Akebia Therapeutics (AKBA) Jefferies London Healthcare Conference 2025 summary

Launch progress and market access

• Vafseo launched in January for dialysis anemia, with strong initial uptake, especially at U.S. Renal Care, and expanding access across other major providers including DaVita and DCI.

• DaVita completed a successful pilot and made Vafseo available to all centers in November, aiming to scale from 100 to over 4,000 centers by year-end.

• Patient access grew from 40,000 in early 2024 to over 260,000 currently, with expectations to reach 275,000 by year-end.

• Operational hurdles, such as system integration and reimbursement, are being addressed as the rollout expands.

• U.S. Renal Care is shifting to three-times-weekly (TIW) dosing in-center to improve adherence and patient management.

Growth outlook and adherence strategies

• Growth is expected to accelerate into 2026 as operational issues are resolved and more centers adopt Vafseo.

• TIW dosing aligns with dialysis center practices, enabling observed dosing and better adherence compared to home administration.

• Prescriber base is stable, with 85% of U.S. Renal Care physicians having prescribed Vafseo.

• Education and operational changes are key to improving refill and adherence rates toward industry standards.

• TIW dosing is expected to be widely adopted, supported by clinical data and provider preference.

Clinical data and standard of care potential

• Recent data from the INNO2VATE phase III study showed statistically significant reductions in mortality and hospitalization rates for Vafseo versus darbepoetin.

• Ongoing studies (VOICE and VOCAL) are evaluating TIW dosing and red blood cell quality, with results expected in late 2026 and early 2027.

• TIW dosing is supported by published studies and is being adopted based on clinical evidence, despite not being in the current label.

• Improved outcomes and physiologic benefits position Vafseo to become standard of care in dialysis anemia.

• Economic benefits from reduced hospitalizations are important for dialysis organizations.