Akebia Therapeutics (AKBA) investor relations material

Commercial performance and product strategy

• Focused on kidney disease with two commercial products: Vafseo (anemia in CKD on dialysis) and Auryxia (phosphate binder), with Vafseo as the primary growth driver.

• Vafseo saw a 28% increase in prescribing physicians and a 60% increase in patients quarter-over-quarter, with most new patients added in March.

• DaVita, the largest dialysis provider, is rolling out Vafseo more cautiously, with significant growth expected in the second half of the year.

• Refill rates for Vafseo with TIW dosing are strong (85%-90% for first refill), and compliance is expected to improve with education and experience.

• Post-TDAPA (after 2026), pricing will align with ESA-like levels, and access will expand to nearly all patients, removing reimbursement barriers.

Clinical development and pipeline updates

• Rare renal disease pipeline includes praliciguat (sGC stimulator, phase II in FSGS) and AKB-097 (tissue-targeted complement inhibitor, basket trial starting H2 2024).

• AKB-9090 (HIF-PHI) is in phase I for cardiac surgery-associated AKI, with top-line data expected in Q1 2025.

• Praliciguat aims for statistically significant reduction in uPCR and higher responder rates; only sGC stimulator in FSGS.

• AKB-097 targets C3d locally, aiming for reduced proteinuria in C3G, lupus nephritis, and IgA nephropathy, with data in 2027.

• Flexibility in pipeline allows for prioritization based on emerging data from basket trials.

Ongoing and future clinical studies

• VOCAL study (DaVita clinics) compares Vafseo TIW to standard of care, with data expected Q4 2024.

• VOICE study (USRC) fully enrolled, evaluating all-cause mortality and hospitalization rates, with data in Q1 2027.

• Health economic data show Vafseo reduces hospitalization events by 7.7% and days by 16%, translating to $3,700 annual savings per patient.