Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today announced preliminary unaudited fourth quarter and
full-year 2022 revenue.
Preliminary Unaudited Fourth Quarter and
Year-End Performance and Business Highlights
- Fourth quarter revenue is expected to
be approximately $36.1 million, a 16% increase compared to
fourth-quarter 2021 excluding the impact of Avive revenue in
2021.*
- Full-year 2022 revenue is expected to
be approximately $138.5 million, a 12% increase compared to 2021
excluding the impact of Avive revenue in 2021.*
- Ended the fourth quarter with 115
direct sales representatives compared to 111 at the end of the
third quarter and 115 as of December 31, 2021.
- Core Accounts totaled 332, an increase
of 1% sequentially, and 18% over an adjusted* prior year level of
282. Revenue from Core Accounts continued to represent
approximately 60% of total revenue.
- Active Accounts totaled 968, up 2%
sequentially, and 3% over an adjusted* prior year level of 941.
Revenue from the top 10% of Active Accounts represents
approximately 35% of total revenue.
- In 2022 we surpassed 75,000 Avance®
Nerve Graft implants since launch.
- The preliminary
unaudited balance of all cash and cash equivalents and investments
on December 31, 2022, is anticipated to be approximately $55.0
million, as compared to a balance of $59.4 million on September 30,
2022. The net change includes capital expenditures of approximately
$5.3 million related to the construction of the company's new
processing facility in Dayton, OH, and approximately $0.9 million
net operating cash flow.
- On January 5, 2023, we
announced the independent publication of comparative nerve gap
repair meta-analysis of peer-reviewed studies of allograft,
autograft, and conduits including over 1,500 nerve repairs across
35 studies which we believe provides the strongest clinical and
economic evidence to-date of the performance of Avance Nerve Graft
across all gap lengths and nerve types.
“We are pleased with our performance in the
quarter, capping off a solid year of execution as hospitals
navigate on-going staffing and broader economic challenges,”
commented Karen Zaderej, chairman, CEO, and president of Axogen,
Inc. “The recently published nerve meta-analysis along with the
previous release of RECON top line results continue to demonstrate
the strength of our clinical portfolio which we believe is
foundational to surgeon adoption and growth. We look forward to
2023 as we transition to our new processing facility in Dayton, OH
in the first half of 2023, submit the BLA for Avance Nerve Graft in
the second half of the year and we continue to innovate and change
the standard of care for patients with nerve injuries.”
Updated 2022 Financial Guidance
Management now expects 2022 revenue to be approximately $138.5
million and continues to expect full-year 2022 gross margin above
80%. Management will address the Company’s full-year 2023 outlook
on its fourth quarter 2022 earnings call on March 14, 2023.
Presentation and investor meetings
scheduled this weekKaren Zaderej will present at the JP
Morgan 41st Annual Healthcare Conference in San Francisco Thursday,
January 12, 2023 at 9:45 a.m. PST (12:45 p.m. EST). The
presentation will be webcast live and accessible through the
Investors page at www.axogeninc.com.
Members of the Axogen senior management team will
also participate in the Solebury Trout Management Access Event
January 9-11, 2023 in San Francisco.
The results disclosed in this press release are
preliminary and unaudited. The Company expects to report full,
audited results for the fourth quarter and year ended December 31,
2022 on March 14, 2023. The company’s updated corporate
presentation is available through the investors page on
www.axogeninc.com.
* The Company voluntarily suspended market
availability of Avive® Soft Tissue Membrane on June 1, 2021. Fourth
quarter 2021 revenue includes $0.5 million from the reversal of a
sales return reserve for Avive recorded in the second quarter of
2021. Avive Soft Tissue Membrane revenue totaled approximately $4.1
million for the full year 2021. See table below for reconciliation
of revenue as reported to revenue excluding the impact of Avive.
For a reconciliation of adjusted Core and Active Account numbers,
please see our Corporate Presentation on the investors page on
www.axogeninc.com.
|
For the three months ended |
|
For the full year ended |
Estimated Revenue |
|
2022 |
|
2021 |
growth |
|
|
2022 |
|
2021 |
growth |
As reported |
$ |
36.1 |
$ |
31.5 |
14 |
% |
|
$ |
138.5 |
$ |
127.3 |
9 |
% |
Avive |
$ |
0.0 |
$ |
0.5 |
|
|
$ |
0.0 |
$ |
4.1 |
|
Excluding Avive |
$ |
36.1 |
$ |
31.0 |
16 |
% |
|
$ |
138.5 |
$ |
123.2 |
12 |
% |
About Axogen
Axogen (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 extracellular matrix (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 Statements
This 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 (1) our preliminary,
unaudited fourth quarter and full year 2022 financial results, (2)
timing of our transitioning to our new processing facility in
Dayton, OH in the first half of 2023, and (3) timing of our
submission of our BLA for Avance Nerve Graft in the second half of
the year. 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 impact of COVID-19 on our business, including but not
limited to global supply chain issues, hospital staffing challenges
and its impact on our business, recessionary pressures, inflation,
interest rate increases, market awareness and adoption of our
products, anticipated capital requirements, including the potential
of future financings, data validation, expected clinical study
enrollment, timing and outcomes, our visibility at and sponsorship
of conferences and our educational events, regulatory process and
approvals, legislative, regulatory, political, geopolitical, and
economic developments, 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.
Contact:Axogen,
Inc.Ed Joyce, Director, Investor
Relationsejoyce@axogeninc.com
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