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Core Viewpoint - Axogen, Inc. has announced an upsized public offering of 4,000,000 shares of common stock priced at $31.00 per share, aiming to raise approximately $124 million before expenses [1][3]. Group 1: Offering Details - The public offering is set to close on January 23, 2026, pending customary closing conditions [2]. - Wells Fargo Securities and Mizuho are the lead book-running managers, with Canaccord Genuity and Raymond James serving as co-managers for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for early payoff and termination of a term loan facility with Oberland Capital, working capital, capital expenditures, and other general corporate purposes [3]. Group 3: Regulatory Information - The offering is made under an automatic shelf registration statement on Form S-3ASR, effective upon filing with the SEC on January 21, 2026 [4]. - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and available for free on their website [4]. Group 4: Company Overview - Axogen focuses on the development and commercialization of technologies for peripheral nerve repair, aiming to establish nerve repair as the standard of care [6]. - The company's product portfolio includes various nerve repair solutions such as Avance® and Axoguard® products [7].

Core Viewpoint - Axogen, Inc. plans to offer and sell $85.0 million of its common stock in a proposed underwritten public offering, with an additional option for underwriters to purchase up to $12.75 million more [1][2] Group 1: Offering Details - The proposed offering is subject to market conditions and other factors, with no assurance on the completion or terms of the offering [1] - Wells Fargo Securities and Mizuho are the lead book-running managers, while Canaccord Genuity and Raymond James are co-managers for the offering [2] - The offering is made under an automatic shelf registration statement that became effective upon filing with the SEC on January 21, 2026 [3] Group 2: Use of Proceeds - Axogen intends to use the net proceeds from the offering for early payoff and termination of its term loan facility with Oberland Capital, working capital, capital expenditures, and other general corporate purposes [2] Group 3: Company Overview - Axogen focuses on the science, development, and commercialization of technologies for peripheral nerve repair, aiming to make nerve repair the expected standard of care [5] - The company's product portfolio includes various nerve repair solutions such as Avance® nerve grafts and Axoguard® products [6]

PresentationGood morning, everyone. Welcome, and thank you for joining us. My name is [indiscernible] I'm an associate in the health care group at JPMorgan. And today, I have the pleasure of introducing the Axogen team. Joining us today is President and CEO, Mike Dale, and we also have CFO, Lindsey Hartley with us. Just a quick reminder on format. This will be a 20-minute presentation followed by 20 minutes of Q&A. Before we start, just be advised that there will be a handheld mic being passed around during ...

Core Insights - AxoGen's strategy focuses on expanding the adoption of peripheral nerve repair and improving profitability following the approval of its biologics license application (BLA) for the Avance Nerve Graft [3][4][5] Product and Technology - The Avance Nerve Graft is a decellularized human nerve allograft designed to bridge nerve gaps without requiring a secondary harvest site, complemented by AxoGuard and Avive products to support healing [1][19] - The Avance product is characterized as "immunologically benign" while retaining bioactive properties to support axon regeneration [1] Market and Growth Strategy - Management targets an annual growth rate of 15% to 20% and expects to achieve a gross margin of over 75% post-BLA [4][6] - The company has added approximately 20 million covered lives, although around 35% of commercial lives remain uncovered, indicating room for growth in reimbursement [3][11] Clinical Pathways and Education - AxoGen targets four major clinical care pathways, emphasizing the importance of education in nerve care, with over 70% of clinical literature published in the last five years driving demand for procedural training [2][7] - The company aims to make nerve repair an expected intervention in clinical care rather than an underutilized option [2] Financial Performance and Projections - AxoGen is currently cash-flow positive and can fund its strategic initiatives through operations, with expectations of normalized profitability following the transition to biologics licensure [4][14] - Management anticipates that gross margins will experience some pressure in 2026 but expects improvements in 2027 as operational initiatives take effect [13] Regulatory and Reimbursement Developments - The recent BLA approval is expected to address payer objections that previously categorized Avance as experimental, facilitating better reimbursement opportunities [11][12] - A new CMS outpatient code effective January 1 is anticipated to enhance the economic viability of outpatient nerve procedures, which have been limited under previous reimbursement structures [12] Future Opportunities - AxoGen is exploring international markets with a focus on those with clear regulatory pathways leading to reimbursement [16] - The company is also monitoring clinical signals from a prostate trial involving 100 patients, with results expected in the second half of 2026 [3][15]

AxoGen Conference Call Summary Company Overview - **Company**: AxoGen - **Industry**: Healthcare, specifically focused on peripheral nerve repair and restoration Core Points and Arguments 1. **Business Purpose**: AxoGen aims to restore peripheral nerve function to improve health and quality of life, addressing under-treatment in the healthcare sector [2][4][10] 2. **Market Opportunities**: The company identifies four clinical care pathways: extremities, breast reconstruction, oral maxillofacial, and prostate procedures, with significant growth potential in each area [4][10][16] 3. **Product Distinction**: The Avance Nerve Graft is highlighted as a unique solution, being the first approved biologic therapeutic for treating nerve discontinuities, which enhances nerve regeneration [5][8][29] 4. **Growth Projections**: AxoGen expects to grow its business by 15%-20% annually, driven by increased awareness and adoption of their products in various clinical pathways [9][24] 5. **Education and Training**: The company emphasizes education as a core competency, engaging with healthcare professionals to improve knowledge and skills in nerve care [12][13] 6. **Reimbursement Progress**: AxoGen has made strides in securing coverage for nerve care, with a goal to achieve full coverage by 2028, having added nearly 20 million covered lives recently [18][30] 7. **Operational Improvements**: Post-BLA approval, the company plans to streamline operations under a single quality system, enhancing efficiency and gross margins [32][33] 8. **Clinical Studies**: AxoGen is initiating large-scale clinical studies to further validate the effectiveness of their products, which will support market adoption and establish standard care practices [22][23] Additional Important Content 1. **Emerging Markets**: AxoGen is considering international expansion, focusing on markets with logical regulatory pathways and reimbursement systems [39][40] 2. **Sales Productivity**: New hires typically take 6-9 months to become productive, aligning with industry standards for med tech companies [35] 3. **Market Dynamics**: The company anticipates a shift towards outpatient procedures due to recent reimbursement changes, which could significantly alter the treatment landscape for nerve care [46][48] 4. **Long-term Vision**: AxoGen is committed to continuous improvement in R&D, aiming to enhance product capabilities and expand clinical applications [21][22] This summary encapsulates the key insights from the AxoGen conference call, highlighting the company's strategic direction, market opportunities, and operational focus.

Market Opportunity & Growth Strategy - The US nerve care market represents a large and underserved $56 billion opportunity[9] - Axogen is pursuing a strategic plan (2025-2028) with a revenue CAGR target of 15-20%[25, 72] - The company aims to achieve operational cash flow exceeding $60 million per year by the end of 2028[73] Clinical & Technological Leadership - Avance is the first FDA-approved biologic treatment for nerve discontinuities in patients aged one month and older[18] - Axogen has treated over 200,000 patients and has over 300 clinical and scientific publications supporting its nerve repair algorithm[26] - Allograft is increasingly preferred for nerve repair, with 41% preferring it for gaps >2cm in 2024[33] Reimbursement & Coverage - Approximately 35% of commercial lives remain uncovered, indicating an opportunity for expanded coverage[24, 46] - In FY25, 198 million lives were added across ten regional BCBS plans (182 million private; 16 million Medicare Advantage)[48] - New outpatient code group and Level 3 Nerve Procedure Code increases reimbursement for hospitals and ASC's[49] Financial Performance - Axogen's revenue has grown from $599 million in 2021 to $2252 million in 2025, representing a 149% 5-year CAGR[66, 67] - The company is expanding EBITDA, with projections of $198 million and $214 million for EBITDA and Adjusted EBITDA respectively in 2025[69]

Company Achievements - Axogen received FDA approval for its unique nerve graft on December 3, 2025, which is a human tissue-based product aimed at repairing damaged peripheral nerves without requiring nerve tissue from patients, granting the company 12 years of market exclusivity [1] - The company is expected to report approximately $225.2 million in annual revenue for FY 2025, marking its highest revenue to date [6] Stock Performance - Axogen's stock (AXGN) experienced a significant increase of 97.60% in 2025, with seven consecutive months of price gains [2] - CEO Michael D. Dale sold 25,000 shares on December 10, 2025, valued at $750,000, which represented 28.24% of his direct holdings prior to the transaction [5] Product and Market Focus - Axogen specializes in surgical solutions for peripheral nerve injuries, developing biologically active nerve grafts, nerve connectors, nerve protectors, nerve caps, and soft tissue membranes for surgical repair and protection of peripheral nerves [3]

Market Opportunity - The total addressable market (TAM) for nerve care in the US is estimated at $5.6 billion, with over 1.5 million peripheral nerve injuries requiring treatment annually[4] - The total addressable market (TAM) is estimated at $5.6 billion with minimal current penetration[25] - Approximately 60% of nerve injuries go undiagnosed prior to patient discharge, indicating a substantial opportunity for market development and patient awareness initiatives[8] - The company has identified four distinct market opportunities at different stages of development[25] Financial Projections - Axogen expects a revenue compound annual growth rate (CAGR) of 15% to 20% from 2025 to 2028, with gross margin improvements anticipated due to process enhancements[24] - The company aims to achieve operational cash flow exceeding $60 million per year by the end of 2028, with a focus on self-funding organic growth initiatives and debt repayment[24] - Positive cash flow is expected, with expanding margins and accelerating growth[25] Reimbursement and Regulatory Changes - In 2026, the Centers for Medicare & Medicaid Services (CMS) will introduce a new outpatient code group, increasing reimbursement for hospitals and ambulatory surgery centers by approximately 40% year-over-year[18] - There are reimbursement tailwinds with expanding coverage and improving payment rates[25] Product Development and Market Strategy - Axogen's Avance® product is the first FDA-approved biologic treatment for nerve discontinuities, with a significant clinical evidence base supporting its use[7] - The company has three active development projects aimed at expanding its product offerings, including new clinical applications for prostate surgery[19] - Axogen's strategic plan includes continuous optimization of the business model and customer creation processes, focusing on elective and planned procedures[9] - The company has a proven commercial model ready to capture market share[25] Customer Reach and Sales Channels - The company has treated over 200,000 patients and has established access in more than 2,700 hospitals and outpatient centers, supported by a large direct sales channel[10]

ALACHUA, Fla. and TAMPA, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function, today announced preliminary unaudited fourth quarter and full-year 2025 key financials. Preliminary Fourth Quarter and Year-End Key Business Highlights Fourth quarter 2025 revenue is expected to be approximately $59.9 million, which represents a 21.3% increase over the fourth quarter of 2024, ...