Amphastar Pharmaceuticals(AMPH) - 2025 Q3 - Quarterly Report

Revenue Performance - Total net revenues for the three months ended September 30, 2025, were $191,840,000, a slight increase of 0.3% compared to $191,214,000 in the same period of 2024[163]. - Product revenues, net, increased by 2% to $191,840,000, driven primarily by a 33% increase in BAQSIMI® sales, which reached $53,608,000[163][164]. - Total net revenues decreased by 2% to $536.8 million for the nine months ended September 30, 2025, compared to $545.4 million in 2024[1]. - Product revenues increased by 2% to $536.8 million, driven primarily by a 63% increase in BAQSIMI® sales, totaling $138.7 million[1][2]. Profitability - Gross profit decreased by 3% to $98,646,000, with gross margin as a percentage of net revenues declining from 53% in 2024 to 51% in 2025[163][170]. - Gross profit declined by 6% to $270.4 million, with gross margins decreasing from 53% to 50% due to lower pricing for glucagon and epinephrine products[1][6]. Expenses - Selling, distribution, and marketing expenses rose by 28% to $11,505,000, largely due to expanded marketing efforts for BAQSIMI® and Primatene MIST®[171]. - Selling, distribution, and marketing expenses rose by 23% to $33.6 million, while general and administrative expenses increased by 59% to $69.5 million, largely due to a litigation provision[1][8]. - General and administrative expenses surged by 166% to $39,467,000, primarily due to a litigation provision that increased expenses by $23.1 million[171]. - Research and development expenses increased by 6% to $22,354,000, including a $5.3 million upfront payment related to a licensing agreement with Anji[173][175]. - Research and development expenses increased by 12% to $62.5 million, primarily due to a $6.0 million licensing agreement with Anji and increased clinical trial costs[1][10]. Non-Operating and Tax Expenses - Non-operating expenses, net, improved significantly, decreasing from $(9,365,000) in 2024 to $(3,807,000) in 2025, primarily due to foreign currency fluctuations and mark-to-market adjustments[177]. - The income tax provision for the three months ended September 30, 2025, was $4,163,000, a decrease of 43% compared to $7,254,000 in 2024[178]. - The effective tax rate increased to 19% in 2025 from 15% in 2024, influenced by differences in pre-tax income positions[180]. - The income tax provision decreased by 24% to $18.0 million, with an effective tax rate increase to 20% from 16%[1][14]. Cash Flow and Working Capital - Working capital increased by $73.9 million to $434.2 million as of September 30, 2025, compared to $360.3 million at the end of 2024[1][16]. - Net cash provided by operating activities was $123.3 million, including net income of $73.7 million for the nine months ended September 30, 2025[1][18]. - Cash requirements are expected to increase significantly due to potential milestone payments of up to $575 million for BAQSIMI® and ongoing investments in manufacturing facilities[1][20]. - Net cash provided by operating activities was $184.4 million for the nine months ended September 30, 2024, including net income of $121.6 million[206]. Investment and Financing Activities - The company incurred $26.6 million in purchases of property, plant, and equipment for the nine months ended September 30, 2025, with $16.9 million in the United States[207]. - The company made $8.1 million in principal payments on long-term debt, primarily paying off a mortgage loan with East West Bank[210]. - Net cash used in investing activities was $89.3 million for the nine months ended September 30, 2024, primarily due to a payment of $129.0 million for the BAQSIMI® acquisition[208]. - Net cash used in financing activities was $47.1 million for the nine months ended September 30, 2024, primarily due to $43.5 million used to purchase treasury stock[210]. Market and Operational Insights - The company anticipates continued fluctuations in sales of glucagon and epinephrine due to competitive dynamics and market demand[167]. - The increase in accounts receivables was primarily due to increased sales, while inventories increased due to higher purchases of raw materials and components[206]. - The company reported no critical observations from inspections conducted by regulatory agencies at its manufacturing facilities during the nine months ended September 30, 2025[216]. - The company is exposed to market risk from changes in the market values of investments, interest rate changes, and foreign currency exchange rate changes[218]. - The company continues to assume distribution responsibilities for BAQSIMI® from Lilly to customers in the United States and certain other countries[206].