Akebia Therapeutics (AKBA) 2024 Wells Fargo Healthcare Conference summary

Commercial program overview and recent progress

• Two commercial products: Auryxia (phosphate binder) and Vafseo (HIF-PHI for anemia in CKD on dialysis).

• Auryxia generated over $170 million in revenue last year and is entering the dialysis bundle next year, with expected stable revenue in the near term.

• Vafseo approved in March, launching in dialysis with product availability in January; reimbursement secured via TDAPA starting January 1.

• Distribution channel for Auryxia shifting from wholesalers to direct dialysis providers, impacting revenue timing.

• Sales force and medical affairs teams are focused on preparing for Vafseo’s launch and driving physician demand.

Product differentiation and clinical benefits

• Vafseo offers a gradual, physiologic increase in hemoglobin, reducing excursions and dose titrations compared to ESAs.

• Mechanism mimics natural oxygen response, potentially improving ease of use and safety.

• Targeting high-dose ESA patients and home dialysis patients for initial adoption.

• VOICE trial underway to demonstrate hospitalization benefits and support further growth.

• Non-dialysis CKD population represents a significant future opportunity, pending further clinical work and FDA feedback.

Market opportunity and strategy

• Dialysis ESA market is ~$1 billion, with 500,000 patients; Vafseo positioned for cost avoidance and economic incentives for providers.

• TDAPA allows separate billing for Vafseo, creating margin opportunities for providers during the two-year period.

• Non-dialysis market is similar in size but underpenetrated, with higher pricing potential and less competition.

• Stepwise approach: initial focus on TDAPA-eligible patients, then broader dialysis population post-TDAPA.

• Existing Auryxia contracts facilitate access and bundling discussions with dialysis providers.