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.
CC
Caitlin Cronin
Canaccord Genuity
4 questions for AXGN
Also covers: ATEC, BVS, ENOV +10 more
DT
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
MS
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
RO
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
MP
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 Discusses BLA Approval, Strategic Growth, and Financial Milestones at J.P. Morgan Conference
AXGN
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- AxoGen announced the completion of the Biologics License Application (BLA) approval for its Avance Nerve Graft in December, establishing it as the first-of-its-kind approved biologic therapeutic solution for nerve discontinuities.
- The company projects 15%-20% annual growth over its strategic planning period, an acceleration from past performance, and has achieved operational leverage, positive cash flow, and profitability. Post-BLA, it anticipates a 75% plus gross margin business.
- Strategic market expansion includes high double-digit growth in breast reconstruction and the development of prostate as a new market application, with clinical signals expected in the second half of 2026.
- Reimbursement efforts have added almost 20 million covered lives last year, and a new CMS level three code for outpatient nerve procedures, effective January 1st, 2026, is expected to make these procedures more economical.
3 days ago
AxoGen Highlights BLA Approval, Growth Outlook, and Financial Milestones
AXGN
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- AxoGen recently achieved Biologics License Application (BLA) approval for its Avance Nerve Graft in December, transitioning it from a device regulatory status to the first-of-its-kind approved biologic therapeutic solution for nerve discontinuities. This is expected to aid in payer engagement and enable more aggressive clinical studies.
- The company projects 15%-20% annual growth over its strategic planning period, an acceleration from the previous five years' 15% growth. This growth is primarily driven by volume.
- AxoGen has reached a financial inflection point, achieving operational leverage, positive cash flow, and profitability. Post-BLA, they anticipate becoming a 75% plus gross margin business, with further improvements expected in 2027.
- Key market developments include a new prostate application with clinical signals expected in the second half of 2026 , and the breast reconstruction (Resensation) business, which is a high double-digit growth area with a 70%-90% addressable market.
- Reimbursement progress includes adding almost 20 million covered lives in the last year and the introduction of a new Level III CMS code for outpatient nerve procedures starting January 1, 2026, which is expected to make these procedures more economical.
3 days ago
AXGN Reports Preliminary 2025 Revenue and Outlines Strategic Growth and Reimbursement Improvements
AXGN
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
- Axogen (AXGN) reported preliminary and unaudited revenue of $225.2 million for 2025 and projects a Revenue CAGR of 15% - 20% for its 2025-2028 Strategic Plan.
- The company expects positive Adjusted EBITDA of $7.8 million in 2025 and anticipates being cashflow positive each year, with operational cashflow exceeding $60 million per year by the end of 2028.
- Avance is highlighted as the first approved biologic treatment for nerve discontinuities and the only FDA approved biologic nerve scaffold.
- CMS is set to improve facility payments in 2026 with a new outpatient code group, increasing reimbursement for CPT Code 64912 (Allograft nerve repair) to $8,965 for hospitals (+40% YoY) and $6,157 for Ambulatory Surgery Centers (+35% YoY).
- Axogen targets a $5.6 billion US Nerve Care Opportunity and is focusing on market development in areas like prostate surgery, which represents a $754 million Total Addressable Market (TAM).
3 days ago
AxoGen Discusses BLA Approval Impact, Growth Strategy, and Financial Milestones at J.P. Morgan Healthcare Conference
AXGN
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- AxoGen recently secured Biologics License Application (BLA) approval for its Avance Nerve Graft, marking it as the first-of-its-kind approved biologic therapeutic for nerve discontinuities, a milestone expected to facilitate full reimbursement coverage by 2028 and streamline manufacturing operations.
- The company projects 15%-20% annual growth over its strategic planning period and expects to be a 75% plus gross margin business post-BLA, having reached a financial inflection point by generating positive cash flow and profitability.
- Key growth drivers include the extremities business and breast reconstruction, with the emerging prostate market expected to show clinical signals in the second half of 2026. Additionally, a new CMS level three code, effective January 1, 2026, is anticipated to make nerve care more economical in outpatient settings.
3 days ago
Axogen, Inc. Reports Preliminary Unaudited Revenue for Fourth Quarter and Full-Year 2025
AXGN
Earnings
Guidance Update
Revenue Acceleration/Inflection
- Axogen, Inc. announced preliminary unaudited fourth quarter 2025 revenue is expected to be approximately $59.9 million, marking a 21.3% increase over the fourth quarter of 2024.
- Preliminary unaudited full-year 2025 revenue is expected to be approximately $225.2 million, representing a 20.2% increase over full-year 2024.
- Gross margin for both the fourth quarter and full-year 2025 is expected to be above 74%, including approximately $1.9 million in one-time costs related to the FDA Biologics License Application (BLA) approval of Avance®.
- The balance of cash, cash equivalents, restricted cash, and investments on December 31, 2025, is expected to be approximately $45.5 million, an increase of approximately $6.0 million over the balance at the end of 2024.
- The FDA approved the BLA for Avance® (acellular nerve allograft-arwx) on December 3, 2025.
6 days ago
Axogen Announces Preliminary Q4 and Full-Year 2025 Results
AXGN
Earnings
Guidance Update
Revenue Acceleration/Inflection
- Axogen expects preliminary fourth quarter 2025 revenue of approximately $59.9 million, a 21.3% increase over Q4 2024, and full-year 2025 revenue of approximately $225.2 million, a 20.2% increase over full-year 2024.
- Gross margin for both the fourth quarter and full-year 2025 is anticipated to be above 74%, including approximately $1.9 million in one-time costs related to the FDA BLA approval of Avance®.
- The company's cash, cash equivalents, restricted cash, and investments balance is expected to be approximately $45.5 million as of December 31, 2025, an increase of approximately $6.0 million from the end of 2024.
- The FDA approved the Biologics License Application (BLA) for Avance® (acellular nerve allograft-arwx) on December 3, 2025.
6 days ago
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.
Dec 4, 2025, 1:03 AM
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.
Dec 4, 2025, 1:01 AM
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.
Dec 2, 2025, 5:30 PM
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.
Dec 2, 2025, 5:30 PM
Quarterly earnings call transcripts for Axogen.
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