Amphastar Pharmaceuticals (AMPH) Q4 2025 earnings summary

Executive summary

• 2025 marked a pivotal year with strong commercial execution, scientific innovation, and regulatory milestones, including FDA approvals for iron sucrose, teriparatide, and Ipratropium Bromide HFA Inhalation Aerosol.

• Operates a fully integrated business model with in-house R&D, manufacturing, and marketing, supporting a dual growth strategy of proprietary pipeline development and strategic acquisitions.

• Proprietary and biosimilar products projected to comprise 85% of the pipeline by 2026, up from 37% in 2021.

• BAQSIMI and Primatene MIST delivered resilient performance, with BAQSIMI commercialized in 26 countries and driving double-digit growth.

• Strategic expansion included three novel peptides and a synthetic corticotropin program targeting oncology, ophthalmology, and immunology.

Financial highlights

• Full-year net revenues were $719.9 million in 2025, down 2% YoY; BAQSIMI contributed $185.4 million (up 46% YoY), and Primatene MIST $108.7 million (up 7% YoY).

• Q4 2025 sales declined 2% YoY to $183.1 million; BAQSIMI sales rose 12%, Primatene MIST fell 3%, glucagon dropped 45%, and epinephrine declined 9%.

• Gross margin for 2025 was 49.5%; Q4 gross margin was 46.8%.

• Q4 GAAP net income was $24.4 million ($0.51/share); full-year GAAP net income was $98.1 million ($2.03/share); adjusted non-GAAP net income was $156.6 million ($3.25/share).

• Operating cash flow for 2025 was $156.1 million.

Outlook and guidance

• 2026 revenue expected to grow mid-to-high single digits, driven by Ipratropium Bromide launch and continued BAQSIMI and Primatene MIST growth.

• Gross margins anticipated to decline due to pricing pressure on legacy high-margin products and higher input costs.

• BAQSIMI U.S. unit growth projected in mid-single digits, offset by international market exits; Primatene MIST to see mid-to-high single-digit unit growth and a 5% price increase.

• R&D and capital spending to increase, especially for pipeline and facility expansion.

• Upcoming launches include AMP-007 (Ipratropium Bromide) in early Q2 2026 and AMP-004 (Insulin Aspart) in 2027.