The Akebia Therapeutics' third quarter 2024 earnings call was marked by optimism and a clear focus on the upcoming launch of Vafseo, its novel oral drug for the treatment of anemia due to chronic kidney disease. The call, led by CEO John Butler, showcased the company's progress in contracting with dialysis organizations, generating clinical data, and securing reimbursement for the product.
Contracting and Reimbursement Progress
The company has made significant strides in securing contracts with key dialysis organizations, including U.S. Renal Care, a leading provider serving 36,000 patients. With these contracts, approximately 60% of patients on dialysis now have access to Vafseo. The successful negotiations have been facilitated by the TDAPA reimbursement system, which encourages the use of innovative products for patients on dialysis. The company is optimistic about securing coverage for nearly 100% of patients on dialysis by the end of the year.
Clinical Data Generation and Label Expansion
Akebia is also making progress in generating clinical data to support the potential benefits of Vafseo. The Vafseo Outcomes In-Center Experience (VOICE) trial, a collaborative research study with U.S. Renal Care, is expected to enroll 2,200 patients and will use 3 times per week dosing. This study will generate important data on key endpoints, such as mortality and hospitalization, that could further educate the physician community and support Vafseo utilization. The company aims to provide a more detailed update on its non-dialysis CKD patient population expansion initiative by the end of the year.
Market Readiness and Commercial Activities
The commercial team at Akebia is focused on market readiness, with sales efforts devoted solely to Vafseo. Awareness and demand are building, and the company is preparing for a strong market reception upon Vafseo's availability in January 2025. The company's pricing strategy, which includes a volume-based rebate system, is designed to encourage increased utilization and market share growth.
Financial Overview and Future Outlook
The financial overview presented during the call highlighted a reduction in revenue primarily due to a decrease in volume and the anticipated disruption to the supply chain for phosphate binders ahead of TDAPA reimbursement in 2025. Despite this, the company remains confident in its financial position, with a well-established sales force and Vafseo inventory in hand. Akebia expects to generate revenue within the first 2 years of market availability and is aiming for broad access to Vafseo from dialysis organizations.
Conclusion
Akebia's third quarter earnings call underscored the company's significant progress in preparing for the launch of Vafseo and its efforts to expand into new patient populations. With a strong focus on contracting, clinical data generation, and market readiness, Akebia is well-positioned to capitalize on the significant unmet need in anemia management for patients with chronic kidney disease. The company's strategic approach and positive interactions at the ASN Kidney Week conference bode well for its future growth and success.