Sudan Loganathan • Stephens

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EVP & CCO Jeff Del Carmen asserted that Translarna would not impact Agamry's role, as steroids are the foundational treatment for DMD. President & CEO Richard Daly addressed strategy, stating that the company is actively evaluating numerous M&A opportunities in a favorable buying environment, while also pursuing organic growth through Agamry's lifecycle management and Firdapse's expansion into oncology.

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CEO Gerard Michel explained that MSLs will be able to discuss the CHOPEN data, while sales reps will be more limited. He attributed the guidance adjustment to strong performance of over two treatments per center per month offsetting slower site activations. He estimated two-thirds of the revenue guidance change was from Hepzato and one-third from ChemoSat.

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CEO Gerard Michel stated that the current six sales territories should be sufficient to reach 40 active sites, but they are prepared to expand if needed. He also noted that while they are open to in-licensing, nothing has met their criteria for a strategic fit. Chief Medical Officer Vojo Vukovic explained the delay in starting new trials is due to the 6-12 month operational process of site activation, including protocol reviews and contracting with large academic centers.

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CEO Gerard Michel emphasized that while Delcath will be cash flow positive in 2025, the company will prioritize funding high-potential R&D opportunities over maintaining positive cash flow if conditions are right. He also clarified that future price increases are linked to the rate of inflation, per CMS rules.

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CEO Gerard Michel acknowledged that site onboarding and preceptorships would also slow during the holiday period but did not foresee a material impact on overall activation targets due to a strong pipeline of sites ready to begin. SVP of Finance Sandra Pennell clarified that the company's cash forecast does not rely on the potential $36 million from remaining warrants, as current cash, recent proceeds, and operating cash flow are expected to be sufficient to fund operations and new trials through profitability.

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EVP & CMO Amy Peterson confirmed that a dual primary endpoint design allows a study to be positive by hitting on one endpoint. CFO Christopher Senner stated that the previous $100 million guidance increase did factor in some contribution from NET, but was primarily driven by the strong performance of the base business.

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Chief Medical Officer Amy Peterson explained that the STELLAR-311 trial is positioned in a slightly different treatment setting, evaluating zanzalitinib as a first oral therapy after progression on an SFA, versus everolimus. She stated that global thought leaders remain excited about the trial and the company is not concerned about competition from CABOMETYX for enrollment.

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President and CEO Michael Morrissey gave a definitive answer, stating, 'The only gauge here is a p-value.' He confirmed that if the trials are successful, Exelixis has the focus and resources to move them forward for regulatory approval with great speed, implying no forced prioritization among successful programs.

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President and CEO Michael Morrissey stated the answer is 'all of the above.' He reiterated that Exelixis is agnostic to modality and mechanism, focusing on assets that offer a high level of conviction for achieving clinical differentiation that can drive commercial success, whether as a standalone agent or in combination.

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CEO John Houston clarified the distinct market dynamics: the second-line setting has a high (~40%) prevalence of ESR1 mutations, representing a major opportunity. In contrast, the first-line setting is predominantly wild-type but endocrine-sensitive. He reiterated that the joint decision with Pfizer is to focus on the significant second-line opportunity and not pursue a first-line trial at this time.

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Chief Medical Officer Noah Berkowitz noted that atirmociclib already has an established safety profile from another Phase III study and that hyperglycemia is not a significant concern for the vepdegestrant combination. CEO John Houston commented on the BCL6 space, stating that with little data available on the BMS compound, Arvinas is confident in its own technology and is focused on advancing its program.

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CFO Bruce Jacobs noted that cash burn will increase, with a steeper trajectory in 2026 as clinical activity intensifies, but the current cash runway extends into mid-2027. CEO Nello Mainolfi added that spending on the STAT6 program (KT-621) will be 'dramatically superior' to the TYK2 program (KT-295) over the next few years.

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President and CEO Nello Mainolfi responded to both questions. On IRF5, he stated that no rebound or resistance mechanisms have been observed in long-term preclinical studies. On STAT6, he explained the initial goal is over 90% degradation in both blood and skin to maximize success, and that upcoming Phase 2b dose-ranging studies are designed to determine the precise degradation levels needed for clinical benefit in different diseases.

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