Release Date: February 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: If the results of MAPLE-HCM are positive, how should we think about the timeline for potential label expansion assuming approval in September? And how would the positive results fit into the company's marketing strategy in the interim? A: Fady Malik, EVP of R&D, mentioned that label expansion would likely occur in 2026 rather than 2025, given the PDUFA date of September 26, 2025. Andrew Callos, EVP and Chief Commercial Officer, added that the second study offers confirmatory evidence, which could reassure physicians and potentially influence guidelines, opening up more prescribers to aficamten.
Q: How do you expect the underdiagnosis of HCM to change over time with two companies on the market educating and promoting cardiac myosin inhibitors? A: Andrew Callos, EVP and Chief Commercial Officer, noted that obstructive HCM diagnoses have been increasing, and non-obstructive HCM is growing at a double-digit rate. Currently, about 30% of the population is diagnosed, and this could reach 50% in the next three to five years. Robert Blum, CEO, added that the amyloidosis and pulmonary arterial hypertension spaces provide good proxies for increased diagnosis and category penetration.
Q: What are your thoughts on the upcoming Edgewise dataset and the possibility of it progressing without any REMS? A: Robert Blum, CEO, refrained from commenting on another company's program but emphasized the importance of data and evidence. Fady Malik, EVP of R&D, stated that it's premature to comment on the safety profile and monitoring until more data is available.
Q: Do you expect mavacamten's REMS to be eased in the U.S., and how would that affect aficamten's REMS? A: Robert Blum, CEO, noted interest in BMS's reporting on changes to the EMA label and looks forward to the FDA's response. Andrew Callos, EVP and Chief Commercial Officer, mentioned that differentiation could be based on various aspects, and if REMS is relaxed for the category, it could benefit the entire class by increasing patient and physician adoption.
Q: How do you plan to educate doctors about the lack of pharmacogenomic and DDI liability with aficamten compared to Camzyos? A: Fady Malik, EVP of R&D, stated that physicians involved in clinical trials recognize the difference in drug interaction profiles and are educated accordingly. Andrew Callos, EVP and Chief Commercial Officer, added that they do not anticipate a REMS program requiring pharmacy monitoring for drug interactions.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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