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Amphastar Pharmaceuticals (AMPH)

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Earnings summaries and quarterly performance for Amphastar Pharmaceuticals.

Recent press releases and 8-K filings for AMPH.

Amphastar Pharmaceuticals Outlines Strategic Shift and 2026 Growth Drivers
AMPH
Guidance Update
Product Launch
New Projects/Investments
  • 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.
Jan 14, 2026, 10:15 PM
Amphastar Pharmaceuticals Updates on Strategic Shift, Pipeline, and 2026 Outlook
AMPH
Guidance Update
Product Launch
New Projects/Investments
  • 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.
Jan 14, 2026, 10:15 PM
Amphastar Pharmaceuticals Updates on Strategic Shift, Pipeline, and 2026 Outlook
AMPH
Guidance Update
New Projects/Investments
Product Launch
  • 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.
Jan 14, 2026, 10:15 PM
Amphastar Pharmaceuticals Enters Exclusive License Agreement for AMP-110
AMPH
New Projects/Investments
Product Launch
  • 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.
Jan 12, 2026, 10:15 PM
Amphastar Pharmaceuticals Outlines Strategic Pipeline Shift and Growth Drivers
AMPH
New Projects/Investments
Product Launch
Guidance Update
  • 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.
Dec 3, 2025, 7:00 PM
Amphastar Pharmaceuticals Discusses Pipeline Shift, 2026 Growth Drivers, and M&A Strategy
AMPH
Product Launch
New Projects/Investments
Guidance Update
  • 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.
Dec 3, 2025, 7:00 PM
Amphastar Provides Update on Pipeline Strategy and 2026-2027 Growth Drivers
AMPH
New Projects/Investments
Product Launch
Guidance Update
  • 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.
Dec 3, 2025, 7:00 PM
Amphastar Pharmaceuticals Discusses 2025 Performance and 2026 Outlook
AMPH
Guidance Update
Product Launch
New Projects/Investments
  • 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.
Nov 19, 2025, 3:30 PM
Amphastar Pharmaceuticals Outlines 2026 Growth Drivers and Strategic Pipeline Shift
AMPH
Guidance Update
Product Launch
New Projects/Investments
  • 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.
Nov 19, 2025, 3:30 PM
Amphastar Pharmaceuticals Highlights 2025 Performance and Outlines 2026 Growth Strategy
AMPH
Product Launch
Guidance Update
Revenue Acceleration/Inflection
  • 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.
Nov 19, 2025, 3:30 PM