Amphastar’s BAQSIMI Pipeline Drives Growth Outlook

Amphastar Pharmaceuticals Inc. (AMPH) highlighted its growth strategy at the Wells Fargo 21st Annual Healthcare Conference on September 8, 2026, emphasizing BAQSIMI as a primary driver of revenue expansion amid operational and regulatory challenges. The company expects mid to high single-digit revenue growth for 2026, with BAQSIMI—its glucagon rescue nasal powder product—projected to reach $250 million to $275 million in peak sales. A 3% price increase in Q2 2026 helped offset earlier headwinds, while efforts to resolve the 340B double-discounting issue, which began in Q3 2025, are expected to resolve by Q4 2026, restoring volume-driven growth. Third-party consultants have already eliminated about 80% of double-discounting cases, with full resolution anticipated by year-end. Penetration of BAQSIMI among insulin patients rose from 10% at acquisition to 12% and targets 15%–16% by 2027, driven by compliance and prescription expansion rather than pricing alone. Meanwhile, Primatene MIST, an over-the-counter asthma inhaler, remains a stable growth driver through advertising and physician outreach. Amphastar’s pipeline includes AMP-007 (generic ipratropium inhalation, with generic exclusivity ending in October 2026), AMP-004 (insulin aspart, targeting interchangeability and launch in 2027), AMP-005 (recombinant human insulin), and AMP-018 (a GLP-1 generic expected in 2027). Early-stage programs in wet AMD, oncology, and cell therapies advance from operating cash flow, with no external financing planned. A warning letter from IMS over FDA quality controls in a 40-year-old clean room has temporarily slowed production but is being addressed with facility upgrades, deferring planned expansion capex. Management remains confident in free cash flow yield of ~16% and upward revisions by five analysts for upcoming earnings, despite no immediate funding needs for pipeline investments.