Akebia Therapeutics (AKBA) FY Conference Transcript

Summary of Akebia Therapeutics Conference Call Company Overview - Company: Akebia Therapeutics - Key Product: Vafsio, an oral HIF for treating anemia due to chronic kidney disease (CKD) in dialysis patients Core Points and Arguments 1. Launch Performance: - Vafsio generated $12 million in revenue in Q1 and $13.3 million in Q2, reflecting a 55% growth quarter-over-quarter [6][9] - Initial access to approximately 40,000 out of 550,000 dialysis patients in the U.S. [7] 2. Market Expansion Plans: - Anticipation of expanding prescribing access to additional dialysis providers, potentially increasing access to 275,000 patients by November [8][9] - Focus on making Vafsio the standard of care for anemia management in dialysis patients [12][48] 3. Market Opportunity: - The anemia of CKD market is primarily in the dialysis population, with 500,000 out of 550,000 patients on ESA treatments [11] - Non-dialysis market presents a significant opportunity, with a potential market size comparable to dialysis, but with a higher average price per patient post-TDAPA [38] 4. Clinical Differentiation: - Vafsio shows a favorable safety profile with no increased risk of major adverse cardiovascular events (MACE) compared to ESAs [20][21] - Fewer hemoglobin excursions and reduced dose titrations required with Vafsio, enhancing convenience for physicians [22][24] 5. Patient Compliance: - Oral administration of Vafsio improves patient compliance compared to injectable ESAs, particularly in home dialysis patients [25][26] 6. Regulatory and Reimbursement Landscape: - TDAPA (Transitional Drug Add-on Payment Adjustment) allows for reimbursement outside the bundled payment for dialysis for two years, facilitating the adoption of Vafsio [41][42] - Post-TDAPA, Vafsio will become part of the bundled payment, necessitating a strategic pricing approach to maintain market share [44][46] 7. Future Studies and Trials: - Plans to initiate a new study in the non-dialysis population, with a target enrollment of 1,500 patients [40][56] - Ongoing studies (VOICE and VOCAL) to explore alternative dosing regimens [27][60] 8. Auryxia Update: - Auryxia, a phosphate binder, lost exclusivity in March but continues to generate revenue without significant marketing efforts [49][50] Additional Important Insights - The dialysis market is valued at approximately $1 billion in the U.S., with significant potential for Vafsio to capture market share [38][45] - The company is focused on aligning with the FDA for future studies to ensure a clear path for product development and market entry [57][60] - The ongoing lack of generic approvals for Auryxia is viewed positively for cash flow, contributing to the company's financial stability [51][52]