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.

Summary of the Conference Call Transcript Industry Overview - The conference call focuses on the **insulin industry in China**, highlighting the significant opportunities for **domestic substitution** following two rounds of **Volume-Based Procurement (VBP)** [1][1]. Key Companies Discussed 1. **Gan & Lee Pharmaceuticals** - Revenue for 3Q25 was **Rmb980 million**, reflecting a **5% year-over-year increase**. However, this was below Goldman Sachs estimates of **Rmb1,140 million** [8][8]. - Net profit for the same period was **Rmb235 million**, also missing estimates of **Rmb309 million** [8][8]. - The company is optimistic about achieving its full-year net profit target of **Rmb1.1 billion**, implying **Rmb280 million** in net profit for 4Q25, supported by expected orders from Brazil [8][8]. - Revised price target (TP) is set at **Rmb73**, down from **Rmb77**, with a **Buy** rating maintained [8][8]. 2. **Tonghua Dongbao (THDB)** - THDB reported 3Q25 revenue of **Rmb806 million**, a **14% year-over-year increase**, exceeding Goldman Sachs estimates of **Rmb724 million** [17][17]. - Net profit surged to **Rmb984 million**, a **500% year-over-year increase**, driven by investment gains from divesting Amoytop Biotech [17][17]. - The company’s sales performance was bolstered by expanding market share in insulin analog products [17][17]. - Revised price target is **Rmb10**, up from **Rmb9**, with a **Neutral** rating maintained [17][17]. Market Dynamics - The localization rates for insulin analogs have increased in 2Q25 compared to 1Q25: - **Insulin glargine**: 51% (unchanged) - **Insulin aspart premix**: 22% (up from 19%) - **Insulin aspart**: 17% (up from 15%) [1][1]. - There is a belief that there is still ample market space for further domestic substitution in the coming years [1][1]. Growth Drivers - **Gan & Lee** is focusing on: - Exporting insulin biosimilars to the US and EU - Continuing to substitute imports in the Chinese market - Expansion into emerging markets [19][19]. - **THDB** is promoting its new third-generation insulin products in private hospitals and pharmacies, which are not affected by the VBP policy [20][20]. Financial Estimates - **Gan & Lee** updated estimates for 2025 to 2027 show a slight decrease in revenue and net profit projections: - 2025 Revenue: **Rmb4,202 million** (down from **Rmb4,400 million**) - 2025 Net Profit: **Rmb1,101 million** (down from **Rmb1,173 million**) [16][16]. - **THDB** updated estimates show significant increases: - 2025 Revenue: **Rmb2,762 million** (up from **Rmb2,689 million**) - 2025 Net Profit: **Rmb1,281 million** (up from **Rmb408 million**) [18][18]. Risks and Catalysts - **Gan & Lee** faces risks such as slower-than-expected launches of insulin biosimilars in the US and R&D progress [23][23]. - **THDB** has upside risks related to stronger-than-expected ramp-up of its third-generation insulin products and faster approval of insulin biosimilars in the US [24][24]. Conclusion - The insulin market in China is experiencing significant growth opportunities, particularly for domestic manufacturers like Gan & Lee and Tonghua Dongbao. Both companies are positioned to benefit from increased localization and market share expansion, despite facing various risks and challenges in the evolving regulatory landscape.