Bettering the Lives of People Impacted by Kidney Disease John Butler, CEO January 2025 1 NASDAQ: AKBA Cautionary note on forward-looking statements 3 Leading commercial-stage company focused on kidney disease Vafseo® (vadadustat) launched as treatment for anemia due to chronic kidney disease for adult patients on dialysis ~$1billion U.S. market opportunity in dialysis patient population1 Statements in this presentation regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectatio ...

John Butler, CEO January 2025 1 NASDAQ: AKBA Cautionary note on forward-looking statements Statements in this presentation regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia's plans, strategies and prospects for its business; Akebia's plans with resp ...

Core Insights - Akebia Therapeutics has published significant data regarding Vafseo (vadadustat) in the Journal of the American Society of Nephrology, focusing on its safety and efficacy in treating anemia related to chronic kidney disease (CKD) [1][2][4] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company dedicated to improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - The company aims to advance the understanding and treatment of kidney diseases through high-impact research [4] Product Information - Vafseo (vadadustat) is a once-daily oral medication approved by the U.S. FDA in March 2024 for treating anemia due to CKD in adults on dialysis for at least three months, and it has been available in the U.S. since January 2025 [3][6] - Vafseo functions as a hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulating the production of erythropoietin to manage anemia [6] Clinical Trial Insights - The global phase 3 clinical trials for vadadustat were open-label, randomized, and noninferiority trials comparing its safety and efficacy to darbepoetin alfa in adult patients with CKD-related anemia [2] - In the U.S. patient subgroup with dialysis-dependent CKD, the safety and efficacy of vadadustat were found to be similar to darbepoetin alfa, while in non-dialysis-dependent CKD patients, vadadustat showed a higher risk for major adverse cardiovascular events (MACE) outside the U.S. [2] Research Publication - The analyses published in JASN reflect the importance of geographic-specific data in understanding treatment outcomes for CKD-related anemia, highlighting how regional differences can affect clinical trial results [4]

Vadadustat clinical data on display for nephrologists and healthcare providersCAMBRIDGE, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced it will present data at the 62nd European Renal Association (ERA) Congress on June 4-7, 2025, both virtually and live in Vienna. Akebia-supported presentations at ERA Congress 2025: A Win-Ratio Analysis of the Cardiovascu ...

Akebia Therapeutics (AKBA) FY 2025 Conference May 20, 2025 02:30 PM ET Speaker0 Right. So I guess we can get started here. So my name is Matthew Caulfield. I'm a senior biotech analyst here at H. C. Wainwright, and we're very excited to be welcoming Akebia Therapeutics. We're joined by John Butler, CEO, and also Nick Grund, chief commercial officer. So thank you very much for joining us today, guys. Speaker1 Thanks for having us, Matt. Great to you. Speaker0 So maybe to start off, you could maybe give us an ...

Financial Data and Key Metrics Changes - Total revenues increased to $57.3 million in Q1 2025 from $32.6 million in Q1 2024, driven by net product revenues of $55.8 million compared to $31 million in the prior year [22][25] - Net income for Q1 2025 was $6.1 million, a significant improvement from a net loss of $18 million in Q1 2024 [25] - Cost of goods sold decreased to $7.6 million in Q1 2025 from $11.6 million in Q1 2024, attributed to the absence of a non-cash amortization charge related to Auryxia [23][24] Business Line Data and Key Metrics Changes - Vafcio generated $12 million in net product revenues in Q1 2025, exceeding guidance of $10 million to $11 million [6][22] - Auryxia net product revenues increased to $43.8 million in Q1 2025 from $31 million in Q1 2024, despite the entry of an authorized generic [22][23] Market Data and Key Metrics Changes - The top five dialysis organizations have ordered Vafcio, with revenues primarily coming from small to mid-sized dialysis organizations treating approximately 150,000 patients collectively [7][14] - The VOICE study is progressing towards full enrollment, with about 75% of the target 2,200 subjects enrolled [9] Company Strategy and Development Direction - The company aims to expand the use of Vafcio in both dialysis and non-dialysis patient populations, with plans to initiate a Phase III VALOR trial in the second half of 2025 [10][11] - The focus remains on increasing the breadth and depth of prescribing among current customers while unlocking new customers [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong early performance of Vafcio, highlighting the importance of prescriber education and patient retention [6][7] - The company is confident in its financial position and believes it is financed to achieve profitability based on its current operating plan [25][26] Other Important Information - The company has at least 12 months of Vafcio inventory on hand in the U.S. and does not expect significant tariff-related impacts [24] - The average compliance rate in dialysis is expected to be around 65%, which will influence refill rates over time [60] Q&A Session Summary Question: Update on timelines for adding Vafcio to protocols at large dialysis organizations - Management indicated that a large pilot is planned to operationalize protocols, with training expected to take about a month before broader rollout [29][31][34] Question: Shift from Auryxia prescriptions to authorized generic - Management noted that the impact of the authorized generic has been minimal in Q1 2025, with expectations of maintaining significant revenue until more generics are approved [47][50] Question: Net price dynamics as large dialysis providers come on board - Management acknowledged the competitive environment and indicated that net price per patient is expected to decrease as volumes increase, with some lumpiness in pricing [55][57] Question: Demand drivers for Vafcio and reimbursement trends - Management highlighted that demand is driven by clinical value and economic incentives, with positive trends in Medicare Advantage coverage [70][78] Question: Inventory stocking trends with large dialysis organizations - Management expects initial stocking for pilots but does not anticipate significant issues with inventory levels due to efficient distribution networks [84][86] Question: Market landscape for label expansion opportunities - Management expressed excitement about the non-dialysis market, estimating a significant patient population and potential revenue opportunities [90][92]

Core Insights - Akebia Therapeutics reported strong initial sales for Vafseo® (vadadustat) with net product revenues of $12.0 million in Q1 2025, contributing to total net product revenues of $55.8 million for the quarter [1][12] - The company completed a $50 million public offering, enhancing its balance sheet with cash and cash equivalents of $113.4 million as of March 31, 2025 [1][12] - Akebia plans to initiate a Phase 3 clinical trial (VALOR) for vadadustat in late-stage CKD patients not on dialysis, expected to begin in the second half of 2025 [5][31] Vafseo U.S. Commercial Updates - Over 640 prescribers have written prescriptions for Vafseo, averaging nearly 12 prescriptions each, with about one-third being refills [5] - The top five dialysis organizations have placed orders for Vafseo, although mid-sized dialysis organizations are currently driving most of the revenue [5] - Akebia estimates it has at least 12 months of Vafseo inventory on hand in the U.S. without potential incremental tariff payments [5] Financial Results - Total revenues for Q1 2025 were $57.3 million, up from $32.6 million in Q1 2024, driven by Vafseo sales and increased Auryxia sales [12] - Auryxia net product revenues were $43.8 million in Q1 2025, compared to $31.0 million in Q1 2024 [12] - Net income for Q1 2025 was $6.1 million, a significant improvement from a net loss of $18.0 million in Q1 2024 [12] Key Business Highlights - Akebia's Vafseo was recommended for symptomatic anemia in adults undergoing dialysis for CKD by the U.K. National Institute for Health and Care Excellence (NICE) [5] - U.S. Renal Care continues enrollment in the VOICE clinical trial for Vafseo, now at 75% of the planned enrollment of approximately 2,200 patients [5] - The company is advancing its existing programs while pursuing label expansion for Vafseo [12][31]