Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today reported financial results and business highlights
for the first quarter ended March 31, 2023.
First Quarter Financial Results and
Business Highlights
- Net revenue was $36.7
million, an increase of 18% over the first quarter of 2022.
- Gross margin was
81.7%, compared to 82.1% in the first quarter of 2022.
- Net loss of $7.1
million, or $0.17 per share, compared to net loss of $11.5 million,
or $0.27 per share in the first quarter of 2022.
- Adjusted net loss of
$4.1 million, or $0.10 per share, compared to adjusted net loss of
$8.5 million, or $0.20 per share, in the first quarter of
2022.
- Adjusted EBITDA loss
of $3.8 million, compared to an adjusted EBITDA loss of $7.4
million in the first quarter of 2022.
- The balance of all
cash and cash equivalents and investments on March 31, 2023,
was $44.1 million, as compared to $55.0 million on
December 31, 2022. The net change includes capital
expenditures of $3.3 million related to the construction of the
Company's new processing facility in Dayton, OH, and $7.6 million
of other cash burn, including approximately $7.2 million of items
which typically occur in the first quarter, including bonuses,
sales meetings and awards, and insurance premiums.
- In
early April, a new comprehensive study was published that analyzed
all-payor data of 1,300 procedural costs of nerve injury repairs.
The authors' findings indicated that there were no significant
differences in procedure cost between autograft and allograft
repair. Additionally, the study concluded that there was
significant operating room time savings of 41 minutes on average,
for allograft compared to autograft in the outpatient setting,
where the majority of nerve repairs are performed.
Additionally, on April 7th, the Company received
FDA 510(k) clearance for the Axoguard HA+ Nerve Protector™. The
category of nerve protection covers a wide range of nerve injuries
including compression, crush injuries, complex traumatic injuries
where the nerve remains intact, and protecting the coaptation sites
of nerve transections. The Company believes that these injury types
and their anatomical locations present diverse challenges requiring
unique targeted solutions. Axoguard HA+ Nerve Protector adds new
proprietary design features, including the benefits of a
hyaluronate-alginate gel layer, which facilitates enhanced nerve
gliding to aid in minimizing soft tissue attachments, while the
base layer is remodeled into a long-term protective tissue layer.
Axoguard HA+ will undergo a pilot launch in the second quarter,
followed by a full product launch in the third quarter.
“The strong revenue growth and operational
execution of this quarter continues the momentum we achieved in the
second half of last year with improved consistency of hospital
staffing and surgical capacity,” commented Karen Zaderej, chairman,
CEO, and president of Axogen, Inc. “We continue to drive innovation
across the broad spectrum of nerve repair solutions. We believe our
new Axoguard HA+ Nerve Protector provides enhanced design features
and improves our access to the nerve protection category.”
Additional Operational and Business
Highlights
- Core Accounts
totaled 350, an increase of 5% sequentially, and 23% over an
adjusted* prior year level of 285. Revenue from Core Accounts
continued to represent approximately 60% of total revenue.
- Active Accounts
totaled 994, up 3% sequentially, and 9% over an adjusted* prior
year level of 916. Revenue from the top 10% of Active Accounts
represents approximately 35% of total revenue.
- Ended the quarter
with a total of 220 peer-reviewed clinical publications featuring
Axogen’s nerve repair product portfolio, up from 215 the previous
quarter.
- Ended the quarter
with 116 direct sales representatives, compared to 115 at the end
of the fourth quarter of 2022, and compared to 116 one year
ago.
2023 Financial GuidanceManagement
continues to expect full-year 2023 revenue to be in the range of
$154 million to $159 million. The Company continues to anticipate
that gross margin will be reduced with the transition to its new
processing facility and expects gross margins will return to
approximately 80% by the fourth quarter of 2023.
*The Company voluntarily suspended market
availability of Avive® Soft Tissue Membrane on June 1, 2021; and
therefore no Avive revenue was recorded in 2022. Core and Active
Account metrics for prior periods were adjusted for Avive revenue.
For a reconciliation of adjusted Core and Active Account numbers,
please see our Corporate Presentation on the investors page on
www.axogeninc.com.
Axoguard HA+ Nerve ProtectorThe
Axoguard HA+ Nerve Protector is a proprietary nerve protection
device designed to provide short- and long-term protection for
peripheral nerve injuries. The device is comprised of a processed
porcine submucosa extracellular matrix (ECM) base layer with a
hyaluronate-alginate gel coating. The gel layer facilitates
enhanced nerve gliding to aid in minimizing soft tissue
attachments, while the base layer is remodeled into a long-term
protective tissue layer. It is available in a variety of sizes to
meet patient’s and surgeon’s needs.
Conference CallThe Company will
host a conference call and webcast for the investment community
today at 8:00 a.m. ET. Investors interested in participating in the
conference call by phone may do so by dialing toll free at (866)
682-6100 or use the direct dial-in number at (862) 298-0702. Those
interested in listening to the conference call live via the
Internet may do so by visiting the Investors page of the Company's
website at www.axogeninc.com and clicking on the webcast link.
Following the conference call, a replay will be
available in the Investors section of the Company's website at
www.axogeninc.com under Investors.
About AxogenAxogen (AXGN) is the
leading Company focused specifically on the science, development,
and commercialization of technologies for peripheral nerve
regeneration and repair. Axogen employees are passionate about
helping to restore peripheral nerve function and quality of life to
patients with physical damage or transection to peripheral nerves
by providing innovative, clinically proven, and economically
effective repair solutions for surgeons and health care providers.
Peripheral nerves provide the pathways for both motor and sensory
signals throughout the body. Every day, people suffer traumatic
injuries or undergo surgical procedures that impact the function of
their peripheral nerves. Physical damage to a peripheral nerve, or
the inability to properly reconnect peripheral nerves, can result
in the loss of muscle or organ function, the loss of sensory
feeling, or the initiation of pain.
Axogen's platform for peripheral nerve repair
features a comprehensive portfolio of products, including Avance
Nerve Graft, a biologically active off-the-shelf processed human
nerve allograft for bridging severed peripheral nerves without the
comorbidities associated with a second surgical site; Axoguard
Nerve Connector®, a porcine submucosa ECM coaptation aid for
tensionless repair of severed peripheral nerves; Axoguard Nerve
Protector®, a porcine submucosa ECM product used to wrap and
protect damaged peripheral nerves and reinforce the nerve
reconstruction while preventing soft tissue attachments; and
Axoguard Nerve Cap®, a porcine submucosa ECM product used to
protect a peripheral nerve end and separate the nerve from the
surrounding environment to reduce the development of symptomatic or
painful neuroma. The Axogen portfolio of products is available in
the United States, Canada, Germany, the United Kingdom, Spain,
South Korea, and several other countries.
Cautionary Statements Concerning
Forward-Looking StatementsThis press
release contains “forward-looking” statements as defined in the
Private Securities Litigation Reform Act of 1995. These statements
are based on management's current expectations or predictions of
future conditions, events, or results based on various assumptions
and management's estimates of trends and economic factors in the
markets in which we are active, as well as our business plans.
Words such as “expects,” “anticipates,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” “projects,” “forecasts,”
“continue,” “may,” “should,” “will,” “goals,” and variations of
such words and similar expressions are intended to identify such
forward-looking statements. Forward-looking statements include
statement on benefits and market opportunities, market launch
timetable for Axoguard HA+, as well as statements under the
subheading "2023 Financial Guidance." Actual results or events
could differ materially from those described in any forward-looking
statements as a result of various factors, including, without
limitation, statements related to the continued impact of COVID-19,
global supply chain issues, record inflation, hospital staffing
issues, product development, product potential, expected clinical
enrollment timing and outcomes, regulatory process and approvals,
APC renovation timing and expense, financial performance, sales
growth, surgeon and product adoption, market awareness of our
products, data validation, our visibility at and sponsorship of
conferences and educational events, global business disruption
caused by Russia’s invasion of Ukraine and related sanctions, as
well as those risk factors described under Part I, Item 1A., “Risk
Factors,” of our Annual Report on Form 10-K for the most recently
ended fiscal year. Forward-looking statements are not a guarantee
of future performance, and actual results may differ materially
from those projected. The forward-looking statements are
representative only as of the date they are made and, except as
required by applicable law, we assume no responsibility to publicly
update or revise any forward-looking statements.
About Non-GAAP Financial Measures
To supplement our consolidated financial statements, we use the
non-GAAP financial measures of EBITDA, which measures earnings
before interest, income taxes, and depreciation and amortization,
and Adjusted EBITDA which further excludes non-cash stock
compensation expense and litigation and related expenses. We also
use the non-GAAP financial measures of Adjusted Net Loss and
Adjusted Net Loss Per Common Share - basic and diluted which
excludes non-cash stock compensation expense and litigation and
related expenses from Net Loss and Net Loss Per Common Share -
basic and diluted, respectively. These non-GAAP measures are not
based on any comprehensive set of accounting rules or principles
and should not be considered a substitute for, or superior to,
financial measures calculated in accordance with GAAP, and may be
different from non-GAAP measures used by other companies. In
addition, these non-GAAP measures should be read in conjunction
with our financial statements prepared in accordance with GAAP. The
reconciliations of the non-GAAP measures to the most directly
comparable financial measures calculated and presented in
accordance with GAAP should be carefully evaluated.
We use these non-GAAP financial measures for
financial and operational decision-making and as a means to
evaluate period-to-period comparisons. We believe that these
non-GAAP financial measures provide meaningful supplemental
information regarding our performance and that both management and
investors benefit from referring to these non-GAAP financial
measures in assessing our performance and when planning,
forecasting, and analyzing future periods. We believe these
non-GAAP financial measures are useful to investors because (1)
they allow for greater transparency with respect to key metrics
used by management in its financial and operational decision-making
and (2) they are used by our institutional investors and the
analyst community to help them analyze the performance of our
business, the Company’s cash available for operations, and the
Company’s ability to meet future capital expenditure and working
capital requirements.
Contact:Axogen, Inc.Ed Joyce, Director, Investor
RelationsInvestorRelations@axogeninc.com |
Axogen, Inc. |
Condensed Consolidated Balance Sheets |
(unaudited) |
(In Thousands, Except Share and Per Share
Amounts) |
|
|
March 31,2023 |
|
December 31,2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
7,707 |
|
|
$ |
15,284 |
|
Restricted cash |
|
6,252 |
|
|
|
6,251 |
|
Investments |
|
30,160 |
|
|
|
33,505 |
|
Accounts receivable, net of allowance for doubtful accounts of $383
and $650, respectively |
|
22,278 |
|
|
|
22,186 |
|
Inventory |
|
19,849 |
|
|
|
18,905 |
|
Prepaid expenses and other |
|
2,453 |
|
|
|
1,944 |
|
Total current assets |
|
88,699 |
|
|
|
98,075 |
|
Property and equipment, net |
|
83,049 |
|
|
|
79,294 |
|
Operating lease right-of-use assets |
|
13,868 |
|
|
|
14,369 |
|
Intangible assets, net |
|
3,858 |
|
|
|
3,649 |
|
Total assets |
$ |
189,474 |
|
|
$ |
195,387 |
|
|
|
|
|
Liabilities and shareholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
20,188 |
|
|
$ |
22,443 |
|
Current maturities of long-term lease obligations |
|
1,050 |
|
|
|
1,310 |
|
Total current liabilities |
|
21,238 |
|
|
|
23,753 |
|
|
|
|
|
Long-term debt, net of debt discount and financing fees |
|
45,931 |
|
|
|
45,712 |
|
Long-term lease obligations |
|
20,089 |
|
|
|
20,405 |
|
Debt derivative liabilities |
|
4,703 |
|
|
|
4,518 |
|
Total liabilities |
|
91,961 |
|
|
|
94,388 |
|
|
|
|
|
Commitments and contingencies - see Note 12 |
|
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
Common stock, $0.01 par value per share; 100,000,000 shares
authorized; 42,809,994 and 42,445,517 shares issued and
outstanding |
|
428 |
|
|
|
424 |
|
Additional paid-in capital |
|
363,739 |
|
|
|
360,155 |
|
Accumulated deficit |
|
(266,654 |
) |
|
|
(259,580 |
) |
Total shareholders’ equity |
|
97,513 |
|
|
|
100,999 |
|
Total liabilities and shareholders’ equity |
$ |
189,474 |
|
|
$ |
195,387 |
|
Axogen, Inc. |
Condensed Consolidated Statements of
Operations |
(unaudited) |
(In Thousands, Except Per Share Amounts) |
|
|
Three Months Ended |
|
March 31,2023 |
|
March 31,2022 |
|
|
|
|
Revenues |
$ |
36,664 |
|
|
$ |
31,007 |
|
Cost of goods sold |
|
6,709 |
|
|
|
5,546 |
|
Gross profit |
|
29,955 |
|
|
|
25,461 |
|
Costs and expenses: |
|
|
|
— |
|
Sales and marketing |
|
21,618 |
|
|
|
20,888 |
|
Research and development |
|
6,679 |
|
|
|
6,275 |
|
General and administrative |
|
8,999 |
|
|
|
9,618 |
|
Total costs and expenses |
|
37,296 |
|
|
|
36,781 |
|
Loss from operations |
|
(7,341 |
) |
|
|
(11,320 |
) |
Other income (expense): |
|
|
|
Investment income (loss) |
|
549 |
|
|
|
(46 |
) |
Interest expense |
|
(16 |
) |
|
|
(354 |
) |
Change in fair value of derivatives |
|
(185 |
) |
|
|
252 |
|
Other expense |
|
(81 |
) |
|
|
(7 |
) |
Total other income (expense), net |
|
267 |
|
|
|
(155 |
) |
Net loss |
$ |
(7,074 |
) |
|
$ |
(11,475 |
) |
|
|
|
|
Weighted average common shares outstanding — basic and diluted |
|
42,571,021 |
|
|
|
41,804,330 |
|
Loss per common share — basic and diluted |
$ |
(0.17 |
) |
|
$ |
(0.27 |
) |
Axogen, Inc. |
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP
FINANCIAL MEASURES |
Three Months Ended March 31, 2023 and 2022 |
(unaudited) |
(In Thousands, Except Per Share Amounts) |
|
|
Three Months Ended |
|
March 31,2023 |
|
March 31,2022 |
|
|
|
|
Net loss |
$ |
(7,074 |
) |
|
$ |
(11,475 |
) |
Depreciation and amortization expense |
|
780 |
|
|
|
773 |
|
Investment (income) loss |
|
(549 |
) |
|
|
46 |
|
Income tax expense |
|
83 |
|
|
|
— |
|
Interest expense |
|
16 |
|
|
|
354 |
|
EBITDA - non GAAP |
$ |
(6,744 |
) |
|
$ |
(10,302 |
) |
|
|
|
|
Non cash stock-based compensation expense |
|
2,954 |
|
|
|
2,678 |
|
Litigation and related costs |
|
— |
|
|
|
267 |
|
Adjusted EBITDA - non GAAP |
$ |
(3,790 |
) |
|
$ |
(7,357 |
) |
|
|
|
|
Net loss |
$ |
(7,074 |
) |
|
$ |
(11,475 |
) |
Non cash stock-based compensation expense |
|
2,954 |
|
|
|
2,678 |
|
Litigation and related costs |
|
— |
|
|
|
267 |
|
Adjusted net loss - non GAAP |
$ |
(4,120 |
) |
|
$ |
(8,530 |
) |
|
|
|
|
Weighted average common shares outstanding — basic and
diluted |
|
42,571,021 |
|
|
|
41,804,330 |
|
|
|
|
|
Loss per common share — basic and diluted |
$ |
(0.17 |
) |
|
$ |
(0.27 |
) |
Non cash stock-based compensation expense |
|
0.07 |
|
|
|
0.06 |
|
Litigation and related costs |
|
— |
|
|
|
0.01 |
|
Adjusted net loss per common share — basic and diluted -
non GAAP |
$ |
(0.10 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
Axogen, Inc. |
Condensed Consolidated Statements of Changes in
Shareholders’ Equity |
(unaudited) |
(In Thousands, Except Share Amounts) |
|
|
Common Stock |
|
Additional Paid-inCapital |
|
AccumulatedDeficit |
|
Total Shareholders'Equity |
|
Shares |
|
Amount |
|
|
|
Three Months Ended March 31, 2023 |
|
|
|
|
|
|
|
|
|
Balance at December 31, 2022 |
42,445,517 |
|
$ |
424 |
|
$ |
360,155 |
|
|
$ |
(259,580 |
) |
|
$ |
100,999 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
|
(7,074 |
) |
|
|
(7,074 |
) |
Stock-based compensation |
— |
|
|
— |
|
|
2,954 |
|
|
|
— |
|
|
|
2,954 |
|
Issuance of restricted and performance stock units |
238,719 |
|
|
3 |
|
|
(3 |
) |
|
|
— |
|
|
|
— |
|
Exercise of stock options and employee stock purchase plan |
125,758 |
|
|
1 |
|
|
633 |
|
|
|
— |
|
|
|
634 |
|
Balance at March 31, 2023 |
42,809,994 |
|
$ |
428 |
|
$ |
363,739 |
|
|
$ |
(266,654 |
) |
|
$ |
97,513 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2022 |
|
|
|
|
|
|
|
|
|
Balance at December 31, 2021 |
41,736,950 |
|
$ |
417 |
|
$ |
342,765 |
|
|
$ |
(230,632 |
) |
|
$ |
112,550 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
|
(11,475 |
) |
|
|
(11,475 |
) |
Stock-based compensation |
— |
|
|
— |
|
|
2,678 |
|
|
|
— |
|
|
|
2,678 |
|
Issuance of restricted and performance stock units |
215,287 |
|
|
2 |
|
|
(2 |
) |
|
|
— |
|
|
|
— |
|
Exercise of stock options and employee stock purchase plan |
20,750 |
|
|
1 |
|
|
97 |
|
|
|
— |
|
|
|
98 |
|
Balance at March 31, 2022 |
41,972,987 |
|
$ |
420 |
|
$ |
345,538 |
|
|
$ |
(242,107 |
) |
|
$ |
103,851 |
|
Axogen, Inc. |
Condensed Consolidated Statements of Cash
Flows |
(unaudited) |
(InThousands) |
|
|
Three Months Ended |
|
March 31,2023 |
|
March 31,2022 |
Cash flows from operating activities: |
|
|
|
Net loss |
$ |
(7,074 |
) |
|
$ |
(11,475 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
|
709 |
|
|
|
704 |
|
Amortization of right-of-use assets |
|
464 |
|
|
|
427 |
|
Amortization of intangible assets |
|
71 |
|
|
|
69 |
|
Amortization of debt discount and deferred financing fees |
|
219 |
|
|
|
220 |
|
Provision for bad debt |
|
(267 |
) |
|
|
267 |
|
Provision for inventory write-down |
|
581 |
|
|
|
459 |
|
Change in fair value of derivatives |
|
185 |
|
|
|
(252 |
) |
Investment (income) loss |
|
(426 |
) |
|
|
96 |
|
Stock-based compensation |
|
2,954 |
|
|
|
2,678 |
|
Change in operating assets and liabilities: |
|
|
|
Accounts receivable |
|
175 |
|
|
|
(624 |
) |
Inventory |
|
(1,525 |
) |
|
|
(1,166 |
) |
Prepaid expenses and other |
|
(509 |
) |
|
|
(1,030 |
) |
Accounts payable and accrued expenses |
|
(2,442 |
) |
|
|
(1,104 |
) |
Operating lease obligations |
|
(537 |
) |
|
|
(320 |
) |
Cash paid for interest portion of finance leases |
|
(1 |
) |
|
|
— |
|
Net cash used in operating activities |
|
(7,423 |
) |
|
|
(11,051 |
) |
Cash flows from investing activities: |
|
|
|
Purchase of property and equipment |
|
(4,304 |
) |
|
|
(5,037 |
) |
Purchase of investments |
|
(10,203 |
) |
|
|
(6,024 |
) |
Proceeds from sale of investments |
|
13,974 |
|
|
|
4,400 |
|
Cash payments for intangible assets |
|
(253 |
) |
|
|
(580 |
) |
Net cash used in investing activities |
|
(786 |
) |
|
|
(7,241 |
) |
Cash flows from financing activities: |
|
|
|
Cash paid for debt portion of finance leases |
|
(1 |
) |
|
|
(2 |
) |
Proceeds from exercise of stock options and ESPP stock
purchases |
|
634 |
|
|
|
97 |
|
Net cash provided by financing activities |
|
633 |
|
|
|
95 |
|
Net decrease in cash, cash equivalents, and restricted
cash |
|
(7,576 |
) |
|
|
(18,197 |
) |
Cash, cash equivalents, and restricted cash, beginning of
period |
|
21,535 |
|
|
|
39,007 |
|
Cash, cash equivalents, and restricted cash, end of
period |
$ |
13,959 |
|
|
$ |
20,810 |
|
Supplemental disclosures of cash flow
activity: |
|
|
|
Cash paid for interest, net of capitalized interest |
$ |
— |
|
|
$ |
— |
|
Supplemental disclosure of non-cash investing and financing
activities: |
|
|
|
Acquisition of fixed assets in accounts payable and accrued
expenses |
$ |
1,026 |
|
|
$ |
1,119 |
|
Obtaining a right-of-use asset in exchange for a lease
liability |
$ |
— |
|
|
$ |
641 |
|
Acquisition of intangible assets in accounts payable and accrued
expenses |
$ |
326 |
|
|
$ |
239 |
|
Axogen (NASDAQ:AXGN)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Axogen (NASDAQ:AXGN)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024