Pharmaceutical company Amphastar Pharmaceuticals (NASDAQAMPH) missed Wall Street’s revenue expectations in Q1 CY2025, with sales flat year on year at $170.5 million. Its non-GAAP profit of $0.74 per share was 7.6% above analysts’ consensus estimates.
Is now the time to buy AMPH? Find out in our full research report (it’s free).
Amphastar Pharmaceuticals (AMPH) Q1 CY2025 Highlights:
- Revenue: $170.5 million vs analyst estimates of $173.9 million (flat year on year, 2% miss)
- Adjusted EPS: $0.74 vs analyst estimates of $0.69 (7.6% beat)
- Operating Margin: 21.9%, down from 27.9% in the same quarter last year
- Market Capitalization: $1.27 billion
StockStory’s Take
Amphastar Pharmaceuticals’ first quarter results reflected the impact of heightened competition across its generic portfolio, particularly in critical care products like Glucagon and Epinephrine. Management emphasized that new entrants led to price and volume declines in these key categories, contributing to flat revenues. CFO William Peters noted, “Glucagon injection sales declined 27%... due to increased competition. Epinephrine sales decreased 29%... due to increased competition for our multi dose vial product.” Meanwhile, the company highlighted growth in its branded products, with Primatene MIST sales rising 20% year-over-year, attributed to increased unit volumes and expanded physician outreach. Management described the quarter as a period of transition, with ongoing efforts to manage cost pressures and adapt to changes in the competitive landscape.
Looking ahead, Amphastar’s outlook is underpinned by the anticipated contributions from pipeline launches and continued expansion of its branded product portfolio. Management reiterated expectations for flat revenue in 2025, contingent on approvals and commercialization of new products such as AMP-002 and AMP-007 later in the year. CEO Tony Marrs discussed the company’s biosimilar insulin program, stating, “Our goal is to become the first product that’s interchangeable,” outlining a strategy that targets interchangeability as a differentiator in the insulin market. The company acknowledged ongoing margin pressures from generic competition but expects that high-margin products like Primatene MIST and BAQSIMI, combined with operational efficiencies, will help offset these challenges. Management remains attentive to regulatory developments and tariff discussions, emphasizing their U.S.-based manufacturing as a relative advantage.
Key Insights from Management’s Remarks
Management attributed the quarter’s performance to competitive pressures in core generics, growth in branded products, and evolving product mix, while highlighting progress on pipeline assets and changes in distribution strategy.
- Branded product momentum: Primatene MIST delivered double-digit growth, driven by higher unit sales and increased physician outreach, which management expects will support future expansion in the branded portfolio.
- Pipeline advancement: Amphastar reported progress on several late-stage filings, including AMP-002 and AMP-007, and shared that the FDA accepted its Biologics License Application for a biosimilar insulin aspart (AMP-004), marking a milestone in its biosimilar strategy.
- Distribution and partnership changes: The company completed the full transition of BAQSIMI operations from Eli Lilly, including a new co-promotion agreement with MannKind, aiming to expand reach and drive higher prescription volumes, especially among endocrinologists.
- Generic portfolio headwinds: Management cited intensified competition and price declines in Glucagon and Epinephrine, as well as continued pressure in Dextrose and Enoxaparin, as key factors behind revenue and margin compression in the quarter.
- Cost control initiatives: Rising costs from expanded sales and marketing activities, combined with R&D investment, contributed to higher expenses, but the company is working to drive cost efficiencies to partially offset margin pressures.
Drivers of Future Performance
Amphastar’s forward outlook is shaped by regulatory approvals, branded product growth, and its ability to manage ongoing competitive and cost challenges.
- Pipeline launches as revenue drivers: Future performance is closely tied to regulatory outcomes for AMP-002, AMP-007, and AMP-015, with management projecting that at least two approvals and subsequent launches are necessary to support flat revenues for the year.
- Branded portfolio expansion: Increased investment in the promotion and distribution of BAQSIMI and Primatene MIST, including the MannKind partnership, is expected to drive volume gains and higher-margin sales, partially offsetting declines in generics.
- Margin management amid competition: Management acknowledged persistent pricing and volume pressures in core generic products, with gross margin expected to face additional headwinds as newer competitors impact high-margin drugs. Cost reduction efforts and a shift toward branded and biosimilar products are intended to help stabilize overall profitability.
Catalysts in Upcoming Quarters
In the coming quarters, StockStory analysts will closely track (1) regulatory progress and potential approval timelines for AMP-002, AMP-007, and the biosimilar insulin AMP-004; (2) BAQSIMI and Primatene MIST’s prescription and market share trends following expanded promotional efforts; and (3) the extent to which generic price competition continues to erode margins in core products. Ongoing tariff developments and execution on cost containment will also be closely watched.
Amphastar Pharmaceuticals currently trades at a forward P/E ratio of 8.2×. At this valuation, is it a buy or sell post earnings? Find out in our full research report (it’s free).
Our Favorite Stocks Right Now
Donald Trump’s victory in the 2024 U.S. Presidential Election sent major indices to all-time highs, but stocks have retraced as investors debate the health of the economy and the potential impact of tariffs.
While this leaves much uncertainty around 2025, a few companies are poised for long-term gains regardless of the political or macroeconomic climate, like our Top 5 Growth Stocks for this month. This is a curated list of our High Quality stocks that have generated a market-beating return of 183% over the last five years (as of March 31st 2025).
Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today.
