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]

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]

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q4 2024 Earnings Conference Call March 13, 2025 8:00 AM ET Company Participants Mercedes Carrasco - Senior Director, IR John Butler - CEO Nick Grund - Chief Commercial Officer Erik Ostrowski - Chief Financial & Business Officer Conference Call Participants Allison Bratzel - Piper Sandler Julian Harrison - BTIG Ed Arce - H.C. Wainwright Operator Good day, and welcome to Akebia's Fourth Quarter 2024 Financial Results Call. At this time, all participants are in a listen- ...