Summary of Akebia Therapeutics Conference Call Company Overview - **Company**: Akebia Therapeutics (NasdaqCM:AKBA) - **Product**: Vafseo (vadadustat), a HIF PHI for treating anemia in dialysis patients Key Points Launch Progress of Vafseo - Vafseo was launched in January 2025, with a strong start primarily in U.S. Renal Care, the third-largest dialysis provider [4][5] - Access to dialysis patients increased from approximately 40,000 at the beginning of the year to 260,000, with expectations to reach 275,000 by year-end [6] - The launch is progressing well, but the adoption rate is slower than desired due to operational complexities within dialysis providers [5][8] Market Dynamics - The two largest dialysis providers, Fresenius and DaVita, are critical for Vafseo's adoption. DaVita has opened the product to all its centers as of November 10, 2025, after a successful pilot [5][6] - U.S. Renal Care has been the primary contributor to current patient numbers, with plans to offer treatment on a TIW (three times a week) basis starting January 2026 [13][14] Prescription and Adherence Challenges - The prescriber base remains stable, with 85% of U.S. Renal doctors having written a prescription for Vafseo [17] - Challenges in refill adherence are noted, with a goal to improve rates to 70-80% through education and operational adjustments [16][19] - The transition to TIW dosing is expected to enhance adherence and patient management [20][21] Clinical Data and Efficacy - Recent data presented at ASN supports the efficacy of TIW dosing, showing a statistically significant lower risk of mortality and hospitalization compared to darbepoetin [25][29] - Ongoing studies (VOICE and vocal) aim to confirm the benefits of TIW dosing and the physiological advantages of Vafseo over traditional treatments [26][29] Economic Considerations - The economic implications of hospitalization rates are significant, as dialysis providers share in costs when patients are hospitalized [30] - The TDAPA (Transitional Drug Add-on Payment Adjustment) period is crucial for revenue generation, with expectations of growth in Medicare Advantage prescriptions [39][40] Financial Position - Akebia has a strong balance sheet with $166 million in cash as of the end of Q3 2025, indicating that the company is financed to profitability [48] Future Pipeline - Akebia is exploring additional opportunities in the NDD (non-dialysis dependent) patient population and has a pipeline of HIF-based compounds, including AKB 9090 for acute kidney injury [46][47] Conclusion - Akebia is optimistic about the long-term adoption of Vafseo as the standard of care in anemia treatment for dialysis patients, supported by clinical data and a strong financial position [44][48]