Akebia Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Commercial and Pipeline Highlights

Q4 2025 net product revenues of$54.3 million; 2025 full-year net product revenues of$227.3 million, representing a 49% increase over 2024 full-year net product revenues

Expect significant Vafseo®(vadadustat) revenue growth in 2026 through expanded access to therapy at dialysis organizations, new patient starts, and improved adherence rates

Pipeline advancement continues with enrollment underway for praliciguat Phase 2 clinical trial in focal segmental glomerulosclerosis (FSGS) and AKB-097 Phase 2 rare kidney disease basket trial planned to begin in 2H 2026

Akebia to Host Conference Call at 8:00 a.m. EST on February 26, 2026

CAMBRIDGE, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) --Akebia Therapeutics®, Inc.(Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full year ended December 31, 2025 and recent business highlights related to the commercial launch of Vafseo®(vadadustat) as well as its robust pipeline.

“Vafseo commercial trends are showing marked improvement in early 2026, built on the solid foundation we created for the brand in its first year of launch,” said John P. Butler, Chief Executive Officer of Akebia. “Patient access to Vafseo therapy now stands at 290,000 patients, and early data points to improved patient adherence rates, which we believe are enhanced as a result of dialysis organizations deciding to implement observed dosing protocols. These dynamics, along with the building evidence of clinical differentiation, are expected to drive significant Vafseo revenue growth in 2026 and beyond as we work toward our goal to make Vafseo standard of care for treating anemia due to CKD in patients on dialysis. Separately, we are advancing our pipeline in rare kidney disease and actively enrolling patients into the Phase 2 trial of praliciguat in FSGS. We expect to initiate an open-label rare kidney disease basket study with our tissue-targeted complement inhibitor, AKB-097, in the second half of 2026 with initial data expected in 2027. Through these efforts, we remain steadfast in working to better the lives of people impacted by kidney disease.”

Akebia will host a conference call on Thursday, February 26, 2026 at 8:00 a.m. EST to discuss fourth quarter and full year 2025 earnings. To access the call, please register by clicking on thisRegistration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the “Investors” section of Akebia's website at:https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website athttps://ir.akebia.comapproximately two hours after the event.

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 atwww.akebia.com, which does not form a part of this release.

Vafseo®(vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.

VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Limitations of Use

Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels.

Please note that this information is not comprehensive. Please clickherefor the Full Prescribing Information, including BOXED WARNING and Medication Guide.

Statements in this press release 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 expectations about Vafseo commercial trends showing marked improvement in early 2026 and the reasons therefor; Akebia’s beliefs that improved patient adherence rates are enhanced as a result of dialysis organizations deciding to implement observed dosing protocols; Akebia’s expectations about significant Vafseo revenue growth in 2026 and beyond through expanded access to therapy at dialysis organizations, new patient starts, and improved adherence rates, along with the building evidence of clinical differentiation; Akebia’s goal to make Vafseo standard of care for treating anemia due to CKD in patients on dialysis; Akebia’s plans and expectations with respect to advancing its pipeline in rare kidney disease, including expectations of the number of patients to be enrolled in the Phase 2 trial of praliciguat in FSGS; Akebia’s plans and expectations with respect to a Phase 2 open-label rare kidney disease basket study with its tissue-targeted complement inhibitor, AKB-097, including the timing of the study and the timing of initial data; Akebia’s beliefs about patient demand for Vafseo and that fewer patients starts in Q4 2025 was the result of providers at select dialysis organizations anticipating the initiation of new in-center observed dosing protocols; Akebia’s plans and expectations with respect to the VOCAL and VOICE trials, including the timing of topline data; Akebia’s plans and expectations with respect to AKB-9090, including the timing of a Phase 1 study and the timing of topline data, and the initial target indication; Akebia’s expectations with respect to generic competition for Auryxia and Auryxia revenues in 2026; and Akebia expectations that its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years and assumptions related thereto.

The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential therapeutic benefits, safety profile, and effectiveness of Vafseo and Akebia’s development candidates; Akebia’s ability to initiate and enroll patients in its clinical trials; the results of preclinical and clinical research; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including generic entrants and the timing thereof; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia's collaborations; and changes in the geopolitical environment and uncertainty surrounding U.S. trade policy on tariffs. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

Akebia Therapeutics®, Auryxia ® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.

Mercedes Carrasco