AXGN
Axogen, Inc.29.35
-0.43-1.44%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
1.35BP/E (TTM)
-Basic EPS (TTM)
-0.05Dividend Yield
0%Recent Filings
8-K
8-K
8-K
FDA extends Avance BLA review
Axogen's BLA for Avance Nerve Graft hit a snag when the FDA deemed its recent manufacturing data submission a major amendment, pushing the PDUFA goal date to December 5, 2025. This three-month extension from the original timeline allows extra review time, with labeling feedback expected in November. The delay tests patience, yet underscores the agency's rigorous process. Forward-looking statements highlight risks like further FDA requests.
8-K
Axogen Q2 revenue surges 18%
Axogen reported Q2 2025 revenue of $56.7 million, up 18.3% from last year, with gross margin edging to 74.2%. Net income swung to $0.6 million from a $1.9 million loss, while adjusted EBITDA climbed to $9.3 million. Broad growth spanned all markets, boosted by expanded reimbursement covering 17 million new lives. The company raised full-year revenue guidance to at least $219 million, targeting 17% growth and net cash flow positivity. BLA approval for Avance Nerve Graft looms in September.
10-Q
Q2 FY2025 results
Axogen swung to an operating profit of $1.7M in Q2 FY2025 ended June 30, 2025, up from a $0.4M loss a year earlier, while revenues climbed 18.3% year-over-year to $56.7M on higher unit volume and better pricing. Gross margins edged up to 74.2% from 73.8%, thanks to fewer inventory write-offs, yet YTD margins dipped to 73.1% from 76.1% due to elevated product costs. Sales and marketing expenses rose 20.8% to support expansion in trauma centers, driving the topline but pressuring overall profitability; diluted EPS improved to $0.01 from -$0.04, consistent with 48.0M weighted shares. Cash and equivalents stood at $20.0M with $9.9M in investments, while $50.0M in debt matures in 2027-2028 at rates up to 13.0%; free cash flow not disclosed in the 10-Q. Revenue growth accelerated. Regulatory hurdles could delay BLA approval for Avance Nerve Graft.
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