ALACHUA, Fla. - Axogen, Inc. (NASDAQ: AXGN), a company specializing in surgical solutions for peripheral nerve injuries, has announced the appointment of Michael Dale as its new Chief Executive Officer and member of its Board of Directors, effective tomorrow. Michael Dale succeeds Karen Zaderej, who will continue to serve in an advisory capacity for the next nine months.
Paul Thomas has also been appointed as the new Chairman of the Board, starting from the same date. Thomas, a current board member with over three decades of healthcare industry experience, will take over the role to help steer the company toward its strategic goals.
The leadership changes come as Axogen aims to focus on commercial expansion, revenue growth, and achieving sustainable positive cash flow and profitability. Amy Wendell, Axogen’s Lead Director, expressed gratitude for Zaderej's 18-year tenure, highlighting her significant role in the company's achievements and the development of the peripheral nerve repair market.
Dale brings over 30 years of experience in the medical device sector, with a history of leading transformative companies in various medical fields. He expressed enthusiasm for his new role, emphasizing Axogen's credible business purpose and technological advantages.
As part of his employment package, Dale has been granted 600,000 performance stock units (PSUs), with 450,000 PSUs tied to company stock price goals over three years and 150,000 PSUs vesting upon the approval of the company’s biologics license application for Avance Nerve Graft within a specified performance period.
Axogen is recognized for its commitment to peripheral nerve regeneration and repair, offering a range of products used in different surgical specialties. The company's portfolio includes Avance® Nerve Graft, Axoguard Nerve Connector®, Axoguard Nerve Protector®, and other specialized products.
The information in this article is based on a press release statement from Axogen, Inc.
In other recent news, Axogen, Inc. has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for its Avance Nerve Graft. This move marks the first step in the application process, with the non-clinical data package already submitted.
The rolling submission could expedite the FDA's review process, and the previously received Regenerative Medicine Advanced Therapy (RMAT) designation may further streamline development and review.
The RMAT designation, part of the 21st Century Cures Act, could provide Axogen with FDA guidance on the drug development process and potentially offer a priority review, shortening the standard review period.
Axogen plans to complete the BLA filing in the third quarter of 2024, with the potential for FDA approval around mid-2025. The company will submit the remaining Clinical and Chemistry, Manufacturing, and Controls components in the upcoming months.
These are the latest developments in Axogen's pursuit of peripheral nerve regeneration and repair solutions, with its products available in several international markets.
InvestingPro Insights
As Axogen, Inc. (NASDAQ: AXGN) welcomes Michael Dale into the role of CEO and Paul Thomas as the new Chairman, the company's financial health and market performance remain critical for investors monitoring the transition. According to InvestingPro data, Axogen's market capitalization stands at $346.14 million. The company's revenue has shown a positive trend with a growth of 13.51% over the last twelve months as of Q1 2024, indicating a solid commercial performance.
InvestingPro Tips for Axogen highlight that the company's liquid assets currently exceed its short-term obligations, which may provide some financial flexibility in executing its strategic goals under the new leadership. However, analysts do not anticipate Axogen to be profitable this year, and the company has not been profitable over the last twelve months. This aligns with the company's focus on achieving sustainable positive cash flow and profitability, as mentioned in the leadership announcement.
The stock's performance has seen a strong return over the last three months, with a price total return of 34.92%, reflecting investor optimism. This may be a point of interest for those considering the company's potential for growth, especially with the new management at the helm. Despite not paying dividends, which is typical for growth-focused companies, Axogen's high return over the last decade suggests a history of strong market performance.
For investors looking for a deeper dive into Axogen's performance and prospects, there are additional InvestingPro Tips available at https://www.investing.com/pro/AXGN. These tips can offer more insights into the company's financial metrics and market position, which could be valuable in assessing the impact of the new CEO and Chairman on the company's future.
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