Amphastar posts 8% sales growth as FDA action trims margin, slows epinephrine syringes
The US drugmaker grew third-quarter revenue and profit, but regulatory fallout at one manufacturing site cut profitability and slowed releases of a key injectable.
Amphastar Pharmaceuticals reported third-quarter 2026 net revenues of $207.6 million on 5 November, up 8% on the year. The company said two of its branded products, BAQSIMI and Primatene MIST, each delivered their best quarterly sales since launch.
Profitability was weaker than the top line suggests. Gross margin narrowed by 3.4 percentage points, to 48.0% from 51.4%. Amphastar linked part of that decline to remediation work at its IMS facility, which follows an FDA warning letter. The same issue has slowed the release of epinephrine pre-filled syringes, so supply of that product is constrained while the work continues.
Earnings stayed solid. GAAP net income came to $37.8 million, or $0.87 a share, while adjusted non-GAAP net income was $49.3 million. The board also added $50 million to the company's share repurchase programme.
Amphastar has two filings under FDA review: one abbreviated new drug application (ANDA) and one biosimilar insulin candidate. For context, an ANDA is the US route for seeking approval of a generic copy of an approved medicine. The company did not provide decision dates for either filing.
Why it matters
- The results show how a regulatory warning can reach the income statement through higher remediation costs and slower product release, even while sales grow.
- Epinephrine pre-filled syringe supply is slower for now, which matters to supply-chain and market-access teams until IMS remediation is complete.
- Record sales of BAQSIMI and Primatene MIST helped offset the pressure on margin.
- The pending ANDA and biosimilar insulin filings have no disclosed decision dates, so their timing remains unknown.
Company's press release (SEC filing): Amphastar Pharmaceuticals, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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