Axogen Reports Preliminary Unaudited Revenue for Fourth Quarter and Full-Year 2021
January 10 2022 - 7:00AM
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 2021 revenue.
Preliminary Unaudited Fourth Quarter and
Year-End Performance Highlights
- Fourth quarter revenue is expected to
be approximately $31.5 million, a 3% decrease compared to
fourth-quarter 2020 revenue of $32.5 million.
- Full-year 2021 revenue is expected to
be approximately $127.3 million, a 13% increase compared to 2020
revenue of $112.3 million.
- Fourth quarter revenue includes $0.5
million from the reversal of a sales return reserve recorded in the
second quarter of 2021 for Avive® Soft Tissue Membrane, for which
the company voluntarily suspended market availability on June 1,
2021. Avive revenue in the fourth quarter 2020 was approximately
$1.6 million; and totaled approximately $4.1 million and $5.5
million for the years ended, 2021 and 2020, respectively.
- Ended the fourth quarter with 115
direct sales representatives compared to 109 at the end of the
third quarter and 111 as of December 31, 2020.
- Increased Core Accounts in the fourth
quarter to 294, a 9% increase compared to 269 in the fourth quarter
a year ago. Revenue from Core Accounts continued to represent
approximately 60% of total revenue.
- Increased Active Accounts in the
fourth quarter to 951, a 6% increase from 893 in the fourth quarter
a year ago. Revenue from the top 10% of our Active Accounts
continued to represent approximately 35% of total revenue.
“Our commercial team continued to navigate
variability in surgical procedure volumes and hospital staffing
challenges, which negatively impacted revenue, particularly in the
final weeks of the quarter due to a surge in COVID-19 cases,”
commented Karen Zaderej, chairman, CEO, and president of Axogen,
Inc. “We drove solid growth in 2021 based on the continued adoption
of our nerve repair solutions despite ongoing market challenges. As
we enter 2022, we look forward to the release of topline results of
our RECON™ study in the second quarter, and we remain focused
on our mission of restoring nerve function and quality of life to
patients with peripheral nerve injuries.”
Updated 2021 Financial Guidance
Management now expects 2021 revenue to be approximately $127.3
million and continues to expect full-year 2021 gross margin above
80%. Management will address the Company’s full-year 2022 outlook
on its fourth quarter 2021 earnings call on February 21, 2022.
Investor meetings scheduled this
weekMembers of the Axogen senior management team will
participate in the Solebury Trout Virtual Management Access Event
January 10-13, 2022. These annual meetings provide an opportunity
for management to meet individually with investors to discuss
Axogen’s differentiated platform for nerve repair in an expanding
set of applications.
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,
2021 on February 21, 2022 after the close of market. The company’s
updated corporate presentation is available through the investors
page on www.axogeninc.com.
About the RECON Clinical
StudyRECON is a multicenter, prospective, randomized,
subject, and evaluator blinded comparative clinical study of nerve
cuffs (manufactured conduits) and Avance® Nerve Graft evaluating
recovery outcomes for the repair of nerve discontinuities. The
phase 3 pivotal study is designed to test for non-inferiority
between the static two-point discrimination outcomes for Avance
Nerve Graft and manufactured conduit. The study design also allows
for a sequential test for superiority of Avance Nerve Graft,
following the non-inferiority analysis.
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 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, the United Kingdom, South Korea, and several other European
and international 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. The forward-looking statements may
include, without limitation, statements related to the
expected impact of COVID-19 on our business, statements regarding
our growth, our 2021 financial guidance, product development,
product potential, regulatory process and approvals, APC renovation
timing and expense, financial performance, sales growth, product
adoption, market awareness of our products, data validation, our
assessment of our internal controls over financial reporting, our
visibility at and sponsorship of conferences and educational
events. The forward-looking statements are and will be subject to
risks and uncertainties, which may cause actual results to differ
materially from those expressed or implied in such forward-looking
statements. Forward-looking statements contained in this press
release should be evaluated together with the many uncertainties
that affect our business and our market, particularly those
discussed under Part I, Item 1A., “Risk Factors,” of our Annual
Report on Form 10-K for the fiscal year ended December 31, 2020, as
well as other risks and cautionary statements set forth in our
filings with the U.S. Securities and Exchange Commission.
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, whether as a result of new information,
future events, changed circumstances, or otherwise.
Contact:Axogen,
Inc.Ed Joyce, Director, Investor
Relationsejoyce@axogeninc.comInvestorRelations@axogeninc.com
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