Akebia Therapeutics(AKBA) - 2025 FY - Earnings Call Transcript

Financial Data and Key Metrics Changes - The first quarter marked the initial launch of Vafsio in the U.S. for anemia in CKD patients receiving dialysis, with nearly 640 physicians having prescribed the product by the end of the quarter [8][9] - Average prescriptions per prescriber were about 12, indicating a transition from trial to adoption [9] Business Line Data and Key Metrics Changes - Vafsio is positioned as a hypoxia-inducible factor prolyl hydroxylase inhibitor, with a focus on becoming the standard of care for all chronic kidney disease patients, including those not on dialysis [4][5] - Auryxia, another commercial product, is a phosphate binder that has positively impacted patients [3] Market Data and Key Metrics Changes - The dialysis market is significant, with 150,000 patients in small and medium providers, and all five top dialysis providers, representing approximately 85% of treatment, have ordered the product [11][12] - The non-dialysis market for CKD anemia is equally substantial, with over 550,000 anemic patients in stages four and five, presenting a larger revenue opportunity compared to dialysis [55][56] Company Strategy and Development Direction - The company aims to expand its pipeline within kidney disease and explore applications of HIF technology beyond the kidney space [5][6] - The strategy includes engaging with the FDA for a path forward to make Vafsio available for non-dialysis patients [5][60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of Vafsio, highlighting the enthusiasm from nephrologists and the potential for broader adoption [7][19] - The company anticipates significant growth in Q4 as pilot programs expand, with expectations for increased prescriber engagement [46][48] Other Important Information - The TDAPA program allows for reimbursement outside the bundled payment system, facilitating the launch of Vafsio [36][38] - The company plans to initiate a Phase III trial for Vafsio in non-dialysis patients by the end of the year [60][61] Q&A Session Summary Question: How is the launch of Vafsio progressing? - The launch is progressing well, with nearly 640 physicians prescribing the product and an average of 12 prescriptions per prescriber [8][9] Question: What is the strategy for engaging with dialysis organizations? - The strategy involves creating contracts and protocols to ensure positive economics for dialysis organizations, which are financially liable for treatment costs [25][31] Question: What are the market opportunities for Vafsio? - The non-dialysis market presents a significant opportunity, with over 550,000 anemic patients in stages four and five, potentially yielding higher revenue compared to the dialysis market [55][56] Question: What are the timelines for upcoming trials? - The pilot for larger dialysis organizations is expected to start in Q3, with broader usage anticipated in Q4 [44][46]