Release Date: May 05, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What has been the feedback on utilizing sweat chloride as a biomarker for ALYFTREK, and how does it influence switching from TRIKAFTA? A: Reshma Kewalramani, CEO, noted that sweat chloride is not routinely used in clinical practice to assess CFTR function, although it's well understood. Stuart Arbuckle, COO, added that the compelling aspects of ALYFTREK include its noninferiority to TRIKAFTA, improvements in CFTR function, additional mutations covered, and the convenience of once-daily dosing.
Q: Can you provide an update on JOURNAVX and the chronic pain indications? A: Reshma Kewalramani, CEO, stated that they are on track for an end of Phase 2 meeting with the FDA this summer. The study designs have been innovated and optimized, and an update is expected this summer. The diabetic peripheral neuropathy study with Suzetrigine is well underway.
Q: How is Vertex addressing the impact of tariffs and the Russia issue on its financials? A: Charles Wagner, CFO, explained that the impact of tariffs is immaterial due to a well-balanced global supply chain and minimal exposure to China. The Russia issue is isolated, with a $100 million impact in Q1 and $200 million for the full year, all included in the current guidance.
Q: What are the early adoption trends for ALYFTREK, and how is JOURNAVX being positioned with commercial payers? A: Stuart Arbuckle, COO, noted that ALYFTREK is seeing uptake across all patient groups, with the fastest uptake among those newly eligible for CFTR modulators. Duncan McKechnie, SVP, mentioned that JOURNAVX is making progress with payers, aiming for coverage with minimal restrictions and optimizing long-term value for Vertex.
Q: What are the key hurdles for CASGEVY uptake, and how is Vertex addressing them? A: Stuart Arbuckle, COO, highlighted that establishing authorized treatment centers, securing access and reimbursement, and centers becoming familiar with the treatment process are key factors. These efforts are expected to continue driving acceleration in CASGEVY uptake.
Q: How is Vertex engaging with Washington leadership regarding biotechnology innovation? A: Reshma Kewalramani, CEO, stated that Vertex is engaged with both DC and state governments on all its medicines and pipeline, finding the meetings constructive and continuing business as usual.
Q: Can you provide more details on the temporary pause of the VX-522 study? A: Reshma Kewalramani, CEO, mentioned that the team is assessing a tolerability issue, and further details will be provided once available to maintain study integrity.
Q: How does the ALYFTREK launch compare to past CF launches, and what is the expected trend? A: Stuart Arbuckle, COO, explained that ALYFTREK's launch is different due to fewer newly eligible patients compared to past launches like ORKAMBI and TRIKAFTA. Uptake is occurring across all anticipated patient groups, and Vertex is pleased with the launch progress.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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