Amphastar Pharmaceuticals(US:AMPH)2021-08-10 08:41Company Overview - Amphastar is a biopharmaceutical company focused on technically challenging BLAs, NDAs, and ANDAs in injectable, inhalable, and intranasal formulations[37] - The company has a fully integrated business model, from product development to manufacturing and distribution, ensuring control over quality and compliance[6] - Amphastar focuses on products with high technical barriers to entry, including injectables, inhalation products, biosimilars, and interchangeable drugs[8, 9] Financial Performance - The company's base business generated approximately $350 million in revenue and approximately $143 million in gross profit in 2020[37] - In 2020, Primatene MIST® contributed $52 million, Enoxaparin $49 million, Vitamin K1 $43 million, and Lidocaine $41 million to net revenue[16] - The company has made self-funded R&D investments of approximately $280 million in the recent 5 years[17] Pipeline and R&D - Amphastar has a robust pipeline of over 20 product candidates, including insulin products, in markets with barriers to entry[37] - The company's generic pipeline includes 12 candidates with technical barriers, with potential IQVIA sales ranging from +$50 million to +$8 billion[24, 25] - The company is developing three insulin candidates, targeting a US market with IQVIA sales of ~$13 billion[26] Strategic Initiatives - Amphastar launched Glucagon for Injection Kit in February 2021, with Eli Lilly's Glucagon Emergency Kit having sales of approximately $144 million[30] - The company plans to repurchase 26% of ANP from external investors for $29 million to secure API supply[23] - Primatene MIST® is indicated for "intermittent asthma," targeting ~35% of adult asthma patients, or 67 million people[35]