Release Date: February 25, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide an update on the orexin 441 trial and the Epidiolex patent settlement? A: Bruce Cozadd, CEO, stated that the Epidiolex settlements with all 10 ANDA filers extend to the very late 2030s, but confidentiality provisions limit further details. Robert Iannone, EVP, Global Head of R&D, mentioned that there are no updates on the orexin 441 trial yet, but they expect it to help define a better therapeutic index.
Q: For the HERIZON-GEA trial, can you confirm the enrollment numbers and comment on the event rate's impact on the trial's success probability? A: Robert Iannone confirmed that they are completing enrollment for the upsized 918 patient target. The slower accrual of events could indicate a significant effect from the experimental arms, but they remain blinded to the results. The control arm has been consistent across similar trials, so no surprises are expected there.
Q: Why hasn't Jazz Pharmaceuticals engaged in significant M&A since the GW acquisition, and how does the Epidiolex patent settlement affect future M&A strategy? A: Bruce Cozadd explained that after the GW acquisition, they focused on reducing leverage, which limited larger transactions. The zanidatamab transaction was a significant focus. Philip Johnson, CFO, added that they have delevered significantly and are actively looking for opportunities in their verticals, including epilepsy, to build growth prospects.
Q: What are the expectations for Zepzelca's performance and potential guideline inclusion for the first-line maintenance indication? A: Renee Gala, COO, noted that Zepzelca had strong performance despite fewer buying days in Q4. They plan to file for first-line extensive-stage small cell lung cancer in the first half of the year and hope to get on treatment guidelines once data is available. They expect growth in Zepzelca but will not promote first-line use until approval.
Q: Can you provide an update on the CEO search and how it might impact M&A strategy? A: Bruce Cozadd stated that the CEO search is ongoing, and they are not in a hurry, focusing on making the right choice. The company is well-positioned for M&A with strong operating results and financial resources, ready to leverage infrastructure and add growth opportunities.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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