Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide an update on the potential for label expansion into the non-dialysis market and the feedback from nephrologists at ASN Kidney Week? A: John Butler, CEO, explained that Akebia plans to engage with the FDA this year to discuss a clinical path for non-dialysis label expansion. The company expects to outline a study protocol that aligns with FDA requirements. Feedback from ASN Kidney Week was positive, with nephrologists expressing a strong interest in Vafseo as an alternative therapy for anemia management.
Q: What is the goal for dialysis center contracts by the launch date in January, and how will the Voice trial impact prescribing? A: John Butler, CEO, stated that the goal is to have 100% of dialysis centers under contract by launch. The Voice trial, which is expected to start enrolling patients soon, will provide important data on Vafseo's dosing and outcomes, potentially influencing prescribing practices and supporting broader adoption post-TDAPA.
Q: How is Akebia addressing the upcoming generic competition for AURYXIA, and what impact does it have on revenue? A: John Butler, CEO, noted that while generic competition is anticipated, Akebia has established contracts that allow for price adjustments to maintain revenue. The company aims to leverage AURYXIA's presence to support Vafseo's growth, viewing it as a tool to facilitate broader market penetration.
Q: What percentage of the home dialysis segment is currently contracted, and what are the plans for early-stage programs like acute kidney injury? A: Nicholas Grund, Chief Commercial Officer, indicated that both home and in-center dialysis populations are included in current contracts, with approximately 60% coverage. For early-stage programs, John Butler, CEO, mentioned that the acute kidney injury program is in pre-IND development, with plans to enter the clinic by the end of next year.
Q: What are the key takeaways from nephrologists regarding Vafseo's clinical use and market readiness? A: Nicholas Grund, Chief Commercial Officer, highlighted that nephrologists are eager to implement Vafseo, asking detailed clinical questions about dosing and transitioning from current therapies. There is a recognized need for alternative therapies, and Vafseo is seen as a potential new standard of care.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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