Amneal Pharmaceuticals, Inc. Q1 FY2025 earnings call

Management Statement and Operational Highlights

• Specialty Segment: CREXONT launch exceeds expectations, with strong market uptake and expanding coverage. The DHE autoinjector for migraine and cluster headache is expected to launch later in 2025.
• GLP-1 Partnership: Collaboration with Metsera is progressing, with construction of 2 new manufacturing facilities for peptide drug substance and advanced sterile fill/finish manufacturing.
• Affordable Medicines: Injectables portfolio expanding with new launches; biosimilars pipeline advancing with filings and launches planned for 2026 and 2027.
• Operations: Global manufacturing infrastructure investment in digitization, automation, and AI. Robust U.S. manufacturing footprint with 7 FDA-approved facilities in the U.S.
• Innovation: CREXONT showing strong KPIs with new data on sleep quality for Parkinson’s patients; DHE autoinjector development ongoing; GLP-1 partnership progress; complex generics and injectables portfolio growth with new product launches planned.

Segment Performance

• Specialty: Q1 revenue was $108 million, growing 3%. The launch of CREXONT for Parkinson’s disease continues to exceed expectations, with market share surpassing 1% and on track to reach over 3% by year-end. U.S. coverage for CREXONT doubled to approximately 60% of U.S. covered lives. Amneal is highly confident in achieving U.S. peak sales of $300 million to $500 million for CREXONT.
• GLP-1s: Partnership with Metsera in the weight loss and obesity space is progressing. Metsera’s lead program MET-097i is expected to deliver Phase 2b trial results midyear. Amneal is Metsera’s preferred global supplier and will commercialize products in 20 emerging markets, including India.
• Affordable Medicines: Q1 revenue was $415 million, growing 6% due to new product launches. The injectables portfolio is expanding, with BORUZU being the fourth 505(b)(2) injectable launch in 2025. Biosimilars: 2024 first 3 biosimilars generated $125 million revenue; expect 6 biosimilars on the market by 2027; 2025 involves filing 5 biosimilar pipeline candidates.
• AvKARE: Q1 revenue was $172 million, growing 6%. Driven by new launches across distribution, government, and unit dose channels. Expected to reach over $900 million by 2027.

Guidance

• 2025 Full Year: Total net revenue expected to be between $3 billion and $3.1 billion (6%-11% growth); adjusted EBITDA expected to be between $650 million and $675 million (4%-8% growth); adjusted EPS expected to be between $0.65 and $0.70 (12%-21% growth).

Risks

• Tariffs: Mitigating actions being developed, including increasing U.S. inventory, securing alternative API sources, renegotiating supply agreements, and portfolio optimization to address potential tariff impacts.

Question and Answer

• Q: Biosimilar top line contribution, vertical integration timeline, injectable top line A: Biosimilars expected to contribute approximately $150 million to $160 million to the top line, with ALYMSYS contributing around $90 million to $100 million. Vertical integration expected by end of 2025 or early 2026. Injectables focus on both complex and volume products, with no lean into one over the other.
• Q: AvKARE exposure to federal cuts, FDA delays, CREXONT ex-U.S. timeline A: AvKARE not exposed to federal cuts as pharmaceuticals are not affected; VA is expanding. No FDA delays observed. CREXONT ex-U.S. partnership in place for Canada, Latin America, Europe, Southeast Asia, and India; launch in India planned soon.
• Q: Tariffs and CREXONT cannibalization A: Leverage U.S. manufacturing capacity if tariffs applied; work with large customers on price increases. CREXONT focus on broader market, with no aggressive conversion from RYTARY expected.