Amneal Pharmaceuticals, Inc.

Overview

• Global diversified biopharmaceutical company that develops, manufactures, markets, and distributes a portfolio of essential medicines.
• Three reportable segments: Affordable Medicines, Specialty, and AvKARE.
• Geographic footprint: United States, India, and Ireland.
• Corporate structure: Reorganized in 2023 to a traditional C‑corporation; owns 100% of Amneal Common Units and consolidates Amneal affiliates.

Business segments

Affordable Medicines

• Broad portfolio of generic, biosimilar, and branded products.
• Over 280 product families in the United States across multiple formulations and delivery systems (oral, injectables, ophthalmics, transdermal, etc.).
• Integrated development and manufacturing with a focus on high-value products and complex formulations.
• Manufacturing mix (2025): 46% of Affordable Medicines net revenue from U.S. facilities; 24% from facilities in India.
• Pipeline (as of 12/31/2025): 61 product families with pending ANDAs and 43 in various development stages.
• Biosimilars: ALYMSYS, Releuko, Flynetra launched 2022–2023; five biosimilars approved in the U.S. by late 2025, including denosumab biosimilars Boncresa and Oziltus (approved Dec 2025).
• Distribution: Exclusive U.S. and Puerto Rico distribution of ALYMSYS through Valorum Oncology (initial term through 2028); Amneal retains regulatory and supply responsibilities.

Specialty

• Branded products focused on CNS disorders and endocrine conditions.
• Major products: CREXONT (carbidopa/levodopa extended release), RYTARY (extended-release carbidopa-levodopa), UNITHROID (levothyroxine), and Brekiya (dihydroergotamine mesylate) autoinjector.
• New launches timed near market exclusivity windows; an authorized generic of RYTARY launched in 2025.
• Brekiya autoinjector approved May 2025 and launched October 2025 — the first ready-to-use dihydroergotamine autoinjector for migraine and cluster headache.

AvKARE

• Government-focused segment supplying pharmaceuticals and related products to the U.S. federal government and performing repackaging and distribution for retail and institutional markets.
• Distribution and operations include facilities in Fountain Run, KY; Glasgow, KY; and Philadelphia, PA.
• Serves Department of Defense and VA markets and follows government procurement and compliance requirements.

Alliances, collaborations, and licensing

• ApiJect Systems (May 8, 2025): 15-year collaboration to install ApiJect BFS manufacturing equipment at Amneal’s Brookhaven, NY site; low-digit royalty on products manufactured with the BFS platform; option to purchase equipment at end of term; collaboration on additional injectable programs.
• Metsera, Inc. (Sept 30, 2024): Amneal named preferred global supply partner for weight‑loss medicines; exclusive license to commercialize certain Metsera products in select emerging markets (India, SE Asia, Africa, Middle East); Metsera committed up to $100 million toward Indian API and fill-finish facilities; upstream rebates and cost-sharing arrangements executed. Metsera was acquired by Pfizer on Nov 13, 2025; on Jan 30, 2026 Pfizer shortened the term of the arrangement to four years from first commercial sale and eliminated rebates and construction cost reimbursements; the cost‑sharing commitment remains.
• Zambon Biotech (Feb 23, 2024): License, distribution, and supply agreement for IPX203 in Europe; exclusive regulatory and commercialization rights for Europe; Amneal to manufacture and supply upon regulatory approval.
• Knight Therapeutics (Jan 24, 2024): 15-year license for exclusive rights to IPX203 in Canada and Latin America, mirroring the Zambon structure.
• BIAL (ONGENTYS, opicapone) License (Dec 5, 2023): U.S. market rights with manufacturing and supply arrangements; termination procedures contemplated for Feb 2028 unless extended.
• Kashiv Biosciences LLC: Development and supply agreements (Dec 2022; amended March 2024) for long-acting injectable (pegfilgrastim) delivery systems; exclusive U.S. license and commercialization for an omalizumab biosimilar in the U.S. and India (announced July 2024); BLA submitted to FDA for the omalizumab biosimilar in Sept 2025.
• Multiple other licensing and supply arrangements across generics and biosimilars, including ongoing Kashiv/KR partnerships.

Geography and manufacturing footprint

• Primary manufacturing locations: United States, India, and Ireland.
• India facilities targeted for API production and fill‑finish operations; two manufacturing facilities under construction with Metsera cost‑sharing involvement.
• AvKARE distribution centers located in Kentucky and Pennsylvania, among other sites.

Customers and concentration

• Approximately 1,300 customers in total, including over 1,100 in AvKARE.
• Four largest customers (Cencora, McKesson Drug Co., Cardinal Health, CVS Health) accounted for about 71% of consolidated net revenue for the year ended 12/31/2025 (around 70% in 2024 and 2023).
• High customer concentration creates sensitivity to loss or reductions in orders from these major customers.

Workforce and human capital

• Total employees: Over 8,500 as of 12/31/2025 (excluding approximately 200 AvKARE employees).
• Geographic distribution: About 2,500 in the U.S.; over 6,000 outside the U.S. (primarily India and Ireland).
• 2025 hiring: Approximately 2,000 new employees added in 2025.
• Turnover: Approximately 17.9% for the year.

Financial snapshot (as of 12/31/2025)

• Total debt outstanding: Approximately $2.7 billion (about $2.1 billion Term Loan due 2032; $600 million Senior Notes due 2032).
• Available liquidity: Up to approximately $678.2 million under credit facilities (roughly $595.2 million under the 2025 Revolving Credit Facility and $83.0 million under the Amended and Restated Rondo Revolving Credit Facility).
• 2026 debt service expectations: Approximately $21.0 million of principal payments on the Term Loan due 2032 and about $193.9 million in interest payments (excluding the impact of interest rate swaps) on the Term Loan and Senior Notes due 2032.

Regulatory and risk context

• Operates in a heavily regulated industry with FDA compliance, pricing, healthcare reform, and antitrust considerations.
• Regulatory events include FDA inspections and warning letters (for example, an August 2025 warning letter at an Amneal facility in Gujarat, India) and ongoing government investigations related to pricing, rebates, and anti‑kickback laws.
• Substantial activity around patents, exclusivities, ANDA/BLA filings, and potential IP litigation typical for generic and biosimilar manufacturers.

Strategic focus

• Expanding injectable and complex‑delivery capabilities (e.g., ApiJect BFS collaboration and respiratory/injectable portfolio expansion).
• Building manufacturing capacity in India for API and fill‑finish operations, supported by collaboration funding arrangements.
• Pursuing global licensing and distribution through strategic partners (Zambon, Knight, BIAL, Kashiv, etc.).
• Growing the biosimilar and branded portfolios within Affordable Medicines and Specialty while managing competitive pricing and distribution dynamics.