AKBA

This article first appeared on GuruFocus. Total Revenues: $49.1 million in Q2 2026, compared to $62.5 million in Q2 2025. Vafseo Net Product Revenue: $21.3 million in Q2 2026, a 60% increase year-over-year and a 34% increase sequentially. Erixia Net Product Revenue: $25.5 million in Q2 2026, compared to $47.2 million in Q2 2025. License, Collaboration and Other Revenues: $2.4 million in Q2 2026, compared to $2 million in Q2 2025. Cost of Goods Sold: $10.4 million in Q2 2026, compared to $9.9 million in Q2 2025. R&D Expenses: $14.1 million in Q2 2026, compared to $11 million in Q2 2025. SG&A Expenses: $28.2 million in Q2 2026, compared to $26.6 million in Q2 2025. Net Loss: $80.9 million in Q2 2026, compared to net income of $0.2 million in Q2 2025. Cash and Cash Equivalents: Approximately $155.5 million as of June 30, 2026, compared to $162.6 million as of March 31, 2026. Patients on Vafseo Therapy: More than 10,500 active patients in Q2 2026, an approximate 41% increase compared with Q1 2026. Warning! GuruFocus has detected 5 Warning Signs with AKBA. Is AKBA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Akebia Therapeutics Inc (NASDAQ:AKBA) reported a significant milestone with over 10,500 patients on VASCO and $21.3 million in net product revenue for Q2 2026, a 34% sequential increase. The VOICE trial met its pre-specified stopping criteria early, demonstrating a statistically significant reduction in the primary composite endpoint of all-cause mortality and hospitalization, driven by a 10% reduction in hospitalizations. The company initiated a Phase II basket trial for Ebrivifus (AKB-097) in IgA nephropathy, lupus nephritis, and C3 glomerulopathy, targeting a differentiated tissue-specific complement inhibitor profile. Prolisiquat's Phase II FSGS trial is enrolling, and the company highlighted its unique mechanism of action (soluble guanylate cyclase stimulation) as potentially complementary to existing therapies like Sparsentan. Commercial diversification is progressing, with approximately one-third of prescribers now outside of USRC, and strong growth from mid-sized dialysis organizations (USRC, IRC, DCI) which still have significant room to expand. The company believes its existing cash resources, expected product revenues, and a plan to refinance its term loan will fund operations for at least two years. Total revenues decreased to $49.1 million in Q2 2026 from $62.5 million in Q2 2025, primarily due to lower Erixia revenues from generic competition and pricing pressure. The company reported a net loss of $80.9 million in Q2 2026, a significant swing from a net income of $0.2 million in the same period last year. Akebia Therapeutics Inc (NASDAQ:AKBA) expects 2027 VASCO revenues to decrease compared to 2026 due to a planned price reduction to align with ESAs after the TDAPA period ends on December 31, 2026. Growth at DaVita, the largest potential opportunity, remains slow, with management not expecting a meaningful increase in adoption until late 2026 or 2027, despite increased engagement. The positive VOICE trial data has not yet been presented at a medical conference or published in a peer-reviewed journal, which may delay its full impact on provider adoption. The company incurred a $1.9 million expense related to a commercial reorganization, and R&D expenses increased due to higher headcount and clinical trial activities, contributing to the wider net loss. Q: Can you provide more color on the progress at DaVita, including any future step-up in uptake timing, and have any dialysis providers changed or accelerated their protocol decisions since the VOICE results were shared?A: John Butler (CEO) noted that DaVita has implemented a three-times-weekly observed dosing protocol, and recent market research shows all-time highs in physician awareness, likelihood to recommend, and preference for VASCO over ESAs at DaVita. While a meaningful increase in the DaVita adoption curve is not expected in Q3, there is heightened senior clinical team engagement regarding detailed operational implementation, which bodes well for more impactful growth at the end of the year and into 2027. Nicholas Grund (CCO) added that DaVita rolled out its three-times-weekly observed dosing protocol in early June, which should help physicians overcome compliance concerns. The feedback since VOICE has been more at the individual physician level, with Dr. Block actively discussing results, but no major protocol changes have been made yet. Q: How much of VASCO's revenue growth was driven by ex-USRC uptake, and what are the key near-term growth drivers?A: Nicholas Grund (CCO) explained that roughly a third of prescribers are now non-USRC physicians, showing diversification. USRC has been growing strongly since the beginning, while IRC and DCI, which started at the beginning of 2026, together make up about the size of USRC and are demonstrating strong growth. The near-term growth is driven by new patients, new clinics, and new providers, with the number of prescribers growing 17% quarter-over-quarter. Additionally, about 25% of patients who discontinued therapy in 2025 have restarted under observed dosing protocols, contributing to growth. Q: Can you better characterize persistence rates (e.g., 90-day and 180-day) and the principal reasons for discontinuation now that three-times-weekly dosing is available? Also, what is the timeline for getting VOICE data in front of medical organizations?A: Nicholas Grund (CCO) reported that first-refill adherence is strong at about 89%, and after that, discontinuation tapers down to normal churn in the dialysis patient population. Reasons for discontinuation include hospitalization (patients may go back on ESAs) and GI intolerance. John Butler (CEO) added that the initial adherence issues were due to hemoglobin drops with QD dosing, which have been resolved with observed dosing protocols. Regarding VOICE data, the results have not yet been presented or published, but Dr. Block is actively discussing them with peers. The data is being shared with dialysis providers, and there is significant excitement, particularly among USRC, IRC, and DCI, which together have about 66,000 patients, most of whom are on ESAs today. Q: Can you provide an update on the enrollment progress for the pipeline programs, particularly the Phase II FSGS trial for prolisiguat, and how do you see the potential for combination use with recently approved therapies?A: John Butler (CEO) stated that enrollment is progressing in the competitive FSGS space, and the team is adding more sites. He noted that the recent approval of Sparsentan in FSGS validates the large commercial opportunity, and multiple products will make a difference for patients. Steven Burke (CMO) explained that prolisiguat works through a completely different pathway (soluble guanylate cyclase) than Sparsentan (endothelin/angiotensin receptor blockade), and there is no reason the two drugs shouldn't work well together. For Ebri, he noted that complement inhibitors could be used in combination with B-cell-directed therapies like APRIL and APRIL/BAFF inhibitors, as Ebri's tissue-specific mechanism avoids systemic complement inhibition, making it inherently safer for long-term use. Q: What were the key drivers of the strong VASCO revenue growth in Q2 2026, and how should we think about the impact of the VOICE trial results on future growth?A: Nicholas Grund (CCO) reported that VASCO net product revenue grew 34% sequentially to $21.3 million, with over 10,500 patients on therapy, a 41% increase from Q1. The quarter saw the highest number of new patient starts since launch. John Butler (CEO) highlighted that the VOICE trial met its pre-specified stopping criteria with a win odds of 1.16 and p-value of 0.0016, demonstrating a statistically significant 10% reduction in hospitalization. This is the first head-to-head study of ESAs to show a significant benefit in hospitalization, and the data is expected to accelerate adoption. The company is working to present and publish the data as quickly as possible. Q: What is the financial outlook for VASCO given the expected end of the TDAPA period on December 31, 2026, and how will this impact 2027 revenues?A: Erik Ostrowski (CFO) explained that upon the expected end of VASCO's TDAPA period, the company plans to price VASCO within the price range of ESAs, which is significantly lower than its current price. While VASCO unit sales volumes are expected to increase in 2027 compared to 2026, 2027 revenues are expected to decrease due to the lower planned price. The company believes its existing cash resources, along with cash generated from product, royalty, supply, and license revenues, and a plan to refinance its senior secured term loan facility, will fund operations for at least two years. Q: Can you elaborate on the differentiation of Ebri (AKB-097) and its potential in complement-mediated kidney diseases?A: Steven Burke (CMO) explained that Ebri is a next-generation complement inhibitor designed to be targeted specifically to sites of complement activation in the glomeruli, avoiding complement inhibition in the blood. This tissue-specific mechanism is expected to provide efficacy without the boxed warning for significant infection risk associated with systemic complement inhibitors. The Phase II basket trial is evaluating Ebri in IgA nephropathy, lupus nephritis, and C3 glomerulopathy, with a once-weekly subcutaneous dose for 26 weeks. The primary endpoint is the incidence of adverse events, with secondary endpoints including changes in proteinuria and kidney function. Initial data is expected in 2027. Q: What is the status of the Phase II basket trial for Ebri, and what are the key endpoints and design?A: Steven Burke (CMO) stated that the Phase II basket trial was recently initiated and will enroll up to 30 patients with IgA nephropathy, lupus neph For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Q2 2026 Vafseo® (vadadustat) net product revenues grew to $21.3 million; more than 10,500 patients now on therapy Advancement of rare kidney disease pipeline continues with initiation of Phase 2 open-label basket trial evaluating ebribafusp for treatment of IgA nephropathy, lupus nephritis and C3 glomerulopathy; initial data expected in 2027 Interim analysis of VOICE trial demonstrated overwhelming statistical evidence of improved safety outcomes for patients treated with Vafseo versus an ESA Akebia to host conference call at 4:30 p.m. EDT on August 5, 2026 CAMBRIDGE, Mass., Aug. 05, 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 second quarter ended June 30, 2026 and shared recent business highlights related to the commercial launch of Vafseo® (vadadustat) and its advancing rare kidney disease pipeline. “We’re pleased with Vafseo’s continued sequential revenue growth this quarter, as well as the recently announced positive VOICE trial results for the primary endpoint, which marks an important step in our ultimate goal of making Vafseo standard of care for the treatment of anemia in patients on dialysis,” said John P. Butler, Chief Executive Officer of Akebia. “We also continue to make strong progress advancing our rare kidney disease pipeline with the initiation of our Phase 2 basket trial evaluating ebribafusp for the treatment of three rare glomerular kidney diseases, with initial data expected in 2027. Further, enrollment continues in our Phase 2 trial of praliciguat in FSGS.” Second Quarter and Recent Business Highlights: Vafseo net product revenues grew to $21.3 million in Q2, representing a 34% increase over Q1 of this year. More than 10,500 patients were active on Vafseo in Q2, representing a 41% increase from the end of Q1 2026. Total number of prescribers increased to approximately 1,200, representing an increase of approximately 17% versus Q1 2026. In August, Akebia announced that it initiated a Phase 2 open-label basket trial of ebribafusp (previously known as AKB-097 and ADX-097), a next-generation complement inhibitor. The trial of ebribafusp in patients with IgA nephropathy, lupus nephritis or C3 glomerulopathy is expected to enroll up to 30 patients dosed subcutaneously once weekly. As part of this study, Akebia will measure urine protein creatinine ratio (UPCR), kidney function measured by estimated glomerular filtration rate (eGFR), and ebribafusp pharmacokinetics. In addition, the trial will measure blood and urine complement biomarkers to determine if ebribafusp reduces complement activity in kidneys while avoiding complement system inhibition in the blood. The Phase 2 basket trial is open-label, and Akebia expects to report initial data in 2027. In June, U.S. Renal Care (USRC) and Akebia announced that a planned interim analysis of the VOICE trial (n=2,116) met its predefined stopping criteria. The data showed a statistically significant improved safety outcome in patients treated with Vafseo dosed three times per week (TIW) versus erythropoiesis stimulating agents (ESA) on the hierarchical composite endpoint of all-cause mortality and hospitalization (win odds 1.16; 95% CI 1.06, 1.28; p=0.0016), driven by a significant reduction in hospitalizations. The trial results replicated the safety outcomes from the post-hoc win statistics analysis of the Phase 3 INNO2VATE clinical trial. USRC expects to submit the data for presentation at an upcoming medical meeting. In June, Akebia announced it had strengthened its Vafseo intellectual property portfolio with a new Orange Book–listed patent (U.S. Patent No. 12,569,474, expiring June 2034) and eligibility for a five-year patent term extension on a composition of matter patent, which would extend that patent's term to mid-2032. Akebia's Vafseo portfolio now includes 14 Orange Book–listed patents, with expiration dates out to 2036. In May, Akebia announced the publication of a post-hoc win statistics analysis of all-cause mortality and hospitalization from its global Phase 3 INNO2VATE program in the Journal of the American Society of Nephrology, which demonstrated a statistically significant improvement relative to the ESA, darbepoetin alfa, on a hierarchical composite endpoint of all-cause mortality and hospitalization in patients with anemia due to chronic kidney disease receiving dialysis. In April, Akebia appointed Philip J. Vickers, Ph.D. to its Board of Directors. Dr. Vickers is the President and Chief Executive Officer and a member of the Board of Directors of Solu Therapeutics. He brings deep expertise spanning research and development, translational science and corporate strategy across a broad range of therapeutic areas to the Board. Financial Results Revenues: Total revenues were $49.1 million in the second quarter of 2026 compared to $62.5 million in the second quarter of 2025. This decrease was due to a decrease in Auryxia® (ferric citrate) revenues which was partially offset by higher Vafseo revenues. Cost of Goods Sold (COGS): Cost of goods sold was $10.4 million in the second quarter of 2026 compared to $9.9 million in the second quarter of 2025. Of note, Vafseo-related COGS in both periods was derived from pre-launch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as research and development expenses in the period incurred prior to Vafseo’s approval in the U.S. Research & Development Expenses: Research and development expenses were $14.1 million in the second quarter of 2026 compared to $11.0 million in the second quarter of 2025. The increase in expenses was driven by increased clinical trial activities related to our mid-stage pipeline assets, which include praliciguat and ebribafusp, as well as higher headcount-related costs. SG&A Expenses: Selling, general and administrative expenses were $28.2 million in the second quarter of 2026 compared to $26.6 million in the second quarter of 2025. This increase was driven by higher commercialization-related activities. Net Income (Loss): Net loss was $8.9 million in the second quarter of 2026 compared to net income of $0.2 million in the second quarter of 2025. The change to a net loss in the second quarter of 2026 resulted from lower revenues and higher expenses during the quarter, including a $1.9 million restructuring expense related to the reorganization of our commercial organization aimed at increasing the efficiency and effectiveness of our commercial efforts. Cash Position: Cash and cash equivalents as of June 30, 2026 were approximately $155.5 million as compared to $162.6 million as of March 31, 2026. We believe our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues, along with our plan to refinance our senior secured term loan facility, will enable us to fund our current operating plan for at least two years. Conference Call Akebia will host a conference call on Wednesday, August 5, 2026 at 4:30 p.m. EDT to discuss second quarter 2026 earnings. To access the call, please dial (646) 307-1963 or toll-free (800) 715-9871 and enter passcode: 4727037. 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 at https://ir.akebia.com approximately two hours after the event. About Akebia Therapeutics 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. About Vafseo® (vadadustat) tablets 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. INDICATION 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 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). 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. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. CONTRAINDICATIONS Known hypersensitivity to VAFSEO or any of its components Uncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. HepatotoxicityHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. HypertensionWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. SeizuresSeizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new- onset seizures, premonitory symptoms, or change in seizure frequency. Gastrointestinal (GI) ErosionGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. MalignancyVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. DRUG INTERACTIONS Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron. Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders. BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction. Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. A pregnancy exposure registry is available to monitor outcomes in women exposed to VAFSEO during pregnancy. Report pregnancies to 1-844-445-3799. Lactation: Breastfeeding not recommended until two days after the final dose. Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease. Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. Forward-Looking Statements 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 plans, strategies and prospects for its business; Akebia’s beliefs regarding Vafseo’s continued revenue growth; Akebia’s beliefs regarding the data and results from the VOICE trial, including that the data demonstrated overwhelming statistical evidence of improved safety outcomes for patients treated with Vafseo versus an ESA; Akebia’s goal of making Vafseo standard of care for the treatment of anemia in patients on dialysis; Akebia’s plans and expectations regarding the Phase 2 open-label basket trial evaluating ebribafusp, including the timing of reporting initial data, the expected number of patients to be enrolled and the timing thereof; Akebia’s beliefs and expectations regarding the progress of its rare kidney disease pipeline, including its Phase 2 trial of praliciguat in FSGS; Akebia and USRC’s plans and expectations regarding submitting data from the VOICE trial for presentation at an upcoming medical meeting; Akebia’s expectations and beliefs about the strength of its Vafseo (vadadustat) intellectual property portfolio and expectations regarding its ability to maintain its intellectual property protection through the respective expiration dates; Akebia’s expectations regarding Auryxia revenues continuing to decrease due to generic competition and pricing pressure; Akebia’s goals and expectations regarding its commercial reorganization aimed at increasing the efficiency and effectiveness of its commercial efforts; Akebia’s beliefs and expectations regarding the cash it expects to generate from product, royalty, supply and license revenues and the sufficiency of, and the period in which Akebia expects to have, cash to fund its current operating plan; and Akebia’s plans to refinance its senior secured term loan facility. The terms "intend," "believe," "plan," "goal," "potential," "anticipate,” "estimate," “target,” “predict,” "expect," "future," “may,” "will," “could,” "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 Akebia’s products and product candidates; risks and uncertainties related to Akebia’s ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials, and the timing of such preclinical studies and clinical trials; the results of Akebia’s preclinical studies and clinical trials, including that initial, preliminary, interim or retrospective data, analysis or results may not be replicated in, or predictive of, final analyses or results of future preclinical or clinical data, analyses or results or that such analysis or results may not support further development of such product candidates; Akebia’s ability to initiate and enroll patients in its clinical trials; 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 Akebia’s commercial products, including estimates regarding the potential market opportunity; the competitive landscape for Akebia’s commercial products, including generic entrants and the timing thereof; Akebia’s ability to obtain and maintain patent protection on its products and product candidates, and to successfully defend these patents against third-party challenges; Akebia’s ability to attract and retain qualified personnel; Akebia's ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; Akebia’s revenue and that its financial results from prior periods may not be indicative of future results; 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 most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC), and other filings that Akebia may make with the SEC 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. Akebia Therapeutics ContactMercedes [email protected]

Interested in Akebia Therapeutics, Inc.? Here are five stocks we like better. Vafseo revenue rose sharply to $21.3 million in Q2 2026, up 34% sequentially and 60% year over year, with more than 10,500 active patients. However, total revenue fell to $49.1 million as Auryxia sales declined amid generic competition. The 2,116-patient VOICE trial met its interim stopping criteria after Vafseo delivered a statistically significant and clinically meaningful reduction in the composite of mortality and hospitalization, driven by a 10% hospitalization reduction. Akebia advanced its kidney-disease pipeline with a Phase II ebribafusp trial and continued enrollment in a Phase II praliciguat study, while warning that Vafseo revenue may decline in 2027 after its TDAPA period ends and pricing is reduced. Akebia Therapeutics Surges on FDA Approval for Anemia Treatment Akebia Therapeutics (NASDAQ:AKBA) reported second-quarter revenue growth for its Vafseo anemia treatment while highlighting an interim clinical result from the VOICE study and progress across its kidney disease pipeline. Vafseo net product revenue reached $21.3 million in the second quarter of 2026, up 34% sequentially and 60% from $13.3 million in the prior-year period. The company said it surpassed 10,500 active patients receiving the treatment during the quarter, with total patients on therapy increasing about 41% from the first quarter. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Total revenue was $49.1 million, down from $62.5 million a year earlier, reflecting lower sales of Auryxia amid generic competition and pricing pressure. Auryxia net product revenue declined to $25.5 million from $47.2 million in the second quarter of 2025. Chief Executive Officer John Butler said an interim analysis of the VOICE trial showed Vafseo achieved a statistically significant and clinically meaningful reduction in the study’s primary composite endpoint of all-cause mortality and hospitalization. The result was driven by a 10% reduction in hospitalization, he said. → 3 Drone Stocks That Should Soar After the Summer Slump The independent data monitoring committee and trial steering committee recommended stopping the trial after the planned interim analysis. The 2,116-patient study met its predefined stopping criteria as of June 1, with a win odds of 1.16 and a p-value of 0.0016, establishing both non-inferiority and superiority on the primary composite endpoint, according to the company. Butler said the data were consistent with a post-hoc analysis from the Phase III INNO2VATE program published earlier this year. He said the results were consistent across daily and three-times-weekly dosing and against both long-acting and short-acting erythropoiesis-stimulating agents, or ESAs. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Akebia has so far shared the VOICE results through a press release. Butler said study investigator Dr. Geoff Block is working to present the data at a medical meeting and publish them in a peer-reviewed journal. Chief Commercial Officer Nick Grund said the number of Vafseo prescribers rose 17% from the first quarter, while new patient starts reached their highest quarterly level since the product’s launch period. Approximately one-third of Vafseo prescribers are now affiliated with large dialysis organizations outside U.S. Renal Care, or USRC, he said. USRC, Innovative Renal Care and Dialysis Clinic Inc. contributed the largest share of patient growth, according to Grund. He said the company sees additional opportunity within those organizations, while DaVita remains its largest potential source of growth from a single dialysis provider. Akebia said DaVita rolled out its three-times-weekly observed dosing protocol across its network in early June. Grund said the company does not expect a meaningful increase in DaVita adoption during the third quarter, but management cited increased engagement with DaVita’s senior clinical team around operational implementation and said it expects more substantial growth later in the year and into 2027. On adherence, Grund said about 89% of patients receiving a Vafseo prescription obtain their first refill. Subsequent discontinuation trends more closely resemble normal turnover in the dialysis population, he said, including hospitalizations, tolerability issues and transitions back to ESAs. Akebia initiated a Phase II open-label basket trial of ebribafusp, formerly known as AKB-097 and ADX-097, in IgA nephropathy, lupus nephritis and C3 glomerulopathy. The company expects to enroll up to 30 patients in the study, which will evaluate once-weekly subcutaneous dosing for 26 weeks followed by a long-term extension for responders. Chief Medical Officer Dr. Steven Burke said the trial’s primary endpoint is adverse events, with secondary measures including changes in proteinuria and kidney function. The study will also assess pharmacokinetics and complement biomarkers in blood and urine. Akebia expects to report initial results in 2027. The company believes ebribafusp could offer tissue-specific complement inhibition at affected kidney glomeruli while avoiding systemic complement inhibition in the blood. Burke said the potential profile could support long-term treatment and possible combinations with B-cell-directed therapies, though he noted that further study will be needed. Akebia also continues to enroll patients in a Phase II trial of praliciguat for focal segmental glomerulosclerosis, or FSGS. The randomized, double-blind, placebo-controlled study is designed to enroll up to 60 patients with primary or genetic FSGS. Its primary endpoint is the change in urine protein-creatinine ratio from baseline through week 24. Butler said enrollment is progressing in what he described as a competitive clinical-trial environment, though the company did not provide a timeline for the data readout. Burke said praliciguat’s soluble guanylate cyclase mechanism differs from that of sparsentan and could potentially support future combination approaches. A third clinical candidate, AKB-9090, remains in a Phase I single-ascending-dose and multiple-ascending-dose study in healthy volunteers. Akebia expects to report data early next year and said it plans to focus development resources in 2027 on ebribafusp and praliciguat. Akebia reported a net loss of $8.9 million for the second quarter, compared with net income of $0.2 million a year earlier. Research and development expense rose to $14.1 million from $11 million, while selling, general and administrative expense increased to $28.2 million from $26.6 million. The company said the quarter included a $1.9 million expense related to a commercial reorganization. Cash and cash equivalents totaled approximately $155.5 million as of June 30, down from $162.6 million at the end of the first quarter. Chief Financial and Chief Business Officer Erik Ostrowski said Akebia believes its cash, expected product and other revenues, and a planned refinancing of its senior secured term loan facility will fund its operating plan for at least two years. Ostrowski also reiterated that Akebia expects Vafseo’s TDAPA period to end Dec. 31, 2026. The company plans to price Vafseo within the range of ESAs afterward, a level significantly below its current price. While Akebia expects Vafseo unit volume to increase in 2027, it expects revenue from the drug to decline from 2026 levels because of the planned price reduction. Akebia Therapeutics, Inc, a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, is focused on the development and commercialization of therapies for patients with kidney disease. The company's lead product candidate, vadadustat, is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis patients. Akebia's research and development efforts also extend to preclinical programs targeting nephrology and related metabolic disorders. Since its founding in 2007, Akebia has pursued strategic collaborations to advance its clinical pipeline and expand its market reach. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Akebia Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

One of the biggest stories of last week was how Akebia Therapeutics, Inc. (NASDAQ:AKBA) shares plunged 23% in the week since its latest first-quarter results, closing yesterday at US$1.16. The results were mixed overall, with revenues slightly ahead of analyst estimates at US$54m. Statutory losses by contrast were 7.1% larger than predictions at US$0.03 per share. Earnings are an important time for investors, as they can track a company's performance, look at what the analysts are forecasting for next year, and see if there's been a change in sentiment towards the company. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Taking into account the latest results, the current consensus, from the five analysts covering Akebia Therapeutics, is for revenues of US$216.2m in 2026. This implies a noticeable 7.0% reduction in Akebia Therapeutics' revenue over the past 12 months. Per-share losses are expected to explode, reaching US$0.13 per share. Before this earnings announcement, the analysts had been modelling revenues of US$222.5m and losses of US$0.056 per share in 2026. So it's pretty clear the analysts have mixed opinions on Akebia Therapeutics after this update; revenues were downgraded and per-share losses expected to increase. Check out our latest analysis for Akebia Therapeutics There was no major change to the consensus price target of US$4.20, signalling that the business is performing roughly in line with expectations, despite lower earnings per share forecasts. That's not the only conclusion we can draw from this data however, as some investors also like to consider the spread in estimates when evaluating analyst price targets. There are some variant perceptions on Akebia Therapeutics, with the most bullish analyst valuing it at US$6.00 and the most bearish at US$3.00 per share. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. One more thing stood out to us about these estimates, and it's the idea that Akebia Therapeutics' decline is expected to accelerate, with revenues forecast to fall at an annualised rate of 9.2% to the end of 2026. This tops off a historical decline of 4.7% a year over the past five years. By contrast, our data suggests that other companies (with analyst coverage) in a similar industry are forecast to see their revenue grow 22% per year. So it's pretty clear that, while it does have declining revenues, the analysts also expect Akebia Therapeutics to suffer worse than the wider industry. The most important thing to note is the forecast of increased losses next year, suggesting all may not be well at Akebia Therapeutics. On the negative side, they also downgraded their revenue estimates, and forecasts imply they will perform worse than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. Keeping that in mind, we still think that the longer term trajectory of the business is much more important for investors to consider. We have forecasts for Akebia Therapeutics going out to 2028, and you can see them free on our platform here. You still need to take note of risks, for example - Akebia Therapeutics has 1 warning sign we think you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Image source: The Motley Fool. Thursday, May 7, 2026 at 8 a.m. ET Chief Executive Officer — John Butler President, Nephrology — Nicholas Grund Chief Financial Officer — Erik Ostrowski Chief Medical Officer — Steven Burke John Butler: Thanks, Mercedes, and thanks to all of you for joining us this morning. We are very pleased and excited by the start to 2026. I want to focus on 3 key areas that we feel we need to execute on to create near- and long-term value for patients and shareholders. First, we have to drive the near-term launch performance of Vafseo. Second, continue to build the clinical evidence to make Vafseo standard of care for patients on dialysis; and third, execute on our impressive kidney disease-focused clinical development pipeline. We've made important progress across each of these areas. Starting with the Vafseo launch, revenues were nearly $16 million in Q1, representing our highest quarter of Vafseo net product revenue to date and demonstrating the growth we expected over Q4 2025. We're pleased with the progress we're seeing within and across dialysis organizations as we expand the breadth and depth of prescribing and continue to educate the nephrology community on the benefits of Vafseo. We believe this growth is being driven by dialysis organizations that have chosen to implement an observed dosing protocol. Nick is going to expand on that important point and provide more detail on the quarter and trends we're seeing in 2026. Now we continue to work to take advantage of the TDAPA opportunity for the balance of '26. Of course, we're already planning for the beginning of 2027 when Vafseo will enter the dialysis bundle. The ESA market today for patients on dialysis is estimated to be approximately $1 billion. This is the market we're competing in, where we continue to work to become standard of care. This leads to the second area of focus - building clinical evidence. And that body of evidence supporting the potential benefits of Vafseo continues to grow. The post-hoc hierarchical composite endpoint analysis from our Phase III INNOVATE program in dialysis was recently published in the Journal of the American Society of Nephrology. The analysis demonstrated that patients treated with Vafseo in the INNOVATE trial experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator. Earlier in Q1, at the Annual Dialysis Conference, we presented an economic analysis on the cost of hospitalizations for patients treated with Vadadustat versus darbepoetin. That analysis showed that patients in the INNOVATE trial treated with Vadadustat had 7.7% fewer hospitalization events annually, a 16% reduction in hospitalization days and based on Medicare cost data, a 14.8% lower annual hospitalization cost. We believe these data further supports the potential benefits of managing anemia with Vafseo and provide critical data to providers and prescribers making care decisions. We continue to share these important data with the medical and scientific community as we gear up for results from the VOCAL study expected by year-end. VOCAL is being conducted at DaVita clinics to evaluate Vafseo dosed 3 times weekly, and it contains a substudy of red blood cell characteristics, which we believe will further differentiate Vafseo's clinical profile versus ESAs. VOCAL top line data will be followed by results from the VOICE trial being run by U.S. Renal Care, evaluating Vafseo versus standard of care on a hierarchical composite endpoint of all-cause mortality and hospitalization rates. Top line data from VOICE are expected in early 2027; if positive, it further support the findings of the recently published Win statistics analysis. Both VOICE and VOCAL utilize a 3x weekly dosing regimen. Alliance organizations are systematically electing to move to an observed dosing protocol. We believe that shift is improving adherence and could lead to greater utilization over time. Now shifting from Vafseo to our third area of focus. Our R&D organization has been highly productive in advancing our kidney disease pipeline, which we believe will be an additional and important value driver for the company going forward. Strategically, this initiative is a natural extension for us as it leverages our expertise in kidney disease drug development, broadens our presence within the kidney community and aligns to our purpose to better the lives of people impacted by kidney disease. In April, we hosted an R&D Day to review our pipeline with the investor community, and we were joined by leading medical experts, Dr. Jim Tumlin, Michael Holers and Jonathan Barratt. During that event, we reviewed the preclinical data in focal segmental glomerulosclerosis or FSGS models and prior clinical data in diabetic kidney disease for praliciguat, our soluble guanylate cyclase stimulator. This is an indication that has received increased attention as there's now an approved treatment specifically for FSGS. We view this as a positive development for patients and the field. And we believe praliciguat could deliver a differentiated approach via a unique mechanism of action in this heterogeneous disease. Enrollment in our Phase II study is ongoing. We're targeting up to approximately 60 patients who are already on maximally tolerated background dose of ACEs or ARBs. The study will evaluate change from baseline in UPCR at 24 weeks as the primary endpoint. AKB-097, whose generic name is Abribafisp or [ abri ], is our tissue-targeted anti-C3D complement inhibitor. We believe this product candidate could have comparable efficacy to the most efficacious currently approved complement inhibitors in a well-characterized pathway. Initial data suggests that [ abri ] quickly leaves the bloodstream, directly targeting the tissue of complement activation, in this case, the kidney. We believe this could avoid the increased infection risk you see with current products. We also believe this will allow [ abri ] to be delivered at a lower dose in a more convenient dosing regimen. As Dr. Barratt articulated during our R&D Day presentation, [ abri ] is a second-generation complement inhibitor. We believe these characteristics support the potential for [ abri ] to be a uniquely differentiated product in the market. We expect to initiate a Phase II open-label basket trial in the second half of this year, evaluating [ abri ] in IgA nephropathy, lupus nephritis and C3 glomerulopathy. These indications represent a substantial market opportunity. And of course, we're evaluating additional indications to investigate as well. As part of the basket study, we'll be evaluating safety, tolerability, pharmacokinetics, pharmacodynamics and effects on disease-relevant biomarkers such as proteinuria and kidney function. Importantly, we expect the study to be designed to be able to demonstrate the efficacy and tissue targeting profile of [ abri ]. As a reminder, as the basket study is open label, we expect to begin reporting initial data in 2027. Lastly, this quarter, we were pleased to announce the initiation of a Phase I study of AKB-9090, our internally developed HIF-PH inhibitor product candidate with an expected initial indication for the prevention of acute kidney injury associated with cardiac surgery. This randomized double-blind, placebo-controlled SAD/MAD study is designed to evaluate safety, tolerability and pharmacodynamics in up to 70 healthy adult participants. And top line data from this program are expected in early 2027. Overall, we've had a strong start to the year, and we're making meaningful progress on both the commercial execution of Vafseo and the advancement of a pipeline that we believe can support long-term growth. Now let me turn it over to Nick for more granularity on the Vafseo launch. Nicholas Grund: Thanks, John. Good morning, folks. Like John, I am encouraged by the growth potential for Vafseo in 2026, which we believe is supported by our first quarter trends. While we ended 2025 with approximately 290,000 patients with prescribing access, the start of 2026 was when prescribing access translated to more widespread prescribing and more patients on therapy. I'll recap the quarterly results first and then explain what I believe is driving growth. With the move to observed dosing protocols across multiple additional dialysis providers, we are no longer receiving as much detailed data as we have in the past, but I believe we can still provide a very good sense of Vafseo utilization and growth. Q1 brought a significant increase in the number of prescribers writing and patients on Vafseo. Approximately 1,025 prescribers wrote a prescription for Vafseo, which was approximately 28% higher than the number of prescribers in Q4 2025. Importantly, approximately 30% of those prescribers were from dialysis organizations other than USRC. Dialysis organizations inventory remained relatively flat from Q4 2025 to Q1 2026. As you know, we reported Vafseo inventory destocking in the fourth quarter of 2025 as a result of dialysis organizations transitioning to observed dosing protocols and the related shift in distribution from shipping bottles to patients' homes to stocking bottles at dialysis centers. From a patient perspective, we note a 60% increase in the number of patients on Vafseo at the end of Q1 '26 over the number of patients at the end of Q4 2025 to nearly 7,500 patients. The number of new patient starts in quarter 1 was the highest in any quarter since the initial quarter of launch. The majority of new patients began in March, so Q1 revenue reflects at most only 1 month of treatment for these patients. We believe increases in number of prescribers writing and number of patients on Vafseo are important indicators that adoption is broadening as more organizations implement Vafseo treatment protocols that allow for greater access. Finally, I want to spend some time on adherence and particularly the transition that dialysis organizations are making toward observed dosing protocol. By the end of the quarter, USRC had observed dosing protocols available in nearly all of their clinics as did IRC and DCI. In quarter 1, approximately 2/3 of all Vafseo patients were being treated 3 times weekly, which we expect to continue to grow in coming quarters due to these protocol decisions. First refill adherence rates through the end of March were approximately 86% for patients treated under an observed dosing protocol. We believe this will reinforce the dialysis organization's decisions to provide access to Vafseo using observed dosing. Because of this expanded access, we anticipate the greatest opportunity for Vafseo revenue growth will be among dialysis organizations that have implemented observed dosing and expect nearly all in-center patients across [indiscernible] to be on an observed dosing protocol by the end of the year. We are clearly seeing more patients start at DaVita, though more slowly than at other dialysis organizations that have ramped up, and that remains our largest potential growth opportunity from a single dialysis organization. We believe DaVita will implement an observed dosing protocol in the second half of the year. To summarize, we are seeing encouraging signs in the underlying commercial indicators that matter most, including broader prescriber engagement, improved adherence in observing dosing patients and increased prescribing at dialysis organizations beyond USRC, which all lead to a significant increase in patients on Vafseo therapy. As prescribers continue to gain real-world experience with Vafseo and we generate and disseminate more data, we expect to further grow the breadth and depth of prescribing. Let me now turn it over to Erik. Erik Ostrowski: Thanks, Nick. We're pleased to deliver Vafseo revenue growth this quarter as we continue our pursuit to make Vafseo standard of care for the treatment of anemia in dialysis patients with CKD. I'll now provide an overview of our Q1 '26 financial results as compared to the prior year. Total revenues, which are comprised of net product revenues and license and collaboration revenues were $53.5 million in Q1 '26 compared to $57.3 million in Q1 '25. This decrease was driven by lower Auryxia revenues, which was partially offset by higher Vafseo revenues. Of these amounts, Vafseo net product revenues were $15.8 million in Q1 '26 compared to $12 million in Q1 '25, representing a 32% increase with an even larger increase in underlying demand as evidenced by the strong Q1 patient growth Nick described as well as by the fact that Q1 '25 revenues reflected initial customer inventory build. Auryxia net product revenues were $36.2 million in Q1 '26 compared to $43.8 million in Q1 '25, which was driven by lower Auryxia pricing. Looking forward, we note that in addition to the authorized generic for Auryxia that has been on the market for the past year, an additional generic form of Auryxia has entered the market. This increased generic competition is consistent with our expectations and prior guidance. Accordingly, as we've previously communicated, we expect Auryxia revenues to decrease in 2026 as compared to 2025. Lastly, license collaboration and other revenues were $1.6 million in Q1 '26 compared to $1.5 million in Q1 '25. Turning to expenses. Cost of goods sold was $12.3 million in Q1 '26 compared to $7.6 million in Q1 '25. This increase was primarily due to an increase in inventory write-downs, including as a result of excess and obsolescence and scrap, primarily related to Auryxia during Q1 '26. Of note, Vafseo-related COGS in both periods was derived from prelaunch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as R&D expenses in the period incurred prior to Vafseo's U.S. approval. R&D expenses were $14.8 million in Q1 '26 compared to $9.8 million in Q1 '25. The increase in expenses was driven by increased clinical trial activities related to praliciguat, which we are evaluating in FSGS and AKB-9090, which we are evaluating for the prevention of cardiac surgery-related acute kidney injury as well as higher headcount-related costs. SG&A expense was $30.4 million in Q1 '26 compared to $25.7 million in Q1 '25. This increase was driven by higher headcount-related costs. Net loss was $9.1 million in Q1 '26 compared to net income of $6.1 million in Q1 '25. The change to a net loss in Q1 '26 resulted from lower Auryxia revenues along with higher expenses this quarter as compared to Q1 '25. Cash and cash equivalents as of March 31, 2026, were $162.6 million compared to $184.8 million as of December 31, 2025. The decrease in cash was driven by the net loss for the quarter, along with an increase in working capital. We expect our existing cash resources and cash from operations will be sufficient to fund our current operating plan for at least 2 years. With that, we welcome questions. Operator: [Operator Instructions] Our first question is from the line of Julian Harrison with BTIG. Julian Harrison: Congrats on the progress. First, I'm wondering if you could talk more about the prominent increase of patients on Vafseo in March. Did you see follow-through of that trend into April? And was there may be a specific dialysis provider or providers accounting for most of that uptake? And then second, is Filspari's recent approval relevant at all to your enrollment efforts in FSGS? Can you maybe walk us through how you're thinking about enrollment dynamics going forward for your Phase II trial? John Butler: Sure. Nick, do you want to take the first question? Nicholas Grund: Yes. Thanks, Julian, for the question. The increase in patients nearly 60% quarter-over-quarter really was across all of our DOs, the major ones. USRC continued to have increases as they've really moved to the observed dosing protocol in all of their clinics, which is really, as we've indicated in previous calls, allowed them to start adding new patients on without the complications of a lower adherence rate that we saw in the QD dosing scheme for in-center patients. In addition, we've seen some restarts at USRC, which I think is an important characteristic. Patients that previously were on QD dosing fell off perhaps for compliance reasons. And now in a TIW, or observed dosing regimen that they're restarting them on therapy with Vafseo, which is really important. IRC and DCI, really, once they got their dosing protocols in place, if you remember that was in Q4, what we saw was a very, very aggressive and accelerated adoption of the product within their physician base. That advocacy that we're seeing at IRC and DCI is strong. DaVita also had significant growth in the period. They're lagging a bit behind the others. They're still under a QD dosing protocol. But we believe in the second quarter -- in the second half of the year, we'll see them moving to an observed dosing protocol as well. And so really great growth across a number of our DOs. We point to diversification. So the diversification away from USRC is an important measure to see how adoption is progressing at other dialysis organizations. John Butler: It's good to see we have significant room still to grow at USRC, DCI and IRC, where we have great momentum. We all know that DaVita needs to increase. And as Nick said, it's growing for sure. But I think it's that observed dosing protocol that's going to make all the difference in the world. So stay tuned. But again, I mean, we're really pleased with the growth that we're seeing in the USRC, DCI and IRC clinics and expect to see significant growth from them as the year progresses. And on the FSGS trial, yes, I mean, we think it's really a positive thing for patients. And from a regulatory perspective, you can see that FDA on this is on praliciguat, your second question, really is supportive of bringing new products for this patient population. We know while everyone is excited that sparsentan has been approved, we know this is not a product that's going to be all the difference in FSGS. So I'll let Steve comment, but I'll say Steve and I were down at an investigator meeting a few weeks ago, and I was incredibly pleased by how excited the physicians were about the opportunity for praliciguat and the unique mechanism of action there. And we're pleased with the progress we're making. There are multiple products in development there. So it is a competitive space. But we're very pleased that they're as excited as they are about praliciguat, and we think that enrollment will progress. I don't know, Steve, is there anything you want to add? Steven Burke: No, I'd just echo what you said, which is the bigger issue in conducting clinical trials is competing with other sponsors for patients. So I don't think the Filspari approval is going to have a significant -- we haven't heard that it's having a significant impact on enrollment. I don't anticipate it will just because it's slightly better than angiotensin receptor blockers or ACE inhibitors. And so the majority of patients are still not going to respond to that drug, and it's going to become basically just a background therapy like ACE and ARBs are. John Butler: Thanks, Julian. And Steve is not here in the room with us because he's down at the NKF Spring Clinical Meeting. So I'm sure he's getting more feedback on our impressive pipeline as well. Sorry Lauren. Operator: Our next question comes from the line of Roger Song with Jefferies. Unknown Analyst: This is Nabil on for Roger. So great to hear about the step-up in patients and prescribers. And then regarding the first refill adherence at 86%, how should we think about that level as we -- dosing scales more broadly across DOs? And then I have a follow-up. John Butler: Nick, do you want to take that one? Nicholas Grund: Yes. In previous quarters, when we talked about first refill, the sample size was still relatively small. Now we're getting to the point where there are -- we've gotten to a sample size or penetration of observed dosing where we see a significant number of patients being utilizing protocols that have observed dosing regimen. And so I feel pretty confident about 86% is going to stick around there. It may move a couple of points one direction or another direction. But there's no reason for us to believe at this point that it shouldn't apply as other DOs bring on. Now every DO has a little bit different protocol, whether it be starting at 900 milligrams daily, how often they titrate up, whether they're coming from Mircera or whether they're coming from Epogen. But we've seen this consistent number here, bouncing around between kind of 85 and 90 for the last couple of quarters. And so right now, we're really confident that's how you should think about it moving forward. Jiale Song: Great. And then as we think about Vafseo throughout the remainder of 2026, should we expect the growth to be more linear from here or more back half weighted as the protocol adoption matures? John Butler: Yes. I mean I don't know that we can guide that granularly to how it's going to go. I mean we've -- as you see with 7,100 or 7,500 patients on the drug, there's lots of room to grow. We see great momentum, USRC. I mean I think particularly excited to see so many of the patients who were -- who went off of the drug last year with the adherence issues that they have being put back on. And with the adherence rate staying on the drug, how quickly that will accelerate. These are all things that will influence it. But there's tremendous room to grow. I remember there's about 66,000 patients just between USRC, DCI and IRC. Not all of them have a TDAPA reimbursement, but the access is quite good. So lots of room just to grow there. And then the question is, how quickly does DaVita move? And DaVita has really taken the strategy of allowing physicians to make the choice, whereas the others, it's more of a top-down push. Here are the patients that are available and you put them on, and they do that over time, as I said, systematically, but it is different. It's kind of a more traditional adoption curve, which it's harder to really kind of handicap exactly how quickly that's going to happen, but we know that pool is so much bigger that we need to tap into it. So I don't think we could say, oh, it's going to be linear or there's going to be some hockey stick at the end of the year. But certainly, once DaVita goes to a TIW protocol, and we -- I mentioned like the JASN paper, the [indiscernible] paper. As I said, that was just published. Before it was published, our medical folks couldn't talk to physicians about it. Right now that it's published, they're out there talking about it. Those are the kinds of data that do change shapes of curve. So -- but exactly how quickly that happens, that's to be determined. But we really are pleased with the momentum that we have in the market today. Operator: Our next question comes from the line of Matthew Caulfield with H.C. Wainwright & Co. Matthew Caufield: For praliciguat development in FSGS, what do you view as the most clinically relevant change for the 24-week UPCR primary endpoint? Is there a certain delta that will be the most clinically relevant there in addition to preserving the podocyte health and just the overall reduced proteinuria? John Butler: Sure. Steve, do you want to take that question? Steven Burke: Sure. I think we would like to see something that's on par with what we've seen with sparsentan. So something around a 20% improvement in the change in UPCR, so 20% over what's achievable with ACE and ARBs. I think the critical thing will be the proportion of patients who end up with a UPCR less than 0.7 grams per gram because that's the approvable endpoint now for FSGS. So that will be the -- really the key metric that will drive our decision to go into Phase III or not. John Butler: Yes, I think that -- obviously, we're -- we think that's the bar, right, the sparsentan bar for approval. But as Steve said, I mean the PARASOL findings really is encouraging that we have this clarity from the FDA around what we need to do to get the product approved. And again, given the heterogeneity of the disease, the uniqueness of our mechanism, we really think that there's a place -- it's about 60,000 FSGS patients in the U.S. The approval of sparsentan is great for patients, but there's significant room for new entrants. And again, hitting that clinical threshold will be critical for us. Thanks for the question, Matthew. Operator: I'm showing no further questions at this time. I would now like to turn it back to John Butler for closing remarks. John Butler: Thank you, Lauren, and thanks again to all of you for joining us this morning. We look forward to continuing to update you on the progress we're making in the launch of Vafseo, building the evidence to support Vafseo's long-term growth and the continued advancement of our robust kidney-focused pipeline. Have a great day, everybody. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Before you buy stock in Akebia Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Akebia Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $475,926!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,296,608!* Now, it’s worth noting Stock Advisor’s total average return is 981% — a market-crushing outperformance compared to 205% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 8, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Akebia (AKBA) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Interested in Akebia Therapeutics, Inc.? Here are five stocks we like better. Akebia's commercial launch of Vafseo showed strong momentum with Q1 net product revenue of $15.8 million, ~1,025 prescribers (up ~28% QoQ), nearly 7,500 patients (up ~60% sequentially) and ~86% first-refill adherence where observed dosing has been adopted. Company-wide revenue fell to $53.5 million as Auryxia sales declined, producing a Q1 net loss of $9.1 million versus a $6.1 million profit a year earlier, but cash and equivalents of $162.6 million are expected to fund operations for at least two years. Pipeline progress includes near-term readouts (VOCAL by year-end, VOICE in early 2027), an ongoing Phase II of praliciguat in FSGS, a planned Phase II open‑label trial of AKB‑097 in H2 2026, and a Phase I of AKB‑9090 with top-line data expected in early 2027. Akebia Therapeutics Surges on FDA Approval for Anemia Treatment Akebia Therapeutics (NASDAQ:AKBA) executives highlighted a “strong start” to 2026 on the company’s first-quarter earnings call, pointing to record quarterly net product revenue for its anemia drug Vafseo, expanding use of observed dosing protocols at dialysis organizations, and continued progress across a kidney disease-focused development pipeline. Chief Executive Officer John Butler said the company is focused on three priorities: “drive the near-term launch performance of Vafseo,” continue building evidence to make it a standard of care for dialysis patients, and advance its kidney-focused pipeline. In the first quarter, Butler said Vafseo net product revenue was “nearly $16 million,” which the company described as its highest quarterly Vafseo net product revenue to date. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Chief Commercial Officer Nick Grund attributed growth to broader protocol adoption at dialysis organizations, particularly moves toward observed dosing. “Most dialysis organizations are systematically electing to move to an observed dosing protocol,” Butler said, adding the shift could improve adherence and increase utilization over time. Grund reported that approximately 1,025 prescribers wrote a Vafseo prescription in the quarter, about 28% more than in the fourth quarter of 2025. He added that approximately 30% of those prescribers were from dialysis organizations other than U.S. Renal Care (USRC). From the patient standpoint, Grund said the number of patients on Vafseo at quarter-end increased about 60% sequentially to “nearly 7,500 patients.” He noted that new patient starts in Q1 were the highest since the initial launch quarter, with most new starts occurring in March, meaning Q1 revenue reflected “at most only one month of treatment for these patients.” → A Prada Payday: Is AMC Back in Style? On adherence, Grund said first-refill adherence through the end of March was approximately 86% for patients treated under observed dosing. In response to a question about whether that level should hold as adoption broadens, he said the company has seen the metric “bouncing around between kind of 85 and 90 for the last couple of quarters” and he felt “pretty confident” the 86% level should persist as additional dialysis organizations bring on observed dosing. Grund also said that by the end of the quarter, observed dosing protocols were available in nearly all USRC clinics, as well as at IRC and DCI. He added that about two-thirds of Vafseo patients were being treated three times weekly by quarter-end, which he expects to rise in coming quarters due to these protocol decisions. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Asked about the sharp increase in March and whether uptake was concentrated in any specific provider, Grund said the growth was broad-based across major dialysis organizations. He said USRC continued to add patients as it expanded observed dosing, and he also pointed to “restarts” at USRC—patients who had previously discontinued daily dosing “perhaps for compliance reasons” and were restarting on therapy under a three-times-weekly observed regimen. He added that IRC and DCI saw “very, very aggressive and accelerated adoption” once their protocols were in place, and that DaVita also posted “significant growth” but remained on a daily dosing protocol and was “lagging a bit behind the others.” Grund said Akebia believes DaVita will implement an observed dosing protocol in the second half of the year. Butler declined to characterize the cadence of Vafseo growth as linear or back-half weighted, saying the trajectory will be influenced by factors such as the pace of restarts and how quickly DaVita changes its approach. He also said the company expects newly published data to influence adoption, noting that after the publication of a paper in the Journal of the American Society of Nephrology, Akebia’s medical team can now discuss the findings more broadly with physicians. Butler emphasized ongoing efforts to build clinical evidence for Vafseo, including new publications and presentations from the Phase III INNO2VATE program. He said a post hoc hierarchical composite endpoint analysis was recently published in the Journal of the American Society of Nephrology, and that the analysis “demonstrated that patients treated with Vafseo in the INNO2VATE trial experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator.” He also highlighted an economic analysis presented earlier in the quarter at an annual dialysis conference comparing hospitalization costs for vadadustat versus darbepoetin. According to Butler, the analysis showed patients treated with vadadustat had 7.7% fewer hospitalization events annually, a 16% reduction in hospitalization days, and, based on Medicare cost data, a 14.8% lower annual hospitalization cost. Looking ahead, Butler said top-line results from the VOCAL study—being conducted at DaVita clinics to evaluate three-times-weekly dosing—are expected by year-end. He noted VOCAL includes a sub-study of red blood cell characteristics that the company believes could further differentiate Vafseo versus ESAs. He said top-line data from the VOICE trial, being run by U.S. Renal Care and evaluating Vafseo versus standard of care on a hierarchical composite endpoint of all-cause mortality and hospitalization rates, are expected in early 2027. Beyond Vafseo, Butler said Akebia’s research and development organization has been “highly productive” in advancing a kidney disease-focused pipeline, which management believes could be an important long-term value driver. He noted the company hosted an R&D day in April featuring external experts and reviewed data supporting praliciguat, a soluble guanylate cyclase stimulator, in focal segmental glomerulosclerosis (FSGS) models and prior clinical data in diabetic kidney disease. Enrollment in Akebia’s Phase II FSGS study is ongoing, targeting up to about 60 patients on maximally tolerated ACE inhibitor or ARB background therapy. Butler said the study’s primary endpoint is change from baseline in UPCR at 24 weeks. In the Q&A, Chief Medical Officer Dr. Stephen Burke addressed what the company views as a clinically relevant outcome for UPCR at 24 weeks, saying Akebia would like to see results “on par with what was seen with sparsentan,” or “something around a 20% improvement in the change in UPCR” over what is achievable with ACE inhibitors and ARBs. Burke added that a key metric will be the proportion of patients reaching UPCR below 0.7 grams per gram, which he called “the approvable endpoint now for FSGS,” and said it would drive the decision on whether to proceed to Phase III. Butler and Burke were also asked whether FILSPARI’s recent approval is relevant to enrollment. Butler said the approval is positive for patients and shows FDA support for new treatments in the population, while Burke said he does not anticipate the approval will have a significant impact on enrollment, describing it as likely to become a background therapy because many patients will not respond. Butler also discussed AKB-097 (abribafus, or “Ebri”), described as a tissue-targeted anti-C3d complement inhibitor. He said initial data suggest it “quickly leaves the bloodstream” to target tissue sites of complement activation such as the kidney, which the company believes could avoid increased reinfection risk seen with some current complement inhibitors and support lower dosing and a more convenient regimen. Akebia expects to initiate a Phase II open-label basket trial in the second half of the year in IgA nephropathy, lupus nephritis, and C3 glomerulopathy, with initial data expected to begin in 2027 due to the open-label design. Finally, Butler said the company initiated a Phase I study of AKB-9090, an internally developed HIF-PH inhibitor candidate with an initial focus on preventing acute kidney injury associated with cardiac surgery. The randomized, double-blind, placebo-controlled SAD/MAD study is designed to evaluate safety, tolerability, and pharmacodynamics in up to 70 healthy adult participants, with top-line data expected in early 2027. Chief Financial and Chief Business Officer Erik Ostrowski reported total revenue of $53.5 million in the first quarter of 2026, down from $57.3 million in the prior-year period. The decrease was driven by lower Auryxia revenue, partially offset by higher Vafseo revenue. Vafseo net product revenue: $15.8 million in Q1 2026 versus $12.0 million in Q1 2025 (a 32% increase). Auryxia net product revenue: $36.2 million in Q1 2026 versus $43.8 million in Q1 2025, which Ostrowski said was driven by lower Auryxia price. License, collaboration, and other revenue: $1.6 million in Q1 2026 versus $1.5 million in Q1 2025. Ostrowski said an additional generic form of Auryxia has entered the market on top of an authorized generic that has been available for the past year, and that the increased generic competition is consistent with Akebia’s expectations and prior guidance. He reiterated that the company expects Auryxia revenue to decline in 2026 compared with 2025. On expenses, cost of goods sold rose to $12.3 million from $7.6 million, primarily due to higher inventory write-downs related to excess, obsolescence, and scrap “primarily related to Auryxia.” R&D expense increased to $14.8 million from $9.8 million, driven by higher clinical trial activity for praliciguat and AKB-9090 and higher headcount costs. SG&A expense increased to $30.4 million from $25.7 million, also due to higher headcount-related costs. Akebia posted a net loss of $9.1 million in Q1 2026 compared with net income of $6.1 million in Q1 2025. Ostrowski attributed the swing to lower Auryxia revenues and higher expenses. Cash and cash equivalents were $162.6 million as of March 31, 2026, down from $184.8 million at the end of 2025, which Ostrowski said reflected the quarterly net loss and a decrease in working capital. He said the company expects its existing cash resources and cash from operations to be sufficient to fund its operating plan for “at least two years.” Akebia Therapeutics, Inc, a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, is focused on the development and commercialization of therapies for patients with kidney disease. The company's lead product candidate, vadadustat, is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis patients. Akebia's research and development efforts also extend to preclinical programs targeting nephrology and related metabolic disorders. Since its founding in 2007, Akebia has pursued strategic collaborations to advance its clinical pipeline and expand its market reach. The article "Akebia Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Q1 2026 Vafseo® (vadadustat) net product revenues grew to $15.8 million; Q1 2026 total net product revenues of $52.0 million Number of patients treated with Vafseo increased 60% in Q1 2026 compared to Q4 2025 Akebia hosted virtual R&D Day highlighting robust kidney disease pipeline, outlining clinical trial plans and timing of expected data catalysts Patient enrollment continues to progress in praliciguat Phase 2 clinical trial in focal segmental glomerulosclerosis (FSGS) Akebia to host conference call on May 7, 2026, at 8:00 a.m. EST CAMBRIDGE, Mass., May 07, 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 first quarter ended March 31, 2026 and shared recent business highlights related to the commercial launch of Vafseo® (vadadustat), now in its second year, as well as its advancing pipeline. “The number of patients on Vafseo increased through the start of the year, and we are further encouraged by trends suggesting continued growth as we leverage improved patient access and adherence as dialysis organizations implement observed dosing protocols,” said John P. Butler, Chief Executive Officer of Akebia. “Increasing the breadth and depth of Vafseo prescribing, complemented by our efforts to generate data that will potentially demonstrate its additional clinical benefits, is critical to achieving our goal to make Vafseo standard of care for patients on dialysis. Separately, I’m pleased with the progress made to advance our clinical pipeline of kidney disease programs, now with two clinical programs enrolling, including a Phase 2 clinical trial of praliciguat in FSGS. We remain on track with plans to initiate a Phase 2 open-label rare kidney disease basket study in the second half of 2026, evaluating AKB-097 in IgA nephropathy, lupus nephritis and C3 glomerulopathy. These efforts were recently highlighted as part of our virtual R&D Day, where key medical experts reinforced the potential of our expanding pipeline.” Vafseo Q1 2026 Commercial Results: Vafseo net product revenues grew to $15.8 million in Q1. Inventory weeks on hand was relatively flat versus Q4 2025. Total number of prescribers increased to approximately 1,025 in Q1, representing an increase of approximately 28% over the number of prescribers in Q4 2025. Total number of patients on Vafseo increased approximately 60% at the end of Q1 compared to the end of Q4 2025. The number of new patient starts in Q1 was the highest in any quarter since the initial quarter of launch. The majority of new patients began in March. Approximately 20% of patients and 30% of prescribers in Q1 2026 were from dialysis organizations other than U.S. Renal Care, representing improved diversification in the patient and prescriber base in Q1. First refill adherence rates through the end of March were approximately 86% for patients treated under an observed dosing protocol where we have historically received patient level data. In Q1, approximately two thirds of all patients were treated under an observed dosing protocol. Akebia continues to build a body of evidence to potentially demonstrate additional clinical benefits of Vafseo. In February, Akebia presented an economic analysis on cost of hospitalizations for patients treated with vadadustat vs darbepoetin alfa at the Annual Dialysis Conference. As reported in a poster titled, “Cost comparison analysis of hospitalizations for vadadustat versus darbepoetin alfa based on the INNO2VATE trials,” of the patients treated with vadadustat versus darbepoetin alfa, 7.7% had fewer hospitalization events annually; 16.0% had fewer hospitalization days; and, based on Medicare cost data, 14.8% had lower annual hospitalization costs per patient. The Journal of the American Society of Nephrology, a leading, peer-reviewed journal in nephrology, published post-hoc win statistics analysis of all-cause mortality and hospitalization from Akebia’s global Phase 3 INNO2VATE program. As reported in the Research Letter titled, “Comparing Vadadustat and Darbepoetin in Maintenance Dialysis with CKD-Related Anemia,” vadadustat demonstrated statistically significant better outcomes relative to the erythropoiesis-stimulating agent (ESA), darbepoetin alfa, on a hierarchical composite endpoint of all-cause mortality and hospitalization in patients with anemia due to chronic kidney disease receiving dialysis. Akebia expects topline data from VOCAL, a Phase 3b trial evaluating three times weekly (TIW) dosing of Vafseo versus ESAs, in Q4 2026 and topline data from VOICE, a large Phase IV trial of over 2,100 patients evaluating Vafseo TIW against standard-of-care ESAs using a hierarchical composite endpoint of all-cause mortality and all-cause hospitalization, in early 2027. Progress on Kidney Disease Pipeline: In January, Akebia announced the dosing of the first patient in a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evaluated for the treatment of biopsy-confirmed FSGS, a rare kidney disease. Akebia expects to enroll up to approximately 60 patients in this trial. In April 2026, Akebia held a virtual R&D Day highlighting its robust kidney disease pipeline. The event featured scientific experts, James A. Tumlin, MD (NephroNet), V. Michael Holers, MD (University of Colorado, Anschutz), and Jonathan Barratt, MD. PhD, FRCP (University of Leicester). A replay of the event is available here. Among highlights, Akebia confirmed plans to initiate a Phase 2 open-label basket study to evaluate AKB-097 in IgA nephropathy, lupus nephritis and C3 glomerulopathy. Akebia expects to initiate the study in the second half of 2026 with initial data expected in 2027. In April 2026, Akebia initiated a Phase 1 study of AKB-9090 in up to 70 healthy volunteers with topline data expected in early 2027. The initial target indication for AKB-9090 is the prevention of cardiac surgery-associated acute kidney injury. Financial Results Revenues: Total revenues were $53.5 million in the first quarter of 2026 compared to $57.3 million in the first quarter of 2025. This decrease was driven by lower Auryxia® (ferric citrate) revenues which were partially offset by higher Vafseo revenues. Vafseo net product revenues were $15.8 million in the first quarter of 2026 compared to $12.0 million in the first quarter of 2025. Auryxia net product revenues were $36.2 million in the first quarter of 2026 as compared to $43.8 million in the first quarter of 2025. We continue to expect generic competition for Auryxia to expand this year and therefore expect Auryxia revenues to decrease in 2026 as compared to 2025 Auryxia revenues. License, collaboration and other revenues were $1.6 million in the first quarter of 2026 compared to $1.5 million in the first quarter of 2025. Cost of Goods Sold: Cost of goods sold was $12.3 million in the first quarter of 2026 compared to $7.6 million in the first quarter of 2025. This increase was primarily due to an increase in inventory write-downs including as a result of excess, obsolescence and scrap during the first quarter of 2026. Of note, Vafseo-related COGS in both periods was derived from pre-launch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as research and development expenses in the period incurred prior to Vafseo’s approval in the U.S. Research & Development Expenses: Research and development expenses were $14.8 million in the first quarter of 2026 compared to $9.8 million in the first quarter of 2025. The increase in expenses was driven by increased clinical trial activities related to praliciguat and AKB-9090 as well as higher headcount-related costs. SG&A Expenses: Selling, general and administrative expenses were $30.4 million in the first quarter of 2026 compared to $25.7 million in the first quarter of 2025. This increase was driven by higher headcount-related costs. Net Income (Loss): Net loss was $9.1 million in the first quarter of 2026 compared to net income of $6.1 million in the first quarter of 2025. The change to a net loss in the first quarter of 2026 resulted from lower revenues and higher expenses during the quarter as compared to the first quarter of 2025. Cash Position: Cash and cash equivalents as of March 31, 2026 were approximately $162.6 million as compared to $184.8 million as of December 31, 2025. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years. Conference Call Akebia will host a conference call on Thursday, May 7 at 8:00 a.m. EDT to discuss first quarter 2026 earnings. To access the call, please register by clicking on this Registration 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 at https://ir.akebia.com approximately two hours after the event. About Akebia Therapeutics 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. About Vafseo® (vadadustat) tablets 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. INDICATION 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 VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. In patients with anemia due to CKD not on dialysis. IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). 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. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. CONTRAINDICATIONS Known hypersensitivity to VAFSEO or any of its components Uncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. Hepatotoxicity Hepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. Hypertension Worsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. Seizures Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new- onset seizures, premonitory symptoms, or change in seizure frequency. Gastrointestinal (GI) Erosion Gastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. Malignancy VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. DRUG INTERACTIONS Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron. Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders. BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction. Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. A pregnancy exposure registry is available to monitor outcomes in women exposed to VAFSEO during pregnancy. Report pregnancies to 1-844-445-3799. Lactation: Breastfeeding not recommended until two days after the final dose. Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease. Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. 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 beliefs regarding the continued growth of the number of patients on Vafseo and ability to leverage improved patient access and adherence; Akebia’s plans with respect to its U.S. commercial launch of Vafseo®, including the potential U.S. market opportunity and plans to increase the breadth and depth of Vafseo prescribing; Akebia’s plans for Vafseo to become standard of care for treatment of anemia due to CKD in dialysis, including its ability to continue to build on the body of evidence demonstrating Vafseo’s value potential, and progress towards that goal; Akebia’s expectations and beliefs about demand for Vafseo, including the number of patients with access to Vafseo and the focus of dialysis organizations; Akebia’s plans and expectations with respect to the VOCAL and VOICE trials, including the timing of top-line data; Akebia’s expectations with respect to the potential of its expanding pipeline; Akebia’s plans and expectations with respect to praliciguat and the Phase 2 trial, including the number of patients to be enrolled in the trial; Akebia’s plans and expectations with respect to AKB-097, including the timing of initiation of, and initial data from, an open label Phase 2 basket study and the indications to be evaluated; Akebia’s plans and expectations with respect to AKB-9090, including the timing of initiation of, and top-line data from, a Phase 1 trial and the indication to be evaluated; the sufficiency of, and the period in which Akebia expects to have, cash to fund its current operating plan. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," “could”, 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; the results of preclinical and clinical research; Akebia’s ability to initiate and enroll patients in its clinical trials; 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 Akebia’s commercial products , including estimates regarding the potential market opportunity; the competitive landscape for Akebia’s commercial products, 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 Report on Form 10-K for the year ended December 31, 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 presentation, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this presentation. Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates. Akebia Therapeutics Contact Mercedes Carrasco [email protected]