Amphastar Pharmaceuticals — Q3 2026 Earnings Summary

Financial Performance:

• Net revenues for the three months ended September 30, 2026, were $207.6 million, an 8% increase from $191.8 million in the prior year period.
• GAAP net income was $37.8 million ($0.87 per diluted share), compared to $17.4 million ($0.37 per diluted share) in the prior year.
• Adjusted non-GAAP net income was $49.3 million ($1.14 per diluted share), compared to $44.7 million ($0.93 per diluted share) in the prior year.
• Gross profit was $99.6 million (48.0% of net revenues), down from $98.6 million (51.4% of net revenues) in the prior year.
• Cost of revenues increased 16% to $108.0 million, driven by remediation efforts and facility expansion.
• Selling, distribution, and marketing expenses increased 4% to $11.9 million, primarily due to higher freight expenses.
• General and administrative expenses decreased 57% to $16.8 million, compared to $39.5 million in the prior year, primarily due to a $23.1 million litigation provision recorded in Q3 2025.
• Research and development expenses decreased 10% to $20.1 million, compared to $22.4 million in the prior year, partially offset by increased material and salary expenses.
• Cash flow provided by operating activities for the nine months ended September 30, 2026, was $142.5 million.
• Cash and cash equivalents were $204.6 million as of September 30, 2026, compared to $170.2 million as of December 31, 2025.
• Long-term debt was $610.5 million as of September 30, 2026, compared to $608.7 million as of December 31, 2025.

Business Segments and Product Lines:

• BAQSIMI® sales increased 10% to $58.8 million, driven by a $7.4 million increase in unit volumes, partially offset by a $2.2 million decrease in average selling price due to changes in gross-to-net discounts.
• Primatene MIST® sales increased 9% to $31.5 million, driven by a $1.6 million increase in average selling price from a Q2 2026 price increase and a $1.0 million increase in unit volumes.
• Lidocaine sales increased 29% to $16.6 million, driven by increased unit volumes due to supplier shortages.
• Ipratropium bromide sales were $6.6 million following its launch in Q2 2026.
• Epinephrine sales decreased 19% to $15.3 million, primarily due to lower unit volumes of pre-filled syringes resulting from slower product releases at the International Medication Systems, Limited (IMS) subsidiary.
• Glucagon sales decreased 37% to $8.6 million, primarily due to a lower average selling price resulting from increased competition.
• Other pharmaceutical product sales increased 9% to $70.2 million, driven by $6.4 million in teriparatide sales (launched December 2025) and $6.2 million in API sales from Amphastar Nanjing Pharmaceuticals, Inc. (ANP).

Risks and Challenges:

• Ongoing remediation efforts at the IMS subsidiary have resulted in slower product releases for epinephrine and decreased sales of several products manufactured at the facility.
• Increased competition has led to lower average selling prices for glucagon.
• Changes in gross-to-net discounts, chargebacks, rebates, and customer mix have impacted the average selling price of BAQSIMI®.
• Foreign currency fluctuations and mark-to-market adjustments on interest rate swap contracts impacted non-operating expenses.

Management Commentary and Tone:

• Dr. Jack Zhang, President and CEO, stated that third-quarter results demonstrated the strength of the diversified portfolio and commercial platform.
• Management noted record sales of BAQSIMI® and Primatene MIST® supported continued revenue growth.
• The Company emphasized advancing programs across complex generic, biosimilar, and proprietary pipelines while investing in manufacturing, quality, and development capabilities.
• Management expressed a focus on disciplined execution, strengthening operations, and deploying capital to create sustainable long-term value.

Other Key Points:

• On November 4, 2026, the Board of Directors authorized a $50 million increase to the share buyback program, expected to continue indefinitely to offset dilution from equity compensation.
• The Company has one ANDA and one biosimilar insulin candidate filed with the FDA targeting a combined market size exceeding $1.6 billion.
• Two biosimilar products in development target a market size exceeding $3.5 billion.
• Three generic products in development target a market size of over $1.2 billion.
• The proprietary pipeline includes four in-licensed products: three proprietary peptides for oncology and ophthalmology, and a fully synthetic corticotropin compound for inflammatory and autoimmune conditions.
• Teriparatide was launched in December 2025.
• Ipratropium bromide was launched in the second quarter of 2026.
• A $23.1 million litigation provision was recorded in Q3 2025 for a matter settled in Q4 2025.
• A $5.3 million upfront payment for a licensing agreement with Nanjing Anji Biotechnology Co., Ltd. was made in Q3 2025.