ALACHUA, Fla. – Axogen, Inc. (Nasdaq: AXGN), a company specializing in surgical solutions for peripheral nerve injuries, announced the appointment of Michael Dale as its new Chief Executive Officer and member of the Board of Directors, effective tomorrow . Michael Dale succeeds Karen Zaderej, who will remain as an advisor for the next nine months.
Paul Thomas has also been appointed as the new Chairman of the Board, effective from the same date. Thomas, a current board member with more than three decades of experience in the healthcare industry, will take over the role to help guide the company toward its strategic goals.
Amid this leadership change, Axogen’s goal is to focus on commercial expansion, revenue growth and achieving sustainable positive cash flow and profitability. Axogen Chief Director Amy Wendell expressed her gratitude to Zaderej for her 18-year tenure, emphasizing the important role she has played in the company’s achievements and the development of the peripheral nerve repair market.
Dale has more than 30 years of experience in the medical device industry and has a history of leading transformative companies in various healthcare sectors. He expressed enthusiasm for his new role and emphasized Axogen’s credible business purpose and technological advantages.
As part of his hiring plan, Dale received 600,000 performance stock units (PSUs), with 450,000 PSUs tied to the company’s three-year stock price target and 150,000 PSUs vesting upon approval of the company’s Avance neural transplant biologics license application. Specified performance period.
Recognized for its commitment to peripheral nerve regeneration and repair, Axogen offers a range of products for use in different surgical specialties. The company’s product portfolio includes Avance® Nerve Grafts, Axoguard Nerve Connector®, Axoguard Nerve Protector® and other specialty products.
The information in this article is based on press release statements from Axogen, Inc.
In other recent news, Axogen, Inc. has initiated a rolling submission process to the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for its Avance nerve graft. The move marks the first step in the application process, with the non-clinical package having been submitted.
Rolling submissions can expedite the FDA review process, and previously obtained Regenerative Medicine Advanced Therapy (RMAT) designation may further streamline development and review.
The RMAT designation is part of the 21st Century Cures Act and could provide Axogen with FDA guidance on the drug development process and potentially provide priority review, thereby shortening the standard review cycle.
Axogen plans to complete BLA filing in the third quarter of 2024 and may receive FDA approval around mid-2025. The company will submit the remaining clinical and chemistry, manufacturing and control components in the coming months.
These are the latest developments in Axogen’s pursuit of peripheral nerve regeneration and repair solutions, with its products already sold in multiple international markets.
Investment Professional Insights
Axogen, Inc. (NASDAQ: AXGN) welcomes Michael Dale as CEO and Paul Thomas as its new chairman, with the company’s financial health and market performance remaining critical to investors monitoring the transition. Axogen has a market capitalization of $346.14 million, according to InvestingPro. The company’s revenue showed a positive trend over the past 12 months as of the first quarter of 2024, growing by 13.51%, indicating solid business performance.
Axogen’s InvestingPro Tips highlights that the company’s liquid assets currently exceed its short-term debt, which may provide new leadership with some financial flexibility to execute on its strategic goals. However, analysts don’t expect Axogen to be profitable this year, and the company hasn’t been profitable in the past 12 months. This is consistent with the company’s focus on achieving sustainable positive cash flow and profitability, as mentioned in the leadership announcement.
The stock has performed strongly over the past three months, with a total share price return of 34.92%, reflecting investor optimism. This may be a point of interest for those considering the company’s growth potential, especially with new management at the helm. Despite not paying a dividend, which is typical for growth-focused companies, Axogen’s high returns over the past decade demonstrate its history of strong market performance.
For investors wishing to gain a deeper understanding of Axogen’s performance and prospects, additional InvestingPro tips are available at https://www.investing.com/pro/AXGN. These techniques can provide a deeper understanding of a company’s financial metrics and market position, which can be valuable in assessing the impact of a new CEO and chairman on the company’s future.
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