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    Cerena Chen • Wells Fargo & Company

    Cerena Chen's questions to Amphastar Pharmaceuticals Inc (AMPH) leadership

    Cerena Chen's questions to Amphastar Pharmaceuticals Inc (AMPH) leadership • Q2 2025

    Question

    Cerena Chen from Wells Fargo questioned the market potential for Amphastar's GLP-1 candidate, AMP-018, noting a significant decrease in market size data and the recent regulatory delay from a Complete Response Letter.

    Answer

    CFO Bill Peters responded that Amphastar anticipates a very crowded generic market for this GLP-1 product and therefore expects it to be a relatively small contributor to the company's overall sales.

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    Cerena Chen's questions to Amphastar Pharmaceuticals Inc (AMPH) leadership • Q1 2025

    Question

    Cerena Chen inquired about the AMP-004 insulin aspart opportunity, including competitive dynamics and the strategic benefits and challenges of pursuing interchangeability from the outset.

    Answer

    CFO William Peters highlighted that insulin aspart is a large market (over $1.4B) where the current generic competitor is not an interchangeable biosimilar, presenting a key opportunity. Executive Tony Marrs added that achieving interchangeability upon first approval is their primary goal, as it allows for immediate pharmacy-level substitution without the need for separate branded marketing efforts, creating significant value.

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    Cerena Chen's questions to Amphastar Pharmaceuticals Inc (AMPH) leadership • Q4 2024

    Question

    Cerena Chen of Wells Fargo & Company asked about Amphastar's launch preparedness for products AMP-007 and AMP-018, which have GDUFA dates in Q2, and questioned if GLP-1 products typically secure first-cycle approvals.

    Answer

    William Peters, CFO, stated that for a Q2 approval, the company would likely be prepared for a commercial launch in Q3. Tony Marrs, Executive Vice President of Regulatory Affairs, added that while first-cycle approvals for GLP-1s are possible, it is an optimistic scenario for most companies in the space.

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    Cerena Chen's questions to Halozyme Therapeutics Inc (HALO) leadership

    Cerena Chen's questions to Halozyme Therapeutics Inc (HALO) leadership • Q2 2025

    Question

    Cerena Chen from Wells Fargo inquired about the status of the intellectual property litigation with Merck, asking for details on the next steps and potential timelines for both the district court case and the Post-Grant Review (PGR) process.

    Answer

    President and CEO Dr. Helen Torley explained that a scheduling order for the district court case is expected in the next couple of months. Regarding the Post-Grant Reviews (PGRs), she noted that four have been instituted with a hearing date set for March 2026 and initial decisions expected around June 2, 2026. Dr. Torley reiterated her confidence in prevailing on the validity issues and in the infringement case against Merck.

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    Cerena Chen's questions to Axsome Therapeutics Inc (AXSM) leadership

    Cerena Chen's questions to Axsome Therapeutics Inc (AXSM) leadership • Q2 2025

    Question

    Cerena Chen asked when Axsome last received confirmation from the FDA that its data package for AXS-05 in Alzheimer's disease agitation is sufficient for submission.

    Answer

    Chief Commercial Officer Ari Maizel referenced the pre-NDA meeting minutes from 'earlier this spring' where the company aligned with the FDA on the submission plan. He confirmed that building the submission has been ongoing since then and remains on track for this quarter.

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    Cerena Chen's questions to Axsome Therapeutics Inc (AXSM) leadership • Q1 2025

    Question

    Cerena Chen of Wells Fargo inquired about the strategic direction of Axsome's pipeline, asking whether the company's focus is more on life cycle management and expansion opportunities for existing assets or on acquiring new molecular entities.

    Answer

    Herriot Tabuteau, CEO, emphasized that the immediate focus is on "crisp execution" of the current late-stage pipeline, which he noted has a potential peak sales opportunity exceeding $16 billion. While acknowledging that the company continuously evaluates internal and external opportunities, he stated the priority is delivering on the existing assets.

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    Cerena Chen's questions to Axsome Therapeutics Inc (AXSM) leadership • Q4 2024

    Question

    Cerena Chen asked about competing in the high-rebate environment of oral CGRPs and what differentiated strategies Axsome might use to manage net price for Symbravo.

    Answer

    Executive Darren Opland acknowledged the high-rebate nature of the category and noted Axsome has studied the launches of oral CGRPs to formulate its own strategy. He expressed confidence in Symbravo's strong clinical profile to drive payer discussions, emphasizing a focus on building access while maintaining long-term profitability.

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    Cerena Chen's questions to Axsome Therapeutics Inc (AXSM) leadership • Q3 2024

    Question

    Cerena Chen of Wells Fargo asked about the reason for the FOCUS study (solriamfetol in ADHD) timeline being pushed to Q1 2025 and the company's plans for initiating the corresponding pediatric ADHD study.

    Answer

    COO Mark Jacobson explained the timeline shift is simply due to the final patient screening and enrollment funnel, with the study already over 95% enrolled. He stated that plans for the pediatric study are in development and its launch is not predicated on the adult FOCUS study results.

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