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1. Company Snapshot

1.a. Company Description

AxoGen, Inc., together with its subsidiaries, develops and markets surgical solutions for physical damage or transection to peripheral nerves.The company's products include Avance Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site; AxoGuard Nerve Connector, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed peripheral nerves; and AxoGuard Nerve Protector, a porcine submucosa ECM product that is used to wrap and protect damaged peripheral nerves, as well as reinforces the nerve reconstruction while preventing soft tissue attachments.Its products also comprise Axoguard Nerve Cap, a porcine submucosa ECM product that is used to protect a peripheral nerve end, as well as separates the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive Soft Tissue Membrane, a processed human umbilical cord membrane that can be used as a resorbable soft tissue covering to separate tissues in the surgical bed.


In addition, the company offers AxoTouch two point discriminator, a tool that is used for measuring the innervation density of surface area of the skin.It provides its products to hospitals, surgery centers, and military hospitals plastic reconstructive surgeons, orthopedic and plastic hand surgeons, and various oral and maxillofacial surgeons in the United States, Canada, Germany, the United Kingdom and other European countries, South Korea, and internationally.AxoGen, Inc.


is headquartered in Alachua, Florida.

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1.b. Last Insights on AXGN

AxoGen, Inc.'s positive drivers include a strong outlook from Wall Street analysts, who expect a 31.2% upside in the stock, driven by increasing optimism about its earnings prospects. The company's recent rating upgrade to "Buy" reflects growing confidence in its growth potential. The addition of Craig Swandal, an experienced medical device manufacturing executive, as VP of Operations is also expected to drive growth. With the company set to report its 2024 fourth quarter and full year financial results on February 25, investors are likely to focus on its continued innovation in surgical solutions for peripheral nerve injuries.

1.c. Company Highlights

2. AxoGen's Q3 Earnings: Strong Revenue Growth and BLA Progress

AxoGen reported Q3 revenue of $60.1 million, a 23.5% increase from the same period last year, driven by strong sales of Avance Nerve Graft. The company's gross profit was $46 million, with a gross margin of 76.6%, up from 74.9% in Q3 2024. The adjusted net income was $6.1 million or $0.12 per share, beating estimates of $0.09 per share. Operating expenses increased to $44.1 million, but as a percentage of revenue, decreased by 2.2%. The company ended the quarter with $39.8 million in cash, cash equivalents, restricted cash, and investments, demonstrating its ability to be free cash flow positive for the year.

Publication Date: Nov -29

📋 Highlights
  • Revenue Growth:: Q3 revenue hit $60.1M (+23.5% YoY), driven by Avance Nerve Graft sales.
  • Gross Margin Expansion:: Gross margin rose to 76.6% (up from 74.9% in Q3 2024), contributing to $46M gross profit.
  • BLA Approval Timeline:: Avance Nerve Graft’s BLA on track for Dec 2025, granting 12 years of market exclusivity.
  • 2025 Guidance Raised:: Revenue growth target increased to at least 19% ($222.8M), with gross margin guidance of 73-75%.
  • Financial Position:: Ended Q3 with $39.8M in cash, and adjusted net income of $6.1M ($0.12/share) despite higher operating expenses.

Revenue Growth and Guidance

The company raised its revenue growth guidance for 2025 to at least 19%, or revenue of at least $222.8 million. Consensus is embedding about 16% revenue growth, but AxoGen has done better than that for three quarters in a row. The revenue growth was driven by typical price increases, and the mix is the same as what they see historically. The company expects to continue its growth trajectory, with plans to incrementally hire on a quarterly basis across all target markets, expanding the sales footprint for several years going forward.

BLA Progress and Commercial Coverage

AxoGen's BLA for Avance Nerve Graft is on track for approval in December 2025, which will provide 12 years of market exclusivity from biosimilar nerve allografts. Label discussions are on track for November, and the PDUFA date is December 5. A positive BLA outcome will support market development efforts and guidelines development. Commercial coverage increased to 64%, primarily reflecting refinement in data. The company is a few weeks away from engaging national payers currently listed as investigational experimental.

Valuation and Growth Prospects

AxoGen's current P/S Ratio is 6.13, and EV/EBITDA is 61.11. Analysts estimate next year's revenue growth at 15.8%. The company's strong revenue growth and progress on its BLA application position it for future growth. A positive BLA outcome will unlock better coverage, particularly in the US, and enable future growth, including potential international market discussions.

Future Plans and Expectations

The company has protocols in development for Level 1 evidence across their portfolio, including breast, and will have one or more studies to kick off formally during 2026. AxoGen assumes a positive outcome for their prostate market efforts but won't see clinical feedback until the middle part of 2026. All segments, including breast, extremity, and OMF, are profitable, and progress in each segment is accretive to the business.

3. NewsRoom

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Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)

Dec -04

Source: globenewswire.com

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FDA approves Axogen's nerve repair graft

Dec -03

Source: reuters.com

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Avance Nerve Graft FDA Verdict Approaches, Why Investors Are Watching Axogen

Dec -01

Source: seekingalpha.com

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Wasatch Micro Cap Value Fund Q3 2025 Contributors And Detractors

Nov -05

Source: seekingalpha.com

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Axogen, Inc. (AXGN) Q3 2025 Earnings Call Transcript

Oct -29

Source: seekingalpha.com

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AxoGen (AXGN) Q3 Earnings and Revenues Top Estimates

Oct -29

Source: zacks.com

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Axogen, Inc. Reports Third Quarter 2025 Financial Results

Oct -29

Source: globenewswire.com

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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Axogen, Inc. - AXGN

Oct -18

Source: prnewswire.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (12.00%)

6. Segments

Peripheral Nerve Regeneration and Repair

Expected Growth: 12.0%

AxoGen's Peripheral Nerve Regeneration and Repair segment growth is driven by increasing adoption of Avance Nerve Graft, increasing awareness of peripheral nerve damage, and growing demand for minimally invasive procedures. Additionally, expansion into new markets, strategic partnerships, and investments in R&D are expected to contribute to the 12.0% growth.

7. Detailed Products

Avance Nerve Graft

A human nerve allograft that provides a natural, biocompatible conduit for nerve regeneration and repair.

Avance Flowable

A flowable, human nerve allograft that provides a natural, biocompatible conduit for nerve regeneration and repair.

AxoGuard Nerve Protector

A porcine-derived, bioabsorbable nerve protector that provides a natural, biocompatible barrier for nerve protection and repair.

AxoGuard Nerve Connector

A porcine-derived, bioabsorbable nerve connector that provides a natural, biocompatible conduit for nerve repair and reconstruction.

8. AxoGen, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

AxoGen, Inc. faces moderate threat from substitutes due to the availability of alternative treatments for peripheral nerve damage, such as autografts and synthetic conduits.

Bargaining Power Of Customers

AxoGen, Inc.'s customers, primarily surgeons and hospitals, have limited bargaining power due to the company's specialized products and limited competition.

Bargaining Power Of Suppliers

AxoGen, Inc. relies on a limited number of suppliers for raw materials, giving them moderate bargaining power, but the company's strong relationships and diversified supply chain mitigate this risk.

Threat Of New Entrants

The threat of new entrants is low due to the high barriers to entry in the medical device industry, including regulatory hurdles and significant R&D investments required to develop competitive products.

Intensity Of Rivalry

The peripheral nerve repair market is highly competitive, with several established players, leading to a high intensity of rivalry among companies like AxoGen, Inc.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 33.48%
Debt Cost 9.26%
Equity Weight 66.52%
Equity Cost 9.26%
WACC 9.26%
Leverage 50.33%

11. Quality Control: AxoGen, Inc. passed 4 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
SI-BONE

A-Score: 4.7/10

Value: 7.0

Growth: 5.8

Quality: 5.6

Yield: 0.0

Momentum: 6.0

Volatility: 4.0

1-Year Total Return ->

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Stock-Card
AxoGen

A-Score: 4.0/10

Value: 2.6

Growth: 7.1

Quality: 3.9

Yield: 0.0

Momentum: 8.0

Volatility: 2.7

1-Year Total Return ->

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Stock-Card
Allurion Technologies

A-Score: 4.0/10

Value: 9.6

Growth: 3.2

Quality: 5.6

Yield: 0.0

Momentum: 5.0

Volatility: 0.7

1-Year Total Return ->

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Stock-Card
TELA Bio

A-Score: 3.3/10

Value: 7.8

Growth: 5.8

Quality: 3.6

Yield: 0.0

Momentum: 1.0

Volatility: 1.3

1-Year Total Return ->

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Stock-Card
Xtant Medical

A-Score: 3.0/10

Value: 6.2

Growth: 2.9

Quality: 3.9

Yield: 0.0

Momentum: 3.5

Volatility: 1.3

1-Year Total Return ->

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Stock-Card
Orthofix Medical

A-Score: 2.8/10

Value: 4.8

Growth: 1.3

Quality: 2.5

Yield: 0.0

Momentum: 3.0

Volatility: 5.0

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

31.73$

Current Price

31.73$

Potential

-0.00%

Expected Cash-Flows