Akebia Therapeutics (AKBA) Investor Update summary

Commercial launch progress

• Vafseo's wholesale acquisition cost is set at $1,278 for a 30-day supply, or $15,500 per patient per year, validated with stakeholders and with discounts available through contracts and volume tiers.

• The launch is progressing well, with strong market reception, a 60% increase in unaided awareness, and significant prescriber interest, especially for home, peritoneal, and high-dose ESA patients.

• Regained full U.S. rights to Vafseo after terminating the CSL Vifor license, enabling direct contracting with dialysis organizations and improving operational efficiency and economics.

• Significant progress in contract discussions with dialysis organizations for both Auryxia and Vafseo, aiming for broad coverage before January 2025.

• TDAPA application submitted in June 2024; expects HCPCS codes by October 2024 and full TDAPA designation by January 1, 2025.

CSL Vifor agreement restructuring / Royalty and financial arrangements

• The license agreement with CSL Vifor was terminated and replaced with a royalty-based structure, granting full US rights to Vafseo.

• Royalties are tiered: high single-digit for sales under $450M, mid-single-digit above, with a buy-down option from July 2027, potentially eliminating royalties on sales above $450M.

• The new structure simplifies operations, enhances transparency, and allows direct contracting with all dialysis organizations.

• Akebia expects a modestly higher bottom-line contribution from Vafseo under the new arrangement compared to the prior profit share.

• The portfolio approach enables direct engagement with both large and small dialysis providers, improving leverage and efficiency.

Market and regulatory outlook / Strategic outlook and risks

• Plans are underway to engage the FDA in 2024 for potential label expansion to non-dialysis CKD patients, a significant growth opportunity.

• Pricing strategy reflects both current dialysis and potential future non-dialysis markets, considering Medicare Part D and commercial reimbursement.

• The company is preparing a briefing document for the FDA and expects feedback before year-end.

• The $450M sales threshold in the royalty agreement reflects negotiations and the anticipated impact of label expansion.

• Forward-looking statements highlight risks including contracting success, market acceptance, regulatory decisions, and competitive landscape.