Amphastar Pharmaceuticals, Inc.

Amphastar Pharmaceuticals, Inc. operates as a biopharmaceutical company focusing on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as active pharmaceutical ingredient (API) products. The company primarily targets the U.S. injectable drug market, which based on a December 2025 IQVIA National Sales Perspective Report was over $480 billion ¹, and the U.S. inhalation drug market, which was approximately $27 billion ² in 2025. Within the injectable market, the company's generic development, including its interchangeable biosimilar portfolio, is targeting opportunities in over $7 billion ³ of this market, while its generic development portfolio in the inhalation market is targeting opportunities in over $1.1 billion ⁴ of that market. The injectable market requires highly technical manufacturing capabilities and compliance with strict current Good Manufacturing Practice (cGMP) requirements, creating high barriers to market entry, and the inhalation market similarly presents significant technical barriers to manufacturing.

The company faces significant competition from pharmaceutical companies focusing on proprietary and generic injectable and inhalation markets, including Pfizer, Inc., BPI Labs, Lupin Pharmaceuticals, Inc., Viatris Inc., Fresenius Kabi USA, Apotex Corp, American Regent Inc., Hikma Pharmaceuticals USA, Inc., Par Pharmaceuticals, Cipla USA Inc., Meitheal Pharmaceuticals, Dr. Reddy's Laboratories, Inc., Xeris Pharmaceuticals, Medefil Inc., Accord Healthcare, and Teva Pharmaceutical USA Inc. The company's competitive advantages include a robust portfolio of over 25 ⁵ commercial products and over 10 ⁶ product candidates, advanced technical capabilities across multiple delivery platforms (injectable, inhalation via metered-dose inhalers, and intranasal), a vertically integrated infrastructure spanning research and development through commercialization, and an experienced management team. The company's primary strategic focus is developing and commercializing products with high technical barriers to market entry, leveraging proprietary research and development capabilities, competitive advantages in sourcing or manufacturing raw materials or APIs, and improvements upon existing drug formulations.

The company generates revenue through the sale of prescription pharmaceutical products, an over-the-counter product, and API products. Revenue is primarily transactional, derived from sales to institutions such as hospitals, long-term care facilities, alternate care sites, clinics, and doctors' offices, as well as to retail pharmacies. Most institutional customers and retail pharmacies are members of group purchasing organizations that negotiate collective purchasing agreements. The company sells through specialty distributors and wholesalers, with three major customers—McKesson, Cencora, and Cardinal Health—accounting for approximately 65% ⁷, 64% ⁸, and 60% ⁹ of total net revenues for the years ended December 31, 2025, 2024, and 2023, respectively. The company also generates revenue from research and development services provided to its Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Ltd. (ANP), and from licensing agreements.

The company's largest products by net revenues include BAQSIMI glucagon nasal powder, Primatene MIST, glucagon, epinephrine, and lidocaine. BAQSIMI, acquired in June 2023, is the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes ages four years and above, available in the United States and 26 ¹⁰ international markets. Primatene MIST is an over-the-counter epinephrine inhalation product indicated for the temporary relief of mild symptoms of intermittent asthma. Glucagon for Injection Emergency Kit, for which the company received the first-ever FDA approval of a generic version of rDNA Glucagon in the fourth quarter of 2020, is indicated for the treatment of severe hypoglycemia and as a diagnostic aid. Enoxaparin is a difficult-to-manufacture injectable low molecular weight heparin used as an anticoagulant, with the company manufacturing the API in-house. The company sells two versions of naloxone injections and REXTOVY, its prescription naloxone nasal spray, for the emergency treatment of known or suspected opioid overdose. Other marketed products include Cortrosyn (cosyntropin for injection), Amphadase (bovine-sourced hyaluronidase injection), epinephrine injection, lidocaine jelly, lidocaine topical solution, phytonadione injection, a portfolio of emergency syringe products, albuterol sulfate inhalation aerosol (launched August 2024), iron sucrose injection (launched August 2025), teriparatide injection (launched December 2025), and Ipratropium Bromide HFA inhalation aerosol (approved February 2026, planned launch early second quarter 2026). The company also manufactures and sells two API products: Recombinant Human Insulin (RHI API) and porcine insulin API, and plans to sell two GLP-1 APIs developed at its ANP facility.

The company's product pipeline includes over 10 ¹¹ product candidates in various stages of development, including generic ANDAs, biosimilar product candidates, and proprietary product candidates. Generic product candidates leverage injectable technologies (pre-filled syringes, vials in solution, suspension, and lyophilized forms), inhalation technologies (MDIs), and sophisticated analytical technologies. Biosimilar product candidates include two interchangeable insulin product candidates—Insulin Aspart (AMP-004) and Recombinant Human Insulin (AMP-005)—and a biosimilar product outside the insulin portfolio, AMP-028, which is expected to leverage the company's API facilities. Proprietary product candidates include intranasal epinephrine (AMP-019) for emergency treatment of allergic reactions; AMP-105, a first-in-class peptide targeting a novel mechanism to modulate cell growth and metastasis of multiple cancers; AMP-107, the first non-injectable anti-vascular endothelial growth factor receptor peptide developed as a topical eye drop for wet age-related macular degeneration; AMP-109, a novel peptide-docetaxel conjugate designed to improve selectivity and bioavailability of docetaxel; and AMP-110, a novel synthetic human corticotropin (ACTH) analog targeting multiple indications. One ANDA and one biosimilar insulin candidate are currently on file with the FDA.

In June 2023, the company completed its acquisition of BAQSIMI from Eli Lilly & Company, financed with proceeds from a senior secured term loan (the Wells Fargo Term Loan) provided under a syndicated credit agreement. In connection with the acquisition, the company entered into a Transition Service Agreement (TSA) with Lilly, under which Lilly provided certain services to support the transition of BAQSIMI operations. As of January 1, 2025, the transition pursuant to the TSA was completed, and the company now distributes and manages the BAQSIMI supply chain in all countries where it is available. In May 2024, the FDA approved the company's albuterol sulfate inhalation aerosol, which was launched in August 2024. In August 2025, the FDA approved the company's iron sucrose injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, launched in August 2025. In December 2025, the FDA approved the company's teriparatide injection, USP 560mcg/2.24mL single-patient-use prefilled pen, launched in December 2025. In February 2026, the FDA approved the company's Ipratropium Bromide HFA inhalation aerosol, 17 mcg/actuation, planned for launch early in the second quarter of 2026. The company has also licensed several peptide proprietary product candidates from Nanjing Anji Biotechnology Co., Ltd. (Anji) and Nanjing Hanxin Pharmaceutical Technology Co., Ltd. (Hanxin). As of December 31, 2025, the company had 1,976 ¹² full-time employees in the United States, China, and France.

For the year ended December 31, 2025, the company recorded net revenues of $719.9 million ¹³, compared to $732.0 million ¹⁴ in 2024 and $644.4 million ¹⁵ in 2023. Net income was $98.1 million ¹⁶ for 2025, compared to $159.5 million ¹⁷ in 2024 and $137.5 million ¹⁸ in 2023. Research and development expense was $85.8 million ¹⁹ for 2025, compared to $73.9 million ²⁰ in 2024 and $73.7 million ²¹ in 2023. Sales from BAQSIMI represented 26% ²², 20% ²³, and 8% ²⁴ of total net revenues for the years ended December 31, 2025, 2024, and 2023, respectively. Sales from Primatene MIST represented 15% ²⁵, 14% ²⁶, and 14% ²⁷ of total net revenues for those same periods. Sales from glucagon represented 10% ²⁸, 15% ²⁹, and 18% ³⁰; sales from epinephrine represented 10% ³¹, 13% ³², and 13% ³³; and sales from lidocaine products represented 8% ³⁴, 8% ³⁵, and 9% ³⁶ of total net revenues for the years ended December 31, 2025, 2024, and 2023, respectively.

A primary growth vector is the company's pipeline of over 10 ³⁷ product candidates in various stages of development, including generic ANDAs, biosimilar product candidates, and proprietary product candidates. The company's generic development in the injectable market is targeting opportunities in over $7 billion ³⁸ of that market, and in the inhalation market, it is targeting opportunities in over $1.1 billion ³⁹ of that market. The company plans to commercialize its product candidates and diversify revenue sources, expecting to expand internal sales and marketing capabilities and, in some cases, enter into strategic alliances. The company's biosimilar pipeline, with a particular emphasis on interchangeable insulin analogs, targets a high-demand diabetes care sector, with two interchangeable insulin product candidates (Insulin Aspart AMP-004 and Recombinant Human Insulin AMP-005) and a biosimilar product outside the insulin portfolio, AMP-028, which is expected to leverage the company's API facilities to participate in a large market without any interchangeable biosimilars. One ANDA and one biosimilar insulin candidate are currently on file with the FDA.

Another growth vector is the expansion of the company's proprietary product portfolio, which includes intranasal epinephrine (AMP-019), AMP-105 (a first-in-class peptide targeting a novel mechanism for multiple cancers), AMP-107 (a topical eye drop for wet age-related macular degeneration), AMP-109 (a novel peptide-docetaxel conjugate), and AMP-110 (a novel synthetic human corticotropin analog). The company has licensed several peptide proprietary product candidates from Anji and Hanxin, which it believes it can develop, manufacture, and commercialize as part of long-term revenue growth. The company also plans to sell two GLP-1 APIs developed and manufactured at its ANP facility to third parties, with sales of small batches for R&D purposes already begun, though more meaningful sales will require regulatory approval outside of the U.S. Additionally, the company is developing formulations using a new environmentally friendly propellant for use in future MDI products as part of ongoing efforts to advance inhalation technologies.

The filing does not contain explicit margin trajectory or cost structure evolution targets.

The company is planning to increase capacity at its plant in Rancho Cucamonga, CA with the goal of allowing it to eventually quadruple the number of units produced at this facility. It is also increasing the capacity of its inhalation facility in Canton, MA and its insulin API production facility at ANP. The company continues to expand its facility in Nanjing, China, and expects further significant investment in this facility. As of December 31, 2025, the company owns or leases a total of 69 ⁴⁰ buildings at six locations in the United States, France and China, comprising 2.5 million ⁴¹ square feet of manufacturing, research and development, distribution, packaging, laboratory, office and warehouse space. The company believes its current manufacturing capacity is adequate for the near term.

Research and development expense was $85.8 million ⁴² for the year ended December 31, 2025. The company's research and development efforts are focused on developing products with high barriers to market entry, requiring significant investment including clinical development. The company's loan agreements contain restrictive covenants that may limit operating flexibility, including limitations on the ability to pay dividends. The filing does not specify a share repurchase authorization amount or capital expenditure plans for the upcoming period.

A significant headwind is the declining revenue from certain key products. The company has experienced declining revenue from glucagon and some of its other existing products, with glucagon and epinephrine multi-dose vial products continuing to see increased competition, resulting in declining per unit prices and lower market share. Since the commercial launch of its glucagon product, the company has experienced significant declines in sales volume, per unit pricing and gross margins attributable to this product. The company has also experienced pricing pressure on many of its other products, including naloxone, and expects this trend to continue. Additionally, the company's BAQSIMI product relies on contract manufacturing organizations (CMOs) for supply, and the company depends on single source suppliers for raw materials, APIs, and components used in certain products, creating supply chain risk.

The company faces structural headwinds from the regulatory environment, including the potential impact of the Inflation Reduction Act of 2022, which established a Medicare Part D inflation rebate scheme and a drug price negotiation program, with the first negotiated prices to take effect in 2026. The American Innovation in Manufacturing Act of 2020 (AIM Act) directs the EPA to address usage of hydrofluorocarbons (HFCs), and one of the company's products, Primatene MIST, utilizes HFCs subject to the AIM Act's reduction mandate, as do many of its inhalation pipeline assets. The company also faces risks related to its international operations, including a significant portion of manufacturing taking place in China, which exposes it to political unrest, tariffs, health epidemics, and changes in laws and regulations governing foreign trade.

The company's five largest products—BAQSIMI, Primatene MIST, glucagon, epinephrine, and lidocaine—collectively represented a significant portion of net revenues, with BAQSIMI alone accounting for 26% ⁴³ of total net revenues in 2025, and the company has experienced declining revenue from glucagon and other products due to increased competition and pricing pressure. The company depends on single source suppliers for raw materials, APIs, and components used in certain products, and on CMOs for the supply of BAQSIMI, with any disruption potentially causing protracted delays in manufacturing. Sales to three customers—McKesson, Cencora, and Cardinal Health—accounted for approximately 65% ⁴⁴ of total net revenues in 2025, creating significant customer concentration risk. The company's outstanding loan agreements, including the Wells Fargo Term Loan and the 2.00% Convertible Senior Notes due 2029, contain restrictive covenants that may limit operating flexibility, and the company's materially increased indebtedness could adversely affect operating results and cash flows. The company faces risks from the AIM Act, which regulates HFCs used in Primatene MIST and many inhalation pipeline assets, and from the Inflation Reduction Act's drug price negotiation program, which could impact pricing and profitability.

Management's message emphasizes the company's strategic shift from primarily complex generics toward proprietary and biosimilar products, reflecting a long-term strategy to expand into higher-value, innovative-driven programs. Key strategic priorities include diversifying revenues by commercializing over 10 ⁴⁵ product candidates in various stages of development, leveraging the company's vertically integrated infrastructure to drive operational efficiencies, and targeting and integrating acquisitions of pharmaceutical companies, products, and technologies. Management highlights the successful completion of the BAQSIMI transition from Eli Lilly & Company as of January 1, 2025, with the company now distributing and managing the BAQSIMI supply chain in all countries where it is available. The filing notes that the company recorded net revenues of $719.9 million ⁴⁶ for the year ended December 31, 2025, and net income of $98.1 million ⁴⁷ for the same period. Management also points to recent FDA approvals and launches, including albuterol sulfate inhalation aerosol (launched August 2024), iron sucrose injection (launched August 2025), teriparatide injection (launched December 2025), and Ipratropium Bromide HFA inhalation aerosol (approved February 2026, planned launch early second quarter 2026).