AMPH Q2 Deep Dive: BAQSIMI Momentum, Margin Pressures, and Pipeline Milestones

Pharmaceutical company Amphastar Pharmaceuticals (NASDAQAMPH) missed Wall Street’s revenue expectations in Q2 CY2025, with sales falling 4.4% year on year to $174.4 million. Its non-GAAP profit of $0.85 per share was 14.6% above analysts’ consensus estimates.

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StockStory’s Take

Amphastar Pharmaceuticals delivered a mixed second quarter, with management highlighting BAQSIMI’s strong sales momentum as a key driver amid ongoing pressures in legacy products. While the company’s non-GAAP profitability was above expectations, management pointed to increased competition in glucagon and epinephrine lines as factors behind revenue softness and margin compression. CFO William J. Peters explained, “We’re proud to share that while revenue was impacted by increased competition in our legacy products, this was largely offset by BAQSIMI, which recorded its highest quarterly sales since the product’s acquisition.”

Looking forward, Amphastar’s outlook is anchored by its advancing pipeline and recent U.S. manufacturing investments intended to support proprietary products and mitigate supply chain risks. Management emphasized the potential for near-term FDA approvals to shape performance, particularly for AMP-002 and AMP-015, while cautioning on continued margin headwinds from competitive pricing. As Executive Vice President Tony Marrs noted, “We remain optimistic for a near-term approval [of AMP-002] and look forward to the opportunity to deliver this important product to patients.”

Key Insights from Management’s Remarks

Management attributed the quarter’s results to BAQSIMI’s rapid growth, stable Primatene MIST sales, and increased R&D investment, while noting the impact of competition on legacy injectable lines and the ramp-up in U.S.-based manufacturing.

• BAQSIMI growth offset declines: BAQSIMI, Amphastar’s nasal glucagon product acquired from Eli Lilly, delivered 21% year-over-year revenue growth, benefiting from full global commercialization and higher U.S. pricing. This performance partially offset sales declines in older glucagon and epinephrine products, which faced stiffer competition and pricing pressure.
• Legacy product headwinds: Sales of glucagon injection and epinephrine multi-dose vials dropped sharply due to increased competition and a shift among prescribers toward newer, ready-to-use products such as BAQSIMI. Management expects further erosion in legacy product revenue as additional competitors enter these markets.
• U.S. manufacturing expansion: Amphastar initiated a significant expansion at its California headquarters, aiming to quadruple domestic manufacturing capacity. This move is designed to reduce reliance on international supply chains, support proprietary pipeline products, and strengthen operational resilience amid evolving geopolitical risks.
• Pipeline progress and regulatory updates: The company advanced multiple regulatory programs, including the AMP-002 and AMP-015 filings, and an inhalation product (AMP-007) expected to receive FDA action in the first half of next year. The insulin aspart biosimilar (AMP-004) remains a long-term focus, with management citing the FDA’s approval of interchangeability in the category as a key industry milestone.
• Increased R&D investment: Amphastar’s R&D expenses rose 14% year-over-year, driven by higher material and clinical trial costs. Management described these investments as essential to maintaining a robust proprietary pipeline and supporting future branded product launches.

Drivers of Future Performance

Amphastar’s forward outlook centers on BAQSIMI expansion, potential product approvals, and continued investment in U.S.-based manufacturing, with competitive pricing and legacy product declines posing ongoing headwinds.

• BAQSIMI expansion and pricing: Management expects BAQSIMI to remain a top performer, with unit growth in the high single digits and a 3% price increase in the U.S. contributing to stable revenue. The MannKind co-promotion agreement is expected to further enhance commercial reach in the second half.
• Pipeline launches and regulatory risk: The company anticipates two potential product launches (AMP-002 and AMP-015) this year, both of which could support flat annual sales despite legacy product declines. However, any regulatory delays or market entry by new competitors may affect the timing and scale of these contributions.
• Margin pressures and cost control: Amphastar projects further margin contraction due to ongoing price competition in glucagon and epinephrine products. Management is focused on cost control efforts and expects new launches to deliver margins at or above the current corporate average, partially offsetting competitive pressures.

Catalysts in Upcoming Quarters

In upcoming quarters, our analysts will focus on (1) progress toward FDA approval and commercial launch of AMP-002 and AMP-015, (2) the pace and impact of Amphastar’s U.S. manufacturing expansion on pipeline execution, and (3) the ability to sustain BAQSIMI’s growth amid increasing competition in glucagon and epinephrine markets. Cost containment and margin stabilization efforts will also be important markers of performance.

Amphastar Pharmaceuticals currently trades at $27, up from $21.65 just before the earnings. At this price, is it a buy or sell? See for yourself in our full research report (it’s free).

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