Earnings summaries and quarterly performance for Amphastar Pharmaceuticals.
Executive leadership at Amphastar Pharmaceuticals.
Jack Zhang
Chief Executive Officer, President, Chief Scientific Officer
Jacob Liawatidewi
Executive Vice President of Sales and Marketing and Corporate Administration Center; President of Amphastar France Pharmaceuticals, S.A.S.; Corporate Secretary
Mary Luo
Chief Operating Officer, Chief Scientist
Rong Zhou
Senior Executive Vice President of Production Center; Executive Vice President of Scientific Affairs; President of Amphastar Nanjing Pharmaceuticals, Co., Ltd.
William Peters
Chief Financial Officer, Executive Vice President of Finance, Treasurer
Board of directors at Amphastar Pharmaceuticals.
Research analysts who have asked questions during Amphastar Pharmaceuticals earnings calls.
David Amsellem
Piper Sandler Companies
4 questions for AMPH
Ekaterina Knyazkova
Cantor Fitzgerald
4 questions for AMPH
Cerena Chen
Wells Fargo & Company
3 questions for AMPH
Jason Gerberry
Bank of America Merrill Lynch
2 questions for AMPH
Pavan Patel
Bank of America
2 questions for AMPH
Serge Belanger
Needham & Company
2 questions for AMPH
John Gionco
Needham & Co.
1 question for AMPH
Recent press releases and 8-K filings for AMPH.
- Amphastar Pharmaceuticals is undergoing a pipeline evolution, targeting a 2026 product mix of 50% proprietary, 35% biosimilar, and 15% generic, a significant shift from 63% generic five years prior.
- The company provided a 2026 revenue growth outlook of mid-single digit to low double digits, primarily driven by the anticipated mid-2026 launch of AMP-007, continued growth from Baqsimi and Primatene Mist, and full-year sales of Teriparatide and iron sucrose.
- Baqsimi peak sales guidance was reiterated at $250-$275 million, with expected mid-single digit growth in 2026, including low double-digit growth in the U.S. and a planned withdrawal from unprofitable international markets.
- The proprietary pipeline includes new peptide products such as AMP-105 (oncology), AMP-107 (ophthalmic), AMP-109 (cancer PDC), and the recently licensed AMP-110 (synthetic corticotropin), supported by an annual R&D investment of $60 million to $75 million.
- Amphastar Pharmaceuticals is undergoing a strategic pipeline shift, targeting 50% proprietary, 35% biosimilar, and 15% generic products by 2026, a significant change from its previous 63% generic focus five years ago.
- The company forecasts mid-single digit to low double-digit revenue growth for 2026, with the mid-2026 launch of AMP-007 expected to be the primary growth driver, supplemented by Baqsimi and Primatene Mist sales.
- Baqsimi, acquired in 2023, is projected to achieve peak sales of $250-$275 million, with mid-single digit growth anticipated in 2026 driven by U.S. expansion and strategic withdrawal from unprofitable international markets.
- Significant pipeline developments include the planned mid-2026 launch of AMP-007, and expected 2027 launches for AMP-018 (GLP-1) and AMP-004 (insulin aspart biosimilar).
- Amphastar maintains a strong R&D focus, investing $60 million-$75 million annually, and recently licensed new chemical entities (NCEs) in August 2025 and early January 2026, including AMP-110.
- Amphastar is strategically shifting its pipeline focus, aiming for 50% proprietary, 35% biosimilar, and 15% generic products by 2026, a significant change from 63% generic five years prior. This includes new chemical entities (NCEs) in oncology and ophthalmology, and biosimilar insulins.
- For 2026, the company projects mid-single digit to low double-digit revenue growth, primarily driven by the anticipated mid-year launch of AMP-007, full-year sales of teriparatide and iron sucrose, and continued growth from Primatene Mist and vaccine sales.
- Baqsimi peak sales guidance remains at $250-$275 million, with mid-single digit growth expected in 2026, and is forecasted to contribute $2-$2.50 of incremental EPS at peak. The company plans to exit unprofitable international markets for Baqsimi in the latter half of 2026 to improve margin profile.
- Recent pipeline additions include the 2023 acquisition of Baqsimi and the licensing of several early-stage NCEs in August 2025, with a new synthetic corticotropin (AMP-110) licensed in January 2026.
- Amphastar Pharmaceuticals, Inc. entered into an exclusive license agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. for AMP-110, a fully synthetic corticotropin compound, for the United States and Canada.
- Under the agreement, dated January 6, 2026, Amphastar made an upfront payment of $2 million and is obligated to pay up to $14 million in development milestone payments and up to $75 million in sales milestone payments.
- Hanxin will also receive royalty payments, capped at $7.5 million annually and a maximum accumulated amount of $60 million.
- AMP-110 targets inflammatory and autoimmune conditions in a U.S. ACTH market that exceeded $684 million annually in 2024.
- The agreement involves related party transactions due to beneficial ownership in Hanxin by Amphastar's CEO and COO, which were approved by the Audit Committee.
- Amphastar is strategically shifting its pipeline to achieve 50% proprietary products by 2026, which is expected to lead to an increase in R&D spend. The company is actively pursuing external business development for late-stage or on-market proprietary assets, particularly in the endocrinology space, and is comfortable with up to four times leverage for acquisitions.
- The company projects high single to low double-digit top-line growth in 2026, primarily driven by the potential first-to-market generic AMP-007, continued growth of Baqsimi, and the launch of a teriparatide generic.
- Looking further ahead, the insulin aspart biosimilar is anticipated as a significant growth opportunity for 2027.
- Amphastar Pharmaceuticals is strategically shifting its pipeline, aiming for 50% proprietary products by 2026, and recently in-licensed three novel peptide assets (AMP-105, AMP-109, AMP-107) for oncology and ophthalmology, currently in preclinical stages.
- The company projects high single to low double-digit top-line growth in 2026, primarily driven by the anticipated launch of AMP-007 (a potential first-to-market generic), continued significant growth from Baqsimi, and contributions from Primatene Mist, Teriparatide, and Iron Sucrose.
- Baqsimi currently holds almost 60% of the ready-to-use glucagon market and benefits from patent protection extending to 2036 and 2039.
- R&D spend is expected to increase due to proprietary product development, while cost optimization efforts are underway. The company is comfortable with debt leverage up to four times for potential M&A, particularly for late-stage or on-market assets in endocrinology.
- Looking to 2027, Insulin Aspart (biosimilar) is highlighted as a significant opportunity, with one to two product filings expected in 2026, including a potential first-to-market inhalation product and biosimilars.
- Amphastar is strategically shifting its pipeline, aiming for 50% proprietary products by 2026, including three new peptide assets (AMP-105, AMP-109, AMP-107) in-licensed in August and currently in preclinical stages. This shift will lead to increased R&D spend, though cost optimization efforts are ongoing.
- The company projects high single-digit to low double-digit growth in 2026, primarily driven by the anticipated launch of AMP-007, expected to be a first-approved generic and the biggest growth driver. Additional growth is expected from Baqsimi, Primatene Mist, Teriparatide, and iron sucrose.
- Baqsimi currently holds almost 60% of the ready-to-use glucagon market, with patent protection extending to 2036 and 2039, and is projected to reach $250 million-$275 million in peak sales. Promotional efforts include a dedicated sales force and a co-promotion agreement with MannKind.
- For 2027, Amphastar anticipates the launch of an insulin aspart biosimilar, considered a significant opportunity, and a GLP-1 generic. The company is open to M&A for late-stage or on-market assets, comfortable with leverage up to four times.
- Amphastar Pharmaceuticals reported strong performance from proprietary products Baqsimi and Primatene Mist in 2025, both achieving double-digit growth, and launched iron sucrose, while overall sales were relatively flat due to competitive dynamics.
- The company expects high single-digit to low double-digit revenue growth in 2026, primarily driven by the anticipated mid-2026 launch of AMP-007, a generic HFA inhalation product with no current generic competitors and potential 180-day marketing exclusivity.
- Amphastar is strategically shifting its focus towards proprietary and biosimilar products, aiming for 50% of its pipeline to be proprietary; this includes the recent in-licensing of three new chemical entities from Nanjing Anji Biotechnology.
- Gross margins faced pressure in 2025 and are expected to decline further in the fourth quarter of 2025, but are projected to improve in 2026 with new product launches, though R&D expenses are anticipated to increase as a percentage of sales.
- The company holds $275 million in cash and short-term investments against $600 million in debt, and is actively engaged in share buybacks while also evaluating potential acquisition targets.
- Amphastar Pharmaceuticals (AMPH) reported strong performance in 2025 from its proprietary products, Baqsimi and Primatene Mist, both achieving double-digit growth, though overall sales were relatively flat due to competitive dynamics on historic products.
- The company projects high single-digit to low double-digit revenue growth in 2026, largely contingent on the anticipated mid-2026 launch of AMP-007, a generic HFA inhalation product expected to be the first generic entrant and eligible for 180 days marketing exclusivity.
- Operating margins contracted in 2025 due to competitive pressures and increased R&D and selling expenses, with further pressure expected in Q4 2025 before potential expansion in 2026 from new product launches.
- Amphastar is strategically shifting its pipeline focus towards proprietary and biosimilar products, aiming for 50% proprietary products by 2026, and recently in-licensed three new peptide chemical entities.
- The company maintains a balance sheet with $275 million in cash and short-term investments against $600 million in debt, and is actively pursuing stock buybacks and evaluating potential acquisitions.
- Amphastar Pharmaceuticals reported strong double-digit growth for its proprietary products, Baqsimi and Primatene Mist, in 2025, and successfully launched iron sucrose.
- The company is strategically shifting its focus towards proprietary and biosimilar products, aiming for 50% of its pipeline to be proprietary next year, and views recent FDA updates on biosimilars as a tailwind.
- Two potential product launches are anticipated in 2026: AMP-015 (generic teriparatide) and AMP-007 (generic HFA inhalation product), with AMP-007 expected to be the most significant growth driver.
- For 2026, Amphastar expects high single-digit to low double-digit revenue growth, largely contingent on the approval and mid-year launch of AMP-007, which is also eligible for 180 days marketing exclusivity.
- The company maintains a strong liquidity position with approximately $275 million in cash and short-term investments and $600 million in debt, and is actively pursuing stock buybacks and potential acquisitions.
Quarterly earnings call transcripts for Amphastar Pharmaceuticals.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more