Release Date: March 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Does the Q1 Vafseo revenue include any stocking or inventory build? What are you seeing in terms of dose frequency for in-center dialysis patients? How is protocolization gaining uptake at large-scale dialysis organizations? A: John Butler, CEO, explained that the Q1 revenue does include some inventory build as they maintain a two- to four-week range of inventory. Most dosing is currently daily (QD), with some smaller centers starting with three times weekly (TIW) dosing. Protocolization involves getting contracts and operational details in place, which takes time, especially for larger organizations. The first half of the year is expected to be driven by small and medium providers, with larger providers expected to move in the second half.
Q: Can you expand on the recent backlog in Auryxia? Has demand exceeded initial expectations? A: John Butler clarified that the backlog was for all phosphate binders and Vafseo, not just Auryxia. The transition to specialty pharmacy for prescriptions caused capacity issues, leading to a backlog. Akebia worked with customers to find capacity, and the backlog has since subsided. The demand is there, and operational issues are being addressed, which bodes well for product growth.
Q: What is the timing of the next regulatory interaction for initiating the VALOR study? Are you seeking alignment on study design? A: John Butler stated that the focus is on study design, and the FDA has shown a positive outlook on the need for an oral therapy for non-dialysis patients. The meeting will likely be a Type C meeting to discuss study design and analysis plans. The goal is to start the study as quickly as possible while ensuring alignment with the FDA.
Q: What launch metrics do you plan to disclose on a quarterly basis? A: Nicholas Grund, Chief Commercial Officer, mentioned that over 500 physicians have prescribed Vafseo with an average of eight prescriptions each. The focus is on driving breadth and depth of prescribing, with acceleration seen throughout the quarter. These metrics will help track progress.
Q: What is the current gross to net, and where do you expect it to settle? What is the split between commercial and Medicare? A: Nicholas Grund explained that Medicare and Medicare Advantage patients make up about 80% of the total, with immediate reimbursement for Medicare fee-for-service. About 15% of prescriptions are for Medicare Advantage patients, indicating successful contracting. Commercial patients are a smaller portion. John Butler added that gross to net will fluctuate with volume-based discounts and that the average dose is expected to increase over time.
Q: Are the costs for the VALOR study embedded within your current run rate? A: John Butler confirmed that the costs for the VALOR study are included in the current operating plan. The study is expected to be run efficiently, focusing on nephrologists and using a standard of care comparator.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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