Earnings summaries and quarterly performance for Axogen.
Executive leadership at Axogen.
Board of directors at Axogen.
Research analysts who have asked questions during Axogen earnings calls.
Caitlin Cronin
Canaccord Genuity
4 questions for AXGN
Also covers: ATEC, BVS, ENOV +10 more
David Turkaly
Citizens JMP
4 questions for AXGN
Also covers: FNA, HAE, LNTH +4 more
Jayson Bedford
Raymond James
4 questions for AXGN
Also covers: DXCM, IART, ICUI +7 more
Michael Sarcone
Jefferies
4 questions for AXGN
Also covers: ALC, CTSO, EDAP +11 more
Christopher Pasquale
Nephron Research
3 questions for AXGN
Also covers: ALC, BSX, COO +12 more
Ross Osborn
Cantor Fitzgerald
3 questions for AXGN
Also covers: CERS, CVRX, ELUT +12 more
Frank Takkinen
Lake Street Capital Markets
2 questions for AXGN
Also covers: ANGO, AORT, BBNX +17 more
Michael Kratky
Leerink Partners
2 questions for AXGN
Also covers: BBNX, DXCM, INSP +6 more
Brett Gasaway
Leerink Partners
1 question for AXGN
Also covers: TNDM
Chris Pasquale
Nephron Research LLC
1 question for AXGN
Also covers: ALC, BSX, COO +7 more
Matthew Park
Cantor Fitzgerald
1 question for AXGN
Also covers: BVS, CERS, ORGO +5 more
Mike Kratky
Leerink Partners
1 question for AXGN
Also covers: DXCM, INSP, MDT +4 more
Recent press releases and 8-K filings for AXGN.
Axogen Announces FDA Approval for AVANCE® Biologics License Application
AXGN
Product Launch
- Axogen, Inc. received U.S. Food and Drug Administration (FDA) approval for its Biologics License Application (BLA) for AVANCE® (acellular nerve allograft-arwx) on December 3, 2025.
- This approval reclassifies AVANCE® from a human tissue product to a biologic, confirming its use for treating peripheral nerve discontinuities in adult and pediatric patients.
- Commercial availability of the licensed AVANCE® product is expected early in the second quarter of 2026, with the product remaining available under the current tissue framework until then.
3 days ago
Axogen Receives FDA Approval for AVANCE Biologics License Application
AXGN
Product Launch
New Projects/Investments
- Axogen, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for AVANCE® (acellular nerve allograft-arwx).
- AVANCE is an acellular nerve scaffold indicated for the treatment of adult and pediatric patients aged one month or older with sensory, mixed, and motor peripheral nerve discontinuities.
- This approval shifts Avance's classification from a human tissue product to a biologic, clarifying and strengthening its regulatory footing and confirming its use for all present nerve repair cases.
- Commercial availability of the licensed Avance product is expected early in the second quarter of 2026.
3 days ago
Axogen Presents Strategic Vision and Growth Outlook
AXGN
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- Axogen's mission is to establish the restoration of peripheral nerve function as a standard of care, addressing significant, undertreated market opportunities in extremities, breast, OMF, head and neck, and prostate.
- The company's business is built upon its unique Avance human allograft, which facilitates nerve regeneration.
- Axogen projects 15%-20% year-on-year growth over its strategic planning period, aiming for continuous gross margin improvement and profitability, funded by organic cash flow. The company has met or exceeded its guidance through Q3 this year for revenue growth, gross margin, and cash flow.
- Current commercial insurance coverage stands at 64%, with expectations to achieve full coverage. Recent CMS payment changes are anticipated to significantly improve reimbursement and broader adoption of nerve repair.
- Strategic investments are focused on new product development for nerve protection, easier nerve coaptation, and the next generation of Avance, alongside expanding the commercial team.
4 days ago
Axogen Provides Business Update and Strategic Outlook
AXGN
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
- Axogen aims to establish peripheral nerve function restoration as a standard of care, targeting a large, untapped market opportunity across extremities, breast, OMF, head and neck, and prostate.
- The company's core offering includes the unique Avance allograft for nerve connection, along with protection and termination products for nerve repair.
- Axogen projects 15%-20% year-on-year growth over its strategic planning period, with continuous improvements in gross margin and profitability, funded by organic cash flow.
- The company has met or exceeded its guidance for overall revenue growth, gross margin, and cash flow through Q3 this year and expects to meet year-end guidance.
- Currently, Axogen has approximately 64% commercial life insurance coverage and expects to achieve near full coverage, supported by recent positive changes in CMS payment policies.
4 days ago
AxoGen CEO Confident in December 5th BLA Approval and Reiterates Growth Outlook
AXGN
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- AxoGen's CEO is confident that the Biologics License Application (BLA) for its peripheral nerve repair product will be approved on its PDUFA date of December 5th.
- The company anticipates significant benefits from BLA clearance, including reaffirming product safety and effectiveness, expanding commercial coverage from the current 66% to full coverage within 3-4 years, and enabling manufacturing efficiencies to improve gross margins.
- AxoGen expects to maintain a minimum 75% gross margin business, despite a one-time 1% impact on 2025 gross margin due to BLA-related costs.
- The company is targeting 15%-20% sales growth and believes the business can double within its strategic planning period, driven by expanding its stratified salesforce and addressing a U.S. market of 1.5 million nerve injuries with low current penetration.
Nov 18, 2025, 4:30 PM
AxoGen Discusses Growth Strategy and BLA Approval Outlook
AXGN
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- AxoGen, a leader in peripheral nerve repair, projects its business to double within the strategic planning period and has an LRP growth framework targeting 15%-20% sales growth.
- The company anticipates Biologics License Application (BLA) approval for its Avance product on December 5th, which is expected to drive significant operational efficiencies, cost reductions, and a transition to a unified quality system.
- Following BLA clearance, AxoGen expects a minimum gross margin of 75%, an increase from the current low 70%s, despite incurring one-time BLA-related costs of $2 million (1% of 2025 gross margin) and $7 million in stock-based compensation.
- AxoGen is actively expanding its sales footprint, including doubling its breast-focused salesforce from 11 to 22 in 2022, and aims to achieve full commercial coverage within three to four years from the current 66%.
Nov 18, 2025, 4:30 PM
Axogen Discusses Growth Strategy, BLA Progress, and Margin Expansion at Jefferies Conference
AXGN
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
- Axogen, a leader in peripheral nerve repair, projects its business can double within the next three to five years and maintains a long-range growth framework of 15%-20% sales growth.
- The company is highly confident in the December 5th PDUFA date for its Biologics License Application (BLA) approval, which is expected to reaffirm product safety and effectiveness, expand commercial coverage from the current 66%, and enable significant operational efficiencies by transitioning to a single quality system.
- Despite one-time BLA-related costs impacting 2025 gross margin by 1% (or $2 million), Axogen expects to maintain a minimum 75% gross margin business post-BLA, driven by efficiency gains from automating processes like electronic batch records.
- Axogen has doubled its breast-focused salesforce from 11 to 22 and expects new representatives to reach break-even and accretion within six to nine months.
Nov 18, 2025, 4:30 PM
Axogen Reports Strong Q3 2025 Results and Updates Full-Year Guidance
AXGN
Earnings
Guidance Update
Revenue Acceleration/Inflection
- 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).
- The company's gross margin for Q3 2025 was 76.6%, and adjusted EBITDA reached $9.2 million, with a 15.4% margin.
- 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%.
- 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.
- 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.
Oct 29, 2025, 12:00 PM
Axogen Reports Strong Q3 2025 Results and Updates Full-Year Guidance
AXGN
Earnings
Guidance Update
Revenue Acceleration/Inflection
- 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. 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).
- Gross profit for Q3 2025 was $46 million, with a gross margin of 76.6%, an increase from 74.9% in Q3 2024.
- 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.
- Axogen raised its full-year 2025 revenue growth guidance to at least 19%, projecting revenue of at least $222.8 million.
- The discontinuation of the case stock sales program for Avance Nerve Graft positively impacted Q3 revenue by an estimated $1.6 million (3%). 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.
Oct 29, 2025, 12:00 PM
AXGN announces Q3 2025 financial results and raises full-year guidance
AXGN
Earnings
Guidance Update
Revenue Acceleration/Inflection
- AXGN reported Q3 2025 revenue of $60.1 million, marking a 23.5% year-over-year increase.
- 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.
- AXGN anticipates FDA approval for Avance® Nerve Graft as a Biologic in the US on December 5, 2025.
- 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%.
- Operational cash, including cash, cash equivalents, restricted cash, and investments, was $39.8 million as of September 30, 2025.
Oct 29, 2025, 12:00 PM
Quarterly earnings call transcripts for Axogen.
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