Amphastar Pharmaceuticals, Inc.

What they do

Amphastar manufactures and sells over 30 prescription pharmaceutical and over-the-counter products, as well as active pharmaceutical ingredient (API) products. It focuses on products with high technical barriers to entry in the injectable and inhalation markets, and also develops generic ANDAs, BLAs and biosimilar insulin candidates. Its largest products by net revenues are BAQSIMI, Primatene MIST, epinephrine, glucagon, lidocaine and ipratropium bromide.

Revenue drivers

• BAQSIMI — Nasal glucagon powder for severe hypoglycemia, acquired from Eli Lilly in June 2023; generated $45.5 million in Q2 2026, the largest single product line.
• Primatene MIST — Over-the-counter epinephrine inhalation product; contributed $21.0 million in Q2 2026 and is one of the company's largest products by net revenues.
• Epinephrine, lidocaine and glucagon — Established generic injectable products; together with BAQSIMI and Primatene MIST the 10-K states these products represent a significant portion of net revenues. Q2 2026 sales were $15.9 million, $15.0 million and $11.9 million respectively.
• Other products, including newly launched ipratropium bromide — The 'other products' group generated $66.2 million in Q2 2026, up 25% year over year, and includes newly approved products such as ipratropium bromide HFA ($8.4 million in Q2 2026), albuterol sulfate, iron sucrose and teriparatide.

Recent performance

Q2 2026 net revenues were $183.9 million, up 5% from $174.4 million in Q2 2025. GAAP net income was $30.3 million, or $0.67 per diluted share, versus $31.0 million and $0.64 a year earlier; adjusted non-GAAP net income was $40.8 million, or $0.91 per share. BAQSIMI declined 3% to $45.5 million on lower average selling price, partially offset by higher unit volumes, while glucagon fell 42% to $11.9 million. The 'other products' category grew 25% to $66.2 million, including $8.4 million from newly launched ipratropium bromide.

Strategy

Management's stated focus is developing and commercializing products with high technical barriers to market entry, particularly injectable and inhalation products, supported by capabilities in peptide and protein synthesis, particle engineering and sustained-release delivery. The company has in-licensed early-stage proprietary products and made strategic acquisitions to add manufacturing, marketing and R&D capabilities, including the June 2023 BAQSIMI acquisition. It continues to advance a pipeline of generic ANDA and BLA candidates, including biosimilar insulin, with one ANDA and one biosimilar insulin candidate on file with the FDA. Recent approvals include albuterol sulfate (launched August 2024), iron sucrose (August 2025), teriparatide (December 2025) and ipratropium bromide HFA (approved February 2026, launched April 2026).

Risks

• Concentration in a few products — The 10-K states BAQSIMI, Primatene MIST, glucagon, epinephrine and lidocaine collectively represent a significant portion of net revenues, so declines in these products could materially hurt results.
• BAQSIMI milestone and third-party manufacture — The June 2026 achievement of the $175.0 million BAQSIMI sales milestone triggers a $100.0 million payment to Eli Lilly due in Q3 2026, and the company relies on a third party for BAQSIMI manufacture.
• cGMP compliance and FDA warning letter — In July 2026 the FDA issued a warning letter to subsidiary IMS regarding cGMP violations at its South El Monte, California facility, though it does not require IMS to stop distributing products.
• Pricing and competition — Q2 2026 results showed glucagon down 42% and epinephrine multi-dose vials pressured by increased competition, and BAQSIMI was affected by gross-to-net discount changes.

Outlook

Management described Q2 2026 as continued execution of a long-term strategy to build a more diversified and innovative biopharmaceutical company, citing revenue growth, gross margin expansion and new product launches. The company does not provide specific financial guidance in the materials reviewed. It continues remediation work with the FDA on the IMS warning letter and states it does not currently anticipate a material adverse effect on the overall business from the matter.