Axogen Inc Stock Price, News & Analysis

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.

Axogen has begun the rolling submission of its Biologics License Application (BLA) for Avance Nerve Graft to the FDA as of May 15, 2024. This milestone marks a important step in transitioning Avance Nerve Graft to a biologic. The initial submission includes non-clinical data, with clinical and manufacturing data to follow. Avance Nerve Graft has received Regenerative Medicine Advanced Therapy (RMAT) designation, providing benefits such as FDA guidance and potential priority review. Axogen aims to complete the BLA filing by Q3 2024, anticipating approval by mid-2025.

Axogen, a leader in surgical solutions for peripheral nerve injuries, announced its participation in the Leerink Partners Healthcare Crossroads Conference.

CEO Karen Zaderej will engage in a fireside chat on May 29, 2024, at 3:40 p.m. CT / 4:40 p.m. ET in Austin, TX.

The event will be webcast live and later archived for 90 days on the company's Investors page.

Axogen, Inc. reported a 12.9% increase in revenue in the first quarter of 2024, reaching $41.4 million. The company's gross margin improved to 78.8%, while net loss decreased to $6.6 million. Adjusted net loss was $2.7 million, with adjusted EBITDA at $1.0 million. Cash, cash equivalents, and investments totaled $23.6 million. Axogen is focusing on reaching profitability, with upcoming product launches and submission milestones.

Axogen, Inc. (NASDAQ: AXGN) announces the first surgical implants of its Avive+ Soft Tissue Matrix™, a resorbable barrier for nerve injuries. The product aims to enhance nerve protection during healing phases. Surgeon feedback is positive, with a national launch expected in Q2 2024. Avive+ is a placenta-based allograft processed under FDA regulations to address various nerve injuries and defects, offering promising solutions for patients experiencing nerve trauma.