Amphastar Pharmaceuticals anticipates $2 million to $3 million per quarter in additional expenses for several quarters due to remediation efforts at its IMS subsidiary, which recently received an FDA warning letter, while maintaining its overall corporate sales growth guidance of mid-single digit to high single-digit for 2026. The warning letter does not require IMS to stop manufacturing or distributing products, and management does not expect a material adverse effect on overall business operations. BAQSIMI generated $178.3 million in net sales, exceeding the $175 million threshold and triggering a first milestone payment to Lilly, with a milestone-triggering contract year and a $100 million payment due in Q3 2026. Second-quarter revenue rose 5% to $183.9 million, driven by the launch of Ipratropium Bromide Inhalation with $8.4 million in sales, while BAQSIMI net sales decreased 3% to $45.5 million due to pricing and rebate dynamics. The company also accelerated share repurchases, buying back approximately $45 million in the quarter, and reported adjusted net income of $40.8 million, or $0.91 per share.
Amphastar PFDA warning letter leads to remediation costs of $2M-$3M per quarter
Eli Lilly and CompanyBAQSIMI sales trigger $100M milestone payment from Amphastar
