Pharmaceutical company Amphastar Pharmaceuticals (NASDAQAMPH) reported Q3 CY2025 results topping the market’s revenue expectations, but sales were flat year on year at $191.8 million. Its non-GAAP profit of $0.93 per share was 12.7% above analysts’ consensus estimates.

Is now the time to buy AMPH? Find out in our full research report (it’s free for active Edge members).

StockStory’s Take

Amphastar Pharmaceuticals' third quarter results for 2025 came in ahead of Wall Street's revenue and profit expectations, despite essentially flat sales compared to the prior year. The quarter was shaped by strong performances from proprietary products BAQSIMI and Primatene MIST, both of which saw double-digit sales growth. Management attributed this momentum to enhanced commercial execution and expanded marketing partnerships. At the same time, the company faced pronounced margin pressure, primarily due to a sales mix shift, pricing declines, and increased competition in legacy products. CFO William Peters pointed to higher operating costs and a litigation provision that weighed on profitability, noting, “cost control measures were implemented to mitigate the impact of pricing pressures.”

Looking ahead, management believes Amphastar’s growth will be driven by continued expansion of its proprietary product pipeline and the launch of new therapies in high-growth markets such as oncology and ophthalmology. The company aims to quadruple U.S. manufacturing capacity and reach a target where proprietary products represent 50% of its pipeline by 2026. While regulatory delays and competition in the diabetes and obesity space are acknowledged risks, management expects double-digit growth in 2026, supported by upcoming launches and ongoing development programs. As CFO William Peters stated, “high single-digit to low double-digit growth rates are likely next year, with BAQSIMI as our #1 growth product.”

Key Insights from Management’s Remarks

Management emphasized the importance of proprietary product growth, strategic portfolio expansion, and new manufacturing investments as key to navigating margin headwinds and driving future performance.

• BAQSIMI and Primatene MIST momentum: Both products delivered double-digit sales growth, with BAQSIMI benefiting from expanded sales execution and Primatene MIST driven by increased marketing efforts and consumer engagement in the over-the-counter respiratory market.
• Pipeline diversification: Amphastar signed an exclusive in-licensing agreement with Nanjing Anji Biotechnology, adding three novel peptide candidates targeting oncology and ophthalmology, broadening its pipeline beyond diabetes and complex generics. Early studies showed promising anti-tumor activity and potential for a non-injectable eye therapy.
• Manufacturing capacity expansion: The company plans to quadruple its U.S. production capacity at its Rancho Cucamonga site, a move intended to strengthen operational agility and support future launches in high-demand therapeutic areas.
• Regulatory progress and product launches: Amphastar secured FDA approval for iron sucrose injection (AMP-002) during the quarter, which generated $2.4 million in initial sales and is now commercially available as a generic therapy in the United States.
• Margin pressure and cost controls: The transition of BAQSIMI commercialization, pricing declines in legacy injectable products, and a litigation provision contributed to a significant year-over-year decline in operating margin. Management responded by implementing cost containment measures and focusing on higher-value proprietary products.

Drivers of Future Performance

Management’s outlook centers on proprietary pipeline launches, expanded manufacturing scale, and resilience amid competitive and regulatory challenges.

• Upcoming product launches: Amphastar expects new regulatory approvals and launches—including AMP-007 (first-to-market generic inhalation), AMP-015 (generic Forteo), and AMP-018 (GLP-1 for diabetes/obesity)—to drive revenue growth, although some are risk-adjusted for regulatory and timing uncertainty.
• Proprietary product focus: The company aims to have proprietary products comprise half its pipeline by 2026, leveraging in-licensed assets and internal R&D. Success here is expected to shift the revenue mix toward higher-margin, less commoditized therapies.
• Competitive and regulatory risks: Management highlighted headwinds from increased competition in legacy products, potential generic entry for Primatene MIST as its patent expires, and regulatory agency bandwidth constraints that could delay product launches, particularly for complex or novel therapies.

Catalysts in Upcoming Quarters

In the next few quarters, the StockStory team will be tracking (1) progress on proprietary pipeline milestones, including regulatory submissions and clinical data for recently in-licensed oncology and ophthalmology assets, (2) the pace and impact of U.S. manufacturing capacity expansion, and (3) commercial traction of new launches such as iron sucrose injection and updates on BAQSIMI’s market share. Evolving competitive dynamics in legacy products and patent developments for Primatene MIST will also be closely monitored.

Amphastar Pharmaceuticals currently trades at $24.58, up from $24.22 just before the earnings. In the wake of this quarter, is it a buy or sell? The answer lies in our full research report (it’s free for active Edge members).

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