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• Teva or Viatris for complex injectable generics and niche proprietary drugs.

• A 'boutique' version of a major generic drug maker like Teva or Viatris, specializing in hard-to-make injectable pharmaceuticals and unique specialty products.

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• Enoxaparin Sodium Injection: A generic anticoagulant used to prevent and treat deep vein thrombosis.
• Naloxone Hydrochloride Injection: An opioid antagonist administered to rapidly reverse the effects of opioid overdose.
• Primatene MIST: An over-the-counter epinephrine inhalation aerosol for the temporary relief of mild intermittent asthma symptoms.
• Glucagon for Injection: Used to treat severe hypoglycemia (very low blood sugar) in patients with diabetes.
• Insulin Aspart Injection: A rapid-acting human insulin analog used to improve glycemic control in adults and children with diabetes mellitus.

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Amphastar Pharmaceuticals (AMPH) primarily sells its products to other companies, specifically major pharmaceutical wholesalers and distributors. The company's most recent 10-K filing (for the fiscal year ended December 31, 2023) identifies the following as major customers, each accounting for a significant portion of its gross product sales:

• McKesson Corporation (Symbol: MCK) - accounted for approximately 35% of gross product sales in 2023.
• AmerisourceBergen Corporation (now Cencora, Symbol: COR) - accounted for approximately 33% of gross product sales in 2023.
• Cardinal Health, Inc. (Symbol: CAH) - accounted for approximately 31% of gross product sales in 2023.

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• Sichuan Tech New Pharmaceutical Co., Ltd.
• Gan & Lee Pharmaceuticals Co., Ltd. (SHE: 603087)

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Jack Y. Zhang, Ph.D. Chief Executive Officer, President, Chief Scientific Officer, and Director

Dr. Jack Y. Zhang co-founded Amphastar Pharmaceuticals in 1996 and has served as its Chief Executive Officer and a member of the Board of Directors since its inception. He also served as the company's President from 1996 until June 2013 and again from April 2020, and as Chief Scientific Officer since 2005. Prior to Amphastar, he co-founded Applied Physics & Chemistry Laboratory (APCL) in May 1989, a chemical analytical laboratory, where he held the position of CEO and President until October 2002. He possesses over 35 years of experience in chemistry, physics, management, and training. Dr. Zhang is named as an inventor on several U.S. and foreign patents.

Mary Ziping Luo, Ph.D. Chairman of the Board, Chief Operating Officer, and Chief Scientist

Dr. Mary Z. Luo co-founded Amphastar Pharmaceuticals in 1996 and has served as its Chief Operating Officer and Chairman of the Board since its inception. She has also been the Chief Scientist since 2005. Dr. Luo is a co-founder of Applied Physics & Chemistry Laboratories Inc (APCL) where she served as Chief Operating Officer. She brings over 30 years of academic and practical experience in chemistry and is a professor emeritus of chemistry at California State Polytechnic University, Pomona. Dr. Luo is also named as an inventor on several U.S. and foreign patents.

William J. Peters Chief Financial Officer, Executive Vice President - Finance, Treasurer, and Director

Mr. William J. Peters joined Amphastar as Chief Financial Officer in April 2014, just before the company's IPO. Prior to Amphastar, he served as Chief Financial Officer of Hi-Tech Pharmacal Co Inc. from June 2004 to April 2014, and as Executive Vice President from August 2013 to April 2014. At Hi-Tech Pharmacal, he was involved in evaluating and executing acquisitions and arranging licensing agreements. Before Hi-Tech, he spent more than seven years at Merck & Co., Inc., holding positions such as Director, Financial Evaluations for Medco Health Solutions, and Manager of Corporate Financial Analysis and Pharmaceutical Economics. He started his career in General Electric's Financial Management Program.

Rong Zhou Executive Vice President - Scientific Affairs; President - Amphastar Nanjing Pharmaceuticals, Co., Ltd; Senior Executive Vice President - Production Center

Mr. Rong Zhou has been the Executive Vice President - Scientific Affairs and President of Amphastar Nanjing Pharmaceuticals, Co., Ltd since 2023. He also holds the role of Senior Executive Vice President - Production Center.

Jacob Liawatidewi Executive Vice President - Sales and Marketing, and Corporate Administration Center; President - Amphastar France Pharmaceuticals, S.A.S.; Director

Mr. Jacob Liawatidewi joined Amphastar in 1997 and has held various positions in business development, sales, and marketing. Since 2020, he has served as Executive Vice President, Corporate Administration Center. He was appointed Company Secretary in June 2013 and is also the President of Amphastar France Pharmaceuticals.

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The most significant risk is intense competition and pricing pressure across its product portfolio, particularly for generic and certain proprietary drugs. This competition can lead to declining average selling prices and erosion of profit margins, negatively impacting revenue and earnings.

Another major risk is the company's revenue concentration in a few key products, such as BAQSIMI, Primatene MIST, glucagon, and epinephrine. A decline in sales or increased competitive pressure for these specific high-margin products can significantly affect Amphastar's overall financial results and profitability.

Finally, the business is exposed to regulatory and pipeline development risks. The successful commercialization of pharmaceutical products is dependent on obtaining and maintaining regulatory approvals. Furthermore, Amphastar's pipeline assets, particularly in its slow transition from generics to branded products, face high clinical and regulatory uncertainties, which could delay launches or lead to underperformance. Legal challenges, such as a patent infringement battle with Teva, also highlight the ongoing regulatory and legal risks.

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The following are clear emerging threats for Amphastar Pharmaceuticals:

• Shift of Naloxone from Prescription to Over-the-Counter (OTC) Availability: The FDA's approval of Narcan (naloxone HCl) nasal spray for OTC use in March 2023, followed by the availability of multiple generic OTC versions, represents a fundamental shift in the market for naloxone. While Amphastar offers an injectable naloxone product, this change directly impacts the demand and market dynamics for prescription naloxone, posing an emerging threat to this product segment.

• Intensified Competition in the Biosimilar and Complex Generic Markets: Amphastar operates in highly competitive biosimilar and complex generic markets, including insulins (e.g., Rejuron human insulin). The increasing focus by the FDA on accelerating biosimilar approvals, coupled with the entry of numerous well-capitalized competitors, including major pharmaceutical companies, is leading to aggressive pricing strategies and rapid market share erosion. This intensified competitive environment, particularly in high-value segments like insulin, poses a clear and emerging threat to Amphastar's profitability and market position.

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Amphastar Pharmaceuticals (AMPH) develops, manufactures, and markets a range of injectable, intranasal, and inhalation products. Below are the addressable market sizes for their main products or services:

• BAQSIMI (Glucagon Nasal Powder): The U.S. glucagon delivery devices market size was estimated at USD 446.98 million in 2023 and is projected to reach USD 781.07 million by 2030. The global glucagon market was valued at USD 409.75 million in 2024 and is projected to reach USD 607.36 million by 2032. North America holds approximately 40-45% of the global glucagon market.
• Epinephrine: The global epinephrine market was valued at USD 2.6 billion in 2022 and is projected to reach USD 4.4 billion by 2032. The U.S. epinephrine autoinjector market size was USD 681.13 million in 2024.
• Primatene Mist (Epinephrine Inhalation Aerosol): This product is an epinephrine inhalation aerosol for the over-the-counter (OTC) market in the United States. While specific market size for Primatene Mist alone is not explicitly stated as a separate market, the broader U.S. inhalation drug market was approximately USD 28 billion in 2021.
• Enoxaparin Sodium Injection: The global enoxaparin sodium market size was USD 4.23 billion in 2024 and is projected to reach USD 10.18 billion by 2033. North America accounted for the largest enoxaparin sodium market share of revenue in 2022. In 2011, Lovenox (branded enoxaparin) and its biosimilar equivalents had total U.S. sales of approximately USD 2.6 billion.
• Naloxone Hydrochloride Injection: The United States naloxone market size was valued at USD 530.57 million in 2023 and is expected to reach USD 1363.7 million by 2033. The global naloxone market was valued at USD 1.33 billion in 2024 and is projected to reach USD 3.48 billion by 2035. North America is the largest market for naloxone globally.
• Phytonadione Injection: As of 2022, the global market for phytonadione was valued approximately at USD 250 million, with North America accounting for nearly 60% of sales.
• Lidocaine Jelly: null
• Cosyntropin Injection: null
• Amphadase Hyaluronidase Injection: null
• Iron Sucrose Injection: null

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Amphastar Pharmaceuticals (AMPH) is poised for future revenue growth over the next 2-3 years, driven by a strategic combination of expanding its proprietary product portfolio, launching new generic and biosimilar products, and extending the market presence of key offerings.

Here are 3-5 expected drivers of future revenue growth:

1. Continued Growth of BAQSIMI: BAQSIMI, an intranasal glucagon for severe hypoglycemia, is a significant revenue generator for Amphastar. The company has been focusing on expanding its market presence by increasing its sales force and territory coverage for BAQSIMI. In Q3 2025, BAQSIMI sales grew 14% year-over-year, contributing $53.6 million to total sales. This continued commercial execution and integration of global commercialization are expected to drive further growth.
2. Launch of New Generic and Biosimilar Products: Amphastar has a robust pipeline of new product launches anticipated over the next few years. The company recently launched its iron sucrose injection in August 2025, which contributed $2.4 million in Q3 2025. Other key upcoming launches include AMP-004 (Insulin Aspart) with a BLA refiling, AMP-028 (a new biosimilar with over $2 billion in IQVIA sales), AMP-007 inhalation in 2026, and a generic teriparatide also in 2026, with additional launches planned for 2027. These new product introductions are central to the company's growth strategy.
3. Expansion of Proprietary and Complex Product Portfolio: Amphastar is strategically shifting its focus from predominantly generic products towards higher-margin proprietary products and biosimilars to drive sustainable growth and improve profitability. This strategic pivot is evident in their pipeline evolution and is expected to transform their product mix significantly by 2026. The company's exclusive licensing agreement with Nanjing Anji Biotechnology for three novel peptides targeting high-growth markets in oncology and ophthalmology further exemplifies this strategy.
4. Growth of Recently Launched Products like Albuterol MDI and Primatene Mist: Amphastar recently launched its Albuterol MDI product, expanding its respiratory portfolio. Additionally, the company is planning physician outreach in 2025 for Primatene Mist to capitalize on continued growth opportunities. These recently launched and existing products are expected to contribute to revenue growth through increased market penetration and sustained demand.
5. Increased Domestic Manufacturing Capacity: Amphastar has announced plans to quadruple its domestic manufacturing capacity. This expansion is intended to support future growth, enhance supply chain resilience, and facilitate the delivery of high-quality therapies. Increased capacity will enable the company to meet anticipated demand for its growing product portfolio.

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Share Repurchases

• Amphastar Pharmaceuticals repurchased $55.070 million of shares year-to-date as of September 30, 2025.
• In Q3 (likely 2024), the company repurchased $35 million worth of its own shares.
• An additional $50 million increase to the share buyback program was authorized on June 3, 2024, primarily to offset dilution from equity compensation programs.

Share Issuance

• As of June 30, 2025, Amphastar issued 1,378,506 shares of common stock under its Employee Stock Purchase Plan (ESPP).
• In May 2025, 89,054 shares were issued under the ESPP at a purchase price of $21.85 per share.
• The Amended and Restated 2015 Equity Incentive Plan, approved in June 2024, reserved 6,657,912 shares of common stock for future issuance as of June 30, 2025.

Outbound Investments

• Amphastar acquired the diabetes therapy BAQSIMI from Eli Lilly and Company in the spring of 2023 for approximately $625 million in cash.
• In August 2025, the company bolstered its proprietary pipeline through an exclusive licensing agreement with Nanjing Anji Biotechnology Co., Ltd.

Capital Expenditures

• Future capital expenditures are expected to significantly increase over the next few years, focusing on upgrading, expanding, and improving manufacturing facilities in the United States and China.
• In July 2025, Amphastar announced its largest investment in company history, focused on domestic manufacturing and supply chain resilience, with plans to quadruple its U.S. production capacity over the next three to five years.
• This expansion includes a new state-of-the-art production plant, expanded automation, and advanced technologies to support the development and manufacture of critical medications, including new pipeline candidates.