Caitlin Cronin

David Turkaly

Jayson Bedford

Michael Sarcone

Christopher Pasquale

Ross Osborn

Frank Takkinen

Michael Kratky

Brett Gasaway

Chris Pasquale

Matthew Park

Mike Kratky

- Axogen reported **Q3 2025 revenue of $60.1 million**, marking a **23.5% increase** compared to the third quarter of 2024, and achieved **net income of $0.7 million** ($0.01 per share) and **adjusted net income of $6.1 million** ($0.12 per share).  **[0000805928_2216050_1]** **[0000805928_2216050_5]** 
- The company's **gross margin** for Q3 2025 was **76.6%**, and **adjusted EBITDA** reached **$9.2 million**, with a **15.4% margin**.  **[0000805928_2216050_5]** 
- Axogen raised its **full-year 2025 revenue guidance** to **at least 19% growth**, projecting revenue of **at least $222.8 million**, and reaffirmed its gross margin guidance of **73%-75%**.  **[0000805928_2216050_6]** 
- The Biologics License Application (BLA) for Avance Nerve Graft is expected to be approved in **December 2025**, with a PDUFA date of **December 5**, which will grant **12 years of market exclusivity**.  **[0000805928_2216050_0]** **[0000805928_2216050_4]** 
- The discontinuation of the case stock sales program for Avance Nerve Graft positively impacted Q3 revenue by **$1.6 million** (3%) as customers shifted to direct sales, a factor to consider for Q4 modeling.  **[0000805928_2216050_2]** **[0000805928_2216050_5]** **[0000805928_2216050_7]**

Axogen Reports Strong Q3 2025 Results and Updates Full-Year Guidance

- **Axogen (AXGN) reported Q3 2025 revenue of $60.1 million, marking a 23.5% increase year-over-year** and a 6% sequential increase from Q2 2025.  **[0000805928_2215863_5]**  The company achieved **net income of $0.7 million ($0.01 per share)** and **adjusted net income of $6.1 million ($0.12 per share)**.  **[0000805928_2215863_5]** 
- **Gross profit for Q3 2025 was $46 million, with a gross margin of 76.6%**, an increase from 74.9% in Q3 2024.  **[0000805928_2215863_5]** 
- The **PDUFA goal date for the Avance Nerve Graft Biologics License Application (BLA) has been extended to December 5, 2025**, due to a major amendment related to facility and manufacturing information.  **[0000805928_2215863_3]** **[0000805928_2215863_4]** 
- Axogen **raised its full-year 2025 revenue growth guidance to at least 19%**, projecting **revenue of at least $222.8 million**.  **[0000805928_2215863_6]** 
- The discontinuation of the case stock sales program for Avance Nerve Graft positively impacted Q3 revenue by an estimated **$1.6 million (3%)**.  **[0000805928_2215863_5]**  Additionally, **1.1 million new lives were covered** for nerve care in Q3 2025, bringing the year-to-date total to **18.1 million additional covered lives**.  **[0000805928_2215863_3]**

- AXGN reported Q3 2025 revenue of **$60.1 million**, marking a **23.5%** year-over-year increase.  **[0000805928_2210747:6]** **[0000805928_2210747:7]** 
- The company achieved **Adjusted Net Income of $6.1 million** and **Adjusted Diluted EPS of $0.12** for Q3 2025, compared to $3.1 million and $0.07, respectively, in Q3 2024.  **[0000805928_2210747:8]** **[0000805928_2210747:9]** 
- AXGN anticipates FDA approval for Avance® Nerve Graft as a Biologic in the US on **December 5, 2025**.  **[0000805928_2210747:7]** 
- Full-year 2025 guidance has been raised, projecting revenue growth of at least **19%** (totaling **$222.8 million**) and a gross margin between **73% and 75%**.  **[0000805928_2210747:8]** 
- Operational cash, including cash, cash equivalents, restricted cash, and investments, was **$39.8 million** as of September 30, 2025.  **[0000805928_2210747:8]**

AXGN announces Q3 2025 financial results and raises full-year guidance

- AxoGen reported **Q3 2025 revenue of $60.1 million**, marking a **23.5% growth** compared to Q3 2024 and a **6% sequential increase** over Q2 2025.  **[0000805928_2211182_5]** 
- The company achieved a **gross profit of $46 million** and a **gross margin of 76.6%** for Q3 2025.  **[0000805928_2211182_5]** 
- **Net income for Q3 2025 was $0.7 million** or **$0.01 per share**, with **adjusted net income at $6.1 million** or **$0.12 per share**.  **[0000805928_2211182_5]** 
- AxoGen anticipates the **Biologics License Application (BLA) approval for Avance Nerve Graft by December 5, 2025**, which is expected to secure **12 years of market exclusivity**.  **[0000805928_2211182_0]** **[0000805928_2211182_4]** 
- The company **raised its full-year 2025 revenue growth guidance to at least 19%**, targeting **at least $222.8 million** in revenue, and expects to be **net cash flow positive** for the year.  **[0000805928_2211182_6]**

AxoGen Reports Strong Q3 2025 Results and Updates BLA Approval Timeline

- Axogen, Inc. reported **third quarter 2025 revenue of $60.1 million**, representing a **23.5% increase** compared to the third quarter of 2024.  **[805928_0000805928-25-000128_ex991axgnearningsreleaseda.htm:0]** 
- The company achieved **net income of $0.7 million, or $0.01 per share**, for Q3 2025, a significant improvement from a net loss of $1.9 million, or $0.04 per share, in the third quarter of 2024.  **[805928_0000805928-25-000128_ex991axgnearningsreleaseda.htm:0]** 
- **Adjusted EBITDA for the third quarter was $9.2 million**, compared to $6.5 million for the third quarter of 2024.  **[805928_0000805928-25-000128_ex991axgnearningsreleaseda.htm:0]** 
- Axogen **raised its full-year 2025 revenue guidance to at least 19% growth, or $222.8 million**.  **[805928_0000805928-25-000128_ex991axgnearningsreleaseda.htm:0]** **[805928_0000805928-25-000128_ex991axgnearningsreleaseda.htm:1]** 
- FDA approval for the Avance® Nerve Graft Biologics License Application (BLA) is now anticipated by **December 5, 2025**.  **[805928_0000805928-25-000128_ex991axgnearningsreleaseda.htm:0]**

Axogen, Inc. Reports Strong Q3 2025 Financial Results and Raises Full-Year Guidance

- Axogen reported **third quarter 2025 revenue of $60.1 million**, marking a **23.5% increase** compared to the third quarter of 2024.  **[805928_7790db95205743e5b530dc862b0d093a_0]** 
- For the third quarter of 2025, the company achieved **net income of $0.7 million**, or **$0.01 per share**, and **Adjusted EBITDA of $9.2 million**.  **[805928_7790db95205743e5b530dc862b0d093a_0]** 
- The company **raised its 2025 revenue guidance** to at least **19% growth**, or **$222.8 million** for the full year, and continues to expect to be **net cash flow positive**.  **[805928_7790db95205743e5b530dc862b0d093a_2]** 
- Axogen noted new position statements from the American Association of Hand Surgery (AAHS) and the American Society for Reconstructive Microsurgery (ASRM) recognizing nerve allograft as a standard medical practice, and the **FDA extended the PDUFA goal date for the Avance® Nerve Graft Biologics License Application (BLA) to December 5, 2025**.  **[805928_7790db95205743e5b530dc862b0d093a_0]** **[805928_7790db95205743e5b530dc862b0d093a_1]**

Axogen Reports Third Quarter 2025 Financial Results and Updates 2025 Guidance

- The U.S. Food and Drug Administration (FDA) has **extended the review period** for Axogen's Biologics License Application (BLA) for the Avance Nerve Graft by **three months to December 5, 2025**.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- This extension was triggered by the submission of **substantial new manufacturing and facility information**, which the FDA classified as a **'major amendment'**.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- The FDA anticipates providing feedback on **product labeling in November 2025**.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- Despite the delay, analysts maintain a **'Buy' rating** on Axogen stock with a **price target of $17.00**, citing strong revenue growth and strategic execution.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- Axogen's share price experienced a **notable drop in premarket trading** following the FDA's decision.  **[805928_e22f9c20d96d47f1ac1225b176003118]**