Akebia Therapeutics (AKBA) Jefferies Global Healthcare Conference summary

Strategic focus and product launch

• Emphasis on improving lives of kidney disease patients, with a focus on dialysis and anemia management.

• Vafseo, a HIF stabilizer for anemia in dialysis patients, is the primary commercial opportunity, with US approval and launches in Europe.

• Launch in the US is planned for January next year to align with TDAPA reimbursement, maximizing provider adoption.

• Preparations include market education, contracting with dialysis providers, and protocol development during the pre-launch period.

• Auryxia, the existing product, continues to generate significant revenue and supports operations.

Market opportunity and reimbursement

• US dialysis market represents a billion-dollar-plus opportunity, with 500,000 patients treated for anemia.

• TDAPA reimbursement allows providers to bill for Vafseo outside the dialysis bundle for two years, incentivizing adoption.

• Contracting and volume discounts are key to broad access and competitive pricing.

• Home dialysis and high ESA dose patients are initial target populations for Vafseo.

• Non-dialysis CKD patients represent a future growth area, potentially doubling the addressable market.

Clinical development and pipeline

• Two HIF-based compounds have entered preclinical development, with one expected in the clinic next year.

• Ongoing studies and data generation aim to support label expansion, including non-dialysis and incident dialysis patients.

• Three-times-weekly dosing data is being prepared for publication and potential label update.

• Engagement with FDA is planned to address label restrictions and expand indications.

• Pipeline includes AKB-9090 for acute kidney injury and AKB-10108 for retinopathy of prematurity.