Company Overview - Axogen, Inc. is a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function [1] - The company focuses specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [2] - Axogen's products address the needs of patients suffering from traumatic injuries or surgical procedures that impact peripheral nerve function [2] Product Portfolio - Axogen offers a comprehensive portfolio of products for peripheral nerve repair, including: - Avance Nerve Graft®, a biologically active processed human nerve allograft for bridging severed peripheral nerves [2] - Axoguard Nerve Connector®, a porcine submucosa extracellular matrix coaptation aid for tensionless repair of severed peripheral nerves [2] - Axoguard Nerve Protector®, a product used to wrap and protect damaged peripheral nerves [2] - Axoguard HA+ Nerve Protector™, designed to enhance nerve gliding and provide protection for peripheral nerve injuries [2] - Avive+ Soft Tissue Matrix™, a multi-layer amniotic membrane allograft for tissue protection during repair [2] - Axoguard Nerve Cap®, used to protect a peripheral nerve end and reduce the development of symptomatic neuroma [2] Market Presence - Axogen's products are available in multiple markets, including the United States, Canada, the United Kingdom, South Korea, and several European and international markets [2] - The company plays a vital role in addressing diverse patient needs in peripheral nerve repair across various applications and surgical specialties [2]

ALACHUA, Fla. and TAMPA, Fla., July 22, 2025 (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 that it will report 2025 second quarter financial results on Tuesday, August 5, 2025, 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 confer ...

AxoGen (AXGN) FY Conference June 11, 2025 02:00 PM ET Speaker0 All good? All right. Well, to everyone who was here today to learn a little bit about AxoGen. Just before I get started, just want to draw everyone's attention to our forward looking statements. You're familiar with these and we will certainly be making forward looking statements but we may or may not be updating these on a regular basis. So, little bit about me. My name is Mike Dale. I've been, as you can tell by my gray hair, around for a litt ...

Company Overview - Axogen, Inc. (NASDAQ: AXGN) is a leader in developing and marketing surgical solutions for peripheral nerve injuries [1][3] - The company focuses on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [3] - Axogen's products aim to restore peripheral nerve function and improve the quality of life for patients with nerve damage [3] Product Portfolio - Axogen offers a comprehensive portfolio of products for various applications, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and pain treatment [3] - Key products include: - Avance Nerve Graft®: a processed human nerve allograft for bridging severed peripheral nerves [3] - Axoguard Nerve Connector®: an extracellular matrix coaptation aid for tensionless repair of severed nerves [3] - Axoguard Nerve Protector®: a product used to protect damaged nerves and reinforce reconstruction [3] - Axoguard HA+ Nerve Protector™: designed to enhance nerve gliding and provide protection for peripheral nerve injuries [3] - Avive+ Soft Tissue Matrix™: an amniotic membrane allograft for tissue protection during repair [3] - Axoguard Nerve Cap®: used to protect a peripheral nerve end and reduce the development of painful neuromas [3] Market Presence - Axogen's products are available in the United States, Canada, the United Kingdom, South Korea, and several other international markets [3] - The company addresses both scheduled and emergent procedures, highlighting its vital role in peripheral nerve repair [3]

Group 1 - AxoGen (AXGN) has experienced a significant downtrend, with a 25% decline in stock price over the past four weeks due to excessive selling pressure [1] - The stock is currently in oversold territory, indicated by an RSI reading of 28.96, suggesting a potential for a trend reversal [5] - Wall Street analysts have raised earnings estimates for AXGN by 9.1% over the last 30 days, indicating a positive outlook for the company's earnings [7] Group 2 - The Zacks Rank for AXGN is 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which supports the potential for a near-term turnaround [8]

[Part I - Financial Information](index=5&type=section&id=Part%20I%20-%20Financial%20Information) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company reported total assets of $196.2 million as of March 31, 2025, a decrease from $203.7 million at year-end 2024, with revenues of $48.6 million and a net loss of $3.8 million for the three months ended March 31, 2025 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets were $196.2 million, a decrease from $203.7 million at December 31, 2024, primarily due to reduced cash and cash equivalents, while total liabilities decreased to $90.8 million and shareholders' equity increased to $105.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,096 | $27,554 | | Total current assets | $93,070 | $99,217 | | Total assets | $196,165 | $203,728 | | **Liabilities & Equity** | | | | Total current liabilities | $21,745 | $30,610 | | Total liabilities | $90,800 | $99,821 | | Total shareholders' equity | $105,365 | $103,907 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, revenues increased 17.4% to $48.6 million, gross profit rose to $34.9 million despite a gross margin decrease to 71.9%, and the net loss narrowed to $3.8 million or ($0.08) per share Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenues | $48,560 | $41,378 | | Gross Profit | $34,933 | $32,620 | | Loss from operations | $(1,661) | $(4,560) | | Net loss | $(3,834) | $(6,635) | | Net loss per common share | $(0.08) | $(0.15) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In the first three months of 2025, net cash used in operating activities was $13.2 million, net cash provided by investing activities was $1.3 million, and financing activities provided $2.4 million, resulting in a net decrease in cash of $9.5 million Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,179) | $(12,266) | | Net cash provided by (used in) investing activities | $1,339 | $(3,251) | | Net cash provided by financing activities | $2,382 | $204 | | **Net decrease in cash** | **$(9,458)** | **$(15,313)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's focus on peripheral nerve repair, potential clawback of **$950,000** for unmet grant milestones, a disagreement with a lender over up to **$12 million** in make-whole payments, and high dependency on Ohio processing facilities - The company's business is focused on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair, with products including Avance® Nerve Graft and Axoguard® Nerve Protector. Substantially all revenues are derived from the U.S.[24](index=24&type=chunk) - The company has not met certain job creation milestones for economic development grants and could be obligated to pay back up to approximately **$950,000**. Discussions with grant authorities are ongoing[70](index=70&type=chunk)[71](index=71&type=chunk) - A disagreement exists with the lender (Oberland Capital) regarding the calculation of make-whole payments on the credit facility. The company's interpretation results in a zero make-whole payment at maturity, while the lender's alternative interpretation could result in payments of approximately **$9 million** for the first tranche and **$3 million** for the second tranche[72](index=72&type=chunk)[73](index=73&type=chunk) - The company is highly dependent on its processing facilities in Vandalia, Ohio (APC Facility) and Dayton, Ohio (leased from Solvita)[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reported a 17.4% revenue increase for Q1 2025, driven by unit volume and price/mix, despite a gross margin decline due to higher product costs and write-offs, while operating expenses decreased, and the company expects sufficient liquidity for the next twelve months, highlighted by the FDA's acceptance of the BLA for Avance® Nerve Graft - The FDA accepted the filing of the company's Biologics License Application (BLA) for Avance® Nerve Graft, with a PDUFA goal date of **September 5, 2025**. Key regulatory milestones were completed in Q1 2025 to support this timeline[87](index=87&type=chunk) - The company's strategy focuses on deepening its presence in high-potential accounts like Level 1 trauma centers and academic hospitals by expanding nerve repair indications and driving adoption of its surgical algorithm[80](index=80&type=chunk) - The company believes existing cash, investments, and cash from sales will fund operations for at least the **next twelve months**[98](index=98&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 revenue grew 17.4% to $48.6 million, driven by a 12.0% increase in unit volume, while gross margin fell to 71.9% due to higher product costs and inventory write-offs, and total operating expenses decreased 1.6% due to reduced R&D costs Revenue and Gross Profit Comparison (in thousands) | Metric | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $48,560 | $41,378 | +17.4% | | Gross Profit | $34,933 | $32,620 | +7.1% | | Gross Margin | 71.9% | 78.8% | -6.9 p.p. | - The increase in Q1 2025 revenue was driven by a **12.0% increase in unit volume**, a **3.2% impact from price changes**, and a **2.1% impact from product mix**[86](index=86&type=chunk) - R&D expenses decreased by **17.8% to $6.1 million**, primarily due to lower product development costs, including non-clinical expenses related to the BLA for Avance Nerve Graft[91](index=91&type=chunk) - Sales and marketing expenses increased **6.2% to $21.0 million** due to higher compensation, travel, and marketing program costs[90](index=90&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$22.1 million** in cash and investments, a decrease of **$11.4 million** from year-end 2024, with net cash used in operations at **$13.2 million** and **$50 million** in outstanding debt, which management asserts is sufficient for at least the next 12 months - Principal sources of liquidity as of March 31, 2025, were cash, cash equivalents, and investments totaling **$22.1 million**[97](index=97&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Operating activities | $(13,179) | $(12,266) | | Investing activities | $1,339 | $(3,251) | | Financing activities | $2,382 | $204 | - The company has **$50 million** in outstanding debt, with **$35 million** maturing in June 2027 and **$15 million** in June 2028. The interest rate was **11.91%** as of March 31, 2025[103](index=103&type=chunk) [Contractual Obligations and Commitments](index=28&type=section&id=Contractual%20Obligations%20and%20Commitments) The company has total contractual obligations of **$101.0 million**, primarily comprising a **$50.0 million** credit facility principal, **$32.2 million** in lease obligations, and **$15.2 million** in estimated interest payments Summary of Contractual Obligations (in thousands) | Contractual Obligations | Total | | :--- | :--- | | Credit Facility principal | $50,000 | | Credit Facility interest | $15,185 | | Credit Facility revenue participation payments | $1,975 | | Operating and financing lease obligations | $32,214 | | Insurance financing agreements | $1,432 | | Transition and separation obligations to former CEO | $151 | | **Total** | **$100,957** | [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure from its **$50 million** variable-rate credit facility, with a 100 basis point increase in interest rates estimated to increase annual interest expense by approximately **$500,000**, which is not considered material - The company has interest rate exposure from its **$50 million credit facility**, with an interest rate of **11.91%** as of March 31, 2025[107](index=107&type=chunk) - A **100 basis point** increase in interest rates would increase annual interest expense by approximately **$500,000**, which the company does not consider material[107](index=107&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[110](index=110&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[111](index=111&type=chunk) [Part II - Other Information](index=30&type=section&id=Part%20II%20-%20Other%20Information) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to various claims and lawsuits in the ordinary course of business, which management believes are either covered by insurance or are not expected to have a **material adverse effect** on the company's financial condition, results of operations, or cash flows - The company is involved in various legal proceedings in the ordinary course of business, which are not expected to have a **material adverse effect**[75](index=75&type=chunk)[113](index=113&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's **2024 Annual Report on Form 10-K** - No material changes to the risk factors disclosed in the **2024 Annual Report on Form 10-K** have occurred[114](index=114&type=chunk) [Other Information](index=30&type=section&id=Item%205.%20Other%20Information) During the first quarter of 2025, two directors adopted Rule 10b5-1 trading plans, with Amy Wendell planning to sell 5,000 shares and William Burke planning to sell 125,983 shares Rule 10b5-1 Trading Plan Adoptions | Name and Title | Action | Date | Securities to be Sold | | :--- | :--- | :--- | :--- | | Amy Wendell, Director | Adopt | 11/20/2024 | 5,000 | | William Burke, Director | Adopt | 3/14/2025 | 125,983 | [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) The filing includes key exhibits such as the forms for the **2025 Performance Stock Unit** and **Restricted Stock Unit Award Agreements**, along with certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act - Key exhibits filed include forms of **2025 Performance Stock Unit** and **Restricted Stock Unit award agreements**[121](index=121&type=chunk) - Certifications by the CEO and CFO pursuant to Sections **302** and **906** of the Sarbanes-Oxley Act were filed with the report[121](index=121&type=chunk)

Company Performance - AxoGen reported a quarterly loss of $0.02 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.01, but an improvement from a loss of $0.06 per share a year ago, indicating a 66.67% year-over-year improvement [1] - The company posted revenues of $48.56 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 0.61% and showing a year-over-year increase from $41.38 million [2] - Over the last four quarters, AxoGen has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Earnings Outlook - The current consensus EPS estimate for the coming quarter is $0.07 on revenues of $53.4 million, and for the current fiscal year, it is $0.23 on revenues of $217 million [7] - The estimate revisions trend for AxoGen is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6] Industry Context - The Medical - Instruments industry, to which AxoGen belongs, is currently in the top 28% of over 250 Zacks industries, indicating a strong industry performance [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact AxoGen's stock performance [5]

AxoGen (AXGN) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Michael Dale - President, CEO & Board DirectorNir Naor - Chief Financial OfficerJens Schroeder Kemp - Chief Marketing OfficerCaitlin Cronin - DirectorChris Pasquale - Partner - Medical Devices & SuppliesBrett Gasaway - VP - Equity ResearchMatthew Park - Equity Research AssociateRick Ditto - VP, Global Health Economics, Reimbursement & PolicyJayson Bedford - Managing Director - Medical Technology Conference Call Participants Mi ...

AxoGen (AXGN) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 Good morning, everyone. Joining me on today's call is Michael Dale, AxoGen's Chief Executive Officer and Director Nir Naor, Chief Financial Officer and Jens Kemp, Chief Marketing Officer. Michael will discuss first quarter twenty twenty five financial results and corporate highlights. Nir will then provide an analysis of our financial performance and guidance and discuss our outlook for the year, followed by a question and answer session. ...

THIS EXECUTIVE EMPLOYMENT AGREEMENT (the "Agreement"), effective as of May 12, 2025 (the "Effective Date"), is made by and between AXOGEN CORPORATION, a Delaware corporation ("AXOGEN"), and Lindsey Hartley ("Employee") (collectively, the "Parties"). RECITALS: WHEREAS, AXOGEN and the Employee desire to enter into this Agreement to state the terms and conditions of the Agreement in its entirety on the Effective Date on the terms and conditions set forth in this Agreement. NOW, THEREFORE, in consideration of t ...