Amphastar Pharmaceuticals (AMPH) investor relations material

Key business developments and performance

• Significant impact from double discounting in 340B programs reduced BAQSIMI sales, prompting immediate mitigation steps including third-party claim adjudication and a 3% price increase effective May 1.

• Expectation that most inappropriate claims will be resolved within a couple of quarters, with product growth anticipated to resume by next year.

• Revenue recognition has been affected by increased accruals for rebates and discounts, which may normalize as pricing issues are resolved.

• BAQSIMI is sold in about 25 countries, but 80% of revenue comes from the US; unprofitable international markets will be gradually exited starting July, improving profitability.

• Compliance is the main lever for BAQSIMI growth, with a target to increase script fill rates among insulin users from 12% to 15-16% to reach $250-$275 million in peak sales.

Product and margin dynamics

• Glucagon and epinephrine legacy products face ongoing pricing and competitive pressures, but declines are expected to stabilize soon.

• New product launches, such as ipratropium and AMP-007, are expected to drive higher margins and offset declines in older products.

• Insulin launch next year will increase factory utilization, balancing its slightly below-average margin with operational efficiencies.

• BAQSIMI and Primatene MIST are expected to contribute above-average gross margins, with first quarter margin of 41% seen as a low point for the year.

• AMP-007 benefits from six-month exclusivity, strong early sales, and high margins, supporting mid-to-high single-digit revenue growth guidance for the year.

Strategic vision and business model

• Operates a fully integrated, one-stop business model with in-house R&D, manufacturing, and distribution, ensuring quality and compliance across all stages.

• Focuses on high quality, efficiency, and technology, resulting in strong net income margins and consistent revenue growth from 2018 to 2025.

• Strategic emphasis on R&D investment, with $369M self-funded over five years, supporting a diverse and scalable proprietary pipeline.