Core Viewpoint - AxoGen, Inc. has initiated a rolling submission of a Biologics License Application (BLA) for its Avance Nerve Graft to the FDA, with completion expected by Q3 2024, aiming for potential approval by mid-2025 [1][4]. Company Developments - The initial submission includes a complete non-clinical data package, with remaining clinical and manufacturing components to be submitted in the coming months [1]. - The Avance Nerve Graft is designed to bridge severed peripheral nerves without the complications of a second surgical site [1]. - The product received Regenerative Medicine Advanced Therapy designation from the FDA in 2018, allowing for a priority review that could shorten the FDA review period from 10 months to 6 months [4]. Product Portfolio - AxoGen offers several products aimed at restoring nerve function, including: - Axoguard Nerve Connector, used for tensionless repair of severed peripheral nerves [5]. - Axoguard Nerve Protector, which protects damaged peripheral nerves and reinforces nerve reconstruction [5]. - Axoguard Nerve Cap, designed to protect peripheral nerve ends and reduce the development of symptomatic neuroma [6]. - Avive+ Soft Tissue Matrix, a multi-layer amniotic membrane allograft for tissue protection during healing [6][7]. Market Performance - Over the past six months, AXGN shares have increased by 1.5%, while the industry has risen by 24.9% and the S&P 500 by 17.5% [2].

Core Insights - Axogen, Inc. has initiated the rolling submission process for a Biologics License Application (BLA) for Avance Nerve Graft, marking a significant regulatory milestone [1] - The initial submission includes a complete non-clinical data package, with remaining clinical and Chemistry, Manufacturing and Controls (CMC) components to be submitted in the coming months [1][3] - The Avance Nerve Graft has received Regenerative Medicine Advanced Therapy (RMAT) designation, which may allow for priority review and a reduced review timeline from 10 months to 6 months [2] Regulatory Process - The rolling submission process allows for pre-agreed components of the BLA to be submitted as they are completed, potentially streamlining the regulatory review [1] - Following the final component submission, the FDA will notify Axogen of formal acceptance and the review timeline approximately 45 to 60 days later [3] - The BLA filing is anticipated to be completed in the third quarter of 2024, with potential approval expected around mid-2025 [3] Company Overview - Axogen is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring nerve function and quality of life for patients [4] - The company offers a comprehensive portfolio of products for various applications, including traumatic injuries and surgical treatments, addressing both scheduled and emergent procedures [5] - Key products include Avance Nerve Graft, Axoguard Nerve Connector, and Axoguard Nerve Protector, among others, which are designed to facilitate nerve repair and protection [6][7]

ALACHUA, Fla. and TAMPA, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, chairman, chief executive officer, and president, will participate in a fireside chat at the Leerink Partners Healthcare Crossroads Conference in Austin, TX, on Wednesday, May 29, 2024, at 3:40 p.m. CT / 4:40 p.m. ET. Webcast events can be accessed live through the Investors pag ...

Financial Data and Key Metrics Changes - Revenue for Q1 2024 increased by 12.9% to $41.4 million compared to the same period last year, with a gross profit of $32.6 million and a gross margin of 78.8% [8][22] - Total operating expenses rose by 3.8% to $37.2 million, while net loss decreased to $6.6 million or $0.15 per share, compared to a net loss of $7.1 million or $0.17 per share in Q1 2023 [23][24] - Adjusted EBITDA improved to $1 million from an adjusted EBITDA loss of $3.8 million in the previous year, indicating enhanced operational efficiency [24] Business Line Data and Key Metrics Changes - The growth was broad-based across products and applications, with a 4.9% increase in unit volume, a 5.3% mix favorability, and a 2.6% increase in price contributing to revenue growth [22] - Core accounts, defined as those generating over $100,000 in revenue, represented approximately 65% of total revenue, with the largest core accounts exceeding $1 million annually [10] Market Data and Key Metrics Changes - The company noted a shift in the timing of elective outpatient procedures, with a strong performance in January and February, followed by a volume uptick in April instead of March [7][27] - The company continues to see growth in the trauma and breast neurotization segments, with increasing demand for the Resensation technique [45] Company Strategy and Development Direction - The growth strategy focuses on deepening relationships with existing core accounts and expanding into new clinical applications [10][11] - The company is on track for the BLA filing for Avance nerve grafts in Q3 2024, which could lead to market exclusivity for 12 years upon approval [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2024 revenue guidance, maintaining a range of $177 million to $181 million, representing an annual growth rate of approximately 11% to 14% [24] - The management highlighted the importance of innovation and expanding the nerve protection portfolio as key growth drivers [12][13] Other Important Information - The company has made strategic changes to its financial reporting, including the removal of revenue breakdowns between scheduled and emergent trauma applications, to better align with its commercial strategy [9][21] - The company is focused on optimizing resource allocation and achieving profitability while continuing to invest in innovation [24] Q&A Session Summary Question: Can you provide color on performance through the quarter, particularly in March? - Management noted that the typical step-up in volume occurred in April instead of March, possibly due to the timing of Easter holidays, but overall growth across products was maintained [27][29] Question: What is the status of the CEO search? - The CEO search is ongoing, led by independent directors with an outside search firm, and an announcement will be made once finalized [31] Question: Can you elaborate on the decision to remove the scheduled versus emerging breakdown? - The decision was based on the conclusion that the previous disclosure did not provide the best insights into the business model and commercial strategy, which focuses on increasing penetration into high potential accounts [34] Question: What is the expected contribution from new product launches in 2024? - New products are included in the guidance, with expectations for modest revenue impact in the second half of the year as they go through value analysis committees [38] Question: How is procedure growth looking in the quarter? - Management reported good procedure growth across segments, particularly in trauma and breast neurotization, with continued interest from surgeons [44]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to______________ Commission file number: 001-36046 Axogen, Inc. (Ex ...

AxoGen (AXGN) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 40%. A quarter ago, it was expected that this regenerative medicine company would post a loss of $0.09 per share when it actually produced a loss of $0.06, delivering a surprise of 33.33%.Over the last four quarters, the company ha ...

Axogen, Inc Reports First Quarter 2024 Financial Results ALACHUA and TAMPA, FL – May 2, 2024 – 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, 2024. First Quarter Financial Results • First quarter revenue was $41.4 million, a 12.9% increase compared to the first quarter of 2023. • In the first quarter of 2024, our gross margin in ...

ALACHUA, Fla. and TAMPA, Fla., April 29, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announces the first surgical implantations of its newest product, Avive+ Soft Tissue Matrix™. "We are excited to expand our offering in nerve protection with the introduction of this resorbable barrier to support the critical phases of healing for nerve injuries," said Karen Zaderej, chairman, CEO, and president ...

ALACHUA, Fla. and TAMPA, Fla., April 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will report first quarter 2024 financial results on Thursday, May 2, 2024, before the market opens. Axogen management will host an investment-community conference call and webcast at 8 a.m. ET following the release. Investors interested in participating in the conference call by phone may ...

AxoGen, Inc. (NASDAQ:AXGN) Q4 2023 Earnings Call Transcript March 5, 2024 8:00 AM ET Company Participants Harold Tamayo - VP, Finance and IR Karen Zaderej - Chairman, CEO and President Nir Naor - CFO Conference Call Participants Chris Pasquale - Nephron Mike Sarcone - Jefferies Mike Kratky - Leerink Partners Caitlin Cronin - Canaccord Genuity Dave Turkaly - Citizens JMP Ross Osborn - Cantor Fitzgerald Operator Hello, and welcome to the AxoGen, Inc. 2023 Fourth Quarter and Full Year Financial Results Confere ...