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Axogen, Inc. (NASDAQ: AXGN) is a leading medical products company specializing in the science, development, and commercialization of technologies for peripheral nerve repair and regeneration. The company's core mission is to restore peripheral nerve function and improve the quality of life for patients suffering from traumatic injuries or surgical procedures that impact nerve function and sensation.
Axogen's innovative product portfolio includes:
- Avance® Nerve Graft: The first and only commercially available allograft for bridging nerve discontinuities.
- Axoguard® Nerve Connector: A coaptation aid designed for the close approximation of severed nerves.
- Axoguard® Nerve Protector: A product that shields nerves during the healing process.
- Axoguard® Nerve Cap: A surgical implant to isolate and protect a peripheral nerve end, minimizing painful neuroma development.
- Axoguard HA+ Nerve Protector: A next-gen nerve protection device designed to provide both short- and long-term protection for peripheral nerve injuries.
- Avive® Soft Tissue Membrane: A biologically active product aiding in nerve healing.
- Axotouch® Two-Point Discriminator: An assessment tool for measuring the innervation density of skin surface areas.
Axogen's products are available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries. The company continues to expand its global presence and partnerships, ensuring that healthcare providers and surgeons have access to clinically and economically effective nerve repair solutions.
Recent achievements include the launch of the Axoguard HA+ Nerve Protector, which provides enhanced nerve gliding and protection for a wide range of peripheral nerve injuries. The company reported strong performance in Q4 2023, with an expected annual revenue growth of 11% to 14% and anticipated gross margins between 76% and 79%.
For more information, visit www.axogeninc.com.
Axogen (NASDAQ: AXGN) reported Q3 2024 financial results with revenue of $48.6 million, up 17.9% year-over-year. Gross margin decreased to 74.9% from 76.8% in Q3 2023. Net loss improved to $1.9 million ($0.04 per share) compared to $4.1 million ($0.10 per share) last year. Adjusted EBITDA reached $6.5 million, up from $2.4 million in Q3 2023.
The FDA accepted the company's Biologics License Application for Avance Nerve Graft with a PDUFA date of September 5th, 2025. Axogen maintains full-year revenue guidance of $182-186 million and expects to be at the high end of its 74-76% gross margin range.
Axogen (NASDAQ: AXGN), a global leader in surgical solutions for peripheral nerve injuries, has announced it will release its third quarter 2024 financial results on Thursday, November 7, 2024, before market opening. The company will host an investment-community conference call and webcast at 8 a.m. ET on the same day. Investors can participate via phone by dialing (877) 407-0993 (toll-free) or (201) 689-8795, or listen online through the Investors page at www.axogeninc.com. A replay will be available on the company's website after the call.
Axogen (NASDAQ: AXGN) has completed the rolling submission process for its Biologics License Application (BLA) to the FDA for Avance Nerve Graft®. This marks a significant step in transitioning Avance from a tissue to a biologic. The company expects FDA notification on submission acceptance and review timeline within 60 days. Avance Nerve Graft has previously received Regenerative Medicine Advanced Therapy (RMAT) designation, potentially streamlining the development process. Axogen has requested priority review status, which could reduce the review timeline from 10 months to 6 months. The company anticipates an FDA determination of approvability between April and September of next year.
Axogen (NASDAQ: AXGN), a leader in surgical solutions for peripheral nerve injuries, has granted an equity inducement award to a new non-executive employee on September 3, 2024. The award, approved by the Compensation Committee of Axogen's Board of Directors, complies with NASDAQ Listing Rule 5635(c)(4) and serves as a material inducement for the employee's acceptance of employment.
The award consists of restricted stock units (RSUs) representing 10,000 shares of Axogen's common stock. The RSUs have a 4-year vesting schedule: 50% vesting after two years, followed by 25% vesting annually for the next two years.
Axogen (NASDAQ: AXGN) announces significant leadership changes effective August 9, 2024. Michael Dale is appointed as the new CEO and Director, succeeding Karen Zaderej, who will remain in an advisory role for nine months. Paul Thomas, a current board member, will become the new Chairman of the Board.
Dale brings over 30 years of experience in leading medical technology companies. The company aims to focus on commercial expansion, broad-based revenue growth, and driving toward sustainable positive cash flow and profitability. As part of his employment agreement, Dale was granted 600,000 performance stock units, with vesting tied to stock price goals and the approval of Axogen's biologics license application for Avance Nerve Graft®.
Axogen, Inc. (NASDAQ: AXGN) reported strong financial results for Q2 2024. Revenue increased by 25.6% to $47.9 million compared to Q2 2023. The company's net loss narrowed to $1.9 million ($0.04 per share), down from $6.7 million in Q2 2023. Adjusted net income was $2.0 million ($0.05 per share), and adjusted EBITDA reached $5.6 million.
Axogen's gross margin decreased to 73.8% from 77.7% in Q2 2023. The company's cash position improved to $27.1 million. Core Accounts grew by 18.7% year-over-year to 412. Axogen initiated the rolling submission process for its Biologics License Application for Avance Nerve Graft® and expects to complete it in Q3 2024.
The company increased its 2024 revenue guidance to $182-$186 million and adjusted gross margin guidance to 74-76%. Axogen anticipates being net cash flow positive from April 1st through year-end.
Axogen, Inc. (NASDAQ: AXGN), a leader in surgical solutions for peripheral nerve injuries, has announced it will release its second quarter 2024 financial results on Thursday, August 8, 2024, before the market opens. The company will host an investment-community conference call and webcast at 8 a.m. ET following the release.
Investors can participate in the conference call by dialing (877) 407-0993 (toll-free) or (201) 689-8795 (direct). The webcast will be available on the Investors page of Axogen's website. A replay of the call will be accessible in the Investors section of the company's website after the conference.
Axogen, a leader in surgical solutions for peripheral nerve injuries, announced an inducement grant under NASDAQ listing rule 5635(c)(4) on July 1, 2024, in connection with the hire of a new non-executive employee. The grant includes 10,000 restricted stock units (RSUs) as part of an Inducement Equity Incentive plan. These RSUs will vest over four years, with 50% vesting after the second year and 25% vesting each year for the next two years, contingent on continuous employment. The grant, approved by Axogen's Compensation Committee, aims to serve as a material inducement for the new hire who commenced employment on June 17, 2024.
Axogen has launched Avive+ Soft Tissue Matrix™, a new product designed to serve as a soft tissue barrier, aiding in peripheral nerve healing.
This resorbable, multi-layer amniotic membrane allograft conforms to FDA requirements for Human Cellular and Tissue-based Products (HCT/P). It provides temporary protection and tissue separation during the critical healing phase.
Company leadership highlighted Avive+'s role in addressing the $800 million nerve protection market composed of various injuries such as carpal and cubital tunnel syndromes and crush injuries.
Avive+ complements Axogen’s existing products like Axoguard Nerve Protector® and Axoguard HA+ Nerve Protector™. Clinical feedback suggests the product enhances patient outcomes in acute traumatic injury cases.
Axogen, a leader in peripheral nerve injury solutions, announced the opening of its Axogen Processing Center (APC) in Vandalia, Ohio. The state-of-the-art facility will process Avance Nerve Graft®, designed to treat peripheral nerve deficits. The 107,000 sq. ft. center features ISO14644 clean rooms, quality labs, and training facilities, providing three times the previous processing capacity. With plans for expansion, the center employs nearly 100 professionals, addressing FDA regulatory transitions from section 361 tissue product to section 351 biologic. The opening ceremony on June 12, 2024, will include remarks from company leaders and tours of the new facility.
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