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 2023 revenue.
Preliminary Unaudited Fourth Quarter and
Year-End Performance and Business Highlights
- Fourth quarter
revenue is expected to be approximately $42.7 million, which
represents an 18% increase over the fourth-quarter of 2022 driven
by solid performance across the product portfolio.
- Full-year 2023
revenue is expected to be approximately $158.8 million, which
represents a 15% increase over the full-year of 2022. This growth
is attributed to the effective implementation of sales strategies
and the performance of our diverse product portfolio including the
launch of Axoguard HA+ Nerve ProtectorTM, mirroring the positive
trends observed in our fourth-quarter results.
- Revenue from Core
Accounts for the full-year 2023 is expected to represent
approximately 65% of revenue. We ended the fourth quarter with Core
Accounts at 375, an increase of 13% over prior year, indicating
solid growth and strengthened relationships within this important
customer base.
- At the end of the
fourth quarter, our team demonstrated efficient sales growth with
116 direct sales representatives, compared to the 115
representatives recorded as of December 31, 2022.
- In 2023, we
achieved a significant milestone by surpassing 100,000 Avance®
Nerve Graft implants since its launch. This achievement reflects
the growing trust and preference for Avance in the healthcare
community.
- We continue our
commitment to drive innovation by the introduction of Axoguard HA+
Nerve ProtectorTM and the strategic roll-out in Q2 of 2024 of
Avive+ Soft Tissue MatrixTM, a resorbable nerve protection product
that provides temporary protection and tissue separation during the
critical phase of healing for nerve injuries. This application was
previously addressed by Avive Soft Tissue membrane. These
initiatives reflect our ongoing dedication to advancing our product
offerings and enhancing value for our patients and
stakeholders.
"We are pleased with our fourth-quarter and
full-year 2023 performance. Growth in the quarter was driven by
improved commercial execution across our products and their
applications,” commented Karen Zaderej, Axogen's Chairman, CEO, and
President. “As we enter 2024, we continue to fortify our foundation
by driving innovation in nerve protection with the planned market
expansion for Axoguard HA+TM, the roll-out for Avive+TM, and our
BLA submission for Avance, which remains on track for the end of
the first half of 2024. In 2024, we look forward to continuing to
enhance patients’ quality of life with our product portfolio and
delivering value for our stakeholders through our drive toward
being cash flow positive and profitable.”
Updated 2023 Financial
Guidance
The Company now expects full-year 2023 revenue
to be at the high end of the $154 million to $159 million guidance
range provided earlier in the year. This represents annual growth
of approximately 15%. The Company continues to believe that gross
margin for the full year 2023 will be approximately 80%.
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,
2023, on March 5, 2024. The company’s updated corporate
presentation is available through the investors page on
www.axogeninc.com.
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 statements regarding
our preliminary, unaudited fourth quarter and full year 2023
performance, the timing of the introduction of the Axoguard HA+
Nerve Protector, timing of the submission of the BLA, development
and market launch timetable for Avive+, as well as statements under
the subheading "Updated 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, 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, APC 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
Relationshtamayo@axogeninc.com
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