Akebia Therapeutics (AKBA) H.C. Wainwright 3rd Annual Kidney Virtual Conference summary

Industry innovation and market landscape

• Significant innovation is occurring in kidney disease, creating new opportunities for patient care.

• The U.S. anemia management market for dialysis patients is estimated at $1 billion, with approximately 541,000 prevalent dialysis CKD patients and 90% treated for anemia.

• Oral HIF activators like Vafseo represent a shift from traditional injectable ESAs, offering a more physiologic approach to anemia management.

• High physician awareness and interest in HIF class drugs, with 85% of nephrologists aware and over half planning to prescribe.

• Home dialysis and high-dose ESA patient segments are early targets for adoption due to convenience and unmet needs, with over 80,000 home dialysis patients and more than 150,000 on higher ESA doses.

Product launch strategy and reimbursement

• Vafseo is approved for dialysis patients and will be available in the U.S. starting January 2025, following a six-month CMS TDAPA reimbursement process.

• The wholesale acquisition cost is set at $1,278 per month for a 30-day supply at the minimum starting dose, with actual prices expected to be lower due to contracting and rebates.

• Contracting with dialysis providers is critical, leveraging the existing Auryxia product and strategies like off-invoice pricing, volume-based rebates, and TDAPA eligibility.

• TDAPA provides a two-year window for premium reimbursement, after which pricing will align with bundled anemia management costs.

• Medicare patients make up 85% of the market, with at least 200,000 patients as the initial target population for Vafseo at launch.

Clinical differentiation and physician adoption

• Vafseo offers once-daily oral dosing, gradual and controlled hemoglobin increases, and fewer dose adjustments compared to ESAs.

• Clinical studies show fewer hemoglobin excursions and easier patient management, especially in home settings.

• Physicians value oral administration, stable hemoglobin, and minimal titration, aligning with Vafseo's clinical profile.

• Early market research indicates strong brand awareness growth and willingness among nephrologists to trial the product, with 60% planning to prescribe a HIF.

• Robust published data from global Phase 3 trials support Vafseo’s efficacy and safety, with ongoing studies for label expansion in non-dialysis populations and alternative dosing regimens.