Earnings summaries and quarterly performance for Amphastar Pharmaceuticals.
Executive leadership at Amphastar Pharmaceuticals.
Jack Zhang
Detailed
Chief Executive Officer, President, Chief Scientific Officer
CEO
Jacob Liawatidewi
Detailed
Executive Vice President of Sales and Marketing and Corporate Administration Center; President of Amphastar France Pharmaceuticals, S.A.S.; Corporate Secretary
Mary Luo
Detailed
Chief Operating Officer, Chief Scientist
Rong Zhou
Detailed
Senior Executive Vice President of Production Center; Executive Vice President of Scientific Affairs; President of Amphastar Nanjing Pharmaceuticals, Co., Ltd.
William Peters
Detailed
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
Also covers: ABBV, ALKS, AMGN +27 more
Ekaterina Knyazkova
Cantor Fitzgerald
4 questions for AMPH
Also covers: ANIP, ELAN, PAHC
Cerena Chen
Wells Fargo & Company
3 questions for AMPH
Also covers: AXSM, HALO
Jason Gerberry
Bank of America Merrill Lynch
2 questions for AMPH
Also covers: ALKS, ARWR, AXSM +21 more
Pavan Patel
Bank of America
2 questions for AMPH
Also covers: CPRX, HRMY, TARS
Serge Belanger
Needham & Company
2 questions for AMPH
Also covers: ARQT, BCRX, CLSD +12 more
John Gionco
Needham & Co.
1 question for AMPH
Also covers: CYTK, PCRX, TRVI
Recent press releases and 8-K filings for AMPH.
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
Amphastar Pharmaceuticals Reports Q3 2025 Results with Strong Product Sales and Pipeline Expansion
AMPH
Earnings
Product Launch
New Projects/Investments
- Amphastar Pharmaceuticals reported net revenues of $191.8 million and adjusted net income of $44.6 million, or $0.93 per diluted share, for Q3 2025.
- Performance was driven by Vaccimi sales of $53.6 million (up 14% year-over-year) and Primatene Mist sales of $28.8 million (up 11% year-over-year), alongside $2.4 million in sales from the newly launched iron sucrose injection.
- The company expanded its proprietary pipeline with an exclusive in-licensing agreement for three early-stage novel peptide candidates in oncology and ophthalmology, leading to a $5.25 million increase in R&D expenditures.
- Amphastar maintains its informal guidance for a flat year-over-year top line in 2025 and anticipates high single-digit to low double-digit growth rates for 2026.
- General and administrative spending increased due to a litigation provision related to a recent jury verdict.
Nov 6, 2025, 10:00 PM
Amphastar Pharmaceuticals Reports Q3 2025 Financial Results
AMPH
Earnings
Product Launch
New Projects/Investments
- Amphastar Pharmaceuticals reported net revenues of $191.8 million for the three months ended September 30, 2025.
- For the third quarter of 2025, the company's GAAP net income was $17.4 million, or $0.37 per diluted share, while adjusted non-GAAP net income was $44.7 million, or $0.93 per diluted share.
- Key revenue drivers included a 14% increase in BAQSIMI® revenue compared to the same period last year, and the launch of iron sucrose injection in August 2025.
- The company bolstered its proprietary pipeline by entering into an exclusive licensing agreement with Nanjing Anji Biotechnology to develop and commercialize three novel peptides targeting oncology and ophthalmology.
- Cash flow provided by operating activities for the nine months ended September 30, 2025, was $123.3 million.
Nov 6, 2025, 9:25 PM
Amphastar Pharmaceuticals Enters Distribution Agreement for BAQSIMI® in Greater China
AMPH
New Projects/Investments
Product Launch
Related Party Transaction
- Amphastar Pharmaceuticals, Inc. (AMPH) entered into a ten-year Distribution Agreement with Nanjing Chengong Pharmaceutical Co., Limited on October 21, 2025.
- The agreement appoints Chengong as the exclusive distributor for Amphastar's nasal powder product, BAQSIMI®, in the Greater China region (Mainland China, Taiwan, Hong Kong, and Macau).
- Chengong is responsible for regulatory approvals and post-marketing clinical trials, and the agreement includes minimum purchase amounts and profit sharing.
- The total revenue for the ten-year period of the agreement is not determinable at this time.
- This agreement is a related party transaction, as Amphastar's CEO and COO, along with family members, beneficially own a majority equity interest in Chengong's parent company; it was approved by the independent Audit Committee.
Oct 24, 2025, 8:21 PM
Amphastar Pharmaceuticals Enters Research Agreement for AMP-107 Development
AMPH
New Projects/Investments
- On September 15, 2025, Amphastar Pharmaceuticals, Inc. entered into a three-year contract research agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd.
- Under the agreement, Hanxin will develop Recombinant Peptide Research Cell Banks (RCBs) for Amphastar's product candidate, AMP-107, with all intellectual property developed belonging to Amphastar.
- The total cost to Amphastar for this agreement will not exceed approximately $2.8 million, with an initial payment of approximately $0.3 million made on the effective date.
- The agreement is a related-party transaction, as Amphastar's CEO, President, and Director, Dr. Jack Zhang, and Chairman, COO, and Director, Dr. Mary Luo, along with family members, beneficially own a majority equity interest in Hanxin; the agreement was approved by the independent members of the Audit Committee.
Sep 18, 2025, 8:46 PM
Quarterly earnings call transcripts for Amphastar Pharmaceuticals.
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