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    Amphastar Pharmaceuticals Inc (AMPH)

    Q3 2024 Earnings Summary

    Reported on Apr 7, 2025 (After Market Close)
    Pre-Earnings Price$53.40Last close (Nov 6, 2024)
    Post-Earnings Price$47.94Open (Nov 7, 2024)
    Price Change
    $-5.46(-10.22%)
    • Diversified Product Portfolio: The company is advancing solid products like BAQSIMI, whose peak sales are expected to reach $250–$275 million, along with strong performances in Primatene MIST and other core products, positioning it well to capture market share.
    • Pipeline and Regulatory Progress: Encouraging discussions with the FDA for products such as AMP-002 and AMP-007—with AMP-007's GDUFA goal extended to Q2 2025—and plans for GLP-1 candidate filings indicate a robust pipeline that could drive future growth.
    • Strategic Sales Force Expansion: The planned increase in an outsourced sales force starting in January 2025 is expected to boost market penetration for key products like BAQSIMI, counteracting short-term supply issues and enhancing revenue potential.
    • Regulatory delays and uncertainty: The extended GDUFA goal date for AMP-007 and remaining pending regulatory actions create uncertainty about the approval timeline, potentially delaying market entry and revenue generation.
    • Supply chain and distribution challenges: BAQSIMI experienced significant supply disruptions in 14 European countries, leading to delivery delays of 4 to 6 weeks and missed sales opportunities, which could adversely affect overall revenue.
    • Growing competitive pressures: Increased competition in key segments—evident in the glucagon and epinephrine markets, where new competitors have impacted pricing and volumes—could further erode margins and market share.
    1. BAQSIMI Sales
      Q: Peak sales potential targets?
      A: Management confirmed BAQSIMI is on track with peak annual sales expected in the range of $250–275 million, noting supply challenges in Europe but overall steady performance and execution of the strategy.

    2. Sales Drivers
      Q: What drove epinephrine and BAQSIMI declines?
      A: For epinephrine, lower volumes in multi-dose vials due to competitor launches were partly offset by increased prefilled shipments to Canada. BAQSIMI’s decline stemmed from European supply disruptions and U.S. pricing pressures; a sales force expansion is planned for January to mitigate these issues.

    3. Pipeline Update
      Q: Update on albuterol, AMP-002, AMP-007?
      A: Management expects the albuterol generic to be a meaningful 2025 contributor despite initial capacity issues. For AMP-002, dialogue with FDA remains encouraging, while AMP-007’s GDUFA timeline was extended without any alarming signals, affirming cautious optimism for the product’s first cycle.

    4. Combination Product
      Q: Define the combination product?
      A: The product is simply a device-drug combination, similar to other inhalation products, with no further comment on competitive aspects provided at this time.

    5. GLP-1 Role
      Q: What is the GLP-1 strategy long-term?
      A: While AMP-018 is on track for 2025, management considers the GLP-1 space highly competitive and has not disclosed detailed plans, indicating that further updates will come closer to market action.