Akebia Therapeutics(AKBA) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were $46.5 million, down from $56.2 million in Q4 2023, and for the full year 2024, revenues were $160.2 million compared to $194.6 million in 2023 [38] - Net product revenues from Auryxia were $44.4 million in Q4 2024, down from $53.2 million in Q4 2023, and for the full year, they were $152.2 million compared to $170.3 million in 2023 [38] - The net loss for Q4 2024 was $22.8 million, compared to a net income of $0.6 million in Q4 2023, and the full year net loss was $69.4 million compared to $51.9 million in 2023 [41][42] Business Line Data and Key Metrics Changes - The launch of Vafseo is in its early stages, with expected net product revenue of $10 million to $11 million for Q1 2025, which is ahead of analyst estimates [10][21] - Auryxia's revenues decreased primarily due to a reduction in volume, partially offset by price increases and execution of contracting strategies [38] Market Data and Key Metrics Changes - The demand for Vafseo is strong, with over 500 physicians prescribing it by the end of February, averaging about eight prescriptions each [33][76] - Approximately 15% of prescriptions in February were written for payers other than Medicare fee-for-service, indicating early Medicare Advantage coverage [36][86] Company Strategy and Development Direction - The company aims to make Vafseo the standard-of-care for patients with anemia due to chronic kidney disease, focusing on both dialysis and non-dialysis patient populations [10][17] - The strategy includes securing contracts with dialysis organizations and building prescriber demand, with a focus on small to medium dialysis organizations initially [12][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early traction of Vafseo and the potential for it to become a standard treatment option [10][38] - The company is preparing for a Phase 3 clinical trial (VALOR) for non-dialysis patients, with plans to initiate the study in the second half of the year [18][96] Other Important Information - The company raised $18.4 million in net proceeds from sales under its ATM facility and drew down $9.3 million from its BlackRock Credit Agreement, strengthening its financial position [44] - Cash and cash equivalents as of December 31, 2024, were $51.9 million, expected to be sufficient to fund operations for at least two years [43] Q&A Session Summary Question: Does Q1 Vafseo revenue include any stocking or inventory build? - Management confirmed that there will be a little bit of inventory included in the revenue guidance, with inventory expected to stay in the two to four week range [48] Question: What are the dose frequency trends for in-center dialysis patients? - Most patients are currently on a daily dosing protocol, with some smaller centers starting protocols with less frequent dosing [49] Question: How is protocolization gaining uptake at large-scale dialysis organizations? - Management noted that operationalizing protocols takes time, and while some larger organizations have written protocols, implementation is slower than desired [52] Question: Can you expand on the recent backlog in Auryxia? - The backlog was for all phosphate binders and Vafseo due to the transition to specialty pharmacies, which initially lacked capacity [60] Question: What is the timing for the VALOR study regulatory interaction? - The focus is on study design, and management is looking to initiate discussions with the FDA to expedite the process [68][96]