Amphastar Pharmaceuticals FY Conference Summary Company Overview - **Company**: Amphastar Pharmaceuticals (NasdaqGS: AMPH) - **Date of Conference**: December 03, 2025 Key Points Industry and Company Strategy - Amphastar is shifting its pipeline composition towards proprietary products, aiming for 50% proprietary products by 2026 [3][4] - The company has historically focused on injectable products due to competitive advantages in technology [2] - Amphastar plans to maintain a balance between generics and proprietary products, continuing to develop select generics [3] Recent Developments - In August, Amphastar in-licensed three peptide assets from Anji Biopharmaceuticals, which are currently in preclinical stages [4][5] - **AMP-105**: Targets various tumor categories - **AMP-109**: Combines with a taxane product for enhanced efficacy - **AMP-107**: An eye drop for wet AMD with anti-VEGF properties Research and Development (R&D) Spending - R&D spending is expected to increase as the company focuses on proprietary drug development [6] - Cost optimization efforts are in place due to pricing pressures on existing products like Glucagon and Epinephrine [8] Product Launches and Market Opportunities - **Iron Sucrose**: Recently entered the market with a competitive landscape, with higher margins than average generics [9] - **AMP-007**: Expected to be the first approved generic inhalation product, with potential for 180-day exclusivity [10] - **Teriparatide Generic**: Anticipated to contribute incremental growth, but not as significant as AMP-007 [11] - **Insulin Aspart Biosimilar**: Targeted for a 2027 launch, with a competitive landscape expected [12][13] - **GLP-1 Generic**: Also planned for a 2027 launch, with a smaller market opportunity [14] Growth Projections for 2026 - Expected growth of high single to low double digits, driven by new product launches and existing product growth [16][17] - Key growth drivers include Baqsimi, Primatene Mist, and the recently launched Iron Sucrose [17] Baqsimi Product Insights - Baqsimi holds nearly 60% of the ready-to-use glucagon market, with significant growth potential [20] - The company aims to increase script fills from 12% to 15-16% to reach peak sales of $250 million-$275 million [21] - High payer access with over 90% coverage and stable gross-to-net ratios [25][26] - Long patent protection expected until 2036 and 2039, making generic competition unlikely [27][28] Future Business Development - Amphastar is prioritizing external business development, particularly in the endocrinology space, to leverage its existing sales force [29] - The company is open to taking on debt for acquisitions but prefers to avoid equity financing due to founder preferences [30][32] Product Lifecycle Management - Primatene is undergoing marketing efforts to drive growth, including TV commercials and physician sampling programs [34] - A next-generation product with a new propellant is in development, with patent filings already submitted [35] Competitive Landscape and Challenges - The base business remains stable, but there are pressures on specific products like phytonadione and Enoxaparin [45] - Anticipated filings for 2026 include one to two products, focusing on inhalation and biosimilars [46][47] This summary encapsulates the strategic direction, product pipeline, and market positioning of Amphastar Pharmaceuticals as discussed in the conference.