CAMBRIDGE, Mass., March 19, 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 announced that it will host a virtual R&D Day on Thursday, April 2, 2026 at 10:00 AM EDT. To register for the Akebia virtual R&D Day, click here. The event will feature scientific experts James A. Tumlin, MD (NephroNet), V. Michael Holers, MD (University of Colorado Anschutz) and Jonathan Barratt, MD, PhD, ...

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Core Insights - The company is focusing on three key strategic areas for capital allocation, with an emphasis on its commercial product, Vafseo, to establish it as the standard of care [1] - There are ongoing Phase IV/IIIb trials aimed at generating data necessary for Vafseo to become the standard of care [1] - The company is committed to advancing its initiatives in kidney disease [2]

Akebia Therapeutics Conference Call Summary Company Overview - **Company**: Akebia Therapeutics (NasdaqCM:AKBA) - **Focus**: Development of therapies for kidney disease, particularly anemia in chronic kidney disease patients Key Strategic Areas 1. **Commercial Product - Vafseo**: - Aim to establish Vafseo as the standard of care for anemia in chronic kidney disease patients on dialysis [3][7] - Ongoing phase four and three B trials to generate necessary data for standardization [3] 2. **Commitment to Kidney Disease**: - Focus on expanding the pipeline related to kidney disease, including drugs like praliciguat and AKB-907 [3][4] 3. **Future Beyond Kidney Disease**: - Small investments in other areas such as aducanumab and retinopathy of prematurity [4] Vafseo Product Insights - **Mechanism**: Vafseo is a HIF-PH inhibitor that offers a new approach to managing anemia, with fewer dose titrations and easier administration for physicians [7][8] - **Clinical Data**: - Phase 3 study showed a statistically significant reduction in mortality and hospitalization rates [8] - An 8% decrease in hospitalization and a 15% cost reduction per patient per year, translating to approximately $3.7 billion savings if all eligible patients switched from ESAs to Vafseo [9][10] - **Market Potential**: - Post-TDAPA market opportunity estimated at $1 billion, with potential for Vafseo to be a $500 million product [26][30] Dosing Strategy - **TIW Dosing**: - Transitioning to TIW (three times a week) dosing to improve patient adherence and ease of use for nephrologists [12][14] - Ongoing studies (VOICE and VOCAL) to validate TIW dosing effectiveness [15][37] Pipeline Developments 1. **Praliciguat**: - Targeting focal segmental glomerulosclerosis (FSGS) with a unique mechanism of action [49][50] - Phase 2 trials initiated, with a focus on demonstrating efficacy in a high unmet need area [50] 2. **AKB-097**: - A complement inhibitor with a tissue-targeted effect, expected to have a better safety profile and dosing regimen compared to existing treatments [51][52] - Basket study planned for multiple indications, including IgAN and lupus nephritis, with data expected in 2027 [53][54] Financial Metrics and Market Perception - **Investor Metrics**: - Focus on increasing the number of prescribers and adherence rates for Vafseo [60] - Balanced capital allocation to support both Vafseo and the pipeline [61] - **Market Understanding**: - Complexity of dialysis reimbursement may lead to underappreciation of Akebia's market potential [62] - Emphasis on the importance of consistent revenue growth and pipeline visibility to attract investor confidence [63][64] Conclusion - Akebia Therapeutics is positioned to leverage its innovative product Vafseo and a robust pipeline to address significant unmet needs in kidney disease, with a clear strategy for market penetration and growth potential in a billion-dollar market.

Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease [3] - The company was founded in 2007 and is headquartered in Cambridge, Massachusetts [3] Upcoming Event - John P. Butler, CEO, and Erik Ostrowski, Chief Financial and Chief Business Officer, will participate in a Fireside Chat at the Leerink Partners 2026 Global Healthcare Conference on March 9, 2026, at 8:00 AM ET [1] - The conference will take place from March 8-11, 2026, in Miami [2] Access to Information - A webcast of the presentation will be available in the "Investors" section of Akebia's website following the conference [2]

Financial Data and Key Metrics Changes - Total revenues increased to $57.6 million in Q4 2025 from $46.5 million in Q4 2024, and for the full year, revenues rose to $236.2 million from $160.2 million in 2024, driven by Vafseo and Auryxia sales [22][25] - Vafseo net product revenues were $6.2 million in Q4 2025 and $45.8 million for the full year, while Auryxia revenues were $48.1 million in Q4 2025 and $181.5 million for the full year [22][25] - Net loss decreased to $12.2 million in Q4 2025 from $22.8 million in Q4 2024, and for the year, net loss was $5.3 million compared to $69.4 million in 2024 [25] Business Line Data and Key Metrics Changes - Vafseo faced challenges in demand growth during the second half of 2025, with a slight decrease in Q4 demand compared to Q3, attributed to a transition to an observed dosing protocol [5][16] - Auryxia sales increased, but the company anticipates a decrease in Auryxia revenues in 2026 due to expected generic competition [23] Market Data and Key Metrics Changes - Over 1,000 prescribers at 24 dialysis organizations have written prescriptions for Vafseo, with 290,000 patients having access to it in dialysis clinics [6][17] - The company noted a significant increase in prescriber access and improved adherence rates among patients on observed dosing regimens [18][19] Company Strategy and Development Direction - The strategy includes making Vafseo the standard of care in a $1 billion U.S. market, supported by ongoing clinical data generation [6][10] - The company is expanding its pipeline with rare kidney disease treatments, including praliciguat and AKB-097, which are expected to be significant value drivers [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of Vafseo, despite previous challenges, and emphasized the importance of clinical data in influencing physician adoption [33][40] - The company plans to host an R&D day to discuss mid-stage assets and the potential of its pipeline [70][71] Other Important Information - Cash and cash equivalents as of December 31, 2025, were $184.8 million, compared to $51.9 million at the end of 2024, indicating a solid financial position [26] Q&A Session Summary Question: Expectations for sequential Vafseo growth in 2026 - Management did not provide specific revenue guidance but indicated that demand has been flat and they expect growth from current levels [29][33] Question: Importance of VOICE study data for uptake - Management highlighted that published data will significantly influence physician utilization and adoption of Vafseo [32][33] Question: Current operationalization of Vafseo access at DaVita - DaVita has made Vafseo widely available and is focusing on educating physicians, particularly in the home dialysis population [34][38] Question: Trends in second and third refill rates - First refill adherence improved significantly, and management noted ongoing positive trends in adherence rates [45] Question: Differentiation of AKB-9090 from prior HIFs - AKB-9090 has a different pharmacokinetic profile, allowing for broader tissue penetration compared to vadadustat [51] Question: Expectations for R&D day on April 2 - The company plans to provide detailed insights into its pipeline, focusing on praliciguat and AKB-097, and will include external experts to discuss the potential of these products [70][71]

Financial Data and Key Metrics Changes - Total revenues increased to $57.6 million in Q4 2025 from $46.5 million in Q4 2024, and for the full year, revenues rose to $236.2 million from $160.2 million in 2024, driven by Vafseo and Auryxia sales [22] - Vafseo net product revenues were $6.2 million in Q4 2025 and $45.8 million for the full year, while Auryxia revenues were $48.1 million in Q4 2025 compared to $44.4 million in Q4 2024 [22] - Net loss decreased to $12.2 million in Q4 2025 from $22.8 million in Q4 2024, and for the year, net loss was $5.3 million compared to $69.4 million in 2024 [25] Business Line Data and Key Metrics Changes - Vafseo faced challenges in demand growth during the second half of 2025, with a slight decrease in Q4 demand leading to $6.2 million in net product revenue [5][16] - Auryxia sales increased, contributing to overall revenue growth, but the company anticipates a decrease in Auryxia revenues in 2026 due to expected generic competition [23] Market Data and Key Metrics Changes - Vafseo has gained access to 290,000 patients in dialysis clinics, with over 1,000 prescribers at 24 different dialysis organizations writing prescriptions [6][17] - The company noted a shift in prescriber dynamics and improved adherence rates, with first refill adherence rising from approximately 75% to 91% among patients on an observed dosing regimen [18] Company Strategy and Development Direction - The company aims to establish Vafseo as the standard of care in a $1 billion U.S. market opportunity, focusing on generating data to support its benefits over existing treatments [6][10] - Akebia is expanding its pipeline with new rare kidney disease products, including praliciguat and AKB-097, which are expected to drive future growth [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential for Vafseo in 2026, despite previous challenges, and emphasized the importance of ongoing data generation to support product adoption [5][33] - The company is confident in its ability to fund operations for at least the next two years, with cash and cash equivalents at $184.8 million as of December 31, 2025 [26] Other Important Information - The company plans to host an R&D day on April 2, 2026, to discuss mid-stage assets and provide insights into its pipeline [11][70] - The VOCAL study is expected to provide important data regarding Vafseo's efficacy compared to existing treatments, which could influence its adoption [61] Q&A Session Summary Question: Expectations for sequential Vafseo growth in 2026 - Management noted that while they are not guiding for revenue, they expect growth from current demand levels, which have been flat recently [29][33] Question: Operationalization of Vafseo access at DaVita - DaVita has made Vafseo widely available and is focusing on educating physicians, particularly in the home dialysis population [34][38] Question: Trends in second and third refill rates - First refill adherence has improved significantly, and there are positive trends in adherence rates for subsequent prescriptions [45] Question: Differentiation of AKB-9090 from prior HIFs - AKB-9090 has different pharmacokinetics and broader tissue penetration compared to vadadustat, which may enhance its efficacy in certain indications [51] Question: Expectations for the R&D day on April 2 - The company plans to provide detailed insights into its pipeline, focusing on praliciguat and AKB-097, and will include external experts to discuss the products [68][70]

Manufacturing and Supply Agreements - Vafseo relies on STA Pharmaceutical and Patheon for the manufacture of drug substance and drug product for commercial use[93]. - Auryxia's drug substance is supplied by Siegfried Evionnaz SA, with pricing structured on a per-kilogram basis, while the drug product is supplied by Patheon on a tiered pricing basis[98]. - The company has established CMO relationships for Auryxia to ensure sufficient material for ongoing commercial sales and clinical trials[98]. - The company controls all clinical and commercial manufacturing of praliciguat, with royalties on net sales subject to reduction upon patent expiration or generic product launch[130]. Licensing and Royalties - The company received an upfront payment of $10.0 million under the Medice License Agreement for Vafseo, with potential commercial milestone payments up to $100.0 million[100][103]. - The Medice License Agreement includes tiered royalties ranging from 10% to 30% of annual net sales of Vafseo in the Medice Territory[103]. - The TPC Agreement allows for potential payments of up to $225.0 million based on development and sales milestones, with tiered royalties of 13% to 20% on annual net sales in the TPC Territory[109]. - The Vifor License Agreement included an upfront payment of $25.0 million and a profit-sharing arrangement where the company receives approximately 66% of the profits[112]. - The company will pay CSL Vifor tiered royalty payments ranging from a high single-digit percentage of net sales of Vafseo up to $450.0 million[114]. - The Averoa License Agreement allows for tiered royalties from mid-single digit to low double-digit percentages of annual net sales, with minimum royalty amounts in certain years[118]. - Under the Q32 Purchase Agreement, the company made an upfront payment of $7.0 million and will make additional payments totaling up to $94.5 million based on development milestones for AKB-097[133]. - The royalty payments for AKB-097 will range from low single digits to mid-teen percentages, expiring on a country-by-country basis after the last patent claim or ten years from the first commercial sale[133]. - The company recorded $5.7 million in license revenue from royalties on net sales of Riona in Japan during the year ended December 31, 2025[122]. - The company recorded $11.3 million in royalties due to Panion related to sales of Auryxia in the U.S. and Riona in Japan during the year ended December 31, 2025[126]. - The Cyclerion Agreement includes a $3.0 million upfront payment and potential milestone payments up to $197.5 million based on product development[129]. Patent and Intellectual Property - The company holds 19 issued patents for vadadustat, with expected expiration dates ranging from 2027 to 2039, plus any extensions or adjustments[139]. - Auryxia's patent portfolio includes 3 issued patents with expected expiration dates between 2026 and 2030[142]. - The company has filed patent term extension applications for several patents covering Vafseo due to delays caused by FDA regulatory review[157]. - The company expects to apply for patent term extensions on issued patents for future product candidates upon receiving regulatory approval[161]. - The expected expiration dates for patents related to ferric citrate in Japan are between 2026 and 2028, with no contested proceedings reported to date[143]. - The company has entered into settlement agreements with six ANDA filers, allowing them to market a generic version of Auryxia starting March 20, 2025, subject to FDA approval[145]. Competition and Market Landscape - The pharmaceutical and biotechnology industries are highly competitive, with increasing demand for better anemia management solutions driving competition[162]. - The company faces competition from both large pharmaceutical companies and smaller biotechnology firms, as well as academic and research institutions[163]. - Vafseo competes with several established drugs including Epogen® and Aranesp®, both marketed by Amgen, and Procrit® by Johnson & Johnson[165]. - In Europe, roxadustat is approved for treating anemia in CKD patients, posing competition to Vafseo[166]. - Auryxia competes in the hyperphosphatemia market against FDA-approved phosphate binders like Renagel® and Renvela®[171]. - Auryxia also faces competition in the iron deficiency anemia market from various oral and intravenous iron formulations[172]. - The company is developing AKB-097 for potential treatment of IgAN, LN, and C3G, amidst competition from other complement inhibitors[179]. - In November 2025, the FDA approved VOYXACT® for reducing proteinuria in adults with primary IgAN, indicating increasing competition in this space[180]. Regulatory Environment - The company is subject to extensive regulations regarding drug development and approval processes, requiring significant time and financial resources[184]. - The FDA requires a 30-day waiting period after the submission of each IND before clinical trials may begin[190]. - Sponsors must prepare and submit an NDA requesting marketing for one or more proposed indications to the FDA[191]. - Clinical trials are conducted in four phases, with Phase 3 trials being pivotal for regulatory approval[204]. - The FDA has issued eight notices of non-compliance as of December 31, 2025, signaling enforcement of clinical trial information submission[198]. - Sponsors are required to develop and submit a diversity action plan for each Phase 3 clinical trial as mandated by the Food and Drug Omnibus Reform Act[205]. - The FDA's final guidance on GCPs aims to modernize clinical trial design and conduct, facilitating the development of medical products[209]. - Progress reports detailing clinical trial results must be submitted annually within 60 days of the IND anniversary[211]. - The Right to Try Act allows certain patients to access investigational drugs that have completed Phase I trials without enrolling in clinical trials[202]. - Expanded access regulations improve access to investigational drugs for patients with serious or life-threatening conditions[199]. - The FDA may impose a clinical hold on trials if there are concerns about patient safety or protocol compliance[193]. - The FDA's application fee for NDA submission in fiscal year 2026 is approximately $4.7 million, with an annual program fee of $442,213 per eligible prescription product[218]. - The FDA aims to complete a preliminary review of all applications within 60 days of receipt, informing sponsors whether the application is sufficiently complete for substantive review[219]. - Most NDA applications are intended to be reviewed within ten months, while priority review products are targeted for six months[220]. - The FDA may extend the review process by three additional months to consider new information provided by the sponsor[221]. - Before approving an NDA, the FDA typically inspects manufacturing facilities to ensure compliance with cGMP requirements[222]. - The FDA may require sponsors to develop a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval to minimize risks associated with the product[225]. - The FDA can designate products for expedited review if they address unmet medical needs for serious or life-threatening conditions[227]. - The FDA may withdraw fast track designation if it believes the designation is no longer supported by emerging clinical trial data[228]. - Accelerated approval may be granted based on surrogate endpoints that predict clinical benefit, with post-marketing trials required as a condition of approval[233]. - New legislation allows the FDA to require confirmatory clinical trials to be underway before granting accelerated approval and mandates progress reports every six months[234]. - The FDA may approve a new drug based on one adequate and well-controlled clinical investigation if confirmatory evidence is provided, as indicated in recent guidance[237]. - A Complete Response Letter (CRL) outlines deficiencies in a submission and may require substantial additional testing or information for reconsideration[239]. - An approval letter authorizes commercial marketing of a product with specific prescribing information, which may include post-approval trials to assess safety[240]. - The FDA's action packages summarizing decisions to approve new drugs must be published within 30 days of approval[241]. - Post-approval requirements may include additional studies and monitoring programs to ensure ongoing safety and effectiveness of the drug[242]. Data Privacy and Compliance - Compliance with evolving federal and state data privacy laws, such as the California Consumer Privacy Act (CCPA), may increase regulatory risks for the company[268]. - At least eighteen states have enacted comprehensive privacy laws similar to the CCPA, which may impact the company's business activities and data handling practices[270]. International Regulatory Considerations - The approval process for marketing products outside the U.S. varies by country and may involve additional testing and administrative review periods[273]. - The EU applies harmonized regulatory rules for medicinal products, but pricing and reimbursement processes differ significantly across member states[274]. - The Clinical Trials Regulation (CTR) No 536/2014 became effective on January 31, 2022, simplifying the approval process for clinical trials in the EU[277]. - The centralized procedure for marketing authorization allows for a single authorization valid across all EU member states, with a maximum evaluation timeframe of 210 days[284]. - For products of major public health interest, accelerated evaluation may be granted, reducing the assessment period to 150 days[284]. - Marketing authorizations are valid for five years and can be renewed based on a reevaluation of the risk-benefit balance[288]. - The Pediatric Investigation Plan (PIP) is mandatory for marketing authorization, covering all pediatric population subsets unless waivers are granted[282]. - The PRIME scheme facilitates the development of innovative products for unmet medical needs, providing early regulatory dialogue and accelerated assessment[281]. - A marketing authorization may only be granted to sponsors established in the EU, with orphan-designated products receiving a 12-year market exclusivity[287]. - The decentralized procedure allows for marketing approval in multiple EU member states based on a single assessment by a reference member state[285]. - MA holders must comply with EU pharmacovigilance legislation, including establishing a pharmacovigilance system and reporting serious adverse reactions[289]. - New marketing authorization applications must include a risk management plan detailing measures to minimize associated risks[290].

Core Insights - Akebia Therapeutics reported Q4 2025 net product revenues of $54.3 million and full-year 2025 revenues of $227.3 million, marking a 49% increase from 2024 [1][7] - The company anticipates significant revenue growth for Vafseo® (vadadustat) in 2026 due to expanded access, new patient starts, and improved adherence rates [1][2] - Akebia is advancing its pipeline with ongoing clinical trials for praliciguat and AKB-097, targeting rare kidney diseases [1][8] Financial Performance - Total revenues for Q4 2025 were $57.6 million, up from $46.5 million in Q4 2024, and $236.2 million for the full year 2025 compared to $160.2 million in 2024 [7][33] - Vafseo net product revenues were $6.2 million in Q4 2025 and $45.8 million for the full year 2025 [7][33] - Auryxia® revenues were $48.1 million in Q4 2025, an increase from $44.4 million in Q4 2024, and $181.5 million for the full year 2025 compared to $152.2 million in 2024 [7][33] Cost and Expenses - Cost of goods sold (COGS) was $12.5 million in Q4 2025, down from $20.4 million in Q4 2024, and $39.5 million for the full year 2025 compared to $63.2 million in 2024 [7][33] - Research and development expenses rose to $26.6 million in Q4 2025 from $11.8 million in Q4 2024, totaling $62.4 million for the full year 2025 compared to $37.7 million in 2024 [7][33] - Selling, general and administrative expenses were $26.1 million in Q4 2025, slightly down from $27.7 million in Q4 2024, and $107.5 million for the full year 2025 compared to $106.5 million in 2024 [7][33] Clinical Development and Pipeline - The number of prescribers for Vafseo increased to approximately 800 in Q4 2025, a 10% rise from Q3 2025 [6] - Patient access to Vafseo therapy reached 290,000, with improved adherence rates noted due to new dosing protocols [2][6] - Akebia is actively enrolling patients in the Phase 2 trial of praliciguat for focal segmental glomerulosclerosis (FSGS) and plans to initiate a Phase 2 study for AKB-097 in late 2026 [1][8] Cash Position - As of December 31, 2025, cash and cash equivalents were approximately $184.8 million, up from $51.9 million at the end of 2024 [7][34] - The company expects its cash resources and operational cash flow to sustain its current operating plan for at least two years [7][34]

Core Viewpoint - Akebia Therapeutics Inc. is identified as a promising growth stock for the next 20 years, despite recent adjustments in price targets by analysts [1]. Financial Performance - In Q3, Akebia reported total revenue of $58.8 million and a net income of $540,000, marking a significant turnaround from a net loss of $20 million in Q3 2024 [2]. - The revenue from the dialysis drug Vafseo was lower than expected at $14.3 million due to operational challenges, but the company expanded patient access to 70,000 and achieved over 700 active prescribers [2]. Future Outlook - Management anticipates a temporary revenue dip in Q4 due to inventory adjustments at US Renal Care, but projects growth to resume in Q1 2026 [3]. - The company is focused on its 2026 pipeline, including the initiation of a Phase 2 study for rare kidney diseases, and asserts that current cash reserves are adequate to support its path to sustained profitability [3].