Company Overview - Amphastar Pharmaceuticals is a fully integrated business with extensive in-house product development capabilities and advanced analytical techniques [3] - The company conducts in-house animal studies and has fully integrated manufacturing processes, producing several of its own active pharmaceutical ingredients (APIs) [3] - All finished products are manufactured in the United States across three plants [3] Growth Strategy - Amphastar employs a dual growth strategy, focusing primarily on development [4]

Core Viewpoint - Amphastar Pharmaceuticals is transitioning towards higher-value proprietary products while maintaining a focus on internal development and strategic acquisitions to enhance growth and profitability [2][5][13]. Growth Strategy - The company's growth strategy is two-pronged: internal development and strategic acquisitions, including the transformative acquisition of Baqsimi and prior acquisitions like the Armstrong facility [1][3]. - Amphastar aims for a 50% proprietary product mix by 2026, shifting from a historical pipeline that was 63% generic [5][6]. Product Development and Pipeline - The company is advancing a peptide pipeline with several promising candidates, including AMP-007 (metered-dose inhaler) expected to launch in mid-2026 and AMP-004 (insulin aspart) projected for 2027 [4][10]. - Four new chemical entities (NCEs) are in development, showing promising preclinical or early clinical data [4][8]. Financial Projections - Peak sales guidance for Baqsimi is set at $250–$275 million, with expectations of mid-single-digit growth this year [3][14]. - The company plans to exit unprofitable international markets to improve margins and forecasts high single-digit growth for Primatene Mist [3][15]. Research and Development Focus - Amphastar consistently invests $60–$75 million annually in R&D, focusing on proprietary programs, including AMP-105 and AMP-107, which target significant market opportunities [8][12]. - The company is evolving its pipeline in response to increased competition in complex generics, aiming for a mix of 50% proprietary, 35% biosimilar, and 15% generic by 2026 [6][20]. Market Position and Competitive Advantage - The acquisition of Baqsimi has strengthened Amphastar's position in the proprietary commercial Rx market and expanded its international footprint [13][18]. - The company has captured a majority of the prescription market for ready-to-use glucagon and is focused on increasing penetration among insulin users [18][19].

Amphastar Pharmaceuticals FY Conference Summary Company Overview - Amphastar Pharmaceuticals is a fully integrated business with extensive in-house product development capabilities, advanced analytical techniques, and integrated manufacturing processes. All finished products are manufactured in the United States at three plants [1][2]. Core Strategies - The company employs a dual growth strategy: - **Internal Development**: Focus on proprietary products, including Primatene Mist and glucagon injection, with a goal of achieving 50% proprietary products by 2026 [3][4][5]. - **Strategic Acquisitions**: Notable acquisitions include the Armstrong facility, a French facility for recombinant human insulin, and Baqsimi from Eli Lilly in 2023 [3][4]. Product Pipeline and Development - The current product pipeline consists of: - **50% Proprietary Products**: Targeting high-quality, high-efficiency, and high-technology products [4][5]. - **Biosimilars and Generics**: Aiming for 35% biosimilars and 15% generics by 2026 [5][6]. - Key products in development include: - **AMP-105**: An oncology product with a novel mechanism of action [9]. - **AMP-107**: A non-injectable anti-VEGFR eye drop targeting wet AMD and DME, with a market size of $9.4 billion in 2024 [10]. - **AMP-109**: A peptide drug conjugate showing strong efficacy for various cancers [10][11]. - **AMP-110**: A novel synthetic human corticotropin currently in phase one clinical development [10][11]. Financial Performance and Growth Outlook - The company expects mid-single digit to low double-digit revenue growth in 2026, driven by the launch of AMP-007 and continued growth of Baqsimi and Primatene Mist [23][24]. - Baqsimi is projected to peak sales of $250-$275 million, with a current market penetration of 12% among insulin users [19][25][26]. - The insulin pipeline is significant, covering a market of $1.7 billion in sales [17]. Market Dynamics and Competitive Landscape - The company has experienced pricing pressure in its generic portfolio but remains focused on proprietary product development [21][22]. - The competitive landscape for glucagon and epinephrine products has intensified, with multiple players affecting market share and pricing [36][37]. Regulatory and Development Updates - AMP-007 is on track for a mid-2026 launch, with confidence in the approval path based on strong data [31]. - The biosimilar portfolio, particularly AMP-004 (insulin aspart), is progressing well, with expectations for meaningful growth in the coming years [38][39]. Business Development and Future Opportunities - Amphastar is interested in smaller acquisitions that align with its capabilities in injectables, inhalation, and intranasal products, particularly in endocrinology and ophthalmology [45][46]. Conclusion - Amphastar Pharmaceuticals is strategically positioned for growth through a focus on proprietary products, strategic acquisitions, and a robust pipeline. The company is navigating market challenges while aiming for significant revenue growth in the coming years.

Agreement expands Amphastar's proprietary peptide pipeline into broader inflammatory and autoimmune conditions RANCHO CUCAMONGA, CA / ACCESS Newswire / January 12, 2026 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) today announced that it has entered into an exclusive license agreement (the "Agreement") with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. ("Hanxin") for the development, and commercialization of a fully synthetic and highly purified human adrenocorticotropic hormone (ACTH) analogs (also ...

RANCHO CUCAMONGA, CA / ACCESS Newswire / January 7, 2026 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Jack Zhang, CEO and President, and Bill Peters, CFO will be presenting at the J.P. Morgan 2026 Healthcare Conference on Wednesday, January 14th, 2026, at 2:15 pm PT. ...

Amphastar Pharmaceuticals, Inc. is a mid-cap biopharmaceutical company specializing in specialty and generic injectable and inhalation products. The company leverages a vertically integrated model, with in-house API production and a diverse product pipeline, to address critical needs in acute care and emergency medicine. Its strategic focus on both proprietary and generic products positions it to capture demand from institutional healthcare providers and respond to evolving market opportunities.Generates re ...

Core Viewpoint - Amphastar Pharmaceuticals, Inc. has received FDA approval for its teriparatide injection, which is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO® [1] Company Summary - Amphastar Pharmaceuticals announced the approval of its Abbreviated New Drug Application (ANDA) for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen [1] - The FDA's determination confirms that Amphastar's teriparatide is equivalent to Eli Lilly's product, indicating a significant milestone for the company in the competitive pharmaceutical market [1] Industry Summary - The approval of teriparatide injection highlights the ongoing developments in the pharmaceutical industry, particularly in the area of biosimilars and generic drugs [1] - The bioequivalence to a well-established product like FORTEO® may enhance market competition and provide more options for patients [1]

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.

Company Strategy & Focus - Amphastar operates with a "Three-H Focus" on High Quality, High Efficiency, and High Technology, leading to high net income margins[8, 15, 17] - The company employs a dual-strategy growth model focusing on both organic pipeline development and inorganic strategic acquisitions[8, 13, 14] - Amphastar is strategically shifting its pipeline towards proprietary products and biosimilars, projecting a change from 21% proprietary, 16% biosimilar, and 63% generic in 2021 to 50% proprietary, 35% biosimilar, and 15% generic by 2026[20] Financial Performance & R&D Investment - Amphastar's revenue has grown from $295 million in 2018 to $732 million in 2024[15] - Adjusted net income margin increased from 3.5% in 2018 to 27.4% in 2024[15] - The company has self-funded approximately $351 million in R&D investment over the recent 5 years[26] Product Pipeline & Market Opportunities - Amphastar's pipeline includes AMP-017 (Inhalation) with an IQVIA sales potential of +$1.3 billion and AMP-005 (Recombinant Human Insulin) with a $4.5 billion market[29] - The company in-licensed three new peptide assets (AMP-105, -107, -109) targeting high-growth therapy areas with a market potential of >$50 billion across oncology indications and >$10 billion in ophthalmology[37] - BAQSIMI® sales are projected to reach a peak of $250 million to $275 million, with an estimated $2.00 to $2.50 incremental adjusted EPS at peak[54, 59] Key Products Sales - Baqsimi® Worldwide Annual Sales reached $166 million in 2024[58] - Primatene MIST® Annual Sales reached $102 million in 2024[61]

Core Insights - Amphastar Pharmaceuticals, Inc. will participate in the 37th Annual Piper Sandler Healthcare Conference on December 3rd, 2025 [1] Company Participation - Bill Peters, CFO, and Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, will be featured in an Analyst-Moderated fireside chat [1] - The event is scheduled for 2:00 pm ET [1] - Access to the conference can be found on Amphastar's Pharmaceuticals website [1]