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 [3]. Upcoming Events - Akebia Executive Management will participate in a Fireside Chat at the Jefferies Global Healthcare Conference on June 5, 2025, at 8:45 AM EDT [1]. - The Jefferies Global Healthcare Conference is scheduled to take place from June 3-5, 2025, in New York City [2]. Investor Relations - A webcast of the presentation will be available in the "Investors" section of Akebia's website following the conference [1].

Core Insights - Akebia Therapeutics, Inc. will present clinical data on Vadadustat at the 62nd European Renal Association Congress from June 4-7, 2025, in Vienna, both virtually and live [1] Company Overview - Akebia Therapeutics is a biopharmaceutical company founded in 2007, headquartered in Cambridge, Massachusetts, focused on improving the lives of individuals affected by kidney disease [2] - The company is fully integrated and aims to address the needs of patients with chronic kidney disease (CKD) [2] Presentation Highlights - Dr. Glenn Chertow will present a win-ratio analysis of the cardiovascular safety of Vadadustat in patients with CKD-related anemia undergoing dialysis on June 6 at 8:15 am CEST [2] - An e-poster will discuss the combination of Vadadustat with Ferric Citrate, highlighting its protective effects against inflammation-induced anemia and anemia caused by chronic kidney disease [2] - Insights from a Japanese database study on the real-world use of HIF-PH inhibitors and erythropoiesis-stimulating agents (ESAs) in non-dialysis-dependent CKD with anemia will also be presented [2]

Financial Data and Key Metrics Changes - The first quarter marked the initial launch of Vafsio in the U.S. for anemia in CKD patients receiving dialysis, with nearly 640 physicians having prescribed the product by the end of the quarter [8][9] - Average prescriptions per prescriber were about 12, indicating a transition from trial to adoption [9] Business Line Data and Key Metrics Changes - Vafsio is positioned as a hypoxia-inducible factor prolyl hydroxylase inhibitor, with a focus on becoming the standard of care for all chronic kidney disease patients, including those not on dialysis [4][5] - Auryxia, another commercial product, is a phosphate binder that has positively impacted patients [3] Market Data and Key Metrics Changes - The dialysis market is significant, with 150,000 patients in small and medium providers, and all five top dialysis providers, representing approximately 85% of treatment, have ordered the product [11][12] - The non-dialysis market for CKD anemia is equally substantial, with over 550,000 anemic patients in stages four and five, presenting a larger revenue opportunity compared to dialysis [55][56] Company Strategy and Development Direction - The company aims to expand its pipeline within kidney disease and explore applications of HIF technology beyond the kidney space [5][6] - The strategy includes engaging with the FDA for a path forward to make Vafsio available for non-dialysis patients [5][60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of Vafsio, highlighting the enthusiasm from nephrologists and the potential for broader adoption [7][19] - The company anticipates significant growth in Q4 as pilot programs expand, with expectations for increased prescriber engagement [46][48] Other Important Information - The TDAPA program allows for reimbursement outside the bundled payment system, facilitating the launch of Vafsio [36][38] - The company plans to initiate a Phase III trial for Vafsio in non-dialysis patients by the end of the year [60][61] Q&A Session Summary Question: How is the launch of Vafsio progressing? - The launch is progressing well, with nearly 640 physicians prescribing the product and an average of 12 prescriptions per prescriber [8][9] Question: What is the strategy for engaging with dialysis organizations? - The strategy involves creating contracts and protocols to ensure positive economics for dialysis organizations, which are financially liable for treatment costs [25][31] Question: What are the market opportunities for Vafsio? - The non-dialysis market presents a significant opportunity, with over 550,000 anemic patients in stages four and five, potentially yielding higher revenue compared to the dialysis market [55][56] Question: What are the timelines for upcoming trials? - The pilot for larger dialysis organizations is expected to start in Q3, with broader usage anticipated in Q4 [44][46]

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release. The H.C. Wainwright BioConnect Investor Conference will take place on May 20, 2025, at the Nasdaq Headquarters in New York City. About Akebia Therapeutics CAMBRIDGE, Mass., May ...

Company Performance - Akebia Therapeutics reported quarterly earnings of $0.03 per share, exceeding the Zacks Consensus Estimate of a loss of $0.03 per share, and showing improvement from a loss of $0.09 per share a year ago, resulting in an earnings surprise of 200% [1] - The company posted revenues of $57.34 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 26.83%, compared to year-ago revenues of $32.61 million [2] - Over the last four quarters, Akebia has surpassed consensus EPS estimates two times and topped consensus revenue estimates twice [2] Stock Performance - Akebia Therapeutics shares have increased approximately 29.5% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.04 on revenues of $44.05 million, and for the current fiscal year, it is -$0.12 on revenues of $192.75 million [7] Industry Outlook - The Medical - Drugs industry, to which Akebia belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Data and Key Metrics Changes - Total revenues increased to $57.3 million in Q1 2025 from $32.6 million in Q1 2024, primarily driven by net product revenues which rose to $55.8 million from $31 million [22][25] - Net income for Q1 2025 was $6.1 million compared to a net loss of $18 million in Q1 2024, reflecting strong revenue growth [25][26] - Cost of goods sold decreased to $7.6 million in Q1 2025 from $11.6 million in Q1 2024, attributed to the full amortization of a non-cash 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 losing IP exclusivity [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 [8][14] - The VOICE study is progressing towards full enrollment, with about 75% of the target 2,200 subjects enrolled [10] 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][27] 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][21] - The company is confident in its financial position and ability to achieve profitability based on its current operating plan [26][27] Other Important Information - The company ended Q1 2025 with $113.4 million in cash and cash equivalents, bolstered by a public offering that raised over $46 million [26] - 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] 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, followed by a pilot duration of two to three months [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 that it will not significantly affect business in Q2 [46][48][49] Question: Net price dynamics as large dialysis providers come on board - Management acknowledged that net prices may decrease as volumes increase, but there will be variability in pricing due to the competitive environment [53][55] Question: Demand drivers for Vafcio and reimbursement trends - Management highlighted that demand is driven by clinical efficacy and economic incentives, with positive trends in Medicare Advantage coverage [70][72][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][88] Question: Market landscape for label expansion opportunities - Management expressed excitement about the non-dialysis market, which is comparable in size to the dialysis market, and emphasized the potential for significant revenue growth [90][92][94]

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]

Financial Performance - Total revenues for Q1 2025 reached $57.336 million, a 75.9% increase from $32.607 million in Q1 2024[20] - Product revenue, net, was $55.791 million in Q1 2025, compared to $31.009 million in Q1 2024, reflecting an increase of 80.2%[20] - Net income for Q1 2025 was $6.112 million, a significant improvement from a net loss of $17.985 million in Q1 2024[20] - Basic net income per share for Q1 2025 was $0.03, compared to a loss of $(0.09) per share in Q1 2024[20] - Total product revenues for the three months ended March 31, 2025, were $55.791 million, a significant increase from $31.009 million in the same period of 2024, representing an 80% year-over-year growth[157] Assets and Liabilities - Total assets increased to $310.185 million as of March 31, 2025, up from $220.670 million at the end of 2024, representing a 40.5% growth[17] - Total liabilities increased to $285.604 million as of March 31, 2025, compared to $269.855 million at the end of 2024[17] - Cash and cash equivalents rose to $113.374 million in Q1 2025, compared to $51.870 million at the end of 2024, marking a 118.5% increase[17] - The company reported an increase in additional paid-in capital to $1.696 billion as of March 31, 2025, from $1.629 billion at the end of 2024[17] Cash Flow and Expenses - The company reported a net cash used in operating activities of $13,587,000 for the three months ended March 31, 2025, compared to $19,432,000 for the same period in 2024, indicating improved cash flow management[26] - Research and development expenses for Q1 2025 were $9.754 million, slightly up from $9.731 million in Q1 2024[20] - Selling, general and administrative expenses were $25.742 million in Q1 2025, compared to $25.438 million in Q1 2024[20] - The company recognized interest expense related to the BlackRock Credit Agreement of $2.1 million for the three months ended March 31, 2025, compared to $1.0 million for the same period in 2024, reflecting a 110% increase[77] Inventory and Assets Management - The total inventories increased to $55.7 million as of March 31, 2025, compared to $51.2 million as of December 31, 2024, reflecting a growth of approximately 8.8%[63] - The company’s long-term inventories increased to $35.97 million as of March 31, 2025, from $34.95 million as of December 31, 2024, an increase of approximately 2.9%[68] - Accounts receivable related to product sales increased to approximately $60.0 million as of March 31, 2025, compared to $32.4 million as of December 31, 2024[162] Market and Product Developments - Vafseo® (vadadustat) was approved in the U.S. in March 2024 and entered the market in January 2025, targeting anemia due to chronic kidney disease[31] - Auryxia lost exclusivity in the U.S. market in March 2025, which may impact future revenue streams[31] - Revenue from Vafseo, which entered the market in January 2025, was $12.034 million, while Auryxia generated $43.757 million in revenue for the same period[157] Financing and Capital Structure - Proceeds from the issuance of common stock, net of issuance costs, amounted to $64,907,000 in the first quarter of 2025, compared to $18,740,000 in the same period of 2024[26] - The Company sold 6,189,974 shares of common stock under the ATM program in 2023, generating gross proceeds of $6.8 million[193] - During the three months ended March 31, 2025, the Company sold 9,437,364 shares of common stock under the ATM program with gross proceeds of $18.7 million[198] - The Company entered into an underwriting agreement for a public offering of 25,000,000 shares at an offering price of $2.00 per share, with net proceeds of $46.5 million[199][200] Legal and Compliance - The company does not expect the resolution of current legal proceedings to have a material adverse effect on its financial position or cash flows[155] - The company maintains director and officer liability insurance coverage to cover potential indemnification obligations[156] - As of March 31, 2025, the company had no outstanding claims related to indemnification obligations, concluding that the fair value of these obligations is negligible[156] Stock Options and Compensation - The Company issued 3,634,400 options to employees under the 2023 Plan during the three months ended March 31, 2025[210] - The Company granted 217,613 options to purchase shares of common stock to new hires during the three months ended March 31, 2025[211] - The Company incurs stock-based compensation expenses of $2.2 million and $2.4 million for the three months ended March 31, 2025 and 2024, respectively[203] - Performance-based stock options are granted based on the achievement of specified commercial, regulatory, and corporate milestones[213]

Akebia Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights Strong initial quarter of Vafseo® (vadadustat) U.S. product launch, with Vafseo net product revenues of $12.0 million in Q1 2025 Total Q1 2025 net product revenues of $55.8 million Bolstered balance sheet and expanded institutional investor ownership through $50 million underwritten public offering of common stock; cash and cash equivalents of $113.4 million as of the end of the quarter Exhibit 99.1 "We are treme ...

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]