Akebia Therapeutics (AKBA) Earnings Call Presentation

Vafseo Launch and Market Opportunity - Vafseo (vadadustat) has launched as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis[8] - The U S market opportunity for Vafseo in the dialysis patient population is approximately $1 billion[8] - Akebia is pursuing label expansion of Vafseo for the late-stage non-dialysis CKD population, representing a multi-billion-dollar U S market opportunity[8] - Contracts are secured covering nearly 100% of U S dialysis patients for Vafseo[12, 20] Clinical and Patient Considerations - Current standard of care for dialysis patients (ESAs) has remained unchanged for 30 years, with nearly 25% of patients falling below target hemoglobin levels[13] - Approximately 20% of patients on dialysis are ESA hyporesponders, leading to higher hospitalization and mortality rates[13] - Market research indicates that over 2 out of 3 nephrologists identify an unmet need for anemia treatment in CKD, particularly for oral options and ESA-resistant patients[14] Vafseo Advantages and Ongoing Trials - Vafseo is an oral HIF-PH inhibitor with the potential to become standard of care, offering a unique mechanism of action and convenient oral dosing[15] - The VOICE trial, with a target enrollment of 2,200 patients, is underway to demonstrate Vafseo's non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization[24] Non-Dialysis Market and Future Plans - In patients with pre-hemodialysis Hb <9 0 g/dL (n=4855), 73 4% did not receive ESA pre-HD[26] - A Phase 3 clinical trial is planned to begin in mid-2025 for Vafseo in patients with late-stage CKD anemia not on dialysis, targeting 1,500 U S subjects[8, 46] Pipeline and Financial Outlook - Akebia expects its existing cash resources and cash from operations to be sufficient to fund its current operating plan for at least two years[8] - Akebia is advancing a HIF-based pipeline targeting high unmet needs, including ROP ($1 5B+ U S market opportunity), ARDS ($2B U S market opportunity), and CS associated AKI (~$1 5B+ U S market opportunity)[50]