Core Insights - Akebia Therapeutics is set to present data on Vafseo (vadadustat) at the American Society of Nephrology Kidney Week 2025, highlighting ongoing real-world studies and insights into its clinical benefits and dosing [1][2][3] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - Vafseo (vadadustat) is a once-daily oral medication approved for treating anemia due to chronic kidney disease (CKD) in adults on dialysis for at least three months, and it is approved in 37 countries [6][7] Clinical Studies and Presentations - Dr. Glenn M. Chertow from Stanford University will present a win odds analysis of all-cause mortality and hospitalization from the INNO2VATE trials, part of the Phase 3 clinical development program for vadadustat [2][4] - Four posters will be presented at ASN Kidney Week, focusing on dosing recommendations and ongoing real-world evidence studies, including the VOICE and VOCAL trials [2][4] Research and Development Focus - The company emphasizes the importance of generating, evaluating, and sharing data to support healthcare providers in making informed treatment decisions regarding Vafseo [3] - Akebia is actively engaged with the nephrology community to identify potential additional clinical benefits of Vafseo through various real-world evidence studies [3]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $62.5 million, up from $43.6 million in Q2 2024, representing an increase of $18.9 million [24] - Net product revenues increased to $60.5 million in Q2 2025 from $41.2 million in Q2 2024, driven by sales of Vaseo and Auryxia [24] - The company generated a net income of $247,000 in Q2 2025 compared to a net loss of $8.6 million in Q2 2024 [26] Business Line Data and Key Metrics Changes - Vaseo generated over $13 million in revenue in Q2 2025, with demand sales increasing by 55% over Q1 [5] - Auryxia sales were $47.2 million in Q2 2025, up from $41.2 million in Q2 2024 [24] - Cost of goods sold decreased to $9.9 million in Q2 2025 from $17 million in Q2 2024, primarily due to the elimination of a non-cash amortization charge [25] Market Data and Key Metrics Changes - The company expects to increase patient access from approximately 40,000 to over 75,000 dialysis patients in Q3 2025, with potential access to 275,000 patients by Q4 2025 [7][23] - Medicare Advantage plans are covering about 20% of total prescriptions, with expectations for growth as more contracts are established [33] Company Strategy and Development Direction - The company aims to establish Vaseo as the standard of care for treating anemia due to chronic kidney disease, focusing on expanding access and enhancing physician education [4][14] - Plans include launching the VALOR trial for non-dialysis patients by the end of 2025, which could significantly expand the addressable market [12][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing launch of Vaseo and the potential for significant growth as more dialysis providers come online [7][23] - The company is optimistic about the resilience of Auryxia's revenue stream despite the presence of an authorized generic [52] Other Important Information - The company ended Q2 2025 with $137.3 million in cash and cash equivalents, indicating a strong financial position to support ongoing operations and growth initiatives [26][27] Q&A Session Summary Question: Insights on patient segments and Medicare Advantage - Management noted that approximately 12% of prescriptions are for home patients, with expectations for continued broad use as more dialysis organizations implement protocols [31][32] - Currently, 20% of prescriptions are filled in the Medicare Advantage segment, with growth anticipated as more contracts are established [33] Question: Average dose strength for prescriptions - The average refill dose is approximately 28% higher than the initial 300 mg starting dose, reflecting increased physician comfort with dosing [36][37] Question: Timeline for DaVita's operational pilot - DaVita's operational pilot is expected to go live around mid-August, with broad access anticipated by November [42][43] Question: Outlook for Auryxia amid generic competition - Management highlighted that Auryxia's growth is supported by increased access post-bundle implementation, and they remain cautious about future generic competition [51][52]

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 sales decline was primarily due to a reduction in volume, partially offset by price increases and effective 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 for Vafseo were written for payers other than Medicare fee-for-service, indicating early success in 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-sized 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 2025 [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 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 TIW dosing [49] Question: How is protocolization gaining uptake at large-scale dialysis organizations? - Management noted that operationalizing protocols is taking longer than expected, but there is a desire from physicians to write prescriptions [52][53] 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, but it has subsided significantly [61] Question: What is the timing for the VALOR study regulatory interaction? - The focus is on study design, and management is looking to initiate the VALOR study as quickly as possible [66][68] Question: What are the launch metrics planned for disclosure? - Over 500 physicians have prescribed Vafseo, with an average of eight prescriptions per prescriber, indicating good breadth and depth of prescribing [76] Question: What is the current gross to net outlook? - Management did not provide specific gross to net figures but indicated that the average prescriptions are for the starting dose, with discounts expected to grow as volumes increase [90][91]