Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and
marketing innovative surgical solutions for peripheral nerve
injuries, today announced that President and Chief Executive
Officer (CEO) Karen Zaderej plans to retire from the Company by
January 2025. The Company’s Board of Directors will retain an
executive recruitment firm to manage a search for her successor.
When a new CEO is in place, Ms. Zaderej will step down from her
executive post and Board duties and continue as a consultant to
Axogen for an additional nine months to support the leadership
transition and the submission process of the Biologics License
Application (BLA) for Avance® Nerve Graft. While the transition is
planned to be no later than Jan. 5, 2025, it could occur sooner
depending on the timing of a new CEO appointment.
Ms. Zaderej has led the transformation of Axogen
from a small start-up company to a category leader in the growing
market of nerve repair. As one of Axogen’s first employees, Ms.
Zaderej initially oversaw the Company’s sales and marketing
function before moving into the role of Chief Operating Officer and
then CEO in 2010. Under her leadership, Axogen has built awareness
of the patient quality of life impact related to nerve damage and
has created the market for nerve repair. She has driven the
diversification of Axogen’s portfolio to address nerve connection,
protection, and termination with multiple nerve repair product
launches and has led the work to develop a unique regulatory
strategy for Avance with a planned filing of a BLA in the second
quarter of this year.
Ms. Zaderej stated, “Axogen is in a strong
position as we start 2024. As announced separately today, we have
promoted several key team members to new leadership roles that will
be important in the next chapter of the Company. We are also
reporting preliminary fourth quarter and full-year 2023 revenue of
approximately $42.7 million and $158.8 million, demonstrating
year-over-year growth of 18% and 15%, respectively. I am proud of
the accomplishments of our team and know that Axogen is positioned
well for continued growth. While I will retire from my roles on the
executive team and Board, I firmly believe in the talent and
strength of the team to continue to improve patient lives and drive
long-term success at Axogen.”
Amy Wendell, Axogen’s Lead Director, added, “The
Board of Directors recognizes and appreciates Karen’s contributions
to the building of the Company as well as the entire peripheral
nerve repair market. She has had an integral role throughout every
stage of Axogen’s development. With the BLA submission for Avance®
Nerve Graft nearing completion and the Company continuing to
demonstrate steady revenue increases year over year, we will look
to bring on board a CEO who will help accelerate Axogen’s next
phase of commercial growth and move towards profitability. The
timing is right for this as the Company begins to shift its focus
in 2024 to what will be a post-BLA commercial expansion
strategy.”
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 that are used across
two primary application categories: scheduled, non-trauma
procedures and emergent trauma procedures. Scheduled procedures are
generally characterized as those where a patient is seeking relief
from conditions caused by a nerve defect or surgical procedure.
These procedures include providing sensation for women seeking
breast reconstruction following a mastectomy, nerve reconstruction
following the surgical removal of painful neuromas, oral and
maxillofacial procedures, and nerve decompression. Emergent
procedures are generally characterized as procedures resulting from
injuries that initially present in an ER. These procedures are
typically referred to and completed by a specialist either
immediately or within a few days following the initial injury.
Axogen’s product portfolio includes 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; Axoguard
HA+ Nerve Protector™, a porcine submucosa ECM base layer coated
with a proprietary hyaluronate-alginate gel, a next-generation
technology designed to enhance nerve gliding and provide short- and
long-term protection for peripheral nerve injuries; 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 the timing of Ms.
Zaderej’s retirement, the timing of the CEO search, the ability to
find suitable CEO candidates, the ability of the new CEO to
accelerate the Company’s commercial growth and focus on the move
towards profitability, the effectiveness of the Company’s new
leadership team, the timing of the BLA submission and the Company’s
preliminary fourth quarter and full-year 2023 revenue and growth.
Actual results or events could differ materially from those
described in any forward-looking statements as a result of various
factors, including, without limitation, potential disruptions
caused by leadership transitions, global supply chain issues,
record inflation, hospital staffing issues, product development,
product potential, expected clinical enrollment timing and
outcomes, regulatory process and approvals, processing facility
transition 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, recent
geopolitical conflicts in the Middle East, 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
and Part II, Item 1A., “Risk Factors,” for our Quarterly Report on
Form 10-Q for the most recently ended fiscal quarter.
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.
For more information, visit
www.axogeninc.com.
Contact:
Axogen, Inc.
Harold D. Tamayo, VP of Finance and Investor
Relations
htamayo@axogeninc.com
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