Group 1 - AxoGen (AXGN) has experienced a significant downtrend, with a 25% decline in stock price over the past four weeks due to excessive selling pressure [1] - The stock is currently in oversold territory, indicated by an RSI reading of 28.96, suggesting a potential for a trend reversal [5] - Wall Street analysts have raised earnings estimates for AXGN by 9.1% over the last 30 days, indicating a positive outlook for the company's earnings [7] Group 2 - The Zacks Rank for AXGN is 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which supports the potential for a near-term turnaround [8]

[Part I - Financial Information](index=5&type=section&id=Part%20I%20-%20Financial%20Information) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company reported total assets of $196.2 million as of March 31, 2025, a decrease from $203.7 million at year-end 2024, with revenues of $48.6 million and a net loss of $3.8 million for the three months ended March 31, 2025 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets were $196.2 million, a decrease from $203.7 million at December 31, 2024, primarily due to reduced cash and cash equivalents, while total liabilities decreased to $90.8 million and shareholders' equity increased to $105.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,096 | $27,554 | | Total current assets | $93,070 | $99,217 | | Total assets | $196,165 | $203,728 | | **Liabilities & Equity** | | | | Total current liabilities | $21,745 | $30,610 | | Total liabilities | $90,800 | $99,821 | | Total shareholders' equity | $105,365 | $103,907 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, revenues increased 17.4% to $48.6 million, gross profit rose to $34.9 million despite a gross margin decrease to 71.9%, and the net loss narrowed to $3.8 million or ($0.08) per share Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenues | $48,560 | $41,378 | | Gross Profit | $34,933 | $32,620 | | Loss from operations | $(1,661) | $(4,560) | | Net loss | $(3,834) | $(6,635) | | Net loss per common share | $(0.08) | $(0.15) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In the first three months of 2025, net cash used in operating activities was $13.2 million, net cash provided by investing activities was $1.3 million, and financing activities provided $2.4 million, resulting in a net decrease in cash of $9.5 million Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,179) | $(12,266) | | Net cash provided by (used in) investing activities | $1,339 | $(3,251) | | Net cash provided by financing activities | $2,382 | $204 | | **Net decrease in cash** | **$(9,458)** | **$(15,313)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's focus on peripheral nerve repair, potential clawback of **$950,000** for unmet grant milestones, a disagreement with a lender over up to **$12 million** in make-whole payments, and high dependency on Ohio processing facilities - The company's business is focused on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair, with products including Avance® Nerve Graft and Axoguard® Nerve Protector. Substantially all revenues are derived from the U.S.[24](index=24&type=chunk) - The company has not met certain job creation milestones for economic development grants and could be obligated to pay back up to approximately **$950,000**. Discussions with grant authorities are ongoing[70](index=70&type=chunk)[71](index=71&type=chunk) - A disagreement exists with the lender (Oberland Capital) regarding the calculation of make-whole payments on the credit facility. The company's interpretation results in a zero make-whole payment at maturity, while the lender's alternative interpretation could result in payments of approximately **$9 million** for the first tranche and **$3 million** for the second tranche[72](index=72&type=chunk)[73](index=73&type=chunk) - The company is highly dependent on its processing facilities in Vandalia, Ohio (APC Facility) and Dayton, Ohio (leased from Solvita)[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reported a 17.4% revenue increase for Q1 2025, driven by unit volume and price/mix, despite a gross margin decline due to higher product costs and write-offs, while operating expenses decreased, and the company expects sufficient liquidity for the next twelve months, highlighted by the FDA's acceptance of the BLA for Avance® Nerve Graft - The FDA accepted the filing of the company's Biologics License Application (BLA) for Avance® Nerve Graft, with a PDUFA goal date of **September 5, 2025**. Key regulatory milestones were completed in Q1 2025 to support this timeline[87](index=87&type=chunk) - The company's strategy focuses on deepening its presence in high-potential accounts like Level 1 trauma centers and academic hospitals by expanding nerve repair indications and driving adoption of its surgical algorithm[80](index=80&type=chunk) - The company believes existing cash, investments, and cash from sales will fund operations for at least the **next twelve months**[98](index=98&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 revenue grew 17.4% to $48.6 million, driven by a 12.0% increase in unit volume, while gross margin fell to 71.9% due to higher product costs and inventory write-offs, and total operating expenses decreased 1.6% due to reduced R&D costs Revenue and Gross Profit Comparison (in thousands) | Metric | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $48,560 | $41,378 | +17.4% | | Gross Profit | $34,933 | $32,620 | +7.1% | | Gross Margin | 71.9% | 78.8% | -6.9 p.p. | - The increase in Q1 2025 revenue was driven by a **12.0% increase in unit volume**, a **3.2% impact from price changes**, and a **2.1% impact from product mix**[86](index=86&type=chunk) - R&D expenses decreased by **17.8% to $6.1 million**, primarily due to lower product development costs, including non-clinical expenses related to the BLA for Avance Nerve Graft[91](index=91&type=chunk) - Sales and marketing expenses increased **6.2% to $21.0 million** due to higher compensation, travel, and marketing program costs[90](index=90&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$22.1 million** in cash and investments, a decrease of **$11.4 million** from year-end 2024, with net cash used in operations at **$13.2 million** and **$50 million** in outstanding debt, which management asserts is sufficient for at least the next 12 months - Principal sources of liquidity as of March 31, 2025, were cash, cash equivalents, and investments totaling **$22.1 million**[97](index=97&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Operating activities | $(13,179) | $(12,266) | | Investing activities | $1,339 | $(3,251) | | Financing activities | $2,382 | $204 | - The company has **$50 million** in outstanding debt, with **$35 million** maturing in June 2027 and **$15 million** in June 2028. The interest rate was **11.91%** as of March 31, 2025[103](index=103&type=chunk) [Contractual Obligations and Commitments](index=28&type=section&id=Contractual%20Obligations%20and%20Commitments) The company has total contractual obligations of **$101.0 million**, primarily comprising a **$50.0 million** credit facility principal, **$32.2 million** in lease obligations, and **$15.2 million** in estimated interest payments Summary of Contractual Obligations (in thousands) | Contractual Obligations | Total | | :--- | :--- | | Credit Facility principal | $50,000 | | Credit Facility interest | $15,185 | | Credit Facility revenue participation payments | $1,975 | | Operating and financing lease obligations | $32,214 | | Insurance financing agreements | $1,432 | | Transition and separation obligations to former CEO | $151 | | **Total** | **$100,957** | [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure from its **$50 million** variable-rate credit facility, with a 100 basis point increase in interest rates estimated to increase annual interest expense by approximately **$500,000**, which is not considered material - The company has interest rate exposure from its **$50 million credit facility**, with an interest rate of **11.91%** as of March 31, 2025[107](index=107&type=chunk) - A **100 basis point** increase in interest rates would increase annual interest expense by approximately **$500,000**, which the company does not consider material[107](index=107&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[110](index=110&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[111](index=111&type=chunk) [Part II - Other Information](index=30&type=section&id=Part%20II%20-%20Other%20Information) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to various claims and lawsuits in the ordinary course of business, which management believes are either covered by insurance or are not expected to have a **material adverse effect** on the company's financial condition, results of operations, or cash flows - The company is involved in various legal proceedings in the ordinary course of business, which are not expected to have a **material adverse effect**[75](index=75&type=chunk)[113](index=113&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's **2024 Annual Report on Form 10-K** - No material changes to the risk factors disclosed in the **2024 Annual Report on Form 10-K** have occurred[114](index=114&type=chunk) [Other Information](index=30&type=section&id=Item%205.%20Other%20Information) During the first quarter of 2025, two directors adopted Rule 10b5-1 trading plans, with Amy Wendell planning to sell 5,000 shares and William Burke planning to sell 125,983 shares Rule 10b5-1 Trading Plan Adoptions | Name and Title | Action | Date | Securities to be Sold | | :--- | :--- | :--- | :--- | | Amy Wendell, Director | Adopt | 11/20/2024 | 5,000 | | William Burke, Director | Adopt | 3/14/2025 | 125,983 | [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) The filing includes key exhibits such as the forms for the **2025 Performance Stock Unit** and **Restricted Stock Unit Award Agreements**, along with certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act - Key exhibits filed include forms of **2025 Performance Stock Unit** and **Restricted Stock Unit award agreements**[121](index=121&type=chunk) - Certifications by the CEO and CFO pursuant to Sections **302** and **906** of the Sarbanes-Oxley Act were filed with the report[121](index=121&type=chunk)

Company Performance - AxoGen reported a quarterly loss of $0.02 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.01, but an improvement from a loss of $0.06 per share a year ago, indicating a 66.67% year-over-year improvement [1] - The company posted revenues of $48.56 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 0.61% and showing a year-over-year increase from $41.38 million [2] - Over the last four quarters, AxoGen has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Earnings Outlook - The current consensus EPS estimate for the coming quarter is $0.07 on revenues of $53.4 million, and for the current fiscal year, it is $0.23 on revenues of $217 million [7] - The estimate revisions trend for AxoGen is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6] Industry Context - The Medical - Instruments industry, to which AxoGen belongs, is currently in the top 28% of over 250 Zacks industries, indicating a strong industry performance [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact AxoGen's stock performance [5]

Financial Data and Key Metrics Changes - Revenue for the first quarter increased to $48.6 million, representing a 17.4% growth compared to the same period last year, driven by a 14% increase in unit volume and a 3% increase in price [22][24] - Gross profit for the quarter was $34.9 million, with a gross margin of approximately 71.9%, down from 78.8% year-over-year [22][23] - The company reported a net loss of $3.8 million or $0.08 per share, compared to a net loss of $6.6 million or $0.15 per share in the first quarter of the previous year [25] Business Line Data and Key Metrics Changes - The extremities market experienced double-digit growth, with continued adoption of the nerve protection portfolio [12] - In the breast segment, there was a 16% increase in the number of surgeons performing breast resensation procedures, totaling 254 surgeons [15] - The oral, maxillofacial, and head and neck markets showed strong growth from the adoption of the nerve algorithm in mandible reconstruction procedures [15] Market Data and Key Metrics Changes - The company is targeting to generate approximately 66% of its growth in 2025 from high potential accounts, with an average account productivity increase of 24% in the first quarter [10][11] - There were 566 active high potential accounts at the end of the first quarter, representing a 5% increase compared to the same period last year [11] Company Strategy and Development Direction - The company is focused on making nerve care a standard of care for all patients, leveraging clinical evidence and societal support [8][19] - Plans to expand commercial infrastructure include adding sales representatives and conducting professional education programs [12][13] - The biologics license application (BLA) for the advanced nerve graft is on track, with expectations for approval in September [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth strategy, highlighting broad-based growth across the portfolio and the importance of high potential accounts [8][9] - The company anticipates improvements in gross margin following BLA approval and the implementation of process improvements [23][26] Other Important Information - A leadership transition was announced, with Nir Naor stepping down as CFO and Lindsay Hartley appointed as the new CFO [5][6] - The company is maintaining its full-year 2025 revenue growth guidance in the range of 15% to 17% [26] Q&A Session Summary Question: Insights on Avance and BLA approval process - Management does not expect major changes to ordering or shipment for Avance post-approval, and reimbursement pathways will remain unchanged [34] Question: Gross margin concerns - The one-time inventory write-offs were significant, and management expects gross margin to improve throughout the year, particularly after BLA approval [36][37] Question: Sales team expansion - The company plans to have approximately 20 net new sales representatives by the end of the year, with hiring running slightly behind schedule [46] Question: High potential accounts initiative - There are approximately 780 high potential accounts, with 566 active accounts, and management sees opportunities to expand within existing and new accounts [52][53] Question: Clinical studies and evidence generation - Management is committed to generating level one evidence to support clinical adoption and reimbursement, with plans for additional studies [62] Question: BLA process and major checkpoints - The next major milestone is the late cycle meeting with the FDA, and management is confident in the progress made so far [98]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 reached $48.6 million, representing a 17.4% increase compared to Q1 2024, driven by a 14% increase in unit volume and a 3% increase in price [21][22] - Gross profit for the quarter was $34.9 million, with a gross margin of approximately 71.9%, down from 78.8% in the same period last year [22][24] - The company reported a net loss of $3.8 million or $0.08 per share, compared to a net loss of $6.6 million or $0.15 per share in Q1 2024 [25] Business Line Data and Key Metrics Changes - The extremities market experienced double-digit growth, with continued adoption of the nerve protection portfolio [10] - In the breast segment, there was a 16% increase in the number of surgeons performing breast resensation procedures, with 254 active surgeons in Q1 2025 [12][13] - The oral, maxillofacial, and head and neck markets saw strong growth from the adoption of the nerve algorithm in mandible reconstruction procedures [13] Market Data and Key Metrics Changes - The company reported an increase in average account productivity of 24% in high potential accounts, exceeding the target of 21% [9] - There were 566 active high potential accounts at the end of Q1 2025, representing a 5% increase compared to Q1 2024 [9] - The prostate clinical and market development plan is on track, with three clinical pilot sites confirmed and discussions ongoing with additional sites [15][16] Company Strategy and Development Direction - The company aims to make nerve care a standard of care for all patients, focusing on high potential hospital providers and physicians [6][8] - Plans for 2025 include expanding the commercial infrastructure and increasing the number of sales representatives in high potential territories [10][11] - The company is advancing its therapeutic reconstruction program and exploring next-generation applications for its protection technologies [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the BLA process for the advanced nerve graft, expecting approval in September 2025 [20] - The company anticipates improvements in gross margin following BLA approval, with ongoing process and quality system enhancements [23][26] - Management remains optimistic about achieving full-year revenue growth guidance in the range of 15% to 17% for 2025 [26][27] Other Important Information - A leadership transition was announced, with Lindsay Hartley succeeding Nir Naor as Chief Financial Officer [4][5] - The company is maintaining its focus on generating clinical evidence to support its technologies and improve surgeon confidence [17][18] Q&A Session Summary Question: Insights on Avance and BLA approval process - Management does not expect major changes to ordering or shipment for Avance post-approval, and reimbursement pathways will remain unchanged [36] Question: Impact of one-time inventory write-offs on gross margin - Significant one-time inventory write-offs impacted Q1 gross margin, but improvements are expected throughout the year [38][39] Question: Status of high potential accounts - There are approximately 780 high potential accounts, with 566 active in Q1 2025; opportunities exist to expand within existing accounts and establish new relationships [56][57] Question: Update on sales team expansion - The company plans to have approximately 20 net new sales representatives by the end of the year, with ongoing recruitment efforts [50][72] Question: BLA process and major checkpoints - The next major milestone is the late cycle meeting with the FDA, where the company will review progress and address any outstanding questions [100]

THIS EXECUTIVE EMPLOYMENT AGREEMENT (the "Agreement"), effective as of May 12, 2025 (the "Effective Date"), is made by and between AXOGEN CORPORATION, a Delaware corporation ("AXOGEN"), and Lindsey Hartley ("Employee") (collectively, the "Parties"). RECITALS: WHEREAS, AXOGEN and the Employee desire to enter into this Agreement to state the terms and conditions of the Agreement in its entirety on the Effective Date on the terms and conditions set forth in this Agreement. NOW, THEREFORE, in consideration of t ...

Core Viewpoint - Axogen, Inc. reported strong financial results for Q1 2025, highlighting robust revenue growth and progress towards long-term objectives, with a focus on enhancing sales productivity and commercial execution [3][5]. Financial Results - Q1 2025 revenue reached $48.6 million, marking a 17.4% increase compared to Q1 2024 [6]. - Gross margin for Q1 2025 was 71.9%, down from 78.8% in Q1 2024, attributed to increased product costs and inventory write-offs [6][7]. - The net loss for the quarter was $3.8 million, or $0.08 per share, an improvement from a net loss of $6.6 million, or $0.15 per share, in Q1 2024 [6][20]. - Adjusted net loss for the quarter was $0.9 million, or $0.02 per share, compared to $2.7 million, or $0.06 per share, in Q1 2024 [6][20]. - Adjusted EBITDA was $2.9 million for the quarter, up from $1.0 million in Q1 2024 [6][20]. Business Highlights - Revenue growth was broad-based across the product portfolio, with double-digit growth in all markets, including Extremities, Oral Maxillofacial & Head and Neck, and Breast [7]. - The FDA accepted the filing of the Biologics License Application (BLA) for Avance® Nerve Graft, with a goal date for approval set for September 5, 2025 [7]. - Regulatory milestones completed in Q1 2025 included a mid-cycle meeting with the FDA and clinical trial site inspections [7]. - Lindsey Hartley, CPA, was appointed as the new Chief Financial Officer effective May 12, 2025, succeeding Nir Naor [7]. 2025 Financial Guidance - The company maintains its full-year revenue growth guidance in the range of 15% to 17% and expects gross margin to be between 73% and 75% [5]. - The company anticipates being net cash flow positive for the full year [5].

Core Insights - Axogen, Inc. has appointed Lindsey Hartley, CPA, as the new Chief Financial Officer, effective May 12, 2025, succeeding Nir Naor, who will remain in an advisory role until July 1, 2025 [1][2] Company Overview - Axogen, Inc. is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring health and improving quality of life through innovative technologies [3][4] - The company offers a range of products including Avance Nerve Graft, Axoguard Nerve Connector, and Axoguard Nerve Protector, which are designed to aid in the repair and protection of peripheral nerves [4][5] Leadership Transition - Michael Dale, President and CEO of Axogen, expressed gratitude for Nir Naor's contributions, highlighting improvements in operating expense and cash flow management during his tenure [2] - Lindsey Hartley brings over 19 years of financial leadership experience, having previously served as Vice President, Corporate Controller at Axogen, where she improved financial reporting processes and reduced month-end close time by 40% [2][3] Strategic Focus - Lindsey Hartley aims to emphasize financial discipline and strategic growth initiatives to support Axogen's mission of restoring nerve function and transforming patients' lives [3]

Core Viewpoint - Axogen, Inc. is set to report its first quarter financial results for 2025 on May 8, 2025, and will host a conference call for the investment community shortly after the release [1]. Company Overview - Axogen, Inc. is a leader in developing and marketing surgical solutions specifically for peripheral nerve injuries, focusing on restoring nerve function and improving patients' quality of life [3]. - The company offers a comprehensive portfolio of products for peripheral nerve repair, including Avance Nerve Graft®, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Avive+ Soft Tissue Matrix™, and Axoguard Nerve Cap® [3]. - Axogen's products are utilized across various surgical specialties and applications, addressing both scheduled and emergent procedures related to peripheral nerve damage [3]. Product Applications - Scheduled procedures include nerve reconstruction for conditions caused by nerve defects, such as breast reconstruction post-mastectomy and oral and maxillofacial surgeries [3]. - Emergent procedures typically arise from traumatic injuries, requiring immediate or timely intervention by specialists [3]. - The company's products are available in multiple markets, including the United States, Canada, the United Kingdom, South Korea, and several European and international markets [3].

ALACHUA, Fla. and TAMPA, Fla., March 24, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the appointment of Rick Ditto as Vice President, Global Health Economics, Reimbursement & Policy. Mr. Ditto will report to Michael Dale, President, and Chief Executive Officer, and will lead the development of the coverage and reimbursement-related strategies required to support Axogen’s mission ...