial term shall be automatically renewed
for successive one-year terms for up to three successive years unless earlier terminated by either party without cause at any time, provided
that the terminating party provides 90 days’ advance written notice of termination. Ms. Salamone is a director of the Company and
is a significant shareholder and the current Chair of the board of directors of Rochal.
Catalyst
Transaction Advisory Services Agreement
In
March 2023, the Company entered into a Transaction Advisory Services Agreement (the “Catalyst Services Agreement”) effective
March 1, 2023 with Catalyst, a related party. Pursuant to the Catalyst Services Agreement, Catalyst, by and through its directors, officers,
employees and affiliates that are not simultaneously serving as directors, officers or employees of the Company (collectively, the “Covered
Persons”), agreed to perform certain transaction advisory, business and organizational strategy, finance, marketing, operational
and strategic planning, relationship access and corporate development services for the Company in connection with any merger, acquisition,
recapitalization, divestiture, financing, refinancing, or other similar transaction in which the Company may be, or may consider becoming,
involved, and any such additional services as mutually agreed upon in writing by and between Catalyst and the Company (the “Catalyst
Services”).
Pursuant
to the Catalyst Services Agreement, the Company agreed to reimburse Catalyst for (i) compensation actually paid by Catalyst to any of
the Covered Persons at a rate no more than a rate consistent with industry practice for the performance of services similar to the Catalyst
Services, as documented in reasonably sufficient detail, and (ii) all reasonable out-of-pocket costs and expenses payable to unaffiliated
third parties, as documented in customary expense reports, as each of (i) and (ii) is incurred in connection with the Catalyst Services
rendered under the Catalyst Services Agreement, with all reimbursements being contingent upon the prior approval of the Audit Committee
of the Company’s Board of Directors. The Company incurred costs pursuant to the Catalyst Services Agreement of $57,000 and $72,986
in the three months ended June 30, 2024 and 2023, respectively, and $113,272 and $72,986 in the six months ended June 30, 2024 and 2023,
respectively and is recorded in “Selling, general and administrative expenses” in the accompanying Consolidated Statements
of Operations.
NOTE
11 – SEGMENT REPORTING
As
discussed in Note 1, the Company historically managed its business on the basis of one
operating and reportable segment. During the second quarter of 2024, the Company changed its reportable segments to better align its
organization based upon the Company’s management structure, products and services offered and markets served. Based on the
growing importance of the value-based wound care program to the Company’s future outlook and how the Company’s chief
operating decision maker (“CODM”), the Chief Executive Officer, reviews operating results and makes decisions about resource allocation, the
Company now has two
reportable segments: Sanara Surgical and THP.
Segment
EBITDA is the primary profitability measure used by the CODM for purposes of assessing financial performance and resource allocation.
The Company defines Segment EBITDA for the reportable segments as net income (loss) excluding interest expense/income, provision/benefit
for income taxes, depreciation and amortization, non-cash share-based compensation expense, change in fair value of earnout liabilities,
executive separation costs, legal and diligence expenses related to acquisitions, and gains/losses on the disposal of property and equipment,
as each are applicable to the periods presented. Segment EBITDA, as it relates to the Company’s reportable segments, is presented
in conformity with ASC 280, Segment Reporting, and is excluded from the definition of non-GAAP financial measures under the Securities
and Exchange Commission’s Regulation G and Item 10(e) of Regulation S-K. Segment EBITDA may not be comparable to similarly titled
measures reported by other companies.
Sanara
Surgical
The
Sanara Surgical segment primarily markets and sells soft tissue repair and bone fusion products for use in the operating room or other
sterile environments. Sanara Surgical’s soft tissue repair products include, among other products, the Company’s lead product, CellerateRX Surgical, and BIASURGE Advanced Surgical Solution, which is a no-rinse, advanced
surgical solution used for wound irrigation. Sanara Surgical’s bone fusion products include, among other products, BiFORM, which
is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site, and ALLOCYTE Plus, which is a human
allograft cellular bone matrix containing bone-derived progenitor cells and conformable bone fibers.
Sanara
Surgical also includes an in-house research and development team (Rochal Technologies) with an extensive pipeline of innovative products
under development.
Tissue
Health Plus
The
THP segment is focused on value-based wound care services. Through THP, the Company plans to offer a first of its kind value-based
wound care program to payers and risk-bearing entities such as accountable care organizations and VBC primary care companies, with Medicare Advantage payers as the initial target market for this program.
THP’s
programs are expected to enable payers to divest wound care spend risk, reduce wound related hospitalizations and improve patient quality
of life. THP plans to coordinate delivery of community and home-based wound care for its managed patients. Community based care spans
a variety of settings including physician offices, skilled nursing facilities, assisted living facilities and senior living facilities. THP
programs are intended to integrate science and evidence-based medicine protocols to standardize wound prevention and treatment.
Currently,
there are no allocated costs included in the THP segment. All corporate and overhead expenses are included in the Sanara Surgical
segment, as substantially all of those costs relate to supporting the operations and activities of the Sanara Surgical segment.
As
a result of the change in reportable segments, certain prior period amounts have been recast to conform to the current period presentation.
Throughout this Quarterly Report on Form 10-Q, unless otherwise indicated, amounts and activity reflect reclassifications related to
the Company’s change in reportable segments. The change in reportable segments had no impact on the Company’s Consolidated
Balance Sheets, Statements of Operations, Cash Flows and Shareholders’ Equity
previously reported.
The
following tables reflect results of operations, Segment EBITDA, segmented assets, and expenditures for long-lived assets for our
reportable segments for the periods indicated below:
SCHEDULE
OF OPERATIONS, ASSETS AND CAPITAL EXPENDITURES FOR OUR BUSINESS SEGMENTS
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Three Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 20,158,823 | | |
$ | - | | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | - | | |
$ | 15,753,164 | |
Gross profit | |
| 18,150,137 | | |
| - | | |
| 18,150,137 | | |
| 13,565,648 | | |
| - | | |
| 13,565,648 | |
Selling, general and administrative
expenses | |
| 18,349,924 | | |
| 607,684 | | |
| 18,957,608 | | |
| 13,301,230 | | |
| 510,246 | | |
| 13,811,476 | |
Research and development | |
| 582,443 | | |
| 403,208 | | |
| 985,651 | | |
| 208,727 | | |
| 968,401 | | |
| 1,177,128 | |
Depreciation and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Interest expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Net income (loss) | |
| (2,214,313 | ) | |
| (1,314,889 | ) | |
| (3,529,202 | ) | |
| 95,098 | | |
| (1,961,278 | ) | |
| (1,866,180 | ) |
Segment EBITDA | |
| 1,393,959 | | |
| (801,778 | ) | |
| 592,181 | | |
| 1,120,207 | | |
| (1,415,831 | ) | |
| (295,624 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Segment
assets (at period end) (1) | |
$ | 51,469,137 | | |
$ | 21,914,468 | | |
$ | 73,383,605 | | |
$ | 51,147,589 | | |
$ | 22,723,560 | | |
$ | 73,871,149 | |
Expenditures for long-lived
assets | |
$ | 58,762 | | |
$ | - | | |
$ | 58,762 | | |
$ | 12,945 | | |
$ | - | | |
$ | 12,945 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Six Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 38,695,461 | | |
$ | - | | |
$ | 38,695,461 | | |
$ | 31,272,351 | | |
$ | 2,730 | | |
$ | 31,275,081 | |
Gross profit | |
| 34,796,729 | | |
| - | | |
| 34,796,729 | | |
| 26,968,141 | | |
| (6,235 | ) | |
| 26,961,906 | |
Selling, general and administrative
expenses | |
| 34,032,964 | | |
| 1,116,903 | | |
| 35,149,867 | | |
| 25,768,626 | | |
| 1,011,919 | | |
| 26,780,545 | |
Research and development | |
| 1,161,424 | | |
| 770,525 | | |
| 1,931,949 | | |
| 443,963 | | |
| 2,050,489 | | |
| 2,494,452 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Net income (loss) | |
| (2,691,798 | ) | |
| (2,636,447 | ) | |
| (5,328,245 | ) | |
| 614,061 | | |
| (3,696,570 | ) | |
| (3,082,509 | ) |
Segment EBITDA | |
| 2,532,145 | | |
| (1,628,543 | ) | |
| 903,602 | | |
| 2,365,280 | | |
| (2,953,734 | ) | |
| (588,454 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Segment assets (at period
end) (1) | |
$ | 51,469,137 | | |
$ | 21,914,468 | | |
$ | 73,383,605 | | |
$ | 51,147,589 | | |
$ | 22,723,560 | | |
$ | 73,871,149 | |
Expenditures for long-lived
assets | |
$ | 124,580 | | |
$ | - | | |
$ | 124,580 | | |
$ | 40,650 | | |
$ | - | | |
$ | 40,650 | |
The
following tables provide a reconciliation of net income (loss) to Segment EBITDA for our reportable segments for the periods indicated
below:
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
Three
Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,214,313 | ) | |
$ | (1,314,889 | ) | |
$ | (3,529,202 | ) | |
$ | 95,098 | | |
$ | (1,961,278 | ) | |
$ | (1,866,180 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest
expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Depreciation
and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Noncash
share-based compensation | |
| 1,046,321 | | |
| 36,429 | | |
| 1,082,750 | | |
| 1,064,516 | | |
| 62,816 | | |
| 1,127,332 | |
Change
in fair value of earnout liabilities | |
| 89,330 | | |
| (103,103 | ) | |
| (13,773 | ) | |
| (436,004 | ) | |
| 75,534 | | |
| (360,470 | ) |
Executive
separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition
costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment
EBITDA | |
$ | 1,393,959 | | |
$ | (801,778 | ) | |
$ | 592,181 | | |
$ | 1,120,207 | | |
$ | (1,415,831 | ) | |
$ | (295,624 | ) |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,691,798 | ) | |
$ | (2,636,447 | ) | |
$ | (5,328,245 | ) | |
$ | 614,061 | | |
$ | (3,696,570 | ) | |
$ | (3,082,509 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Noncash share-based compensation | |
| 1,799,936 | | |
| 86,200 | | |
| 1,886,136 | | |
| 1,609,729 | | |
| 114,908 | | |
| 1,724,637 | |
Change in fair value of earnout liabilities | |
| (14,451 | ) | |
| (65,000 | ) | |
| (79,451 | ) | |
| (627,132 | ) | |
| (186,025 | ) | |
| (813,157 | ) |
Executive separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment EBITDA | |
$ | 2,532,145 | | |
$ | (1,628,543 | ) | |
$ | 903,602 | | |
$ | 2,365,280 | | |
$ | (2,953,734 | ) | |
$ | (588,454 | ) |
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of the financial condition and results of operations of Sanara MedTech Inc. (together with its wholly
owned or majority-owned subsidiaries on a consolidated basis, the “Company,” “Sanara MedTech,” “Sanara,”
“our,” “us,” or “we”) should be read in conjunction with the “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” section and audited consolidated financial statements and related
notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023 and with the unaudited consolidated financial
statements and related notes thereto presented in this Quarterly Report on Form 10-Q.
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws. Forward-looking
statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking
statements because they contain words such as “aims,” “anticipates,” “believes,” “contemplates,”
“continue,” “could,” “estimates,” “expects,” “forecast,” “guidance,”
“intends,” “may,” “plans,” “possible,” “potential,” “predicts,”
“preliminary,” “projects,” “seeks,” “should,” “target,” “will”
or “would” or the negative of these words, variations of these words or other similar terms or expressions that concern our
expectations, strategy, plans, or intentions. Such forward-looking statements are subject to certain risks, uncertainties and assumptions
relating to factors that could cause actual results to differ materially from those anticipated in such statements, including, without
limitation, the following:
● |
shortfalls
in forecasted revenue growth; |
|
|
● |
our
ability to implement our comprehensive wound and skincare strategy through acquisitions and investments and our ability to realize
the anticipated benefits of such acquisitions and investments; |
|
|
● |
our
ability to meet our future capital requirements; |
|
|
● |
our
ability to retain and recruit key personnel; |
|
|
● |
the
intense competition in the markets in which we operate and our ability to compete within our markets; |
|
|
● |
the
failure of our products to obtain market acceptance; |
|
|
● |
the
effect of security breaches and other disruptions; |
|
|
● |
our
ability to maintain effective internal controls over financial reporting; |
|
|
● |
our
ability to develop and commercialize new products and products under development, including the manufacturing, distribution, marketing
and sale of such products; |
|
|
● |
our
ability to maintain and further grow clinical acceptance and adoption of our products; |
|
|
● |
the
impact of competitors inventing products that are superior to ours; |
|
|
● |
disruptions
of, or changes in, our distribution model, consumer base or the supply of our products; |
|
|
● |
our
ability to manage product inventory in an effective and efficient manner; |
|
|
● |
the
failure of third-party assessments to demonstrate desired outcomes in proposed endpoints; |
|
|
● |
our
ability to successfully expand into wound and skincare virtual consult and other services; |
|
|
● |
our
ability and the ability of our research and development partners to protect the proprietary rights to technologies used in certain
of our products and the impact of any claim that we have infringed on intellectual property rights of others; |
● |
our
dependence on technologies and products that we license from third parties; |
|
|
● |
the
effects of current and future laws, rules, regulations and reimbursement policies relating to the labelling, marketing and sale of
our products and our planned expansion into wound and skincare virtual consult and other services and our ability to comply with
the various laws, rules and regulations applicable to our business; and |
|
|
● |
the
effect of defects, failures or quality issues associated with our products. |
For
a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ
materially from those anticipated in forward-looking statements, see “Risk Factors” in Part I, Item 1A of our Annual Report
on Form 10-K for the year ended December 31, 2023, Part II, Item 1A “Risk Factors” and elsewhere in this Quarterly Report
on Form 10-Q. Forward-looking statements speak only as of the date on which they are made, and the Company does not assume any obligation
to update these forward-looking statements, except to the extent required by applicable securities laws.
OVERVIEW
We
are a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and
reduce healthcare expenditures in the surgical, chronic wound and skincare markets. Our products, services and technologies are designed
to achieve our goal of providing better clinical outcomes at a lower overall cost for patients regardless of where they receive care.
We strive to be one of the most innovative and comprehensive providers of effective surgical, wound and skincare solutions and are continually
seeking to expand our offerings for patients requiring treatments across the entire continuum of care in the United States.
We
currently market several products across surgical and chronic wound care applications and have multiple products in our pipeline. On
August 1, 2023, we acquired, among other things, the underlying intellectual property of, as well as the rights to manufacture and sell,
CellerateRX Surgical Activated Collagen (“CellerateRX Surgical”), our primary product, from Applied Nutritionals, LLC (“Applied”)
for human wound care use (for more information regarding this acquisition, see the “Recent Acquisitions” section below).
Prior to such time, we had licensed the rights to these products through a sublicense agreement (the “Sublicense Agreement”)
with CGI Cellerate RX, LLC (“CGI Cellerate RX”), an affiliate of The Catalyst Group, Inc. (“Catalyst”), both
of which are related parties (for additional information regarding related parties, see the section titled “Material Transactions
with Related Parties” below). In connection with the asset purchase, Applied assigned its license agreement with CGI Cellerate
RX to a wholly owned subsidiary of the Company. We also license certain products from Rochal Industries, LLC (“Rochal”) and
Cook Biotech Inc.
In
April 2022, we entered into a merger agreement through which Precision Healing Inc. (“Precision Healing”) became a wholly
owned subsidiary of the Company. Precision Healing is developing a diagnostic imager and lateral flow assay (“LFA”) for assessing
a patient’s wound and skin conditions. This comprehensive wound and skin assessment technology is designed to quantify biochemical
markers to determine the trajectory of a wound’s condition to enable better diagnosis and treatment protocol. In December 2023,
we received 510(k) clearance from the U.S. Food and Drug Administration for the Precision Healing diagnostic imager. We are currently
evaluating regulatory pathways for the Precision Healing LFA.
In
July 2022, we entered into a membership interest purchase agreement with Scendia Biologics, LLC (“Scendia”) and Ryan Phillips
(“Phillips”) pursuant to which we acquired 100% of the issued and outstanding membership interests in Scendia from Phillips.
Since our acquisition of Scendia, we have been selling a full line of regenerative and orthobiologic technologies including (i) TEXAGEN
Amniotic Membrane Allograft (“TEXAGEN”), (ii) BiFORM Bioactive Moldable Matrix (“BiFORM”), (iii) ACTIGEN Verified
Inductive Bone Matrix (“ACTIGEN”) and (iv) ALLOCYTE Plus Advanced Cellular Bone Matrix (“ALLOCYTE Plus”).
In
November 2022, we established a partnership with InfuSystem Holdings, Inc. (“InfuSystem”) focused on delivering a complete
wound care solution targeted at improving patient outcomes, lowering the cost of care, and increasing patient and provider satisfaction.
The partnership is expected to enable InfuSystem to offer innovative products, including our advanced wound care product line and associated
services to new customers.
In
November 2023, we launched BIASURGE Advanced Surgical Solution (“BIASURGE”). BIASURGE is a no-rinse, advanced surgical solution
used for wound irrigation. It contains an antimicrobial preservative effective against a broad spectrum of pathogenic microorganisms.
BIASURGE is indicated for use in the mechanical cleansing and removal of debris, including microorganisms, from surgical wounds.
COMPREHENSIVE
VALUE-BASED CARE STRATEGY
In
June 2020, we formed a subsidiary, United Wound and Skin Solutions, LLC (formerly known as “WounDerm”), to hold certain investments
and operations in wound and skincare virtual consult services. In 2023, WounDerm was renamed and is now doing business as “Tissue
Health Plus” (“THP”). THP is continuing its current mission to simplify skin health, starting with wound care through
a refined business plan. Through THP, we plan to offer a first of its kind value-based wound care program to payers and risk-bearing
entities such as accountable care organizations and value-based care (“VBC”) primary care companies, with Medicare Advantage
payers as the initial target market for this program.
THP’s
programs are expected to enable payers to divest wound care spend risk, reduce wound related hospitalizations and improve patient quality
of life. THP plans to coordinate delivery of community and home-based wound care for its managed patients. Community based care spans
a variety of settings including physician offices, skilled nursing homes, assisted living facilities and senior living facilities. THP
programs are intended to integrate science and evidence-based medicine protocols to standardize wound prevention and treatment.
We
anticipate that THP’s customer contracts will have three-to-five-year terms. These contracts are expected to incorporate a mix
of value-based pricing methodologies including episodic, “per member per month”, and “fee for value” pricing.
We believe this approach is aligned with the financial goals of the payers and will help deliver outstanding clinical outcomes for the
patients.
Our
vision for our comprehensive approach consists of three key sets of planned capabilities:
|
(a) |
Care
Hub – This virtual patient monitoring, care coordination and navigation center is expected to help doctors and nurses support
their patients throughout their wound care journey, from prevention to treatment. We expect to have Care Hub staffed by wound care
certified nurse practitioners (“NPs”) and registered nurses (“RNs”), incorporating care delivery best practices
from partnerships with Direct Dermatology Inc. and certain physician-led multispecialty wound care groups. With NPs leading the care
hub, RNs are expected to be the wound specialists, providing patients with expert review and support of the overarching plan of care
on each patient’s journey through the process. In addition, care navigators are expected to serve as a primary point of contact
for patients and their providers, coordinating care, managing appointments and ensuring seamless communication among all team members. |
|
|
|
|
(b) |
Managed
Services Organization (“MSO”) Network – With respect to patient-side wound care, our plan is that THP’s
programs would be performed by a network of third-party providers who will be contracted through managed services agreements. These
providers would include podiatrists, wound care provider groups, primary care physicians and home health agencies. The providers
in the THP network are expected to leverage THP’s standard of care, patient education and tools to deliver optimal patient
outcomes with high predictability and efficiency. |
|
|
|
|
(c) |
Technology
Platform – THP’s technology platform will focus on scaling workflows of THP’s Care Hub and MSO Network through
automation and integration. We expect the THP technology platform to enable enhanced patient empowerment and self-healthcare. We
anticipate that our platform will leverage our technology investments and partnerships with Precision Healing, Pixalere Healthcare,
Inc. (“Pixalere”) and others, by leveraging modern technology including artificial intelligence and machine learning.
Our platform technology is expected to manage program economics, standards of care, patient monitoring, wound assessments, network
performance monitoring, and revenue cycle management. We expect that each of these components will work in concert with each other,
constantly improving economics and care delivery. |
We
are seeking partners to facilitate commercialization of THP and share in the cost of development of the program.
CHANGE
IN REPORTABLE SEGMENTS
Historically,
we managed our business on the basis of one operating and reportable segment. During the second quarter of 2024, we changed our reportable
segments to reflect a change in the manner in which the business is managed. Based on the growing importance of the value-based wound
care program to our future outlook and how our chief operating decision maker (“CODM”), the Chief Executive Officer,
reviews operating results and makes decisions about resource allocation, we now have two reportable segments: Sanara Surgical
and THP.
Sanara
Surgical
The
Sanara Surgical segment primarily markets and sells soft tissue repair and bone fusion products for use in the operating room or
other sterile environments. Sanara Surgical’s soft tissue repair products include, among other products, our
lead product, CellerateRX Surgical, and BIASURGE Advanced Surgical Solution, which
is a no-rinse, advanced surgical solution used for wound irrigation. Sanara Surgical’s bone fusion products include, among
other products, BiFORM, which is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site,
and ALLOCYTE Plus, which is a human allograft cellular bone matrix containing bone-derived progenitor cells and conformable bone
fibers.
Sanara
Surgical also includes an in-house research and development team (Rochal Technologies) with an extensive pipeline of innovative products
under development.
Tissue
Health Plus
The THP
segment is focused on value-based wound care services. Through THP, we plan to offer a first of its kind value-based wound care
program to payers and risk-bearing entities such as accountable care organizations and VBC primary
care companies, with Medicare Advantage payers as the initial target market for this program.
THP’s
programs are expected to enable payers to divest wound care spend risk, reduce wound related hospitalizations and improve patient quality
of life. THP plans to coordinate delivery of community and home-based wound care for its managed patients. Community based care spans
a variety of settings including physician offices, skilled nursing facilities, assisted living facilities and senior living facilities. THP
programs are intended to integrate science and evidence-based medicine protocols to standardize wound prevention and treatment.
See
the section titled “Results of Operations” below for more information regarding our reportable segments. As a result of this
change, certain prior period amounts have been recast to conform to the current period presentation. Throughout this Quarterly Report
on Form 10-Q, unless otherwise indicated, amounts and activity reflect reclassifications related to our change in reportable segments.
RECENT
ACQUISITIONS
Applied
Asset Purchase
On
August 1, 2023, we entered into an Asset Purchase Agreement (the “Applied Purchase Agreement”) by and among the Company,
as guarantor, Sanara MedTech Applied Technologies, LLC, a wholly owned subsidiary of the Company (“SMAT”), Applied, The Hymed
Group Corporation (“Hymed” and together with Applied, the “Sellers”), and Dr. George D. Petito (the “Owner”),
pursuant to which SMAT acquired certain assets of the Sellers and the Owner, including, among others, the Sellers’ and Owner’s
inventory, intellectual property, manufacturing and related equipment, goodwill, rights and claims, other than certain excluded assets,
all as more specifically set forth in the Applied Purchase Agreement (collectively, the “Applied Purchased Assets”), and
assumed certain Assumed Liabilities (as defined in the Applied Purchase Agreement), upon the terms and subject to the conditions set
forth in the Applied Purchase Agreement (such transaction, the “Applied Asset Purchase”). The Applied Purchased Assets include
the underlying intellectual property of, as well as the rights to manufacture and sell, certain hydrolyzed collagen products, including
CellerateRX Surgical, for human wound care use.
The
Applied Purchased Assets were purchased for an initial aggregate purchase price of $15.25 million, consisting of (i) $9.75 million in
cash (the “Cash Closing Consideration”), (ii) 73,809 shares of our common stock (the “Stock Closing Consideration”)
with an agreed upon value of $3.0 million and (iii) $2.5 million in cash (the “Installment Payments”), to be paid in four
equal installments on each of the next four anniversaries of the closing of the Applied Asset Purchase (the “Closing”).
In
addition to the Cash Closing Consideration, Stock Closing Consideration and Installment Payments, the Applied Purchase Agreement provides
that the Sellers are entitled to receive up to an additional $10.0 million (the “Applied Earnout”), which is payable to the
Sellers in cash, upon the achievement of certain performance thresholds relating to SMAT’s collections from net sales of a collagen-based
product currently under development. Upon expiration of the seventh anniversary of the Closing, to the extent the Sellers have not earned
the entirety of the Applied Earnout, SMAT shall pay the Sellers a pro-rata amount of the Applied Earnout based on collections from net
sales of the product, with such amount to be due credited against any Applied Earnout payments already made by SMAT (the “True-Up
Payment”). The Applied Earnout, minus the True-Up Payment and any Applied Earnout payments already made by SMAT, may be earned
at any point in the future, including after the True-Up Payment is made.
In
connection with the Applied Asset Purchase and pursuant to the Applied Purchase Agreement, effective August 1, 2023, we entered into
a professional services agreement (the “Petito Services Agreement”) with the Owner, pursuant to which the Owner, as an independent
contractor, agreed to provide certain services to us, including, among other things, assisting with the development of products already
in development and assisting with research, development, formulation, invention and manufacturing of any future products (the “Petito
Services”). As consideration for the Petito Services, the Owner is entitled to receive: (i) a base salary of $12,000 per month
during the term of the Petito Services Agreement, (ii) a royalty payment equal to three percent (3%) of the actual collections from net
sales of certain products the Owner develops or co-develops that reach commercialization, (iii) a royalty payment equal to five percent
(5%) for the first $50.0 million in aggregate collections from net sales of certain future products and a royalty payment of two and
one-half percent (2.5%) on aggregate collections from net sales of certain future products on any amounts exceeding $50.0 million but
up to $100.0 million, (iv) $500,000 in cash in the event that 510(k) clearance is issued for any future product accepted by the Company
and (v) $1.0 million in cash in the event that a U.S. patent is issued for a certain product; provided that with respect to the incentive
payments described in (iv) and (v) of the foregoing, the Owner shall not earn more than $2.5 million. The Petito Services Agreement has
an initial term of three years and is subject to automatic successive one-month renewals unless earlier terminated in accordance with
its terms. The Petito Services Agreement may be terminated upon the Owner’s death or disability or by us or the Owner “For
Cause” (as defined in the Petito Services Agreement); provided, however, that the base salary described in (i) of the foregoing
paragraph shall survive termination through the three-year initial term and the royalty payments and incentive payments described in
(ii)-(v) of the foregoing paragraph shall survive termination of the Petito Services Agreement.
RECENT
DEVELOPMENTS
Cadence
Loan Agreement
In
connection with the entry into the Applied Purchase Agreement, on August 1, 2023, we, as guarantor, and SMAT, as borrower, entered into
a loan agreement (the “Cadence Loan Agreement”) with Cadence Bank (the “Bank”) which provided for, among other
things, an advancing term loan in the aggregate principal amount of $12.0 million (the “Cadence Term Loan”). Pursuant to
the Cadence Loan Agreement, the Bank agreed to make, at any time and from time to time prior to February 1, 2024, one or more advances
to SMAT. On August 1, 2023, the Bank made an advance under the Cadence Term Loan for $9.75 million, the proceeds of which were used to
fund the Cash Closing Consideration for the Applied Asset Purchase. As described in further detail below, on April 17, 2024, the Cadence
Loan Agreement with the Bank was terminated and all outstanding amounts under the Cadence Term Loan were repaid in full and all security
interest and other liens granted to or held by the Bank were terminated and released. For more information regarding the Cadence Loan
Agreement, see the “Liquidity and Capital Resources” section below.
CRG
Term Loan
On
April 17, 2024 (the “Closing Date”), we, as borrower, entered into a Term Loan Agreement (the “CRG Term Loan Agreement”)
with the subsidiary guarantors party thereto from time to time (collectively, the “Guarantors”), CRG Servicing LLC as administrative
agent and collateral agent (the “Agent”), and the lenders party thereto from time to time, providing for a senior secured
term loan of up to $55.0 million (the “CRG Term Loan”). A portion of the proceeds of the CRG Term Loan were used to repay
the Cadence Term Loan and to pay fees and expenses related to the CRG Term Loan Agreement. The remaining proceeds shall be used for certain
permitted acquisitions and similar investments and for general working capital and corporate purposes. For more information regarding
the CRG Term Loan, see the “Liquidity and Capital Resources” section below.
COMPONENTS
OF RESULTS OF OPERATIONS
Sources
of Revenues
Our
revenue is derived primarily from sales of our soft tissue repair and bone fusion products to hospitals and other acute care facilities.
In particular, the substantial majority of our product sales revenue is derived from sales of CellerateRX Surgical. Our revenue is driven
by direct orders shipped by us to our customers, and to a lesser extent, direct sales to customers through delivery at the time of procedure
by one of our sales representatives. We generally recognize revenue when a purchase order is received from the customer and our product
is received by the customer.
Revenue
streams from product sales and royalties are summarized below for the three and six months ended June 30, 2024 and 2023.
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Soft tissue repair products | |
$ | 17,641,318 | | |
$ | 13,249,742 | | |
$ | 33,723,610 | | |
$ | 26,122,223 | |
Bone fusion products | |
| 2,516,599 | | |
| 2,453,172 | | |
| 4,970,945 | | |
| 5,052,358 | |
Royalty revenue | |
| 906 | | |
| 50,250 | | |
| 906 | | |
| 100,500 | |
Total Net Revenue | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | 38,695,461 | | |
$ | 31,275,081 | |
Cost
of Goods Sold
Cost
of goods sold consists primarily of the acquisition costs from the manufacturers of our licensed products, raw material costs for certain
components sourced directly by us, and all related royalties due as a result of the sale of our products. Our gross profit represents
total net revenue less the cost of goods sold, and gross margin represents gross profit expressed as a percentage of total revenue.
Operating
Expenses
Selling,
general and administrative (“SG&A”) expenses consist primarily of salaries, sales commissions, benefits, bonuses and
share-based compensation. SG&A also includes outside legal counsel fees, audit fees, insurance premiums, rent and other corporate
expenses. We expense all SG&A expenses as incurred.
Research
and development (“R&D”) expenses include costs related to enhancements to our currently available products and
additional investments in our product, services and technologies development pipeline. This includes personnel-related expenses,
including salaries, share-based compensation and benefits for all personnel directly engaged in R&D activities, contracted
services, materials, prototype expenses and allocated overhead, which is comprised of compensation and benefits, lease expense and
other facilities related costs. We expense R&D costs as incurred. We generally expect that R&D expenses will increase as we
continue to support product enhancements and bring new products to market.
Depreciation
and amortization expenses include depreciation of fixed assets and amortization of intangible assets that have a finite life, such as
product licenses, patents and intellectual property, customer relationships and assembled workforces.
Change
in fair value of earnout liabilities represents our measurement of the change in fair value at the balance sheet date of our earnout
liabilities that were established at the time of our Precision Healing merger and Scendia acquisition.
Other
Income (Expense)
Other
income (expense) is primarily comprised of interest expense and other nonoperating activities.
RESULTS
OF OPERATIONS
The
following tables present certain information about the results of our reportable business segments. See Note 11, Segment Reporting, in
Part I, Item 1 of this report for more information on our reportable business segments:
| |
Three Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 20,158,823 | | |
$ | - | | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | - | | |
$ | 15,753,164 | |
Gross profit | |
| 18,150,137 | | |
| - | | |
| 18,150,137 | | |
| 13,565,648 | | |
| - | | |
| 13,565,648 | |
Selling, general and administrative expenses | |
| 18,349,924 | | |
| 607,684 | | |
| 18,957,608 | | |
| 13,301,230 | | |
| 510,246 | | |
| 13,811,476 | |
Research and development | |
| 582,443 | | |
| 403,208 | | |
| 985,651 | | |
| 208,727 | | |
| 968,401 | | |
| 1,177,128 | |
Depreciation and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Interest expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Net income (loss) | |
| (2,214,313 | ) | |
| (1,314,889 | ) | |
| (3,529,202 | ) | |
| 95,098 | | |
| (1,961,278 | ) | |
| (1,866,180 | ) |
Segment EBITDA | |
| 1,393,959 | | |
| (801,778 | ) | |
| 592,181 | | |
| 1,120,207 | | |
| (1,415,831 | ) | |
| (295,624 | ) |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 38,695,461 | | |
$ | - | | |
$ | 38,695,461 | | |
$ | 31,272,351 | | |
$ | 2,730 | | |
$ | 31,275,081 | |
Gross profit | |
| 34,796,729 | | |
| - | | |
| 34,796,729 | | |
| 26,968,141 | | |
| (6,235 | ) | |
| 26,961,906 | |
Selling, general and administrative expenses | |
| 34,032,964 | | |
| 1,116,903 | | |
| 35,149,867 | | |
| 25,768,626 | | |
| 1,011,919 | | |
| 26,780,545 | |
Research and development | |
| 1,161,424 | | |
| 770,525 | | |
| 1,931,949 | | |
| 443,963 | | |
| 2,050,489 | | |
| 2,494,452 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Net income (loss) | |
| (2,691,798 | ) | |
| (2,636,447 | ) | |
| (5,328,245 | ) | |
| 614,061 | | |
| (3,696,570 | ) | |
| (3,082,509 | ) |
Segment EBITDA | |
| 2,532,145 | | |
| (1,628,543 | ) | |
| 903,602 | | |
| 2,365,280 | | |
| (2,953,734 | ) | |
| (588,454 | ) |
Net
Revenue. For the three months ended June 30, 2024, we generated net revenue of $20.2 million compared to net revenue of $15.8
million for the three months ended June 30, 2023, a 28% increase from the prior year period. For the six months ended June 30, 2024,
we generated net revenue of $38.7 million compared to net revenue of $31.3 million for the six months ended June 30, 2023, a 24% increase
from the prior year period. The higher net revenue for the three and six months ended June 30, 2024 was primarily due to increased sales
of soft tissue repair products, including CellerateRX Surgical, as a result of our increased market penetration, geographic expansion,
and our continuing strategy to expand our independent distribution network in both new and existing U.S. markets. For the three and six months ended June 30, 2023 and 2024, all of our net
revenue was generated from Sanara Surgical as THP has not commercially launched. We plan to commercially launch the THP program during
the second half of 2025.
Gross Profit. For the three months ended
June 30, 2024, we generated gross profit of $18.2 million compared to gross profit of $13.6 million for the three months ended June 30,
2023, a 34% increase from the prior year period. For the six months ended June 30, 2024, we generated gross profit of $34.8 million compared
to gross profit of $27.0 million for the six months ended June 30, 2023, a 29% increase from the prior year period. The higher gross profit
for the three and six months ended June 30, 2024 was primarily due to increased sales of soft tissue repair products, including CellerateRX
Surgical, as a result of our increased market penetration, geographic expansion, and our continuing strategy to expand our independent
distribution network in both new and existing U.S. markets. For the three and six months ended June 30, 2023 and 2024, all of our gross
profit was generated from Sanara Surgical as THP has not commercially launched. We plan to commercially launch the THP program during
the second half of 2025.
Cost
of goods sold. Cost of goods sold for the three months ended June 30, 2024 was $2.0 million compared to cost of goods sold of
$2.2 million for the three months ended June 30, 2023. Cost of goods sold for the six months ended June 30, 2024, was $3.9 million, compared
to costs of goods sold of $4.3 million for the six months ended June 30, 2023. The decrease in cost of goods sold for the three and six
months ended June 30, 2024 was primarily due to the elimination of royalties paid on the sales of CellerateRX Surgical as a result of
the Applied Asset Purchase. Gross margins were approximately 90% and 86% for the three and six months ended June 30, 2024 and 2023, respectively.
The gross margins for the three and six months ended June 30, 2024 included higher margins realized due to increased sales of soft tissue
repair products, including CellerateRX and the elimination of royalties paid on the sales of CellerateRX Surgical
as a result of the Applied Asset Purchase.
Selling,
general and administrative expenses. SG&A expenses for the three months ended June 30, 2024 were $19.0 million compared to
SG&A expenses of $13.8 million for the three months ended June 30, 2023. SG&A expenses included $0.6 million and $0.5 million
attributable to our THP segment for the three months ended June 30, 2024 and 2023, respectively. SG&A expenses for the six months
ended June 30, 2024, were $35.1 million compared to SG&A expenses of $26.8 million for the six months ended June 30, 2023. SG&A
expenses included $1.1 million and $1.0 million related to our THP segment for the six months ended June 30, 2024 and 2023, respectively.
The
higher SG&A expenses for the three and six months ended June 30, 2024 were primarily due to higher direct sales and marketing
expenses, which accounted for approximately $3.4 million and $5.6 million, respectively, of the increases compared to the prior year
periods. The higher direct sales and marketing expenses for the three and six months ended June 30, 2024 were primarily attributable
to an increase in sales commissions of $2.2 million and $3.8 million, respectively, as a result of higher product sales. SG&A
expenses during the second quarter of 2024 also included $0.9 million of executive separation costs and $0.4 million of acquisition costs.
Research
and development expenses. R&D expenses for the three months ended June 30, 2024 were $1.0 million compared to R&D expenses
of $1.2 million for the three months ended June 30, 2023. R&D expenses included $0.4 million and $1.0 million attributable to our
THP segment for the three months ended June 30, 2024 and 2023, respectively. R&D expenses for the six months ended June 30, 2024,
were $1.9 million compared to $2.5 million for the six months ended June 30, 2023. R&D expenses included $0.8 million and $2.1 million
related to our THP segment for the six months ended June 30, 2024 and 2023, respectively.
The
lower R&D expenses for the three and six months ended June 30, 2024 compared to the three and six months ended June 30, 2023 were
primarily due to lower costs associated with the Precision Healing diagnostic imager and LFA within the THP segment.
Depreciation
and amortization expense. Depreciation and amortization expense for the three months ended June 30, 2024 was $1.1 million compared
to depreciation and amortization expense of $0.8 million for the three months ended June 30, 2023. Depreciation and amortization expense
included $0.4 million attributable to our THP segment for the three months ended June 30, 2024 and 2023. Depreciation and amortization
expense for the six months ended June 30, 2024 was $2.2 million compared to $1.6 million for the six months ended June 30, 2023. Depreciation
and amortization expense included $0.8 million related to our THP segment for the six months ended June 30, 2024 and 2023.
The
increase in depreciation and amortization expense during the three and six months ended June 30, 2024 was primarily due to the amortization
of intangible assets acquired as part of the Applied Asset Purchase.
Change
in fair value of earnout liabilities. Change in fair value of earnout liabilities was a benefit of $13,773 for the three
months ended June 30, 2024 compared to a benefit of $0.4 million for the three months ended June 30, 2023. Change in fair value of
earnout liabilities was a benefit of $79,451 for the six months ended June 30, 2024 compared to a benefit of $0.8 million for the
six months ended June 30, 2023.
The
current expense is a result of an increase in the estimated fair value of the earnout liabilities established at the time of our Precision
Healing merger and Scendia acquisition. The increase in the estimated fair value was due to a decrease in the projected undiscounted
amounts to be paid, partially offset by accretion. The prior year period benefit was due to a decrease in the estimated fair value due
to a change in the discount factor utilized in the valuation models, a decrease in the projected undiscounted amounts to be paid, as
well as adjustments to the projected timing of the payments to be made, partially offset by accretion.
Other
income (expense). Other income (expense) for the three months ended June 30, 2024 was $0.6 million compared to zero for the three
months ended June 30, 2023. Other income (expense) for the three months ended June 30, 2024 included interest expense, amortization of
debt issuance costs, paid-in-kind interest, and accretion of back-end fees related to the CRG Term Loan and interest expense and the
write-off of debt issuance costs related to the termination of the Cadence Term Loan. Other income (expense) for the six months ended
June 30, 2024 was $0.9 million compared to zero for the six months ended June 30, 2023. Other income (expense) for the six months ended
June 30, 2024 included interest expense, amortization of debt issuance costs, paid-in-kind interest, and accretion of back-end fees related
to the CRG Term Loan and interest expense, amortization of debt issuance costs, and the write-off of debt issuance costs related to the
termination of the Cadence Term Loan.
Net
loss. For the three months ended June 30, 2024 we had a net loss of $3.5 million compared to a net loss of $1.9 million for the
three months ended June 30, 2023. Our net loss included $1.3 million and $2.0 million attributable to our THP segment for the three months
ended June 30, 2024 and 2023, respectively. For the six months ended June 30, 2024, we had a net loss of $5.3 million, compared to a
net loss of $3.1 million for the six months ended June 30, 2023. Our net loss included $2.6 million and $3.7 million related to our THP
segment for the six months ended June 30, 2024 and 2023, respectively. The higher net loss for the six months ended June 30, 2024 was
primarily due to higher SG&A costs, higher interest expense related to our new CRG Term Loan, a lower change in fair value of earnout
liabilities and higher amortization of our acquired intangible assets as discussed above, partially offset by higher gross profit and
lower R&D expenses.
Segment
EBITDA. Segment EBITDA is the primary profitability measure used by the CODM for
purposes of assessing financial performance and resource allocation. We define Segment EBITDA for the reportable segments as net income
(loss) excluding interest expense/income, provision/benefit for income taxes, depreciation and amortization, non-cash share-based compensation
expense, change in fair value of earnout liabilities, executive separation costs, legal and diligence expenses related to acquisitions,
and gains/losses on the disposal of property and equipment, as each are applicable to the periods presented. Segment EBITDA is a non-GAAP
measure and should be considered in addition to, not as a substitute for, net income (loss), cash flow and other measures of financial
performance reported in accordance with GAAP. We believe Segment EBITDA is useful to investors because
it facilitates comparisons of our core business operations across periods on a consistent basis. Accordingly, we adjust for certain items,
such as change in fair value of earnout liabilities, when calculating Segment EBITDA because we believe that such items are not related
to our core business operations. We do not, nor do we suggest that investors should, consider these non-GAAP financial measures in isolation
from, or as a substitute for, financial information prepared in accordance with GAAP. Material limitations associated with the use of
such measures include that they do not reflect all costs included in operating expenses and may not be comparable with similarly named
financial measures of other companies. Furthermore, these non-GAAP financial measures are based on subjective determinations of management
regarding the nature and classification of events and circumstances. We present these non-GAAP financial measures to provide investors
with information to evaluate our operating results in a manner similar to how management evaluates business performance. To compensate
for any limitations in such non-GAAP financial measures, management believes that it is useful in understanding and analyzing the results
of the business to review both GAAP information and the related non-GAAP financial measures.
The
following tables provide a reconciliation of net income (loss) to Segment EBITDA for our business segments for the periods indicated
below:
| |
Three Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,214,313 | ) | |
$ | (1,314,889 | ) | |
$ | (3,529,202 | ) | |
$ | 95,098 | | |
$ | (1,961,278 | ) | |
$ | (1,866,180 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Depreciation and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Noncash share-based compensation | |
| 1,046,321 | | |
| 36,429 | | |
| 1,082,750 | | |
| 1,064,516 | | |
| 62,816 | | |
| 1,127,332 | |
Change in fair value of earnout liabilities | |
| 89,330 | | |
| (103,103 | ) | |
| (13,773 | ) | |
| (436,004 | ) | |
| 75,534 | | |
| (360,470 | ) |
Executive separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment EBITDA | |
$ | 1,393,959 | | |
$ | (801,778 | ) | |
$ | 592,181 | | |
$ | 1,120,207 | | |
$ | (1,415,831 | ) | |
$ | (295,624 | ) |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,691,798 | ) | |
$ | (2,636,447 | ) | |
$ | (5,328,245 | ) | |
$ | 614,061 | | |
$ | (3,696,570 | ) | |
$ | (3,082,509 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Noncash share-based compensation | |
| 1,799,936 | | |
| 86,200 | | |
| 1,886,136 | | |
| 1,609,729 | | |
| 114,908 | | |
| 1,724,637 | |
Change in fair value of earnout liabilities | |
| (14,451 | ) | |
| (65,000 | ) | |
| (79,451 | ) | |
| (627,132 | ) | |
| (186,025 | ) | |
| (813,157 | ) |
Executive separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment EBITDA | |
$ | 2,532,145 | | |
$ | (1,628,543 | ) | |
$ | 903,602 | | |
$ | 2,365,280 | | |
$ | (2,953,734 | ) | |
$ | (588,454 | ) |
(1) - Includes $328,795 of share-based
compensation related to executive separation costs.
For the three months ended June 30, 2024, we had Segment
EBITDA of $0.6 million compared to ($0.3) million for the three months ended June 30, 2023. Our Segment EBITDA included ($0.8) million
and ($1.4) million attributable to our THP segment for the three months ended June 30, 2024 and 2023, respectively. For the six months
ended June 30, 2024, our Segment EBITDA was $0.9 million, compared to ($0.6) million for the six months ended June 30, 2023. Our Segment
EBITDA included ($1.6) million and ($3.0) million related to our THP segment for the six months ended June 30, 2024 and 2023, respectively.
The positive Segment EBITDA for the three and six months ended June 30, 2024 was primarily due to higher amortization of our acquired
intangible assets, executive separation costs and acquisition costs, as discussed above.
LIQUIDITY
AND CAPITAL RESOURCES
Cash
on hand at June 30, 2024 was $6.2 million, compared to $5.1 million at December 31, 2023. Historically, we have financed our operations
primarily from the sale of equity securities. In February 2023, we entered into a Controlled Equity Offering SM Sales Agreement
(the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which we could
offer and sell from time to time, to or through Cantor, shares of our common stock having an aggregate offering price of up to $75.0
million.
Sales
of the shares, pursuant to the Sales Agreement, were made in sales deemed to be an “at the market offering” as defined in
Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. Upon delivery of a placement notice and subject to the terms
and conditions of the Sales Agreement, Cantor agreed to use commercially reasonable efforts consistent with its normal trading and sales
practices, applicable state and federal law, rules and regulations and the rules of The Nasdaq Capital Market to sell the shares from
time to time based upon our instructions, including any price, time period or size limits specified by us. We had no obligation to sell
any of the shares under the Sales Agreement and could suspend or terminate the offering of our common stock pursuant to the Sales Agreement
upon notice to Cantor and subject to other conditions. Pursuant to the Sales Agreement, we paid Cantor a commission of 3.0% of the aggregate
gross proceeds from each sale of the shares.
In
2023, we sold an aggregate of 26,143 shares of common stock for gross proceeds of approximately $1.1 million and net proceeds of approximately
$1.0 million pursuant to the Sales Agreement. We paused the offering at the end of the first quarter of 2023 and did not reactivate it
during the remainder of 2023. The Registration Statement on Form S-3 relating to this offering expired in January 2024.
On
August 1, 2023, we, as guarantor, and SMAT, as borrower, entered into the Cadence Loan Agreement with the Bank providing for, among other
things, a term loan in the aggregate principal amount of up to $12.0 million, which was evidenced by an advancing promissory note. Pursuant
to the Cadence Loan Agreement, the Bank agreed to make, at any time and from time to time prior to February 1, 2024, one or more advances
to SMAT. On August 1, 2023, the Bank made an advance under the Cadence Term Loan for $9.75 million, the proceeds of which were used to
fund the Cash Closing Consideration for the Applied Asset Purchase. For more information regarding the Cadence Loan Agreement, see the
“Cadence Loan Agreement” section below.
On
April 17, 2024, we entered into the CRG Term Loan Agreement by and among us, as borrower, the Guarantors, the Agent and the lenders party
thereto from time to time, providing for a senior secured term loan of up to $55.0 million. On the closing date of the CRG Term Loan,
a $15.0 million advance was made to repay the Cadence Term Loan and to pay certain fees and expenses related to the CRG Loan Agreement.
The remaining proceeds of $4.4 million were distributed to us. As a result, the Cadence Term Loan Agreement was terminated and all outstanding
amounts under the Cadence Term Loan were repaid in full and all security interest and other liens granted to or held by the Bank were
terminated and released.
We
expect to significantly increase our investment in the THP technology platform and related infrastructure during the second half of
2024. As a result, we estimate that THP’s operating expenses and net loss will increase by approximately $4.0 to $5.0 million
during the six-month period ending December 31, 2024 compared to the six-month period ended June 30, 2024. We plan to
commercially launch the THP program during the second half of 2025.
We
expect our future needs for cash to include the funding of our additional investment in THP, potential acquisitions, further developing
our products, services and technologies pipeline and clinical studies, expanding our sales force, repayment of debt as it becomes due
and for general corporate purposes. If we seek to consummate acquisitions in the future, we expect to finance such acquisitions with
the proceeds from equity or debt issuances. Based on our current plan of operations, we believe our cash on hand, when combined with
expected cash flows from operations and available proceeds from the CRG Term Loan discussed herein, will be sufficient to fund our growth
strategy and to meet our anticipated operating expenses and capital expenditures for at least the next twelve months. We expect to make
another borrowing under the CRG Term Loan during the second half of 2024.
Applied
Asset Purchase
On
August 1, 2023, we entered into the Applied Purchase Agreement by and among the Company, SMAT, Hymed, Applied and the Owner, pursuant
to which SMAT acquired the Applied Purchased Assets and assumed certain Assumed Liabilities upon the terms and subject to the conditions
set forth in the Applied Purchase Agreement. The transaction closed on August 1, 2023. The Applied Purchased Assets were purchased for
an initial aggregate purchase price of $15.25 million, consisting of (i) $9.75 million in cash, (ii) 73,809 shares of our common stock,
with an agreed upon value of $3.0 million and (iii) $2.5 million in cash, to be paid in four equal installments on each of the next four
anniversaries of the Closing.
In
addition to the Cash Closing Consideration, Stock Closing Consideration and Installment Payments, the Applied Purchase Agreement provides
that the Sellers are entitled to receive up to an additional $10.0 million, which is payable to the Sellers in cash, upon the achievement
of certain performance thresholds relating to SMAT’s collections from net sales of a collagen-based product currently under development.
Upon expiration of the seventh anniversary of the Closing, to the extent the Sellers have not earned the entirety of the Applied Earnout,
SMAT shall pay the Sellers the True-Up Payment. The Applied Earnout, minus the True-Up Payment and any Applied Earnout payments already
made by SMAT, may be earned at any point in the future, including after the True-Up Payment is made.
Cadence
Loan Agreement
In
connection with the entry into the Applied Purchase Agreement, on August 1, 2023, we, as guarantor, and SMAT, as borrower, entered into
the Cadence Loan Agreement with the Bank providing for, among other things, a term loan in the aggregate principal amount of $12.0 million,
which was evidenced by an advancing promissory note. Pursuant to the Cadence Loan Agreement, the Bank agreed to make, at any time and
from time to time prior to February 1, 2024, one or more advances to SMAT.
The
proceeds of the advances under the Cadence Loan Agreement were to be used for working capital and for purposes of financing up to one
hundred percent (100%) of the Cash Closing Consideration and Installment Payments for the Applied Asset Purchase and related fees and
expenses, including any subsequent payments that were due to the Sellers after the Closing. On August 1, 2023, the Bank, at the request
of SMAT, made an advance for $9.75 million. The proceeds from the advance were used to fund the Cash Closing Consideration for the Applied
Asset Purchase.
The
unpaid principal balance of outstanding advances under the Cadence Term Loan bore interest, subject to certain conditions, at the lesser
of the Maximum Rate (as defined in the Cadence Loan Agreement) or the Base Rate, which was for any day, a rate per annum equal to the
term secured overnight financing rate (Term SOFR) (as administered by the Federal Reserve Bank of New York) for a one-month tenor in
effect on such day plus three percent (3.0%).
Pursuant
to the Cadence Loan Agreement, SMAT was required to maintain a minimum Debt Service Coverage Ratio and a Cash Flow Leverage Ratio.
As
noted above, on the Closing Date the Cadence Loan Agreement was terminated and all outstanding amounts under the Cadence Term Loan were
repaid in full and all security interest and other liens granted to or held by the Bank were terminated and released. The aggregate principal
amount of the Cadence Term Loan outstanding under the Cadence Loan Agreement was $9.8 million at the time of termination, and the Cadence
Term Loan bore interest at a per annum rate equal to the term secured overnight financing rate (Term SOFR) (as administered by the Federal
Reserve Bank of New York) for a one-month tenor in effect on such day plus three percent (3.0%). At the time of termination, we also
paid the Bank approximately $27.1 thousand, which consisted of interest accrued or deemed payable under the Cadence Loan Agreement. We
did not pay an exit fee or prepayment fee in connection with our voluntary repayment of the Cadence Term Loan.
CRG
Term Loan Agreement
On
April 17, 2024, we, as borrower, entered into the CRG Term Loan Agreement with the Guarantors, the Agent, and the lenders party thereto
from time to time, providing for a senior secured term loan of up to $55.0 million. The CRG Term Loan Agreement provides for (i) $15.0
million of the CRG Term Loan that was borrowed on the Closing Date (the “First Borrowing”) and (ii) up to an aggregate of
$40.0 million available for borrowing in two subsequent borrowings, provided that each such borrowing must be at least $5.0 million
or a multiple of $5.0 million and occur between the Closing Date and June 30, 2025, subject to the satisfaction of certain conditions,
including that the First Borrowing having previously occurred and the Agent having received certain fees.
The
CRG Term Loan is due and payable on March 30, 2029 (the “Maturity Date”), absent any acceleration. Pursuant to the CRG Term
Loan Agreement, a portion of the proceeds of the CRG Term Loan we used to repay the Cadence Term Loan and to pay fees and expenses related
to the CRG Term Loan Agreement. The remainder of the proceeds may be used for certain permitted acquisitions and similar investments
and for general working capital and corporate purposes.
The
CRG Term Loan bears interest at a per annum rate equal to 13.25% (subject to a 4.0% increase during an event of default), of which 8.00%
must be paid in cash and 5.25% may, at our election, be deferred through the 19th quarterly Payment Date (defined below) by
adding such amount to the aggregate principal loan amount, so long as no default or event of default under the CRG Term Loan Agreement
has occurred and is continuing. We are required to make quarterly interest payments on the final business day of each calendar quarter
following the Closing Date, commencing on the first such date to occur at least 30 days after the Closing Date (each, a “Payment
Date”). Interest is payable on each Payment Date in arrears with respect to the time between each Payment Date and upon the payment
or prepayment of the CRG Term Loan, ending on the Maturity Date. In addition, we are required to pay an upfront fee of 1.50% of the principal
amount of the CRG Term Loan, which is payable as amounts are advanced under the CRG Term Loan on a pro rata basis. We are also required
to pay a back-end fee equal to 7.00% of the aggregate principal amount advanced under the CRG Term Loan Agreement. We paid upfront fees
of $225,000 on the Closing Date related to the First Borrowing. As of June 30, 2024, there was $15.2 million of principal outstanding
and $39.8 million available for future borrowing under the CRG Term Loan.
Subject
to certain exceptions, we are required to make mandatory prepayments of the CRG Term Loan with the proceeds of certain assets sales and
in the event of a change of control of the Company. In addition, we may make a voluntary prepayment of the CRG Term Loan, in whole or
in part, at any time. All mandatory and voluntary prepayments of the CRG Term Loan are subject to the payment of prepayment premiums
as follows: (i) if prepayment occurs on or prior to the date that is one year following the applicable borrowing (the “Borrowing
Date”), an amount equal to 10.0% of the aggregate outstanding principal amount of the Loan being prepaid and (ii) if prepayment
occurs one year after the applicable Borrowing Date and on or prior to two years following the applicable Borrowing Date, an amount equal
to 5.0% of the aggregate outstanding principal amount of the CRG Term Loan being prepaid. No prepayment premium is due on any principal
prepaid if prepayment occurs two years or more after the applicable Borrowing Date.
Certain
of our current and future subsidiaries, including the Guarantors, are guaranteeing our obligations under the CRG Term Loan Agreement.
As security for our obligations under the CRG Term Loan Agreement, on the Closing Date, we and the Guarantors entered into a security
agreement with the Agent pursuant to which we and the Guarantors granted to the Agent, as collateral agent for the lenders, a lien on
substantially all of our and the Guarantors’ assets, including intellectual property (subject to certain exceptions).
The
CRG Term Loan Agreement contains affirmative and negative covenants customary for financings of this type, including limitations on our
and the Guarantors’ abilities, among other things, to incur additional debt, grant or permit additional liens, make investments
and acquisitions above certain thresholds, merge or consolidate with others, dispose of assets, pay dividends and distributions and enter
into affiliate transactions, in each case, subject to certain exceptions. In addition, the CRG Term Loan Agreement contains the following
financial covenants requiring us and the Guarantors in the aggregate to maintain:
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●
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liquidity
in an amount which shall exceed the greater of (i) $3.0 million and (ii) to the extent we have incurred certain permitted debt, the
minimum cash balance, if any, required of us by the creditors of such permitted debt; and |
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annual
minimum revenue: (i) for the twelve-month period beginning on January 1, 2024 and ending on December 31, 2024, of at least $60.0
million, (ii) for the twelve-month period beginning on January 1, 2025 and ending on December 31, 2025, of at least $75.0 million,
(iii) for the twelve-month period beginning on January 1, 2026 and ending on December 31, 2026, of at least $85.0 million, (iv) for
the twelve-month period beginning on January 1, 2027 and ending on December 31, 2027, of at least $95.0 million and (v) during each
twelve-month period beginning on January 1 of a given year thereafter, of at least $105.0 million.
|
Cash
Flow Analysis
For
the six months ended June 30, 2024, net cash used in operating activities was $3.0 million compared to $3.5 million used in operating
activities for the six months ended June 30, 2023. The lower use of cash in the six months ended June 30, 2024 was due to net revenue
growth outpacing the growth of our cash operating expenses and timing of cash expenditures for certain accrued payables and prepaids.
For
the six months ended June 30, 2024, net cash used in investing activities was $0.1 million compared to an immaterial amount used in investing
activities during the six months ended June 30, 2023. The higher use of cash used in investing activities during the six months ended
June 30, 2024 was due to cash paid for purchases of property and equipment.
For
the six months ended June 30, 2024, net cash provided by financing activities was $4.1 million as compared to $0.6 million provided by
financing activities for the six months ended June 30, 2023. The cash provided by financing activities during the six months ended June
30, 2024 was primarily due to proceeds received from the CRG Term Loan, which were partially offset by the payoff of the Cadence Term
Loan.
MATERIAL
TRANSACTIONS WITH RELATED PARTIES
CellerateRX
Surgical Sublicense Agreement
We
have an exclusive, world-wide sublicense to distribute CellerateRX Surgical products into the surgical and wound care markets from an
affiliate of Catalyst, CGI Cellerate RX, which, prior to the Applied Asset Purchase, licensed the rights to CellerateRX from Applied.
Sales of CellerateRX Surgical comprised the substantial majority of our sales during the six months ended June 30, 2024 and 2023. Prior
to the Applied Asset Purchase discussed above, we paid royalties based on the annual Net Sales of licensed products (as defined in the
Sublicense Agreement) consisting of 3% of all collected Net Sales each year up to $12.0 million, 4% of all collected Net Sales each year
that exceed $12.0 million up to $20.0 million, and 5% of all collected Net Sales each year that exceed $20.0 million. Ronald T. Nixon,
our Chief Executive Officer and Executive Chairman, is the founder and managing partner of Catalyst.
In
August 2023, we acquired the underlying intellectual property of, as well as the rights to manufacture and sell, certain hydrolyzed collagen
products, including CellerateRX Surgical, from Applied. In connection with this acquisition, Applied assigned its license agreement with
CGI Cellerate RX to a wholly owned subsidiary of the Company, SMAT, and no further royalties will be due to Applied thereunder.
Consulting
Agreement
In
July 2021, we entered into an asset purchase agreement with Rochal, a related party. Concurrent with the Rochal asset purchase, we entered
into a consulting agreement with Ann Beal Salamone pursuant to which Ms. Salamone agreed to provide us with consulting services with
respect to, among other things, writing new patents, conducting patent intelligence and participating in certain grant and contract reporting.
In consideration for the consulting services to be provided to us, Ms. Salamone is entitled to receive an annual consulting fee of $177,697,
with payments to be paid once per month. The consulting agreement has an initial term of three years, unless earlier terminated by us,
and is subject to renewal. Effective July 13, 2024, the consulting agreement with Ms. Salamone was amended to provide that the initial
term shall be automatically renewed for successive one-year terms for up to three successive years unless earlier terminated by either
party without cause at any time, provided that the terminating party provides ninety days advance written notice of termination. Ms.
Salamone is a director of the Company, is a significant shareholder and the current chair of the board of directors of Rochal.
Catalyst
Transaction Advisory Services Agreement
In
March 2023, we entered into a Transaction Advisory Services Agreement (the “Catalyst Services Agreement”) effective March
1, 2023 with Catalyst, a related party. Pursuant to the Catalyst Services Agreement, Catalyst, by and through its directors, officers,
employees and affiliates that are not simultaneously serving as directors, officers or employees of the Company (collectively, the “Covered
Persons”), agreed to perform certain transaction advisory, business and organizational strategy, finance, marketing, operational
and strategic planning, relationship access and corporate development services for us in connection with any merger, acquisition, recapitalization,
divestiture, financing, refinancing, or other similar transaction in which we may be, or may consider becoming, involved, and any such
additional services as mutually agreed upon in writing by and between Catalyst and us (the “Catalyst Services”).
Pursuant
to the Catalyst Services Agreement, we agreed to reimburse Catalyst for (i) compensation actually paid by Catalyst to any of the Covered
Persons at a rate no more than a rate consistent with industry practice for the performance of services similar to the Catalyst Services,
as documented in reasonably sufficient detail, and (ii) all reasonable out-of-pocket costs and expenses payable to unaffiliated third
parties, as documented in customary expense reports, as each of (i) and (ii) is incurred in connection with the Catalyst Services rendered
under the Catalyst Services Agreement, with all reimbursements being contingent upon the prior approval of the Audit Committee of our
Board of Directors. We incurred costs relating to the Catalyst Services Agreement of $57,000 and $72,986 during the three months ended
June 30, 2024 and 2023, respectively, and $113,272 and $72,986 during the six months ended June 30, 2024 and 2023, respectively.
Receivables
and Payables
We
had outstanding related party receivables totaling $111,412 at June 30, 2024, and $8,400 at December 31, 2023. We had outstanding related
party payables totaling $145,487 at June 30, 2024, and $77,805 at December 31, 2023.
IMPACT
OF INFLATION AND CHANGING PRICES
Inflation
and changing prices have not had a material impact on our historical results of operations. We do not currently anticipate that inflation
and changing prices will have a material impact on our future results of operations.
CRITICAL
ACCOUNTING ESTIMATES
The
preparation of financial statements in accordance with U.S. generally accepted accounting principles requires management to make estimates
and assumptions that affect the amounts reported in the unaudited consolidated financial statements and accompanying notes. Although
we base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances,
actual results may differ from the estimates on which our financial statements are prepared at any given point of time. Changes in these
estimates could materially affect our consolidated financial position, results of operations or cash flows. Significant items that are
subject to such estimates and assumptions include revenue and expense accruals, the fair value measurement of assets and liabilities
and the allocation of purchase price to the fair value of assets acquired. Our critical accounting estimates have not significantly changed
since December 31, 2023 and are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As
a smaller reporting company, we are not required to provide this information.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports
that we file or submit to the SEC under the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified by the SEC’s
rules and forms, and that information is accumulated and communicated to our management, including our principal executive and principal
financial officers (whom we refer to in this periodic report as our Certifying Officers), as appropriate to allow timely decisions regarding
required disclosure. Our management evaluated, with the participation of our Certifying Officers, the effectiveness of our disclosure
controls and procedures as of June 30, 2024, pursuant to Rule 13a-15(b) under the Exchange Act. Based upon that evaluation, our Certifying
Officers concluded that, as of June 30, 2024, our disclosure controls and procedures were effective.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2024 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part
II - Other Information
ITEM
1. LEGAL PROCEEDINGS
From
time to time, we may be involved in claims and legal actions that arise in the ordinary course of business. To our knowledge, there are
no material pending legal proceedings to which we are a party or of which any of our property is the subject.
ITEM
1A. RISK FACTORS
Except
as provided below, there were no material changes to the Risk Factors disclosed in “Item 1A. Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2023. For more information concerning our risk factors, please see “Item 1A.
Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023.
Our
indebtedness could adversely affect our financial condition and prevent us from fulfilling our obligations.
A
significant portion of our future cash flow is required to pay interest and principal on our outstanding indebtedness, and we may be
unable to generate sufficient cash flow from operations, or have future borrowings available, to enable us to repay our indebtedness
or to fund other liquidity needs. Among other consequences, this indebtedness could:
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● |
require
us to use a significant percentage of our cash flow from operations for debt service and the satisfaction of repayment obligations,
and not for other purposes, such as funding working capital and capital expenditures or making future acquisitions; |
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● |
limit
our flexibility in planning for or reacting to changes in our business and limit our ability to exploit future business opportunities;
and |
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● |
cause
us to be more highly leveraged than some of our competitors, which may place us at a competitive disadvantage. |
Our
outstanding indebtedness is subject to certain operating and financial covenants that restrict our business and financing activities
and may adversely affect our cash flow and our ability to operate our business.
The
CRG Term Loan Agreement requires us, as borrower, and the Guarantors to maintain compliance with certain operating and financial covenants,
which provide that we and the Guarantors, among other things, may not, subject to certain exceptions:
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● |
create,
incur, assume or permit to exist any indebtedness, whether directly or indirectly; |
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● |
create,
incur, assume or permit the existence of additional liens on our property or assets, or assign or sell any income or revenues (including
accounts receivable) or rights in respect of any thereof; |
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● |
enter
into any transaction of merger, amalgamation or consolidation or liquidate, wind up or dissolve itself (or suffer any liquidation
or dissolution), or make certain acquisitions; |
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● |
engage
to any material extent in any business other than the business engaged in on the date of closing or a business that constitutes a
reasonable extension or expansion thereof; |
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● |
make,
directly or indirectly, or permit to remain outstanding any investments; |
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declare
or make, or agree to pay or make, directly or indirectly, any restricted payments as described in the CRG Term Loan Agreement; |
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● |
make
any payments in respect of any subordinated debt or certain other indebtedness incurred pursuant to the CRG Term Loan Agreement; |
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sell,
lease, license, transfer, or otherwise dispose of any of its property to any person in one transaction or series of transactions; |
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sell,
lease, license or otherwise transfer any assets to, or purchase, lease, license or otherwise acquire any assets from, or otherwise
engage in any other transactions with, any of its affiliates; |
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● |
directly
or indirectly, enter into, incur or permit to exist any restrictive agreement; |
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enter
into any amendment to or modification of its organizational documents in a manner that would be materially adverse to the interests,
or rights or remedies, of the Agent and the lenders; |
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engage
in sale-leasebacks; |
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● |
make
any significant change in accounting treatment or reporting practices, except as required or permitted by GAAP; |
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dispose
of, whether by sale, contribution, investment or otherwise, any material intellectual property to any Guarantor that is not an obligor
or to any joint venture; or |
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● |
contribute
or otherwise invest any material intellectual property in any Guarantor that is not an obligor or to any joint venture. |
In
addition, the CRG Term Loan Agreement requires us and the Guarantors in the aggregate to maintain:
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● |
liquidity
in an amount which shall exceed the greater of (i) $3.0 million and (ii) to the extent we have incurred certain permitted debt, the
minimum cash balance, if any, required of us by the creditors of such permitted debt; and |
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annual
minimum revenue: (i) for the twelve-month period beginning on January 1, 2024 and ending on December 31, 2024, of at least $60.0
million, (ii) for the twelve-month period beginning on January 1, 2025 and ending on December 31, 2025, of at least $75.0 million,
(iii) for the twelve-month period beginning on January 1, 2026 and ending on December 31, 2026, of at least $85.0 million, (iv) for
the twelve-month period beginning on January 1, 2027 and ending on December 31, 2027, of at least $95.0 million and (v) during each
twelve-month period beginning on January 1 of a given year thereafter, of at least $105.0 million. |
A
breach of any of the covenants under our loan agreements, subject to certain cure periods, will result in an event of default, which
could cause all of our outstanding indebtedness under the CRG Term Loan Agreement to become immediately due and payable, and a default
interest rate of up to an additional 4.0% per annum may be applied to the outstanding loan balance. If our indebtedness is accelerated,
we cannot be certain that we will have sufficient funds available to pay the accelerated indebtedness or that we will have the ability
to refinance the accelerated indebtedness on terms favorable to us or at all.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
There
were no sales of unregistered securities during the quarter ended June 30, 2024 that were not previously reported on a Current Report
on Form 8-K.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
This
item is not applicable.
ITEM
5. OTHER INFORMATION
During
the three months ended June 30, 2024, no director or officer (as defined in Rule 16a-1(f) of the Exchange Act) of the Company adopted,
modified, or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (in each
case, as defined in Item 408(a) of Regulation S-K).
ITEM
6. EXHIBITS
The
exhibits listed below are filed as part of this report or incorporated herein by reference.
Exhibit
No. |
|
Description |
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2.1# |
|
Asset Purchase Agreement, dated July 14, 2021, by and between Sanara MedTech Inc., as Purchaser, and Rochal Industries, LLC, as Seller (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 19, 2021). |
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2.2# |
|
Agreement and Plan of Merger, dated April 1, 2022, by and among Sanara MedTech Inc., United Wound and Skin Solutions, LLC, Precision Healing Inc., PH Merger Sub I, Inc., PH Merger Sub II, LLC and Furneaux Capital Holdco, LLC (d/b/a BlueIO) (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on April 4, 2022). |
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2.3# |
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Membership Interest Purchase Agreement, dated July 1, 2022, by and among Sanara MedTech Inc., Scendia Biologics, LLC and Ryan Phillips (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on July 5, 2022). |
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2.4# |
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Asset Purchase Agreement, dated August 1, 2023, by and among Sanara MedTech Inc., Sanara MedTech Applied Technologies, LLC, The Hymed Group Corporation, Applied Nutritionals, LLC and Dr. George D. Petito (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on August 2, 2023). |
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3.1 |
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Amended and Restated Certificate of Formation of Sanara MedTech Inc. (incorporated by reference to Exhibit 3.1 to the Company’s current Report on Form 8-K filed on June 17, 2024). |
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3.2 |
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Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March 22, 2024). |
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10.1
† |
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Employment Agreement, effective April 15, 2024, by and between Sanara MedTech Inc. and Jacob A. Waldrop (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 5, 2024). |
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10.2# |
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Term Loan Agreement, dated April 17, 2024, by and among Sanara MedTech Inc., as borrower, the Subsidiary Guarantors party thereto, the lenders party thereto and CRG Servicing LLC, as administrative agent and collateral agent (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 18, 2024). |
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10.3# |
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Form of Security Agreement, by and among Sanara MedTech Inc., the Subsidiary Guarantors party thereto and CRG Servicing LLC (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on April 18, 2024). |
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10.4*† |
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Separation Agreement and General Release, dated as of May 29, 2024, by and between Sanara MedTech Inc. and Zachary B. Fleming. |
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10.5† |
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Sanara MedTech Inc. 2024 Omnibus Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 18, 2024). |
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10.6*† |
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Form of Restricted Stock Award Agreement under the Sanara MedTech Inc. 2024 Omnibus Long-Term Incentive Plan. |
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10.7*† |
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First Amendment to Consulting Agreement, dated July 13, 2024, by and between Sanara MedTech Inc. and Ann Beal Salamone. |
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31.1* |
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Certification of Principal Executive Officer in accordance with 18 U.S.C. Section 1350, as adopted by Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2* |
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Certification of Principal Financial Officer in accordance with 18 U.S.C. Section 1350, as adopted by Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1** |
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Certification of Principal Executive Officer in accordance with 18 U.S.C. Section 1350, as adopted by Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2** |
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Certification of Principal Financial Officer in accordance with 18 U.S.C. Section 1350, as adopted by Section 906 of the Sarbanes-Oxley Act of 2002. |
|
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101.INS |
|
Inline
XBRL Instance Document. |
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document. |
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document. |
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document. |
101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document. |
101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document. |
104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
*
Filed herewith.
#
Certain schedules and exhibits to this agreement have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted
schedule or exhibit will be furnished supplementally to the Securities and Exchange Commission or its staff upon request. If indicated
on the first page of such agreement, certain confidential information has been excluded pursuant to Item 601(b)(2)(ii) of Regulation
S-K. Such excluded information is not material and is the type that the Company treats as private or confidential.
**
The certifications attached as Exhibit 32.1 and Exhibit 32.2 are not deemed “filed” with the Securities and Exchange Commission
and are not to be incorporated by reference into any filing of Sanara MedTech Inc. under the Securities Act of 1933, as amended, or the
Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective
of any general incorporation language contained in such filing.
†
Identifies a management contract or compensatory plan.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
|
SANARA
MEDTECH INC. |
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|
August
12, 2024 |
By: |
/s/
Michael D. McNeil |
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Michael
D. McNeil |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial Officer and duly authorized officer) |
Exhibit
10.4
SEPARATION
AGREEMENT AND GENERAL RELEASE
This
Separation Agreement and General Release (“Agreement”) is made and entered into by Zachary Fleming (“Employee”)
on the one hand, and Sanara MedTech Inc. (hereinafter “Company”) on the other hand, as of the date of the last of the Parties’
signatures, below. For purposes of this Agreement, Employee and Company are collectively referred to as the “Parties.”
In
consideration of the payments, covenants, and releases described below, and in consideration of other good and valuable consideration,
the receipt and sufficiency of all of which is hereby acknowledged, the Parties agree as follows:
|
1. |
Termination
of Employment. |
It
is understood and agreed that Employee’s employment with Company and any of Company’s direct and/or indirect subsidiaries
terminated effective May 10, 2024. Employee acknowledges and agrees that Company has met all of its obligations to Employee and has paid
Employee all salary, wages, overtime payments, commissions, bonuses, accrued benefits, and any other amounts due to Employee through
the date of execution of this Agreement and further acknowledges and agrees that, except for the Severance Proceeds specifically set
forth in Paragraph 2 of this Agreement, Company owes no additional amounts to Employee for any reason.
|
2. |
Payments
and Actions by the Company. |
a.
Severance Proceeds. In consideration of Employee’s general release and the other promises contained in this Agreement, Company
agrees to pay Employee an amount equal to twelve (12) months of Employee’s base salary, less applicable withholdings for taxes
and any other items as to which a withholding obligation may exist, at Employee’s regular salary rate as of the effective date
of Employee’s termination (the “Severance Proceeds”). The Severance Proceeds will be paid in approximately equal installments
on or about regular payroll dates over a twelve (12) month period (the “Severance Period”).
b.
Insurance Premiums. In further consideration of Employee’s general release and the other promises contained in this Agreement,
Company agrees to pay the premiums for extended health insurance coverage under the Consolidated Omnibus Budget Reconciliation Act (“COBRA”)
for Employee and Employee’s eligible dependents during the Severance Period, or until the date Employee’s coverage otherwise
terminates in accordance with COBRA or on account of Employee’ eligibility to receive coverage under a program of a subsequent
employer or otherwise, if earlier (the payment of such premiums is hereinafter included in the term “Severance Proceeds”).
| | | | ZF | | MM |
| | | | Employee Initials | | Company Initials |
c.
Unvested Equity Awards. In further consideration of Employee’s general release and the other promises contained in this
Agreement, Company agrees to permit 11,815 (fifty percent (50%) of the current total) of Employee’s outstanding unvested shares
of restricted stock (the “Retained Restricted Shares”) to continue to vest on the time schedule set forth in the applicable
restricted stock award agreements, subject to Employee’s continued compliance with the Restrictive Covenants set forth in Sections
seven (7), ten (10), eleven (11), and twelve (12) of the Amended and Restated Employment Agreement between the Parties dated January
1, 2022 (the “Employment Agreement”) (the continued vesting is hereinafter included in the term “Severance Proceeds”).
The vesting schedule does not affect or change the timelines set forth in Section seven (7), ten (10), eleven (11), and twelve (12) of
the Employment Agreement.
Notwithstanding
the preceding paragraph, the Parties acknowledge and agree that Employee will incur a tax liability with respect to the Retained Restricted
Shares as of the effective date of this Agreement (as set forth in Section 3 below, the “Effective Date”) and prior to the
time the Retained Restricted Shares would vest in accordance with the preceding paragraph. In light of such tax liability, the Parties
further agree that a number of Retained Restricted Shares having a fair market value as of the Effective Date equal to the amount required
to satisfy all tax withholding requirements applicable thereto shall vest as of the Effective Date (the “Released Shares”).
The Company shall withhold the Released Shares to satisfy such withholding obligations, and remaining Retained Restricted Shares will
continue to vest in accordance with the preceding paragraph.
For
the avoidance of doubt, the remaining 11,815 (fifty percent (50%) of the current total) of Employee’s outstanding unvested shares
of restricted stock that had previously been granted to Employee have been forfeited.
Employee
acknowledges the receipt and sufficiency of the Severance Proceeds and expressly agrees that no further act or payment is owed to Employee
or to any of Employee’s attorneys, agents, or assigns by Company or any of its affiliates or any of their past and present officers,
directors, shareholders, employees, volunteers, agents, parent corporations, predecessors, subsidiaries, affiliates, branches, insurers,
benefit plans, estates, successors, assigns, or attorneys. Employee further acknowledges and agrees that Employee’s receipt of
the Severance Proceeds is conditioned upon his compliance with the terms of this Agreement and with the Restrictive Covenants set forth
in Sections seven (7), ten (10), eleven (11), and twelve (12) of the Employment Agreement.
Employee,
on behalf of Employee, Employee’s successors, and Employee’s assigns, now and forever unconditionally releases and discharges
Company and all of its affiliates, including, without limitation, all of their past and present officers, directors, shareholders, employees,
volunteers, agents, parent corporations, predecessors, subsidiaries, affiliates, branches, insurers, benefit plans, estates, successors,
assigns, and attorneys (hereinafter collectively referred to as “Releasees”) from any and all claims, charges, actions, causes
of action, sums of money due, attorneys’ fees, suits, debts, covenants, contracts, agreements, promises, demands, or liabilities
(hereinafter collectively referred to as “Claims”) whatsoever, in law or in equity, whether known or unknown, which Employee
ever had, now has, or might in the future have against any of the Releasees based upon facts occurring prior to the date of this Agreement.
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| 2 |
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| ZF |
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MM |
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| |
| Employee Initials |
|
Company Initials |
Without
limiting the generality of the foregoing, Employee acknowledges and covenants that, in consideration for the Severance Proceeds set forth
in Paragraph 2 above, Employee has knowingly waived any right or opportunity to assert any Claim which is in any way connected with any
employment relationship, or the termination of any employment relationship, that existed between Company and Employee. Employee further
understands and agrees that Employee has knowingly relinquished, waived, and forever released any and all remedies arising out of the
aforesaid employment relationship or the termination thereof, including, without limitation, claims for back pay, front pay, liquidated
damages, compensatory damages, general damages, special damages, punitive damages, exemplary damages, costs, expenses, and attorneys’
fees.
Employee
further specifically acknowledges and agrees that Employee has knowingly and voluntarily released Company and all other Releasees from
any and all claims arising under the Age Discrimination in Employment Act (“ADEA”), 29 U.S.C. § 621, et seq., which
Employee has or may have against any of the Releasees based upon facts occurring prior to the date of this Agreement, including but not
limited to those claims that are in any way connected with any employment relationship, or the termination of any employment relationship,
that existed between Company and Employee. Employee acknowledges and agrees that Employee is advised to consult with an attorney prior
to executing this Agreement and that Employee has been given twenty-one (21) days to consider this Agreement prior to its execution.
Employee also understands that Employee may revoke this Agreement at any time within seven (7) days following its execution. Employee
understands, however, that this Agreement shall not become effective and that none of the consideration described above shall be paid
to Employee until after the expiration of the seven (7) day revocation period.
Employee
understands that nothing contained in this Agreement limits any of the following (the “Protected Rights”): (a) Employee’s
ability to file a charge or complaint with the Equal Employment Opportunity Commission, the National Labor Relations Board, or any other
federal, state, or local governmental agency or commission (“Government Agencies”); (b) Employee’s ability to communicate
with any Government Agencies or otherwise participate in any investigation or proceeding that may be conducted by any Government Agencies
in connection with any charge or complaint, whether filed by Employee, on Employee’s behalf, or by any other individual; however,
based on Employee’s release of claims set forth in Section 3 of this Agreement, Employee understands that Employee is releasing
all claims that Employee may have, as well as Employee’s right to recover monetary damages, except as otherwise required by law,
or obtain other relief that is personal to Employee in connection with any charge or complaint that may be filed with any Government
Agencies relating to Employee’s employment with Company; and (c) Employee’s rights under the National Labor Relations Act
(“NLRA”) to bargain collectively or to exercise Employee’s rights under the NLRA to discuss, communicate, engage in
concerted activity, or assist other employees regarding wages, benefits, hours, workplace issues, labor disputes, unfair labor practices,
working conditions, or other terms and conditions of employment, and Employee does not need to notify Company or seek Company’s
prior authorization before making such disclosures or engaging in such communications or activity.
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Employee
agrees to return all documents, materials, equipment, keys, recordings, client contact information, other client-related information,
sales information, workforce information, production information, computer data, and other material and information relating to Company
or any of the other Releasees, or the business of Company or any of the other Releasees, and not to retain or provide to anyone else
any copies, excerpts, transcripts, descriptions, portions, abstracts, or other representations thereof. By executing this Agreement,
Employee warrants and agrees that Employee already has returned all such information and material to Company. Employee further represents
and warrants that Employee has not provided any property belonging to Company or any of the other Releasees, including any documents,
equipment, or other tangible property, but with the exception of non-confidential materials generally distributed by Company to customers
or the general public, to any other person. This Paragraph 5 is not intended to in any way limit any of the Protected Rights contained
in Paragraph 4 of this Agreement.
|
6. |
Non-Assignment
of Claims. |
Employee
acknowledges and warrants, understanding that the truth of said acknowledgment and warranty is material to the making of this Agreement,
that Employee has not assigned or otherwise transferred any of the Claims released by Employee through this Agreement, and Employee hereby
promises to indemnify and hold harmless the Releasees with respect to any damages, costs, or other injuries, including the payment of
attorneys’ fees, which might arise through the assertion against one or more Releasees of any Claim released herein by Employee.
Subject
to the Protected Rights set forth in Section 4 above, Employee promises that Employee has not and will not disclose or publish, verbally,
in writing, or otherwise, to any person or entity of any kind the negotiations leading up to the making of this Agreement, the amount
of consideration passing pursuant to this Agreement, or any other term or condition of this Agreement or the subject compromise; provided,
however, that Employee may disclose the provisions of the Agreement (a) to Employee’s spouse; (b) to Employee’s attorney,
accountant, and financial advisor; and (c) as required by order of a court of competent jurisdiction or as otherwise required by law.
If Employee finds it necessary to disclose the existence or terms of this Agreement to Employee’s spouse, attorney, accountant,
or financial advisor, Employee agrees that, prior to such disclosure, Employee will inform such individuals of their obligation to maintain
the confidentiality of the existence and terms of the Agreement and their obligation not to disclose those terms to any third party and
Employee will be responsible for any breach of confidentiality by such persons.
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It
is understood and agreed by the Parties that this Agreement represents a settlement and compromise of doubtful and disputed claims and
neither this Agreement itself, any of the payments or covenants described herein, nor anything else connected with this Agreement is
to be construed as an admission of any liability whatsoever on the part of Employee, Company, or any of the other Releasees, by whom
liability is expressly denied.
|
9. |
Knowing
and Voluntary. |
This
Agreement is executed by Employee voluntarily and is not based upon any representations or statements of any kind made by Company or
any of the other Releasees as to the merits, legal liabilities, or value of any claims that Employee may have against Company or any
of the other Releasees.
|
10. |
Warranty
Regarding Charges and Claims. |
Employee
represents and warrants, understanding that the truth of said representation and warranty is material to the making of this Agreement,
that Employee has submitted or filed no charges, claims, or allegations with any administrative agency, court, or similar such body involving
Company or any of the other Releasees. The Parties agree that, in the event of a violation of the representation and warranty set forth
in this paragraph, Company shall have the right, but not the obligation, to declare this Agreement void and exercise all remedies otherwise
available at law with respect to Employee, including requiring Employee to repay all monies paid to Employee under the terms of this
Agreement.
This
Agreement shall be interpreted and enforced in accordance with the laws of the State of Texas.
|
12. |
Predecessors,
Successors, and Assigns. |
The
Parties’ respective rights under this Agreement shall inure to the benefit of their predecessors, successors, assigns, heirs, and
transferees.
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Company
hereby advises Employee to consult with an attorney or other advisor prior to executing this Agreement. Employee expressly acknowledges
and agrees that Employee has read this Agreement carefully, that Employee has had ample opportunity to consult with an attorney, that
Employee fully understands that the Agreement is final and binding, and that Employee has executed the Agreement voluntarily and without
coercion, undue influence, threat, or intimidation of any kind whatsoever. Employee further acknowledges that this Agreement contains
a release of potentially valuable claims, and that the only promises or representations Employee has relied upon in signing this Agreement
are those specifically contained in the Agreement itself. Employee also acknowledges and agrees that Employee has been offered at least
twenty-one (21) days to consider this Agreement before signing, that Employee has not requested or been denied additional time to consider
this Agreement, and that Employee is signing this Agreement voluntarily, with the full intent of releasing Company from all claims.
Employee
acknowledges and agrees that this Agreement may not be revoked at any time after the expiration of the seven (7) day revocation period
referenced in Paragraph 3 above. Employee agrees that, with the exception of an action to challenge Employee’s waiver of claims
under the ADEA, should Employee ever attempt to revoke, rescind, void, or challenge this Agreement or if Employee ever attempts to make,
assert, or prosecute any Claims released by Employee through this Agreement, Employee will as a condition precedent return to Company
any and all Severance Proceeds made by Company under this Agreement, plus interest at the highest legal rate. Furthermore, with the exception
of an action to challenge Employee’s waiver of claims under the ADEA, if Employee does not prevail in an action to challenge this
Agreement, to obtain an order declaring this Agreement to be null and void, or in any action against Company or any other Releasee based
upon a claim which is covered by the general release set forth herein, Employee shall pay to Company and/or the appropriate Releasee
all their costs and attorneys’ fees incurred in their defense of Employee’s action. Nothing in this Agreement shall limit
Company’s right to seek and obtain other remedies for breach of this Agreement.
|
15. |
Entire
Agreement and Severability. |
This
Agreement supersedes any and all prior negotiations or agreements between the Parties and contains the entire agreement between the Parties
as to the subject matter hereof, except that the Restrictive Covenants set forth in Sections seven (7), ten (10), eleven (11), and twelve
(12) of the Employment Agreement will remain in full force and effect for the terms specified therein. The Parties hereby acknowledge
and agree that there have been no offers or inducements which have led to the execution of this Agreement other than as stated herein.
Because this Agreement is the product of negotiations between both parties, neither party may be considered the drafter of the Agreement
and no ambiguity in any provision shall be construed against either party on account of that party being considered the drafter of that
provision or of the Agreement. The Parties agree that all provisions of this Agreement, except the Release by Employee set forth in Paragraph
3 of the Agreement, are severable from one another and this Agreement may not be modified except by a written document signed by both
parties expressly stating that it is intended as an amendment.
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16. |
Non-Disparagement
and Neutral Reference. |
Subject
to the Protected Rights set forth in Section 4 above, Employee acknowledges and agrees that, except as required by law or compelled through
valid legal process, Employee will not make any derogatory or disparaging statements about Company (or any other Releasee) or its products,
services, business, or employment practices, regardless of the truth or falsity of such statements.
Company
acknowledges and agrees that it will instruct its Senior Management team that, except as required by law or compelled through valid legal
process, they should not make any derogatory or disparaging statements about Employee, regardless of the truth or falsity of such statements.
In addition, should any prospective employer of Employee need confirmation of Employee’s employment with Company, Employee agrees
to direct that prospective employer to contact Michael McNeil and Company will instruct Mr. McNeil to confirm only Employee’s job
title and dates of employment.
In
consideration for the Severance Proceeds being paid pursuant to Paragraph 2 above, Employee agrees to cooperate with and assist Company
by providing information relevant to matters as to which Employee gained knowledge while employed by Company and/or its predecessors,
including, without limitation, all matters involving litigation, and that, upon request and reasonable notice from Company, Employee
will voluntarily, and without additional payment or requiring a subpoena or other process, meet with Company’s attorneys and other
representatives, appear at hearings, depositions, trials, and other proceedings relating to such matters, and provide truthful written
statements and testimony relating to such matters. Company shall reimburse Employee for all reasonable and necessary out-of-pocket expenses
necessitated by Employee’s cooperation under this Paragraph 17.
|
18. |
No
Voluntary Cooperation. |
Employee
acknowledges and agrees that Employee will not voluntarily testify or otherwise cooperate or participate in any way in any currently
pending or future claim, charge, or action asserted against Company or any other Releasee.
This
Paragraph 18 is not intended to in any way limit any of the Protected Rights contained in Paragraph 4 of this Agreement.
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The
Parties agree that this Agreement is to be interpreted and administered in accordance with the requirements of Section 409A of the Internal
Revenue Code (“Section 409A”), although Company makes no covenants and assumes no liability with respect to such compliance
or noncompliance.
|
/s/
Zachary Flemming |
|
ZACHARY
FLEMING |
|
|
|
|
May
23, 2024 |
|
Date |
|
|
|
|
SANARA
MEDTECH INC. |
|
|
|
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By:
|
/s/
Michael D. McNeil |
|
Title:
|
Chief
Financial Officer |
|
Printed
Name: |
Michael
D. McNeil |
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|
May
29, 2024 |
|
Date |
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Exhibit 10.6
RESTRICTED
STOCK AWARD AGREEMENT
Sanara
medtech inc.
2024
OMNIBUS LONG-TERM INCENTIVE PLAN
1. Grant
of Award. Pursuant to the Sanara MedTech Inc. 2024 Omnibus Long-Term Incentive Plan (the “Plan”) for key
Employees, key Consultants, and Outside Directors of Sanara MedTech Inc., a Texas corporation (the “Company”),
___________________________
(the
“Participant”)
has
been granted a Restricted Stock Award in accordance with Section 6.4 of the Plan. The number of shares of Common Stock awarded under
this Restricted Stock Award Agreement (this “Agreement”) is ______________________________ (____________________)
shares (the “Awarded Shares”). The “Date of Grant” of this Award is ____________,
20__.
2. Subject
to Plan. This Agreement is subject to the terms and conditions of the Plan, and the terms of the Plan shall control to the extent
not otherwise inconsistent with the provisions of this Agreement. To the extent the terms of the Plan are inconsistent with the provisions
of this Agreement, this Agreement shall control. The capitalized terms used herein that are defined in the Plan shall have the same meanings
assigned to them in the Plan. This Agreement is subject to any rules promulgated pursuant to the Plan by the Board or the Committee and
communicated to the Participant in writing.
3. Vesting.
Except as specifically provided in this Agreement and subject to certain restrictions and conditions set forth in the Plan, the Awarded
Shares shall vest as follows: [to be updated with specific vesting terms]
a. ______________________________
of the total Awarded Shares shall vest on the first anniversary of the Date of Grant, provided the Participant is employed by (or, if
the Participant is a Consultant or an Outside Director, is providing services to) the Company or a Subsidiary on that date.
b. ______________________________
of the total Awarded Shares shall vest on the second anniversary of the Date of Grant, provided the Participant is employed by (or, if
the Participant is a Consultant or an Outside Director, is providing services to) the Company or a Subsidiary on that date.
c. ______________________________
of the total Awarded Shares shall vest on the third anniversary of the Date of Grant, provided the Participant is employed by (or, if
the Participant is a Consultant or an Outside Director, is providing services to) the Company or a Subsidiary on that date.
d. In
the event that a Change in Control occurs, then immediately prior to the effective date of such Change in Control, all Awarded Shares
not previously vested shall thereupon immediately become fully vested.
[e.
All Awarded Shares not previously vested shall immediately become fully vested upon (i) the Participant’s death or (ii) the
Participant’s Termination of Service as a result of the Participant’s Total and Permanent Disability.]
4. Forfeiture
of Awarded Shares. Awarded Shares that are not vested in accordance with Section 3 shall be forfeited on the date of the Participant’s
Termination of Service. Upon forfeiture, all of the Participant’s rights with respect to the forfeited Awarded Shares shall cease
and terminate, without any further obligations on the part of the Company.
5. Restrictions
on Awarded Shares. Subject to the provisions of the Plan and the terms of this Agreement, from the Date of Grant until the date the
Awarded Shares are vested in accordance with Section 3 and are no longer subject to forfeiture in accordance with Section 4
(the “Restriction Period”), the Participant shall not be permitted to sell, transfer, pledge, or assign
any of the Awarded Shares. Except for these limitations, the Committee may in its sole discretion, remove any or all of the restrictions
on such Awarded Shares whenever it may determine that, by reason of changes in Applicable Laws or other changes in circumstances arising
after the date of this Agreement, such action is appropriate.
6. Legend.
Awarded Shares electronically registered in the Participant’s name shall note that such shares are Restricted Stock. If certificates
for Awarded Shares are issued, the following legend shall be placed on all such certificates:
On
the face of the certificate:
“Transfer
of this stock is restricted in accordance with conditions printed on the reverse of this certificate.”
On
the reverse:
“The
shares of stock evidenced by this certificate are subject to and transferable only in accordance with that certain Sanara MedTech Inc.
2024 Omnibus Long-Term Incentive Plan, a copy of which is on file in the office of the Secretary of the Company at the principal office
of the Company in Fort Worth, Texas. No transfer or pledge of the shares evidenced hereby may be made except in accordance with and subject
to the provisions of said Plan. By acceptance of this certificate, any holder, transferee or pledgee hereof agrees to be bound by all
of the provisions of said Plan.”
The
following legend shall be inserted on a certificate, if issued, evidencing Common Stock issued under the Plan if the shares were not
issued in a transaction registered under the applicable federal and state securities laws:
“Shares
of stock represented by this certificate have been acquired by the holder for investment and not for resale, transfer or distribution,
have been issued pursuant to exemptions from the registration requirements of applicable state and federal securities laws, and may not
be offered for sale, sold or transferred other than pursuant to effective registration under such laws, or in transactions otherwise
in compliance with such laws, and upon evidence satisfactory to the Company of compliance with such laws, as to which the Company may
rely upon an opinion of counsel satisfactory to the Company.”
All
Awarded Shares owned by the Participant shall be subject to the terms of this Agreement and shall be represented by a certificate or
certificates bearing the foregoing legend.
7. Registration
of Shares; Delivery of Certificates. The Company shall electronically register the Awarded Shares in the Participant’s name
or, if requested in writing by the Participant in accordance with Section 6.4(a) of the Plan, shall deliver certificates for the
Awarded Shares free of restriction under this Agreement as soon as administratively practicable after, and only after, the Restriction
Period has expired without forfeiture pursuant to Section 4. In connection with the issuance of a certificate for Restricted Stock,
the Participant shall endorse such certificate in blank or execute a stock power in a form satisfactory to the Company in blank and deliver
such certificate and executed stock power to the Company.
8. Rights
of a Stockholder. Except as provided in Section 4 and Section 5 above, the Participant shall have, with respect to
the Awarded Shares, all of the rights of a stockholder of the Company, including the right to vote the shares and the right to receive
any dividends thereon.
9. Voting.
The Participant, as record holder of the Awarded Shares, has the exclusive right to vote, or consent with respect to, such Awarded Shares
until such time as the Awarded Shares are transferred in accordance with this Agreement; provided, however, that this Section
9 shall not create any voting right where the holders of such Awarded Shares otherwise have no such right.
10. Adjustment
to Number of Awarded Shares. The number of Awarded Shares shall be subject to adjustment in accordance with Articles 11-13
of the Plan.
11. Specific
Performance. The parties acknowledge that remedies at law will be inadequate remedies for breach of this Agreement and consequently
agree that this Agreement shall be enforceable by specific performance. The remedy of specific performance shall be cumulative of all
of the rights and remedies at law or in equity of the parties under this Agreement.
12. Participant’s
Representations. Notwithstanding any of the provisions hereof, the Participant hereby agrees that he or she will not acquire any
Awarded Shares, and that the Company will not be obligated to issue any Awarded Shares to the Participant hereunder, if the issuance
of such shares shall constitute a violation by the Participant or the Company of any provision of any law or regulation of any governmental
authority. Any determination in this connection by the Company shall be final, binding, and conclusive. The rights and obligations of
the Company and the rights and obligations of the Participant are subject to all Applicable Laws.
13. Participant’s
Acknowledgments. The Participant acknowledges that a copy of the Plan has been made available for the Participant’s review
by the Company, and represents that he or she is familiar with the terms and provisions thereof, and hereby accepts this Award subject
to all the terms and provisions thereof. The Participant hereby agrees to accept as binding, conclusive, and final all decisions or interpretations
of the Committee or the Board, as appropriate, upon any questions arising under the Plan or this Agreement.
14. Law
Governing. This Agreement shall be governed by, construed, and enforced in accordance with the laws of the State of Texas (excluding
any conflict of laws rule or principle of Texas law that might refer the governance, construction, or interpretation of this Agreement
to the laws of another state).
15. No
Right to Continue Service or Employment. Nothing herein shall be construed to confer upon the Participant the right to continue in
the employ or to provide services to the Company or any Subsidiary, whether as an Employee, Consultant, or Outside Director, or to interfere
with or restrict in any way the right of the Company or any Subsidiary to discharge the Participant as an Employee, Consultant, or Outside
Director at any time.
16. Legal
Construction. In the event that any one or more of the terms, provisions, or agreements that are contained in this Agreement shall
be held by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect for any reason, the invalid, illegal,
or unenforceable term, provision, or agreement shall not affect any other term, provision, or agreement that is contained in this Agreement,
and this Agreement shall be construed in all respects as if the invalid, illegal, or unenforceable term, provision, or agreement had
never been contained herein.
17. Covenants
and Agreements as Independent Agreements. Each of the covenants and agreements that are set forth in this Agreement shall be construed
as a covenant and agreement independent of any other provision of this Agreement. The existence of any claim or cause of action of the
Participant against the Company, whether predicated on this Agreement or otherwise, shall not constitute a defense to the enforcement
by the Company of the covenants and agreements that are set forth in this Agreement.
18. Entire
Agreement. This Agreement together with the Plan supersede any and all other prior understandings and agreements, either oral or
in writing, between the parties with respect to the subject matter hereof and constitute the sole and only agreements between the parties
with respect to the said subject matter. All prior negotiations and agreements between the parties with respect to the subject matter
hereof are merged into this Agreement. Each party to this Agreement acknowledges that no representations, inducements, promises, or agreements,
orally or otherwise, have been made by any party or by anyone acting on behalf of any party, which are not embodied in this Agreement
or the Plan and that any agreement, statement, or promise that is not contained in this Agreement or the Plan shall not be valid or binding
or of any force or effect.
19. Parties
Bound. The terms, provisions, and agreements that are contained in this Agreement shall apply to, be binding upon, and inure to the
benefit of the parties and their respective heirs, executors, administrators, legal representatives, and permitted successors and assigns,
subject to the limitation on assignment expressly set forth herein. No person shall be permitted to acquire any Awarded Shares without
first executing and delivering an agreement in the form satisfactory to the Company making such person or entity subject to the restrictions
on transfer contained herein.
20. Modification.
No change or modification of this Agreement shall be valid or binding upon the parties unless the change or modification is in writing
and signed by the parties. Notwithstanding the preceding sentence, the Company may amend the Plan to the extent permitted by the Plan.
21. Headings.
The headings that are used in this Agreement are used for reference and convenience purposes only and do not constitute substantive matters
to be considered in construing the terms and provisions of this Agreement.
22. Gender
and Number. Words of any gender used in this Agreement shall be held and construed to include any other gender, and words in the
singular number shall be held to include the plural, and vice versa, unless the context requires otherwise.
23. Notice.
Any notice required or permitted to be delivered hereunder shall be deemed to be delivered only when actually received by the Company
or by the Participant, as the case may be, at the addresses set forth below, or at such other addresses as they have theretofore specified
by written notice delivered in accordance herewith:
a. Notice
to the Company shall be addressed and delivered as follows:
Sanara
MedTech Inc.
1200
Summit Ave #414
Fort
Worth, Texas 76102
Attn:
____________________________
Email:
____________________________
b. Notice
to the Participant shall be addressed and delivered as set forth on the signature page.
24. Tax
Requirements. The Participant is hereby advised to consult immediately with his or her own tax advisor regarding the tax consequences
of this Agreement, the method and timing for filing an election to include this Agreement in income under Section 83(b) of the Code,
and the tax consequences of such election. By execution of this Agreement, the Participant agrees that if the Participant makes such
an election, the Participant shall provide the Company with written notice of such election in accordance with the regulations promulgated
under Section 83(b) of the Code. The Company or, if applicable, any Subsidiary (for purposes of this Section 24, the term
“Company” shall be deemed to include any applicable Subsidiary), shall have the right to deduct from all amounts
paid in cash or other form in connection with the Plan and this Agreement, any federal, state, local, or other taxes required by law
to be withheld in connection with this Award. The Company may, in its sole discretion, also require the Participant receiving shares
of Common Stock issued under the Plan to pay the Company the amount of any taxes that the Company is required to withhold in connection
with the Participant’s income arising with respect to this Award. Such payments shall be required to be made when requested by
Company and may be required to be made prior to the removal of any restrictions on such shares or the delivery of any certificate representing
shares of Common Stock, if such certificate is requested by the Participant in accordance with Section 6.4(a) of the Plan. Such
payment may be made by (i) the delivery of cash to the Company in an amount that equals or exceeds (to avoid the issuance of fractional
shares under (iii) below) the required tax withholding obligations of the Company; (ii) if the Company, in its sole discretion, so consents
in writing, the actual delivery by the Participant to the Company of shares of Common Stock that the Participant has not acquired from
the Company within six (6) months prior thereto, which shares so delivered have an aggregate Fair Market Value that equals or exceeds
(to avoid the issuance of fractional shares under (iii) below) the required tax withholding payment; (iii) if the Company, in its sole
discretion, so consents in writing, the Company’s withholding of a number of shares to be delivered upon the vesting of this Award,
which shares so withheld have an aggregate Fair Market Value that equals (but does not exceed) the required tax withholding payment;
or (iv) any combination of (i), (ii), or (iii). The Company may, in its sole discretion, withhold any such taxes from any other cash
remuneration otherwise paid by the Company to the Participant.
25. Counterparts.
This Agreement may be executed in separate counterparts, each of which shall be deemed to be an original, and all of which taken together
shall constitute one and the same agreement between the parties hereto.
[Remainder
of Page Intentionally Left Blank.
Signature
Page Follows]
IN
WITNESS WHEREOF, the Company has caused this Agreement to be executed by its duly authorized officer, and the Participant, to evidence
the Participant’s consent and approval of all the terms hereof, has duly executed this Agreement, as of the date specified in Section
1 hereof.
|
COMPANY: |
|
|
|
SANARA
MEDTECH INC. |
|
|
|
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By: |
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|
Name: |
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|
Title: |
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Exhibit
10.7
FIRST
AMENDMENT TO CONSULTING AGREEMENT
THIS
FIRST AMENDMENT TO CONSULTING AGREEMENT (this “Amendment”) is executed to be effective as of July 13, 2024
(the “Effective Date”) by and between Sanara MedTech Inc., a Texas corporation (the “Company”),
and Ms. Ann Beal Salamone, an individual residing in Florida, for purposes of amending that certain Consulting Agreement executed to
be effective as of July 14, 2021, by and between the Company and Ms. Salamone (the “Agreement”). The Company
and Ms. Salamone may be referred to singularly as “Party” or collectively as “Parties”.
Capitalized terms used but not otherwise defined herein shall have the meanings set forth in the Agreement.
WHEREAS,
the Agreement may be amended by a writing signed by both Parties;
WHEREAS,
consistent with the terms hereof, the Parties desire to amend Sections 6(a), 6(b) and 6(c) of the Agreement to update the termination
and renewal terms of the Agreement; and
WHEREAS,
consistent with the terms hereof, the Parties desire to add Section 7(c) to provide certain exceptions to the confidentiality terms
of the Agreement.
NOW,
THEREFORE, in consideration of the foregoing, of the mutual promises contained herein and of other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the Parties hereby amend the Agreement as follows:
1.
Sections 6(a), 6(b) and 6(c) of the Agreement are hereby amended by deleting said sections in their entirety and replacing them with
the following:
“(a)
This Agreement shall have an initial term of three (3) years and shall be automatically renewed for successive one-year terms for up
to three (3) successive years, unless earlier terminated as set forth herein.
(b)
This Agreement and Consultant’s engagement may be terminated by either party without cause at any time provided that the terminating
party provides ninety (90) days advance written notice of termination to the other party.
(c)
Reserved.”
2.
Section 7 of the Agreement is hereby amended by adding a subsection (c) as follows:
“(c)
Notwithstanding any other provision of this Agreement, (i) Consultant may disclose Confidential Information when required to do so by
a court of competent jurisdiction, by any governmental agency having authority over Consultant or the business of the Company or by any
administrative body or legislative body (including a committee thereof) with jurisdiction to order Consultant to divulge, disclose or
make accessible such information; and (ii) nothing in this Agreement is intended to interfere with Consultant’s right to (a) report
possible violations of state or federal law or regulation to any governmental or law enforcement agency or entity, including the Securities
and Exchange Commission (“SEC”); (b) make other disclosures that are protected under the whistleblower provisions
of state or federal law or regulation; (c) file a claim or charge with the Equal Employment Opportunity Commission (“EEOC”),
any state human rights commission, or any other governmental agency or entity; or (d) testify, assist, or participate in an investigation,
hearing, or proceeding conducted by the SEC, EEOC, any state human rights commission, any other governmental or law enforcement agency
or entity, or any court. For purposes of clarity, in making or initiating any such reports or disclosures or engaging in any of the conduct
outlined in subsection (ii) above, Consultant may disclose Confidential Information to the extent necessary to such governmental or law
enforcement agency or entity or such court, and need not seek prior authorization. Consultant is further notified in accordance with
the Defend Trade Secrets Act of 2016 that she will not be held criminally or civilly liable under any federal or state trade secret law
for the disclosure of a trade secret that: (a) is made (i) in confidence to a federal, state, or local government official, either directly
or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (b)
is made in a complaint or other document that is filed under seal in a lawsuit or other proceeding. Consultant is further notified that
if she files a lawsuit for retaliation against the Company for reporting a suspected violation of law, she may disclose the Company’s
trade secrets to her attorney and use the trade secret information in the court proceeding if she: (a) files any document containing
the trade secret under seal; and (b) does not disclose the trade secret, except pursuant to court order.”
4.
This Amendment supersedes all other prior oral or written agreements between Ms. Salamone and the Company, their respective affiliates
and persons acting on their behalf with respect to the matters discussed herein. Except as specifically set forth in this Amendment,
no other provision of the Agreement shall be deemed amended or modified and the Agreement shall otherwise remain in full force and effect.
*
* * * *
IN
WITNESS WHEREOF, the Parties have caused this Amendment to be duly executed to be effective as of the Effective Date.
|
SANARA
MEDTECH INC. |
|
|
|
|
By: |
/s/
Michael D. McNeil |
|
Name: |
Michael
D. McNeil |
|
Title: |
Chief
Financial Officer |
|
CONSULTANT |
|
|
|
/s/
Ann Beal Salamone |
|
Ann
Beal Salamone |
Signature
Page to
First
Amendment to Consulting Agreement
EXHIBIT
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
IN
ACCORDANCE WITH 18 U.S.C. SECTION 1350,
AS
ADOPTED BY SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Ronald T. Nixon, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Sanara MedTech Inc. for the period ended June 30, 2024; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 12, 2024
/s/
Ronald T. Nixon |
|
Ronald
T. Nixon, Chief Executive Officer |
|
EXHIBIT
31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
IN
ACCORDANCE WITH 18 U.S.C. SECTION 1350,
AS
ADOPTED BY SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Michael D. McNeil, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Sanara MedTech Inc. for the period ended June 30, 2024; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 12, 2024
/s/
Michael D. McNeil |
|
Michael
D. McNeil, Chief Financial Officer |
|
EXHIBIT
32.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
IN
ACCORDANCE WITH 18 U.S.C. SECTION 1350,
AS
ADOPTED BY SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of Sanara MedTech Inc. (the “Company”) for the period ended June 30, 2024
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Ronald T. Nixon, in my capacity
as Chief Executive Officer of the Company and not in my individual capacity, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant
to § 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
|
(1) |
The
Report fully complies with the requirements of section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and |
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company as of, and for, the periods presented in the Report. |
August
12, 2024
/s/
Ronald T. Nixon |
|
Ronald
T. Nixon, Chief Executive Officer |
|
The
foregoing certification is being furnished as an exhibit to the Report pursuant to Item 601(b)(32) of Regulation S-K and Section 906
of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and, accordingly,
is not being filed as part of the Report for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not incorporated
by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language
in such filing.
EXHIBIT
32.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
IN
ACCORDANCE WITH 18 U.S.C. SECTION 1350,
AS
ADOPTED BY SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of Sanara MedTech Inc. (the “Company”) for the period ended June 30, 2024
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael D. McNeil, in my capacity
as Chief Financial Officer of the Company and not in my individual capacity, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant
to § 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
|
(1) |
The
Report fully complies with the requirements of section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and |
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company as of, and for, the periods presented in the Report. |
August
12, 2024
/s/
Michael D. McNeil |
|
Michael
D. McNeil, Chief Financial Officer |
|
The
foregoing certification is being furnished as an exhibit to the Report pursuant to Item 601(b)(32) of Regulation S-K and Section 906
of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) and, accordingly,
is not being filed as part of the Report for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not incorporated
by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language
in such filing.
v3.24.2.u1
Cover - $ / shares
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6 Months Ended |
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Jun. 30, 2024 |
Aug. 09, 2024 |
Cover [Abstract] |
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|
|
Current Fiscal Year End Date |
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|
|
Entity File Number |
001-39678
|
|
Entity Registrant Name |
SANARA
MEDTECH INC.
|
|
Entity Central Index Key |
0000714256
|
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Entity Tax Identification Number |
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Entity Incorporation, State or Country Code |
TX
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Suite 414
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Fort Worth
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TX
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v3.24.2.u1
Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
|
Cash |
$ 6,150,375
|
|
$ 5,147,216
|
Royalty receivable |
|
|
49,344
|
Inventory, net |
3,564,659
|
|
4,717,533
|
Prepaid and other assets |
489,240
|
|
608,411
|
Total current assets |
20,811,428
|
|
19,005,869
|
Long-term assets |
|
|
|
Intangible assets, net |
42,977,404
|
|
44,926,061
|
Goodwill |
3,601,781
|
|
3,601,781
|
Investment in equity securities |
3,084,278
|
|
3,084,278
|
Right of use assets – operating leases |
1,792,448
|
|
1,995,204
|
Property and equipment, net |
1,116,266
|
|
1,257,956
|
Total long-term assets |
52,572,177
|
|
54,865,280
|
Total assets |
73,383,605
|
[1] |
73,871,149
|
Current liabilities |
|
|
|
Accrued bonuses and commissions |
6,715,062
|
|
7,676,770
|
Accrued royalties and expenses |
2,475,488
|
|
2,047,678
|
Earnout liabilities – current |
1,085,549
|
|
1,100,000
|
Current portion of debt |
|
|
580,357
|
Operating lease liabilities – current |
393,663
|
|
361,185
|
Total current liabilities |
11,565,787
|
|
13,767,877
|
Long-term liabilities |
|
|
|
Long-term debt, net of current portion |
14,371,485
|
|
9,113,123
|
Earnout liabilities – long-term |
2,654,001
|
|
2,723,001
|
Operating lease liabilities – long-term |
1,512,584
|
|
1,737,445
|
Other long-term liabilities |
1,877,753
|
|
1,941,686
|
Total long-term liabilities |
20,415,823
|
|
15,515,255
|
Total liabilities |
31,981,610
|
|
29,283,132
|
Commitments and contingencies (Note 8) |
|
|
|
Shareholders’ equity |
|
|
|
Common Stock: $0.001 par value, 20,000,000 shares authorized; 8,746,976 issued and outstanding as of June 30, 2024 and 8,535,239 issued and outstanding as of December 31, 2023 |
8,747
|
|
8,535
|
Additional paid-in capital |
75,085,515
|
|
72,860,556
|
Accumulated deficit |
(33,387,960)
|
|
(28,036,814)
|
Total Sanara MedTech shareholders’ equity |
41,706,302
|
|
44,832,277
|
Equity attributable to noncontrolling interest |
(304,307)
|
|
(244,260)
|
Total shareholders’ equity |
41,401,995
|
|
44,588,017
|
Total liabilities and shareholders’ equity |
73,383,605
|
|
73,871,149
|
Nonrelated Party [Member] |
|
|
|
Current assets |
|
|
|
Accounts receivable |
10,495,742
|
|
8,474,965
|
Current liabilities |
|
|
|
Accounts payable |
750,538
|
|
1,924,082
|
Related Party [Member] |
|
|
|
Current assets |
|
|
|
Accounts receivable |
111,412
|
|
8,400
|
Current liabilities |
|
|
|
Accounts payable |
$ 145,487
|
|
$ 77,805
|
|
|
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v3.24.2.u1
Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
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20,000,000
|
20,000,000
|
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8,746,976
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|
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v3.24.2.u1
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Net Revenue |
$ 20,158,823
|
$ 15,753,164
|
$ 38,695,461
|
$ 31,275,081
|
Cost of goods sold |
2,008,686
|
2,187,516
|
3,898,732
|
4,313,175
|
Gross profit |
18,150,137
|
13,565,648
|
34,796,729
|
26,961,906
|
Operating expenses |
|
|
|
|
Selling, general and administrative expenses |
18,957,608
|
13,811,476
|
35,149,867
|
26,780,545
|
Research and development |
985,651
|
1,177,128
|
1,931,949
|
2,494,452
|
Depreciation and amortization |
1,105,507
|
803,694
|
2,210,927
|
1,582,569
|
Change in fair value of earnout liabilities |
(13,773)
|
(360,470)
|
(79,451)
|
(813,157)
|
Total operating expenses |
21,034,993
|
15,431,828
|
39,213,292
|
30,044,409
|
Operating loss |
(2,884,856)
|
(1,866,180)
|
(4,416,563)
|
(3,082,503)
|
Other expense |
|
|
|
|
Interest expense |
(644,346)
|
|
(911,682)
|
(6)
|
Total other expense |
(644,346)
|
|
(911,682)
|
(6)
|
Net loss |
(3,529,202)
|
(1,866,180)
|
(5,328,245)
|
(3,082,509)
|
Less: Net loss attributable to noncontrolling interest |
(25,188)
|
(38,447)
|
(60,047)
|
(76,876)
|
Net loss attributable to Sanara MedTech shareholders |
$ (3,504,014)
|
$ (1,827,733)
|
$ (5,268,198)
|
$ (3,005,633)
|
Net loss per share of common stock, basic |
$ (0.41)
|
$ (0.22)
|
$ (0.62)
|
$ (0.37)
|
Net loss per share of common stock, diluted |
$ (0.41)
|
$ (0.22)
|
$ (0.62)
|
$ (0.37)
|
Weighted average number of common shares outstanding, basic |
8,468,835
|
8,226,271
|
8,444,101
|
8,200,173
|
Weighted average number of common shares outstanding, diluted |
8,468,835
|
8,226,271
|
8,444,101
|
8,200,173
|
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v3.24.2.u1
Consolidated Statements of Changes in Shareholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Noncontrolling Interest [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 8,300
|
$ 65,213,987
|
$ (23,394,757)
|
$ (107,555)
|
$ 41,719,975
|
Balance, shares at Dec. 31, 2022 |
8,299,957
|
|
|
|
|
Share-based compensation |
$ 75
|
597,230
|
|
|
597,305
|
Share-based compensation, shares |
74,781
|
|
|
|
|
Net settlement and retirement of equity-based awards |
$ (16)
|
(315,572)
|
(340,354)
|
|
(655,942)
|
Net settlement and retirement of equity-based awards, shares |
(15,854)
|
|
|
|
|
Issuance of common stock in equity offering |
$ 26
|
1,033,735
|
|
|
1,033,761
|
Issuance of common stock in equity offering, shares |
26,143
|
|
|
|
|
Net income (loss) |
|
|
(1,177,900)
|
(38,429)
|
(1,216,329)
|
Balance at Mar. 31, 2023 |
$ 8,385
|
66,529,380
|
(24,913,011)
|
(145,984)
|
41,478,770
|
Balance, shares at Mar. 31, 2023 |
8,385,027
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 8,300
|
65,213,987
|
(23,394,757)
|
(107,555)
|
41,719,975
|
Balance, shares at Dec. 31, 2022 |
8,299,957
|
|
|
|
|
Net income (loss) |
|
|
|
|
(3,082,509)
|
Balance at Jun. 30, 2023 |
$ 8,440
|
67,881,419
|
(26,740,930)
|
(184,431)
|
40,964,498
|
Balance, shares at Jun. 30, 2023 |
8,439,745
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 8,300
|
65,213,987
|
(23,394,757)
|
(107,555)
|
41,719,975
|
Balance, shares at Dec. 31, 2022 |
8,299,957
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 8,535
|
72,860,556
|
(28,036,814)
|
(244,260)
|
44,588,017
|
Balance, shares at Dec. 31, 2023 |
8,535,239
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 8,385
|
66,529,380
|
(24,913,011)
|
(145,984)
|
41,478,770
|
Balance, shares at Mar. 31, 2023 |
8,385,027
|
|
|
|
|
Share-based compensation |
$ 33
|
1,127,299
|
|
|
1,127,332
|
Share-based compensation, shares |
33,355
|
|
|
|
|
Net settlement and retirement of equity-based awards |
$ 22
|
224,740
|
(186)
|
|
224,576
|
Net settlement and retirement of equity-based awards, shares |
21,363
|
|
|
|
|
Net income (loss) |
|
|
(1,827,733)
|
(38,447)
|
(1,866,180)
|
Balance at Jun. 30, 2023 |
$ 8,440
|
67,881,419
|
(26,740,930)
|
(184,431)
|
40,964,498
|
Balance, shares at Jun. 30, 2023 |
8,439,745
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 8,535
|
72,860,556
|
(28,036,814)
|
(244,260)
|
44,588,017
|
Balance, shares at Dec. 31, 2023 |
8,535,239
|
|
|
|
|
Share-based compensation |
$ 101
|
803,285
|
|
|
803,386
|
Share-based compensation, shares |
100,662
|
|
|
|
|
Net settlement and retirement of equity-based awards |
$ (13)
|
(483,633)
|
(97,148)
|
|
(580,794)
|
Net settlement and retirement of equity-based awards, shares |
(13,162)
|
|
|
|
|
Net income (loss) |
|
|
(1,764,184)
|
(34,859)
|
(1,799,043)
|
Balance at Mar. 31, 2024 |
$ 8,623
|
73,180,208
|
(29,898,146)
|
(279,119)
|
43,011,566
|
Balance, shares at Mar. 31, 2024 |
8,622,739
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 8,535
|
72,860,556
|
(28,036,814)
|
(244,260)
|
44,588,017
|
Balance, shares at Dec. 31, 2023 |
8,535,239
|
|
|
|
|
Net income (loss) |
|
|
|
|
(5,328,245)
|
Balance at Jun. 30, 2024 |
$ 8,747
|
75,085,515
|
(33,387,960)
|
(304,307)
|
41,401,995
|
Balance, shares at Jun. 30, 2024 |
8,746,976
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 8,623
|
73,180,208
|
(29,898,146)
|
(279,119)
|
43,011,566
|
Balance, shares at Mar. 31, 2024 |
8,622,739
|
|
|
|
|
Share-based compensation |
$ 67
|
1,411,478
|
|
|
1,411,545
|
Share-based compensation, shares |
67,294
|
|
|
|
|
Net settlement and retirement of equity-based awards |
$ 57
|
493,829
|
14,200
|
|
508,086
|
Net settlement and retirement of equity-based awards, shares |
56,943
|
|
|
|
|
Net income (loss) |
|
|
(3,504,014)
|
(25,188)
|
(3,529,202)
|
Balance at Jun. 30, 2024 |
$ 8,747
|
$ 75,085,515
|
$ (33,387,960)
|
$ (304,307)
|
$ 41,401,995
|
Balance, shares at Jun. 30, 2024 |
8,746,976
|
|
|
|
|
X |
- DefinitionStock issued during period shares for net settlement and retirement of equity based awards.
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v3.24.2.u1
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (5,328,245)
|
$ (3,082,509)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
2,210,927
|
1,582,569
|
Credit loss expense |
155,930
|
86,000
|
Inventory obsolescence |
259,577
|
69,990
|
Share-based compensation |
2,214,931
|
1,724,637
|
Noncash lease expense |
202,756
|
144,628
|
Back-end fee |
52,500
|
|
Paid-in-kind interest |
161,875
|
|
Accretion of finance liabilities |
117,267
|
|
Amortization and write-off of debt issuance costs |
100,883
|
|
Change in fair value of earnout liabilities |
(79,451)
|
(813,157)
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable, net |
(2,127,363)
|
(371,094)
|
Accounts receivable – related parties |
(103,012)
|
77,886
|
Inventory, net |
893,297
|
(941,854)
|
Prepaid and other assets |
119,172
|
618,877
|
Accounts payable |
(1,173,544)
|
(376,521)
|
Accounts payable – related parties |
67,682
|
62,620
|
Accrued royalties and expenses |
402,610
|
(248,769)
|
Accrued bonuses and commissions |
(961,709)
|
(1,859,029)
|
Operating lease liabilities |
(192,383)
|
(135,436)
|
Net cash used in operating activities |
(3,006,300)
|
(3,461,162)
|
Cash flows from investing activities: |
|
|
Purchases of property and equipment |
(124,580)
|
(40,650)
|
Proceeds from disposal of property and equipment |
|
650
|
Net cash used in investing activities |
(124,580)
|
(40,000)
|
Cash flows from financing activities: |
|
|
Loan proceeds, net |
14,112,747
|
|
Pay off line of credit |
(9,750,000)
|
|
Equity offering net proceeds |
|
1,033,761
|
Net settlement of equity-based awards |
(72,708)
|
(431,366)
|
Cash payment of finance and earnout liabilities |
(156,000)
|
|
Net cash provided by financing activities |
4,134,039
|
602,395
|
Net increase (decrease) in cash |
1,003,159
|
(2,898,767)
|
Cash, beginning of period |
5,147,216
|
8,958,995
|
Cash, end of period |
6,150,375
|
6,060,228
|
Cash paid during the period for: |
|
|
Interest |
549,227
|
6
|
Supplemental noncash investing and financing activities: |
|
|
Right of use assets obtained in exchange for lease obligations |
|
$ 1,369,164
|
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
Net Income (Loss) |
$ (3,504,014)
|
$ (1,827,733)
|
$ (5,268,198)
|
$ (3,005,633)
|
X |
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v3.24.2.u1
NATURE OF BUSINESS AND BACKGROUND
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
NATURE OF BUSINESS AND BACKGROUND |
NOTE
1 – NATURE OF BUSINESS AND BACKGROUND
Sanara
MedTech Inc. (together with its wholly owned and majority owned subsidiaries on a consolidated basis, the “Company”) is a
medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce
healthcare expenditures in the surgical, chronic wound and skincare markets. Each of the Company’s products, services and technologies
are designed to achieve the Company’s goal of providing better clinical outcomes at a lower overall cost for patients regardless
of where they receive care. The Company strives to be one of the most innovative and comprehensive providers of effective surgical, wound
and skincare solutions and is continually seeking to expand its offerings for patients requiring treatments across the entire continuum
of care in the United States.
In
June 2020, the Company formed a subsidiary, United Wound and Skin Solutions, LLC (formerly known as “WounDerm”), to hold
certain investments and operations in wound and skincare virtual consult services. In 2023, WounDerm was renamed and is now doing business
as “Tissue Health Plus” (“THP”). THP is continuing its mission to simplify skin health, starting with
wound care through a refined business plan. Through THP, the Company plans to offer a first of its kind value-based wound care program
to payers and risk-bearing entities such as accountable care organizations and value-based care primary care companies, with Medicare
Advantage payers as the initial target market for this program.
As
further discussed in Note 11, the Company historically managed its business on the basis of one operating and reportable segment. During
the second quarter of 2024, the Company changed its reportable segments to reflect the manner in which the business is currently managed.
Based on the growing importance of the value-based wound care program to the Company’s future outlook and how the Company’s
chief operating decision maker, the Chief Executive Officer, reviews operating results and makes decisions about resource allocation,
the Company now has two reportable segments: Sanara Surgical and THP.
Sanara
Surgical
The
Sanara Surgical segment primarily markets and sells soft tissue repair and bone fusion products for use in the operating room or
other sterile environments. Sanara Surgical’s soft tissue repair products include, among other products, the Company’s
lead product, CellerateRX Surgical Activated Collagen (“CellerateRX Surgical”), and BIASURGE Advanced Surgical Solution, which
is a no-rinse, advanced surgical solution used for wound irrigation. Sanara Surgical’s bone fusion products include, among
other products, BiFORM, which is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site,
and ALLOCYTE Plus, which is a human allograft cellular bone matrix containing bone-derived progenitor cells and conformable bone
fibers.
Sanara
Surgical also includes an in-house research and development team (Rochal Technologies) with an extensive pipeline of innovative products
under development.
Tissue
Health Plus
The
THP segment is focused on value-based wound care services. Through THP, the Company plans to offer a first of its kind
value-based wound care program to payers and risk-bearing entities such as accountable care organizations and value-based care
(“VBC”) primary care companies, with Medicare Advantage payers as the initial target market for this
program.
THP’s
programs are expected to enable payers to divest wound care spend risk, reduce wound related hospitalizations and improve patient
quality of life. THP plans to coordinate delivery of community and home-based wound care for its managed patients. Community-based
care spans a variety of settings including physician offices, skilled nursing facilities, assisted living facilities and senior living
facilities. THP’s programs are intended to integrate science and evidence-based medicine protocols to standardize wound prevention and
treatment.
As
a result of the change in reportable segments, certain prior period amounts have been recast to conform to the current period presentation.
Throughout this Quarterly Report on Form 10-Q, unless otherwise indicated, amounts and activity reflect reclassifications related to
the Company’s change in reportable segments. The change in reportable segments had no impact on the Company’s Consolidated
Balance Sheets, Statements of Operations, Cash Flows and Shareholders’ Equity
previously reported.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation and Basis of Presentation
The
accompanying unaudited consolidated financial statements include the accounts of Sanara MedTech Inc. and its wholly owned and majority-owned
subsidiaries, as well as other entities in which the Company has a controlling financial interest. All significant intercompany profits,
losses, transactions and balances have been eliminated in consolidation. Certain prior year amounts have been reclassified to conform
to the current year presentation.
The
accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles
for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include
all the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the
opinion of management of the Company, all adjustments (consisting of normal accruals) considered necessary for a fair presentation
have been included. Operating results for interim periods are not necessarily indicative of the results that may be expected for the
full year period. These financial statements and notes should be read in conjunction with the financial statements for each of the two
years ended December 31, 2023 and 2022, which are included in the Company’s most recent Annual Report on Form 10-K.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date
of the consolidated financial statements, and the reported revenue and expenses during the reporting period. However, actual results
could differ from those estimates and there may be changes to the Company’s estimates in future periods.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.
Income/Loss
Per Share
The
Company computes income/loss per share in accordance with Accounting Standards Codification (“ASC”) Topic 260, Earnings per
Share, which requires the Company to present basic and diluted income per share when the effect is dilutive. Basic income per share is
computed by dividing income available to common shareholders by the weighted average number of shares of common stock outstanding. Diluted
income per share is computed similarly to basic income per share, except that the denominator is increased to include the number of additional
shares of common stock that would have been outstanding if the potential shares of common stock had been issued and if the additional
shares of common stock were dilutive. All common stock equivalents were excluded from the calculations for the periods presented as their
inclusion would have been anti-dilutive during the six months ended June 30, 2024 and 2023 due to the Company’s net loss.
The
following table summarizes the shares of common stock that were potentially issuable but were excluded from the computation of diluted
net loss per share for the six months ended June 30, 2024 and 2023 as such shares would have had an anti-dilutive effect:
SCHEDULE
OF COMPUTATION OF DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | |
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Stock options
(a) | |
| 31,013 | | |
| 124,191 | |
Warrants (b) | |
| 16,725 | | |
| 16,725 | |
Unvested restricted stock | |
| 230,277 | | |
| 164,755 | |
Anti-dilutive securities | |
| 230,277 | | |
| 164,755 | |
|
(a) |
Shares
underlying stock options assumed pursuant to the merger agreement with Precision Healing, Inc. (“Precision Healing”)
in April 2022. |
|
(b) |
Shares
underlying warrants assumed pursuant to the merger agreement with Precision Healing in April 2022. |
Revenue
Recognition
The
Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Revenues
are recognized when a purchase order is received from the customer and control of the promised goods or services is transferred to the
customer in an amount that reflects the consideration the Company expects to be entitled to receive in exchange for transferring those
goods or services. Revenue is recognized based on the following five-step model:
-
Identification of the contract with a customer
-
Identification of the performance obligations in the contract
-
Determination of the transaction price
-
Allocation of the transaction price to the performance obligations in the contract
-
Recognition of revenue when, or as, the Company satisfies a performance obligation
Details
of this five-step process are as follows:
Identification
of the contract with a customer
Customer
purchase orders are generally considered to be contracts under ASC 606. Purchase orders typically identify the specific terms of products
to be delivered, create the enforceable rights and obligations of both parties and result in commercial substance. No other forms of
contract revenue recognition, such as the completed contract or percentage of completion methods, were utilized by the Company in either
2024 or 2023.
Performance
obligations
The
Company’s performance obligation is generally limited to delivery of the requested items to its customers at the agreed upon quantities
and prices.
Determination
and allocation of the transaction price
The
Company has established prices for its products. These prices are effectively agreed to when customers place purchase orders with the
Company. Rebates and discounts, if any, are recognized in full at the time of sale as a reduction of net revenue. Allocation of transaction
prices is not necessary where only one performance obligation exists.
Recognition
of revenue as performance obligations are satisfied
Product
revenues are recognized when a purchase order is received from the customer, the products are delivered and control of the goods and
services passes to the customer.
Disaggregation
of Revenue
Revenue
streams from product sales and royalties are summarized below for the three and six months ended June 30, 2024 and 2023.
SCHEDULE
OF REVENUE FROM PRODUCT SALES AND ROYALTIES
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Soft tissue repair products | |
$ | 17,641,318 | | |
$ | 13,249,742 | | |
$ | 33,723,610 | | |
$ | 26,122,223 | |
Bone fusion products | |
| 2,516,599 | | |
| 2,453,172 | | |
| 4,970,945 | | |
| 5,052,358 | |
Royalty revenue | |
| 906 | | |
| 50,250 | | |
| 906 | | |
| 100,500 | |
Total Net Revenue | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | 38,695,461 | | |
$ | 31,275,081 | |
Accounts
Receivable Allowances
Accounts
receivable are typically due within 30 days of invoicing. The Company establishes an allowance for credit losses to provide for an estimate
of accounts receivable which are not expected to be collectible. The Company bases the allowance on an assessment of customer creditworthiness,
historical payment experience, the age of outstanding receivables and other information as applicable and will record its allowance based
on the estimated credit losses. The Company recorded credit loss expense of $90,930 and $50,000 during the three months ended June 30,
2024 and 2023, respectively and $155,930 and $86,000 during the six months ended June 30, 2024 and 2023, respectively. The allowance
for credit losses was $683,960 at June 30, 2024 and $528,030 at December 31, 2023. Credit loss reserves are maintained based on a variety
of factors, including the length of time receivables are past due and a detailed review of certain individual customer accounts. The
Company also establishes other allowances to provide for estimated customer rebates and other expected customer deductions. These allowances
totaled $4,437 at June 30, 2024 and $3,820 at December 31, 2023. If circumstances related to customers change, estimates of the recoverability
of receivables would be further adjusted.
Inventories
Inventories
are stated at the lower of cost or net realizable value, with cost computed on a first-in, first-out basis. Inventories consist primarily
of finished goods, and also include an immaterial amount of raw materials and related packaging components. The Company recorded inventory
obsolescence expense of $164,342 and $39,479 during the three months ended June 30, 2024 and 2023, respectively, and $259,577 and $69,990
during the six months ended June 30, 2024 and 2023, respectively. The allowance for obsolete and slow-moving inventory had a balance
of $467,508 at June 30, 2024, and $446,917 at December 31, 2023.
Property
and Equipment
Property
and equipment are stated at cost, less accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated
useful lives of the related assets, ranging from two to ten years. Below is a summary of property and equipment for the periods presented:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
Useful | |
June 30, | | |
December 31, | |
| |
Life | |
2024 | | |
2023 | |
Computers | |
3-5 years | |
$ | 230,532 | | |
$ | 194,788 | |
Office equipment | |
3-7 years | |
| 214,190 | | |
| 201,785 | |
Furniture and fixtures | |
5-10 years | |
| 346,508 | | |
| 304,338 | |
Leasehold improvements | |
2-5 years | |
| 168,431 | | |
| 134,170 | |
Internal use software | |
5 years | |
| 1,618,999 | | |
| 1,618,999 | |
| |
| |
| | | |
| | |
Property and equipment, gross | |
| |
| 2,578,660 | | |
| 2,454,080 | |
Less accumulated depreciation | |
| |
| (1,462,394 | ) | |
| (1,196,124 | ) |
| |
| |
| | | |
| | |
Property and equipment, net | |
| |
$ | 1,116,266 | | |
$ | 1,257,956 | |
Depreciation
expense related to property and equipment was $133,301 and $108,492 for the three months ended June 30, 2024 and 2023, respectively,
and $266,270 and $216,166 for the six months ended June 30, 2024 and 2023, respectively.
Internal
Use Software
The
Company accounts for costs incurred to develop or acquire computer software for internal use in accordance with ASC Topic 350-40, Intangibles
– Goodwill and Other. The Company capitalizes the costs incurred during the application development stage, which generally includes
third-party developer fees to design the software configuration and interfaces, coding, installation and testing.
The
Company begins capitalization of qualifying costs when both the preliminary project stage is completed and management has authorized
further funding for the completion of the project. Costs incurred during the preliminary project stage along with post implementation
stages of internal-use computer software are expensed as incurred. The Company also capitalizes costs related to specific upgrades and
enhancements when it is probable the expenditures will result in additional functionality. Capitalized development costs are classified
as “Property and equipment, net” in the Consolidated Balance Sheets and are depreciated over the estimated useful life of
the software, which is generally five years.
Goodwill
The
excess of purchase price over the fair value of identifiable net assets acquired in business combinations is recorded as goodwill. As
of June 30, 2024 and December 31, 2023, all of the Company’s goodwill relates to the acquisition of Scendia Biologics, LLC (“Scendia”), which is included in the Sanara Surgical segment. Goodwill has an indefinite useful life and is not amortized. Goodwill is tested annually
as of December 31 for impairment, or more frequently if circumstances indicate impairment may have occurred. The Company may first perform
a qualitative assessment to determine if it is more likely than not that the fair value of the reporting unit is less than the respective
carrying value. If it is determined that it is more likely than not that a reporting unit’s fair value is less than its carrying
value, then the Company will determine the fair value of the reporting unit and record an impairment charge for the difference between
fair value and carrying value (not to exceed the carrying amount of goodwill). No impairment was recorded during the six months ended
June 30, 2024 or 2023.
Intangible
Assets
Intangible
assets are stated at cost of acquisition less accumulated amortization and impairment loss, if any. Cost of acquisition includes the
purchase price and any cost directly attributable to bringing the asset to its working condition for the intended use. The Company amortizes
its finite-lived intangible assets on a straight-line basis over the estimated useful life of the respective assets which is generally
the life of the related patents or licenses, seven years for customer relationships and five years for assembled workforces. See Note
4 for more information on intangible assets.
Impairment
of Long-Lived Assets
Long-lived
assets, including certain identifiable intangibles held and to be used by the Company, are reviewed for impairment whenever events or
changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The Company continuously evaluates
the recoverability of its long-lived assets based on estimated future cash flows and the estimated liquidation value of such long-lived
assets and provides for impairment if such undiscounted cash flows are insufficient to recover the carrying amount of the long-lived
assets. If impairment exists, an adjustment is made to write the asset down to its fair value, and a loss is recorded as the difference
between the carrying value and fair value. Fair values are determined based on quoted market values, undiscounted cash flows or internal
and external appraisals, as applicable. Assets to be disposed of are carried at the lower of carrying value or estimated fair value less
cost to sell. No impairment was recorded during the six months ended June 30, 2024 or 2023.
Investments
in Equity Securities
The
Company’s equity investments consist of nonmarketable equity securities in privately held companies without readily determinable
fair values. Unless accounted for under the equity method of accounting, the investments are reported at cost minus impairment, if any,
plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the
same issuer. The Company did not have any investments which are recorded applying the equity method of accounting as of June 30, 2024.
The
Company has reviewed the carrying value of its investments and has determined there was no impairment or observable price changes as
of or for the six months ended June 30, 2024 and 2023.
Fair
Value Measurement
As
defined in ASC Topic 820, Fair Value Measurement (“ASC 820”), fair value is the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price).
The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including
assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable,
market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to
measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or
liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). This fair value measurement
framework applies at both the initial and subsequent measurement.
The
three levels of the fair value hierarchy defined by ASC 820 are as follows:
Level
1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets
are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on
an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and
listed equities.
Level
2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly
observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies.
These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities,
time value, volatility factors, and current market and contractual prices for the underlying instruments, as well as other relevant economic
measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be
derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments
in this category generally include nonexchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
Level
3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used
with internally developed methodologies that result in management’s best estimate of fair value.
The
carrying amounts of cash, accounts receivable, accounts payable and accrued expenses, other than acquisition-related expenses, approximate
fair value because of the short-term nature of these instruments. The fair value of acquisition-related accrued expenses is categorized
as Level 2 of the fair value hierarchy. The value of these instruments has been estimated using discounted cash flow analysis based on
the Company’s incremental borrowing rate. The carrying value of the Company’s CRG Term Loan (defined below), which has a
fixed interest rate approximates fair value based on instruments with similar terms (Level 2 inputs). The carrying value of the Company’s
Cadence Term Loan (defined below), which had variable interest rates determined each month, approximates fair value based on instruments
with similar terms (Level 2 inputs). The fair value of the contingent earnout consideration and the acquisition date fair value of goodwill
and intangibles related to the acquisitions discussed in Notes 3 and 4 are based on Level 3 inputs.
Liabilities
for contingent consideration for the Precision Healing merger, acquisition of Scendia and Applied Asset Purchase (defined below)
(see Note 3 for more information) are measured at fair value each reporting period, with the acquisition-date fair value included as
part of the consideration transferred. Subsequent changes in fair value for the Precision Healing merger and Scendia acquisition are
reported under the line item captioned “Change in fair value of earnout liabilities” in the Company’s Consolidated
Statements of Operations. Due to the Applied Asset Purchase being accounted for as an asset acquisition and given that the
transaction did not include contingent shares, subsequent revaluations of contingent consideration for the Applied Asset Purchase
results in an adjustment to the contingent consideration liability and the intellectual property intangible asset with a cumulative
catch-up amortization adjustment. The current year changes in fair value of earnout liabilities below are as a result of a net
decrease in the estimated fair value of the earnout liabilities established at the time of the Company’s Precision Healing
merger and Scendia acquisition. The current year revaluation of earnout liability below is a result of a decrease in the estimated
value of the earnout liability established at the time of the Applied Asset Purchase. The following table sets forth a summary of
the changes in fair value for the Level 3 contingent earnout considerations.
SCHEDULE
OF CHANGES IN FAIR VALUE FOR CONTINGENT EARNOUT CONSIDERATION
| |
| | |
Balance at December 31, 2023 | |
$ | 3,823,001 | |
Changes in fair value of earnout liabilities | |
| (79,451 | ) |
Revaluation of earnout liability | |
| (4,000 | ) |
Balance at June 30, 2024 | |
$ | 3,739,550 | |
Income
Taxes
Income
taxes are accounted for under the asset and liability method, whereby deferred income taxes are recorded for temporary differences between
financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax
rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it
is more likely than not that some or all the deferred tax asset will not be realized.
Share-based
Compensation
The
Company accounts for share-based compensation to employees and nonemployees in accordance with ASC Topic 718, Compensation – Share
Compensation. Share-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as expense
over the stipulated vesting period, if any. The Company estimates the fair value of share-based payments using the Black-Scholes option-pricing
model for common stock options and warrants, and the closing price of the Company’s common stock for grants of common stock, including
restricted stock awards.
Research
and Development Costs
Research
and development (“R&D”) expenses consist of personnel-related expenses, including salaries share-based compensation
and benefits for all personnel directly engaged in R&D activities, contracted services, materials, prototype expenses and
allocated overhead which is comprised of compensation and benefits, lease expense and other facilities-related costs. R&D
expenses include costs related to enhancements to the Company’s currently available products and additional investments in the
product and platform development pipeline. The Company expenses R&D costs as incurred.
Recently
Adopted Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”)
2016-13, Financial Instruments - Credit Losses (Topic 326). This update amends the impairment model by requiring entities to use a
forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments
that are not measured at fair value through net income. The Company adopted the new guidance effective January 1, 2023. The adoption
did not have a material impact on the Company’s consolidated financial position, results of operations or cash
flows.
Recently
Issued Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU
2023-07”), which requires disclosure of incremental segment information on an annual and interim basis. ASU 2023-07 is effective
for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective
basis. The Company is currently evaluating the effect of this pronouncement on its disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”),
which expands the disclosure required for income taxes. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024,
with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The
Company is currently evaluating the effect of this pronouncement on its disclosures.
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v3.24.2.u1
APPLIED ASSET PURCHASE
|
6 Months Ended |
Jun. 30, 2024 |
Applied Asset Purchase |
|
APPLIED ASSET PURCHASE |
NOTE
3 – APPLIED ASSET PURCHASE
On
August 1, 2023, the Company entered into an Asset Purchase Agreement (the “Applied Purchase Agreement”) by and among the
Company, as guarantor, Sanara MedTech Applied Technologies, LLC, a Texas limited liability company and wholly owned subsidiary of the
Company (“SMAT”), The Hymed Group Corporation, a Delaware corporation (“Hymed”), Applied Nutritionals, LLC, a
Delaware limited liability company (“Applied”, and together with Hymed, the “Sellers”), and Dr. George D. Petito
(the “Owner”), pursuant to which SMAT acquired certain assets of the Sellers and the Owner, including, among others, the
Sellers’ and Owner’s inventory, intellectual property, manufacturing and related equipment, goodwill, rights and claims,
other than certain excluded assets, all as more specifically set forth in the Applied Purchase Agreement (collectively, the “Applied
Purchased Assets”), and assumed certain Assumed Liabilities (as defined in the Applied Purchase Agreement), upon the terms and
subject to the conditions set forth in the Applied Purchase Agreement (such transaction, the “Applied Asset Purchase”). The
Applied Purchased Assets include the underlying intellectual property of, as well as the rights to manufacture and sell, certain hydrolyzed
collagen products, including CellerateRX Surgical, for human wound care use.
The
Applied Purchased Assets were purchased for an initial aggregate purchase price of $15.25 million, consisting of (i) $9.75 million in
cash (the “Cash Closing Consideration”), (ii) 73,809 shares of the Company’s common stock (the “Stock Closing
Consideration”) with an agreed upon value of $3.0 million and (iii) $2.5 million in cash (the “Installment Payments”),
to be paid in four equal installments on each of the next four anniversaries of the closing of the Applied Asset Purchase (the “Closing”).
Prior
to the Closing, the Company licensed certain of its products from Applied through a sublicense agreement (the “Sublicense Agreement”)
with CGI Cellerate RX, LLC (“CGI Cellerate RX”), a related party (see Note 10 for additional information regarding transactions
with related parties). Pursuant to the Sublicense Agreement, the Company has an exclusive, world-wide sublicense to distribute certain
hydrolyzed collagen products, including CellerateRX Surgical, into the surgical and wound care markets. In connection with the Applied
Asset Purchase, Applied assigned its license agreement with CGI Cellerate RX to SMAT.
In
addition to the Cash Closing Consideration, Stock Closing Consideration and Installment Payments, the Applied Purchase Agreement provides
that the Sellers are entitled to receive up to an additional $10.0 million (the “Applied Earnout”), which is payable to the
Sellers in cash, upon the achievement of certain performance thresholds relating to SMAT’s collections from net sales of a collagen-based
product currently under development. Upon expiration of the seventh anniversary of the Closing, to the extent the Sellers have not earned
the entirety of the Applied Earnout, SMAT shall pay the Sellers a pro-rata amount of the Applied Earnout based on collections from net
sales of the product, with such amount to be due credited against any Applied Earnout payments already made by SMAT (the “True-Up
Payment”). The Applied Earnout, minus the True-Up Payment and any Applied Earnout payments already made by SMAT, may be earned
at any point in the future, including after the True-Up Payment is made.
In
connection with the Applied Asset Purchase and pursuant to the Applied Purchase Agreement, effective August 1, 2023, the Company entered
into a professional services agreement (the “Petito Services Agreement”) with the Owner, pursuant to which the Owner, as
an independent contractor, agreed to provide certain services to the Company, including, among other things, assisting with the development
of products already in development and assisting with research, development, formulation, invention and manufacturing of any future products
(the “Petito Services”). As consideration for the Petito Services, the Owner is entitled to receive: (i) a base salary of
$12,000 per month during the term of the Petito Services Agreement, (ii) a royalty payment equal to three percent (3%) of the actual
collections from net sales of certain products the Owner develops or co-develops that reach commercialization, (iii) a royalty payment
equal to five percent (5%) for the first $50.0 million in aggregate collections from net sales of certain future products and a royalty
payment of two and one-half percent (2.5%) on aggregate collections from net sales of certain future products on any amounts exceeding
$50.0 million but up to $100.0 million, (iv) $500,000 in cash in the event that 510(k) clearance is issued for any future product accepted
by the Company and (v) $1.0 million in cash in the event that a U.S. patent is issued for a certain product; provided that with respect
to the incentive payments described in (iv) and (v) of the foregoing, the Owner shall not earn more than $2.5 million.
The
Petito Services Agreement has an initial term of three years and is subject to automatic successive one-month renewals unless earlier
terminated in accordance with its terms. The Petito Services Agreement may be terminated upon the Owner’s death or disability or
by the Company or the Owner “For Cause” (as defined in the Petito Services Agreement); provided, however, that the base salary
described in (i) of the foregoing paragraph shall survive termination through the three-year initial term and the royalty payments and
incentive payments described in (ii)-(v) of the foregoing paragraph shall survive termination of the Petito Services Agreement.
As
the contingent consideration was negotiated as part of the transfer of assets, the contingent obligation was measured at fair value and
included in the total purchase consideration transferred. Accordingly, since the Applied Asset Purchase was accounted for as an asset
acquisition and did not include contingent shares, the contingent consideration is classified as a liability at its estimated fair value
at each reporting period with subsequent revaluations recognized as an adjustment to the intellectual property intangible asset and the
earnout liability with a cumulative catch-up amortization adjustment.
The
total purchase consideration for the Applied Asset Purchase as determined by the Company was as follows:
SCHEDULE
OF ASSET PURCHASE CONSIDERATIONS
Consideration | |
Equity Shares | | |
Dollar Value | |
Cash Closing Consideration | |
| | | |
$ | 9,750,000 | |
Fair value of Stock Closing Consideration | |
| 73,809 | | |
| 3,089,645 | |
Fair value of Installment Payments | |
| | | |
| 2,040,808 | |
Cash paid for inventory | |
| | | |
| 30,007 | |
Fair value of Petito Services Agreement defined payments | |
| | | |
| 825,834 | |
Fair value of Petito Services Agreement contingent consideration | |
| | | |
| 893,000 | |
Direct transaction costs | |
| | | |
| 162,743 | |
Total purchase consideration | |
| | | |
$ | 16,792,037 | |
Based
on guidance provided by ASC 805, Business Combinations (“ASC 805”), the Company recorded the Applied Asset Purchase as
an asset acquisition due to the determination that substantially all the fair value of the assets acquired was concentrated in a
group of similar identifiable assets. The Company believes the “substantially all” criterion was met with respect to the
acquired intellectual property being the only significant asset acquired. Accordingly, the Company accounted for the transaction as
an asset acquisition.
The
purchase consideration, plus transaction costs, was allocated to the individual assets according to their fair values as a percentage
of the total fair value of the assets purchased, with no goodwill recognized. Based on the estimated fair value of the gross assets acquired,
the total fair value of the net assets acquired was primarily attributable to, and classified as, finite-lived intellectual property
in the third quarter of 2023. The total purchase consideration was allocated based on the relative estimated fair value of such assets
as follows:
SCHEDULE
OF PURCHASE CONSIDERATION ON FAIR VALUE OF ASSETS ACQUIRED
Description | |
Amount | |
Inventory | |
$ | 30,007 | |
Equipment | |
| 33,062 | |
Intellectual property | |
| 16,728,968 | |
Net assets acquired | |
$ | 16,792,037 | |
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v3.24.2.u1
GOODWILL AND INTANGIBLES, NET
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
GOODWILL AND INTANGIBLES, NET |
NOTE
4 – GOODWILL AND INTANGIBLES, NET
The
changes in the carrying amount of the Company’s goodwill were as follows:
SCHEDULE
OF CHANGES IN THE CARRYING AMOUNT OF THE GOODWILL
| |
Total | |
Balance as of December 31, 2022 | |
$ | 3,601,781 | |
Acquisitions | |
| - | |
Balance as of December 31, 2023 | |
| 3,601,781 | |
Acquisitions | |
| - | |
Balance as of June 30, 2024 | |
$ | 3,601,781 | |
In connection with the change in reportable operating segments, the Company
reassessed goodwill with respect to the change in reportable operating segments as they are presented in this report. Goodwill was recorded in connection
with the acquisition of Scendia and is included entirely within the Sanara Surgical Segment. The Company’s assessment determined
that these changes, or any other matters noted, did not alter the Company’s conclusion that goodwill is not impaired as of June
30, 2024 or for the periods then ended.
The
carrying values of the Company’s intangible assets were as follows for the periods presented:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
Accumulated | | |
| | |
| | |
Accumulated | | |
| |
| |
Cost | | |
Amortization | | |
Net | | |
Cost | | |
Amortization | | |
Net | |
Amortizable Intangible Assets: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Product Licenses | |
$ | 4,793,879 | | |
$ | (1,535,647 | ) | |
$ | 3,258,232 | | |
$ | 4,793,879 | | |
$ | (1,342,626 | ) | |
$ | 3,451,253 | |
Patents and Other IP | |
| 38,566,549 | | |
| (4,348,964 | ) | |
| 34,217,585 | | |
| 38,570,549 | | |
| (3,181,186 | ) | |
| 35,389,363 | |
Customer relationships and other | |
| 7,947,332 | | |
| (2,445,745 | ) | |
| 5,501,587 | | |
| 7,947,332 | | |
| (1,861,887 | ) | |
| 6,085,445 | |
Total | |
$ | 51,307,760 | | |
$ | (8,330,356 | ) | |
$ | 42,977,404 | | |
$ | 51,311,760 | | |
$ | (6,385,699 | ) | |
$ | 44,926,061 | |
As
of June 30, 2024, the weighted-average amortization period for finite-lived intangible assets was 14.5 years. Amortization expense related
to intangible assets was $972,206 and $695,202 for the three months ended June 30, 2024 and 2023, respectively, and $1,944,657 and $1,366,403
for the six months ended June 30, 2024 and 2023, respectively. The estimated remaining amortization expense as of June 30, 2024 for finite-lived
intangible assets is as follows:
SCHEDULE
OF FUTURE AMORTIZATION EXPENSE
| |
| | |
Remainder of 2024 | |
$ | 1,944,768 | |
2025 | |
| 3,889,537 | |
2026 | |
| 3,872,281 | |
2027 | |
| 3,758,429 | |
2028 | |
| 3,725,187 | |
2029 | |
| 3,725,187 | |
Thereafter | |
| 22,062,015 | |
Total | |
$ | 42,977,404 | |
The
Company has reviewed the carrying value of intangible assets and has determined there was no impairment during the six months ended June
30, 2024 or 2023.
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v3.24.2.u1
INVESTMENTS IN EQUITY SECURITIES
|
6 Months Ended |
Jun. 30, 2024 |
Schedule of Investments [Abstract] |
|
INVESTMENTS IN EQUITY SECURITIES |
NOTE
5 – INVESTMENTS IN EQUITY SECURITIES
The
Company’s equity investments consist of nonmarketable equity securities in privately held companies without readily determinable
fair values. Unless accounted for under the equity method of accounting, the investments are reported at cost minus impairment, if any,
plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the
same issuer.
In
July 2020, the Company made a $500,000 long-term investment to purchase certain nonmarketable securities consisting of 7,142,857 Series
B-2 Preferred Shares of Direct Dermatology Inc. (“DirectDerm”), representing approximately 2.9% ownership of DirectDerm at
that time. Through this investment, the Company received exclusive rights to utilize DirectDerm’s technology in all acute and post-acute
care settings such as skilled nursing facilities, home health and wound clinics. In 2021, the Company purchased an additional 3,571,430
shares of DirectDerm’s Series B-2 Preferred for $250,000. In March 2022, the Company purchased an additional 3,571,429 shares of
DirectDerm’s Series B-2 Preferred for $250,000. The Company’s ownership of DirectDerm was approximately 8.1% as of June 30,
2024. The Company does not have the ability to exercise significant influence over DirectDerm’s operating and financial activities.
In
June 2021, the Company invested $2,084,278
to purchase 278,587
Class A Preferred Shares (the “Pixalere Shares”) of Canada based Pixalere Healthcare Inc. (“Pixalere”). The
Pixalere Shares are convertible into approximately 27.3%
of the outstanding equity of Pixalere. Pixalere provides a cloud-based wound care software tool that empowers nurses, specialists
and administrators to deliver better care for patients. In connection with the Company’s purchase of the Pixalere Shares,
Pixalere granted Pixalere Healthcare USA, LLC (“Pixalere USA”), a subsidiary of the Company, a royalty-free exclusive
license to use the Pixalere software and platform in the United States. In conjunction with the grant of the license, the Company
issued Pixalere a 27.3%
equity ownership interest in Pixalere USA valued at $93,879.
The
Company has reviewed the characteristics of the Pixalere Shares in accordance with ASC Topic 323, Investments – Equity Method and
Joint Ventures. Due to the substantive liquidation preferences of the Pixalere Shares over Pixalere’s common stock, the Pixalere
Shares are not “in-substance” common stock, and therefore, the Company does not utilize the equity method of accounting for
this investment. In accordance with ASC Topic 321, Investments - Equity Securities, this investment was reported at cost as of June 30,
2024.
The
following summarizes the Company’s investments for the periods presented:
SCHEDULE
OF INVESTMENTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Carrying Amount | | |
Economic Interest | | |
Carrying Amount | | |
Economic Interest | |
Cost Method Investments | |
| | |
| | |
| | |
| |
Direct Dermatology, Inc. | |
$ | 1,000,000 | | |
| | | |
$ | 1,000,000 | | |
| | |
Pixalere Healthcare Inc. | |
| 2,084,278 | | |
| | | |
| 2,084,278 | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Total Cost Method Investments | |
$ | 3,084,278 | | |
| | | |
$ | 3,084,278 | | |
| | |
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v3.24.2.u1
OPERATING LEASES
|
6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
|
OPERATING LEASES |
NOTE
6 – OPERATING LEASES
The
Company periodically enters operating lease contracts for office space and equipment. Arrangements are evaluated at inception to determine
whether such arrangements constitute a lease. Right of use assets (“ROU assets”) represent the right to use an underlying
asset for the lease term, and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease
ROU assets and liabilities were recognized on the transition date based on the present value of lease payments over the respective lease
term, with the office space ROU asset adjusted for deferred rent liability.
The
Company has three material operating leases for office space. In March and September of 2023, the Company amended its primary office
lease to obtain additional space, as well as extend the term. The leases have remaining lease terms of 78, 14 and 31 months as of June
30, 2024. For practical expediency, the Company has elected to not recognize ROU assets and lease liabilities related to short-term
leases.
In
accordance with ASC Topic 842, Leases, the Company has recorded ROU assets of $1,792,448 and a related lease liability of $1,906,247
as of June 30, 2024. The Company recorded lease expense of $277,596 and $184,575 for the six months ended June 30, 2024 and 2023, respectively.
Cash paid for amounts included in the measurement of operating lease liabilities was $267,223 and $175,382 for the six months ended June
30, 2024 and 2023, respectively.
The
present value of the Company’s operating lease liabilities as of June 30, 2024 is shown below.
Maturity
of Operating Lease Liabilities
SCHEDULE OF OPERATING LEASE LIABILITY
| |
June 30, 2024 | |
Remainder of 2024 | |
$ | 237,793 | |
2025 | |
| 532,053 | |
2026 | |
| 379,529 | |
2027 | |
| 297,947 | |
2028 | |
| 295,689 | |
2029 | |
| 300,158 | |
Thereafter | |
| 303,892 | |
| |
| | |
Total lease payments | |
| 2,347,061 | |
Less imputed interest | |
| (440,814 | ) |
Present Value of Lease Liabilities | |
$ | 1,906,247 | |
| |
| | |
Operating lease liabilities – current | |
$ | 393,663 | |
Operating lease liabilities – long-term | |
$ | 1,512,584 | |
As
of June 30, 2024, the Company’s operating leases had a weighted average remaining lease term of 5.5 years and a weighted average
discount rate of 7.64%.
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v3.24.2.u1
DEBT AND CREDIT FACILITIES
|
6 Months Ended |
Jun. 30, 2024 |
Debt And Credit Facilities |
|
DEBT AND CREDIT FACILITIES |
NOTE
7 – DEBT AND CREDIT FACILITIES
CRG
Term Loan Agreement
On
April 17, 2024 (the “Closing Date”), the Company entered into the CRG Term Loan Agreement, by and among the Company, as
borrower, the subsidiary guarantors party thereto from time to time (collectively, the “Guarantors”), CRG Servicing LLC
as administrative agent and collateral agent (the “Agent”), and the lenders party thereto from time to time (the
“CRG Term Loan Agreement”), providing for a senior secured term loan of up to $55.0
million (the “CRG Term Loan”). The CRG Term Loan Agreement provides for (i) $15.0 million
of the CRG Term Loan that was borrowed on the Closing Date (the “First Borrowing”) and (ii) up to an aggregate of
$40.0
million available for borrowing in two subsequent borrowings, provided that each
such borrowing must be at least $5.0 million or a multiple of $5.0 million and occur between the Closing Date and June 30,
2025, subject to the satisfaction of certain conditions, including that the First Borrowing having previously occurred and
the Agent having received certain fees. The Company used part of the initial proceeds under the CRG Term Loan to extinguish the
Cadence Term Loan described further below.
The
CRG Term Loan is due and payable on March 30, 2029 (the “Maturity Date”), absent any acceleration. Pursuant to the CRG Term
Loan Agreement, the proceeds of the CRG Term Loan shall be used to repay the Cadence Term Loan, to pay fees and expenses related to the
CRG Term Loan Agreement, for certain permitted acquisitions and similar investments and for general working capital and corporate purposes.
The
CRG Term Loan bears interest at a per annum rate equal to 13.25%
(subject to a 4.0%
increase during an event of default), of which 8.00%
must be paid in cash and 5.25%
may, at the election of the Company, be deferred through the 19th quarterly Payment Date (defined below) by adding such
amount to the aggregate principal loan amount, so long as no default or event of default under the CRG Term Loan Agreement has
occurred and is continuing. The Company is required to make quarterly interest payments on the final business day of each calendar
quarter following the Closing Date, commencing on the first such date to occur at least 30 days after the Closing Date (each, a
“Payment Date”). Interest is payable on each Payment Date in arrears with respect to the time between each Payment Date
and upon the payment or prepayment of the CRG Term Loan, ending on the Maturity Date. In addition, the Company is required to pay an
upfront fee of 1.50%
of the principal amount of the CRG Term Loan, which is payable as amounts are advanced under the CRG Term Loan on a pro rata basis.
The Company will also be required to pay a back-end fee equal to 7.00%
of the aggregate principal amount advanced under the CRG Term Loan Agreement. For the three and six months ended June 30, 2024, the
Company paid $246,667
of interest in cash and recorded $161,875
of interest paid-in-kind related to the CRG Term Loan. The paid-in-kind interest was applied to the principal balance of the CRG
Term Loan. The Company recorded $52,500
for the three and six months ended June 30, 2024 to interest expense related to the back-end fee. The back-end fee is accreted and
amortized to interest expense over the term of the CRG Term Loan. Paid-in-kind interest and the accreted back-end fee are included
in “Long-term debt, net of current portion” on the Consolidated Balance Sheets.
Subject
to certain exceptions, the Company is required to make mandatory prepayments of the CRG Term Loan with the proceeds of certain
assets sales and in the event of a change of control of the Company. In addition, the Company may make a voluntary prepayment of the
CRG Term Loan, in whole or in part, at any time. All mandatory and voluntary prepayments of the CRG Term Loan are subject to the
payment of prepayment premiums as follows: (i)
if prepayment occurs on or prior to the date that is one year following the applicable borrowing (the “Borrowing Date”),
an amount equal to 10.0% of the aggregate outstanding principal amount of the CRG Term Loan being prepaid and (ii) if prepayment
occurs one year after the applicable Borrowing Date and on or prior to two years following the applicable Borrowing Date, an amount
equal to 5.0% of the aggregate outstanding principal amount of the CRG Term Loan being prepaid. No prepayment premium is due
on any principal prepaid if prepayment occurs two years or more after the applicable Borrowing Date.
Certain
of the Company’s current and future subsidiaries, including the Guarantors, are guaranteeing the obligations of the Company under
the CRG Term Loan Agreement. As security for their obligations under the CRG Term Loan Agreement, on the Closing Date, the Company and
the Guarantors entered into a security agreement with the Agent pursuant to which the Company and the Guarantors granted to the Agent,
as collateral agent for the lenders, a lien on substantially all of the Company’s and the Guarantors’ assets, including intellectual
property (subject to certain exceptions).
The
CRG Term Loan Agreement contains affirmative and negative covenants customary for financings of this type, including limitations on the
Company’s and the Guarantors’ abilities, among other things, to incur additional debt, grant or permit additional liens,
make investments and acquisitions above certain thresholds, merge or consolidate with others, dispose of assets, pay dividends and distributions
and enter into affiliate transactions, in each case, subject to certain exceptions. In addition, the CRG Term Loan Agreement contains
the following financial covenants requiring the Company and the Guarantors in the aggregate to maintain:
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liquidity
in an amount which shall exceed the greater of (i) $3.0 million and (ii) to the extent the Company has incurred certain permitted
debt, the minimum cash balance, if any, required of the Company by the creditors of such permitted debt; and |
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annual
minimum revenue: (i) for the twelve-month period beginning on January 1, 2024 and ending on December 31, 2024, of at least $60.0
million, (ii) for the twelve-month period beginning on January 1, 2025 and ending on December 31, 2025, of at least $75.0 million,
(iii) for the twelve-month period beginning on January 1, 2026 and ending on December 31, 2026, of at least $85.0 million, (iv) for
the twelve-month period beginning on January 1, 2027 and ending on December 31, 2027, of at least $95.0 million and (v) during each
twelve-month period beginning on January 1 of a given year thereafter, of at least $105.0 million. |
The
CRG Term Loan Agreement contains representations and warranties of the Company and the Guarantors customary for financings of this type,
and also includes events of default customary for financings of this type, including, among other things, non-payment, inaccuracy of
representations and warranties, covenant breaches, a material adverse change, bankruptcy and insolvency, material judgments and a change
of control, in certain cases subject to customary periods to cure. The occurrence and continuance of an event of default could result
in the acceleration of the obligations under the CRG Term Loan Agreement.
Cadence
Term Loan
In
connection with the entry into the Applied Purchase Agreement, on August 1, 2023, SMAT, as borrower, and the Company, as guarantor, entered
into a loan agreement (the “Cadence Loan Agreement”) with Cadence Bank (the “Bank”) providing for, among other
things, an advancing term loan in the aggregate principal amount of $12.0 million (the “Cadence Term Loan”), which was evidenced
by an advancing promissory note. Pursuant to the Cadence Loan Agreement, the Bank agreed to make, at any time and from time to time prior
to February 1, 2024, one or more advances to SMAT.
The
proceeds of the advances under the Cadence Loan Agreement were used for working capital and for purposes of financing up to one hundred
percent (100%) of the Cash Closing Consideration and Installment Payments for the Applied Asset Purchase and related fees and expenses,
including any subsequent payments that were due to the Sellers after the Closing. On August 1, 2023, the Bank, at the request of SMAT,
made an advance for $9.75 million. The proceeds from the advance were used to fund the Cash Closing Consideration for the Applied Asset
Purchase.
Advances
under the Cadence Term Loan were scheduled to begin amortizing in monthly installments commencing on August 5, 2024. All remaining unpaid
balances under the Cadence Term Loan were due and payable in full on August 1, 2028 (the “Cadence Loan Maturity Date”). SMAT
was permitted to prepay amounts due under the Cadence Term Loan. All accrued but unpaid interest on the unpaid principal balance of outstanding
advances was due and payable monthly, beginning on September 5, 2023 and continued monthly on the fifth day of each month thereafter
until the Cadence Loan Maturity Date. The unpaid principal balance of outstanding advances bore interest, subject to certain conditions,
at the lesser of the Maximum Rate (as defined in the Cadence Loan Agreement) or the Base Rate, which was for any day, a rate per annum
equal to the term secured overnight financing rate (Term SOFR) (as administered by the Federal Reserve Bank of New York) for a one-month
tenor in effect on such day plus three percent (3.0%).
The
obligations of SMAT under the Cadence Loan Agreement and the other loan documents delivered in connection therewith were guaranteed by
the Company and were secured by a first priority security interest in substantially all of the existing and future assets of SMAT.
The
Cadence Loan Agreement contained customary representations and warranties and certain covenants that limited (subject to certain exceptions)
the ability of SMAT and the Company to, among other things, (i) create, assume or guarantee certain liabilities, (ii) create, assume
or suffer liens securing indebtedness, (iii) make or permit loans and advances, (iv) acquire any assets outside the ordinary course of
business, (v) consolidate, merge or sell all or a material part of its assets, (vi) pay dividends or other distributions on, or redeem
or repurchase, interest in an obligor, including the Company, as guarantor (vii) cease, suspend or materially curtail business operations
or (viii) engage in certain affiliate transactions. In addition, the Cadence Loan Agreement contained financial covenants that required
SMAT to maintain (i) a minimum Debt Services Coverage Ratio of 1.2 to 1.0 as of the last day of each applicable fiscal quarter and (ii)
a maximum Cash Flow Leverage Ratio of not more than (a) 4.5 to 1.0 as of the last day of the fiscal quarter ending on September 30, 2023,
(b) 4.0 to 1.0 as of the last day of each fiscal quarter ending on December 31, 2023 and March 31, 2024, (c) 3.5 to 1.0 as of the last
day of each fiscal quarter ending June 30, 2024 and September 30, 2024 and (d) 3.0 to 1.0 as of the last day of each fiscal quarter thereafter.
Pursuant to the Cadence Loan Agreement, in the event that SMAT failed to comply with the financial covenants described above, the Company
was required to contribute cash to SMAT in an amount equal to the amount required to satisfy the financial covenants.
The
Cadence Loan Agreement contained customary events of default. If such an event of default occurred, the Bank was entitled to take various
actions, including the acceleration of amounts due under the Cadence Loan Agreement and actions permitted to be taken by a secured creditor.
On
the Closing Date, the Cadence Loan Agreement was terminated and all outstanding
amounts under the Cadence Term Loan were repaid in full and all security interest and other liens granted to or held by Cadence were
terminated and released. In addition, unamortized debt issuance costs as of the termination date of $53,438 were included in “Interest
expense” on the Consolidated Statement of Operations.
The
table below presents the components of outstanding debt for the periods presented:
As
of June 30, 2024, the interest rate on the CRG Term Loan was 13.25% per annum and as of December 31, 2023, the interest rate
on the advance under the Cadence Term Loan was 8.3%.
SCHEDULE
OF LONG-TERM DEBT
| |
June 30, 2024 | | |
December 31, 2023 | |
Cadence Term Loan | |
$ | - | | |
$ | 9,750,000 | |
CRG Term Loan | |
| 15,000,000 | | |
| - | |
Paid-in-kind interest | |
| 161,875 | | |
| - | |
Back-end fee | |
| 52,500 | | |
| - | |
Debt | |
| 15,214,375 | | |
| 9,750,000 | |
| |
| | | |
| | |
Less: debt issuance costs | |
| (887,253 | ) | |
| (61,658 | ) |
Accumulated amortization of debt issuance costs | |
| 44,363 | | |
| 5,138 | |
Net debt issuance costs | |
| (842,890 | ) | |
| (56,520 | ) |
| |
| | | |
| | |
Debt, net of debt issuance costs | |
| 14,371,485 | | |
| 9,693,480 | |
| |
| | | |
| | |
Less: Current portion of long-term debt | |
| - | | |
| 580,357 | |
Long-term debt | |
$ | 14,371,485 | | |
$ | 9,113,123 | |
The
table below presents the aggregate maturities of the Company’s outstanding debt as of June 30, 2024:
SCHEDULE
OF MATURITIES OUTSTANDING DEBT
Year | |
Total | |
| |
| |
Remainder of 2024 | |
$ | - | |
2025 | |
| - | |
2026 | |
| - | |
2027 | |
| - | |
2028 | |
| - | |
Thereafter | |
| 15,214,375 | |
Total debt | |
$ | 15,214,375 | |
In
connection with the CRG Term Loan, the Company incurred $887,253 in debt issuance costs during the six months ended June 30, 2024. Debt
issuance costs are amortized to “Interest expense” on the Consolidated Statement of Operations over the life of
the debt to which they pertain. The total unamortized debt issuance costs were $842,890 and $56,520 as of June 30, 2024 and December
31, 2023, respectively. Debt issuance costs are included in “Long-term debt, net of current portion” on the Consolidated
Balance Sheets. Amortization expense related to debt issuance costs was $100,883 and zero for the six months ended June 30, 2024 and
2023, respectively.
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
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6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
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COMMITMENTS AND CONTINGENCIES |
NOTE
8 - COMMITMENTS AND CONTINGENCIES
License
Agreements and Royalties
CellerateRX
Surgical
In
August 2018, the Company entered an exclusive, world-wide sublicense agreement with CGI Cellerate RX, LLC (“CGI Cellerate RX”)
to distribute certain hydrolyzed collagen products, including CellerateRX Surgical, into the surgical and wound care markets. Pursuant
to the Sublicense Agreement, the Company paid royalties of 3-5% of annual collected net sales of these products. As amended in January
2021, the term of the sublicense was extended through May 2050, with automatic successive year-to-year renewal terms thereafter so long
as the Company’s Net Sales (as defined in the Sublicense Agreement) each year are equal to or in excess of $1,000,000. If the Company’s
Net Sales fall below $1,000,000 for any year after the expiration date, CGI Cellerate RX has the right to terminate the Sublicense Agreement
upon written notice.
Under
this agreement, royalty expense, which was recorded in “Cost of goods sold” in the accompanying Consolidated Statements of
Operations, totaled zero and $548,430, respectively, for the three months ended June 30, 2024 and 2023 and zero and $1,069,244, respectively,
for the six months ended June 30, 2024 and 2023. Sales of CellerateRX Surgical comprised the substantial majority of the Company’s
sales during the three and six months ended June 30, 2024 and 2023.
As
discussed further in Note 3, on August 1, 2023, the Company purchased certain assets from Applied, including the rights to manufacture
and sell certain hydrolyzed collagen products, including CellerateRX Surgical, for use in the human wound care market. In connection
with the Applied Asset Purchase, Applied assigned its license agreement with CGI Cellerate RX to SMAT.
BIAKŌS
Antimicrobial Wound Gel and BIAKŌS Antimicrobial Skin and Wound Cleanser
In
July 2019, the Company executed a license agreement with Rochal Industries, LLC (“Rochal”), a related party, pursuant to
which the Company acquired an exclusive world-wide license to market, sell and further develop antimicrobial products for the prevention
and treatment of microbes on the human body utilizing certain Rochal patents and pending patent applications (the “BIAKŌS
License Agreement”). Currently, the products covered by the BIAKŌS License Agreement are BIAKŌS Antimicrobial Wound
Gel, BIAKŌS Antimicrobial Skin and Wound Cleanser and BIASURGE Advanced Surgical Solution. All three products are 510(k) cleared.
Future
commitments under the terms of the BIAKŌS License Agreement include:
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● |
The
Company pays Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal was $133,000 for 2023 and will increase
by 10% each subsequent calendar year up to a maximum amount of $150,000. |
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● |
The
Company pays additional royalty annually based on specific net profit targets from sales of the licensed products, subject to a maximum
of $1,000,000 during any calendar year. |
Unless
previously terminated by the parties, the BIAKŌS License Agreement expires with the related patents in December 2031.
Under
this agreement, royalty expense, which is recorded in “Cost of goods sold” in the accompanying Consolidated Statements of
Operations, was $42,305 and $32,500 for the three months ended June 30, 2024 and 2023, respectively. For the six months ended June 30,
2024 and 2023, royalty expense under this agreement was $77,305 and $65,000, respectively. The Company’s Executive Chairman and
Chief Executive Officer is a director of Rochal, and indirectly a significant shareholder of Rochal, and through the potential exercise
of warrants, a majority shareholder of Rochal. Another one of the Company’s directors is also a director and significant shareholder
of Rochal.
CuraShield
Antimicrobial Barrier Film and No Sting Skin Protectant
In
October 2019, the Company executed a license agreement with Rochal pursuant to which the Company acquired an exclusive world-wide license
to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care
market utilizing certain Rochal patents and pending patent applications (the “ABF License Agreement”). Currently, the products
covered by the ABF License Agreement are CuraShield Antimicrobial Barrier Film and a no sting skin protectant product.
Future
commitments under the terms of the ABF License Agreement include:
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● |
The
Company will pay Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal will be $50,000 beginning with the
first full calendar year following the year in which first commercial sales of the products occur. The annual minimum royalty will
increase by 10% each subsequent calendar year up to a maximum amount of $75,000. |
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● |
The
Company will pay additional royalties annually based on specific net profit targets from sales of the licensed products, subject
to a maximum of $500,000 during any calendar year. |
Unless
previously terminated or extended by the parties, the ABF License Agreement will terminate upon expiration of the last U.S. patent in
October 2033. No commercial sales or royalties have been recognized under this agreement as of June 30, 2024.
Debrider
License Agreement
In
May 2020, the Company executed a product license agreement with Rochal, pursuant to which the Company acquired an exclusive world-wide
license to market, sell and further develop a debrider for human medical use to enhance skin condition or treat or relieve skin disorders,
excluding uses primarily for beauty, cosmetic, or toiletry purposes (the “Debrider License Agreement”).
Future
commitments under the terms of the Debrider License Agreement include:
|
● |
Upon
FDA clearance of the licensed products, the Company will pay Rochal $500,000 in cash and an additional $1,000,000, which at the Company’s
option may be paid in any combination of cash and its common stock. |
|
● |
The
Company will pay Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal will be $100,000 beginning with
the first full calendar year following the year in which first commercial sales of the licensed products occur and increase by 10%
each subsequent calendar year up to a maximum amount of $150,000. |
|
● |
The
Company will pay additional royalty annually based on specific net profit targets from sales of the licensed products, subject to
a maximum of $1,000,000 during any calendar year. |
Unless
previously terminated or extended by the parties, the Debrider License Agreement will expire in October 2034. No commercial sales or
royalties have been recognized under this agreement as of June 30, 2024.
Rochal
Asset Acquisition
The
Company entered into an asset purchase agreement with Rochal effective July 1, 2021, pursuant to which the Company purchased certain
assets of Rochal. Pursuant to the asset purchase agreement, for the three-year period after the effective date, Rochal is entitled to
receive consideration for any new product relating to the business that is directly and primarily based on an invention conceived and
reduced to practice by a member or members of Rochal’s science team. For the three-year period after the effective date, Rochal
is also entitled to receive an amount in cash equal to twenty-five percent of the proceeds received for any Grant (as defined in the
asset purchase agreement) by either the Company or Rochal. In addition, the Company agreed to use commercially reasonable efforts to
perform Minimum Development Efforts (as defined in the asset purchase agreement) with respect to certain products under development,
which if obtained, will entitle the Company to intellectual property rights from Rochal in respect of such products.
Precision
Healing Merger Agreement
In
April 2022, the Company closed a merger transaction with Precision Healing pursuant to which Precision Healing became a wholly owned
subsidiary of the Company. Pursuant to the terms of the merger agreement, holders of Precision Healing common stock and preferred stock,
other than the Company, were entitled to receive closing consideration, consisting of $125,966 in cash consideration, which was paid
to stockholders who were not accredited investors, 165,738 shares of the Company’s common stock, which was paid only to accredited
investors, and the payment in cash of approximately $0.6 million of transaction expenses of Precision Healing. The Company recorded the
issuance of the 165,738 shares to accredited investors and cash payments to nonaccredited investors based on the closing price per share
of the Company’s common stock on April 4, 2022, which was $30.75.
Upon
the closing of the merger, the Precision Healing outstanding options previously granted under the Precision Healing Plan converted, pursuant
to their terms, into options to acquire an aggregate of 144,191 shares of Company common stock with a weighted average exercise price
of $10.71 per share. These options expire between August 2030 and April 2031. In addition, outstanding and unexercised Precision Healing
warrants converted into rights to receive warrants to purchase (i) 4,424 shares of the Company’s common stock with an initial exercise
price of $7.32 per share and an expiration date of April 22, 2031, and (ii) 12,301 shares of the Company’s common stock with an
initial exercise price of $12.05 per share and an expiration date of August 10, 2030. Concurrent with the assumption of the Precision
Healing Plan, the Company terminated the ability to offer future awards under the Precision Healing Plan.
Pursuant
to the merger agreement, upon the achievement of certain performance thresholds, the securityholders of Precision Healing, including
the holders of options and warrants to purchase Precision Healing common stock and certain persons promised options to purchase Precision
Healing common stock, are also entitled to receive payments of up to $10.0 million, which was accounted for as contingent consideration
pursuant to ASC 805. The earnout consideration is payable in cash or, at the Company’s election, is payable to accredited investors
in shares of Company common stock at a price per share equal to the greater of (i) $27.13 or (ii) the average closing price of Company
common stock for the 20 trading days prior to the date such earnout consideration is due and payable. Pursuant to the merger agreement,
a minimum percentage of the earnout consideration may be required to be issued to accredited investors in shares of Company common stock
for tax purposes. The amount and composition of the portion of earnout consideration payable is subject to adjustment and offsets as
set forth in the merger agreement.
Scendia
Purchase Agreement
In
July 2022, the Company closed the Scendia acquisition pursuant to which Scendia became a wholly owned subsidiary of the Company. Pursuant
to the purchase agreement, the aggregate consideration for the acquisition at closing was approximately $7.6 million, subject to customary
post-closing adjustments. The consideration consisted of (i) approximately $1.6 million of cash, subject to certain adjustments, and
(ii) 291,686 shares of common stock of the Company. Pursuant to the purchase agreement, at closing, the Company withheld 94,798 Indemnity
Holdback Shares, which such Indemnity Holdback Shares were withheld to the extent provided in the purchase agreement to satisfy Phillips’
indemnification obligations and subsequently issued and released to Phillips in July 2023.
In
addition to the cash consideration and the stock consideration, the purchase agreement provides that Phillips is entitled to receive
two potential earnout payments, payable on an annual basis, not to exceed $10.0 million in the aggregate, which was accounted for as
contingent consideration pursuant to ASC 805. The earnout consideration is payable to Phillips in cash or, at the Company’s election,
in up to 486,145 shares of the Company’s common stock upon the achievement of certain performance thresholds relating to net revenue
attributable to sales of Scendia products during the two-year period following the closing. The Company made the first earnout payment
of approximately $693,000 in cash in August 2023. The Company expects the final earnout payment to be made in the third quarter of 2024.
Applied
Asset Purchase
On
August 1, 2023, the Company closed the Applied Asset Purchase. The Applied Purchased Assets were purchased for an initial aggregate purchase
price of $15.25 million, consisting of (i) the Cash Closing Consideration, (ii) the Stock Closing Consideration and (iii) the Installment
Payments.
In
addition to the Cash Closing Consideration, Stock Closing Consideration and Installment Payments, the Applied Purchase Agreement provides
that the Sellers are entitled to receive the Applied Earnout, which is payable to the Sellers in cash, upon the achievement of certain
performance thresholds relating to SMAT’s collections from net sales of a collagen-based product currently under development. Upon
expiration of the seventh anniversary of the Closing, to the extent the Sellers have not earned the entirety of the Applied Earnout,
SMAT shall pay the Sellers the True-Up Payment. The Applied Earnout, minus the True-Up Payment and any Applied Earnout payments already
made by SMAT, may be earned at any point in the future, including after the True-Up Payment is made.
In
connection with the Applied Asset Purchase and pursuant to the Applied Purchase Agreement, effective August 1, 2023, the Company entered
into the Petito Services Agreement with the Owner, pursuant to which the Owner, as an independent contractor, agreed to provide the Petito
Services. As consideration for the Petito Services, the Owner is entitled to receive: (i) a base salary of $12,000 per month during the
term of the Petito Services Agreement, (ii) a royalty payment equal to three percent (3%) of the actual collections from net sales of
certain products the Owner develops or codevelops that reach commercialization, (iii) a royalty payment equal to five percent (5%) for
the first $50.0 million in aggregate collections from net sales of certain future products and a royalty payment of two and one-half
percent (2.5%) on aggregate collections from net sales of certain future products on any amounts exceeding $50.0 million but up to $100.0
million, (iv) $500,000 in cash in the event that 510(k) clearance is issued for any future product accepted by the Company and (v) $1.0
million in cash in the event that a U.S. patent is issued for a certain product; provided that with respect to the incentive payments
described in (iv) and (v) of the foregoing, the Owner shall not earn more than $2.5 million.
The
Petito Services Agreement has an initial term of three years and is subject to automatic successive one-month renewals unless earlier
terminated in accordance with its terms. The Petito Services Agreement may be terminated upon the Owner’s death or disability or
by the Company or the Owner “For Cause” (as defined in the Petito Services Agreement); provided, however, that the base salary
described in (i) of the foregoing paragraph shall survive termination through the three-year initial term and the royalty payments and
incentive payments described in (ii)-(v) of the foregoing paragraph shall survive termination of the Petito Services Agreement.
Other
Commitments
On
December 20, 2023, the Company signed an exclusive license agreement with Tufts University (“Tufts”) to develop and commercialize
patented technology covering 18 unique collagen peptides. As part of this agreement, the Company formed a new subsidiary, Sanara Collagen
Peptides, LLC (“SCP”) and 10% of SCP’s outstanding units were issued to Tufts. SCP has exclusive rights to develop
and commercialize new products based on the licensed patents and patents pending. SCP will pay royalties to Tufts based on net sales
of licensed products and technologies. Under the exclusive license agreement, royalties will be calculated at a rate of 1.5% or 3%, depending
on the type of product or technology developed. SCP will pay Tufts a minimum annual royalty of $50,000 on January 1 of the year following
the first anniversary of the first commercial sale of the licensed products or technologies. SCP will pay Tufts a $100,000 minimum annual
royalty on January 1 of each subsequent year during the royalty term specified in the exclusive license agreement. There have been no
material accounting impacts related to this arrangement as of June 30, 2024.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
SHAREHOLDERS’ EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SHAREHOLDERS’ EQUITY |
NOTE
9 – SHAREHOLDERS’ EQUITY
Common
Stock
At
the Company’s Annual Meeting of Shareholders held in July 2020, the Company approved the Restated 2014 Omnibus Long Term Incentive
Plan (the “2014 LTIP”) in which the Company’s directors, officers, employees and consultants are eligible to participate.
A total of 748,453 shares had been issued under the 2014 LTIP and 1,251,547 were available for issuance as of June 30, 2024.
In
April 2022, the Company closed a merger transaction with Precision Healing pursuant to which Precision Healing became a wholly owned
subsidiary of the Company. Pursuant to the terms of the merger agreement, holders of Precision Healing common stock and preferred stock,
other than the Company, were entitled to receive closing consideration, consisting of $125,966 in cash consideration, which was paid
to stockholders who were not accredited investors, 165,738 shares of the Company’s common stock, which was paid only to accredited
investors, and the payment in cash of approximately $0.6 million of transaction expenses of Precision Healing. The Company recorded the
issuance of the 165,738 shares to accredited investors and cash payments to nonaccredited investors based on the closing price per share
of the Company’s common stock on April 4, 2022, which was $30.75.
Upon
the closing of the merger, the Precision Healing outstanding options previously granted under the Precision Healing Plan converted, pursuant
to their terms, into options to acquire an aggregate of 144,191 shares of Company common stock with a weighted average exercise price
of $10.71 per share. These options expire between August 2030 and April 2031. In addition, outstanding and unexercised Precision Healing
warrants converted into rights to receive warrants to purchase (i) 4,424 shares of the Company’s common stock with an initial exercise
price of $7.32 per share and an expiration date of April 22, 2031, and (ii) 12,301 shares of the Company’s common stock with an
initial exercise price of $12.05 per share and an expiration date of August 10, 2030. Concurrent with the assumption of the Precision
Healing Plan, the Company terminated the ability to offer future awards under the Precision Healing Plan.
Pursuant
to the merger agreement, upon the achievement of certain performance thresholds, the securityholders of Precision Healing, including
the holders of options and warrants to purchase Precision Healing common stock and certain persons promised options to purchase Precision
Healing common stock, are also entitled to receive payments of up to $10.0 million, which was accounted for as contingent consideration
pursuant to ASC 805. The earnout consideration is payable in cash or, at the Company’s election, is payable to accredited investors
in shares of Company common stock at a price per share equal to the greater of (i) $27.13 or (ii) the average closing price of Company
common stock for the 20 trading days prior to the date such earnout consideration is due and payable. Pursuant to the merger agreement,
a minimum percentage of the earnout consideration may be required to be issued to accredited investors in shares of Company common stock
for tax purposes. The amount and composition of the portion of earnout consideration payable is subject to adjustment and offsets as
set forth in the merger agreement.
In
July 2022, the Company closed the Scendia acquisition pursuant to which Scendia became a wholly owned subsidiary of the Company. Pursuant
to the purchase agreement, the aggregate consideration at closing for the acquisition was approximately $7.6 million, subject to customary
post-closing adjustments. The consideration consisted of (i) approximately $1.6 million of cash, subject to certain adjustments, and
(ii) 291,686 shares of common stock of the Company. Pursuant to the purchase agreement, at closing, the Company withheld 94,798 Indemnity
Holdback Shares, which such Indemnity Holdback Shares were withheld to the extent provided in the purchase agreement to satisfy Phillips’
indemnification obligations and subsequently issued and released to Phillips in July 2023.
In
addition to the cash consideration and the stock consideration, the purchase agreement provides that Phillips is entitled to receive
two potential earnout payments, payable on an annual basis, not to exceed $10.0 million in the aggregate, which was accounted for as
contingent consideration pursuant to ASC 805. The earnout consideration is payable to Phillips in cash or, at the Company’s election,
in up to 486,145 shares of the Company’s common stock upon the achievement of certain performance thresholds relating to net revenue
attributable to sales of Scendia products during the two-year period following the closing. The Company made the first earnout payment
of approximately $693,000 in cash in August 2023.
In
February 2023, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”)
with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which the Company could offer and sell from time
to time, to or through Cantor, shares of the Company’s common stock having an aggregate offering price of up to $75,000,000.
Sales
of the shares were made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under
the Securities Act of 1933, as amended. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement,
Cantor agreed to use commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal
law, rules and regulations and the rules of The Nasdaq Capital Market to sell the shares from time to time based upon the Company’s
instructions, including any price, time period or size limits specified by the Company. The Company had no obligation to sell any of
the shares under the Sales Agreement and could suspend or terminate the offering of its common stock pursuant to the Sales Agreement
upon notice to Cantor and subject to other conditions. Cantor’s obligations to sell the shares under the Sales Agreement were subject
to satisfaction of certain conditions, including customary closing conditions. Pursuant to the Sales Agreement, the Company paid Cantor
a commission of 3.0% of the aggregate gross proceeds from each sale of the shares.
In
2023, the Company sold an aggregate of 26,143 shares of common stock for gross proceeds of approximately $1.1 million and net proceeds
of approximately $0.9 million pursuant to the Sales Agreement. The Company paused the offering at the end of the first quarter of 2023
and did not reactivate it during the remainder of 2023. The Form S-3 registration statement for this offering expired at the beginning
of 2024.
On
August 1, 2023, the Company closed the Applied Asset Purchase. Included in the purchase price was 73,809 shares of the Company’s
common stock. See Note 3 for more information regarding the acquisition of Applied.
On
June 12, 2024, the Company’s shareholders approved the 2024 Omnibus Long-Term Incentive Plan (the “2024 LTIP”), which
went into effect upon shareholder approval. The maximum number of shares of the Company’s common stock that may be delivered pursuant
to awards granted under the 2024 LTIP is 1,000,000, subject to increase by any awards under the 2014 LTIP (i) that were outstanding on
or after June 12, 2024, and that, on or after such date, are forfeited, expire or are canceled, and (ii) any shares subject to awards
relating to common stock under the 2014 LTIP that are settled in cash on or after June 12, 2024 (the “Prior LTIP Awards”).
The 2024 LTIP also provides that, to the extent an award under the 2024 LTIP or a Prior LTIP Award is forfeited, expires or is canceled,
in whole or in part, the shares subject to such forfeited, expired or canceled award may again be awarded under the 2024 LTIP.
Restricted
Stock Awards
During
the six months ended June 30, 2024, the Company issued restricted stock awards under the 2014 LTIP which are subject to certain vesting
provisions and other terms and conditions set forth in each recipient’s respective restricted stock agreement. The Company granted
and issued 167,956 shares, net of forfeitures, of restricted common stock to employees, directors, and certain advisors of the Company
under the 2014 LTIP during the six months ended June 30, 2024. The fair value of these awards was $5,894,731 based on the closing price
of the Company’s common stock on the respective grant dates, which will be recognized as compensation expense on a straight-line
basis over the vesting period of the awards.
Share-based
compensation expense of $1,411,545 and $1,127,332 was recognized in “Selling, general and administrative expenses” and “Research
and development” in the accompanying Consolidated Statements of Operations during the three months ended June 30, 2024 and 2023,
respectively. Share-based compensation expense of $2,214,930 and $1,724,637 was recognized in “Selling, general and administrative
expenses” and “Research and development” in the accompanying Consolidated Statements of Operations during the six months
ended June 30, 2024 and 2023, respectively.
At
June 30, 2024, there was $6,557,465 of total unrecognized share-based compensation expense related to unvested share-based equity awards.
Unrecognized share-based compensation expense is expected to be recognized over a weighted-average period of 1 year.
Below
is a summary of restricted stock activity for the six months ended June 30, 2024:
SCHEDULE
OF RESTRICTED STOCK ACTIVITY
| |
For the Six Months Ended | |
| |
June 30, 2024 | |
| |
| | |
Weighted Average | |
| |
Shares | | |
Grant Date Fair Value | |
Nonvested at beginning of period | |
| 144,211 | | |
$ | 34.07 | |
Granted | |
| 190,240 | | |
| 35.03 | |
Vested | |
| (81,890 | ) | |
| 33.19 | |
Forfeited | |
| (22,284 | ) | |
| 34.53 | |
Nonvested at June 30, 2024 | |
| 230,277 | | |
$ | 35.13 | |
Stock
Options
A
summary of the status of outstanding stock options at June 30, 2024 and changes during the six months then ended is presented below:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
For the Six Months Ended | | |
| |
| |
June 30, 2024 | | |
| |
| |
| | |
Weighted Average | | |
Weighted Average | | |
Aggregate | |
| |
| | |
Exercise | | |
Remaining | | |
Intrinsic | |
| |
Options | | |
Price | | |
Contract Life | | |
Value | |
Outstanding at beginning of period | |
| 93,892 | | |
$ | 10.22 | | |
| | | |
| | |
Granted or assumed | |
| - | | |
| - | | |
| | | |
| | |
Exercised | |
| (62,879 | ) | |
| 10.05 | | |
| | | |
| | |
Forfeited | |
| - | | |
| - | | |
| | | |
| | |
Expired | |
| - | | |
| - | | |
| | | |
| | |
Outstanding at June 30, 2024 | |
| 31,013 | | |
$ | 10.57 | | |
| 6.3 | | |
$ | 547,530.6 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 31,013 | | |
$ | 10.57 | | |
| 6.3 | | |
$ | 547,530.6 | |
Warrants
A
summary of the status of outstanding warrants to purchase common stock at June 30, 2024 and changes during the six months then ended
is presented below:
SCHEDULE OF WARRANTS TO PURCHASE COMMON STOCK
| |
For the Six Months Ended | |
| |
June 30, 2024 | |
| |
| | |
Weighted Average | | |
Weighted Average | |
| |
| | |
Exercise | | |
Remaining | |
| |
Warrants | | |
Price | | |
Contract Life | |
Outstanding at beginning of period | |
| 16,725 | | |
$ | 10.80 | | |
| | |
Granted or assumed | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| | |
Forfeited | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| | |
Outstanding at June 30, 2024 | |
| 16,725 | | |
$ | 10.80 | | |
| 6.3 | |
| |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 16,725 | | |
$ | 10.80 | | |
| 6.3 | |
|
X |
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v3.24.2.u1
RELATED PARTIES
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTIES |
NOTE
10 – RELATED PARTIES
CellerateRX
Sublicense Agreement
The
Company has an exclusive, world-wide sublicense to distribute certain hydrolyzed collagen products, including CellerateRX Surgical into
the surgical and wound care markets from an affiliate of The Catalyst Group, Inc. (“Catalyst”), CGI Cellerate RX, which licensed
the rights to these products from Applied. Sales of CellerateRX Surgical have comprised the substantial majority of the Company’s
sales during the six months ended June 30, 2024 and 2023. As amended in January 2021, the term of the Sublicense Agreement was extended
through May 2050, with automatic successive one-year renewals so long as annual net sales of the licensed products exceed $1,000,000.
As
discussed further in Note 3, on August 1, 2023, the Company purchased certain assets from Applied, including the underlying intellectual
property of, as well as the rights to manufacture and sell certain hydrolyzed collagen products, including CellerateRX Surgical. In connection
with the Applied Asset Purchase, Applied assigned its license agreement with CGI Cellerate RX to SMAT. Ronald T. Nixon, the Company’s
Chief Executive Officer and Executive Chairman, is the founder and managing partner of Catalyst.
Product
License Agreements
In
July 2019, the Company executed a license agreement with Rochal, a related party, whereby the Company acquired an exclusive world-wide
license to market, sell and further develop antimicrobial products for the prevention and treatment of microbes on the human body utilizing
certain Rochal patents and pending patent applications. Currently, the products covered by the BIAKŌS License Agreement are BIAKŌS
Antimicrobial Wound Gel and BIAKŌS Antimicrobial Skin and Wound Cleanser. Both products are 510(k) cleared. Mr. Nixon is a director
of Rochal, and indirectly a significant shareholder of Rochal, and through the potential exercise of warrants, a majority shareholder
of Rochal. Another one of the Company’s directors is also a director and significant shareholder of Rochal.
In
October 2019, the Company executed the ABF License Agreement with Rochal whereby the Company acquired an exclusive world-wide license
to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care
market utilizing certain Rochal patents and pending patent applications. Currently, the products covered by the ABF License Agreement
are CuraShield Antimicrobial Barrier Film and a no sting skin protectant product.
In
May 2020, the Company executed a product license agreement with Rochal, whereby the Company acquired an exclusive world-wide license
to market, sell and further develop a debrider for human medical use to enhance skin condition or treat or relieve skin disorders, excluding
uses primarily for beauty, cosmetic, or toiletry purposes.
See
Note 8 for more information on these product license agreements.
Consulting
Agreement
Concurrent
with the Rochal asset purchase, in July 2021, the Company entered into a consulting agreement with Ann Beal Salamone pursuant to which
Ms. Salamone agreed to provide the Company with consulting services with respect to, among other things, writing new patents, conducting
patent intelligence, and participating in certain grant and contract reporting. In consideration for the consulting services to be provided
to the Company, Ms. Salamone is entitled to receive an annual consulting fee of $177,697, with payments to be paid once per month. The
consulting agreement has an initial term of three years, unless earlier terminated by the Company, and is subject to renewal. Effective
July 13, 2024, the consulting agreement with Ms. Salamone was amended to provide that the initial term shall be automatically renewed
for successive one-year terms for up to three successive years unless earlier terminated by either party without cause at any time, provided
that the terminating party provides 90 days’ advance written notice of termination. Ms. Salamone is a director of the Company and
is a significant shareholder and the current Chair of the board of directors of Rochal.
Catalyst
Transaction Advisory Services Agreement
In
March 2023, the Company entered into a Transaction Advisory Services Agreement (the “Catalyst Services Agreement”) effective
March 1, 2023 with Catalyst, a related party. Pursuant to the Catalyst Services Agreement, Catalyst, by and through its directors, officers,
employees and affiliates that are not simultaneously serving as directors, officers or employees of the Company (collectively, the “Covered
Persons”), agreed to perform certain transaction advisory, business and organizational strategy, finance, marketing, operational
and strategic planning, relationship access and corporate development services for the Company in connection with any merger, acquisition,
recapitalization, divestiture, financing, refinancing, or other similar transaction in which the Company may be, or may consider becoming,
involved, and any such additional services as mutually agreed upon in writing by and between Catalyst and the Company (the “Catalyst
Services”).
Pursuant
to the Catalyst Services Agreement, the Company agreed to reimburse Catalyst for (i) compensation actually paid by Catalyst to any of
the Covered Persons at a rate no more than a rate consistent with industry practice for the performance of services similar to the Catalyst
Services, as documented in reasonably sufficient detail, and (ii) all reasonable out-of-pocket costs and expenses payable to unaffiliated
third parties, as documented in customary expense reports, as each of (i) and (ii) is incurred in connection with the Catalyst Services
rendered under the Catalyst Services Agreement, with all reimbursements being contingent upon the prior approval of the Audit Committee
of the Company’s Board of Directors. The Company incurred costs pursuant to the Catalyst Services Agreement of $57,000 and $72,986
in the three months ended June 30, 2024 and 2023, respectively, and $113,272 and $72,986 in the six months ended June 30, 2024 and 2023,
respectively and is recorded in “Selling, general and administrative expenses” in the accompanying Consolidated Statements
of Operations.
|
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v3.24.2.u1
SEGMENT REPORTING
|
6 Months Ended |
Jun. 30, 2024 |
Segment Reporting [Abstract] |
|
SEGMENT REPORTING |
NOTE
11 – SEGMENT REPORTING
As
discussed in Note 1, the Company historically managed its business on the basis of one
operating and reportable segment. During the second quarter of 2024, the Company changed its reportable segments to better align its
organization based upon the Company’s management structure, products and services offered and markets served. Based on the
growing importance of the value-based wound care program to the Company’s future outlook and how the Company’s chief
operating decision maker (“CODM”), the Chief Executive Officer, reviews operating results and makes decisions about resource allocation, the
Company now has two
reportable segments: Sanara Surgical and THP.
Segment
EBITDA is the primary profitability measure used by the CODM for purposes of assessing financial performance and resource allocation.
The Company defines Segment EBITDA for the reportable segments as net income (loss) excluding interest expense/income, provision/benefit
for income taxes, depreciation and amortization, non-cash share-based compensation expense, change in fair value of earnout liabilities,
executive separation costs, legal and diligence expenses related to acquisitions, and gains/losses on the disposal of property and equipment,
as each are applicable to the periods presented. Segment EBITDA, as it relates to the Company’s reportable segments, is presented
in conformity with ASC 280, Segment Reporting, and is excluded from the definition of non-GAAP financial measures under the Securities
and Exchange Commission’s Regulation G and Item 10(e) of Regulation S-K. Segment EBITDA may not be comparable to similarly titled
measures reported by other companies.
Sanara
Surgical
The
Sanara Surgical segment primarily markets and sells soft tissue repair and bone fusion products for use in the operating room or other
sterile environments. Sanara Surgical’s soft tissue repair products include, among other products, the Company’s lead product, CellerateRX Surgical, and BIASURGE Advanced Surgical Solution, which is a no-rinse, advanced
surgical solution used for wound irrigation. Sanara Surgical’s bone fusion products include, among other products, BiFORM, which
is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site, and ALLOCYTE Plus, which is a human
allograft cellular bone matrix containing bone-derived progenitor cells and conformable bone fibers.
Sanara
Surgical also includes an in-house research and development team (Rochal Technologies) with an extensive pipeline of innovative products
under development.
Tissue
Health Plus
The
THP segment is focused on value-based wound care services. Through THP, the Company plans to offer a first of its kind value-based
wound care program to payers and risk-bearing entities such as accountable care organizations and VBC primary care companies, with Medicare Advantage payers as the initial target market for this program.
THP’s
programs are expected to enable payers to divest wound care spend risk, reduce wound related hospitalizations and improve patient quality
of life. THP plans to coordinate delivery of community and home-based wound care for its managed patients. Community based care spans
a variety of settings including physician offices, skilled nursing facilities, assisted living facilities and senior living facilities. THP
programs are intended to integrate science and evidence-based medicine protocols to standardize wound prevention and treatment.
Currently,
there are no allocated costs included in the THP segment. All corporate and overhead expenses are included in the Sanara Surgical
segment, as substantially all of those costs relate to supporting the operations and activities of the Sanara Surgical segment.
As
a result of the change in reportable segments, certain prior period amounts have been recast to conform to the current period presentation.
Throughout this Quarterly Report on Form 10-Q, unless otherwise indicated, amounts and activity reflect reclassifications related to
the Company’s change in reportable segments. The change in reportable segments had no impact on the Company’s Consolidated
Balance Sheets, Statements of Operations, Cash Flows and Shareholders’ Equity
previously reported.
The
following tables reflect results of operations, Segment EBITDA, segmented assets, and expenditures for long-lived assets for our
reportable segments for the periods indicated below:
SCHEDULE
OF OPERATIONS, ASSETS AND CAPITAL EXPENDITURES FOR OUR BUSINESS SEGMENTS
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Three Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 20,158,823 | | |
$ | - | | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | - | | |
$ | 15,753,164 | |
Gross profit | |
| 18,150,137 | | |
| - | | |
| 18,150,137 | | |
| 13,565,648 | | |
| - | | |
| 13,565,648 | |
Selling, general and administrative
expenses | |
| 18,349,924 | | |
| 607,684 | | |
| 18,957,608 | | |
| 13,301,230 | | |
| 510,246 | | |
| 13,811,476 | |
Research and development | |
| 582,443 | | |
| 403,208 | | |
| 985,651 | | |
| 208,727 | | |
| 968,401 | | |
| 1,177,128 | |
Depreciation and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Interest expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Net income (loss) | |
| (2,214,313 | ) | |
| (1,314,889 | ) | |
| (3,529,202 | ) | |
| 95,098 | | |
| (1,961,278 | ) | |
| (1,866,180 | ) |
Segment EBITDA | |
| 1,393,959 | | |
| (801,778 | ) | |
| 592,181 | | |
| 1,120,207 | | |
| (1,415,831 | ) | |
| (295,624 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Segment
assets (at period end) (1) | |
$ | 51,469,137 | | |
$ | 21,914,468 | | |
$ | 73,383,605 | | |
$ | 51,147,589 | | |
$ | 22,723,560 | | |
$ | 73,871,149 | |
Expenditures for long-lived
assets | |
$ | 58,762 | | |
$ | - | | |
$ | 58,762 | | |
$ | 12,945 | | |
$ | - | | |
$ | 12,945 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Six Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 38,695,461 | | |
$ | - | | |
$ | 38,695,461 | | |
$ | 31,272,351 | | |
$ | 2,730 | | |
$ | 31,275,081 | |
Gross profit | |
| 34,796,729 | | |
| - | | |
| 34,796,729 | | |
| 26,968,141 | | |
| (6,235 | ) | |
| 26,961,906 | |
Selling, general and administrative
expenses | |
| 34,032,964 | | |
| 1,116,903 | | |
| 35,149,867 | | |
| 25,768,626 | | |
| 1,011,919 | | |
| 26,780,545 | |
Research and development | |
| 1,161,424 | | |
| 770,525 | | |
| 1,931,949 | | |
| 443,963 | | |
| 2,050,489 | | |
| 2,494,452 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Net income (loss) | |
| (2,691,798 | ) | |
| (2,636,447 | ) | |
| (5,328,245 | ) | |
| 614,061 | | |
| (3,696,570 | ) | |
| (3,082,509 | ) |
Segment EBITDA | |
| 2,532,145 | | |
| (1,628,543 | ) | |
| 903,602 | | |
| 2,365,280 | | |
| (2,953,734 | ) | |
| (588,454 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Segment assets (at period
end) (1) | |
$ | 51,469,137 | | |
$ | 21,914,468 | | |
$ | 73,383,605 | | |
$ | 51,147,589 | | |
$ | 22,723,560 | | |
$ | 73,871,149 | |
Expenditures for long-lived
assets | |
$ | 124,580 | | |
$ | - | | |
$ | 124,580 | | |
$ | 40,650 | | |
$ | - | | |
$ | 40,650 | |
(1) | - Segment assets
for 2023 represent assets as of 12.31.23. |
The
following tables provide a reconciliation of net income (loss) to Segment EBITDA for our reportable segments for the periods indicated
below:
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
Three
Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,214,313 | ) | |
$ | (1,314,889 | ) | |
$ | (3,529,202 | ) | |
$ | 95,098 | | |
$ | (1,961,278 | ) | |
$ | (1,866,180 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest
expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Depreciation
and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Noncash
share-based compensation | |
| 1,046,321 | | |
| 36,429 | | |
| 1,082,750 | | |
| 1,064,516 | | |
| 62,816 | | |
| 1,127,332 | |
Change
in fair value of earnout liabilities | |
| 89,330 | | |
| (103,103 | ) | |
| (13,773 | ) | |
| (436,004 | ) | |
| 75,534 | | |
| (360,470 | ) |
Executive
separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition
costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment
EBITDA | |
$ | 1,393,959 | | |
$ | (801,778 | ) | |
$ | 592,181 | | |
$ | 1,120,207 | | |
$ | (1,415,831 | ) | |
$ | (295,624 | ) |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,691,798 | ) | |
$ | (2,636,447 | ) | |
$ | (5,328,245 | ) | |
$ | 614,061 | | |
$ | (3,696,570 | ) | |
$ | (3,082,509 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Noncash share-based compensation | |
| 1,799,936 | | |
| 86,200 | | |
| 1,886,136 | | |
| 1,609,729 | | |
| 114,908 | | |
| 1,724,637 | |
Change in fair value of earnout liabilities | |
| (14,451 | ) | |
| (65,000 | ) | |
| (79,451 | ) | |
| (627,132 | ) | |
| (186,025 | ) | |
| (813,157 | ) |
Executive separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment EBITDA | |
$ | 2,532,145 | | |
$ | (1,628,543 | ) | |
$ | 903,602 | | |
$ | 2,365,280 | | |
$ | (2,953,734 | ) | |
$ | (588,454 | ) |
(1) | - Includes $328,795
of share-based compensation related to executive separation costs. |
|
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Principles of Consolidation and Basis of Presentation |
Principles
of Consolidation and Basis of Presentation
The
accompanying unaudited consolidated financial statements include the accounts of Sanara MedTech Inc. and its wholly owned and majority-owned
subsidiaries, as well as other entities in which the Company has a controlling financial interest. All significant intercompany profits,
losses, transactions and balances have been eliminated in consolidation. Certain prior year amounts have been reclassified to conform
to the current year presentation.
The
accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles
for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include
all the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the
opinion of management of the Company, all adjustments (consisting of normal accruals) considered necessary for a fair presentation
have been included. Operating results for interim periods are not necessarily indicative of the results that may be expected for the
full year period. These financial statements and notes should be read in conjunction with the financial statements for each of the two
years ended December 31, 2023 and 2022, which are included in the Company’s most recent Annual Report on Form 10-K.
|
Use of Estimates |
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date
of the consolidated financial statements, and the reported revenue and expenses during the reporting period. However, actual results
could differ from those estimates and there may be changes to the Company’s estimates in future periods.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.
|
Income/Loss Per Share |
Income/Loss
Per Share
The
Company computes income/loss per share in accordance with Accounting Standards Codification (“ASC”) Topic 260, Earnings per
Share, which requires the Company to present basic and diluted income per share when the effect is dilutive. Basic income per share is
computed by dividing income available to common shareholders by the weighted average number of shares of common stock outstanding. Diluted
income per share is computed similarly to basic income per share, except that the denominator is increased to include the number of additional
shares of common stock that would have been outstanding if the potential shares of common stock had been issued and if the additional
shares of common stock were dilutive. All common stock equivalents were excluded from the calculations for the periods presented as their
inclusion would have been anti-dilutive during the six months ended June 30, 2024 and 2023 due to the Company’s net loss.
The
following table summarizes the shares of common stock that were potentially issuable but were excluded from the computation of diluted
net loss per share for the six months ended June 30, 2024 and 2023 as such shares would have had an anti-dilutive effect:
SCHEDULE
OF COMPUTATION OF DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | |
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Stock options
(a) | |
| 31,013 | | |
| 124,191 | |
Warrants (b) | |
| 16,725 | | |
| 16,725 | |
Unvested restricted stock | |
| 230,277 | | |
| 164,755 | |
Anti-dilutive securities | |
| 230,277 | | |
| 164,755 | |
|
(a) |
Shares
underlying stock options assumed pursuant to the merger agreement with Precision Healing, Inc. (“Precision Healing”)
in April 2022. |
|
(b) |
Shares
underlying warrants assumed pursuant to the merger agreement with Precision Healing in April 2022. |
|
Revenue Recognition |
Revenue
Recognition
The
Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Revenues
are recognized when a purchase order is received from the customer and control of the promised goods or services is transferred to the
customer in an amount that reflects the consideration the Company expects to be entitled to receive in exchange for transferring those
goods or services. Revenue is recognized based on the following five-step model:
-
Identification of the contract with a customer
-
Identification of the performance obligations in the contract
-
Determination of the transaction price
-
Allocation of the transaction price to the performance obligations in the contract
-
Recognition of revenue when, or as, the Company satisfies a performance obligation
Details
of this five-step process are as follows:
Identification
of the contract with a customer
Customer
purchase orders are generally considered to be contracts under ASC 606. Purchase orders typically identify the specific terms of products
to be delivered, create the enforceable rights and obligations of both parties and result in commercial substance. No other forms of
contract revenue recognition, such as the completed contract or percentage of completion methods, were utilized by the Company in either
2024 or 2023.
Performance
obligations
The
Company’s performance obligation is generally limited to delivery of the requested items to its customers at the agreed upon quantities
and prices.
Determination
and allocation of the transaction price
The
Company has established prices for its products. These prices are effectively agreed to when customers place purchase orders with the
Company. Rebates and discounts, if any, are recognized in full at the time of sale as a reduction of net revenue. Allocation of transaction
prices is not necessary where only one performance obligation exists.
Recognition
of revenue as performance obligations are satisfied
Product
revenues are recognized when a purchase order is received from the customer, the products are delivered and control of the goods and
services passes to the customer.
Disaggregation
of Revenue
Revenue
streams from product sales and royalties are summarized below for the three and six months ended June 30, 2024 and 2023.
SCHEDULE
OF REVENUE FROM PRODUCT SALES AND ROYALTIES
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Soft tissue repair products | |
$ | 17,641,318 | | |
$ | 13,249,742 | | |
$ | 33,723,610 | | |
$ | 26,122,223 | |
Bone fusion products | |
| 2,516,599 | | |
| 2,453,172 | | |
| 4,970,945 | | |
| 5,052,358 | |
Royalty revenue | |
| 906 | | |
| 50,250 | | |
| 906 | | |
| 100,500 | |
Total Net Revenue | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | 38,695,461 | | |
$ | 31,275,081 | |
|
Accounts Receivable Allowances |
Accounts
Receivable Allowances
Accounts
receivable are typically due within 30 days of invoicing. The Company establishes an allowance for credit losses to provide for an estimate
of accounts receivable which are not expected to be collectible. The Company bases the allowance on an assessment of customer creditworthiness,
historical payment experience, the age of outstanding receivables and other information as applicable and will record its allowance based
on the estimated credit losses. The Company recorded credit loss expense of $90,930 and $50,000 during the three months ended June 30,
2024 and 2023, respectively and $155,930 and $86,000 during the six months ended June 30, 2024 and 2023, respectively. The allowance
for credit losses was $683,960 at June 30, 2024 and $528,030 at December 31, 2023. Credit loss reserves are maintained based on a variety
of factors, including the length of time receivables are past due and a detailed review of certain individual customer accounts. The
Company also establishes other allowances to provide for estimated customer rebates and other expected customer deductions. These allowances
totaled $4,437 at June 30, 2024 and $3,820 at December 31, 2023. If circumstances related to customers change, estimates of the recoverability
of receivables would be further adjusted.
|
Inventories |
Inventories
Inventories
are stated at the lower of cost or net realizable value, with cost computed on a first-in, first-out basis. Inventories consist primarily
of finished goods, and also include an immaterial amount of raw materials and related packaging components. The Company recorded inventory
obsolescence expense of $164,342 and $39,479 during the three months ended June 30, 2024 and 2023, respectively, and $259,577 and $69,990
during the six months ended June 30, 2024 and 2023, respectively. The allowance for obsolete and slow-moving inventory had a balance
of $467,508 at June 30, 2024, and $446,917 at December 31, 2023.
|
Property and Equipment |
Property
and Equipment
Property
and equipment are stated at cost, less accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated
useful lives of the related assets, ranging from two to ten years. Below is a summary of property and equipment for the periods presented:
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
Useful | |
June 30, | | |
December 31, | |
| |
Life | |
2024 | | |
2023 | |
Computers | |
3-5 years | |
$ | 230,532 | | |
$ | 194,788 | |
Office equipment | |
3-7 years | |
| 214,190 | | |
| 201,785 | |
Furniture and fixtures | |
5-10 years | |
| 346,508 | | |
| 304,338 | |
Leasehold improvements | |
2-5 years | |
| 168,431 | | |
| 134,170 | |
Internal use software | |
5 years | |
| 1,618,999 | | |
| 1,618,999 | |
| |
| |
| | | |
| | |
Property and equipment, gross | |
| |
| 2,578,660 | | |
| 2,454,080 | |
Less accumulated depreciation | |
| |
| (1,462,394 | ) | |
| (1,196,124 | ) |
| |
| |
| | | |
| | |
Property and equipment, net | |
| |
$ | 1,116,266 | | |
$ | 1,257,956 | |
Depreciation
expense related to property and equipment was $133,301 and $108,492 for the three months ended June 30, 2024 and 2023, respectively,
and $266,270 and $216,166 for the six months ended June 30, 2024 and 2023, respectively.
|
Internal Use Software |
Internal
Use Software
The
Company accounts for costs incurred to develop or acquire computer software for internal use in accordance with ASC Topic 350-40, Intangibles
– Goodwill and Other. The Company capitalizes the costs incurred during the application development stage, which generally includes
third-party developer fees to design the software configuration and interfaces, coding, installation and testing.
The
Company begins capitalization of qualifying costs when both the preliminary project stage is completed and management has authorized
further funding for the completion of the project. Costs incurred during the preliminary project stage along with post implementation
stages of internal-use computer software are expensed as incurred. The Company also capitalizes costs related to specific upgrades and
enhancements when it is probable the expenditures will result in additional functionality. Capitalized development costs are classified
as “Property and equipment, net” in the Consolidated Balance Sheets and are depreciated over the estimated useful life of
the software, which is generally five years.
|
Goodwill |
Goodwill
The
excess of purchase price over the fair value of identifiable net assets acquired in business combinations is recorded as goodwill. As
of June 30, 2024 and December 31, 2023, all of the Company’s goodwill relates to the acquisition of Scendia Biologics, LLC (“Scendia”), which is included in the Sanara Surgical segment. Goodwill has an indefinite useful life and is not amortized. Goodwill is tested annually
as of December 31 for impairment, or more frequently if circumstances indicate impairment may have occurred. The Company may first perform
a qualitative assessment to determine if it is more likely than not that the fair value of the reporting unit is less than the respective
carrying value. If it is determined that it is more likely than not that a reporting unit’s fair value is less than its carrying
value, then the Company will determine the fair value of the reporting unit and record an impairment charge for the difference between
fair value and carrying value (not to exceed the carrying amount of goodwill). No impairment was recorded during the six months ended
June 30, 2024 or 2023.
|
Intangible Assets |
Intangible
Assets
Intangible
assets are stated at cost of acquisition less accumulated amortization and impairment loss, if any. Cost of acquisition includes the
purchase price and any cost directly attributable to bringing the asset to its working condition for the intended use. The Company amortizes
its finite-lived intangible assets on a straight-line basis over the estimated useful life of the respective assets which is generally
the life of the related patents or licenses, seven years for customer relationships and five years for assembled workforces. See Note
4 for more information on intangible assets.
|
Impairment of Long-Lived Assets |
Impairment
of Long-Lived Assets
Long-lived
assets, including certain identifiable intangibles held and to be used by the Company, are reviewed for impairment whenever events or
changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The Company continuously evaluates
the recoverability of its long-lived assets based on estimated future cash flows and the estimated liquidation value of such long-lived
assets and provides for impairment if such undiscounted cash flows are insufficient to recover the carrying amount of the long-lived
assets. If impairment exists, an adjustment is made to write the asset down to its fair value, and a loss is recorded as the difference
between the carrying value and fair value. Fair values are determined based on quoted market values, undiscounted cash flows or internal
and external appraisals, as applicable. Assets to be disposed of are carried at the lower of carrying value or estimated fair value less
cost to sell. No impairment was recorded during the six months ended June 30, 2024 or 2023.
|
Investments in Equity Securities |
Investments
in Equity Securities
The
Company’s equity investments consist of nonmarketable equity securities in privately held companies without readily determinable
fair values. Unless accounted for under the equity method of accounting, the investments are reported at cost minus impairment, if any,
plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the
same issuer. The Company did not have any investments which are recorded applying the equity method of accounting as of June 30, 2024.
The
Company has reviewed the carrying value of its investments and has determined there was no impairment or observable price changes as
of or for the six months ended June 30, 2024 and 2023.
|
Fair Value Measurement |
Fair
Value Measurement
As
defined in ASC Topic 820, Fair Value Measurement (“ASC 820”), fair value is the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price).
The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including
assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable,
market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to
measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or
liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). This fair value measurement
framework applies at both the initial and subsequent measurement.
The
three levels of the fair value hierarchy defined by ASC 820 are as follows:
Level
1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets
are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on
an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and
listed equities.
Level
2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly
observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies.
These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities,
time value, volatility factors, and current market and contractual prices for the underlying instruments, as well as other relevant economic
measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be
derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments
in this category generally include nonexchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
Level
3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used
with internally developed methodologies that result in management’s best estimate of fair value.
The
carrying amounts of cash, accounts receivable, accounts payable and accrued expenses, other than acquisition-related expenses, approximate
fair value because of the short-term nature of these instruments. The fair value of acquisition-related accrued expenses is categorized
as Level 2 of the fair value hierarchy. The value of these instruments has been estimated using discounted cash flow analysis based on
the Company’s incremental borrowing rate. The carrying value of the Company’s CRG Term Loan (defined below), which has a
fixed interest rate approximates fair value based on instruments with similar terms (Level 2 inputs). The carrying value of the Company’s
Cadence Term Loan (defined below), which had variable interest rates determined each month, approximates fair value based on instruments
with similar terms (Level 2 inputs). The fair value of the contingent earnout consideration and the acquisition date fair value of goodwill
and intangibles related to the acquisitions discussed in Notes 3 and 4 are based on Level 3 inputs.
Liabilities
for contingent consideration for the Precision Healing merger, acquisition of Scendia and Applied Asset Purchase (defined below)
(see Note 3 for more information) are measured at fair value each reporting period, with the acquisition-date fair value included as
part of the consideration transferred. Subsequent changes in fair value for the Precision Healing merger and Scendia acquisition are
reported under the line item captioned “Change in fair value of earnout liabilities” in the Company’s Consolidated
Statements of Operations. Due to the Applied Asset Purchase being accounted for as an asset acquisition and given that the
transaction did not include contingent shares, subsequent revaluations of contingent consideration for the Applied Asset Purchase
results in an adjustment to the contingent consideration liability and the intellectual property intangible asset with a cumulative
catch-up amortization adjustment. The current year changes in fair value of earnout liabilities below are as a result of a net
decrease in the estimated fair value of the earnout liabilities established at the time of the Company’s Precision Healing
merger and Scendia acquisition. The current year revaluation of earnout liability below is a result of a decrease in the estimated
value of the earnout liability established at the time of the Applied Asset Purchase. The following table sets forth a summary of
the changes in fair value for the Level 3 contingent earnout considerations.
SCHEDULE
OF CHANGES IN FAIR VALUE FOR CONTINGENT EARNOUT CONSIDERATION
| |
| | |
Balance at December 31, 2023 | |
$ | 3,823,001 | |
Changes in fair value of earnout liabilities | |
| (79,451 | ) |
Revaluation of earnout liability | |
| (4,000 | ) |
Balance at June 30, 2024 | |
$ | 3,739,550 | |
|
Income Taxes |
Income
Taxes
Income
taxes are accounted for under the asset and liability method, whereby deferred income taxes are recorded for temporary differences between
financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax
rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it
is more likely than not that some or all the deferred tax asset will not be realized.
|
Share-based Compensation |
Share-based
Compensation
The
Company accounts for share-based compensation to employees and nonemployees in accordance with ASC Topic 718, Compensation – Share
Compensation. Share-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as expense
over the stipulated vesting period, if any. The Company estimates the fair value of share-based payments using the Black-Scholes option-pricing
model for common stock options and warrants, and the closing price of the Company’s common stock for grants of common stock, including
restricted stock awards.
|
Research and Development Costs |
Research
and Development Costs
Research
and development (“R&D”) expenses consist of personnel-related expenses, including salaries share-based compensation
and benefits for all personnel directly engaged in R&D activities, contracted services, materials, prototype expenses and
allocated overhead which is comprised of compensation and benefits, lease expense and other facilities-related costs. R&D
expenses include costs related to enhancements to the Company’s currently available products and additional investments in the
product and platform development pipeline. The Company expenses R&D costs as incurred.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”)
2016-13, Financial Instruments - Credit Losses (Topic 326). This update amends the impairment model by requiring entities to use a
forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments
that are not measured at fair value through net income. The Company adopted the new guidance effective January 1, 2023. The adoption
did not have a material impact on the Company’s consolidated financial position, results of operations or cash
flows.
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU
2023-07”), which requires disclosure of incremental segment information on an annual and interim basis. ASU 2023-07 is effective
for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024 on a retrospective
basis. The Company is currently evaluating the effect of this pronouncement on its disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”),
which expands the disclosure required for income taxes. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024,
with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The
Company is currently evaluating the effect of this pronouncement on its disclosures.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SCHEDULE OF COMPUTATION OF DILUTED NET LOSS PER SHARE |
The
following table summarizes the shares of common stock that were potentially issuable but were excluded from the computation of diluted
net loss per share for the six months ended June 30, 2024 and 2023 as such shares would have had an anti-dilutive effect:
SCHEDULE
OF COMPUTATION OF DILUTED NET LOSS PER SHARE
| |
2024 | | |
2023 | |
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Stock options
(a) | |
| 31,013 | | |
| 124,191 | |
Warrants (b) | |
| 16,725 | | |
| 16,725 | |
Unvested restricted stock | |
| 230,277 | | |
| 164,755 | |
Anti-dilutive securities | |
| 230,277 | | |
| 164,755 | |
|
(a) |
Shares
underlying stock options assumed pursuant to the merger agreement with Precision Healing, Inc. (“Precision Healing”)
in April 2022. |
|
(b) |
Shares
underlying warrants assumed pursuant to the merger agreement with Precision Healing in April 2022. |
|
SCHEDULE OF REVENUE FROM PRODUCT SALES AND ROYALTIES |
Revenue
streams from product sales and royalties are summarized below for the three and six months ended June 30, 2024 and 2023.
SCHEDULE
OF REVENUE FROM PRODUCT SALES AND ROYALTIES
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Soft tissue repair products | |
$ | 17,641,318 | | |
$ | 13,249,742 | | |
$ | 33,723,610 | | |
$ | 26,122,223 | |
Bone fusion products | |
| 2,516,599 | | |
| 2,453,172 | | |
| 4,970,945 | | |
| 5,052,358 | |
Royalty revenue | |
| 906 | | |
| 50,250 | | |
| 906 | | |
| 100,500 | |
Total Net Revenue | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | 38,695,461 | | |
$ | 31,275,081 | |
|
SCHEDULE OF PROPERTY AND EQUIPMENT |
SCHEDULE
OF PROPERTY AND EQUIPMENT
| |
Useful | |
June 30, | | |
December 31, | |
| |
Life | |
2024 | | |
2023 | |
Computers | |
3-5 years | |
$ | 230,532 | | |
$ | 194,788 | |
Office equipment | |
3-7 years | |
| 214,190 | | |
| 201,785 | |
Furniture and fixtures | |
5-10 years | |
| 346,508 | | |
| 304,338 | |
Leasehold improvements | |
2-5 years | |
| 168,431 | | |
| 134,170 | |
Internal use software | |
5 years | |
| 1,618,999 | | |
| 1,618,999 | |
| |
| |
| | | |
| | |
Property and equipment, gross | |
| |
| 2,578,660 | | |
| 2,454,080 | |
Less accumulated depreciation | |
| |
| (1,462,394 | ) | |
| (1,196,124 | ) |
| |
| |
| | | |
| | |
Property and equipment, net | |
| |
$ | 1,116,266 | | |
$ | 1,257,956 | |
|
SCHEDULE OF CHANGES IN FAIR VALUE FOR CONTINGENT EARNOUT CONSIDERATION |
SCHEDULE
OF CHANGES IN FAIR VALUE FOR CONTINGENT EARNOUT CONSIDERATION
| |
| | |
Balance at December 31, 2023 | |
$ | 3,823,001 | |
Changes in fair value of earnout liabilities | |
| (79,451 | ) |
Revaluation of earnout liability | |
| (4,000 | ) |
Balance at June 30, 2024 | |
$ | 3,739,550 | |
|
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v3.24.2.u1
APPLIED ASSET PURCHASE (Tables) - Applied Asset Purchase [Member]
|
6 Months Ended |
Jun. 30, 2024 |
Restructuring Cost and Reserve [Line Items] |
|
SCHEDULE OF ASSET PURCHASE CONSIDERATIONS |
The
total purchase consideration for the Applied Asset Purchase as determined by the Company was as follows:
SCHEDULE
OF ASSET PURCHASE CONSIDERATIONS
Consideration | |
Equity Shares | | |
Dollar Value | |
Cash Closing Consideration | |
| | | |
$ | 9,750,000 | |
Fair value of Stock Closing Consideration | |
| 73,809 | | |
| 3,089,645 | |
Fair value of Installment Payments | |
| | | |
| 2,040,808 | |
Cash paid for inventory | |
| | | |
| 30,007 | |
Fair value of Petito Services Agreement defined payments | |
| | | |
| 825,834 | |
Fair value of Petito Services Agreement contingent consideration | |
| | | |
| 893,000 | |
Direct transaction costs | |
| | | |
| 162,743 | |
Total purchase consideration | |
| | | |
$ | 16,792,037 | |
|
SCHEDULE OF PURCHASE CONSIDERATION ON FAIR VALUE OF ASSETS ACQUIRED |
SCHEDULE
OF PURCHASE CONSIDERATION ON FAIR VALUE OF ASSETS ACQUIRED
Description | |
Amount | |
Inventory | |
$ | 30,007 | |
Equipment | |
| 33,062 | |
Intellectual property | |
| 16,728,968 | |
Net assets acquired | |
$ | 16,792,037 | |
|
X |
- DefinitionTabular disclosure of asset acquisition.
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v3.24.2.u1
GOODWILL AND INTANGIBLES, NET (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
SCHEDULE OF CHANGES IN THE CARRYING AMOUNT OF THE GOODWILL |
The
changes in the carrying amount of the Company’s goodwill were as follows:
SCHEDULE
OF CHANGES IN THE CARRYING AMOUNT OF THE GOODWILL
| |
Total | |
Balance as of December 31, 2022 | |
$ | 3,601,781 | |
Acquisitions | |
| - | |
Balance as of December 31, 2023 | |
| 3,601,781 | |
Acquisitions | |
| - | |
Balance as of June 30, 2024 | |
$ | 3,601,781 | |
|
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS |
The
carrying values of the Company’s intangible assets were as follows for the periods presented:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
Accumulated | | |
| | |
| | |
Accumulated | | |
| |
| |
Cost | | |
Amortization | | |
Net | | |
Cost | | |
Amortization | | |
Net | |
Amortizable Intangible Assets: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Product Licenses | |
$ | 4,793,879 | | |
$ | (1,535,647 | ) | |
$ | 3,258,232 | | |
$ | 4,793,879 | | |
$ | (1,342,626 | ) | |
$ | 3,451,253 | |
Patents and Other IP | |
| 38,566,549 | | |
| (4,348,964 | ) | |
| 34,217,585 | | |
| 38,570,549 | | |
| (3,181,186 | ) | |
| 35,389,363 | |
Customer relationships and other | |
| 7,947,332 | | |
| (2,445,745 | ) | |
| 5,501,587 | | |
| 7,947,332 | | |
| (1,861,887 | ) | |
| 6,085,445 | |
Total | |
$ | 51,307,760 | | |
$ | (8,330,356 | ) | |
$ | 42,977,404 | | |
$ | 51,311,760 | | |
$ | (6,385,699 | ) | |
$ | 44,926,061 | |
|
SCHEDULE OF FUTURE AMORTIZATION EXPENSE |
SCHEDULE
OF FUTURE AMORTIZATION EXPENSE
| |
| | |
Remainder of 2024 | |
$ | 1,944,768 | |
2025 | |
| 3,889,537 | |
2026 | |
| 3,872,281 | |
2027 | |
| 3,758,429 | |
2028 | |
| 3,725,187 | |
2029 | |
| 3,725,187 | |
Thereafter | |
| 22,062,015 | |
Total | |
$ | 42,977,404 | |
|
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v3.24.2.u1
INVESTMENTS IN EQUITY SECURITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Schedule of Investments [Abstract] |
|
SCHEDULE OF INVESTMENTS |
The
following summarizes the Company’s investments for the periods presented:
SCHEDULE
OF INVESTMENTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Carrying Amount | | |
Economic Interest | | |
Carrying Amount | | |
Economic Interest | |
Cost Method Investments | |
| | |
| | |
| | |
| |
Direct Dermatology, Inc. | |
$ | 1,000,000 | | |
| | | |
$ | 1,000,000 | | |
| | |
Pixalere Healthcare Inc. | |
| 2,084,278 | | |
| | | |
| 2,084,278 | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Total Cost Method Investments | |
$ | 3,084,278 | | |
| | | |
$ | 3,084,278 | | |
| | |
|
X |
- DefinitionTabular disclosure of equity method investments including, but not limited to, name of each investee or group of investments, percentage ownership, difference between recorded amount of an investment and the value of the underlying equity in the net assets, and summarized financial information.
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v3.24.2.u1
OPERATING LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases [Abstract] |
|
SCHEDULE OF OPERATING LEASE LIABILITY |
Maturity
of Operating Lease Liabilities
SCHEDULE OF OPERATING LEASE LIABILITY
| |
June 30, 2024 | |
Remainder of 2024 | |
$ | 237,793 | |
2025 | |
| 532,053 | |
2026 | |
| 379,529 | |
2027 | |
| 297,947 | |
2028 | |
| 295,689 | |
2029 | |
| 300,158 | |
Thereafter | |
| 303,892 | |
| |
| | |
Total lease payments | |
| 2,347,061 | |
Less imputed interest | |
| (440,814 | ) |
Present Value of Lease Liabilities | |
$ | 1,906,247 | |
| |
| | |
Operating lease liabilities – current | |
$ | 393,663 | |
Operating lease liabilities – long-term | |
$ | 1,512,584 | |
|
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v3.24.2.u1
DEBT AND CREDIT FACILITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt And Credit Facilities |
|
SCHEDULE OF LONG-TERM DEBT |
The
table below presents the components of outstanding debt for the periods presented:
As
of June 30, 2024, the interest rate on the CRG Term Loan was 13.25% per annum and as of December 31, 2023, the interest rate
on the advance under the Cadence Term Loan was 8.3%.
SCHEDULE
OF LONG-TERM DEBT
| |
June 30, 2024 | | |
December 31, 2023 | |
Cadence Term Loan | |
$ | - | | |
$ | 9,750,000 | |
CRG Term Loan | |
| 15,000,000 | | |
| - | |
Paid-in-kind interest | |
| 161,875 | | |
| - | |
Back-end fee | |
| 52,500 | | |
| - | |
Debt | |
| 15,214,375 | | |
| 9,750,000 | |
| |
| | | |
| | |
Less: debt issuance costs | |
| (887,253 | ) | |
| (61,658 | ) |
Accumulated amortization of debt issuance costs | |
| 44,363 | | |
| 5,138 | |
Net debt issuance costs | |
| (842,890 | ) | |
| (56,520 | ) |
| |
| | | |
| | |
Debt, net of debt issuance costs | |
| 14,371,485 | | |
| 9,693,480 | |
| |
| | | |
| | |
Less: Current portion of long-term debt | |
| - | | |
| 580,357 | |
Long-term debt | |
$ | 14,371,485 | | |
$ | 9,113,123 | |
|
SCHEDULE OF MATURITIES OUTSTANDING DEBT |
The
table below presents the aggregate maturities of the Company’s outstanding debt as of June 30, 2024:
SCHEDULE
OF MATURITIES OUTSTANDING DEBT
Year | |
Total | |
| |
| |
Remainder of 2024 | |
$ | - | |
2025 | |
| - | |
2026 | |
| - | |
2027 | |
| - | |
2028 | |
| - | |
Thereafter | |
| 15,214,375 | |
Total debt | |
$ | 15,214,375 | |
|
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v3.24.2.u1
SHAREHOLDERS’ EQUITY (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF RESTRICTED STOCK ACTIVITY |
Below
is a summary of restricted stock activity for the six months ended June 30, 2024:
SCHEDULE
OF RESTRICTED STOCK ACTIVITY
| |
For the Six Months Ended | |
| |
June 30, 2024 | |
| |
| | |
Weighted Average | |
| |
Shares | | |
Grant Date Fair Value | |
Nonvested at beginning of period | |
| 144,211 | | |
$ | 34.07 | |
Granted | |
| 190,240 | | |
| 35.03 | |
Vested | |
| (81,890 | ) | |
| 33.19 | |
Forfeited | |
| (22,284 | ) | |
| 34.53 | |
Nonvested at June 30, 2024 | |
| 230,277 | | |
$ | 35.13 | |
|
SCHEDULE OF STOCK OPTION ACTIVITY |
A
summary of the status of outstanding stock options at June 30, 2024 and changes during the six months then ended is presented below:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
For the Six Months Ended | | |
| |
| |
June 30, 2024 | | |
| |
| |
| | |
Weighted Average | | |
Weighted Average | | |
Aggregate | |
| |
| | |
Exercise | | |
Remaining | | |
Intrinsic | |
| |
Options | | |
Price | | |
Contract Life | | |
Value | |
Outstanding at beginning of period | |
| 93,892 | | |
$ | 10.22 | | |
| | | |
| | |
Granted or assumed | |
| - | | |
| - | | |
| | | |
| | |
Exercised | |
| (62,879 | ) | |
| 10.05 | | |
| | | |
| | |
Forfeited | |
| - | | |
| - | | |
| | | |
| | |
Expired | |
| - | | |
| - | | |
| | | |
| | |
Outstanding at June 30, 2024 | |
| 31,013 | | |
$ | 10.57 | | |
| 6.3 | | |
$ | 547,530.6 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 31,013 | | |
$ | 10.57 | | |
| 6.3 | | |
$ | 547,530.6 | |
|
SCHEDULE OF WARRANTS TO PURCHASE COMMON STOCK |
A
summary of the status of outstanding warrants to purchase common stock at June 30, 2024 and changes during the six months then ended
is presented below:
SCHEDULE OF WARRANTS TO PURCHASE COMMON STOCK
| |
For the Six Months Ended | |
| |
June 30, 2024 | |
| |
| | |
Weighted Average | | |
Weighted Average | |
| |
| | |
Exercise | | |
Remaining | |
| |
Warrants | | |
Price | | |
Contract Life | |
Outstanding at beginning of period | |
| 16,725 | | |
$ | 10.80 | | |
| | |
Granted or assumed | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| | |
Forfeited | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| | |
Outstanding at June 30, 2024 | |
| 16,725 | | |
$ | 10.80 | | |
| 6.3 | |
| |
| | | |
| | | |
| | |
Exercisable at June 30, 2024 | |
| 16,725 | | |
$ | 10.80 | | |
| 6.3 | |
|
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v3.24.2.u1
SEGMENT REPORTING (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Segment Reporting [Abstract] |
|
SCHEDULE OF OPERATIONS, ASSETS AND CAPITAL EXPENDITURES FOR OUR BUSINESS SEGMENTS |
The
following tables reflect results of operations, Segment EBITDA, segmented assets, and expenditures for long-lived assets for our
reportable segments for the periods indicated below:
SCHEDULE
OF OPERATIONS, ASSETS AND CAPITAL EXPENDITURES FOR OUR BUSINESS SEGMENTS
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Three Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 20,158,823 | | |
$ | - | | |
$ | 20,158,823 | | |
$ | 15,753,164 | | |
$ | - | | |
$ | 15,753,164 | |
Gross profit | |
| 18,150,137 | | |
| - | | |
| 18,150,137 | | |
| 13,565,648 | | |
| - | | |
| 13,565,648 | |
Selling, general and administrative
expenses | |
| 18,349,924 | | |
| 607,684 | | |
| 18,957,608 | | |
| 13,301,230 | | |
| 510,246 | | |
| 13,811,476 | |
Research and development | |
| 582,443 | | |
| 403,208 | | |
| 985,651 | | |
| 208,727 | | |
| 968,401 | | |
| 1,177,128 | |
Depreciation and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Interest expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Net income (loss) | |
| (2,214,313 | ) | |
| (1,314,889 | ) | |
| (3,529,202 | ) | |
| 95,098 | | |
| (1,961,278 | ) | |
| (1,866,180 | ) |
Segment EBITDA | |
| 1,393,959 | | |
| (801,778 | ) | |
| 592,181 | | |
| 1,120,207 | | |
| (1,415,831 | ) | |
| (295,624 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Segment
assets (at period end) (1) | |
$ | 51,469,137 | | |
$ | 21,914,468 | | |
$ | 73,383,605 | | |
$ | 51,147,589 | | |
$ | 22,723,560 | | |
$ | 73,871,149 | |
Expenditures for long-lived
assets | |
$ | 58,762 | | |
$ | - | | |
$ | 58,762 | | |
$ | 12,945 | | |
$ | - | | |
$ | 12,945 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Six Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Net revenue | |
$ | 38,695,461 | | |
$ | - | | |
$ | 38,695,461 | | |
$ | 31,272,351 | | |
$ | 2,730 | | |
$ | 31,275,081 | |
Gross profit | |
| 34,796,729 | | |
| - | | |
| 34,796,729 | | |
| 26,968,141 | | |
| (6,235 | ) | |
| 26,961,906 | |
Selling, general and administrative
expenses | |
| 34,032,964 | | |
| 1,116,903 | | |
| 35,149,867 | | |
| 25,768,626 | | |
| 1,011,919 | | |
| 26,780,545 | |
Research and development | |
| 1,161,424 | | |
| 770,525 | | |
| 1,931,949 | | |
| 443,963 | | |
| 2,050,489 | | |
| 2,494,452 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Net income (loss) | |
| (2,691,798 | ) | |
| (2,636,447 | ) | |
| (5,328,245 | ) | |
| 614,061 | | |
| (3,696,570 | ) | |
| (3,082,509 | ) |
Segment EBITDA | |
| 2,532,145 | | |
| (1,628,543 | ) | |
| 903,602 | | |
| 2,365,280 | | |
| (2,953,734 | ) | |
| (588,454 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Segment assets (at period
end) (1) | |
$ | 51,469,137 | | |
$ | 21,914,468 | | |
$ | 73,383,605 | | |
$ | 51,147,589 | | |
$ | 22,723,560 | | |
$ | 73,871,149 | |
Expenditures for long-lived
assets | |
$ | 124,580 | | |
$ | - | | |
$ | 124,580 | | |
$ | 40,650 | | |
$ | - | | |
$ | 40,650 | |
(1) | - Segment assets
for 2023 represent assets as of 12.31.23. |
The
following tables provide a reconciliation of net income (loss) to Segment EBITDA for our reportable segments for the periods indicated
below:
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
| |
Three
Months Ended | |
| |
June
30, | |
| |
2024 | | |
2023 | |
| |
Sanara
Surgical | | |
THP | | |
Total | | |
Sanara
Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,214,313 | ) | |
$ | (1,314,889 | ) | |
$ | (3,529,202 | ) | |
$ | 95,098 | | |
$ | (1,961,278 | ) | |
$ | (1,866,180 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest
expense | |
| 644,346 | | |
| - | | |
| 644,346 | | |
| - | | |
| - | | |
| - | |
Depreciation
and amortization | |
| 698,407 | | |
| 407,100 | | |
| 1,105,507 | | |
| 396,597 | | |
| 407,097 | | |
| 803,694 | |
Noncash
share-based compensation | |
| 1,046,321 | | |
| 36,429 | | |
| 1,082,750 | | |
| 1,064,516 | | |
| 62,816 | | |
| 1,127,332 | |
Change
in fair value of earnout liabilities | |
| 89,330 | | |
| (103,103 | ) | |
| (13,773 | ) | |
| (436,004 | ) | |
| 75,534 | | |
| (360,470 | ) |
Executive
separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition
costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment
EBITDA | |
$ | 1,393,959 | | |
$ | (801,778 | ) | |
$ | 592,181 | | |
$ | 1,120,207 | | |
$ | (1,415,831 | ) | |
$ | (295,624 | ) |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
| |
Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
Sanara Surgical | | |
THP | | |
Total | | |
Sanara Surgical | | |
THP | | |
Total | |
Net Income (Loss) | |
$ | (2,691,798 | ) | |
$ | (2,636,447 | ) | |
$ | (5,328,245 | ) | |
$ | 614,061 | | |
$ | (3,696,570 | ) | |
$ | (3,082,509 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| 911,682 | | |
| - | | |
| 911,682 | | |
| 6 | | |
| - | | |
| 6 | |
Depreciation and amortization | |
| 1,396,908 | | |
| 814,019 | | |
| 2,210,927 | | |
| 768,616 | | |
| 813,953 | | |
| 1,582,569 | |
Noncash share-based compensation | |
| 1,799,936 | | |
| 86,200 | | |
| 1,886,136 | | |
| 1,609,729 | | |
| 114,908 | | |
| 1,724,637 | |
Change in fair value of earnout liabilities | |
| (14,451 | ) | |
| (65,000 | ) | |
| (79,451 | ) | |
| (627,132 | ) | |
| (186,025 | ) | |
| (813,157 | ) |
Executive separation costs(1) | |
| 904,780 | | |
| - | | |
| 904,780 | | |
| - | | |
| - | | |
| - | |
Acquisition costs | |
| 225,088 | | |
| 172,685 | | |
| 397,773 | | |
| - | | |
| - | | |
| - | |
Segment EBITDA | |
$ | 2,532,145 | | |
$ | (1,628,543 | ) | |
$ | 903,602 | | |
$ | 2,365,280 | | |
$ | (2,953,734 | ) | |
$ | (588,454 | ) |
(1) | - Includes $328,795
of share-based compensation related to executive separation costs. |
|
X |
- DefinitionTabular disclosure of the profit or loss and total assets for each reportable segment. An entity discloses certain information on each reportable segment if the amounts (a) are included in the measure of segment profit or loss reviewed by the chief operating decision maker or (b) are otherwise regularly provided to the chief operating decision maker, even if not included in that measure of segment profit or loss.
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- DefinitionNumber of operating segments. An operating segment is a component of an enterprise: (a) that engages in business activities from which it may earn revenues and incur expenses (including revenues and expenses relating to transactions with other components of the same enterprise), (b) whose operating results are regularly reviewed by the enterprise's chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance, and (c) for which discrete financial information is available. An operating segment may engage in business activities for which it has yet to earn revenues, for example, start-up operations may be operating segments before earning revenues.
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v3.24.2.u1
SCHEDULE OF REVENUE FROM PRODUCT SALES AND ROYALTIES (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Product Information [Line Items] |
|
|
|
|
Total Net Revenue |
$ 20,158,823
|
$ 15,753,164
|
$ 38,695,461
|
$ 31,275,081
|
Soft Tissue Repair Products [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total Net Revenue |
17,641,318
|
13,249,742
|
33,723,610
|
26,122,223
|
Bone Fusion Products [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total Net Revenue |
2,516,599
|
2,453,172
|
4,970,945
|
5,052,358
|
Royalty [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Total Net Revenue |
$ 906
|
$ 50,250
|
$ 906
|
$ 100,500
|
X |
- DefinitionAmount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.
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v3.24.2.u1
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 2,578,660
|
$ 2,454,080
|
Less accumulated depreciation |
(1,462,394)
|
(1,196,124)
|
Property and equipment, net |
1,116,266
|
1,257,956
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 230,532
|
194,788
|
Computer Equipment [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
3 years
|
|
Computer Equipment [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
5 years
|
|
Office Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 214,190
|
201,785
|
Office Equipment [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
3 years
|
|
Office Equipment [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
7 years
|
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 346,508
|
304,338
|
Furniture and Fixtures [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
5 years
|
|
Furniture and Fixtures [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
10 years
|
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 168,431
|
134,170
|
Leasehold Improvements [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
2 years
|
|
Leasehold Improvements [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful life |
5 years
|
|
Internal Use Software [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 1,618,999
|
$ 1,618,999
|
Useful life |
5 years
|
|
X |
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
|
|
|
Bad debt expense |
$ 90,930
|
$ 50,000
|
$ 155,930
|
$ 86,000
|
|
Allowance for doubtful accounts |
683,960
|
|
683,960
|
|
$ 528,030
|
Accounts receivable allowances |
4,437
|
|
4,437
|
|
3,820
|
Inventory obsolescence expense |
164,342
|
39,479
|
259,577
|
69,990
|
|
Allowance for obsolete and slow-moving inventory |
467,508
|
|
467,508
|
|
$ 446,917
|
Depreciation |
$ 133,301
|
$ 108,492
|
266,270
|
216,166
|
|
Impairment of goodwill |
|
|
0
|
0
|
|
Impairment of long-lived assets |
|
|
$ 0
|
$ 0
|
|
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v3.24.2.u1
SCHEDULE OF ASSET PURCHASE CONSIDERATIONS (Details)
|
Aug. 01, 2023
USD ($)
shares
|
Applied Asset Purchase |
|
Cash Closing Consideration |
$ 9,750,000
|
Fair value of Stock Closing Consideration |
$ 3,089,645
|
Equity Shares | shares |
73,809
|
Fair value of Installment Payments |
$ 2,040,808
|
Cash paid for inventory |
30,007
|
Fair value of Petito Services Agreement defined payments |
825,834
|
Fair value of Petito Services Agreement contingent consideration |
893,000
|
Direct transaction costs |
162,743
|
Total purchase consideration |
$ 16,792,037
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APPLIED ASSET PURCHASE (Details Narrative) $ in Thousands |
Aug. 01, 2023
USD ($)
shares
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Cash consideration |
$ 10,000
|
Applied Asset Purchase [Member] |
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Purchase agreement description |
As consideration for the Petito Services, the Owner is entitled to receive: (i) a base salary of
$12,000 per month during the term of the Petito Services Agreement, (ii) a royalty payment equal to three percent (3%) of the actual
collections from net sales of certain products the Owner develops or co-develops that reach commercialization, (iii) a royalty payment
equal to five percent (5%) for the first $50.0 million in aggregate collections from net sales of certain future products and a royalty
payment of two and one-half percent (2.5%) on aggregate collections from net sales of certain future products on any amounts exceeding
$50.0 million but up to $100.0 million, (iv) $500,000 in cash in the event that 510(k) clearance is issued for any future product accepted
by the Company and (v) $1.0 million in cash in the event that a U.S. patent is issued for a certain product; provided that with respect
to the incentive payments described in (iv) and (v) of the foregoing, the Owner shall not earn more than $2.5 million.
|
Cash Closing Consideration [Member] |
|
Business Acquisition, Contingent Consideration [Line Items] |
|
Payments to acquire productive assets |
$ 15,250
|
Cash consideration |
$ 9,750
|
Stock issued during period shares issued for services | shares |
73,809
|
Stock Closing Consideration [Member] |
|
Business Acquisition, Contingent Consideration [Line Items] |
|
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$ 3,000
|
Cash consideration |
$ 2,500
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v3.24.2.u1
SCHEDULE OF CHANGES IN THE CARRYING AMOUNT OF THE GOODWILL (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
Balance as of December 31, 2023 |
$ 3,601,781
|
$ 3,601,781
|
Acquisitions |
|
|
Balance as of June 30, 2024 |
$ 3,601,781
|
$ 3,601,781
|
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v3.24.2.u1
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Finite-Lived Intangible Assets [Line Items] |
|
|
Net |
$ 42,977,404
|
$ 44,926,061
|
Licensing Agreements [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Cost |
4,793,879
|
4,793,879
|
Accumulated amortization |
(1,535,647)
|
(1,342,626)
|
Net |
3,258,232
|
3,451,253
|
Patents [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Cost |
38,566,549
|
38,570,549
|
Accumulated amortization |
(4,348,964)
|
(3,181,186)
|
Net |
34,217,585
|
35,389,363
|
Customer Relationships and Other [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Cost |
7,947,332
|
7,947,332
|
Accumulated amortization |
(2,445,745)
|
(1,861,887)
|
Net |
5,501,587
|
6,085,445
|
Amortizable Intangible Assets [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Cost |
51,307,760
|
51,311,760
|
Accumulated amortization |
(8,330,356)
|
(6,385,699)
|
Net |
$ 42,977,404
|
$ 44,926,061
|
X |
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v3.24.2.u1
SCHEDULE OF FUTURE AMORTIZATION EXPENSE (Details)
|
Jun. 30, 2024
USD ($)
|
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Remainder of 2024 |
$ 1,944,768
|
2025 |
3,889,537
|
2026 |
3,872,281
|
2027 |
3,758,429
|
2028 |
3,725,187
|
2029 |
3,725,187
|
Thereafter |
22,062,015
|
Total |
$ 42,977,404
|
X |
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v3.24.2.u1
GOODWILL AND INTANGIBLES, NET (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
|
|
Weighted average useful life |
|
|
14 years 6 months
|
|
Amortization of intangible assets |
$ 972,206
|
$ 695,202
|
$ 1,944,657
|
$ 1,366,403
|
X |
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v3.24.2.u1
SCHEDULE OF INVESTMENTS (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Cost method investment |
$ 3,084,278
|
$ 3,084,278
|
Direct Dermatology Inc. [Member] |
|
|
Cost method investment |
1,000,000
|
1,000,000
|
Pixalere Healthcare Inc. [Member] |
|
|
Cost method investment |
$ 2,084,278
|
$ 2,084,278
|
X |
- DefinitionIncludes other investments and securities that are not at fair value as of the balance sheet date and those that are not accounted for under the equity method.
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v3.24.2.u1
INVESTMENTS IN EQUITY SECURITIES (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
12 Months Ended |
|
|
Mar. 31, 2022 |
Jun. 30, 2021 |
Jul. 31, 2020 |
Mar. 31, 2023 |
Dec. 31, 2021 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Long term investments |
|
|
|
|
|
$ 3,084,278
|
$ 3,084,278
|
Value of shares purchased |
|
|
|
$ 1,033,761
|
|
|
|
Series B-2 Preferred Shares [Member] | Direct Derm's [Member] |
|
|
|
|
|
|
|
Ownership interest |
|
|
2.90%
|
|
|
8.10%
|
|
Series B-2 Preferred Shares [Member] |
|
|
|
|
|
|
|
Long term investments |
|
|
$ 500,000
|
|
|
|
|
Purchase of additional shares |
|
|
7,142,857
|
|
|
|
|
Series B-2 Preferred Shares [Member] | Direct Derm's [Member] |
|
|
|
|
|
|
|
Purchase of additional shares |
3,571,429
|
|
|
|
3,571,430
|
|
|
Value of shares purchased |
$ 250,000
|
|
|
|
$ 250,000
|
|
|
Class A Preferred Shares [Member] | Pixalere Healthcare Inc. [Member] |
|
|
|
|
|
|
|
Purchase of additional shares |
|
278,587
|
|
|
|
|
|
Investments |
|
$ 2,084,278
|
|
|
|
|
|
Conversion of shares |
|
27.30%
|
|
|
|
|
|
Class A Preferred Shares [Member] | Pixalere Healthcare Inc. [Member] |
|
|
|
|
|
|
|
Ownership interest |
|
27.30%
|
|
|
|
|
|
Ownership amount |
|
$ 93,879
|
|
|
|
|
|
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v3.24.2.u1
SCHEDULE OF OPERATING LEASE LIABILITY (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Leases [Abstract] |
|
|
Remainder of 2024 |
$ 237,793
|
|
2025 |
532,053
|
|
2026 |
379,529
|
|
2027 |
297,947
|
|
2028 |
295,689
|
|
2029 |
300,158
|
|
Thereafter |
303,892
|
|
Total lease payments |
2,347,061
|
|
Less imputed interest |
(440,814)
|
|
Present Value of Lease Liabilities |
1,906,247
|
|
Operating lease liabilities – current |
393,663
|
$ 361,185
|
Operating lease liabilities – long-term |
$ 1,512,584
|
$ 1,737,445
|
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v3.24.2.u1
OPERATING LEASES (Details Narrative) - USD ($)
|
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
|
Operating lease right of use asset |
$ 1,792,448
|
|
$ 1,995,204
|
Operating lease liability |
1,906,247
|
|
|
Operating lease expenses |
277,596
|
$ 184,575
|
|
Operating lease payments |
$ 267,223
|
$ 175,382
|
|
Weighted average remaining lease term |
5 years 6 months
|
|
|
Weighted average discount rate |
7.64%
|
|
|
Office Space One [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Remaining lease term |
78 months
|
|
|
Office Space Two [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Remaining lease term |
14 months
|
|
|
Office Space Three [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Remaining lease term |
31 months
|
|
|
X |
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v3.24.2.u1
SCHEDULE OF LONG-TERM DEBT (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Short-Term Debt [Line Items] |
|
|
Debt |
$ 15,214,375
|
$ 9,750,000
|
Less: debt issuance costs |
(887,253)
|
(61,658)
|
Accumulated amortization of debt issuance costs |
44,363
|
5,138
|
Net debt issuance costs |
(842,890)
|
(56,520)
|
Debt, net of debt issuance costs |
14,371,485
|
9,693,480
|
Less: Current portion of long-term debt |
|
580,357
|
Long-term debt |
14,371,485
|
9,113,123
|
Cadence Term Loan [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Debt |
|
9,750,000
|
CRG Term Loan [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Debt |
15,000,000
|
|
Paid-In-Kind Interest [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Debt |
161,875
|
|
Back-end Fee [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Debt |
$ 52,500
|
|
X |
- DefinitionAmount of accumulated amortization of debt issuance costs.
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v3.24.2.u1
DEBT AND CREDIT FACILITIES (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
|
|
|
|
Apr. 17, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Aug. 05, 2024 |
Dec. 31, 2023 |
Aug. 31, 2023 |
Aug. 01, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
Loan to be borrowed |
|
$ 14,371,485
|
|
$ 14,371,485
|
|
|
$ 9,693,480
|
|
|
Accreted and principal outstanding balance |
|
644,346
|
|
911,682
|
$ 6
|
|
|
|
|
Interest paid-in-kind |
|
|
|
161,875
|
|
|
|
|
|
Minimum cash balance |
|
3,000,000.0
|
|
3,000,000.0
|
|
|
|
$ 693,000
|
|
Annual minimum revenue, year one |
|
|
|
60,000,000.0
|
|
|
|
|
|
Annual minimum revenue, year two |
|
|
|
75,000,000.0
|
|
|
|
|
|
Annual minimum revenue, year three |
|
|
|
85,000,000.0
|
|
|
|
|
|
Annual minimum revenue, year four |
|
|
|
95,000,000.0
|
|
|
|
|
|
Annual minimum revenue, year five |
|
|
|
105,000,000.0
|
|
|
|
|
|
Debt issuance costs |
|
887,253
|
|
887,253
|
|
|
61,658
|
|
|
Unamortized debt issuance costs |
|
$ 842,890
|
|
842,890
|
|
|
$ 56,520
|
|
|
Amortization expense related to debt issuance cost |
|
|
|
$ 100,883
|
|
|
|
|
|
Loan Agreement [Member] |
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
|
|
$ 12,000,000.0
|
Loan agreement percentage |
|
|
|
|
|
|
|
|
100.00%
|
Loan bank advance |
|
|
|
|
|
|
|
|
$ 9,750,000
|
Bank, interest rate |
|
|
|
|
|
3.00%
|
|
|
|
Loan agreement, description |
|
|
|
(i) create, assume or guarantee certain liabilities, (ii) create, assume
or suffer liens securing indebtedness, (iii) make or permit loans and advances, (iv) acquire any assets outside the ordinary course of
business, (v) consolidate, merge or sell all or a material part of its assets, (vi) pay dividends or other distributions on, or redeem
or repurchase, interest in an obligor, including the Company, as guarantor (vii) cease, suspend or materially curtail business operations
or (viii) engage in certain affiliate transactions. In addition, the Cadence Loan Agreement contained financial covenants that required
SMAT to maintain (i) a minimum Debt Services Coverage Ratio of 1.2 to 1.0 as of the last day of each applicable fiscal quarter and (ii)
a maximum Cash Flow Leverage Ratio of not more than (a) 4.5 to 1.0 as of the last day of the fiscal quarter ending on September 30, 2023,
(b) 4.0 to 1.0 as of the last day of each fiscal quarter ending on December 31, 2023 and March 31, 2024, (c) 3.5 to 1.0 as of the last
day of each fiscal quarter ending June 30, 2024 and September 30, 2024 and (d) 3.0 to 1.0 as of the last day of each fiscal quarter thereafter
|
|
|
|
|
|
Interest expense and other |
|
|
|
$ 53,438
|
|
|
|
|
|
CRG Term Loan [Member] |
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
Term loan percentage |
|
13.25%
|
|
13.25%
|
|
|
|
|
|
Cadence Term Loan [Member] |
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
Term loan percentage |
|
|
|
|
|
|
8.30%
|
|
|
Term Loan [Member] |
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
Debt issuance costs |
|
$ 887,253
|
|
$ 887,253
|
|
|
|
|
|
CRG Term Loan Agreement [Member] |
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
Secured term loan |
$ 55,000,000.0
|
|
|
|
|
|
|
|
|
Loan to be borrowed |
15,000,000.0
|
|
|
|
|
|
|
|
|
Remaining amount available for borrowing |
$ 40,000,000.0
|
|
|
|
|
|
|
|
|
Borrowing capacity description |
each
such borrowing must be at least $5.0 million or a multiple of $5.0 million and occur between the Closing Date and June 30,
2025
|
|
|
|
|
|
|
|
|
Interest rate per annum percentage |
13.25%
|
|
|
|
|
|
|
|
|
Incremental increase during an event of default |
4.00%
|
|
|
|
|
|
|
|
|
Cash paid percentage |
8.00%
|
|
|
|
|
|
|
|
|
Paid-in-kind and aggregate principal loan amount, percentage |
5.25%
|
|
|
|
|
|
|
|
|
Debt instrument interest rate upfront fee percentage |
1.50%
|
|
|
|
|
|
|
|
|
Debt instrument interest rate back-end fee percentage |
7.00%
|
|
|
|
|
|
|
|
|
Accreted and principal outstanding balance |
|
246,667
|
|
246,667
|
|
|
|
|
|
Interest paid-in-kind |
|
161,875
|
|
161,875
|
|
|
|
|
|
Debt instrument rate description |
(i)
if prepayment occurs on or prior to the date that is one year following the applicable borrowing (the “Borrowing Date”),
an amount equal to 10.0% of the aggregate outstanding principal amount of the CRG Term Loan being prepaid and (ii) if prepayment
occurs one year after the applicable Borrowing Date and on or prior to two years following the applicable Borrowing Date, an amount
equal to 5.0% of the aggregate outstanding principal amount of the CRG Term Loan being prepaid
|
|
|
|
|
|
|
|
|
CRG Term Loan Agreement [Member] | Back-end Fee [Member] |
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
Accreted and principal outstanding balance |
|
$ 52,500
|
|
$ 52,500
|
|
|
|
|
|
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
Jan. 01, 2024 |
Dec. 20, 2023 |
Aug. 01, 2023 |
Aug. 27, 2018 |
Jul. 31, 2022 |
Apr. 30, 2022 |
May 31, 2020 |
Apr. 30, 2020 |
Oct. 31, 2019 |
Jul. 31, 2019 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Aug. 31, 2023 |
Apr. 04, 2022 |
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash consideration |
|
|
$ 16,792,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options to acquire shares |
|
|
|
|
|
144,191
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted exercise price |
|
|
|
|
|
$ 10.71
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
|
|
|
|
|
4,424
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
$ 7.32
|
|
|
|
|
|
|
|
|
|
|
|
|
Expiration date |
|
|
|
|
|
Apr. 22, 2031
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments receive |
|
|
893,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
cash |
|
|
|
|
|
|
|
|
|
|
$ 3,000,000.0
|
|
|
$ 3,000,000.0
|
|
|
$ 693,000
|
|
Cash consideration |
|
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
|
|
|
486,145
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Closing Consideration [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase price |
|
|
$ 15,250,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
|
|
|
|
|
12,301
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
$ 12.05
|
|
|
|
|
|
|
|
|
|
|
|
|
Expiration date |
|
|
|
|
|
Aug. 10, 2030
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares isssued |
|
|
|
|
|
|
|
|
|
|
|
|
26,143
|
|
|
|
|
|
Precision Healing Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash consideration |
|
|
|
|
|
$ 125,966
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments receive |
|
|
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
|
Precision Healing [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments receive |
|
|
|
|
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
|
|
|
|
Rochal [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of cash |
|
|
|
|
|
|
$ 500,000
|
|
|
|
|
|
|
|
|
|
|
|
Accredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
|
|
|
165,738
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonaccredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 30.75
|
Precision Healing [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment in cash |
|
|
|
|
|
$ 600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
|
|
$ 27.13
|
|
$ 27.13
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty expense |
|
|
|
|
|
|
|
|
|
|
0
|
$ 548,430
|
|
0
|
$ 1,069,244
|
|
|
|
Sub License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License agreement and royalties description |
|
|
|
In
August 2018, the Company entered an exclusive, world-wide sublicense agreement with CGI Cellerate RX, LLC (“CGI Cellerate RX”)
to distribute certain hydrolyzed collagen products, including CellerateRX Surgical, into the surgical and wound care markets. Pursuant
to the Sublicense Agreement, the Company paid royalties of 3-5% of annual collected net sales of these products. As amended in January
2021, the term of the sublicense was extended through May 2050, with automatic successive year-to-year renewal terms thereafter so long
as the Company’s Net Sales (as defined in the Sublicense Agreement) each year are equal to or in excess of $1,000,000. If the Company’s
Net Sales fall below $1,000,000 for any year after the expiration date, CGI Cellerate RX has the right to terminate the Sublicense Agreement
upon written notice.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BIAKOS License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty expense |
|
|
|
|
|
|
|
|
|
|
$ 42,305
|
$ 32,500
|
|
$ 77,305
|
$ 65,000
|
|
|
|
Royalty annual minimum percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.00%
|
|
|
|
|
BIAKOS License Agreement [Member] | Rochal Industries LLC [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty percentage |
|
|
|
|
|
|
|
|
|
2.00%
|
|
|
|
|
|
|
|
|
Maximum amount of royalty |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 133,000
|
|
|
BIAKOS License Agreement [Member] | Rochal Industries LLC [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty percentage |
|
|
|
|
|
|
|
|
|
4.00%
|
|
|
|
|
|
|
|
|
Maximum amount of royalty |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 150,000
|
|
|
|
|
BIAKOS Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment for additional royalties |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1,000,000
|
|
|
|
|
ABF License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty annual minimum percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.00%
|
|
|
|
|
ABF License Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty percentage |
|
|
|
|
|
|
|
|
2.00%
|
|
|
|
|
|
|
|
|
|
Maximum amount of royalty |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 50,000
|
|
|
|
|
ABF License Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty percentage |
|
|
|
|
|
|
|
|
4.00%
|
|
|
|
|
|
|
|
|
|
Maximum amount of royalty |
|
|
|
|
|
|
|
|
|
|
|
|
|
75,000
|
|
|
|
|
Payment for additional royalties |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 500,000
|
|
|
|
|
Debrider License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty annual minimum percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
10.00%
|
|
|
|
|
Payment of cash |
|
|
|
|
|
|
$ 1,000,000
|
|
|
|
|
|
|
|
|
|
|
|
Debrider License Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty percentage |
|
|
|
|
|
|
2.00%
|
|
|
|
|
|
|
|
|
|
|
|
Debrider License Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty percentage |
|
|
|
|
|
|
4.00%
|
|
|
|
|
|
|
|
|
|
|
|
Maximum amount of royalty |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 150,000
|
|
|
|
|
Payment for additional royalties |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1,000,000
|
|
|
|
|
Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition consideration transferred |
|
|
|
|
$ 7,600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
cash |
|
|
|
|
$ 1,600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for purchase of assets |
|
|
|
|
291,686
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares isssued |
|
|
|
|
94,798
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase price |
|
|
|
|
$ 7,600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Services Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase agreement description |
|
|
As consideration for the Petito Services, the Owner is entitled to receive: (i) a base salary of $12,000 per month during the
term of the Petito Services Agreement, (ii) a royalty payment equal to three percent (3%) of the actual collections from net sales of
certain products the Owner develops or codevelops that reach commercialization, (iii) a royalty payment equal to five percent (5%) for
the first $50.0 million in aggregate collections from net sales of certain future products and a royalty payment of two and one-half
percent (2.5%) on aggregate collections from net sales of certain future products on any amounts exceeding $50.0 million but up to $100.0
million, (iv) $500,000 in cash in the event that 510(k) clearance is issued for any future product accepted by the Company and (v) $1.0
million in cash in the event that a U.S. patent is issued for a certain product; provided that with respect to the incentive payments
described in (iv) and (v) of the foregoing, the Owner shall not earn more than $2.5 million.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty expense |
$ 50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding units percentage |
|
10.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License Agreement [Member] | Royalty Agreement Terms [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty expense |
$ 100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty expense percentage |
|
1.50%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty expense percentage |
|
3.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SCHEDULE OF RESTRICTED STOCK ACTIVITY (Details)
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Equity [Abstract] |
|
Non-vested shares, beginning | shares |
144,211
|
Weighted average grant date fair value, beginning | $ / shares |
$ 34.07
|
Granted | shares |
190,240
|
Weighted average grant date fair value, granted | $ / shares |
$ 35.03
|
Vested | shares |
(81,890)
|
Weighted average grant date fair value, vested | $ / shares |
$ 33.19
|
Forfeited | shares |
(22,284)
|
Weighted average grant date fair value, forfeited | $ / shares |
$ 34.53
|
Non-vested shares, ending | shares |
230,277
|
Weighted average grant date fair value, ending | $ / shares |
$ 35.13
|
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SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($)
|
1 Months Ended |
6 Months Ended |
Apr. 30, 2022 |
Jun. 30, 2024 |
Equity [Abstract] |
|
|
Number of options outstanding, beginning |
|
93,892
|
Weighted average exercise price outstanding, beginning |
|
$ 10.22
|
Granted |
144,191
|
|
Weighted average exercise price, Granted |
|
|
Exercised |
|
(62,879)
|
Weighted average exercise price, Exercised |
|
$ 10.05
|
Forfeited |
|
|
Weighted average exercise price, Forfeited |
|
|
Expired |
|
|
Number of options outstanding, ending |
|
31,013
|
Weighted average exercise price outstanding, ending |
|
$ 10.57
|
Weighted average remaining contract life outstanding |
|
6 years 3 months 18 days
|
Aggregate intrinsic value, ending |
|
$ 547,530.6
|
Number of options exercisable, ending |
|
31,013
|
Weighted average exercise price outstanding, ending |
|
$ 10.57
|
Weighted average remaining contract life exercisable, ending |
|
6 years 3 months 18 days
|
Aggregate intrinsic value, exercisable |
|
$ 547,530.6
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v3.24.2.u1
SCHEDULE OF WARRANTS TO PURCHASE COMMON STOCK (Details)
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Equity [Abstract] |
|
Number of warrants outstanding, Balance | shares |
16,725
|
Weighted average exercise price outstanding, Balance |
$ 10.80
|
Number of warrants outstanding, Exercised | shares |
|
Weighted average exercise price outstanding, Granted or assumed |
|
Weighted average exercise price outstanding, Exercised |
|
Number of warrants outstanding, Forfeited | shares |
|
Weighted average exercise price outstanding, Forfeited |
|
Number of warrants outstanding, Expired | shares |
|
Weighted average exercise price outstanding, Expired |
|
Number of warrants outstanding, Balance | shares |
16,725
|
Weighted average exercise price outstanding, Balance |
$ 10.80
|
Weighted average remaining contract life, Outstanding |
6 years 3 months 18 days
|
Number of warrants, Exercisable Balance | shares |
16,725
|
Weighted average exercise price outstanding, Exercisable Balance |
$ 10.80
|
Weighted average remaining contract life, Exercisable |
6 years 3 months 18 days
|
X |
- DefinitionWeighted average price at which grantees can acquire the shares reserved for issuance under the warrant exercisable.
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v3.24.2.u1
SHAREHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
Jun. 12, 2024 |
Aug. 01, 2023 |
Aug. 31, 2023 |
Feb. 28, 2023 |
Jul. 31, 2022 |
Apr. 30, 2022 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Apr. 04, 2022 |
Apr. 30, 2020 |
Cash consideration |
|
$ 16,792,037
|
|
|
|
|
|
|
|
|
|
|
|
|
Options to acquire shares |
|
|
|
|
|
144,191
|
|
|
|
|
|
|
|
|
Weighted exercise price |
|
|
|
|
|
$ 10.71
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
|
|
|
|
|
4,424
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
$ 7.32
|
|
|
|
|
|
|
|
|
Payment of contingent consideration |
|
893,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
$ 693,000
|
|
|
|
$ 3,000,000.0
|
|
|
$ 3,000,000.0
|
|
|
|
|
Cash consideration |
|
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
|
|
|
486,145
|
|
|
|
|
|
|
|
|
|
Earnout payment |
|
|
$ 693,000
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued, value |
|
|
|
|
|
|
|
|
$ 1,033,761
|
|
|
|
|
|
Number of award shares |
1,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock granted and issued |
|
|
|
|
|
|
|
|
|
167,956
|
|
|
|
|
Restricted stock award, gross |
|
|
|
|
|
|
|
|
|
$ 5,894,731
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
1,082,750
|
$ 1,127,332
|
|
2,214,931
|
$ 1,724,637
|
|
|
|
Unrecognized share-based compensation expense |
|
|
|
|
|
|
6,557,465
|
|
|
6,557,465
|
|
|
|
|
Selling, General and Administrative Expenses [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
$ 1,411,545
|
$ 1,127,332
|
|
$ 2,214,930
|
$ 1,724,637
|
|
|
|
Cash Closing Consideration [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments to acquire assets |
|
$ 15,250,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period shares issued for services |
|
73,809
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in equity offering, shares |
|
|
|
|
94,798
|
|
|
|
|
|
|
|
|
|
Payments to acquire assets |
|
|
|
|
$ 7,600,000
|
|
|
|
|
|
|
|
|
|
Cash |
|
|
|
|
$ 1,600,000
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for purchase of assets |
|
|
|
|
291,686
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in equity offering, shares |
|
|
|
|
|
|
|
|
26,143
|
|
|
|
|
|
Warrants to purchase shares |
|
|
|
|
|
12,301
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
$ 12.05
|
|
|
|
|
|
|
|
|
Number of shares issued, value |
|
|
|
|
|
|
|
|
$ 26
|
|
|
|
|
|
Common Stock [Member] | Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in equity offering, shares |
|
|
|
|
|
|
|
|
|
|
|
26,143
|
|
|
Number of shares issued, value |
|
|
|
|
|
|
|
|
|
|
|
$ 1,100,000
|
|
|
Net proceeds |
|
|
|
|
|
|
|
|
|
|
|
$ 900,000
|
|
|
Precision Healing [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment in cash |
|
|
|
|
|
$ 600,000
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
|
|
$ 27.13
|
|
|
|
|
|
|
|
$ 27.13
|
Cantor Fitzgerald and Co [Member] | Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of commissions payable to sales agent |
|
|
|
3.00%
|
|
|
|
|
|
|
|
|
|
|
Cantor Fitzgerald and Co [Member] | Sales Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, consideration received on transaction |
|
|
|
$ 75,000,000
|
|
|
|
|
|
|
|
|
|
|
Accredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accredited investors shares |
|
|
|
|
|
165,738
|
|
|
|
|
|
|
|
|
Nonaccredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
|
|
|
|
|
|
|
|
|
$ 30.75
|
|
Precision Healing Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash consideration |
|
|
|
|
|
$ 125,966
|
|
|
|
|
|
|
|
|
Payment of contingent consideration |
|
|
|
|
|
$ 10,000,000.0
|
|
|
|
|
|
|
|
|
Restated 2014 Omnibus Long Term Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares available for issuance |
|
|
|
|
|
|
1,251,547
|
|
|
1,251,547
|
|
|
|
|
Restated 2014 Omnibus Long Term Incentive Plan [Member] | Directors Officers Employees [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock in equity offering, shares |
|
|
|
|
|
|
|
|
|
748,453
|
|
|
|
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v3.24.2.u1
RELATED PARTIES (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Jul. 31, 2021 |
Jan. 31, 2021 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Consulting Agreement [Member] | Ms Salamone [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Professional fees |
$ 177,697
|
|
|
|
|
|
Cellerate Rx Sub License Agreement [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Net sale |
|
$ 1,000,000
|
|
|
|
|
Catalyst Services Agreement [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Cost and expenses related party |
|
|
$ 57,000
|
$ 72,986
|
$ 113,272
|
$ 72,986
|
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SCHEDULE OF OPERATIONS, ASSETS AND CAPITAL EXPENDITURES FOR OUR BUSINESS SEGMENTS (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Segment Reporting Information [Line Items] |
|
|
|
|
|
|
|
Net revenue |
|
$ 20,158,823
|
|
$ 15,753,164
|
|
$ 38,695,461
|
$ 31,275,081
|
Gross profit |
|
18,150,137
|
|
13,565,648
|
|
34,796,729
|
26,961,906
|
Selling, general and administrative expenses |
|
18,957,608
|
|
13,811,476
|
|
35,149,867
|
26,780,545
|
Research and development |
|
985,651
|
|
1,177,128
|
|
1,931,949
|
2,494,452
|
Depreciation and amortization |
|
1,105,507
|
|
803,694
|
|
2,210,927
|
1,582,569
|
Interest expense |
|
(644,346)
|
|
|
|
(911,682)
|
(6)
|
Net loss |
|
(3,529,202)
|
$ (1,799,043)
|
(1,866,180)
|
$ (1,216,329)
|
(5,328,245)
|
(3,082,509)
|
Segment EBITDA |
|
592,181
|
|
(295,624)
|
|
903,602
|
(588,454)
|
Segment assets (at period end) |
[1] |
73,383,605
|
|
73,871,149
|
|
73,383,605
|
73,871,149
|
Expenditures for long-lived assets |
|
58,762
|
|
12,945
|
|
124,580
|
40,650
|
Segment EBITDA |
|
592,181
|
|
(295,624)
|
|
903,602
|
(588,454)
|
Interest expense |
|
644,346
|
|
|
|
911,682
|
6
|
Noncash share-based compensation |
|
1,082,750
|
|
1,127,332
|
|
2,214,931
|
1,724,637
|
Change in fair value of earnout liabilities |
|
(13,773)
|
|
(360,470)
|
|
(79,451)
|
(813,157)
|
Executive separation costs |
[2] |
904,780
|
|
|
|
904,780
|
|
Acquisition costs |
|
397,773
|
|
|
|
397,773
|
|
Noncash share-based compensation |
|
|
|
|
|
1,886,136
|
1,724,637
|
Share based compensation related to executive separation costs |
|
|
|
|
|
328,795
|
|
Sanara Surgical [Member] |
|
|
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
|
|
Net revenue |
|
20,158,823
|
|
15,753,164
|
|
38,695,461
|
31,272,351
|
Gross profit |
|
18,150,137
|
|
13,565,648
|
|
34,796,729
|
26,968,141
|
Selling, general and administrative expenses |
|
18,349,924
|
|
13,301,230
|
|
34,032,964
|
25,768,626
|
Research and development |
|
582,443
|
|
208,727
|
|
1,161,424
|
443,963
|
Depreciation and amortization |
|
698,407
|
|
396,597
|
|
1,396,908
|
768,616
|
Interest expense |
|
(644,346)
|
|
|
|
(911,682)
|
(6)
|
Net loss |
|
(2,214,313)
|
|
95,098
|
|
(2,691,798)
|
614,061
|
Segment EBITDA |
|
1,393,959
|
|
1,120,207
|
|
2,532,145
|
2,365,280
|
Segment assets (at period end) |
[1] |
51,469,137
|
|
51,147,589
|
|
51,469,137
|
51,147,589
|
Expenditures for long-lived assets |
|
58,762
|
|
12,945
|
|
124,580
|
40,650
|
Segment EBITDA |
|
1,393,959
|
|
1,120,207
|
|
2,532,145
|
2,365,280
|
Interest expense |
|
644,346
|
|
|
|
911,682
|
6
|
Noncash share-based compensation |
|
1,046,321
|
|
1,064,516
|
|
|
|
Change in fair value of earnout liabilities |
|
89,330
|
|
(436,004)
|
|
(14,451)
|
(627,132)
|
Executive separation costs |
[2] |
904,780
|
|
|
|
904,780
|
|
Acquisition costs |
|
225,088
|
|
|
|
225,088
|
|
Noncash share-based compensation |
|
|
|
|
|
1,799,936
|
1,609,729
|
THP [Member] |
|
|
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
|
|
Net revenue |
|
|
|
|
|
|
2,730
|
Gross profit |
|
|
|
|
|
|
(6,235)
|
Selling, general and administrative expenses |
|
607,684
|
|
510,246
|
|
1,116,903
|
1,011,919
|
Research and development |
|
403,208
|
|
968,401
|
|
770,525
|
2,050,489
|
Depreciation and amortization |
|
407,100
|
|
407,097
|
|
814,019
|
813,953
|
Interest expense |
|
|
|
|
|
|
|
Net loss |
|
(1,314,889)
|
|
(1,961,278)
|
|
(2,636,447)
|
(3,696,570)
|
Segment EBITDA |
|
(801,778)
|
|
(1,415,831)
|
|
(1,628,543)
|
(2,953,734)
|
Segment assets (at period end) |
[1] |
21,914,468
|
|
22,723,560
|
|
21,914,468
|
22,723,560
|
Expenditures for long-lived assets |
|
|
|
|
|
|
|
Segment EBITDA |
|
(801,778)
|
|
(1,415,831)
|
|
(1,628,543)
|
(2,953,734)
|
Interest expense |
|
|
|
|
|
|
|
Noncash share-based compensation |
|
36,429
|
|
62,816
|
|
|
|
Change in fair value of earnout liabilities |
|
(103,103)
|
|
75,534
|
|
(65,000)
|
(186,025)
|
Executive separation costs |
[2] |
|
|
|
|
|
|
Acquisition costs |
|
$ 172,685
|
|
|
|
172,685
|
|
Noncash share-based compensation |
|
|
|
|
|
$ 86,200
|
$ 114,908
|
|
|
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