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AxoGen (AXGN)
NASDAQ:AXGN
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AxoGen (AXGN) AI Stock Analysis

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AXGN

AxoGen

(NASDAQ:AXGN)

Rating:69Neutral
Price Target:
$16.00
▲(3.90% Upside)
AxoGen's overall stock score reflects strong revenue growth and strategic execution, as highlighted in the earnings call. Technical indicators support a positive outlook, but valuation concerns due to negative earnings and profitability challenges weigh on the score.
Positive Factors
Financial Performance
AXGN reported 2Q25 sales of $56.7mn, which is 8% higher than the consensus.
Regulatory Milestones
AXGN completed significant regulatory milestones related to the Avance Nerve Graft BLA, including a late-cycle meeting and inspections under the FDA’s Bioresearch Monitoring program.
Revenue Growth
Management noted that revenue growth was broad-based with double-digit percentage growth in all markets.
Negative Factors
Gross Margin Concerns
Lower-than-expected gross and Adjusted EBITDA in 1Q25 margin may prompt investor questions.
Regulatory Uncertainty
The delayed PDUFA date adds some additional uncertainty on the setup through year-end.
Stock Price Target
Lower price target to $24 from $26 due to retracted comparative multiples for the small cap group.

AxoGen (AXGN) vs. SPDR S&P 500 ETF (SPY)

AxoGen Business Overview & Revenue Model

Company DescriptionAxoGen, 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.
How the Company Makes MoneyAxoGen generates revenue primarily through the sale of its nerve repair products to hospitals and surgical centers. Their revenue model is based on the direct sales of their core products, which are used in various surgical procedures, particularly in the fields of orthopedics, plastic surgery, and neurosurgery. The company also benefits from reimbursement from insurance providers for its products, which makes them more accessible to healthcare providers and patients. Significant partnerships with healthcare institutions and participation in clinical studies further enhance their product visibility and credibility, contributing to increased sales. Additionally, AxoGen invests in research and development to innovate and expand its product offerings, aiming to capture a larger share of the growing market for nerve repair solutions.

AxoGen Earnings Call Summary

Earnings Call Date:Aug 05, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 11, 2025
Earnings Call Sentiment Positive
The earnings call reflected strong revenue growth and successful strategic execution, particularly in high potential accounts and surgeon training. Challenges remain with gross margin pressures and potential logistical changes due to the BLA approval process. However, the overall financial performance and raised guidance indicate a positive trajectory.
Q2-2025 Updates
Positive Updates
Strong Revenue Growth
Q2 sales increased to $56.7 million, growing 18.3% year-over-year. This reflects double-digit growth across all nerve repair target markets, including extremities, oral maxillofacial and head and neck, and breast.
High Potential Accounts Performance
Approximately 70% of revenue growth driven by high potential accounts. Average high potential account productivity is up 21% year-over-year.
Surgeon Training Success
Met or on track to meet 2025 training targets across all segments, including breast, extremities, and oral maxillofacial and head and neck.
Commercial Coverage Expansion
17 million additional lives covered year-to-date, bringing coverage amongst commercial payers to more than 55%.
Financial Performance and Outlook
Net income for the quarter was $0.6 million, compared to a net loss of $1.9 million in the second quarter of 2024. Adjusted EBITDA for the quarter was $9.3 million. Revenue guidance for 2025 raised to at least 17% growth.
Negative Updates
Decreased Gross Margin for First Half of 2025
Gross margin for the first half of 2025 was 73.1%, 3% less than the first half of 2024. This was driven by a 2.8% increase in year-over-year product cost.
Impact of BLA Approval Process on Logistics
There may be changes in logistics and mechanics due to the BLA approval process, potentially impacting supply chain dynamics.
Company Guidance
During the second quarter 2025 earnings call, Axogen provided updated guidance for the fiscal year. The company reported a significant Q2 sales increase of 18.3% to $56.7 million compared to the same period last year, driven by double-digit growth across all target markets, including extremities, oral maxillofacial, and breast. Gross profit rose to $42 million, with a gross margin of 74.2%. Operating expenses reached $40.3 million, highlighting enhanced operating leverage. Axogen achieved a net income of $0.6 million, or $0.01 per share, with adjusted net income at $5.7 million, or $0.12 per share. The company raised its full-year revenue growth guidance to at least 17%, projecting a minimum of $219 million in revenue, and maintained its gross margin guidance between 73% and 75%. Axogen anticipates BLA approval for Avance Nerve Graft in September, securing 12 years of market exclusivity, and expects to remain net cash flow positive, self-funding its strategic plan through growing operational cash flow.

AxoGen Financial Statement Overview

Summary
AxoGen's financial performance shows positive revenue growth and improved cash flow management. However, profitability challenges persist with a negative net profit margin and return on equity, despite a strong gross profit margin and low leverage.
Income Statement
65
Positive
AxoGen's income statement shows a positive revenue growth trend with a 4.5% increase in TTM, indicating a steady demand for its products. However, the company is still facing profitability challenges, as evidenced by the negative net profit margin of -2.3% in TTM. The gross profit margin remains strong at 74.3%, suggesting efficient production processes. The EBIT and EBITDA margins have improved, but remain low, indicating ongoing operational challenges.
Balance Sheet
70
Positive
The balance sheet reflects a stable financial position with a low debt-to-equity ratio of 0.18 in TTM, indicating conservative leverage. However, the return on equity is negative at -4.4%, highlighting profitability issues. The equity ratio is healthy, suggesting a strong asset base relative to liabilities.
Cash Flow
60
Neutral
Cash flow analysis reveals significant improvement in free cash flow growth at 278.5% in TTM, indicating better cash management. The operating cash flow to net income ratio is 0.29, showing moderate cash generation relative to earnings. However, the free cash flow to net income ratio of 0.77 suggests that cash flow is not yet fully supporting profitability.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue203.27M187.34M159.01M138.58M127.36M112.30M
Gross Profit150.96M141.98M127.87M114.44M104.43M90.72M
EBITDA10.84M6.08M-13.33M-23.47M-20.89M-19.27M
Net Income-4.66M-9.96M-21.72M-28.95M-26.98M-23.79M
Balance Sheet
Total Assets205.45M203.73M196.83M195.39M208.02M201.38M
Cash, Cash Equivalents and Short-Term Investments35.92M33.48M31.02M48.79M84.09M103.97M
Total Debt68.19M68.69M69.29M67.43M67.45M54.63M
Total Liabilities93.18M99.82M101.16M94.39M95.47M78.23M
Stockholders Equity112.28M103.91M95.67M101.00M112.55M123.15M
Cash Flow
Free Cash Flow5.54M11.00K-20.63M-37.32M-41.80M-32.22M
Operating Cash Flow7.19M4.54M-5.72M-16.07M-13.40M-9.63M
Investing Cash Flow-11.42M-10.30M19.25M-3.20M-23.65M-16.96M
Financing Cash Flow5.08M2.29M1.95M1.79M20.45M40.47M

AxoGen Technical Analysis

Technical Analysis Sentiment
Positive
Last Price15.40
Price Trends
50DMA
13.34
Positive
100DMA
13.03
Positive
200DMA
14.93
Positive
Market Momentum
MACD
0.71
Positive
RSI
56.55
Neutral
STOCH
66.67
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AXGN, the sentiment is Positive. The current price of 15.4 is above the 20-day moving average (MA) of 15.27, above the 50-day MA of 13.34, and above the 200-day MA of 14.93, indicating a bullish trend. The MACD of 0.71 indicates Positive momentum. The RSI at 56.55 is Neutral, neither overbought nor oversold. The STOCH value of 66.67 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AXGN.

AxoGen Risk Analysis

AxoGen disclosed 63 risk factors in its most recent earnings report. AxoGen reported the most risks in the "Legal & Regulatory" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

AxoGen Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
69
Neutral
$722.86M-4.48%17.17%72.68%
62
Neutral
$709.67M-14.18%22.93%43.83%
56
Neutral
$596.94M-0.10%5.08%99.38%
54
Neutral
$588.07M-24.63%4.84%0.85%
54
Neutral
$554.97M45.80-46.17%1.48%-6091.13%
52
Neutral
$452.07M26.25%
51
Neutral
$7.91B-0.36-41.70%2.23%23.45%-1.86%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AXGN
AxoGen
15.40
2.15
16.23%
OFIX
Orthofix
14.70
-2.33
-13.68%
AVNS
Avanos Medical
12.66
-11.47
-47.53%
SIBN
SI-Bone
16.35
0.52
3.28%
BVS
Bioventus
7.10
-2.56
-26.50%
CBLL
Ceribell, Inc.
12.33
-13.17
-51.65%

AxoGen Corporate Events

Product-Related AnnouncementsRegulatory Filings and Compliance
FDA Extends Review for AxoGen’s Avance Nerve Graft
Neutral
Aug 25, 2025

On August 22, 2025, Axogen, Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for the Avance® Nerve Graft by three months to December 5, 2025. This extension follows the FDA’s classification of Axogen’s recent submission of new manufacturing and facility information as a Major Amendment, necessitating additional review time. The FDA also plans to provide feedback on product labeling in November 2025. This development is significant for Axogen as it continues to transition Avance Nerve Graft from a tissue product to a BLA-approved biologic, potentially impacting its market positioning and stakeholder interests.

Business Operations and StrategyFinancial Disclosures
Axogen Reports Strong Q2 2025 Financial Results
Positive
Aug 5, 2025

On August 5, 2025, Axogen, Inc. reported its financial results for the second quarter of 2025, showcasing a significant revenue increase of 18.3% compared to the same period in 2024. The company also raised its full-year revenue guidance to at least 17% growth, or $219 million, reflecting strong market development strategies and commercial execution. The quarter saw broad-based revenue growth across all markets, including Extremities, Oral Maxillofacial & Head and Neck, and Breast. Additionally, Axogen expanded coverage and reimbursement for nerve repair, adding approximately 10 million new covered lives in 2025. The U.S. FDA accepted the company’s Biologics License Application for Avance® Nerve Graft, with a goal date for approval set for September 5, 2025.

Shareholder MeetingsBusiness Operations and Strategy
AxoGen Holds Annual Shareholder Meeting with Key Votes
Neutral
Jun 20, 2025

On June 18, 2025, AxoGen, Inc. held its annual meeting of shareholders where five proposals were voted on, including the election of eight directors, ratification of Deloitte & Touche LLP as auditors, approval of executive compensation, amendment of the long-term incentive plan, and the frequency of future votes on executive compensation. The outcomes of these votes are expected to influence the company’s governance and operational strategies, potentially impacting its market positioning and stakeholder engagement.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Aug 26, 2025