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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended September 30, 2023
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 001-40943
Biofrontera
Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
47-3765675 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(IRS
Employer
Identification
No.) |
|
|
|
120
Presidential Way, Suite 330, Woburn,
Massachusetts |
|
01801 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(781)
245-1325
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
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, par value $0.001 per share |
|
BFRI |
|
The
Nasdaq Stock Market LLC |
Preferred
Stock Purchase Rights |
|
|
|
The
Nasdaq Stock Market LLC |
Warrants
to purchase common stock |
|
BFRIW |
|
The
Nasdaq Stock Market LLC |
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 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 the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 8, 2023 there were 1,517,628 shares outstanding of the registrant’s common stock, par value $0.001 per share.
TABLE
OF CONTENTS
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value and share amounts)
| |
September 30,
2023 | | |
December 31,
2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 3,422 | | |
$ | 17,208 | |
Investment, related party | |
| 3,341 | | |
| 10,548 | |
Accounts receivable, net | |
| 3,793 | | |
| 3,748 | |
Other receivables, related party | |
| 2,713 | | |
| 3,658 | |
Inventories, net | |
| 16,068 | | |
| 7,168 | |
Prepaid expenses and other current assets | |
| 274 | | |
| 810 | |
| |
| | | |
| | |
Total current assets | |
| 29,611 | | |
| 43,140 | |
| |
| | | |
| | |
Other receivables long term, related party | |
| - | | |
| 2,813 | |
Property and equipment, net | |
| 154 | | |
| 204 | |
Operating lease right-of-use assets | |
| 1,129 | | |
| 1,375 | |
Intangible asset, net | |
| 2,718 | | |
| 3,032 | |
Other assets | |
| 492 | | |
| 320 | |
| |
| | | |
| | |
Total assets | |
$ | 34,104 | | |
$ | 50,884 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
| 1,634 | | |
| 1,278 | |
Accounts payable, related parties | |
| 6,988 | | |
| 1,312 | |
Accounts payable | |
| 6,988 | | |
| 1,312 | |
Acquisition contract liabilities, net | |
| 7,211 | | |
| 6,942 | |
Operating lease liabilities | |
| 555 | | |
| 498 | |
Accrued expenses and other current liabilities | |
| 11,039 | | |
| 10,864 | |
Line of credit | |
| 1,697 | | |
| - | |
| |
| | | |
| | |
Total current liabilities | |
| 29,124 | | |
| 20,894 | |
| |
| | | |
| | |
Long-term liabilities: | |
| | | |
| | |
Acquisition contract liabilities, net | |
| 2,500 | | |
| 2,400 | |
Warrant liabilities | |
| 842 | | |
| 2,843 | |
Operating lease liabilities, non-current | |
| 562 | | |
| 848 | |
Other liabilities | |
| 38 | | |
| 21 | |
| |
| | | |
| | |
Total liabilities | |
| 33,066 | | |
| 27,006 | |
| |
| | | |
| | |
Commitments and contingencies (Note 18) | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| - | | |
| - | |
Common Stock, $0.001 par value, 15,000,000 shares authorized; 1,367,628 and 1,334,950 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| 1 | | |
| 1 | |
Additional paid-in capital | |
| 104,213 | | |
| 103,396 | |
Accumulated deficit | |
| (103,176 | ) | |
| (79,519 | ) |
| |
| | | |
| | |
Total stockholders’ equity | |
| 1,038 | | |
| 23,878 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 34,104 | | |
$ | 50,884 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts and number of shares)
(Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended September 30, | | |
Nine months ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Product revenues, net | |
$ | 8,879 | | |
$ | 4,290 | | |
$ | 23,423 | | |
$ | 18,467 | |
Revenues, related party | |
| 17 | | |
| 32 | | |
| 52 | | |
| 63 | |
| |
| | | |
| | | |
| | | |
| | |
Total revenues, net | |
| 8,896 | | |
| 4,322 | | |
| 23,475 | | |
| 18,530 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Cost of revenues, related party | |
| 4,495 | | |
| 2,127 | | |
| 11,814 | | |
| 9,504 | |
Cost of revenues, other | |
| 95 | | |
| 98 | | |
| 262 | | |
| 425 | |
Selling, general and administrative | |
| 8,619 | | |
| 7,765 | | |
| 29,874 | | |
| 25,050 | |
Selling, general and administrative, related party | |
| 74 | | |
| 171 | | |
| 193 | | |
| 612 | |
Research and development | |
| 33 | | |
| - | | |
| 44 | | |
| - | |
Change in fair value of contingent consideration | |
| 200 | | |
| (2,200 | ) | |
| 100 | | |
| (4,100 | ) |
| |
| | | |
| | | |
| | | |
| | |
Total operating expenses | |
| 13,516 | | |
| 7,961 | | |
| 42,287 | | |
| 31,491 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (4,620 | ) | |
| (3,639 | ) | |
| (18,812 | ) | |
| (12,961 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense) | |
| | | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| 598 | | |
| 3,814 | | |
| 2,001 | | |
| 17,896 | |
Warrant inducement expense | |
| - | | |
| (2,629 | ) | |
| - | | |
| (2,629 | ) |
Realized/Unrealized losses in investment, related party | |
| (2,212 | ) | |
| - | | |
| (6,635 | ) | |
| - | |
Interest expense, net | |
| (142 | ) | |
| (89 | ) | |
| (256 | ) | |
| (160 | ) |
Other income, net | |
| 35 | | |
| (22 | ) | |
| 65 | | |
| 30 | |
| |
| | | |
| | | |
| | | |
| | |
Total other income (expense) | |
| (1,721 | ) | |
| 1,074 | | |
| (4,825 | ) | |
| 15,137 | |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| 1 | | |
| 1 | | |
| 20 | | |
| 31 | |
| |
| | | |
| | | |
| | | |
| | |
Net income (loss) | |
$ | (6,342 | ) | |
$ | (2,566 | ) | |
$ | (23,657 | ) | |
$ | 2,145 | |
| |
| | | |
| | | |
| | | |
| | |
Income (loss) per common share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
Diluted | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 978,018 | |
Diluted | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 980,251 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In
thousands, except number of shares)
(Unaudited)
Three
and Nine Months Ended September 30, 2023
| |
Shares | | |
Amount | | |
In Capital | | |
Deficit | | |
Total | |
| |
Common Stock | | |
Additional Paid- | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
In Capital | | |
Deficit | | |
Total | |
Balance, June 30, 2023 | |
| 1,343,538 | | |
$ | 1 | | |
$ | 104,006 | | |
$ | (96,834 | ) | |
$ | 7,173 | |
Issuance of shares in reverse stock split (for fractional shares) | |
| 24,090 | | |
| 0 | | |
| - | | |
| - | | |
| - | |
Stock based compensation | |
| - | | |
| - | | |
| 207 | | |
| - | | |
| 207 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (6,342 | ) | |
| (6,342 | ) |
Balance, September 30, 2023 | |
| 1,367,628 | | |
$ | 1 | | |
$ | 104,213 | | |
$ | (103,176 | ) | |
$ | 1,038 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2022 | |
| 1,334,950 | | |
$ | 1 | | |
$ | 103,396 | | |
$ | (79,519 | ) | |
$ | 23,878 | |
Issuance of shares for vested restricted stock units | |
| 8,588 | | |
| 0 | | |
| - | | |
| - | | |
| - | |
Issuance of shares in reverse stock split (for fractional shares) | |
| 24,090 | | |
| 0 | | |
| - | | |
| - | | |
| - | |
Stock based compensation | |
| - | | |
| - | | |
| 817 | | |
| - | | |
| 817 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (23,657 | ) | |
| (23,657 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, September 30, 2023 | |
| 1,367,628 | | |
$ | 1 | | |
$ | 104,213 | | |
$ | (103,176 | ) | |
$ | 1,038 | |
Three
and Nine Months Ended September 30, 2022
| |
Common Stock | | |
Additional Paid- | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
In Capital | | |
Deficit | | |
Total | |
Balance, June 30, 2022 | |
| 950,573 | | |
$ | 1 | | |
$ | 91,400 | | |
$ | (74,168 | ) | |
$ | 17,233 | |
Exercise of pre-funded warrants | |
| 78,450 | | |
| 0 | | |
| 2,841 | | |
| | | |
| 2,841 | |
Exercise of PIPE warrants | |
| 142,857 | | |
| 0 | | |
| 4,686 | | |
| - | | |
| 4,686 | |
Issuance of shares for vested restricted stock units | |
| 5,668 | | |
| 0 | | |
| - | | |
| - | | |
| - | |
Stock based compensation | |
| - | | |
| - | | |
| 401 | | |
| - | | |
| 401 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (2,566 | ) | |
| (2,566 | ) |
Balance, September 30, 2022 | |
| 1,177,548 | | |
$ | 1 | | |
$ | 99,328 | | |
$ | (76,734 | ) | |
$ | 22,595 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2021 | |
| 855,237 | | |
$ | 1 | | |
$ | 90,216 | | |
$ | (78,879 | ) | |
$ | 11,338 | |
Issuance of common stock and warrants under private placement, net of issuance costs | |
| 92,500 | | |
| 0 | | |
| 116 | | |
| - | | |
| 116 | |
Exercise of pre-funded warrants | |
| 78,450 | | |
| 0 | | |
| 2,841 | | |
| | | |
| 2,841 | |
Exercise of PIPE warrants | |
| 142,857 | | |
| 0 | | |
| 4,686 | | |
| - | | |
| 4,686 | |
Issuance of shares for vested restricted stock units | |
| 8,504 | | |
| 0 | | |
| - | | |
| - | | |
| - | |
Stock based compensation | |
| - | | |
| - | | |
| 1,469 | | |
| - | | |
| 1,469 | |
Net income | |
| - | | |
| - | | |
| - | | |
| 2,145 | | |
| 2,145 | |
Net income (loss) | |
| - | | |
| - | | |
| - | | |
| 2,145 | | |
| 2,145 | |
Balance, September 30, 2022 | |
| 1,177,548 | | |
$ | 1 | | |
$ | 99,328 | | |
$ | (76,734 | ) | |
$ | 22,595 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
Thousands)
(Unaudited)
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
| |
| | | |
| | |
Net income (loss) | |
$ | (23,657 | ) | |
$ | 2,145 | |
| |
| | | |
| | |
Adjustments to reconcile net income (loss) to cash flows used in operations: | |
| | | |
| | |
| |
| | | |
| | |
Depreciation | |
| 65 | | |
| 80 | |
Amortization of right-of-use assets | |
| 390 | | |
| - | |
Amortization of acquired intangible assets | |
| 314 | | |
| 314 | |
Realized/Unrealized losses in investment, related party | |
| 6,635 | | |
| - | |
Change in fair value of contingent consideration | |
| 100 | | |
| (4,100 | ) |
Change in fair value of warrant liabilities | |
| (2,001 | ) | |
| (17,896 | ) |
Warrant inducement expense | |
| - | | |
| 2,629 | |
Stock-based compensation | |
| 817 | | |
| 1,469 | |
Provision for inventory obsolescence | |
| - | | |
| 100 | |
Provision for doubtful accounts | |
| 158 | | |
| 111 | |
Non-cash interest expense | |
| 296 | | |
| 268 | |
| |
| | | |
| | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (204 | ) | |
| 2,111 | |
Other receivables, related party | |
| 3,652 | | |
| 5,145 | |
Prepaid expenses and other assets | |
| 347 | | |
| 4,121 | |
Inventories | |
| (8,900 | ) | |
| (7,728 | ) |
Accounts payable and related party payables | |
| 6,137 | | |
| 3,519 | |
Operating lease liabilities | |
| (375 | ) | |
| - | |
Accrued expenses and other liabilities | |
| 197 | | |
| (216 | ) |
| |
| | | |
| | |
Cash flows used in operating activities | |
| (16,029 | ) | |
| (7,928 | ) |
| |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | |
Disbursement for loan receivable | |
| - | | |
| (3,033 | ) |
Sales of equity investment, related party | |
| 560 | | |
| - | |
Purchases of property and equipment | |
| (14 | ) | |
| (37 | ) |
| |
| | | |
| | |
Cash flows provided by (used) in investing activities | |
| 546 | | |
| (3,070 | ) |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from line of credit | |
| 13,546 | | |
| - | |
Proceeds from issuance of common stock and warrants in private placement, net of issuance costs | |
| - | | |
| 9,391 | |
Proceeds from exercise of warrants | |
| - | | |
| 4,630 | |
Repayment of line of credit | |
| (11,849 | ) | |
| - | |
| |
| | | |
| | |
Cash flows provided by financing activities | |
| 1,697 | | |
| 14,021 | |
| |
| | | |
| | |
Net increase (decrease) in cash and cash equivalents | |
| (13,786 | ) | |
| 3,023 | |
Cash, cash equivalents and restricted cash, at the beginning of the period | |
| 17,408 | | |
| 24,742 | |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash, at the end of the period | |
$ | 3,622 | | |
$ | 27,765 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information | |
| | | |
| | |
Interest paid | |
$ | 31 | | |
$ | 10 | |
Interest paid, related party | |
$ | 22 | | |
| - | |
Income taxes paid, net | |
$ | 21 | | |
$ | 30 | |
| |
| | | |
| | |
Supplemental non-cash investing and financing activities | |
| | | |
| | |
Conversion of warrant liability to equity | |
$ | - | | |
$ | 6,840 | |
Addition of right-of-use assets in exchange for operating lease liabilities | |
$ | 147 | | |
$ | - | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Biofrontera
Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
1.
Business Overview
Biofrontera
Inc. (the “Company” or “Biofrontera”) is a U.S.-based biopharmaceutical company commercializing a portfolio of
pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”) and topical
antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions
as well as impetigo, a bacterial skin infection. In May 2023, the Company began research and development (“R&D”) activities
to support PDT growth and will continue to opportunistically invest in these activities going forward. Our research and development program
currently aims to improve the capabilities of our BF-RhodoLED® lamps to better fulfill the needs of dermatologists and
improve the effectiveness of our commercial team by letting sales representatives carry approved devices with them allowing for easier
product demonstrations and evaluations.
Biofrontera includes its wholly owned subsidiary Bio-FRI GmbH (“Bio-FRI”), a limited liability company organized under the laws
of Germany. Our subsidiary, Bio-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship with the Ameluz
Licensor.
Our
principal licensed product is Ameluz®, which is a prescription drug approved for use in combination with the RhodoLED®
lamp series, for PDT. In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic
keratoses of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in
the U.S. under an exclusive license and supply agreement (“Ameluz LSA”) with Biofrontera Pharma (“Pharma”) GmbH
and Biofrontera Bioscience GmbH (“Bioscience” and together, the “Ameluz Licensor”).
Our
second prescription drug licensed product is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial
growth. It is approved for use in the United States
in adults and children 2 months and older. We are currently selling Xepi® for this indication in the United States under an exclusive
license and supply agreement, as amended (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”) that was assumed
by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc.(“Cutanea”). There has been limited
revenue during the current reporting periods and recent developments with the third-party manufacturer that was providing our supply
of Xepi® have resulted in further delays of our commercialization of the product. However, Ferrer is qualifying a new Contract manufacturer,
Cambrex, which is expected to begin production in 2024.
Reverse
Stock Split
On
June 28, 2023, the Company, filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the
“Amendment”) with the Secretary of State of the State of Delaware to (i) effect a 1-for-20 reverse stock split (the
“Reverse Stock Split”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and (ii) effect a related proportional reduction in the number of the Company’s authorized shares of Common
Stock from 300,000,000 to 15,000,000
(the “Authorized Share Reduction”).
Pursuant
to the Amendment, the Reverse Stock Split and Authorized Share Reduction was effective at 11:59 p.m. on July 3, 2023 (the “Split
Effective Time”), and the Common Stock began trading on the Nasdaq Capital Market on a post-split basis on July 5, 2023. The par
value and other terms of the Common Stock were not affected.
Following
the Split Effective Time, every 20 shares of Biofrontera Common Stock issued and outstanding were automatically combined and
reclassified into one share of Common Stock. Outstanding equity-based awards, warrants and other equity rights were proportionately
adjusted pursuant to their terms and the number of shares authorized and reserved for issuance upon vesting of restricted stock
units or exercise of stock options and warrants were reduced proportionately. No fractional shares were issued as a result of the
Reverse Stock Split. Stockholders who would otherwise hold a fractional share as a result of the Reverse Stock Split received an
additional share of Common Stock.
Under
the terms of the applicable warrant agreement, the number of shares of Common Stock issuable on exercise of each warrant will be proportionately
decreased. Specifically, following effectiveness of the Reverse Stock Split, every 20 shares of Common Stock that may be purchased pursuant
to the exercise of public warrants now represents one share of Common Stock that may be purchased pursuant to such warrants. Accordingly,
for the Company’s warrants trading under the symbol “BFRIW”, every 20 warrants will be exercisable for one share of
Common Stock at an exercise price of $100.00 per share of Common Stock.
The
Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in the
Company’s equity (other than as a result of the rounding up of fractional shares). All information included in these
consolidated financial statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock Split as if it had been
effective from the beginning of the earliest period presented, unless otherwise stated. All outstanding securities entitling their
holders to purchase shares of Common Stock or acquire shares of Common Stock, including stock options, restricted stock units, and
warrants, were adjusted as a result of the Reverse Stock Split.
Liquidity
and Going Concern
The
Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, proceeds
from the sale of our investment, related party, and cash flows from a revolving line of credit. As of September 30, 2023, we had cash
and cash equivalents of $3.4 million and investment, related party of $3.3 million, compared to $17.2 million and $10.5 million as of
December 31, 2022, respectively.
Since
we commenced operations in 2015, we have generated significant losses. For the nine months ended September 30, 2023 and 2022, we incurred
loss from operations of $18.8
million and $13.0
million, respectively. We incurred net cash outflows
from operations of $16.0
million and $7.9
million, for the same periods, respectively.
We had an accumulated deficit as of September 30, 2023 of $103.2
million. Additionally, we expect to continue
to incur operating losses due to significant discretionary sales and marketing, medical affairs, and dermatology community outreach efforts
as we seek to expand the commercialization of our licensed products in the United States.
In
connection with our assessment of going concern considerations under applicable accounting standards, the Company’s management
has determined that substantial doubt exists about our ability to continue as a going concern for at least one year from the date
the unaudited condensed consolidated financial statements were issued.
The
future viability of the Company is dependent on its ability to continue to execute its growth plan and raise additional capital or
find alternative methods of financing to fund its operations during the first half of 2024, and until cash flow from operations is
sufficient, if ever. We have implemented plans to improve our working capital position, particularly around inventory levels, and do
not expect to need a delivery until sometime in Q3 2024, depending on actual sales until then. Management believes that the anticipated implementation of such plans, together with the recent
net capital raise of $4.1
million (See Note 21, Subsequent Events) will provide the opportunity for the Company to continue as a going concern.
However, no assurance can be given that the Company will be successful in these efforts.
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability
and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the
uncertainties described above. There could be a material adverse effect on the Company and its financial statements if management’s plans
are not achieved on a timely basis.
2.
Summary of Significant Accounting Policies
Basis
for Preparation of the Financial Statements
The
accompanying unaudited interim condensed consolidated financial statements of the Company have been prepared pursuant to the rules
and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Certain information
and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. generally accepted
accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the
Company’s opinion, the unaudited condensed consolidated financial statements include all material adjustments, all of which
are of a normal and recurring nature, necessary to present fairly the Company’s financial position as of September 30, 2023,
the Company’s operating results for the three and nine months ended September 30, 2023 and 2022, and the Company’s cash
flows for the nine months ended September 30, 2023 and 2022. The accompanying financial information as of December 31, 2022 is
derived from audited financial statements. Interim results are not necessarily indicative of results for a full year. The
information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s reaudited
consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 (“reaudited Consolidated Financial
Statements”), and the revised Management’s Discussion and Analysis of Financial Condition and Results of Operations for
the fiscal years ended December 31, 2022 and December 31, 2021 (“revised MD&A”), filed in a Current Report on From
8-K with the SEC on October 3, 2023.
All
amounts shown in these financial statements and tables are in thousands and amounts in the notes are in millions, except percentages
and per share and share amounts.
With the exception of the accounting policies below, there have been no new or material changes to the significant
accounting policies discussed in the Company’s reaudited Consolidated Financial Statements.:
Reverse
Stock Split
All
information included in these consolidated financial statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock
Split as if it had been effective from the beginning of the earliest period presented, unless otherwise stated. All outstanding securities
entitling their holders to purchase shares of Common Stock or acquire shares of Common Stock, including stock options, restricted stock
units, and warrants, were adjusted as a result of the Reverse Stock Split, as required by the terms of those securities.
Research
and Development Costs
Research
and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct
research and development activities, and other operational costs related to the Company’s research and development activities.
Use
of Estimates
The
preparation of the financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions by management that
affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities, as reported on the
balance sheet date, and the reported amounts of revenues and expenses arising during the reporting period. The main areas in which assumptions,
estimates and the exercising of judgment are appropriate relate to, valuation allowances for receivables and inventory, valuation of
contingent consideration and warrant liabilities, realization of intangible and other long-lived assets, product sales allowances and
reserves, share-based payments and income taxes including deferred tax assets and liabilities. Estimates are based on historical experience
and other assumptions that are considered appropriate in the circumstances. They are continuously reviewed but may vary from the actual
values.
Recently
Adopted Accounting Pronouncements
In
September 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables,
as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard was effective
for us on January 1, 2023, and did not have a material effect on our consolidated financial statements.
3.
Acquisition Contract Liabilities
On
March 25, 2019, we entered into an agreement (as amended, the “Share Purchase Agreement”) with Maruho Co, Ltd. (“Maruho”)
to acquire 100% of the shares of Cutanea Life Sciences, Inc. (“Cutanea”). As of the date of the acquisition, Maruho owned approximately 29.9% of Biofrontera AG through its fully owned subsidiary Maruho Deutschland GmbH. Biofrontera AG is our former
parent, and currently a significant shareholder.
Pursuant
to the Share Purchase Agreement, Maruho provided $7.3
million in start-up cost financing for Cutanea’s redesigned business activities (“start-up costs”). These start-up
costs are to be paid back to Maruho by the end of 2023 in accordance with contractual obligations related to an earn-out
arrangement. In addition, as part of the earn-out arrangement with Maruho, the product profit amount from the sale of Cutanea
products as defined in the Share Purchase Agreement will be shared equally between Maruho and Biofrontera until 2030
(“contingent consideration”).
The
contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of
approximately 6.0% over the applicable term. The contingent consideration is recorded within acquisition contract liabilities, net. The
amount of contingent consideration that could be payable is not subject to a cap under the agreement. The Company re-measures contingent consideration and re-assesses the underlying
assumptions and estimates at each reporting period utilizing a scenario-based method. The contingent consideration liability was valued at $2.5 million with payments coming due May of 2028 through May 2031.
Acquisition
contract liabilities, net consist of the following:
Schedule of Acquisition Contract Liabilities
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Short-term acquisition contract liabilities: | |
| | | |
| | |
| |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (89 | ) | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 7,211 | | |
$ | 6,942 | |
| |
| | | |
| | |
Long-term acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
| |
| | | |
| | |
Total acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (89 | ) | |
| (358 | ) |
Total acquisition contract liabilities, net | |
$ | 9,711 | | |
$ | 9,342 | |
4.
Fair Value Measurements
The
following table presents information about the Company’s assets that are measured at fair value on a recurring basis at September
30, 2023 and December 31, 2022 and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such
fair value:
Schedule of Fair Value Hierarchy Valuation Inputs
(in thousands) | |
Level | | |
September 30, 2023 | | |
December 31, 2022 | |
Assets: | |
| | | |
| | | |
| | |
Investment, related party | |
| 1 | | |
$ | 3,341 | | |
$ | 10,548 | |
Liabilities: | |
| | | |
| | | |
| | |
Contingent Consideration | |
| 3 | | |
$ | 2,500 | | |
$ | 2,400 | |
Warrant liability – 2022 Purchase Warrants | |
| 3 | | |
$ | 366 | | |
$ | 1,129 | |
Warrant liability - 2022 Inducement Warrants | |
| 3 | | |
$ | 476 | | |
$ | 1,714 | |
Warrant liability | |
| 3 | | |
$ | 476 | | |
$ | 1,714 | |
Investment,
related party
As
of September 30, 2023 and December 31, 2022, the Company has an investment in 5,745,678
and 6,446,946,
respectively of common shares of Biofrontera AG, a company traded on the Frankfurt Stock Exchange and a
significant shareholder of Biofrontera. The fair value of this investment was determined with Level 1 inputs through references to
quoted market prices. See Note 6. Investment Related Party and Note 13. Related Party Transactions.
Contingent
Consideration
Contingent
consideration, which relates to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, is reflected
at fair value within acquisition contract liabilities, net on the consolidated balance sheets. The fair value is based on significant
inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The valuation of the contingent
consideration utilizes a scenario-based method under which a set of payoffs are calculated using the term of the earnout, projections,
and an appropriate metric risk premium. These payoffs are then discounted back from the payment date to the valuation date using a payment
discount rate. The scenario-based
method incorporates the following key assumptions: (i) the forecasted product profit amounts, (ii) the remaining contractual term, (iii)
a metric risk premium, and (iv) a payment discount rate. The Company re-measures contingent consideration and re-assesses the underlying
assumptions and estimates at each reporting period.
The
following table provides a roll forward of the fair value of the contingent consideration:
Schedule of Fair Value of Contingent Consideration
(in thousands) | |
| |
Balance at December 31, 2022 | |
$ | 2,400 | |
Change in fair value of contingent consideration | |
| 100 | |
Balance at September 30, 2023 | |
$ | 2,500 | |
| |
| | |
Balance at December 31, 2021 | |
$ | 6,200 | |
Change in fair value of contingent consideration | |
| (4,100 | ) |
Balance at September 30, 2022 | |
$ | 2,100 | |
Warrant
Liabilities
The
warrant liabilities are comprised of (i) currently outstanding warrants to purchase 170,950
shares of Common Stock originally issued in a private placement on May 16, 2022, expiring five and one-half years after the issue
date and with an exercise price of $55.40
per share (the “Purchase Warrants”), and (ii) a warrant to purchase 214,286
shares of Common Stock issued on July 26, 2022, expiring on December 1, 2026 with an exercise price of $33.20
per share (the “Inducement Warrants”) and were accounted for as liabilities in accordance with ASC 815-40 and are
presented within warrant liabilities in the accompanying consolidated balance sheets. The warrant liabilities are measured at fair
value at inception and on a recurring basis, with changes in fair value presented within the consolidated statements of operations.
The
Company utilizes a Black-Scholes option pricing model to estimate the fair value of the Purchase Warrants and Inducement Warrants which
is considered a Level 3 fair value measurement. Certain inputs utilized in our Black-Scholes pricing model may fluctuate in future periods
based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the
calculation of fair value may cause a significant change to the fair value of our warrant liabilities which could also result in material
non-cash gain or loss being reported in our consolidated statements of operations.
The
fair value for the Level 3 warrants at September 30, 2023 was estimated using a Black-Scholes pricing model based on the following assumptions:
Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 8.77 | | |
$ | 8.77 | |
Expiration term (in years) | |
| 4.13 | | |
| 3.17 | |
Volatility | |
| 80.0 | % | |
| 80.0 | % |
Risk-free Rate | |
| 4.63 | % | |
| 4.73 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
The
fair value for the Level 3 warrants at December 31, 2022 was estimated using a Black-Scholes pricing model based on the following assumptions:
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 18.40 | | |
$ | 18.40 | |
Expiration term (in years) | |
| 4.88 | | |
| 3.92 | |
Volatility | |
| 70.0 | % | |
| 75. | % |
Risk-free Rate | |
| 3.96 | % | |
| 4.07 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
The
following table presents the changes in the Level 3 warrant liabilities measured at fair value (in thousands):
Schedule of Changes in Level 3 Warrant Liabilities
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Fair value at beginning of period | |
$ | 2,843 | | |
$ | 12,854 | |
Issuance of new warrants | |
| - | | |
| 13,217 | |
Exercise of warrants | |
| - | | |
| (6,840 | ) |
Change in fair value of warrant liabilities | |
| (2,001 | ) | |
| (15,267 | ) |
Fair value at end of period | |
$ | 842 | | |
$ | 3,964 | |
5.
Revenue
We
generate revenue primarily through the sales of our licensed products Ameluz®, BF-RhodoLED® lamps and Xepi®. Revenue from
the sales of our BF-RhodoLED® lamp and Xepi® are relatively insignificant compared with the revenues generated through our sales
of Ameluz®.
Related
party revenue relates to an agreement with Bioscience for BF-RhodoLED® leasing and installation
service. Refer to Note 13, Related Party Transactions.
An
analysis of the changes in product revenue allowances and reserves is summarized as follows:
Schedule of Revenue Allowance and Accrual Activties
(in thousands): | |
Returns | | |
Co-pay assistance program | | |
Prompt pay discounts | | |
Government and payor rebates | | |
Total | |
Balance at December 31, 2021 | |
$ | 43 | | |
$ | 101 | | |
$ | 48 | | |
$ | 54 | | |
$ | 246 | |
Provision related to current period sales | |
| 8 | | |
| 503 | | |
| 16 | | |
| 164 | | |
| 691 | |
Credit or payments made during the period | |
| (5 | ) | |
| (400 | ) | |
| (23 | ) | |
| (149 | ) | |
| (577 | ) |
Balance at September 30, 2022 | |
$ | 46 | | |
$ | 204 | | |
$ | 41 | | |
$ | 69 | | |
$ | 360 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at December 31, 2022 | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
Beginning Balance | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
Provision related to current period sales | |
| 4 | | |
| 156 | | |
| 3 | | |
| 266 | | |
| 429 | |
Credit or payments made during the period | |
| - | | |
| (145 | ) | |
| (2 | ) | |
| (231 | ) | |
| (378 | ) |
Balance at September 30, 2023 | |
$ | 52 | | |
| 20 | | |
| 6 | | |
| 55 | | |
| 133 | |
Ending Balance | |
$ | 52 | | |
| 20 | | |
| 6 | | |
| 55 | | |
| 133 | |
6.
Investment, Related Party
As
of September 30, 2023 and December 31, 2022, our investment in equity securities consisted solely of 5,745,678 and 6,446,946, respectively
of common shares of Biofrontera AG, a significant shareholder. (See Note 13. Related Party Transactions). Of these shares,
3,377,346 are not fully in our control to vote or dispose of as we see fit as they are not held in a brokerage account registered in
our name, however, we are currently engaged with advisors to transfer such shares to our brokerage account. Equity securities gains and
losses include unrealized gains and losses from changes in fair values during the period on equity securities we still own, as well as
gains and losses on securities we sold during the period. As reflected in the consolidated statements of cash flows, we received proceeds
from sales of equity securities of approximately $0.6 million during the nine months ended September 30, 2023.
Unrealized
losses on investment, related party were $1.9 million and $6.2 million, respectively, for the three and nine months ended September 30, 2023. There were
no unrealized gains and losses for the three and nine months ended September 30, 2022.
Schedule of Unrealized Gains and Losses on Investments in Equity Securities
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended September 30, | | |
Nine months ended September 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Net losses recognized during the period on equity securities | |
$ | (2,212 | ) | |
$ | - | | |
$ | (6,635 | ) | |
$ | - | |
Less: Net realized losses on equity securities
sold | |
| 345 | | |
| - | | |
| 420 | | |
| - | |
Unrealized losses recognized during the reporting period on equity securities still held at the reporting date | |
$ | (1,867 | ) | |
$ | - | | |
$ | (6,215 | ) | |
$ | - | |
7.
Accounts Receivable, net
Accounts
receivables are mainly attributable to the sale of Ameluz®. It is expected that all trade receivables will be settled
within twelve months of the balance sheet date. Trade accounts receivable are stated at their net realizable value. The allowance for
credit losses reflects our best estimate of expected credit losses of the receivables determined on the basis of historical experience
and current information. In developing the estimate for expected credit losses, trade accounts receivables are segmented into pools of
assets depending primarily on delinquency status, and fixed reserve percentages are established for each pool of trade accounts receivables.
In
determining the reserve percentages for each pool of trade accounts receivables, we considered our historical experience with certain
customers, regulatory and legal environments and other relevant current and future forecasted macroeconomic factors. If we become aware
of any customer-specific factors that impact credit risk, specific allowances for these known troubled accounts are recorded.
The
allowance for credit losses was $0.2 million and $0.1 million as of September 30, 2023 and December 31, 2022, respectively.
8.
Other Receivables, Related Party
As
of September 30, 2023 the Company has a receivable, related party of $2.7 million primarily due from Biofrontera AG for its 50% share
of the balance of a legal settlement (See Note 18. Commitments and Contingencies – Legal proceedings) for which both parties
are jointly and severally liable. The Company has a contractual right to repayment of its share of the settlement payments, plus interest
and other miscellaneous settlement costs, from Biofrontera AG under the Settlement Allocation Agreement (“Allocation Agreement”)
entered into on December 9, 2021 and as amended on March 31, 2022, which provides that the settlement payments would first be made by
the Company and then reimbursed by Biofrontera AG for its share. The Allocation Agreement, as amended, provides certain remedies to the
Company, if Biofrontera AG fails to make timely reimbursements, which the Company may implement in its sole discretion, including the
ability to charge interest at a rate of 6.0% per annum for each day that any reimbursement is past
due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by the Company (including amounts
owed under the Company’s license and supply agreement for Ameluz®). As
such, no reserve for the receivable was deemed necessary as of September 30, 2023 or December
31, 2022.
9.
Intangible Asset, Net
Intangible
asset, net consists of the following:
Schedule of Intangible Asset Net
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Xepi® license | |
$ | 4,600 | | |
$ | 4,600 | |
Less: Accumulated amortization | |
| (1,882 | ) | |
| (1,568 | ) |
Intangible asset, net | |
$ | 2,718 | | |
$ | 3,032 | |
The
Xepi® license intangible asset was recorded at acquisition-date fair value of $4.6 million and is amortized on a straight-line basis
over the useful life of 11 years. Amortization expense for the three months ended September 30, 2023 and 2022 was $0.1 million and $0.3
million for the nine months ended September 30, 2023 and 2022.
We
review the Xepi® license intangible asset for impairment whenever events or changes in circumstances indicate that the
carrying amount of the assets may not be fully recoverable. There has been limited revenue during the current reporting periods and recent developments with the third-party
manufacturer that was providing our supply of Xepi® have resulted in further constraints on the commercialization of the product.
However, Ferrer is qualifying a new Contract manufacturer, Cambrex, which is expected to begin production in 2024.
The
Company performed an impairment analysis because of this situation and determined no impairment charges were deemed necessary during
the three and nine months ended September 30, 2023.
10.
Cash Balances and Statement of Cash Flows Reconciliation
The
Company maintains its cash balances at financial institutions that are insured by the Federal Deposit Insurance Corporation (“FDIC”).
The FDIC provides coverage of up to $250,000 per depositor, per financial institution. At September 30, 2023, approximately $3.0 million
of the Company’s cash balances were in excess of FDIC limits. The Company has not experienced any losses on these accounts and
management does not believe that the Company is exposed to any significant risks.
Restricted
cash consists primarily of deposits of cash collateral held in accordance with the terms of our corporate credit cards. Long-term restricted cash was recorded in other assets in the consolidated
balance sheet.
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the consolidated
statements of cash flows:
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Cash and cash equivalents | |
$ | 3,422 | | |
$ | 17,208 | |
Long-term restricted cash | |
| 200 | | |
| 200 | |
Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows | |
$ | 3,622 | | |
$ | 17,408 | |
11.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consist of the following:
Schedule of Accrued Expenses and Other Current Liabilities
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Legal settlement (See note 18) | |
$ | 6,028 | | |
$ | 6,207 | |
Employee compensation and benefits | |
| 2,948 | | |
| 2,850 | |
Professional fees | |
| 1,253 | | |
| 1,353 | |
Product revenue allowances and reserves | |
| 134 | | |
| 82 | |
Other | |
| 676 | | |
| 372 | |
Total | |
$ | 11,039 | | |
$ | 10,864 | |
12.
Line of Credit
On
May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC,
providing us with a revolving line of credit in the aggregate principal amount of up to $6.5 million, subject to a borrowing base and
an availability block, with a maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets
of the Company, subject to customary exceptions.
Advances
under the Loan Agreement bear interest at the 30-Day Adjusted Term Secured Overnight Financing Rate (“SOFR Rate”), set monthly
on the first day of the month based on 30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25%,
plus 4.00% calculated and charged monthly in arrears. In the event of a called event of default, a default interest rate of 3.00% percent
shall be added to the aforementioned rate. Under the terms of the Loan Agreement, amounts available for advances would be subject to
a borrowing base, which is a formula based on certain eligible receivables and inventory, and a block on such availability in the amount
of $650,000. Currently, our borrowing capacity is based on our eligible receivables with an additional $1.0 million borrowing capacity
based on inventory. The borrowing base is up to 85% of accounts receivable, plus the least of (a) $1.0 million for inventory
and (b) 85% of accounts receivable, less borrowing base reserve, if any, as defined in the Loan Agreement. The Loan Agreement also includes
an Unused Line Fee Rate of 0.375% of the Credit Limit less all outstanding advances, which shall be paid on a monthly basis.
The
interest rate as of September 30, 2023 was 5.48% and interest expense for the nine months ended September 30, 2023 was negligible. The
Company recorded approximately $0.2 million of costs related to the line of credit as an asset to be amortized on a straight-line basis
over the term of the line of credit. The Company recognized minimal amortization expense in connection with this Line of Credit for the
nine months ended September 30, 2023, which is recorded as interest expense on the accompanying consolidated statement of operations.
13.
Related Party Transactions
License
and Supply Agreement
On
October 8, 2021, we entered into an amendment to the Ameluz LSA under which the price we pay per unit will be based upon our sales
history. Under the agreement, the Company obtained an exclusive, non-transferable license to use Pharma’s technology to market
and sell the licensed products, Ameluz® and BF-RhodoLED® and must purchase the licensed products exclusively from Pharma. As
a result of this amendment, the purchase price we pay the Ameluz Licensor for Ameluz® will be determined in the
following manner:
● |
fifty
percent of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from
the Ameluz Licensor during a given Commercial Year (as defined in the Ameluz LSA); |
|
|
● |
forty
percent of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the
products we license from the Ameluz Licensor; and |
|
|
● |
thirty
percent of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license
from the Ameluz Licensor. |
Purchases
of the licensed products during the three and nine months ended September 30, 2023 were $5.1 million and $18.8 million, respectively,
and $5.2 million and $16.6 million, respectively for the three and nine months ended September 30, 2022. Amounts due and payable to Pharma as of September 30, 2023 and December 31, 2022 were $7.0 million and $1.3 million, respectively,
which were recorded in accounts payable, related parties in the consolidated balance sheets.
Service
Agreements
In
December 2021, we entered into an Amended and Restated Master Contract Services Agreement, or “Services Agreement”, which
provides for the execution of statements of work that will replace the applicable provisions of our previous intercompany services agreement
dated January 1, 2016, or 2016 Services Agreement, by and among us, Biofrontera AG, Biofrontera Pharma and Biofrontera Bioscience, enabling
us to continue to use the IT resources of Biofrontera AG and its wholly owned subsidiaries (the “Biofrontera Group”) as well
as providing access to the Biofrontera Group’s resources with respect to quality management, regulatory affairs and medical affairs.
We currently have statements of work in place regarding IT, regulatory affairs, medical affairs, and pharmacovigilance, and are continuously
assessing the other services historically provided to us by Biofrontera AG to determine 1) if they will be needed, and 2) whether they
can or should be obtained from other third-party providers. As of September 30, 2023, we have migrated away from Biofrontera AG to third
party providers for most of our significant IT services. Expenses related to the service agreement were $0.1 million and $0.2 million
for the three and nine months ended September 30, 2023 and $0.2 million and $0.6 million for the three and nine months ended September
30, 2022, respectively. These expenses were recorded in selling, general and administrative, related party. Amounts due to Biofrontera
AG related to the service agreement as of September 30, 2023 and December 31, 2022 were $0.2 million and $0.2 million, respectively,
which were offset against other receivables, related party in the consolidated balance sheet.
Clinical
Lamp Lease Agreement
On
August 1, 2018, the Company executed a clinical lamp lease agreement with Bioscience to provide
lamps and associated services.
Total
revenue related to the clinical lamp lease agreement was minimal and $0.1 million for the three and nine months ended September 30, 2023,
respectively and minimal for the three and nine months ended September 30, 2022, and was recorded as revenues, related party. Amounts
due from Bioscience for clinical lamp and other reimbursements were approximately $0.1 million as of September 30, 2023 and December
31, 2022, which were recorded as other receivables, related party in the consolidated balance sheets.
Others
The
Company has recorded a receivable of $2.8
million and $6.4
million as of September 30, 2023 and December
31, 2022, respectively, due from Biofrontera AG for its 50%
share of the balance of a legal settlement for which both parties are jointly and severally liable. (See Note 8. Other Receivables,
Related Party). There was no
interest income recognized for the nine months
ended September 30, 2023 and $0.1
million of interest income for the nine months
ended September 30, 2022, in connection with this receivable.
As
of September 30, 2023, our investment, related party is valued at $3.3 million and consists of 5,745,678
common shares of Biofrontera AG, a significant shareholder of the Company. See Note 6. Investment, Related Party.
14.
Stockholders’ Equity
Under
the Company’s Certificate of Amendment to the Amended and Restated Certificate of incorporation, effective July 3, 2023, the Company
is authorized to issue 15,000,000 shares
of Common Stock and 20,000,000 shares
of preferred stock, par value $.001
per share. See Note 1. Reverse Stock Split for information
and disclosures relating to adjustments for the 1-for-20
Reverse Stock Split.
The
holders of Common Stock are entitled to one vote for each share held. Common Stockholders are not entitled to receive dividends,
unless declared by the Board of Directors. The Company has not declared dividends since inception. In the event of liquidation of
the Company, dissolution or winding up, the holders of Common Stock are entitled to share ratably in all assets remaining after
payment of liabilities. The Common Stock has no preemptive or conversion rights or other subscription rights. There are no
redemption or sinking fund provisions applicable to the Common Stock. The outstanding shares of Common Stock are fully paid and
non-assessable.
15.
Equity Incentive Plans and Share-Based Payments
2021
Omnibus Incentive Plan
In
2021, our Board of Directors adopted and our shareholders approved, the 2021 Omnibus Incentive Plan (“2021 Plan). Under the original
2021 Plan, 137,500 shares are reserved and authorized for awards and the maximum contractual term is 10 years for stock options issued
under the 2021 Plan. On December 12, 2022, the 2021 Plan was amended by our stockholders and the number of shares authorized for awards
under the 2021 Plan was increased by 129,490 to 266,990. As of September 30, 2023, there were 163,362 shares available for future awards
under the amended 2021 Plan.
Non-qualified
stock options
We
maintain the 2021 Plan for the benefit of our officers, directors and employees. Employee stock options granted under the 2021 Plan generally
vest in equal annual installments over three years and are exercisable for a period of up to ten years from the grant date. Non-employee
director options vest in equal monthly installments following the date of grant and will be fully vested on the one-year anniversary
of the date of grant. All stock options are exercisable at a price as set by the Company at the time of the grant but shall not be less
than the market value of the common shares underlying the option on the grant date.
The
Company recognizes the grant-date fair value of share-based awards granted as compensation expense on a straight-line basis over the
requisite service period. The fair value of stock options is estimated at the time of grant using the Black-Scholes (“BSM”)
option pricing model, which requires the use of inputs and assumptions such as the fair value of the underlying stock, exercise price
of the option, expected term, risk-free interest rate, expected volatility and dividend yield. The Company elects to account for forfeitures
as they occur.
The
fair value of each option was estimated on the date of the grant using the BSM option pricing model with the following assumptions:
Schedule of Stock Options Assumptions
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Expected volatility | |
| 70% - 95 | % | |
| 55% - 70 | % |
Expected term (in years) | |
| 6.0 | | |
| 5.24 -6.0 | |
Risk-free interest rate | |
| 3.5% - 3.9 | % | |
| 1.34% - 4.10 | % |
Expected dividend yield | |
| 0.0 | % | |
| 0.0 | % |
Share-based
compensation expense of approximately $0.1 million and $0.5 million was recorded in selling, general and administrative expenses on the
accompanying consolidated statement of operations for the three and nine months ended September 30, 2023, respectively and $0.3 million
and $0.6 million for the three and nine months ended September 30, 2022.
Options
outstanding and exercisable under the employee share option plan as of September 30, 2023 and a summary of option activity during the
nine months then ended is presented below.
Schedule of Stock Option Activity
| |
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | | |
Aggregate Intrinsic Value (1) | |
Outstanding at December 31, 2022 | |
| 86,951 | | |
$ | 62.16 | | |
| | | |
| | |
Granted | |
| 22,477 | | |
$ | 13.98 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (31,480 | ) | |
$ | 53.58 | | |
| | | |
| | |
Outstanding at September 30, 2023 | |
| 77,948 | | |
$ | 51.74 | | |
| 8.45 | | |
$ | 0 | |
Exercisable at September 30, 2023 | |
| 24,210 | | |
$ | 62.23 | | |
| 7.75 | | |
$ | 0 | |
As
of September 30, 2023, there was $1.0 million of unrecognized compensation cost related to unvested stock options, which is expected
to be recognized over a weighted-average period of approximately 1.8 years.
Share-Based
Compensation (RSUs)
Restricted
Stock Units (“RSUs”) will vest annually over two years, subject to the recipient’s continued service with the Company
through the applicable vesting dates. The fair value of each RSU is estimated based on the closing market price of the Company’s
Common Stock on the grant date.
Share-based
compensation expense of $0.1 million and $0.3 million for the RSUs for the three and nine months ended September 30, 2023, respectively,
and $0.1 million and $0.9 million for the three and nine months ended September 30, 2022 and was recorded in selling, general and administrative
expenses in the accompanying consolidated statements of operations.
Schedule of Restricted Stock Units
| |
Shares | | |
Weighted Average Remaining Contractual Term | | |
| |
Weighted Average Grant Date Fair Value | |
Outstanding at December 31, 2022 | |
| 17,176 | | |
| | | |
| |
$ | 52.20 | |
Awarded | |
| - | | |
| | | |
| |
$ | - | |
Vested | |
| (8,588 | ) | |
| | | |
| |
$ | 52.20 | |
Canceled or forfeited | |
| (3,817 | ) | |
| 0.63 | | |
| |
$ | - | |
Outstanding at September 30, 2023 | |
| 4,771 | | |
| 0.63 | | |
| |
$ | 52.20 | |
As
of September 30, 2023, there was $0.2 million of unrecognized compensation cost related to unvested RSUs, which is expected to be recognized
over a weighted-average period of approximately 0.6 years.
16.
Interest Expense, net
Interest
expense, net consists of the following:
Schedule of Interest Expense
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For three months ended September 30, | | |
For nine months ended September 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Interest expense | |
$ | (43 | ) | |
$ | (3 | ) | |
$ | (77 | ) | |
$ | (10 | ) |
Interest expense, related party | |
$ | (22 | ) | |
$ | - | | |
$ | (22 | ) | |
$ | - | |
Contract asset interest expense | |
| (90 | ) | |
| (89 | ) | |
| (268 | ) | |
| (268 | ) |
Interest income – related party | |
| - | | |
| 1 | | |
| - | | |
| 110 | |
Interest income – other | |
| 13 | | |
| 2 | | |
| 111 | | |
| 8 | |
Interest expense, net | |
$ | (142 | ) | |
$ | (89 | ) | |
$ | (256 | ) | |
$ | (160 | ) |
Interest
expense is comprised primarily of interest on our Loan and Security Agreement with MidCap Business Credit LLC.
Contract
asset interest expense relates to the $1.7
million contract asset in connection with the $7.3
million start-up cost financing received from Maruho under the Cutanea acquisition Share Purchase Agreement. The contract asset is
amortized on a straight-line basis using a 6%
interest rate over the financing arrangement contract term, which ends on December
31, 2023.
Interest
income - related party interest income relates to default interest on the recorded receivable of $6.1 million as of September 30, 2022
from Biofrontera AG for its 50% share of the balance of a legal settlement.
17.
Net Earnings (Loss) per Share
Basic
net earnings (loss) per common share are calculated by dividing net income by the weighted average number of common shares
outstanding during the period. Diluted net earnings per common share are calculated by dividing net income (loss) by the diluted
weighted average number of common shares outstanding during the period. The diluted shares include the dilutive effect of
stock-based awards based on the treasury stock method. In periods where a net loss is recorded, no effect is given to potentially
dilutive securities, since the effect would be anti-dilutive.
The
following table sets forth the computation of the Company’s basic and diluted net earnings (loss) per share attributable to common stockholders
(in thousands, except share and per share data):
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net income (loss) | |
$ | (6,342 | ) | |
$ | (2,566 | ) | |
$ | (23,657 | ) | |
$ | 2,145 | |
| |
| | | |
| | | |
| | | |
| | |
Shares: | |
| | | |
| | | |
| | | |
| | |
Basic weighted average common shares outstanding | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 978,018 | |
Add: Effect of dilutive securities | |
| | | |
| | | |
| | | |
| | |
Stock options and restricted stock units | |
| - | | |
| - | | |
| - | | |
| 2,233 | |
Diluted weighted average common shares outstanding | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 980,251 | |
| |
| | | |
| | | |
| | | |
| | |
Net earnings (loss) per share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
Diluted | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
The
following table sets forth the securities that were anti-dilutive for diluted EPS for the periods presented but which
could potentially dilute EPS in the future:
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share
Nine Months Ended September 30, | |
2023 | | |
2022 | |
Common stock warrants | |
| 459,856 | | |
| 459,856 | |
Common stock options and RSUs | |
| 82,719 | | |
| 55,620 | |
Unit Purchase Options | |
| 20,182 | | |
| 20,182 | |
Anti-dilutive securities excluded from computation of earnings per share | |
| 20,182 | | |
| 20,182 | |
Common
Stock warrants include Purchase Warrants, Inducement Warrants and warrants issued in the Initial Public Offering.
18.
Commitments and Contingencies
Leases
The
Company leases its corporate headquarters under an operating lease that expires in August 2025. The Company has the option to extend
the term of the lease for one five (5) year period upon written notice to the landlord. The extension period has not been included in
the determination of the ROU asset or the lease liability as the Company concluded that it is not reasonably certain that it would exercise
this option. The Company provided the landlord with a security deposit in the amount of $0.1 million, which was recorded as other assets
in the consolidated balance sheets.
The
Company has also entered into a master lease agreement for its vehicles. After an initial non-cancelable twelve-month period, each vehicle
is leased on a month-to-month basis. Based on historical retention experience of approximately three years, the vehicles have varying
expiration dates through January 2027.
The
components of lease expense for the three and nine months ended September 30, 2023 were as follows (in thousands except lease term and
discount rate):
Schedule of Components of Lease Expense and Other Information
Lease expense | |
Operating Leases | |
Amortization of ROU assets (operating lease cost) | |
$ | 390 | |
Interest on lease liabilities | |
| 54 | |
Total lease expense | |
$ | 444 | |
Other Information | |
| |
Operational cash flow used for operating leases | |
$ | 428 | |
Weighted -average remaining lease term (in years) | |
| 2.01 | |
Weighted -average discount rate | |
| 6.75 | % |
Future
lease payments under non-cancelable leases as of September 30, 2023 were as follows (in thousands):
Schedule of Future Commitments and Sublease Income
Years ending December 31, | |
Future lease commitments | |
2023 | |
$ | 171 | |
2024 | |
| 584 | |
2025 | |
| 393 | |
2026 | |
| 44 | |
2027 | |
| 1 | |
Total future minimum lease payments | |
| 1,193 | |
Less imputed interest | |
| (76 | ) |
Total lease liability | |
$ | 1,117 | |
Schedule of Operating Lease Liability
Reported as: | |
| |
Operating lease liability, current | |
$ | 555 | |
Operating lease liability, non-current | |
| 562 | |
Total | |
$ | 1,117 | |
Cutanea
payments
We
have a contract in which we agreed to repay to Maruho $3.6 million on December 31, 2022 and $3.7 million on December 31, 2023 in start-up
cost financing paid to us in connection with the Cutanea acquisition.
We
have filed for arbitration against Maruho with the International Chamber of Commerce regarding issues with Maruho’s
contract manufacturer that were not disclosed at the time of the Share Purchase Agreement and therefore are withholding the repayment
of the start-up cost financing until a decision is reached through the arbitration process. The arbitration notes that Maruho breached
the agreement with Cutanea due to undisclosed manufacturing issues and seeks damages as well as a declaration that we are not obligated
to repay Maruho. As such, the required contractual payments noted above have not been made as of the financial statement filing date.
We
are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Refer to Note 3, Acquisition
Contract Liabilities.
Milestone
payments with Ferrer Internacional S.A.
Under
the Xepi LSA, we are obligated to make payments to Ferrer upon the occurrence of certain milestones. Specifically, we must pay Ferrer
i) $2,000,000 upon the first occasion when annual net sales of Xepi® under the Xepi LSA exceed $25,000,000, and ii) $4,000,000
upon the first occasion annual net sales of Xepi® under the Xepi LSA exceed $50,000,000. No Xepi® milestones
have been achieved as of the financial statement filing date.
Licensing
Agreement with Optical Tools
On
December 2, 2022, the Company entered into the technology transfer agreement with Optical Tools LLC (“Optical Tools”), and
Stephen Tobin and Paul Sowyrda (the “Agreement”). The Agreement allowed for the transfer of the assigned patents and trademarks,
and upon notification by the Company to Optical Tools, the research and development of certain prototypes. The Company paid a licensing
fee of $0.2 million which was expensed during the year ended December 31, 2022.
On
May 28, 2023, the Company authorized Optical Tools to design, develop, manufacture, and deliver at least two portable photodynamic therapy
lamp prototypes (“PDT Device”) using the technology in the assigned patents. The PDT Device provides illumination, based
on different light profiles, to the external skin surface of the human body. The Company shall reimburse Optical Tools for all reasonable
out-of-pocket, material and labor costs per the Agreement.
As
part of the Agreement, Optical Tools will be eligible to receive regulatory and sales milestone payments totaling up to $1.0 million,
and royalties of up to 3% of net revenue of certain products developed under this Agreement.
The
Company did not make any milestone or royalty payments during the three or nine months ended September 30, 2023.
Legal
proceedings
At
each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably
estimable under the provisions of FASB ASC Topic 450, Contingencies. The Company expenses as incurred the legal costs related
to such legal proceedings.
Settlement
Agreement with DUSA Pharmaceuticals Inc.
On
November 29, 2021, the Company entered into a settlement and release agreement with respect to a lawsuit filed March 23, 2018 in the
United States District Court for the District of Massachusetts in which we were alleged to have infringed on certain patents and misappropriated
certain trade secrets. In the settlement, the Company and Biofrontera AG together agreed to make an aggregate payment of $22.5 million
and engage a forensic expert to destroy data at issue in the litigation to settle the claims in the litigation.
While
Biofrontera AG has agreed to pay fifty percent of the settlement costs, we remain jointly and severally liable to DUSA Pharmaceuticals
Inc. (“DUSA”) for the full cash settlement amount, meaning that in the event Biofrontera AG does not pay all or a portion
of the amount it owes under the settlement agreement, DUSA could compel us to pay Biofrontera AG’s share. As of September 30, 2023, we have reflected a legal settlement liability in the amount
of $6.0 million for the remaining payments due under the settlement, including the estimated remaining cost of the forensic expert and
a related receivable from related party of $2.8 million for the remaining legal settlement costs to be reimbursed in accordance with
the Settlement Allocation Agreement, which provided that the settlement payments, including the cost of the forensic expert, would first
be made by the Company and then reimbursed by Biofrontera AG for its share. Pursuant to the Settlement Agreement, if DUSA believes Biofrontera
has violated any terms of the settlement and release agreement, the parties must engage in certain alternative dispute resolution activities,
including a meeting between company representatives and non-binding mediation before a court action can be initiated.
Settlement
Agreement with Biofrontera AG
Pursuant
to the terms of that certain Settlement Agreement, dated as of April 11, 2023, among the Company, Biofrontera AG and certain current
and former directors of the Company (the “Settlement Agreement”), the Company has taken or committed, among other
things, to take the following actions:
|
● |
On
July 7, 2023, in connection with the Biofrontera AG settlement agreement, the board of directors of the Company appointed Heikki
Lanckriet to the Board. Mr. Lanckriet will serve as a Class I Director to hold office for a term expiring at the annual meeting of
the Company’s stockholders for fiscal year 2025. Mr. Lanckriet’s term as director began upon his appointment at the July
7, 2023 meeting. |
|
● |
The Company will begin
a search, pursuant to the conditions set forth in the Settlement Agreement including a strike right granted to the aforementioned
director nominated by Biofrontera AG, for an additional director candidate, who is fully independent from Biofrontera AG, Deutsche
Balaton Aktiengesellschaft (“DB”) and any of their respective affiliates, to be nominated for election as a Class II
Director at the Company’s 2024 annual meeting of stockholders. |
|
● |
The
Board will increase its size to seven members, including the two directors appointed and elected pursuant to the Settlement Agreement
as noted above. |
In
addition, the Settlement Agreement contains provisions to maintain Biofrontera AG’s representation on the Board of Directors as
long as it holds at least 20% of the Company’s outstanding common stock and to limit further increases in the size of the Board
of Directors or changes to the Company’s stockholder rights plan. Under the Settlement Agreement, Biofrontera AG also agrees, subject
to certain conditions, to vote in support of the directors nominated by, and the proposals recommended by, the Board of Directors.
Legal
Claim
On
September 13, 2023, Biofrontera was served with a complaint filed in United Stated District Court for the District of Massachusetts
by DUSA Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries LTD (collectively
“DUSA” or “Plaintiffs”) in which DUSA alleges breach of contract, violation of the Lanham Act, and unfair
trade practices. All claims stem from allegations that Biofrontera has promoted its Ameluz product in a manner that is inconsistent
with its approved FDA labeling. Though this complaint was originally filed in the U.S. District Court for the District of
Massachusetts, this matter has been transferred by agreement of the parties to the U.S. District Court for the District of New
Jersey.
The
Company denies the Plaintiffs’ claims and intends to defend these matters vigorously. Based on the Company’s assessment of
the facts underlying the above claims, the uncertainty of litigation and the preliminary stage of the case, the Company cannot estimate
the possibility of a material loss, nor the potential range of loss that may result from this action. If the final resolution of the
matter is adverse to the Company, it could have a material impact on the Company’s financial position, results of operations, or
cash flows.
19.
Retirement Plan
The
Company has a defined-contribution plan under Section 401(k) of Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan
covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual
compensation on a pre-tax basis. The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary.
Matching
contribution costs paid by the Company for the three and nine months ended September 30, 2023 were $0.1 million and $0.2 million,
respectively and $0.1 million
and $0.2 million
for the three and nine months ended September 30, 2022, respectively.
20. Reclassification of Prior Year Presentation
Certain prior year amounts have been reclassified
to their own line items within the Consolidated Statement of Operations and Consolidated Statements of Cash Flow. Specifically, warrant
inducement expense of $2.6 million was reclassed from change in fair value of warrant liabilities for prior year presentation. These reclassifications
had no effect on the reported results of operations.
21.
Subsequent Events
We
have completed an evaluation of subsequent events after the balance sheet date of September 30, 2023 through the date this Quarterly
Report on Form 10-Q was submitted to the SEC.
Capital
Raise
On
October 30, 2023, the Company entered into a securities purchase agreement (“Purchase Agreement”) with an institutional investor
for the purchase and sale, in a registered public offering by the Company (the “Public Offering”) of an aggregate of 1,205,000
shares of the Company’s Common Stock,
or pre-funded warrants to purchase Common Stock in lieu thereof, each of which is coupled with a warrant to purchase one and one-half
shares of Common Stock. Specifically, the
Company agreed to issue and sell to the institutional investor: (i) 150,000 shares of Common Stock at a combined offering price of $3.74, (ii) 1,055,000 pre-funded warrants to purchase up to 1,055,000 shares of Common Stock (the “Pre-Funded Warrants”)
at a combined offering price of $3.7399 and (iii) 1,205,000 warrants to purchase up to 1,807,500 shares of Common
Stock (the “Common Warrants”), resulting in gross proceeds of approximately $4.5 million. The Public Offering closed on November
2, 2023.
The
Common Warrants are exercisable upon issuance, will expire five years following the date of issuance and have an exercise price of $3.55
per share. The Pre-Funded Warrants are exercisable upon issuance, will expire five years following the date of issuance and have an exercise
price of $0.0001 per share.
Warrant
Amendment
As
previously reported in a Current Report on Form 8-K filed with the SEC on May 20, 2022, the Company issued (i) a common stock
purchase warrant, dated May 16, 2022 and exercisable until November 18, 2027, to purchase up to 170,950 shares of Common Stock, at an
exercise price of $55.40 and (ii) a common stock purchase warrant, dated July 26, 2022 and exercisable until December 1, 2026, to purchase
up to 214,286 shares of Common Stock at an exercise price of $33.20 (collectively, the “Existing Warrants”) to an institutional
investor.
On
October 30, 2023, in connection with the Purchase Agreement, the Company entered into an amendment to the Existing Warrants pursuant
to which the Company agreed, effective November 2, 2023, to (i) revise the exercise price of the Existing Warrants to $3.55 and (ii)
extend the date until which the Existing Warrants can be exercised until November 2, 2028. No other terms of the Existing Warrants were
revised or changed.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking
Statements
The
Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain statements
in this Form 10-Q constitute “forward-looking statements”. Such statements include estimates of our expenses, future revenue,
capital requirements, our need for additional financing, statements regarding the efficacy and intended use of our technologies under
development, the timelines and strategy for bringing licensed products to market, the timeline for regulatory review and approval of
our licensed products, and other statements that are not historical facts, including statements which may be preceded by the words “intends,”
“may,” “will,” “plans,” “expects,” “anticipates,” “projects,”
“predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”
or similar words. Forward-looking statements are not guaranties of future performance, are based on certain assumptions and are subject
to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from
the expectations contained in the forward-looking statements.
Factors
that may cause such differences include, but are not limited to:
|
● |
our
reliance on sales of products we license from other companies as our sole source of revenue; |
|
|
|
|
● |
the
success of our competitors in developing generic topical dermatological products that successfully compete with our licensed products; |
|
|
|
|
● |
the
success of our principal licensed product Ameluz®; |
|
|
|
|
● |
the
ability of Biofrontera Pharma, Biofrontera Bioscience and Ferrer Internacional S.A. (“Ferrer”),
referred to collectively as our (“licensors”) to establish and maintain relationships with contract manufacturers that
are able to supply us with enough of the licensed products to meet our demand; |
|
|
|
|
● |
the
ability of our licensors or our licensors’ manufacturing partners, as applicable, to supply Ameluz®, BF-RhodoLED® lamps,
Xepi® or other licensed products that we market in sufficient quantities and at acceptable quality and cost levels, and to fully
comply with current good manufacturing practice or other applicable manufacturing regulations; |
|
|
|
|
● |
the
ability of our licensors to successfully defend or enforce patents related to our licensed products; |
|
● |
the
availability of insurance coverage and medical expense reimbursement for our licensed products; |
|
|
|
|
● |
the
impact of legislative and regulatory changes; |
|
|
|
|
● |
competition
from other pharmaceutical and medical device companies and existing treatments, such as simple curettage and cryotherapy; |
|
|
|
|
● |
our
success in achieving profitability; |
|
|
|
|
● |
our
ability to obtain additional financing as needed to implement our growth strategy; |
|
|
|
|
● |
the
effect of the COVID-19 global pandemic, including mitigation efforts and economic effects; |
|
|
|
|
● |
our
ability to retain and recruit key personnel; |
|
|
|
|
● |
such
other risks identified in Item 1A. Risk Factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022,
Item 1A of Part II of this Quarterly Report on Form 10-Q and any other filings with the SEC. |
More
detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward-looking
statements in this Quarterly Report on Form 10-Q, is set forth in our filings with the SEC, including our Annual Report on Form 10-K
for the fiscal year ended December 31, 2022. We urge investors and security holders to read those documents free of charge at the SEC’s
web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information,
future events or otherwise, except as required by law.
Note
About Reverse Stock Split
All
information included in these consolidated financial statements has been adjusted, on a retrospective basis, to reflect our 1-for-20
Reverse Stock Split as if it had been effective from the beginning of the earliest period presented, unless otherwise
stated.
Overview
Biofrontera
Inc (the “Company” or “Biofrontera”). is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products
for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”) and topical antibiotics. The
Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions as well as
impetigo, a bacterial skin infection. In May 2023, the Company began research and development (“R&D”) activities to
support PDT growth and will continue to opportunistically invest in these activities going forward. Our research and development
program currently aims to improve the capabilities of our BF-RhodoLED® lamps to better fulfill the needs of dermatologists and
improve the effectiveness of our commercial team by letting sales representatives carry approved devices with them allowing for
easier product demonstrations and evaluations.
Biofrontera includes its wholly owned subsidiary Bio-FRI GmbH (“Bio-Fri”), a limited liability company organized under the laws
of Germany. Our subsidiary, Bioi-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship with the Ameluz
Licensor.
Our
principal licensed product is Ameluz®, which is a prescription drug approved for use in combination with the RhodoLED®
lamp series, for PDT. In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic
keratoses (“AK”) of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for
this indication in the U.S. under an exclusive license and supply agreement (“Ameluz LSA”) between Biofrontera and
the Ameluz Licensors.
Our
second prescription drug licensed product is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial
growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for the treatment
of impetigo, a common skin infection, due to Staphylococcus aureus or Streptococcus pyogenes. It is approved for use in the United States
in adults and children 2 months and older. We are currently selling Xepi® for this indication in the United States. under an exclusive
license and supply agreement, as amended (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”) that was assumed
by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc.(“Cutanea”). There has been limited
revenue during the current reporting periods and recent developments with the third-party manufacturer that was providing our supply
of Xepi® have resulted in further delays of our commercialization of the product. However, Ferrer is qualifying a new Contract manufacturer,
Cambrex, which is expected to begin production early 2024.
Our
principal objective is to increase the sales of our licensed products in the United States. The key elements of our strategy include
the following:
● |
expanding
our sales in the United States of Ameluz® in combination with the BF-RhodoLED® lamp for the treatment
of minimally to moderately thick actinic keratoses of the face and scalp and positioning Ameluz® to be the standard
of care in the United States by growing our dedicated sales and marketing infrastructure in the United States; |
|
|
● |
leveraging
the potential for future approvals and label extensions of our portfolio products that are in the pipeline for the U.S. market through
the LSAs with our Licensors; and |
|
|
● |
opportunistically
adding complementary products or services to our portfolio by acquiring or licensing IP to further leverage our commercial infrastructure
and customer relationships. |
We
devote a substantial portion of our cash resources to the commercialization of our licensed products, Ameluz® and the
BF-RhodoLED® lamp series. We have financed our operating and capital expenditures through cash proceeds generated from
our product sales and proceeds received in equity financings.
We
believe that important measures of our results of operations include product revenue, operating income (loss) and adjusted EBITDA (a
non-U.S. GAAP measure as defined below). Our sole source of product revenue is sales of products that we license from certain related
and unrelated companies. Our long-term financial objectives include consistent revenue growth and expanding operating margins. Accordingly,
we are focused on licensed product sales expansion to drive revenue growth and improve operating efficiencies, including effective resource
utilization, information technology leverage, and overhead cost management.
Key
factors affecting our performance
As
a result of a number of factors, our historical results of operations may not be comparable to our results of operations in future periods,
and our results of operations may not be directly comparable from period to period. Set forth below is a brief discussion of the key
factors impacting our results of operations.
Seasonality
Because
traditional photodynamic therapy treatments using a lamp are performed more frequently during the winter, our revenue is subject to some
seasonality and has historically been higher during the first and fourth quarters than during the second and third quarters.
Supply
Chain
While
our Licensors take reasonable precautions to ensure the successful production of our commercially licensed products, their contract manufacturers
may experience a myriad of business difficulties (i.e., workforce instability, supply chain issues, erosion of customer base, etc.) that
could impact their financial solvency. In December 2021, we were notified by Ferrer of third-party manufacturing delays for the Xepi®
product. Although we have inventory of Xepi® on hand, we expect a delay in further shipments of Xepi® for
the next 6 to 12 months. Despite these delays, our total revenues will not be significantly impacted since the majority of our revenues
are from sales of Ameluz®. We continue to monitor the impacts of the supply chain on our business and are focused on ensuring
the stability of the supply chains for Ameluz® and BF-RhodoLED®.
Components
of Our Results of Operations
Product
Revenue, net
We
generate product revenues through the third-party sales of our licensed products Ameluz®, BF-RhodoLED®
lamps and Xepi®. Revenues from product sales are recorded net of discounts,
rebates and other incentives, including trade discounts and allowances, product returns, government rebates, and other incentives such
as patient co-pay assistance. Revenue from the sales of our BF-RhodoLED® lamp and Xepi® are relatively
insignificant compared with revenues generated through our sales of Ameluz®.
The
primary factors that determine our revenue derived from our licensed products are:
● |
the
level of orders generated by our sales force; |
|
|
● |
the
level of prescriptions and institutional demand for our licensed products; and |
|
|
● |
unit
sales prices. |
Related
Party Revenues
We
also generate insignificant related party revenue in connection with an agreement with Biofrontera Bioscience to provide RhodoLED®
lamps and associated services for the clinical trials performed by Biofrontera Bioscience.
Cost
of Revenues, Related Party
Cost
of revenues, related party, is comprised of purchase costs of our licensed products, Ameluz® and BF-RhodoLED®
lamps from Biofrontera Pharma GmbH and insignificant inventory adjustments due to scrapped, expiring and excess products.
On
October 8, 2021, we entered into an amendment to the Ameluz LSA under which the price we pay per unit will be based upon our sales history.
As a result of this amendment, the purchase price we pay the Ameluz Licensor for Ameluz® will be determined in the following
manner:
● |
fifty
percent of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from
the Ameluz Licensor during a given Commercial Year (as defined in the Ameluz LSA); |
|
|
● |
forty
percent of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the
products we license from the Ameluz Licensor; and |
|
|
● |
thirty
percent of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license
from the Ameluz Licensor. |
Cost
of Revenues, Other
Cost
of revenues, other, is comprised of purchase costs of our licensed product, Xepi®, third-party logistics and distribution
costs including packaging, freight, transportation, shipping and handling costs, inventory adjustment due to expiring Xepi®
products, as well as sales-based Xepi® royalties.
Selling,
General and Administrative Expense
Selling,
general and administrative expenses consist principally of costs associated with our sales force, commercial support personnel, personnel
in executive and other administrative functions, as well as medical affairs professionals. Other selling, general and administrative
expenses include marketing, trade, and other commercial costs necessary to support the commercial operation of our licensed products
and professional fees for legal, consulting and accounting services. Selling, general and administrative expenses also include the amortization
of our intangible asset and our legal settlement expenses.
Selling,
General and Administrative Expenses, Related Party
Selling,
general and administrative expenses, related party, primarily relate to the services provided by our significant stockholder, Biofrontera
AG, for IT support, and pharmacovigilance. In December 2021, we entered into an Amended and Restated Master Contract Services Agreement,
or “Services Agreement”, which provides for the execution of statements of work that supersede the applicable provisions
of the 2016 Services Agreement. The Services Agreement enables us to continue relying on Biofrontera AG and its subsidiaries for various
services it has historically provided to us, including IT and pharmacovigilance support for as long as we deem necessary. We currently
have statements of work in place regarding IT, regulatory affairs, medical affairs, pharmacovigilance, and Investor Relations services,
and are continuously assessing the other services historically provided to us by Biofrontera AG to determine 1) if they will be needed,
and 2) whether they can or should be obtained from other third-party providers. As of September 30, 2023, we have migrated most of our
significant IT services from Biofrontera AG to third party providers.
Research
and Development
Our
current research and development programs aim to improve the capabilities of our BF-RhodoLED® lamps to better fulfill
the needs of dermatologists and improve the effectiveness of our commercial team.
Change
in Fair Value of Contingent Consideration
In
connection with the Cutanea acquisition, we recorded contingent consideration related to the estimated profits from the sale of Cutanea
products to be shared equally with Maruho. The fair value of such contingent consideration was determined to be $6.5 million on the acquisition
date of March 25, 2019 and is re-measured at each reporting date, with changes in fair value presented in the consolidated statement
of operations, until the contingency is resolved.
Change
in Fair Value of Warrant Liabilities
Common
Stock warrants issued in conjunction with private placement financing transactions are accounted for as liabilities in accordance
with ASC 815-40.
The
warrant liability is measured at fair value at inception and on a recurring basis, with changes in fair value presented within the consolidated
statements of operations.
Warrant
Inducement Expense
The
warrant inducement expense represents the accounting fair value of consideration issued to induce conversion of the 2021 Purchase Warrant.
On July 26, 2022, the Company entered into the Inducement Letter, in which the Company agreed to lower the exercise price of the 2021
Purchase Warrant and issue a new warrant (the “Inducement Warrant”) in exchange for $4.6 million in proceeds.
Change
in Fair Value of Investment, Related Party
Our
investment is comprised of equity securities in shares of Biofrontera AG, which are initially recorded at cost, plus transaction costs,
and subsequently measured at fair value, based on quoted market prices, with the gains and losses reported in the Company’s consolidated
statement of operations along with gains and losses
on securities we sold during the period. For the investments held in foreign currencies, the change
in fair value attributable to changes in foreign exchange rates is also included in gains
and losses in the consolidated statement of operations.
The
Company may sell its equity securities in response to changes in interest rates, risk/reward characteristics, liquidity needs or other
factors.
Interest
Expense, net
Interest
expense, net, primarily consists of amortization of the contract asset related to the start-up cost financing from Maruho under the Share
Purchase and Transfer Agreement dated March 25, 2019 (as amended, the “Share Purchase Agreement”), and interest expense related
to our Loan and Security Agreement with MidCap Business Credit LLC, offset by interest income of
6% per annum for each day that any reimbursement is past due related to the Amended Settlement Allocation Agreement with Biofrontera
AG, and immaterial amounts of interest income earned on our financing of customer purchases of BF-RhodoLED® lamps.
Other
Income (Expense), net
Other
income (expense), net primarily includes (i) gain (loss) on sale of leased assets and (ii) gain (loss) on foreign currency transactions.
Income
Taxes
As
a result of the net losses, we have incurred in each fiscal year since inception, we have recorded no provision for federal income taxes
during such periods. Income tax expense incurred relates to state income taxes.
Results
of Operations
Comparison
of the Three Months ended September 30, 2023 and 2022
The
following table summarizes our results of operations for the three months ended September 30, 2023 and 2022:
(in thousands) | |
2023 | | |
2022 | | |
Change | |
| |
| | |
| | |
| |
Product revenues, net | |
$ | 8,879 | | |
$ | 4,290 | | |
$ | 4,589 | |
Related party revenues | |
| 17 | | |
| 32 | | |
| (15 | ) |
Revenues, net | |
| 8,896 | | |
$ | 4,322 | | |
| 4,574 | |
| |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | |
Cost of revenues, related party | |
| 4,495 | | |
| 2,127 | | |
| 2,368 | |
Cost of revenues, other | |
| 95 | | |
| 98 | | |
| (3 | ) |
Selling, general and administrative | |
| 8,619 | | |
| 7,765 | | |
| 854 | |
Selling, general and administrative, related party | |
| 74 | | |
| 171 | | |
| (97 | ) |
Research and development | |
| 33 | | |
| - | | |
| 33 | |
Change in fair value of contingent consideration | |
| 200 | | |
| (2,200 | ) | |
| 2,400 | |
Total operating expenses | |
| 13,516 | | |
| 7,961 | | |
| 5,555 | |
Loss from operations | |
| (4,620 | ) | |
| (3,639 | ) | |
| (981 | ) |
Change in fair value of warrant liabilities | |
| 598 | | |
| 3,814 | | |
| (3,216 | ) |
Warrant inducement expense | |
| - | | |
| (2,629 | ) | |
| 2,629 | |
Change in fair value of investment, related party | |
| (2,212 | ) | |
| - | | |
| (2,212 | ) |
Interest expense, net | |
| (142 | ) | |
| (89 | ) | |
| (53 | ) |
Other income (expense), net | |
| 35 | | |
| (22 | ) | |
| 57 | |
Loss before income taxes | |
| (6,341 | ) | |
| (2,565 | ) | |
| (3,776 | ) |
Income tax expenses | |
| 1 | | |
| 1 | | |
| - | |
Net loss | |
$ | (6,342 | ) | |
$ | (2,566 | ) | |
$ | (3,776 | ) |
Product
Revenue, net
Net
product revenue for the three months ended September 30, 2023 increased by $4.6 million, or 107.0% as compared to the three months ended September 30, 2022. This increase was driven by a
higher volume of Ameluz revenue in Q3 2023, caused in part by an expansion of our sales force in 2023, higher adoption of Ameluz by
dermatologists, as well as the buy-in impact due to a price increase. Our price for Ameluz increased by 5% on October 1, 2023,
causing some dermatologists to accelerate their purchases of Ameluz in Q3 2023. We increased our price on April 1, 2022, and thus
revenues in Q3 2022 were not impacted by the effects of the previous increase.
Operating
Expenses
Cost
of Revenues, Related Party
Cost
of revenues, related party for the three months ended September 30, 2023 increased by $2.4 million, or 111.3% as compared to the three months ended September 30, 2022. This was
driven by the increase in Ameluz product revenue. Cost of revenues, related party, is directly correlated to the selling price of
Ameluz under the Ameluz LSA.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses for the three months ended September 30, 2023 increased by $0.9 million, or 11.0% as compared to the three months ended September 30, 2022. The increase
was primarily driven by $0.8 million of personnel costs, due to higher sales and medical headcount. This increase reflects a
realignment of our workforce strategy to reduce selling, general and administrative costs and deploy some of these costs to revenue
generating functions. The increase was further driven by $0.4 million of legal expenses and $0.1 million of increase sales and
marketing expense. These expenses were offset by a decrease of $0.3 million in non-recurring issuance costs, related to our liability classified warrants incurred in Q3
2022.
Change
in Fair Value of Contingent Consideration
The
change in fair value of contingent consideration was an increase of $0.2 million for the three months ended September 30, 2023 compared
to a decrease of $2.2 million for the three months ended September 30, 2022. The change in fair value of contingent consideration is
driven by the estimated profit share the Company is required to pay under the Share Purchase Agreement. The estimated profit share was
reduced in Q3 2022 after receiving notification of third-party manufacturing delays that impacted
the timing of sales expansion and improved market positioning of the Xepi® product.
Change
in Fair Value of Warrant Liabilities
The
change in fair value of warrant liabilities was $0.6 million for three months ended September 30, 2023 compared to $3.8 million for the three months ended September 30, 2022. The change in fair value of warrant liabilities was driven primarily
by changes in the underlying value of the Common Stock.
Warrant
Inducement Expense
The
warrant inducement expense was $2.6 million for the three months ended September 30, 2022. The change was driven by changes in the underlying
value of the Common Stock, related to the modification and exercise of the 2021 Purchase Warrant in Q3 2022.
Change
in fair value of investment, related party
The
change in fair value of investment, related party was a decrease of $2.2 million, driven by changes in the quoted
market price of the common stock of Biofrontera AG and losses on such securities we sold during the period.
Comparison
of the nine months ended September 30, 2023 and 2022
The
following table summarizes our results of operations for the nine months ended September 30, 2023 and 2022:
(in thousands) | |
2023 | | |
2022 | | |
Change | |
| |
| | |
| | |
| |
Product revenues, net | |
$ | 23,423 | | |
$ | 18,467 | | |
$ | 4,956 | |
Related party revenues | |
| 52 | | |
| 63 | | |
| 11 | |
Revenues, net | |
| 23,475 | | |
$ | 18,530 | | |
| 4,945 | |
| |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | |
Cost of revenues, related party | |
| 11,814 | | |
| 9,504 | | |
| 2,310 | |
Cost of revenues, other | |
| 262 | | |
| 425 | | |
| (163 | ) |
Selling, general and administrative | |
| 29,874 | | |
| 25,050 | | |
| 4,824 | |
Selling, general and administrative, related party | |
| 193 | | |
| 612 | | |
| (419 | ) |
Research and Development | |
| 44 | | |
| - | | |
| 44 | |
Change in fair value of contingent consideration | |
| 100 | | |
| (4,100 | ) | |
| 4,200 | |
Total operating expenses | |
| 42,287 | | |
| 31,491 | | |
| 10,796 | |
Loss from operations | |
| (18,812 | ) | |
| (12,961 | ) | |
| (5,851 | ) |
Change in fair value of warrant liabilities | |
| 2,001 | | |
| 17,896 | | |
| (15,895 | ) |
Warrant inducement expense | |
| - | | |
| (2,629 | ) | |
| 2,629 | |
Change in fair value of investment, related party | |
| (6,635 | ) | |
| - | | |
| (6,635 | ) |
Interest expense, net | |
| (256 | ) | |
| (160 | ) | |
| (96 | ) |
Other income, net | |
| 65 | | |
| 30 | | |
| 35 | |
Income (loss) before income taxes | |
| (23,637 | ) | |
| 2,176 | | |
| (25,813 | ) |
Income tax expenses | |
| 20 | | |
| 31 | | |
| (11 | ) |
Net Income (loss) | |
$ | (23,657 | ) | |
$ | 2,145 | | |
$ | (25,802 | ) |
Product
Revenue, net
Net
product revenue for the nine months ended September 30, 2023 increased by $4.9 million, or 26.8% as compared to the nine months ended September 30, 2022. The increase was primarily driven
by a higher volume of Ameluz sales in Q3 2023 due to the expansion of the sales team and higher adoption
of Ameluz by dermatologists of $4.8 million and the impact of a higher average Ameluz selling price in 2023 of $0.1
million.
Cost
of Revenues, Related Party
Cost
of revenues, related party for the nine months ended September 30, 2023 increased by $2.3 million, or 24.3% as compared to the nine months
ended September 30, 2022. This was driven by the increase in Ameluz product revenue. Cost of revenues, related party, is directly correlated
to the selling price of Ameluz under the Ameluz LSA.
Operating
Expenses
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses for the nine months ended September 30, 2023 increased by $4.8 million, or 19.3% as compared to
the nine months ended September 30, 2022. The increase was primarily driven by personnel-related expenses of $2.9 million,
reflecting a realignment of our workforce strategy to reduce selling, general and administrative costs and deploy some of these
costs to revenue generating functions. The increase is further driven by sales related travel and medical education expenses of $0.7
million, external legal expenses related to a legal settlement of $1.2 million and other non-recurring legal costs of $1.2 million;
partially offset by issuance costs related to liability classified warrants of $1.0 million incurred in 2022 and a decrease of $0.6
million in business insurance.
Selling,
General and Administrative Expenses, Related Party
Selling,
general and administrative expenses for the nine months ended September 30, 2023 decreased by $0.4 million, or 68.5% as compared to the nine months ended September 30, 2022. Related party
expenses are based on statements of work issued under the Services Agreement with the Biofrontera Group. We currently have
statements of work in place regarding IT, regulatory affairs, medical affairs, pharmacovigilance, and investor relations services.
The decrease is driven by the Company utilizing fewer IT services from the Biofrontera Group in the current year when compared to
the prior year.
Change
in Fair Value of Contingent Consideration
The
change in fair value of contingent consideration was an increase of $0.1 million for the nine months ended September 30, 2023, compared
to a decrease of $4.1 million for the nine months ended September 30, 2022. The change in fair value of contingent consideration is driven
by the estimated profit share the Company is required to pay under the Share Purchase Agreement. The estimated profit share was reduced
in Q3 2022 after receiving notification of third-party manufacturing delays that impacted the timing
of sales expansion and improved market positioning of the Xepi® product.
Change
in Fair Value of Warrant Liabilities
The
change in fair value of warrant liabilities was a decrease of $2.0 million for the nine months ended September 31, 2023 and a decrease
of $17.9 million for the nine months ended September 30, 2022. The change in fair value of warrant liabilities was driven primarily by
a decrease in the underlying value of our Common Stock.
Warrant
Inducement Expense
The
warrant inducement expense was $2.6 million for the nine months ended September 30, 2022. The change was driven by changes in the underlying
value of the Common Stock, related to the modification and exercise of the 2021 Purchase Warrant in July 2022.
Change
in fair value of investment, related party
The
change in fair value of investment, related party was a decrease of $6.6 million, driven by changes in the quoted market price of the
common stock of Biofrontera AG and losses on such securities we sold during the period.
Net
Income (Loss) to Adjusted EBITDA Reconciliation for the Three and Nine Months Ended September 30, 2023 and 2022
We
define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other
non-operating items from our consolidated statements of operations as well as certain other items considered outside the normal course
of our operations specifically described below. Adjusted EBITDA is not a presentation made in accordance with U.S. generally accepted
accounting principles (“U.S. GAAP”). Our definition of adjusted EBITDA may vary from the use of similarly titled measures
by others in our industry due to the potential inconsistencies in the method of calculation and differences due to items subject to interpretation.
Adjusted EBITDA should not be considered as an alternative to net income or loss, operating income/(loss), cash flows from operating
activities or any other performance measures derived in accordance with U.S. GAAP as measures of operating performance or liquidity.
Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our
results as reported under U.S. GAAP.
Change
in fair value of contingent consideration: Pursuant to the Share Purchase Agreement, the profits from the sale of Cutanea
products will be shared equally between Maruho and Biofrontera until 2030. The fair value of the contingent consideration was
determined to be $6.5 million on the acquisition date and is re-measured at each reporting date, with changes in fair value
presented within the consolidated statements of operations. We exclude the impact of the change in fair value of contingent
consideration as this is not currently payable and is a non-cash adjustment.
Change
in fair value of warrant liabilities: The Warrants issued in conjunction with our private placement offerings were accounted for
as liabilities in accordance with ASC 815-40. The warrant liabilities are measured at fair value at inception and on a recurring basis,
with changes in fair value presented within the consolidated statements of operations. We exclude the impact of the change in fair value
of warrant liabilities as this is non-cash.
Warrant
inducement expense: The warrant inducement expense was determined using the Black-Scholes option pricing model and was calculated
as the difference between the fair value of the 2021 Purchase Warrant prior to, and immediately after, the reduction in the exercise
price on the date of repricing in addition to the fair value of the Inducement Warrant issued and is presented within the statement of
operations. We exclude the impact of the change in fair value of the warrant modification as this is non-cash.
Change
in fair value of investment, related party: The Company accounts for its investment, related party in accordance with ASC 321, Investments
— Equity Securities (“ASC 321”). Equity securities, which are comprised of investments in common stock, are initially
recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and
losses reported in the Company’s consolidated statement of operations. For the investments held in foreign currencies, the change
in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statements of operations.
We exclude the impact of the change in fair value of investments as this is non-cash.
Legal
settlement expenses: To measure operating performance, we exclude legal settlement expenses. We do not expect to incur these types
of legal expenses on a recurring basis and believe the exclusion of such amounts allows management and the users of the financial statements
to better understand our financial results.
Stock
Based Compensation: To measure operating performance, we exclude the impact of costs relating
to share-based compensation. Due to the subjective assumptions and a variety of award types, we believe that the exclusion of share-based
compensation expense, which is typically non-cash, allows for more meaningful comparisons of our operating results to peer companies.
Share-based compensation expense can vary significantly based on the timing, size and nature of awards granted.
Adjusted
EBITDA margin is adjusted EBITDA for a particular period expressed as a percentage of revenues for that period.
We
use adjusted EBITDA to measure our performance from period to period and to compare our results to those of our competitors. In addition
to adjusted EBITDA being a significant measure of performance for management purposes, we also believe that this presentation provides
useful information to investors regarding financial and business trends related to our results of operations and that when non-U.S. GAAP
financial information is viewed with U.S. GAAP financial information, investors are provided with a more meaningful understanding of
our ongoing operating performance.
The
below table presents a reconciliation from net income (loss) to Adjusted EBITDA for the three and nine months ended September 30, 2023
and 2022:
|
|
Three
months ended
September
30, |
|
|
Nine
months ended
September
30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net
income (loss) |
|
$ |
(6,342 |
) |
|
$ |
(2,566 |
) |
|
$ |
(23,657 |
) |
|
$ |
2,145 |
|
Interest
expense, net |
|
|
142 |
|
|
|
89 |
|
|
|
256 |
|
|
|
160 |
|
Income
tax expense |
|
|
1 |
|
|
|
1 |
|
|
|
20 |
|
|
|
31 |
|
Depreciation
and amortization |
|
|
251 |
|
|
|
130 |
|
|
|
769 |
|
|
|
394 |
|
EBITDA |
|
|
(5,948 |
) |
|
|
(2,346 |
) |
|
|
(22,612 |
) |
|
|
2,730 |
|
Change
in fair value of contingent consideration |
|
|
200 |
|
|
|
(2,200 |
) |
|
|
100 |
|
|
|
(4,100 |
) |
Change
in fair value of warrant liabilities |
|
|
(598 |
) |
|
|
(3,814 |
) |
|
|
(2,001 |
) |
|
|
(17,896 |
) |
Warrant
inducement expense |
|
|
- |
|
|
|
2,629 |
|
|
|
- |
|
|
|
2,629 |
|
Change
in fair value of investment, related party |
|
|
2,212 |
|
|
|
- |
|
|
|
6,635 |
|
|
|
- |
|
Legal
settlement expenses |
|
|
- |
|
|
|
- |
|
|
|
1,225 |
|
|
|
- |
|
Stock
compensation expense |
|
|
207 |
|
|
|
401 |
|
|
|
817 |
|
|
|
1,469 |
|
Expensed
issuance costs |
|
|
- |
|
|
|
320 |
|
|
|
|
- |
|
|
1,045 |
|
Adjusted
EBITDA |
|
$ |
(3,927 |
) |
|
$ |
(5,010 |
) |
|
$ |
(15,836 |
) |
|
$ |
(14,123 |
) |
Adjusted
EBITDA margin |
|
|
-44.1 |
% |
|
|
-115.9 |
% |
|
|
-67.5 |
% |
|
|
-76.2 |
% |
Adjusted
EBITDA
Adjusted
EBITDA increased from ($5.0) million during the three months ended September 30, 2022 to ($3.9) million for the three months ended September
30, 2023. The increase in Adjusted EBITDA is primarily driven by higher revenues of $4.6 million, net of increased cost of revenues of
$2.4 million; partially offset by an increase in our selling, general, and administrative costs of $1.2 million.
Adjusted
EBITDA decreased from ($14.1) million during the nine months ended September 30, 2022 to ($15.8) million for the nine months ended September
30, 2023. The decrease in Adjusted EBITDA is primarily driven by an increase in selling, general and administrative costs of $4.5 million,
due primarily to increased personnel costs related to increased headcount to expand key customer facing roles and severance agreements
relating to the realignment of our workforce strategy. This is partially offset by an increase in our revenues of $4.9 million, net of
increased cost of revenues of $2.1 million. We expect our revenues to continue to increase throughout the remainder of the year as our
commercial team increases productivity after an expansion earlier in the year.
Liquidity
and Capital Resources
The
Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, proceeds
from the sale of our investment, related party, and cash flows from a revolving line of credit. As of September 30, 2023, we had cash
and cash equivalents of $3.4 million and investment, related party of $3.3 million, compared to $17.2 million and $10.5 million as of
December 31, 2022, respectively.
Since
we commenced operations in 2015, we have generated significant losses. For the nine months ended September 30, 2023 and 2022, we
incurred loss from operations of $18.8 million and $13.0 million, respectively. We incurred net cash outflows from operations of
$16.0 million and $7.9 million, for the same periods, respectively. We had an accumulated deficit as of September 30, 2023 of $103.2
million. Additionally, we expect to continue to incur operating losses due to
significant discretionary sales and marketing, medical affairs, and dermatology community outreach efforts as we seek to expand the
commercialization of our licensed products in the United States.
In connection with our assessment of going concern
considerations under applicable accounting standards, the Company’s management has determined that substantial doubt exists about
our ability to continue as a going concern for at least one year from the date the unaudited condensed consolidated financial statements
were issued.
The future viability of the Company is dependent
on its ability to continue to execute its growth plan and raise additional capital or find alternative methods of financing to fund its
operations during the first half of 2024, and until cash flow from operations is sufficient, if ever. We have implemented plans to improve
our working capital position, particularly around inventory levels. We have not placed any orders nor plan to place any orders for 2024
deliveries in 2023. We expect to need a delivery sometime in Q3 2024, depending on sales between now and then, and will place the appropriate
orders in early 2024. Management believes that the anticipated implementation of such plans, together with the recent net capital raise
of $4.1 million will provide the opportunity for the Company to continue as a going concern. However, no assurance can be given that
the Company will be successful in these efforts.
The accompanying financial statements have been prepared
on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business.
The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or
the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. There could be
a material adverse effect on the Company and its financial statements if management’s plans are not achieved on a timely basis.
Our
future use of operating cash and capital requirements will depend on many forward-looking factors, including the following:
● |
the
costs of our commercialization activities for Ameluz®; |
|
|
● |
the
extent to which we acquire or invest in licensed products, businesses and technologies; |
|
|
● |
the
extent to which we choose to establish collaboration, co-promotion, distribution or other similar agreements for our licensed products; |
|
|
● |
the
cost to fulfill our contractual obligations for various operating leases on vehicles and office space; |
|
|
● |
the
ability to liquidate our investment in equity securities on a timely basis; and |
|
|
● |
the
requirement to pay back $7.3 million of start-up cost financing to Maruho and make any contingent profit- sharing payments to Maruho
in connection with the Cutanea acquisition. |
We
will continue to assess our operating costs and expenses and our cash and cash equivalents and, if circumstances warrant, we will make
appropriate adjustments to our operating plan.
Cash
Flows
The
following table summarizes our cash provided by and (used in) operating, investing and financing activities:
| |
Nine Months Ended September 30, | |
(in thousands) | |
2023 | | |
2022 | |
Net cash used in operating activities | |
$ | (16,029 | ) | |
$ | (7,928 | ) |
Net cash provided by (used) in investing activities | |
| 546 | | |
| (3,070 | ) |
Net cash provided by financing activities | |
| 1,697 | | |
| 14,021 | |
Net increase (decrease) in cash and restricted cash | |
$ | (13,786 | ) | |
$ | 3,023 | |
Operating
Activities
During
the nine months ended September 30, 2023, operating activities used $16.0 million of cash, primarily resulting from our loss from operations
of $23.7 million, adjusted for non-cash expense of stock-based compensation of $0.8 million, non-cash interest expense of $0.3 million,
depreciation and amortization in the aggregate of $0.8 million, net cash used by changes in our operating assets and liabilities of $0.9
million, the change in fair value of contingent consideration of $0.1 million and the change in fair value of investment, related party
of $6.6 million; partially offset by the change in fair value of warrant liabilities of $2.0 million.
During
the nine months ended September 30, 2022, operating activities used $7.9 million of cash, primarily resulting from our net income of
$1.1 million, decreased by the non-cash change in fair value of warrant liabilities of $15.3 million and the change in fair value of
contingent consideration of $3.4 million and offset by the non-cash expense of stock-based compensation of $1.5 million, $0.4 million
depreciation and amortization, $0.3 million interest expense as well as $7.3 million of working capital changes.
Investing
Activities
During
the nine months ended September 30, 2023, net cash provided by investing activities of $0.5 million consisted of the proceeds from
the sales of equity investments, partially offset by the purchase of machinery & computer equipment.
During
the nine months ended September 30, 2022 investing activities used $3.1 million, primarily resulting from the distribution of a short-term
loan of $3.1 million, which was repayable at the option of the holder, Quirin PrivatbankAG, in cash or in shares of Biofrontera AG acquired
with the funds from the loan.
Financing
Activities
During
the nine months ended September 30, 2023, net cash from financing activities consisted of a net $1.7 million of proceeds from our line
of credit.
During
the nine months ended September 30, 2022, net cash from financing activities was $14 million driven entirely by proceeds from the sale
of Common Stock and warrants in a private placement, as well as the exercise of warrants.
Accounting
Policies and Significant Judgments and Estimates
Our
management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial
statements, which have been prepared in accordance with generally accepted accounting principles of the United States, or U.S. GAAP.
The preparation of the financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions by management
that affect the value of assets and liabilities, as well as contingent assets and liabilities, as reported on the balance sheet date,
and revenues and expenses arising during the reporting period. The main areas in which assumptions, estimates and the exercising of a
degree of judgment are appropriate relate to fair value measurements of contingent consideration, warrant liabilities, and stock compensation.
Estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances. They are continuously
reviewed but may vary from the actual values.
Our
significant accounting policies are described in more detail in Note 2 – Summary of Significant Accounting Policies, to
our consolidated financial statements included in our reaudited consolidated financial statements for the fiscal years ended
December 31, 2022 and 2021 (“reaudited Consolidated Financial Statements”), filed in a Current Report on From 8-K with
the SEC on October 3, 2023.
Critical
Accounting Estimates
A
summary of our critical accounting estimates is included in the Company’s revised Management’s Discussion and Analysis
of Financial Condition and Results of Operations for the fiscal years ended December 31, 2022 and December 31, 2021 (“revised
MD&A”), filed in a Current Report on From 8-K with the SEC on October 3, 2023 for the year ended December 31, 2022. There
were no material changes to our critical accounting estimates for the nine months ended September 30, 2023.
Off-balance
Sheet Arrangements
Other
than those items reflected in Note 18. Commitments and Contingencies we did not have during the periods presented, and we do not
currently have, any other off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Emerging
Growth Company Status
The
Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended
transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise
apply to private companies. We have elected to take advantage of such extended transition period, which means that when an accounting
standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised
standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably
elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
As
a “smaller reporting company,” we are not required to provide the information required by this Item.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated, as of the end of the period
covered by this Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under
the Exchange Act). Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September
30, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting during the most recent fiscal quarter ended September 30, 2023 that
materially affected, or is reasonably likely to materially affect, our internal control over financial reporting (as defined in Rule
13a-15(f) under the Exchange Act).
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
For
information regarding legal proceedings in which we are involved, (see Note 18 - Commitments and Contingencies under the subsection titled
“Legal Proceedings” in our Notes to Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form
10-Q).
Item
1A. Risk Factors
As
a smaller reporting company, we are not required to provide disclosure pursuant to this item in this Form 10-Q. However, as of the date
of this Quarterly Report, other than as set forth below, there have been no material changes with respect to those risk factors previously
disclosed under “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as
filed with the Securities and Exchange Commission on March 13, 2023 (the “Form 10-K”). The following should be carefully
considered, together with other information in this Quarterly Report on Form 10-Q, our Form 10-K, and our other filings with the SEC
before making investment decisions regarding our Common Stock.
The
results of our research and development efforts are uncertain and there can be no assurance they will enhance the commercial success
of our products.
We
believe that we will need to incur additional research and development expenditures to improve the capabilities of our BF-RhodoLED®
lamps to better fulfill the needs of dermatologists and may also incur research and development expenditures to develop new products.
The products we are developing and may develop in the future may not be technologically successful. At this time, we have limited internal
research and development personnel, which makes us dependent on consulting relationships.
In
addition, the length of our product development cycle may be greater than we originally expected, and we may experience delays in product
development. If our resulting products are not technologically successful, they may not achieve market acceptance or compete effectively
with our competitors’ products and services.
There
is substantial doubt about our ability to continue as a “going concern.”
In
connection with our assessment of going concern considerations under applicable accounting standards, the Company’s management
has determined that our growth plans, upcoming inventory purchases and a final settlement payment to DUSA Pharmaceuticals, Inc. substantial
doubt exists about our ability to continue as a going concern through approximately one year from the date the unaudited condensed financial
statements included in Item 1. “Financial Statements” were issued. The future viability of the Company is dependent on its
ability to continue to execute its growth plan and raise additional capital or find alternative methods of financing to fund its operations.
There can be no guarantee that the actions presently being taken by the Company will be successful in raising additional capital or finding
alternative methods of financing. If the Company is not successful in these endeavors, it would likely have a material adverse effect
on the Company’s business, results of operations and financial condition.
For
additional discussion of the risks and uncertainties that affect our business, see “Item 1A. Risk Factors” included in our
Form 10-K.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
Applicable.
Item
5. Other Information
None
Item
6. Exhibits
The
following exhibits are filed herewith or are incorporated by reference to exhibits previously filed with the SEC.
Exhibit
No. |
|
|
|
|
|
4.1
|
|
Form
of Common Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on
November 2, 2023) |
|
|
|
4.2
|
|
Form
of Pre-Funded Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC
on November 2, 2023) |
|
|
|
10.1 |
|
Securities
Purchase Agreement, dated October 30, 2023, by and between Biofrontera Inc. and an institutional investor (incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 2, 2023) |
|
|
|
10.2
|
|
Placement Agency Agreement, dated October 30, 2023, by and between Biofrontera Inc. and Roth Capital Partner, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed with the SEC on November 2, 2023) |
|
|
|
10.3
|
|
Amendment to Common Stock Purchase Warrants, dated October 30, 2023, by and between Biofrontera Inc. and institutional investor (incorporated by reference to Exhibit 10.3 to the Company’s Form 8-K filed with the SEC on November 2, 2023) |
|
|
|
10.4 |
|
Amendment No. 1 to Settlement Agreement dated as of October 12, 2023, between Biofrontera Inc., Hermann Luebbert, John J. Borer, Loretta M. Wedge, Beth J. Hoffman, Kevin D. Weber and Biofrontera AG (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 13, 2023) |
|
|
|
31.1* |
|
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002 |
|
|
|
31.2*
|
|
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002 |
|
|
|
32.1*
|
|
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002 |
|
|
|
32.2* |
|
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002 |
|
|
|
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 (embedded within the Inline XBRL document and included in Exhibit 101) |
* |
Filed
herewith. |
# |
Indicates
a management contract or compensatory plan or arrangement. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned thereunto duly authorized.
|
BIOFRONTERA
INC. |
|
|
|
Date:
November 9, 2023 |
By: |
/s/
Hermann Luebbert |
|
Name:
|
Hermann
Luebbert |
|
Title: |
Chief
Executive Officer & Chairman
(Principal
Executive Officer) |
|
|
|
Date:
November 9, 2023 |
By: |
/s/
E. Fred Leffler III |
|
Name:
|
E.
Fred Leffler, III |
|
Title: |
Chief
Financial Officer
(Principal
Financial Officer) |
Exhibit 31.1
Certification
I, Hermann Luebbert, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q
of Biofrontera Inc.;
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 me by others within those entities, particularly during the
period in which this report is being prepared;
b) 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
c) 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 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) All significant deficiencies and material weaknesses
in the design or operation of internal control 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: November 9, 2023 |
By: |
/s/ Hermann Luebbert |
|
|
Hermann Luebbert |
|
|
Chief Executive Officer & Chairman |
|
|
(Principal Executive Officer) |
Exhibit 31.2
Certification
I, Eugene Frederick Leffler, III, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q
of Biofrontera Inc.;
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 me by others within those entities, particularly during the
period in which this report is being prepared;
b) 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
c) 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 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) All significant deficiencies and material weaknesses
in the design or operation of internal control 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: November 9, 2023 |
By: |
/s/ E. Fred Leffler III |
|
|
E. Fred Leffler, III |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer) |
Exhibit 32.1
Certification*
In connection with the Quarterly Report of Biofrontera
Inc. (the “Company”) on Form 10-Q for the quarter ended September 30, 2023 as filed with the Securities and Exchange Commission
on the date hereof (the “Quarterly Report”) pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C.§
1350), I, Hermann Luebbert, Chief Executive Officer of the Company, do hereby certify, to the best of my knowledge:
1. The Quarterly Report fully complies with
the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
2. The information contained in the Quarterly
Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the period covered
by the Quarterly Report.
Date: November 9, 2023 |
By: |
/s/ Hermann Luebbert |
|
|
Hermann Luebbert |
|
|
Chief Executive Officer & Chairman |
|
|
(Principal Executive Officer) |
* |
This certification accompanies the Quarterly Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Biofrontera 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 the Quarterly Report), irrespective of any general incorporation language contained in such filing. |
Exhibit 32.2
Certification*
In connection with the Quarterly Report of Biofrontera
Inc. (the “Company”) on Form 10-Q for the quarter ended September 30, 2023 as filed with the Securities and Exchange Commission
on the date hereof (the “Quarterly Report”) pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C.§
1350), I, Eugene Frederick Leffler, III, Chief Financial Officer of the Company, do hereby certify, to the best of my knowledge:
1. The Quarterly Report fully complies with
the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
2. The information contained in the Quarterly
Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the period covered
by the Quarterly Report.
Date: November 9, 2023 |
By: |
/s/ E. Fred Leffler III |
|
|
E. Fred Leffler, III |
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer) |
* |
This certification accompanies the Quarterly Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Biofrontera 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 the Quarterly Report), irrespective of any general incorporation language contained in such filing. |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 08, 2023 |
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-40943
|
|
Entity Registrant Name |
Biofrontera
Inc.
|
|
Entity Central Index Key |
0001858685
|
|
Entity Tax Identification Number |
47-3765675
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
120
Presidential Way
|
|
Entity Address, Address Line Two |
Suite 330
|
|
Entity Address, City or Town |
Woburn
|
|
Entity Address, State or Province |
MA
|
|
Entity Address, Postal Zip Code |
01801
|
|
City Area Code |
(781)
|
|
Local Phone Number |
245-1325
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
Elected Not To Use the Extended Transition Period |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
1,517,628
|
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Not
Applicable
|
|
Common Stock [Member] |
|
|
Title of 12(b) Security |
Common
stock, par value $0.001 per share
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BFRI
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Security Exchange Name |
NASDAQ
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|
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Warrants
to purchase common stock
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BFRIW
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NASDAQ
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v3.23.3
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 3,422
|
$ 17,208
|
Accounts receivable, net |
3,793
|
3,748
|
Inventories, net |
16,068
|
7,168
|
Prepaid expenses and other current assets |
274
|
810
|
Total current assets |
29,611
|
43,140
|
Property and equipment, net |
154
|
204
|
Operating lease right-of-use assets |
1,129
|
1,375
|
Intangible asset, net |
2,718
|
3,032
|
Other assets |
492
|
320
|
Total assets |
34,104
|
50,884
|
Current liabilities: |
|
|
Acquisition contract liabilities, net |
7,211
|
6,942
|
Operating lease liabilities |
555
|
498
|
Accrued expenses and other current liabilities |
11,039
|
10,864
|
Line of credit |
1,697
|
|
Total current liabilities |
29,124
|
20,894
|
Long-term liabilities: |
|
|
Acquisition contract liabilities, net |
2,500
|
2,400
|
Warrant liabilities |
842
|
2,843
|
Operating lease liabilities, non-current |
562
|
848
|
Other liabilities |
38
|
21
|
Total liabilities |
33,066
|
27,006
|
Commitments and contingencies (Note 18) |
|
|
Stockholders’ equity: |
|
|
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of September 30, 2023 and December 31, 2022 |
|
|
Common Stock, $0.001 par value, 15,000,000 shares authorized; 1,367,628 and 1,334,950 shares issued and outstanding as of September 30, 2023 and December 31, 2022 |
1
|
1
|
Additional paid-in capital |
104,213
|
103,396
|
Accumulated deficit |
(103,176)
|
(79,519)
|
Total stockholders’ equity |
1,038
|
23,878
|
Total liabilities and stockholders’ equity |
34,104
|
50,884
|
Related Party [Member] |
|
|
Current assets: |
|
|
Investment, related party |
3,341
|
10,548
|
Other receivables, related party |
2,713
|
3,658
|
Other receivables long term, related party |
|
2,813
|
Current liabilities: |
|
|
Accounts payable |
6,988
|
1,312
|
Nonrelated Party [Member] |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 1,634
|
$ 1,278
|
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v3.23.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
15,000,000
|
15,000,000
|
Common stock, shares issued |
1,367,628
|
1,334,950
|
Common stock, shares outstanding |
1,367,628
|
1,334,950
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Product revenues, net |
$ 8,879
|
$ 4,290
|
$ 23,423
|
$ 18,467
|
Revenues, related party |
17
|
32
|
52
|
63
|
Total revenues, net |
8,896
|
4,322
|
23,475
|
18,530
|
Operating expenses |
|
|
|
|
Cost of revenues, related party |
4,495
|
2,127
|
11,814
|
9,504
|
Cost of revenues, other |
95
|
98
|
262
|
425
|
Selling, general and administrative |
8,619
|
7,765
|
29,874
|
25,050
|
Selling, general and administrative, related party |
74
|
171
|
193
|
612
|
Research and development |
33
|
|
44
|
|
Change in fair value of contingent consideration |
200
|
(2,200)
|
100
|
(4,100)
|
Total operating expenses |
13,516
|
7,961
|
42,287
|
31,491
|
Loss from operations |
(4,620)
|
(3,639)
|
(18,812)
|
(12,961)
|
Other income (expense) |
|
|
|
|
Change in fair value of warrant liabilities |
598
|
3,814
|
2,001
|
17,896
|
Warrant inducement expense |
|
(2,629)
|
|
(2,629)
|
Realized/Unrealized losses in investment, related party |
(2,212)
|
|
(6,635)
|
|
Interest expense, net |
(142)
|
(89)
|
(256)
|
(160)
|
Other income, net |
35
|
(22)
|
65
|
30
|
Total other income (expense) |
(1,721)
|
1,074
|
(4,825)
|
15,137
|
Income (loss) before income taxes |
(6,341)
|
(2,565)
|
(23,637)
|
2,176
|
Income tax expense |
1
|
1
|
20
|
31
|
Net income (loss) |
$ (6,342)
|
$ (2,566)
|
$ (23,657)
|
$ 2,145
|
Income (loss) per common share: |
|
|
|
|
Basic |
$ (4.64)
|
$ (2.26)
|
$ (17.57)
|
$ 2.19
|
Diluted |
$ (4.64)
|
$ (2.26)
|
$ (17.57)
|
$ 2.19
|
Weighted-average common shares outstanding: |
|
|
|
|
Basic |
1,366,842
|
1,136,291
|
1,346,264
|
978,018
|
Diluted |
1,366,842
|
1,136,291
|
1,346,264
|
980,251
|
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v3.23.3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 1
|
$ 90,216
|
$ (78,879)
|
$ 11,338
|
Beginning balance, shares at Dec. 31, 2021 |
855,237
|
|
|
|
Stock based compensation |
|
1,469
|
|
1,469
|
Net income (loss) |
|
|
2,145
|
2,145
|
Issuance of shares for vested restricted stock units |
$ 0
|
|
|
|
Issuance of shares for vested restricted stock units, shares |
8,504
|
|
|
|
Exercise of pre-funded warrants |
$ 0
|
2,841
|
|
2,841
|
Exercise of pre-funded warrants, shares |
78,450
|
|
|
|
Exercise of PIPE warrants |
$ 0
|
4,686
|
|
4,686
|
Exercise of PIPE warrants, shares |
142,857
|
|
|
|
Issuance of common stock and warrants under private placement, net of issuance costs |
$ 0
|
116
|
|
116
|
Issuance of common stock and warrants under private placement, net of issuance costs, shares |
92,500
|
|
|
|
Ending balance, value at Sep. 30, 2022 |
$ 1
|
99,328
|
(76,734)
|
22,595
|
Ending balance, shares at Sep. 30, 2022 |
1,177,548
|
|
|
|
Beginning balance, value at Jun. 30, 2022 |
$ 1
|
91,400
|
(74,168)
|
17,233
|
Beginning balance, shares at Jun. 30, 2022 |
950,573
|
|
|
|
Stock based compensation |
|
401
|
|
401
|
Net income (loss) |
|
|
(2,566)
|
(2,566)
|
Issuance of shares for vested restricted stock units |
$ 0
|
|
|
|
Issuance of shares for vested restricted stock units, shares |
5,668
|
|
|
|
Exercise of pre-funded warrants |
$ 0
|
2,841
|
|
2,841
|
Exercise of pre-funded warrants, shares |
78,450
|
|
|
|
Exercise of PIPE warrants |
$ 0
|
4,686
|
|
4,686
|
Exercise of PIPE warrants, shares |
142,857
|
|
|
|
Ending balance, value at Sep. 30, 2022 |
$ 1
|
99,328
|
(76,734)
|
22,595
|
Ending balance, shares at Sep. 30, 2022 |
1,177,548
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 1
|
103,396
|
(79,519)
|
23,878
|
Beginning balance, shares at Dec. 31, 2022 |
1,334,950
|
|
|
|
Issuance of shares in reverse stock split (for fractional shares) |
$ 0
|
|
|
|
Issuance of shares in reverse stock split (for fractional shares), shares |
24,090
|
|
|
|
Stock based compensation |
|
817
|
|
817
|
Net income (loss) |
|
|
(23,657)
|
(23,657)
|
Issuance of shares for vested restricted stock units |
$ 0
|
|
|
|
Issuance of shares for vested restricted stock units, shares |
8,588
|
|
|
|
Ending balance, value at Sep. 30, 2023 |
$ 1
|
104,213
|
(103,176)
|
1,038
|
Ending balance, shares at Sep. 30, 2023 |
1,367,628
|
|
|
|
Beginning balance, value at Jun. 30, 2023 |
$ 1
|
104,006
|
(96,834)
|
7,173
|
Beginning balance, shares at Jun. 30, 2023 |
1,343,538
|
|
|
|
Issuance of shares in reverse stock split (for fractional shares) |
$ 0
|
|
|
|
Issuance of shares in reverse stock split (for fractional shares), shares |
24,090
|
|
|
|
Stock based compensation |
|
207
|
|
207
|
Net income (loss) |
|
|
(6,342)
|
(6,342)
|
Ending balance, value at Sep. 30, 2023 |
$ 1
|
$ 104,213
|
$ (103,176)
|
$ 1,038
|
Ending balance, shares at Sep. 30, 2023 |
1,367,628
|
|
|
|
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v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities: |
|
|
Net income (loss) |
$ (23,657)
|
$ 2,145
|
Adjustments to reconcile net income (loss) to cash flows used in operations: |
|
|
Depreciation |
65
|
80
|
Amortization of right-of-use assets |
390
|
|
Amortization of acquired intangible assets |
314
|
314
|
Realized/Unrealized losses in investment, related party |
6,635
|
|
Change in fair value of contingent consideration |
100
|
(4,100)
|
Change in fair value of warrant liabilities |
(2,001)
|
(17,896)
|
Warrant inducement expense |
|
2,629
|
Stock-based compensation |
817
|
1,469
|
Provision for inventory obsolescence |
|
100
|
Provision for doubtful accounts |
158
|
111
|
Non-cash interest expense |
296
|
268
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(204)
|
2,111
|
Other receivables, related party |
3,652
|
5,145
|
Prepaid expenses and other assets |
347
|
4,121
|
Inventories |
(8,900)
|
(7,728)
|
Accounts payable and related party payables |
6,137
|
3,519
|
Operating lease liabilities |
(375)
|
|
Accrued expenses and other liabilities |
197
|
(216)
|
Cash flows used in operating activities |
(16,029)
|
(7,928)
|
Cash flows from investing activities |
|
|
Disbursement for loan receivable |
|
(3,033)
|
Sales of equity investment, related party |
560
|
|
Purchases of property and equipment |
(14)
|
(37)
|
Cash flows provided by (used) in investing activities |
546
|
(3,070)
|
Cash flows from financing activities |
|
|
Proceeds from line of credit |
13,546
|
|
Proceeds from issuance of common stock and warrants in private placement, net of issuance costs |
|
9,391
|
Proceeds from exercise of warrants |
|
4,630
|
Repayment of line of credit |
(11,849)
|
|
Cash flows provided by financing activities |
1,697
|
14,021
|
Net increase (decrease) in cash and cash equivalents |
(13,786)
|
3,023
|
Cash, cash equivalents and restricted cash, at the beginning of the period |
17,408
|
24,742
|
Cash, cash equivalents and restricted cash, at the end of the period |
3,622
|
27,765
|
Supplemental disclosure of cash flow information |
|
|
Interest paid |
31
|
10
|
Interest paid, related party |
22
|
|
Income taxes paid, net |
21
|
30
|
Supplemental non-cash investing and financing activities |
|
|
Conversion of warrant liability to equity |
|
6,840
|
Addition of right-of-use assets in exchange for operating lease liabilities |
$ 147
|
|
X |
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v3.23.3
Business Overview
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Business Overview |
1.
Business Overview
Biofrontera
Inc. (the “Company” or “Biofrontera”) is a U.S.-based biopharmaceutical company commercializing a portfolio of
pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”) and topical
antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions
as well as impetigo, a bacterial skin infection. In May 2023, the Company began research and development (“R&D”) activities
to support PDT growth and will continue to opportunistically invest in these activities going forward. Our research and development program
currently aims to improve the capabilities of our BF-RhodoLED® lamps to better fulfill the needs of dermatologists and
improve the effectiveness of our commercial team by letting sales representatives carry approved devices with them allowing for easier
product demonstrations and evaluations.
Biofrontera includes its wholly owned subsidiary Bio-FRI GmbH (“Bio-FRI”), a limited liability company organized under the laws
of Germany. Our subsidiary, Bio-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship with the Ameluz
Licensor.
Our
principal licensed product is Ameluz®, which is a prescription drug approved for use in combination with the RhodoLED®
lamp series, for PDT. In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic
keratoses of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in
the U.S. under an exclusive license and supply agreement (“Ameluz LSA”) with Biofrontera Pharma (“Pharma”) GmbH
and Biofrontera Bioscience GmbH (“Bioscience” and together, the “Ameluz Licensor”).
Our
second prescription drug licensed product is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial
growth. It is approved for use in the United States
in adults and children 2 months and older. We are currently selling Xepi® for this indication in the United States under an exclusive
license and supply agreement, as amended (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”) that was assumed
by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc.(“Cutanea”). There has been limited
revenue during the current reporting periods and recent developments with the third-party manufacturer that was providing our supply
of Xepi® have resulted in further delays of our commercialization of the product. However, Ferrer is qualifying a new Contract manufacturer,
Cambrex, which is expected to begin production in 2024.
Reverse
Stock Split
On
June 28, 2023, the Company, filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the
“Amendment”) with the Secretary of State of the State of Delaware to (i) effect a 1-for-20 reverse stock split (the
“Reverse Stock Split”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and (ii) effect a related proportional reduction in the number of the Company’s authorized shares of Common
Stock from 300,000,000 to 15,000,000
(the “Authorized Share Reduction”).
Pursuant
to the Amendment, the Reverse Stock Split and Authorized Share Reduction was effective at 11:59 p.m. on July 3, 2023 (the “Split
Effective Time”), and the Common Stock began trading on the Nasdaq Capital Market on a post-split basis on July 5, 2023. The par
value and other terms of the Common Stock were not affected.
Following
the Split Effective Time, every 20 shares of Biofrontera Common Stock issued and outstanding were automatically combined and
reclassified into one share of Common Stock. Outstanding equity-based awards, warrants and other equity rights were proportionately
adjusted pursuant to their terms and the number of shares authorized and reserved for issuance upon vesting of restricted stock
units or exercise of stock options and warrants were reduced proportionately. No fractional shares were issued as a result of the
Reverse Stock Split. Stockholders who would otherwise hold a fractional share as a result of the Reverse Stock Split received an
additional share of Common Stock.
Under
the terms of the applicable warrant agreement, the number of shares of Common Stock issuable on exercise of each warrant will be proportionately
decreased. Specifically, following effectiveness of the Reverse Stock Split, every 20 shares of Common Stock that may be purchased pursuant
to the exercise of public warrants now represents one share of Common Stock that may be purchased pursuant to such warrants. Accordingly,
for the Company’s warrants trading under the symbol “BFRIW”, every 20 warrants will be exercisable for one share of
Common Stock at an exercise price of $100.00 per share of Common Stock.
The
Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in the
Company’s equity (other than as a result of the rounding up of fractional shares). All information included in these
consolidated financial statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock Split as if it had been
effective from the beginning of the earliest period presented, unless otherwise stated. All outstanding securities entitling their
holders to purchase shares of Common Stock or acquire shares of Common Stock, including stock options, restricted stock units, and
warrants, were adjusted as a result of the Reverse Stock Split.
Liquidity
and Going Concern
The
Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, proceeds
from the sale of our investment, related party, and cash flows from a revolving line of credit. As of September 30, 2023, we had cash
and cash equivalents of $3.4 million and investment, related party of $3.3 million, compared to $17.2 million and $10.5 million as of
December 31, 2022, respectively.
Since
we commenced operations in 2015, we have generated significant losses. For the nine months ended September 30, 2023 and 2022, we incurred
loss from operations of $18.8
million and $13.0
million, respectively. We incurred net cash outflows
from operations of $16.0
million and $7.9
million, for the same periods, respectively.
We had an accumulated deficit as of September 30, 2023 of $103.2
million. Additionally, we expect to continue
to incur operating losses due to significant discretionary sales and marketing, medical affairs, and dermatology community outreach efforts
as we seek to expand the commercialization of our licensed products in the United States.
In
connection with our assessment of going concern considerations under applicable accounting standards, the Company’s management
has determined that substantial doubt exists about our ability to continue as a going concern for at least one year from the date
the unaudited condensed consolidated financial statements were issued.
The
future viability of the Company is dependent on its ability to continue to execute its growth plan and raise additional capital or
find alternative methods of financing to fund its operations during the first half of 2024, and until cash flow from operations is
sufficient, if ever. We have implemented plans to improve our working capital position, particularly around inventory levels, and do
not expect to need a delivery until sometime in Q3 2024, depending on actual sales until then. Management believes that the anticipated implementation of such plans, together with the recent
net capital raise of $4.1
million (See Note 21, Subsequent Events) will provide the opportunity for the Company to continue as a going concern.
However, no assurance can be given that the Company will be successful in these efforts.
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability
and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the
uncertainties described above. There could be a material adverse effect on the Company and its financial statements if management’s plans
are not achieved on a timely basis.
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- DefinitionThe entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure.
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v3.23.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
Basis
for Preparation of the Financial Statements
The
accompanying unaudited interim condensed consolidated financial statements of the Company have been prepared pursuant to the rules
and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Certain information
and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. generally accepted
accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the
Company’s opinion, the unaudited condensed consolidated financial statements include all material adjustments, all of which
are of a normal and recurring nature, necessary to present fairly the Company’s financial position as of September 30, 2023,
the Company’s operating results for the three and nine months ended September 30, 2023 and 2022, and the Company’s cash
flows for the nine months ended September 30, 2023 and 2022. The accompanying financial information as of December 31, 2022 is
derived from audited financial statements. Interim results are not necessarily indicative of results for a full year. The
information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s reaudited
consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 (“reaudited Consolidated Financial
Statements”), and the revised Management’s Discussion and Analysis of Financial Condition and Results of Operations for
the fiscal years ended December 31, 2022 and December 31, 2021 (“revised MD&A”), filed in a Current Report on From
8-K with the SEC on October 3, 2023.
All
amounts shown in these financial statements and tables are in thousands and amounts in the notes are in millions, except percentages
and per share and share amounts.
With the exception of the accounting policies below, there have been no new or material changes to the significant
accounting policies discussed in the Company’s reaudited Consolidated Financial Statements.:
Reverse
Stock Split
All
information included in these consolidated financial statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock
Split as if it had been effective from the beginning of the earliest period presented, unless otherwise stated. All outstanding securities
entitling their holders to purchase shares of Common Stock or acquire shares of Common Stock, including stock options, restricted stock
units, and warrants, were adjusted as a result of the Reverse Stock Split, as required by the terms of those securities.
Research
and Development Costs
Research
and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct
research and development activities, and other operational costs related to the Company’s research and development activities.
Use
of Estimates
The
preparation of the financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions by management that
affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities, as reported on the
balance sheet date, and the reported amounts of revenues and expenses arising during the reporting period. The main areas in which assumptions,
estimates and the exercising of judgment are appropriate relate to, valuation allowances for receivables and inventory, valuation of
contingent consideration and warrant liabilities, realization of intangible and other long-lived assets, product sales allowances and
reserves, share-based payments and income taxes including deferred tax assets and liabilities. Estimates are based on historical experience
and other assumptions that are considered appropriate in the circumstances. They are continuously reviewed but may vary from the actual
values.
Recently
Adopted Accounting Pronouncements
In
September 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables,
as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard was effective
for us on January 1, 2023, and did not have a material effect on our consolidated financial statements.
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v3.23.3
Acquisition Contract Liabilities
|
9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
|
Acquisition Contract Liabilities |
3.
Acquisition Contract Liabilities
On
March 25, 2019, we entered into an agreement (as amended, the “Share Purchase Agreement”) with Maruho Co, Ltd. (“Maruho”)
to acquire 100% of the shares of Cutanea Life Sciences, Inc. (“Cutanea”). As of the date of the acquisition, Maruho owned approximately 29.9% of Biofrontera AG through its fully owned subsidiary Maruho Deutschland GmbH. Biofrontera AG is our former
parent, and currently a significant shareholder.
Pursuant
to the Share Purchase Agreement, Maruho provided $7.3
million in start-up cost financing for Cutanea’s redesigned business activities (“start-up costs”). These start-up
costs are to be paid back to Maruho by the end of 2023 in accordance with contractual obligations related to an earn-out
arrangement. In addition, as part of the earn-out arrangement with Maruho, the product profit amount from the sale of Cutanea
products as defined in the Share Purchase Agreement will be shared equally between Maruho and Biofrontera until 2030
(“contingent consideration”).
The
contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of
approximately 6.0% over the applicable term. The contingent consideration is recorded within acquisition contract liabilities, net. The
amount of contingent consideration that could be payable is not subject to a cap under the agreement. The Company re-measures contingent consideration and re-assesses the underlying
assumptions and estimates at each reporting period utilizing a scenario-based method. The contingent consideration liability was valued at $2.5 million with payments coming due May of 2028 through May 2031.
Acquisition
contract liabilities, net consist of the following:
Schedule of Acquisition Contract Liabilities
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Short-term acquisition contract liabilities: | |
| | | |
| | |
| |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (89 | ) | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 7,211 | | |
$ | 6,942 | |
| |
| | | |
| | |
Long-term acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
| |
| | | |
| | |
Total acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (89 | ) | |
| (358 | ) |
Total acquisition contract liabilities, net | |
$ | 9,711 | | |
$ | 9,342 | |
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v3.23.3
Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
4.
Fair Value Measurements
The
following table presents information about the Company’s assets that are measured at fair value on a recurring basis at September
30, 2023 and December 31, 2022 and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such
fair value:
Schedule of Fair Value Hierarchy Valuation Inputs
(in thousands) | |
Level | | |
September 30, 2023 | | |
December 31, 2022 | |
Assets: | |
| | | |
| | | |
| | |
Investment, related party | |
| 1 | | |
$ | 3,341 | | |
$ | 10,548 | |
Liabilities: | |
| | | |
| | | |
| | |
Contingent Consideration | |
| 3 | | |
$ | 2,500 | | |
$ | 2,400 | |
Warrant liability – 2022 Purchase Warrants | |
| 3 | | |
$ | 366 | | |
$ | 1,129 | |
Warrant liability - 2022 Inducement Warrants | |
| 3 | | |
$ | 476 | | |
$ | 1,714 | |
Warrant liability | |
| 3 | | |
$ | 476 | | |
$ | 1,714 | |
Investment,
related party
As
of September 30, 2023 and December 31, 2022, the Company has an investment in 5,745,678
and 6,446,946,
respectively of common shares of Biofrontera AG, a company traded on the Frankfurt Stock Exchange and a
significant shareholder of Biofrontera. The fair value of this investment was determined with Level 1 inputs through references to
quoted market prices. See Note 6. Investment Related Party and Note 13. Related Party Transactions.
Contingent
Consideration
Contingent
consideration, which relates to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, is reflected
at fair value within acquisition contract liabilities, net on the consolidated balance sheets. The fair value is based on significant
inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The valuation of the contingent
consideration utilizes a scenario-based method under which a set of payoffs are calculated using the term of the earnout, projections,
and an appropriate metric risk premium. These payoffs are then discounted back from the payment date to the valuation date using a payment
discount rate. The scenario-based
method incorporates the following key assumptions: (i) the forecasted product profit amounts, (ii) the remaining contractual term, (iii)
a metric risk premium, and (iv) a payment discount rate. The Company re-measures contingent consideration and re-assesses the underlying
assumptions and estimates at each reporting period.
The
following table provides a roll forward of the fair value of the contingent consideration:
Schedule of Fair Value of Contingent Consideration
(in thousands) | |
| |
Balance at December 31, 2022 | |
$ | 2,400 | |
Change in fair value of contingent consideration | |
| 100 | |
Balance at September 30, 2023 | |
$ | 2,500 | |
| |
| | |
Balance at December 31, 2021 | |
$ | 6,200 | |
Change in fair value of contingent consideration | |
| (4,100 | ) |
Balance at September 30, 2022 | |
$ | 2,100 | |
Warrant
Liabilities
The
warrant liabilities are comprised of (i) currently outstanding warrants to purchase 170,950
shares of Common Stock originally issued in a private placement on May 16, 2022, expiring five and one-half years after the issue
date and with an exercise price of $55.40
per share (the “Purchase Warrants”), and (ii) a warrant to purchase 214,286
shares of Common Stock issued on July 26, 2022, expiring on December 1, 2026 with an exercise price of $33.20
per share (the “Inducement Warrants”) and were accounted for as liabilities in accordance with ASC 815-40 and are
presented within warrant liabilities in the accompanying consolidated balance sheets. The warrant liabilities are measured at fair
value at inception and on a recurring basis, with changes in fair value presented within the consolidated statements of operations.
The
Company utilizes a Black-Scholes option pricing model to estimate the fair value of the Purchase Warrants and Inducement Warrants which
is considered a Level 3 fair value measurement. Certain inputs utilized in our Black-Scholes pricing model may fluctuate in future periods
based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the
calculation of fair value may cause a significant change to the fair value of our warrant liabilities which could also result in material
non-cash gain or loss being reported in our consolidated statements of operations.
The
fair value for the Level 3 warrants at September 30, 2023 was estimated using a Black-Scholes pricing model based on the following assumptions:
Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 8.77 | | |
$ | 8.77 | |
Expiration term (in years) | |
| 4.13 | | |
| 3.17 | |
Volatility | |
| 80.0 | % | |
| 80.0 | % |
Risk-free Rate | |
| 4.63 | % | |
| 4.73 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
The
fair value for the Level 3 warrants at December 31, 2022 was estimated using a Black-Scholes pricing model based on the following assumptions:
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 18.40 | | |
$ | 18.40 | |
Expiration term (in years) | |
| 4.88 | | |
| 3.92 | |
Volatility | |
| 70.0 | % | |
| 75. | % |
Risk-free Rate | |
| 3.96 | % | |
| 4.07 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
The
following table presents the changes in the Level 3 warrant liabilities measured at fair value (in thousands):
Schedule of Changes in Level 3 Warrant Liabilities
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Fair value at beginning of period | |
$ | 2,843 | | |
$ | 12,854 | |
Issuance of new warrants | |
| - | | |
| 13,217 | |
Exercise of warrants | |
| - | | |
| (6,840 | ) |
Change in fair value of warrant liabilities | |
| (2,001 | ) | |
| (15,267 | ) |
Fair value at end of period | |
$ | 842 | | |
$ | 3,964 | |
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v3.23.3
Revenue
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
5.
Revenue
We
generate revenue primarily through the sales of our licensed products Ameluz®, BF-RhodoLED® lamps and Xepi®. Revenue from
the sales of our BF-RhodoLED® lamp and Xepi® are relatively insignificant compared with the revenues generated through our sales
of Ameluz®.
Related
party revenue relates to an agreement with Bioscience for BF-RhodoLED® leasing and installation
service. Refer to Note 13, Related Party Transactions.
An
analysis of the changes in product revenue allowances and reserves is summarized as follows:
Schedule of Revenue Allowance and Accrual Activties
(in thousands): | |
Returns | | |
Co-pay assistance program | | |
Prompt pay discounts | | |
Government and payor rebates | | |
Total | |
Balance at December 31, 2021 | |
$ | 43 | | |
$ | 101 | | |
$ | 48 | | |
$ | 54 | | |
$ | 246 | |
Provision related to current period sales | |
| 8 | | |
| 503 | | |
| 16 | | |
| 164 | | |
| 691 | |
Credit or payments made during the period | |
| (5 | ) | |
| (400 | ) | |
| (23 | ) | |
| (149 | ) | |
| (577 | ) |
Balance at September 30, 2022 | |
$ | 46 | | |
$ | 204 | | |
$ | 41 | | |
$ | 69 | | |
$ | 360 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at December 31, 2022 | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
Beginning Balance | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
Provision related to current period sales | |
| 4 | | |
| 156 | | |
| 3 | | |
| 266 | | |
| 429 | |
Credit or payments made during the period | |
| - | | |
| (145 | ) | |
| (2 | ) | |
| (231 | ) | |
| (378 | ) |
Balance at September 30, 2023 | |
$ | 52 | | |
| 20 | | |
| 6 | | |
| 55 | | |
| 133 | |
Ending Balance | |
$ | 52 | | |
| 20 | | |
| 6 | | |
| 55 | | |
| 133 | |
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v3.23.3
Investment, Related Party
|
9 Months Ended |
Sep. 30, 2023 |
Investments, All Other Investments [Abstract] |
|
Investment, Related Party |
6.
Investment, Related Party
As
of September 30, 2023 and December 31, 2022, our investment in equity securities consisted solely of 5,745,678 and 6,446,946, respectively
of common shares of Biofrontera AG, a significant shareholder. (See Note 13. Related Party Transactions). Of these shares,
3,377,346 are not fully in our control to vote or dispose of as we see fit as they are not held in a brokerage account registered in
our name, however, we are currently engaged with advisors to transfer such shares to our brokerage account. Equity securities gains and
losses include unrealized gains and losses from changes in fair values during the period on equity securities we still own, as well as
gains and losses on securities we sold during the period. As reflected in the consolidated statements of cash flows, we received proceeds
from sales of equity securities of approximately $0.6 million during the nine months ended September 30, 2023.
Unrealized
losses on investment, related party were $1.9 million and $6.2 million, respectively, for the three and nine months ended September 30, 2023. There were
no unrealized gains and losses for the three and nine months ended September 30, 2022.
Schedule of Unrealized Gains and Losses on Investments in Equity Securities
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended September 30, | | |
Nine months ended September 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Net losses recognized during the period on equity securities | |
$ | (2,212 | ) | |
$ | - | | |
$ | (6,635 | ) | |
$ | - | |
Less: Net realized losses on equity securities
sold | |
| 345 | | |
| - | | |
| 420 | | |
| - | |
Unrealized losses recognized during the reporting period on equity securities still held at the reporting date | |
$ | (1,867 | ) | |
$ | - | | |
$ | (6,215 | ) | |
$ | - | |
|
X |
- DefinitionThe entire disclosure for investment.
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v3.23.3
Accounts Receivable, net
|
9 Months Ended |
Sep. 30, 2023 |
Credit Loss [Abstract] |
|
Accounts Receivable, net |
7.
Accounts Receivable, net
Accounts
receivables are mainly attributable to the sale of Ameluz®. It is expected that all trade receivables will be settled
within twelve months of the balance sheet date. Trade accounts receivable are stated at their net realizable value. The allowance for
credit losses reflects our best estimate of expected credit losses of the receivables determined on the basis of historical experience
and current information. In developing the estimate for expected credit losses, trade accounts receivables are segmented into pools of
assets depending primarily on delinquency status, and fixed reserve percentages are established for each pool of trade accounts receivables.
In
determining the reserve percentages for each pool of trade accounts receivables, we considered our historical experience with certain
customers, regulatory and legal environments and other relevant current and future forecasted macroeconomic factors. If we become aware
of any customer-specific factors that impact credit risk, specific allowances for these known troubled accounts are recorded.
The
allowance for credit losses was $0.2 million and $0.1 million as of September 30, 2023 and December 31, 2022, respectively.
|
X |
- DefinitionThe entire disclosure for accounts receivable, contract receivable, receivable held-for-sale, and nontrade receivable.
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v3.23.3
Other Receivables, Related Party
|
9 Months Ended |
Sep. 30, 2023 |
Receivables [Abstract] |
|
Other Receivables, Related Party |
8.
Other Receivables, Related Party
As
of September 30, 2023 the Company has a receivable, related party of $2.7 million primarily due from Biofrontera AG for its 50% share
of the balance of a legal settlement (See Note 18. Commitments and Contingencies – Legal proceedings) for which both parties
are jointly and severally liable. The Company has a contractual right to repayment of its share of the settlement payments, plus interest
and other miscellaneous settlement costs, from Biofrontera AG under the Settlement Allocation Agreement (“Allocation Agreement”)
entered into on December 9, 2021 and as amended on March 31, 2022, which provides that the settlement payments would first be made by
the Company and then reimbursed by Biofrontera AG for its share. The Allocation Agreement, as amended, provides certain remedies to the
Company, if Biofrontera AG fails to make timely reimbursements, which the Company may implement in its sole discretion, including the
ability to charge interest at a rate of 6.0% per annum for each day that any reimbursement is past
due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by the Company (including amounts
owed under the Company’s license and supply agreement for Ameluz®). As
such, no reserve for the receivable was deemed necessary as of September 30, 2023 or December
31, 2022.
|
X |
- DefinitionThe entire disclosure for claims held for amounts due a company, excluding disclosure for allowance for credit losses. Examples include, but are not limited to, trade accounts receivables, notes receivables, loans receivables. Also excludes disclosure for financing receivables.
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v3.23.3
Intangible Asset, Net
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Asset, Net |
9.
Intangible Asset, Net
Intangible
asset, net consists of the following:
Schedule of Intangible Asset Net
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Xepi® license | |
$ | 4,600 | | |
$ | 4,600 | |
Less: Accumulated amortization | |
| (1,882 | ) | |
| (1,568 | ) |
Intangible asset, net | |
$ | 2,718 | | |
$ | 3,032 | |
The
Xepi® license intangible asset was recorded at acquisition-date fair value of $4.6 million and is amortized on a straight-line basis
over the useful life of 11 years. Amortization expense for the three months ended September 30, 2023 and 2022 was $0.1 million and $0.3
million for the nine months ended September 30, 2023 and 2022.
We
review the Xepi® license intangible asset for impairment whenever events or changes in circumstances indicate that the
carrying amount of the assets may not be fully recoverable. There has been limited revenue during the current reporting periods and recent developments with the third-party
manufacturer that was providing our supply of Xepi® have resulted in further constraints on the commercialization of the product.
However, Ferrer is qualifying a new Contract manufacturer, Cambrex, which is expected to begin production in 2024.
The
Company performed an impairment analysis because of this situation and determined no impairment charges were deemed necessary during
the three and nine months ended September 30, 2023.
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v3.23.3
Cash Balances and Statement of Cash Flows Reconciliation
|
9 Months Ended |
Sep. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Cash Balances and Statement of Cash Flows Reconciliation |
10.
Cash Balances and Statement of Cash Flows Reconciliation
The
Company maintains its cash balances at financial institutions that are insured by the Federal Deposit Insurance Corporation (“FDIC”).
The FDIC provides coverage of up to $250,000 per depositor, per financial institution. At September 30, 2023, approximately $3.0 million
of the Company’s cash balances were in excess of FDIC limits. The Company has not experienced any losses on these accounts and
management does not believe that the Company is exposed to any significant risks.
Restricted
cash consists primarily of deposits of cash collateral held in accordance with the terms of our corporate credit cards. Long-term restricted cash was recorded in other assets in the consolidated
balance sheet.
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the consolidated
statements of cash flows:
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Cash and cash equivalents | |
$ | 3,422 | | |
$ | 17,208 | |
Long-term restricted cash | |
| 200 | | |
| 200 | |
Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows | |
$ | 3,622 | | |
$ | 17,408 | |
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v3.23.3
Accrued Expenses and Other Current Liabilities
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
11.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consist of the following:
Schedule of Accrued Expenses and Other Current Liabilities
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Legal settlement (See note 18) | |
$ | 6,028 | | |
$ | 6,207 | |
Employee compensation and benefits | |
| 2,948 | | |
| 2,850 | |
Professional fees | |
| 1,253 | | |
| 1,353 | |
Product revenue allowances and reserves | |
| 134 | | |
| 82 | |
Other | |
| 676 | | |
| 372 | |
Total | |
$ | 11,039 | | |
$ | 10,864 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.23.3
Line of Credit
|
9 Months Ended |
Sep. 30, 2023 |
Debt Disclosure [Abstract] |
|
Line of Credit |
12.
Line of Credit
On
May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC,
providing us with a revolving line of credit in the aggregate principal amount of up to $6.5 million, subject to a borrowing base and
an availability block, with a maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets
of the Company, subject to customary exceptions.
Advances
under the Loan Agreement bear interest at the 30-Day Adjusted Term Secured Overnight Financing Rate (“SOFR Rate”), set monthly
on the first day of the month based on 30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25%,
plus 4.00% calculated and charged monthly in arrears. In the event of a called event of default, a default interest rate of 3.00% percent
shall be added to the aforementioned rate. Under the terms of the Loan Agreement, amounts available for advances would be subject to
a borrowing base, which is a formula based on certain eligible receivables and inventory, and a block on such availability in the amount
of $650,000. Currently, our borrowing capacity is based on our eligible receivables with an additional $1.0 million borrowing capacity
based on inventory. The borrowing base is up to 85% of accounts receivable, plus the least of (a) $1.0 million for inventory
and (b) 85% of accounts receivable, less borrowing base reserve, if any, as defined in the Loan Agreement. The Loan Agreement also includes
an Unused Line Fee Rate of 0.375% of the Credit Limit less all outstanding advances, which shall be paid on a monthly basis.
The
interest rate as of September 30, 2023 was 5.48% and interest expense for the nine months ended September 30, 2023 was negligible. The
Company recorded approximately $0.2 million of costs related to the line of credit as an asset to be amortized on a straight-line basis
over the term of the line of credit. The Company recognized minimal amortization expense in connection with this Line of Credit for the
nine months ended September 30, 2023, which is recorded as interest expense on the accompanying consolidated statement of operations.
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v3.23.3
Related Party Transactions
|
9 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
13.
Related Party Transactions
License
and Supply Agreement
On
October 8, 2021, we entered into an amendment to the Ameluz LSA under which the price we pay per unit will be based upon our sales
history. Under the agreement, the Company obtained an exclusive, non-transferable license to use Pharma’s technology to market
and sell the licensed products, Ameluz® and BF-RhodoLED® and must purchase the licensed products exclusively from Pharma. As
a result of this amendment, the purchase price we pay the Ameluz Licensor for Ameluz® will be determined in the
following manner:
● |
fifty
percent of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from
the Ameluz Licensor during a given Commercial Year (as defined in the Ameluz LSA); |
|
|
● |
forty
percent of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the
products we license from the Ameluz Licensor; and |
|
|
● |
thirty
percent of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license
from the Ameluz Licensor. |
Purchases
of the licensed products during the three and nine months ended September 30, 2023 were $5.1 million and $18.8 million, respectively,
and $5.2 million and $16.6 million, respectively for the three and nine months ended September 30, 2022. Amounts due and payable to Pharma as of September 30, 2023 and December 31, 2022 were $7.0 million and $1.3 million, respectively,
which were recorded in accounts payable, related parties in the consolidated balance sheets.
Service
Agreements
In
December 2021, we entered into an Amended and Restated Master Contract Services Agreement, or “Services Agreement”, which
provides for the execution of statements of work that will replace the applicable provisions of our previous intercompany services agreement
dated January 1, 2016, or 2016 Services Agreement, by and among us, Biofrontera AG, Biofrontera Pharma and Biofrontera Bioscience, enabling
us to continue to use the IT resources of Biofrontera AG and its wholly owned subsidiaries (the “Biofrontera Group”) as well
as providing access to the Biofrontera Group’s resources with respect to quality management, regulatory affairs and medical affairs.
We currently have statements of work in place regarding IT, regulatory affairs, medical affairs, and pharmacovigilance, and are continuously
assessing the other services historically provided to us by Biofrontera AG to determine 1) if they will be needed, and 2) whether they
can or should be obtained from other third-party providers. As of September 30, 2023, we have migrated away from Biofrontera AG to third
party providers for most of our significant IT services. Expenses related to the service agreement were $0.1 million and $0.2 million
for the three and nine months ended September 30, 2023 and $0.2 million and $0.6 million for the three and nine months ended September
30, 2022, respectively. These expenses were recorded in selling, general and administrative, related party. Amounts due to Biofrontera
AG related to the service agreement as of September 30, 2023 and December 31, 2022 were $0.2 million and $0.2 million, respectively,
which were offset against other receivables, related party in the consolidated balance sheet.
Clinical
Lamp Lease Agreement
On
August 1, 2018, the Company executed a clinical lamp lease agreement with Bioscience to provide
lamps and associated services.
Total
revenue related to the clinical lamp lease agreement was minimal and $0.1 million for the three and nine months ended September 30, 2023,
respectively and minimal for the three and nine months ended September 30, 2022, and was recorded as revenues, related party. Amounts
due from Bioscience for clinical lamp and other reimbursements were approximately $0.1 million as of September 30, 2023 and December
31, 2022, which were recorded as other receivables, related party in the consolidated balance sheets.
Others
The
Company has recorded a receivable of $2.8
million and $6.4
million as of September 30, 2023 and December
31, 2022, respectively, due from Biofrontera AG for its 50%
share of the balance of a legal settlement for which both parties are jointly and severally liable. (See Note 8. Other Receivables,
Related Party). There was no
interest income recognized for the nine months
ended September 30, 2023 and $0.1
million of interest income for the nine months
ended September 30, 2022, in connection with this receivable.
As
of September 30, 2023, our investment, related party is valued at $3.3 million and consists of 5,745,678
common shares of Biofrontera AG, a significant shareholder of the Company. See Note 6. Investment, Related Party.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.3
Stockholders’ Equity
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
14.
Stockholders’ Equity
Under
the Company’s Certificate of Amendment to the Amended and Restated Certificate of incorporation, effective July 3, 2023, the Company
is authorized to issue 15,000,000 shares
of Common Stock and 20,000,000 shares
of preferred stock, par value $.001
per share. See Note 1. Reverse Stock Split for information
and disclosures relating to adjustments for the 1-for-20
Reverse Stock Split.
The
holders of Common Stock are entitled to one vote for each share held. Common Stockholders are not entitled to receive dividends,
unless declared by the Board of Directors. The Company has not declared dividends since inception. In the event of liquidation of
the Company, dissolution or winding up, the holders of Common Stock are entitled to share ratably in all assets remaining after
payment of liabilities. The Common Stock has no preemptive or conversion rights or other subscription rights. There are no
redemption or sinking fund provisions applicable to the Common Stock. The outstanding shares of Common Stock are fully paid and
non-assessable.
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v3.23.3
Equity Incentive Plans and Share-Based Payments
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Equity Incentive Plans and Share-Based Payments |
15.
Equity Incentive Plans and Share-Based Payments
2021
Omnibus Incentive Plan
In
2021, our Board of Directors adopted and our shareholders approved, the 2021 Omnibus Incentive Plan (“2021 Plan). Under the original
2021 Plan, 137,500 shares are reserved and authorized for awards and the maximum contractual term is 10 years for stock options issued
under the 2021 Plan. On December 12, 2022, the 2021 Plan was amended by our stockholders and the number of shares authorized for awards
under the 2021 Plan was increased by 129,490 to 266,990. As of September 30, 2023, there were 163,362 shares available for future awards
under the amended 2021 Plan.
Non-qualified
stock options
We
maintain the 2021 Plan for the benefit of our officers, directors and employees. Employee stock options granted under the 2021 Plan generally
vest in equal annual installments over three years and are exercisable for a period of up to ten years from the grant date. Non-employee
director options vest in equal monthly installments following the date of grant and will be fully vested on the one-year anniversary
of the date of grant. All stock options are exercisable at a price as set by the Company at the time of the grant but shall not be less
than the market value of the common shares underlying the option on the grant date.
The
Company recognizes the grant-date fair value of share-based awards granted as compensation expense on a straight-line basis over the
requisite service period. The fair value of stock options is estimated at the time of grant using the Black-Scholes (“BSM”)
option pricing model, which requires the use of inputs and assumptions such as the fair value of the underlying stock, exercise price
of the option, expected term, risk-free interest rate, expected volatility and dividend yield. The Company elects to account for forfeitures
as they occur.
The
fair value of each option was estimated on the date of the grant using the BSM option pricing model with the following assumptions:
Schedule of Stock Options Assumptions
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Expected volatility | |
| 70% - 95 | % | |
| 55% - 70 | % |
Expected term (in years) | |
| 6.0 | | |
| 5.24 -6.0 | |
Risk-free interest rate | |
| 3.5% - 3.9 | % | |
| 1.34% - 4.10 | % |
Expected dividend yield | |
| 0.0 | % | |
| 0.0 | % |
Share-based
compensation expense of approximately $0.1 million and $0.5 million was recorded in selling, general and administrative expenses on the
accompanying consolidated statement of operations for the three and nine months ended September 30, 2023, respectively and $0.3 million
and $0.6 million for the three and nine months ended September 30, 2022.
Options
outstanding and exercisable under the employee share option plan as of September 30, 2023 and a summary of option activity during the
nine months then ended is presented below.
Schedule of Stock Option Activity
| |
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | | |
Aggregate Intrinsic Value (1) | |
Outstanding at December 31, 2022 | |
| 86,951 | | |
$ | 62.16 | | |
| | | |
| | |
Granted | |
| 22,477 | | |
$ | 13.98 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (31,480 | ) | |
$ | 53.58 | | |
| | | |
| | |
Outstanding at September 30, 2023 | |
| 77,948 | | |
$ | 51.74 | | |
| 8.45 | | |
$ | 0 | |
Exercisable at September 30, 2023 | |
| 24,210 | | |
$ | 62.23 | | |
| 7.75 | | |
$ | 0 | |
(1) |
The
aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value
of the Common Stock for the options that were in the money at September 30, 2023. |
As
of September 30, 2023, there was $1.0 million of unrecognized compensation cost related to unvested stock options, which is expected
to be recognized over a weighted-average period of approximately 1.8 years.
Share-Based
Compensation (RSUs)
Restricted
Stock Units (“RSUs”) will vest annually over two years, subject to the recipient’s continued service with the Company
through the applicable vesting dates. The fair value of each RSU is estimated based on the closing market price of the Company’s
Common Stock on the grant date.
Share-based
compensation expense of $0.1 million and $0.3 million for the RSUs for the three and nine months ended September 30, 2023, respectively,
and $0.1 million and $0.9 million for the three and nine months ended September 30, 2022 and was recorded in selling, general and administrative
expenses in the accompanying consolidated statements of operations.
Schedule of Restricted Stock Units
| |
Shares | | |
Weighted Average Remaining Contractual Term | | |
| |
Weighted Average Grant Date Fair Value | |
Outstanding at December 31, 2022 | |
| 17,176 | | |
| | | |
| |
$ | 52.20 | |
Awarded | |
| - | | |
| | | |
| |
$ | - | |
Vested | |
| (8,588 | ) | |
| | | |
| |
$ | 52.20 | |
Canceled or forfeited | |
| (3,817 | ) | |
| 0.63 | | |
| |
$ | - | |
Outstanding at September 30, 2023 | |
| 4,771 | | |
| 0.63 | | |
| |
$ | 52.20 | |
As
of September 30, 2023, there was $0.2 million of unrecognized compensation cost related to unvested RSUs, which is expected to be recognized
over a weighted-average period of approximately 0.6 years.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Interest Expense, net
|
9 Months Ended |
Sep. 30, 2023 |
Interest Expense, net |
16.
Interest Expense, net
Interest
expense, net consists of the following:
Schedule of Interest Expense
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For three months ended September 30, | | |
For nine months ended September 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Interest expense | |
$ | (43 | ) | |
$ | (3 | ) | |
$ | (77 | ) | |
$ | (10 | ) |
Interest expense, related party | |
$ | (22 | ) | |
$ | - | | |
$ | (22 | ) | |
$ | - | |
Contract asset interest expense | |
| (90 | ) | |
| (89 | ) | |
| (268 | ) | |
| (268 | ) |
Interest income – related party | |
| - | | |
| 1 | | |
| - | | |
| 110 | |
Interest income – other | |
| 13 | | |
| 2 | | |
| 111 | | |
| 8 | |
Interest expense, net | |
$ | (142 | ) | |
$ | (89 | ) | |
$ | (256 | ) | |
$ | (160 | ) |
Interest
expense is comprised primarily of interest on our Loan and Security Agreement with MidCap Business Credit LLC.
Contract
asset interest expense relates to the $1.7
million contract asset in connection with the $7.3
million start-up cost financing received from Maruho under the Cutanea acquisition Share Purchase Agreement. The contract asset is
amortized on a straight-line basis using a 6%
interest rate over the financing arrangement contract term, which ends on December
31, 2023.
Interest
income - related party interest income relates to default interest on the recorded receivable of $6.1 million as of September 30, 2022
from Biofrontera AG for its 50% share of the balance of a legal settlement.
|
X |
- DefinitionThe entire disclosure for interest income and interest expense for enterprises that derive a significant portion of their revenue from interest collected on investments, loans, and securities.
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v3.23.3
Net Earnings (Loss) per Share
|
9 Months Ended |
Sep. 30, 2023 |
Income (loss) per common share: |
|
Net Earnings (Loss) per Share |
17.
Net Earnings (Loss) per Share
Basic
net earnings (loss) per common share are calculated by dividing net income by the weighted average number of common shares
outstanding during the period. Diluted net earnings per common share are calculated by dividing net income (loss) by the diluted
weighted average number of common shares outstanding during the period. The diluted shares include the dilutive effect of
stock-based awards based on the treasury stock method. In periods where a net loss is recorded, no effect is given to potentially
dilutive securities, since the effect would be anti-dilutive.
The
following table sets forth the computation of the Company’s basic and diluted net earnings (loss) per share attributable to common stockholders
(in thousands, except share and per share data):
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net income (loss) | |
$ | (6,342 | ) | |
$ | (2,566 | ) | |
$ | (23,657 | ) | |
$ | 2,145 | |
| |
| | | |
| | | |
| | | |
| | |
Shares: | |
| | | |
| | | |
| | | |
| | |
Basic weighted average common shares outstanding | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 978,018 | |
Add: Effect of dilutive securities | |
| | | |
| | | |
| | | |
| | |
Stock options and restricted stock units | |
| - | | |
| - | | |
| - | | |
| 2,233 | |
Diluted weighted average common shares outstanding | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 980,251 | |
| |
| | | |
| | | |
| | | |
| | |
Net earnings (loss) per share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
Diluted | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
The
following table sets forth the securities that were anti-dilutive for diluted EPS for the periods presented but which
could potentially dilute EPS in the future:
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share
Nine Months Ended September 30, | |
2023 | | |
2022 | |
Common stock warrants | |
| 459,856 | | |
| 459,856 | |
Common stock options and RSUs | |
| 82,719 | | |
| 55,620 | |
Unit Purchase Options | |
| 20,182 | | |
| 20,182 | |
Anti-dilutive securities excluded from computation of earnings per share | |
| 20,182 | | |
| 20,182 | |
Common
Stock warrants include Purchase Warrants, Inducement Warrants and warrants issued in the Initial Public Offering.
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
18.
Commitments and Contingencies
Leases
The
Company leases its corporate headquarters under an operating lease that expires in August 2025. The Company has the option to extend
the term of the lease for one five (5) year period upon written notice to the landlord. The extension period has not been included in
the determination of the ROU asset or the lease liability as the Company concluded that it is not reasonably certain that it would exercise
this option. The Company provided the landlord with a security deposit in the amount of $0.1 million, which was recorded as other assets
in the consolidated balance sheets.
The
Company has also entered into a master lease agreement for its vehicles. After an initial non-cancelable twelve-month period, each vehicle
is leased on a month-to-month basis. Based on historical retention experience of approximately three years, the vehicles have varying
expiration dates through January 2027.
The
components of lease expense for the three and nine months ended September 30, 2023 were as follows (in thousands except lease term and
discount rate):
Schedule of Components of Lease Expense and Other Information
Lease expense | |
Operating Leases | |
Amortization of ROU assets (operating lease cost) | |
$ | 390 | |
Interest on lease liabilities | |
| 54 | |
Total lease expense | |
$ | 444 | |
Other Information | |
| |
Operational cash flow used for operating leases | |
$ | 428 | |
Weighted -average remaining lease term (in years) | |
| 2.01 | |
Weighted -average discount rate | |
| 6.75 | % |
Future
lease payments under non-cancelable leases as of September 30, 2023 were as follows (in thousands):
Schedule of Future Commitments and Sublease Income
Years ending December 31, | |
Future lease commitments | |
2023 | |
$ | 171 | |
2024 | |
| 584 | |
2025 | |
| 393 | |
2026 | |
| 44 | |
2027 | |
| 1 | |
Total future minimum lease payments | |
| 1,193 | |
Less imputed interest | |
| (76 | ) |
Total lease liability | |
$ | 1,117 | |
Schedule of Operating Lease Liability
Reported as: | |
| |
Operating lease liability, current | |
$ | 555 | |
Operating lease liability, non-current | |
| 562 | |
Total | |
$ | 1,117 | |
Cutanea
payments
We
have a contract in which we agreed to repay to Maruho $3.6 million on December 31, 2022 and $3.7 million on December 31, 2023 in start-up
cost financing paid to us in connection with the Cutanea acquisition.
We
have filed for arbitration against Maruho with the International Chamber of Commerce regarding issues with Maruho’s
contract manufacturer that were not disclosed at the time of the Share Purchase Agreement and therefore are withholding the repayment
of the start-up cost financing until a decision is reached through the arbitration process. The arbitration notes that Maruho breached
the agreement with Cutanea due to undisclosed manufacturing issues and seeks damages as well as a declaration that we are not obligated
to repay Maruho. As such, the required contractual payments noted above have not been made as of the financial statement filing date.
We
are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Refer to Note 3, Acquisition
Contract Liabilities.
Milestone
payments with Ferrer Internacional S.A.
Under
the Xepi LSA, we are obligated to make payments to Ferrer upon the occurrence of certain milestones. Specifically, we must pay Ferrer
i) $2,000,000 upon the first occasion when annual net sales of Xepi® under the Xepi LSA exceed $25,000,000, and ii) $4,000,000
upon the first occasion annual net sales of Xepi® under the Xepi LSA exceed $50,000,000. No Xepi® milestones
have been achieved as of the financial statement filing date.
Licensing
Agreement with Optical Tools
On
December 2, 2022, the Company entered into the technology transfer agreement with Optical Tools LLC (“Optical Tools”), and
Stephen Tobin and Paul Sowyrda (the “Agreement”). The Agreement allowed for the transfer of the assigned patents and trademarks,
and upon notification by the Company to Optical Tools, the research and development of certain prototypes. The Company paid a licensing
fee of $0.2 million which was expensed during the year ended December 31, 2022.
On
May 28, 2023, the Company authorized Optical Tools to design, develop, manufacture, and deliver at least two portable photodynamic therapy
lamp prototypes (“PDT Device”) using the technology in the assigned patents. The PDT Device provides illumination, based
on different light profiles, to the external skin surface of the human body. The Company shall reimburse Optical Tools for all reasonable
out-of-pocket, material and labor costs per the Agreement.
As
part of the Agreement, Optical Tools will be eligible to receive regulatory and sales milestone payments totaling up to $1.0 million,
and royalties of up to 3% of net revenue of certain products developed under this Agreement.
The
Company did not make any milestone or royalty payments during the three or nine months ended September 30, 2023.
Legal
proceedings
At
each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably
estimable under the provisions of FASB ASC Topic 450, Contingencies. The Company expenses as incurred the legal costs related
to such legal proceedings.
Settlement
Agreement with DUSA Pharmaceuticals Inc.
On
November 29, 2021, the Company entered into a settlement and release agreement with respect to a lawsuit filed March 23, 2018 in the
United States District Court for the District of Massachusetts in which we were alleged to have infringed on certain patents and misappropriated
certain trade secrets. In the settlement, the Company and Biofrontera AG together agreed to make an aggregate payment of $22.5 million
and engage a forensic expert to destroy data at issue in the litigation to settle the claims in the litigation.
While
Biofrontera AG has agreed to pay fifty percent of the settlement costs, we remain jointly and severally liable to DUSA Pharmaceuticals
Inc. (“DUSA”) for the full cash settlement amount, meaning that in the event Biofrontera AG does not pay all or a portion
of the amount it owes under the settlement agreement, DUSA could compel us to pay Biofrontera AG’s share. As of September 30, 2023, we have reflected a legal settlement liability in the amount
of $6.0 million for the remaining payments due under the settlement, including the estimated remaining cost of the forensic expert and
a related receivable from related party of $2.8 million for the remaining legal settlement costs to be reimbursed in accordance with
the Settlement Allocation Agreement, which provided that the settlement payments, including the cost of the forensic expert, would first
be made by the Company and then reimbursed by Biofrontera AG for its share. Pursuant to the Settlement Agreement, if DUSA believes Biofrontera
has violated any terms of the settlement and release agreement, the parties must engage in certain alternative dispute resolution activities,
including a meeting between company representatives and non-binding mediation before a court action can be initiated.
Settlement
Agreement with Biofrontera AG
Pursuant
to the terms of that certain Settlement Agreement, dated as of April 11, 2023, among the Company, Biofrontera AG and certain current
and former directors of the Company (the “Settlement Agreement”), the Company has taken or committed, among other
things, to take the following actions:
|
● |
On
July 7, 2023, in connection with the Biofrontera AG settlement agreement, the board of directors of the Company appointed Heikki
Lanckriet to the Board. Mr. Lanckriet will serve as a Class I Director to hold office for a term expiring at the annual meeting of
the Company’s stockholders for fiscal year 2025. Mr. Lanckriet’s term as director began upon his appointment at the July
7, 2023 meeting. |
|
● |
The Company will begin
a search, pursuant to the conditions set forth in the Settlement Agreement including a strike right granted to the aforementioned
director nominated by Biofrontera AG, for an additional director candidate, who is fully independent from Biofrontera AG, Deutsche
Balaton Aktiengesellschaft (“DB”) and any of their respective affiliates, to be nominated for election as a Class II
Director at the Company’s 2024 annual meeting of stockholders. |
|
● |
The
Board will increase its size to seven members, including the two directors appointed and elected pursuant to the Settlement Agreement
as noted above. |
In
addition, the Settlement Agreement contains provisions to maintain Biofrontera AG’s representation on the Board of Directors as
long as it holds at least 20% of the Company’s outstanding common stock and to limit further increases in the size of the Board
of Directors or changes to the Company’s stockholder rights plan. Under the Settlement Agreement, Biofrontera AG also agrees, subject
to certain conditions, to vote in support of the directors nominated by, and the proposals recommended by, the Board of Directors.
Legal
Claim
On
September 13, 2023, Biofrontera was served with a complaint filed in United Stated District Court for the District of Massachusetts
by DUSA Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries LTD (collectively
“DUSA” or “Plaintiffs”) in which DUSA alleges breach of contract, violation of the Lanham Act, and unfair
trade practices. All claims stem from allegations that Biofrontera has promoted its Ameluz product in a manner that is inconsistent
with its approved FDA labeling. Though this complaint was originally filed in the U.S. District Court for the District of
Massachusetts, this matter has been transferred by agreement of the parties to the U.S. District Court for the District of New
Jersey.
The
Company denies the Plaintiffs’ claims and intends to defend these matters vigorously. Based on the Company’s assessment of
the facts underlying the above claims, the uncertainty of litigation and the preliminary stage of the case, the Company cannot estimate
the possibility of a material loss, nor the potential range of loss that may result from this action. If the final resolution of the
matter is adverse to the Company, it could have a material impact on the Company’s financial position, results of operations, or
cash flows.
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.3
Retirement Plan
|
9 Months Ended |
Sep. 30, 2023 |
Retirement Benefits [Abstract] |
|
Retirement Plan |
19.
Retirement Plan
The
Company has a defined-contribution plan under Section 401(k) of Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan
covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual
compensation on a pre-tax basis. The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary.
Matching
contribution costs paid by the Company for the three and nine months ended September 30, 2023 were $0.1 million and $0.2 million,
respectively and $0.1 million
and $0.2 million
for the three and nine months ended September 30, 2022, respectively.
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v3.23.3
Reclassification of Prior Year Presentation
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Reclassification of Prior Year Presentation |
20. Reclassification of Prior Year Presentation
Certain prior year amounts have been reclassified
to their own line items within the Consolidated Statement of Operations and Consolidated Statements of Cash Flow. Specifically, warrant
inducement expense of $2.6 million was reclassed from change in fair value of warrant liabilities for prior year presentation. These reclassifications
had no effect on the reported results of operations.
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- DefinitionThe entire disclosure for classifying current financial statements, which may be different from classifications in the prior year's financial statements. Disclose any material changes in classification including an explanation of the reason for the change and the areas impacted.
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
21.
Subsequent Events
We
have completed an evaluation of subsequent events after the balance sheet date of September 30, 2023 through the date this Quarterly
Report on Form 10-Q was submitted to the SEC.
Capital
Raise
On
October 30, 2023, the Company entered into a securities purchase agreement (“Purchase Agreement”) with an institutional investor
for the purchase and sale, in a registered public offering by the Company (the “Public Offering”) of an aggregate of 1,205,000
shares of the Company’s Common Stock,
or pre-funded warrants to purchase Common Stock in lieu thereof, each of which is coupled with a warrant to purchase one and one-half
shares of Common Stock. Specifically, the
Company agreed to issue and sell to the institutional investor: (i) 150,000 shares of Common Stock at a combined offering price of $3.74, (ii) 1,055,000 pre-funded warrants to purchase up to 1,055,000 shares of Common Stock (the “Pre-Funded Warrants”)
at a combined offering price of $3.7399 and (iii) 1,205,000 warrants to purchase up to 1,807,500 shares of Common
Stock (the “Common Warrants”), resulting in gross proceeds of approximately $4.5 million. The Public Offering closed on November
2, 2023.
The
Common Warrants are exercisable upon issuance, will expire five years following the date of issuance and have an exercise price of $3.55
per share. The Pre-Funded Warrants are exercisable upon issuance, will expire five years following the date of issuance and have an exercise
price of $0.0001 per share.
Warrant
Amendment
As
previously reported in a Current Report on Form 8-K filed with the SEC on May 20, 2022, the Company issued (i) a common stock
purchase warrant, dated May 16, 2022 and exercisable until November 18, 2027, to purchase up to 170,950 shares of Common Stock, at an
exercise price of $55.40 and (ii) a common stock purchase warrant, dated July 26, 2022 and exercisable until December 1, 2026, to purchase
up to 214,286 shares of Common Stock at an exercise price of $33.20 (collectively, the “Existing Warrants”) to an institutional
investor.
On
October 30, 2023, in connection with the Purchase Agreement, the Company entered into an amendment to the Existing Warrants pursuant
to which the Company agreed, effective November 2, 2023, to (i) revise the exercise price of the Existing Warrants to $3.55 and (ii)
extend the date until which the Existing Warrants can be exercised until November 2, 2028. No other terms of the Existing Warrants were
revised or changed.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis for Preparation of the Financial Statements |
Basis
for Preparation of the Financial Statements
The
accompanying unaudited interim condensed consolidated financial statements of the Company have been prepared pursuant to the rules
and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Certain information
and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. generally accepted
accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the
Company’s opinion, the unaudited condensed consolidated financial statements include all material adjustments, all of which
are of a normal and recurring nature, necessary to present fairly the Company’s financial position as of September 30, 2023,
the Company’s operating results for the three and nine months ended September 30, 2023 and 2022, and the Company’s cash
flows for the nine months ended September 30, 2023 and 2022. The accompanying financial information as of December 31, 2022 is
derived from audited financial statements. Interim results are not necessarily indicative of results for a full year. The
information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s reaudited
consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 (“reaudited Consolidated Financial
Statements”), and the revised Management’s Discussion and Analysis of Financial Condition and Results of Operations for
the fiscal years ended December 31, 2022 and December 31, 2021 (“revised MD&A”), filed in a Current Report on From
8-K with the SEC on October 3, 2023.
All
amounts shown in these financial statements and tables are in thousands and amounts in the notes are in millions, except percentages
and per share and share amounts.
With the exception of the accounting policies below, there have been no new or material changes to the significant
accounting policies discussed in the Company’s reaudited Consolidated Financial Statements.:
|
Reverse Stock Split |
Reverse
Stock Split
All
information included in these consolidated financial statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock
Split as if it had been effective from the beginning of the earliest period presented, unless otherwise stated. All outstanding securities
entitling their holders to purchase shares of Common Stock or acquire shares of Common Stock, including stock options, restricted stock
units, and warrants, were adjusted as a result of the Reverse Stock Split, as required by the terms of those securities.
|
Research and Development Costs |
Research
and Development Costs
Research
and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct
research and development activities, and other operational costs related to the Company’s research and development activities.
|
Use of Estimates |
Use
of Estimates
The
preparation of the financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions by management that
affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities, as reported on the
balance sheet date, and the reported amounts of revenues and expenses arising during the reporting period. The main areas in which assumptions,
estimates and the exercising of judgment are appropriate relate to, valuation allowances for receivables and inventory, valuation of
contingent consideration and warrant liabilities, realization of intangible and other long-lived assets, product sales allowances and
reserves, share-based payments and income taxes including deferred tax assets and liabilities. Estimates are based on historical experience
and other assumptions that are considered appropriate in the circumstances. They are continuously reviewed but may vary from the actual
values.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
In
September 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables,
as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard was effective
for us on January 1, 2023, and did not have a material effect on our consolidated financial statements.
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v3.23.3
Acquisition Contract Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
|
Schedule of Acquisition Contract Liabilities |
Acquisition
contract liabilities, net consist of the following:
Schedule of Acquisition Contract Liabilities
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Short-term acquisition contract liabilities: | |
| | | |
| | |
| |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (89 | ) | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 7,211 | | |
$ | 6,942 | |
| |
| | | |
| | |
Long-term acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
| |
| | | |
| | |
Total acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,500 | | |
$ | 2,400 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (89 | ) | |
| (358 | ) |
Total acquisition contract liabilities, net | |
$ | 9,711 | | |
$ | 9,342 | |
|
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v3.23.3
Fair Value Measurements (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value Hierarchy Valuation Inputs |
The
following table presents information about the Company’s assets that are measured at fair value on a recurring basis at September
30, 2023 and December 31, 2022 and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such
fair value:
Schedule of Fair Value Hierarchy Valuation Inputs
(in thousands) | |
Level | | |
September 30, 2023 | | |
December 31, 2022 | |
Assets: | |
| | | |
| | | |
| | |
Investment, related party | |
| 1 | | |
$ | 3,341 | | |
$ | 10,548 | |
Liabilities: | |
| | | |
| | | |
| | |
Contingent Consideration | |
| 3 | | |
$ | 2,500 | | |
$ | 2,400 | |
Warrant liability – 2022 Purchase Warrants | |
| 3 | | |
$ | 366 | | |
$ | 1,129 | |
Warrant liability - 2022 Inducement Warrants | |
| 3 | | |
$ | 476 | | |
$ | 1,714 | |
Warrant liability | |
| 3 | | |
$ | 476 | | |
$ | 1,714 | |
|
Schedule of Fair Value of Contingent Consideration |
The
following table provides a roll forward of the fair value of the contingent consideration:
Schedule of Fair Value of Contingent Consideration
(in thousands) | |
| |
Balance at December 31, 2022 | |
$ | 2,400 | |
Change in fair value of contingent consideration | |
| 100 | |
Balance at September 30, 2023 | |
$ | 2,500 | |
| |
| | |
Balance at December 31, 2021 | |
$ | 6,200 | |
Change in fair value of contingent consideration | |
| (4,100 | ) |
Balance at September 30, 2022 | |
$ | 2,100 | |
|
Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions |
The
fair value for the Level 3 warrants at September 30, 2023 was estimated using a Black-Scholes pricing model based on the following assumptions:
Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 8.77 | | |
$ | 8.77 | |
Expiration term (in years) | |
| 4.13 | | |
| 3.17 | |
Volatility | |
| 80.0 | % | |
| 80.0 | % |
Risk-free Rate | |
| 4.63 | % | |
| 4.73 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
The
fair value for the Level 3 warrants at December 31, 2022 was estimated using a Black-Scholes pricing model based on the following assumptions:
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 18.40 | | |
$ | 18.40 | |
Expiration term (in years) | |
| 4.88 | | |
| 3.92 | |
Volatility | |
| 70.0 | % | |
| 75. | % |
Risk-free Rate | |
| 3.96 | % | |
| 4.07 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
|
Schedule of Changes in Level 3 Warrant Liabilities |
The
following table presents the changes in the Level 3 warrant liabilities measured at fair value (in thousands):
Schedule of Changes in Level 3 Warrant Liabilities
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Fair value at beginning of period | |
$ | 2,843 | | |
$ | 12,854 | |
Issuance of new warrants | |
| - | | |
| 13,217 | |
Exercise of warrants | |
| - | | |
| (6,840 | ) |
Change in fair value of warrant liabilities | |
| (2,001 | ) | |
| (15,267 | ) |
Fair value at end of period | |
$ | 842 | | |
$ | 3,964 | |
|
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v3.23.3
Revenue (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Revenue Allowance and Accrual Activties |
An
analysis of the changes in product revenue allowances and reserves is summarized as follows:
Schedule of Revenue Allowance and Accrual Activties
(in thousands): | |
Returns | | |
Co-pay assistance program | | |
Prompt pay discounts | | |
Government and payor rebates | | |
Total | |
Balance at December 31, 2021 | |
$ | 43 | | |
$ | 101 | | |
$ | 48 | | |
$ | 54 | | |
$ | 246 | |
Provision related to current period sales | |
| 8 | | |
| 503 | | |
| 16 | | |
| 164 | | |
| 691 | |
Credit or payments made during the period | |
| (5 | ) | |
| (400 | ) | |
| (23 | ) | |
| (149 | ) | |
| (577 | ) |
Balance at September 30, 2022 | |
$ | 46 | | |
$ | 204 | | |
$ | 41 | | |
$ | 69 | | |
$ | 360 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at December 31, 2022 | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
Beginning Balance | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
Provision related to current period sales | |
| 4 | | |
| 156 | | |
| 3 | | |
| 266 | | |
| 429 | |
Credit or payments made during the period | |
| - | | |
| (145 | ) | |
| (2 | ) | |
| (231 | ) | |
| (378 | ) |
Balance at September 30, 2023 | |
$ | 52 | | |
| 20 | | |
| 6 | | |
| 55 | | |
| 133 | |
Ending Balance | |
$ | 52 | | |
| 20 | | |
| 6 | | |
| 55 | | |
| 133 | |
|
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v3.23.3
Investment, Related Party (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Investments, All Other Investments [Abstract] |
|
Schedule of Unrealized Gains and Losses on Investments in Equity Securities |
Unrealized
losses on investment, related party were $1.9 million and $6.2 million, respectively, for the three and nine months ended September 30, 2023. There were
no unrealized gains and losses for the three and nine months ended September 30, 2022.
Schedule of Unrealized Gains and Losses on Investments in Equity Securities
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three months ended September 30, | | |
Nine months ended September 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Net losses recognized during the period on equity securities | |
$ | (2,212 | ) | |
$ | - | | |
$ | (6,635 | ) | |
$ | - | |
Less: Net realized losses on equity securities
sold | |
| 345 | | |
| - | | |
| 420 | | |
| - | |
Unrealized losses recognized during the reporting period on equity securities still held at the reporting date | |
$ | (1,867 | ) | |
$ | - | | |
$ | (6,215 | ) | |
$ | - | |
|
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v3.23.3
Intangible Asset, Net (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Intangible Asset Net |
Intangible
asset, net consists of the following:
Schedule of Intangible Asset Net
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Xepi® license | |
$ | 4,600 | | |
$ | 4,600 | |
Less: Accumulated amortization | |
| (1,882 | ) | |
| (1,568 | ) |
Intangible asset, net | |
$ | 2,718 | | |
$ | 3,032 | |
|
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v3.23.3
Cash Balances and Statement of Cash Flows Reconciliation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash |
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the consolidated
statements of cash flows:
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Cash and cash equivalents | |
$ | 3,422 | | |
$ | 17,208 | |
Long-term restricted cash | |
| 200 | | |
| 200 | |
Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows | |
$ | 3,622 | | |
$ | 17,408 | |
|
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v3.23.3
Accrued Expenses and Other Current Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Current Liabilities |
Accrued
expenses and other current liabilities consist of the following:
Schedule of Accrued Expenses and Other Current Liabilities
(in thousands) | |
September 30,
2023 | | |
December 31,
2022 | |
Legal settlement (See note 18) | |
$ | 6,028 | | |
$ | 6,207 | |
Employee compensation and benefits | |
| 2,948 | | |
| 2,850 | |
Professional fees | |
| 1,253 | | |
| 1,353 | |
Product revenue allowances and reserves | |
| 134 | | |
| 82 | |
Other | |
| 676 | | |
| 372 | |
Total | |
$ | 11,039 | | |
$ | 10,864 | |
|
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v3.23.3
Equity Incentive Plans and Share-Based Payments (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Options Assumptions |
The
fair value of each option was estimated on the date of the grant using the BSM option pricing model with the following assumptions:
Schedule of Stock Options Assumptions
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Expected volatility | |
| 70% - 95 | % | |
| 55% - 70 | % |
Expected term (in years) | |
| 6.0 | | |
| 5.24 -6.0 | |
Risk-free interest rate | |
| 3.5% - 3.9 | % | |
| 1.34% - 4.10 | % |
Expected dividend yield | |
| 0.0 | % | |
| 0.0 | % |
|
Schedule of Stock Option Activity |
Options
outstanding and exercisable under the employee share option plan as of September 30, 2023 and a summary of option activity during the
nine months then ended is presented below.
Schedule of Stock Option Activity
| |
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | | |
Aggregate Intrinsic Value (1) | |
Outstanding at December 31, 2022 | |
| 86,951 | | |
$ | 62.16 | | |
| | | |
| | |
Granted | |
| 22,477 | | |
$ | 13.98 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (31,480 | ) | |
$ | 53.58 | | |
| | | |
| | |
Outstanding at September 30, 2023 | |
| 77,948 | | |
$ | 51.74 | | |
| 8.45 | | |
$ | 0 | |
Exercisable at September 30, 2023 | |
| 24,210 | | |
$ | 62.23 | | |
| 7.75 | | |
$ | 0 | |
(1) |
The
aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value
of the Common Stock for the options that were in the money at September 30, 2023. |
|
Schedule of Restricted Stock Units |
Schedule of Restricted Stock Units
| |
Shares | | |
Weighted Average Remaining Contractual Term | | |
| |
Weighted Average Grant Date Fair Value | |
Outstanding at December 31, 2022 | |
| 17,176 | | |
| | | |
| |
$ | 52.20 | |
Awarded | |
| - | | |
| | | |
| |
$ | - | |
Vested | |
| (8,588 | ) | |
| | | |
| |
$ | 52.20 | |
Canceled or forfeited | |
| (3,817 | ) | |
| 0.63 | | |
| |
$ | - | |
Outstanding at September 30, 2023 | |
| 4,771 | | |
| 0.63 | | |
| |
$ | 52.20 | |
|
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v3.23.3
Interest Expense, net (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Schedule of Interest Expense |
Interest
expense, net consists of the following:
Schedule of Interest Expense
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For three months ended September 30, | | |
For nine months ended September 30, | |
(in thousands) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Interest expense | |
$ | (43 | ) | |
$ | (3 | ) | |
$ | (77 | ) | |
$ | (10 | ) |
Interest expense, related party | |
$ | (22 | ) | |
$ | - | | |
$ | (22 | ) | |
$ | - | |
Contract asset interest expense | |
| (90 | ) | |
| (89 | ) | |
| (268 | ) | |
| (268 | ) |
Interest income – related party | |
| - | | |
| 1 | | |
| - | | |
| 110 | |
Interest income – other | |
| 13 | | |
| 2 | | |
| 111 | | |
| 8 | |
Interest expense, net | |
$ | (142 | ) | |
$ | (89 | ) | |
$ | (256 | ) | |
$ | (160 | ) |
|
X |
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v3.23.3
Net Earnings (Loss) per Share (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Income (loss) per common share: |
|
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders |
The
following table sets forth the computation of the Company’s basic and diluted net earnings (loss) per share attributable to common stockholders
(in thousands, except share and per share data):
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net income (loss) | |
$ | (6,342 | ) | |
$ | (2,566 | ) | |
$ | (23,657 | ) | |
$ | 2,145 | |
| |
| | | |
| | | |
| | | |
| | |
Shares: | |
| | | |
| | | |
| | | |
| | |
Basic weighted average common shares outstanding | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 978,018 | |
Add: Effect of dilutive securities | |
| | | |
| | | |
| | | |
| | |
Stock options and restricted stock units | |
| - | | |
| - | | |
| - | | |
| 2,233 | |
Diluted weighted average common shares outstanding | |
| 1,366,842 | | |
| 1,136,291 | | |
| 1,346,264 | | |
| 980,251 | |
| |
| | | |
| | | |
| | | |
| | |
Net earnings (loss) per share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
Diluted | |
$ | (4.64 | ) | |
$ | (2.26 | ) | |
$ | (17.57 | ) | |
$ | 2.19 | |
|
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share |
The
following table sets forth the securities that were anti-dilutive for diluted EPS for the periods presented but which
could potentially dilute EPS in the future:
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share
Nine Months Ended September 30, | |
2023 | | |
2022 | |
Common stock warrants | |
| 459,856 | | |
| 459,856 | |
Common stock options and RSUs | |
| 82,719 | | |
| 55,620 | |
Unit Purchase Options | |
| 20,182 | | |
| 20,182 | |
Anti-dilutive securities excluded from computation of earnings per share | |
| 20,182 | | |
| 20,182 | |
|
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v3.23.3
Commitments and Contingencies (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Components of Lease Expense and Other Information |
The
components of lease expense for the three and nine months ended September 30, 2023 were as follows (in thousands except lease term and
discount rate):
Schedule of Components of Lease Expense and Other Information
Lease expense | |
Operating Leases | |
Amortization of ROU assets (operating lease cost) | |
$ | 390 | |
Interest on lease liabilities | |
| 54 | |
Total lease expense | |
$ | 444 | |
Other Information | |
| |
Operational cash flow used for operating leases | |
$ | 428 | |
Weighted -average remaining lease term (in years) | |
| 2.01 | |
Weighted -average discount rate | |
| 6.75 | % |
|
Schedule of Future Commitments and Sublease Income |
Future
lease payments under non-cancelable leases as of September 30, 2023 were as follows (in thousands):
Schedule of Future Commitments and Sublease Income
Years ending December 31, | |
Future lease commitments | |
2023 | |
$ | 171 | |
2024 | |
| 584 | |
2025 | |
| 393 | |
2026 | |
| 44 | |
2027 | |
| 1 | |
Total future minimum lease payments | |
| 1,193 | |
Less imputed interest | |
| (76 | ) |
Total lease liability | |
$ | 1,117 | |
|
Schedule of Operating Lease Liability |
Schedule of Operating Lease Liability
Reported as: | |
| |
Operating lease liability, current | |
$ | 555 | |
Operating lease liability, non-current | |
| 562 | |
Total | |
$ | 1,117 | |
|
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v3.23.3
Business Overview (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
3 Months Ended |
9 Months Ended |
|
|
|
Jul. 03, 2023 |
Jun. 28, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Nov. 28, 2023 |
Jun. 27, 2023 |
Dec. 31, 2022 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
|
|
Reverse stock split |
1-for-20
|
1-for-20
|
|
|
|
|
|
|
|
Common stock par value |
|
|
$ 0.001
|
|
$ 0.001
|
|
$ 0.001
|
|
$ 0.001
|
Common stock shares authorized |
15,000,000
|
15,000,000
|
15,000,000
|
|
15,000,000
|
|
|
300,000,000
|
15,000,000
|
Exercise price per share |
|
$ 100.00
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
$ 3,422
|
|
$ 3,422
|
|
|
|
$ 17,208
|
Operating Income (Loss) |
|
|
4,620
|
$ 3,639
|
18,812
|
$ 12,961
|
|
|
|
Net Cash Provided by (Used in) Operating Activities |
|
|
|
|
16,029
|
$ 7,928
|
|
|
|
Retained Earnings (Accumulated Deficit) |
|
|
103,176
|
|
103,176
|
|
|
|
79,519
|
Net capital |
|
|
4,100
|
|
4,100
|
|
|
|
|
Related Party [Member] |
|
|
|
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
|
|
|
Investments in equity securities |
|
|
$ 3,341
|
|
$ 3,341
|
|
|
|
$ 10,548
|
X |
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v3.23.3
Schedule of Acquisition Contract Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
Contingent consideration |
$ 2,500
|
$ 2,400
|
$ 2,100
|
$ 6,200
|
Start-up cost financing |
7,300
|
7,300
|
|
|
Contract asset |
(89)
|
(358)
|
|
|
Acquisition contract liabilities, net |
7,211
|
6,942
|
|
|
Total acquisition contract liabilities, net |
9,711
|
9,342
|
|
|
Short-Term Debt [Member] |
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
Start-up cost financing |
7,300
|
7,300
|
|
|
Contract asset |
(89)
|
(358)
|
|
|
Acquisition contract liabilities, net |
7,211
|
6,942
|
|
|
Long-Term Debt [Member] |
|
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
|
Contingent consideration |
$ 2,500
|
$ 2,400
|
|
|
X |
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v3.23.3
Acquisition Contract Liabilities (Details Narrative) - USD ($) $ in Thousands |
Mar. 25, 2019 |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Business Acquisition [Line Items] |
|
|
|
|
|
Contingent consideration |
|
$ 2,500
|
$ 2,400
|
$ 2,100
|
$ 6,200
|
Long-Term Debt [Member] |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
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|
2,500
|
$ 2,400
|
|
|
Monte Carlo Simulation Model [Member] | Long-Term Debt [Member] |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
Contingent consideration |
|
$ 2,500
|
|
|
|
Monte Carlo Simulation Model [Member] | Measurement Input, Discount Rate [Member] |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
Derivative liability measuremnet input |
6.0
|
|
|
|
|
Cutanea Life Sciences, Inc. [Member] |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
Equity interest in acquiree, percentage |
100.00%
|
|
|
|
|
Cutanea Life Sciences, Inc. [Member] | Share Purchase Agreement [Member] |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
Start-up cost financing |
$ 7,300
|
|
|
|
|
Biofrontera AG [Member] |
|
|
|
|
|
Business Acquisition [Line Items] |
|
|
|
|
|
Equity interest in acquiree, percentage |
29.90%
|
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v3.23.3
Schedule of Fair Value Hierarchy Valuation Inputs (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Fair Value, Inputs, Level 1 [Member] | Related Party [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Investment, related party |
$ 3,341
|
$ 10,548
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Contingent Consideration |
2,500
|
2,400
|
|
|
Warrant liability – 2022 Purchase Warrants |
842
|
2,843
|
$ 3,964
|
$ 12,854
|
Fair Value, Inputs, Level 3 [Member] | 2022 Common Warrant [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Warrant liability – 2022 Purchase Warrants |
366
|
1,129
|
|
|
Fair Value, Inputs, Level 3 [Member] | 2022 Inducement Warrants [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Warrant liability |
$ 476
|
$ 1,714
|
|
|
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v3.23.3
Schedule of Fair Value of Contingent Consideration (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Fair Value Disclosures [Abstract] |
|
|
|
|
Beginning balance, fair value of contingent consideration |
|
|
$ 2,400
|
$ 6,200
|
Change in fair value of contingent consideration |
$ 200
|
$ (2,200)
|
100
|
(4,100)
|
Ending balance, fair value of contingent consideration |
$ 2,500
|
$ 2,100
|
$ 2,500
|
$ 2,100
|
X |
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v3.23.3
Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions (Details) - Fair Value, Inputs, Level 3 [Member]
|
Sep. 30, 2023
$ / shares
|
Dec. 31, 2022
$ / shares
|
Measurement Input, Share Price [Member] | Purchase Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Stock price |
$ 8.77
|
$ 18.40
|
Measurement Input, Share Price [Member] | Inducement Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Stock price |
$ 8.77
|
$ 18.40
|
Measurement Input, Expected Term [Member] | Purchase Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Expiration term (in years) |
4 years 1 month 17 days
|
4 years 10 months 17 days
|
Measurement Input, Expected Term [Member] | Inducement Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Expiration term (in years) |
3 years 2 months 1 day
|
3 years 11 months 1 day
|
Measurement Input, Option Volatility [Member] | Purchase Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant outstanding, measurement input |
80.0
|
70.0
|
Measurement Input, Option Volatility [Member] | Inducement Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant outstanding, measurement input |
80
|
75
|
Measurement Input, Risk Free Interest Rate [Member] | Purchase Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant outstanding, measurement input |
4.63
|
3.96
|
Measurement Input, Risk Free Interest Rate [Member] | Inducement Warrants [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant outstanding, measurement input |
4.73
|
4.07
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant outstanding, measurement input |
0.0
|
0.0
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
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0.0
|
0.0
|
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v3.23.3
Schedule of Changes in Level 3 Warrant Liabilities (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Change in fair value of warrant liabilities |
$ (598)
|
$ (3,814)
|
$ (2,001)
|
$ (17,896)
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Fair value at beginning of period |
|
|
2,843
|
12,854
|
Issuance of new warrants |
|
|
|
13,217
|
Exercise of warrants |
|
|
|
(6,840)
|
Change in fair value of warrant liabilities |
|
|
(2,001)
|
(15,267)
|
Fair value at end of period |
$ 842
|
$ 3,964
|
$ 842
|
$ 3,964
|
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|
Sep. 30, 2023 |
Dec. 31, 2022 |
Jun. 28, 2023 |
Jul. 26, 2022 |
May 16, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
Investment in equity securities, shares |
5,745,678
|
6,446,946
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
$ 100.00
|
|
|
Fair Value, Inputs, Level 3 [Member] | Purchase Warrants [Member] |
|
|
|
|
|
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|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
|
$ 55.40
|
Fair Value, Inputs, Level 3 [Member] | Inducement Warrants [Member] |
|
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
|
Class of warrant or right, number of securities called by warrants or rights |
|
|
|
214,286
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
$ 33.20
|
|
Fair Value, Inputs, Level 3 [Member] | Private Placement [Member] |
|
|
|
|
|
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|
|
|
|
|
Class of warrant or right, number of securities called by warrants or rights |
|
|
|
|
170,950
|
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v3.23.3
Schedule of Unrealized Gains and Losses on Investments in Equity Securities (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
Net losses recognized during the period on equity securities |
$ (2,212,000)
|
|
$ (6,635,000)
|
|
Less: Net realized losses on equity securities sold |
345,000
|
|
420,000
|
|
Unrealized losses recognized during the reporting period on equity securities still held at the reporting date |
(1,867,000)
|
|
(6,215,000)
|
|
Related Party [Member] |
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
Unrealized gain loss on investments |
$ 1,900,000
|
$ 0
|
$ 6,200,000
|
$ 0
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|
|
9 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Investments, All Other Investments [Abstract] |
|
|
|
|
Investment in equity securities, shares |
5,745,678
|
6,446,946
|
|
|
Investment in equity securities additional information |
|
|
3,377,346
|
|
Proceeds from sale of equity securities |
|
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$ 560
|
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Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Cash and Cash Equivalents [Abstract] |
|
|
Cash and cash equivalents |
$ 3,422
|
$ 17,208
|
Long-term restricted cash |
200
|
200
|
Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows |
$ 3,622
|
$ 17,408
|
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v3.23.3
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Legal settlement (See note 18) |
$ 6,028
|
$ 6,207
|
Employee compensation and benefits |
2,948
|
2,850
|
Professional fees |
1,253
|
1,353
|
Product revenue allowances and reserves |
134
|
82
|
Other |
676
|
372
|
Total |
$ 11,039
|
$ 10,864
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v3.23.3
Line of Credit (Details Narrative) - USD ($)
|
|
9 Months Ended |
May 08, 2023 |
Sep. 30, 2023 |
Line of Credit Facility [Line Items] |
|
|
Debt instrument term amount |
|
$ 650,000
|
Interest rate percentage |
|
5.48%
|
Line of credit value |
|
$ 200,000
|
Loan Agreement [Member] |
|
|
Line of Credit Facility [Line Items] |
|
|
Line of credit maximum borrowing capacity |
|
$ 1,000,000.0
|
Debt instrument term amount |
$ 1,000,000.0
|
|
Revolving Credit Facility [Member] | Loan Agreement [Member] |
|
|
Line of Credit Facility [Line Items] |
|
|
Line of credit maximum borrowing capacity |
$ 6,500,000
|
|
Debt instrument, interest rate terms |
Advances
under the Loan Agreement bear interest at the 30-Day Adjusted Term Secured Overnight Financing Rate (“SOFR Rate”), set monthly
on the first day of the month based on 30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25%,
plus 4.00% calculated and charged monthly in arrears. In the event of a called event of default, a default interest rate of 3.00% percent
shall be added to the aforementioned rate.
|
|
Unused line fee rate |
0.375%
|
|
X |
- DefinitionAmount of the total principal payments made during the annual reporting period.
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v3.23.3
Related Party Transactions (Details Narrative) - USD ($) $ in Thousands |
|
|
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Oct. 08, 2021 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Accounts receivable, related parties |
$ 3,793
|
$ 3,748
|
|
$ 3,793
|
|
$ 3,793
|
|
Legal settlements receivable percentage |
50.00%
|
|
|
50.00%
|
|
50.00%
|
|
Interest Income, Operating |
|
|
|
|
$ 1
|
|
$ 110
|
Number of shares in equity securities investment, shares |
5,745,678
|
6,446,946
|
|
|
|
|
|
Biofrontera Pharma GmbH [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Interest Income, Operating |
|
|
|
|
|
|
100
|
Biofrontera AG [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Loss Contingency, Receivable |
$ 2,800
|
$ 6,400
|
|
$ 2,800
|
|
$ 2,800
|
|
Legal settlements receivable percentage |
50.00%
|
|
|
50.00%
|
|
50.00%
|
|
License and Supply Agreement [Member] | Biofrontera Pharma GmbH [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Related party costs |
|
|
|
$ 5,100
|
5,200
|
$ 18,800
|
16,600
|
Accounts payable related parties |
$ 7,000
|
1,300
|
|
7,000
|
|
7,000
|
|
License and Supply Agreement [Member] | Fifty Percent of Anticipated Net Price [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Revenue from sales |
|
|
$ 30,000
|
|
|
|
|
License and Supply Agreement [Member] | Forty Percent of Anticipated Net Price [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Revenue from sales |
|
|
30,000
|
|
|
|
|
License and Supply Agreement [Member] | Forty Percent of Anticipated Net Price [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Revenue from sales |
|
|
50,000
|
|
|
|
|
License and Supply Agreement [Member] | Thirty Percent of Anticipated Net Price [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Revenue from sales |
|
|
$ 50,000
|
|
|
|
|
Service Agreements [Member] | Biofrontera AG [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Accounts payable related parties |
200
|
200
|
|
200
|
|
200
|
|
Expenses related to service |
|
|
|
100
|
$ 200
|
200
|
$ 600
|
Clinica Lamp Lease Agreement [Member] | Biofrontera Pharma GmbH [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Revenue from sales |
|
|
|
100
|
|
100
|
|
Accounts receivable, related parties |
$ 100
|
$ 100
|
|
$ 100
|
|
100
|
|
Share Purchase and Transfer Agreement [Member] | Maruho Co, Ltd. [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Number of shares in equity securities investment value |
|
|
|
|
|
$ 3,300
|
|
Number of shares in equity securities investment, shares |
|
|
|
|
|
5,745,678
|
|
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v3.23.3
Stockholders’ Equity (Details Narrative) - $ / shares
|
Jul. 03, 2023 |
Jun. 28, 2023 |
Sep. 30, 2023 |
Jun. 27, 2023 |
Dec. 31, 2022 |
Equity [Abstract] |
|
|
|
|
|
Common Stock, Shares Authorized |
15,000,000
|
15,000,000
|
15,000,000
|
300,000,000
|
15,000,000
|
Preferred Stock, Shares Authorized |
20,000,000
|
|
20,000,000
|
|
20,000,000
|
Preferred Stock, Par or Stated Value Per Share |
$ 0.001
|
|
$ 0.001
|
|
$ 0.001
|
Stockholders' Equity, Reverse Stock Split |
1-for-20
|
1-for-20
|
|
|
|
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- DefinitionThe maximum number of common shares permitted to be issued by an entity's charter and bylaws.
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- DefinitionThe estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term.
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v3.23.3
Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands |
9 Months Ended |
Sep. 30, 2023
USD ($)
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
|
Number of Shares Outstanding, Beginning Balance | shares |
86,951
|
|
Weighted Average Exercise Price, Beginning Balance | $ / shares |
$ 62.16
|
|
Number of Shares Outstanding, Beginning Balance | shares |
22,477
|
|
Weighted Average Exercise Price, Beginning Balance | $ / shares |
$ 13.98
|
|
Number of Shares Outstanding, Beginning Balance | shares |
|
|
Weighted Average Exercise Price, Beginning Balance | $ / shares |
|
|
Number of Shares Outstanding, Beginning Balance | shares |
(31,480)
|
|
Weighted Average Exercise Price, Beginning Balance | $ / shares |
$ 53.58
|
|
Number of Shares Outstanding, Ending Balance | shares |
77,948
|
|
Weighted Average Exercise Price, Ending Balance | $ / shares |
$ 51.74
|
|
Weighted Average Remaining Contractual Life (in Years), Outstanding |
8 years 5 months 12 days
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Intrinsic Value | $ |
$ 0
|
[1] |
Number of Exercisable Shares Outstanding, Balance | shares |
24,210
|
|
Weighted Average Exercise Price, Balance | $ / shares |
$ 62.23
|
|
Weighted Average Remaining Contractual Life (in Years), Exercisable |
7 years 9 months
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Intrinsic Value | $ |
$ 0
|
[1] |
|
|
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- DefinitionThe number of shares into which fully or partially vested stock options outstanding as of the balance sheet date can be currently converted under the option plan.
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v3.23.3
Schedule of Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member]
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of shares outstanding, beginning balance | shares |
17,176
|
Number of shares weighted average grant date fair value, beginning balance | $ / shares |
$ 52.20
|
Number of shares outstanding, Awarded | shares |
|
Number of shares weighted average grant date fair value, Awarded | $ / shares |
|
Number of shares outstanding, Vested | shares |
(8,588)
|
Number of shares weighted average grant date fair value,Vested | $ / shares |
$ 52.20
|
Number of shares outstanding, Canceled or expired | shares |
(3,817)
|
Weighted Average Remaining Contractual Life (in Years), Canceled or forfeited |
7 months 17 days
|
Number of shares weighted average grant date fair value, Canceled or forfeited | $ / shares |
|
Number of shares outstanding, ending balance | shares |
4,771
|
Weighted Average Remaining Contractual Life (in Years), Outstanding Ending Balance |
7 months 17 days
|
Number of shares weighted average grant date fair value, outstanding ending balance | $ / shares |
$ 52.20
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v3.23.3
Equity Incentive Plans and Share-Based Payments (Details Narrative) - USD ($) $ in Millions |
|
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Dec. 12, 2022 |
Dec. 11, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Unrecognized compensation cost |
|
|
$ 1.0
|
|
$ 1.0
|
|
|
Compensation cost recognized, weighted average period |
|
|
|
|
1 year 9 months 18 days
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Unrecognized compensation cost |
|
|
0.2
|
|
$ 0.2
|
|
|
Compensation cost recognized, weighted average period |
|
|
|
|
7 months 6 days
|
|
|
Selling, General and Administrative Expenses [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Share based compensation expenses |
|
|
0.1
|
$ 0.3
|
$ 0.5
|
$ 0.6
|
|
Selling, General and Administrative Expenses [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Share based compensation expenses |
|
|
$ 0.1
|
$ 0.1
|
$ 0.3
|
$ 0.9
|
|
Omnibus Incentive Plan [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant |
|
|
163,362
|
|
163,362
|
|
137,500
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Terms of Award |
|
|
|
|
|
|
10 years for stock options issued
under the 2021 Plan.
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Period Increase (Decrease) |
266,990
|
129,490
|
|
|
|
|
|
X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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Interest Expense, net (Details Narrative) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Contract asset |
$ (89)
|
$ (358)
|
|
Startup cost financing |
$ 7,300
|
$ 7,300
|
|
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50.00%
|
|
|
Maruho Co, Ltd. [Member] | Cutanea Acquisition Agreement [Member] |
|
|
|
Contract asset |
$ 1,700
|
|
|
Startup cost financing |
$ 7,300
|
|
|
Debt instrument stated percentage |
6.00%
|
|
|
Debt maturity date |
Dec. 31, 2023
|
|
|
Biofrontera AG [Member] |
|
|
|
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|
|
50.00%
|
Biofrontera AG [Member] | Related Party [Member] |
|
|
|
Due from related party |
|
|
$ 6,100
|
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v3.23.3
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income (loss) per common share: |
|
|
|
|
Net income (loss) |
$ (6,342)
|
$ (2,566)
|
$ (23,657)
|
$ 2,145
|
Shares: |
|
|
|
|
Basic weighted average common shares outstanding |
1,366,842
|
1,136,291
|
1,346,264
|
978,018
|
Stock options and restricted stock units |
|
|
|
2,233
|
Diluted weighted average common shares outstanding |
1,366,842
|
1,136,291
|
1,346,264
|
980,251
|
Net earnings (loss) per share: |
|
|
|
|
Basic |
$ (4.64)
|
$ (2.26)
|
$ (17.57)
|
$ 2.19
|
Diluted |
$ (4.64)
|
$ (2.26)
|
$ (17.57)
|
$ 2.19
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Commitments and Contingencies (Details Narrative) - USD ($)
|
|
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Nov. 29, 2021 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Product Liability Contingency [Line Items] |
|
|
|
|
|
Lease option to extend |
|
|
option to extend
the term of the lease for one five (5) year period
|
|
|
Security deposit |
$ 250,000
|
|
$ 250,000
|
|
|
Start-up cost financing |
7,300,000
|
|
7,300,000
|
|
$ 7,300,000
|
Settlement liability |
|
$ 22,500,000
|
|
|
|
Biofrontera AG [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Settlement liability |
6,000,000.0
|
|
|
|
|
Loss contingency, receivable |
2,800,000
|
|
2,800,000
|
|
6,400,000
|
Licensing Agreement [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Licensing fee |
|
|
|
|
200,000
|
Maximum [Member] | Licensing Agreement [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Sales milestone payments |
$ 1,000,000.0
|
|
$ 1,000,000.0
|
|
|
Royalties percentage related to royalties |
3.00%
|
|
3.00%
|
|
|
Xepi LSA [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Contractual Obligation |
$ 2,000,000
|
|
$ 2,000,000
|
$ 4,000,000
|
|
Xepi LSA [Member] | Maximum [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Revenues |
|
|
25,000,000
|
$ 50,000,000
|
|
Maruho Co, Ltd. [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Repayments of related party debt |
|
|
|
|
$ 3,600,000
|
Maruho Co, Ltd. [Member] | December 31, 2023 [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Start-up cost financing |
3,700,000
|
|
3,700,000
|
|
|
Facility Leases [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Security deposit |
$ 100,000
|
|
$ 100,000
|
|
|
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v3.23.3
Subsequent Events (Details Narrative) - $ / shares
|
Oct. 30, 2023 |
Jul. 26, 2022 |
May 16, 2022 |
Jun. 28, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
Warrant exercise price |
|
|
|
$ 100.00
|
Date from warrant exercisable |
|
Dec. 01, 2026
|
Nov. 18, 2027
|
|
Warrant Amendment [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Warrant exercise price |
|
$ 33.20
|
$ 55.40
|
|
Common Stock [Member] | Warrant Amendment [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Shares issued for capital raise |
|
214,286
|
170,950
|
|
Subsequent Event [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
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Sale of Stock, Description of Transaction |
the
Company agreed to issue and sell to the institutional investor: (i) 150,000 shares of Common Stock at a combined offering price of $3.74, (ii) 1,055,000 pre-funded warrants to purchase up to 1,055,000 shares of Common Stock (the “Pre-Funded Warrants”)
at a combined offering price of $3.7399 and (iii) 1,205,000 warrants to purchase up to 1,807,500 shares of Common
Stock (the “Common Warrants”), resulting in gross proceeds of approximately $4.5 million. The Public Offering closed on November
2, 2023
|
|
|
|
Subsequent Event [Member] | Warrant [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Warrant expiry period |
5 years
|
|
|
|
Warrant exercise price |
$ 3.55
|
|
|
|
Subsequent Event [Member] | Prefunded Warrant [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Warrant expiry period |
5 years
|
|
|
|
Warrant exercise price |
$ 0.0001
|
|
|
|
Subsequent Event [Member] | IPO [Member] | Common Stock [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Shares issued for capital raise |
1,205,000
|
|
|
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Biofrontera (NASDAQ:BFRI)
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