Q4 2025 net product revenues of $54.3 million; 2025 full-year net product revenues of $227.3 million, representing a 49% increase over 2024 full-year net product revenues Expect significant Vafseo® (vadadustat) revenue growth in 2026 through expanded access to therapy at dialysis organizations, new patient starts, and improved adherence rates Pipeline advancement continues with enrollment underway for praliciguat Phase 2 clinical trial in focal segmental glomerulosclerosis (FSGS) and AKB-097 Phase 2 rare ...

Core Insights - Akebia Therapeutics is positioned to enhance the prescribing of Vafseo, targeting approximately 275,000 patients by 2026, with ongoing clinical trials and pipeline developments in rare kidney diseases [1][2] Vafseo Commercial Business - The company anticipates increased demand for Vafseo as existing customers accelerate adoption and new customers implement Vafseo protocols [2] - Vafseo is being positioned as the standard of care for treating anemia due to chronic kidney disease (CKD) in dialysis patients, supported by ongoing clinical data [2] - The company expects Q4 2025 net product revenue for Vafseo to be between $5 million and $6 million, with a projected revenue growth resuming in Q1 2026 [5] Clinical Trials and Pipeline Developments - The first patient has been dosed in the Phase 2 clinical trial for Praliciguat, targeting focal segmental glomerulosclerosis (FSGS) [1] - The AKB-097 Phase 2 rare kidney disease basket trial is set to begin in the second half of 2026, with initial data expected in 2027 [1][12] - Enrollment in the VOICE trial, a Phase IV study with over 2,100 patients, has been completed, with topline results expected in early 2027 [5] Performance Metrics - The total number of prescribers for Vafseo increased by 8% in Q4 2025, reaching approximately 785 [5] - At least 25% of new patients in Q4 2025 came from dialysis organizations other than U.S. Renal Care, up from less than 10% in Q3 [5] - The underlying patient dosing demand for Vafseo in Q4 2025 was estimated between $10.5 million and $11.5 million [5] Rare Kidney Disease Pipeline - AKB-9090, a HIF-PH inhibitor, is entering Phase 1 for acute kidney injury associated with cardiac surgery in the first half of 2026 [7] - The company plans to evaluate IgA Nephropathy, Lupus Nephritis, and C3 Glomerulopathy as part of the AKB-097 study [12]

Core Insights - Akebia Therapeutics Inc. has officially established a rare kidney disease pipeline, focusing on two main product candidates: AKB-097 and praliciguat [1][3] - The company aims to position Vafseo as the standard treatment for anemia in dialysis patients while simultaneously developing a robust pipeline for rare kidney conditions [1] Product Details - Vafseo is an oral treatment for anemia due to chronic kidney disease in adults on dialysis for at least three months, approved in 37 countries, and stimulates endogenous erythropoietin production [2] - AKB-097, previously known as ADX-097, is a humanized anti-C3d monoclonal antibody fusion protein designed to target complement activation at the organ level, potentially reducing infection risks and dosing frequency [3] Financial Transactions - Akebia entered into an Asset Purchase Agreement with Q32 Bio Inc. to acquire global rights to AKB-097, paying an upfront fee of $7 million, with an additional $3 million due six months post-closing [3]

Market Trends - Capital is shifting from high-multiple mega-cap stocks to small caps, cyclical sectors, and international markets, driven by easy monetary policy and anticipated fiscal policy impacts on the US economy [1] - The S&P SmallCap 600 is highlighted as a preferred investment vehicle for small caps due to its concentration in industrials and financials [1] - Small caps are considered undervalued and historically outperform during rate-cutting cycles [1] Small Cap Performance - The Russell 2000 index reached new all-time highs in September, while the S&P 600 struggled initially, indicating a prior reliance on lower-quality stocks [2] - Recently, the S&P 600 has joined the upward trend of the Russell 2000, nearing its own all-time highs [2] - Small caps are currently at levels similar to those four years ago, suggesting potential for significant upside if the breakout holds [2] Company Insights: Ambev (NYSE:ABEV) - Ambev has a forward P/E ratio of 13.30 and a share price of $2.30, with 20 hedge fund holders [8] - The company reported a normalized net income of BRL 3.8 billion, a 7% increase, and a stated net income of BRL 4.9 billion, a 36% surge year-over-year [11] - Ambev's premiumization strategy led to over 9% growth in volumes for premium brands, capturing nearly 50% market share in Brazil [10] Company Insights: Akebia Therapeutics Inc. (NASDAQ:AKBA) - Akebia has a forward P/E ratio of 8.73 and a share price of $1.66, with 21 hedge fund holders [13] - The company is expanding its pipeline for rare kidney diseases, focusing on two product candidates: AKB-097 and praliciguat [13] - Akebia's Vafseo is an oral treatment for anemia in dialysis patients, approved in 37 countries, with a Boxed Warning for increased risks of serious health issues [14]

Core Insights - Akebia Therapeutics reported a significant increase in net product revenues for Vafseo, reaching $14.3 million in Q3 2025, contributing to total net product revenues of $56.8 million for the quarter [1][12] - The company aims to make Vafseo the standard of care for treating anemia in dialysis patients, with expectations to quadruple prescribing access by year-end [2][4] - A recent post-hoc analysis presented at ASN Kidney Week indicated that patients receiving vadadustat had statistically more favorable outcomes in terms of all-cause mortality and hospitalization compared to those receiving erythropoiesis-stimulating agents (ESAs) [1][6] Financial Results - Total revenues increased to $58.8 million in Q3 2025 from $37.4 million in Q3 2024, driven by Vafseo and Auryxia sales [12] - Auryxia net product revenues were $42.5 million in Q3 2025, up from $35.6 million in Q3 2024, despite the loss of exclusivity in March 2025 [12] - The company reported a net income of $0.5 million in Q3 2025, a significant improvement from a net loss of $20.0 million in Q3 2024 [12][32] Operational Highlights - An operational pilot of Vafseo at DaVita is expected to complete in Q4 2025, with access anticipated for 275,000 patients by year-end [1][6] - The number of prescribers for Vafseo reached approximately 725 in Q3 2025, with an average of 12.7 prescriptions written per prescriber [6] - The average dose of refills for Vafseo increased by 5% over Q2 2025, indicating growing acceptance among healthcare providers [6] Regulatory Update - Akebia did not achieve alignment with the FDA on its proposed path for a Phase 3 clinical trial in non-dialysis patients and does not plan to initiate the VALOR clinical trial [4][29]

Core Insights - Akebia Therapeutics Inc. is experiencing a decline in stock price following an unsuccessful meeting with the U.S. FDA regarding the VALOR trial design for vadadustat, aimed at treating anemia in late-stage chronic kidney disease patients not on dialysis [1][4]. Company Developments - The company has decided not to initiate the VALOR trial and will not pursue a broad label for Vafseo for non-dialysis dependent chronic kidney disease patients [2]. - Vafseo is currently approved in the U.S. for treating anemia due to chronic kidney disease in adults who have been on dialysis for at least three months, with prescriptions starting in January 2025 [2]. Regulatory Feedback - Akebia completed a Type C meeting with the FDA, which indicated that regulatory alignment for the VALOR trial would necessitate a significantly larger patient population than initially proposed, leading to increased time and costs [3]. - The CEO of Akebia expressed disappointment with the meeting's outcome but stated that the decision not to pursue a broad label is in the best interests of shareholders [4]. Market Reaction - Following the news, Akebia Therapeutics shares fell by 25.71%, trading at $2.29 at the time of publication [4].

Core Viewpoint - Akebia Therapeutics does not plan to initiate the VALOR clinical trial for vadadustat to treat anemia in patients with late-stage chronic kidney disease (CKD) not on dialysis, following feedback from the U.S. FDA indicating a need for a larger patient population and increased time and costs for the trial [1][2][3] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [4] Product Information - Vafseo® (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved for treating anemia due to CKD in adults who have been on dialysis for at least three months, with approval in 37 countries [5] Regulatory Feedback - The FDA's feedback from the Type C meeting suggests that regulatory alignment for the VALOR trial would necessitate a significantly larger patient cohort than initially proposed, leading to increased time and costs [2][3] Future Directions - Despite the setback with the VALOR trial, the company remains committed to addressing the unmet need for oral anemia treatment in CKD patients not on dialysis and is exploring potential clinical trial designs for smaller subgroups of CKD patients [3]

Core Insights - Akebia Therapeutics has initiated a post-marketing study, the VOCAL trial, to evaluate the efficacy and safety of Vafseo (vadadustat) in patients with anemia due to chronic kidney disease (CKD) undergoing hemodialysis [1][2] - The trial aims to compare the three times per week dosing of Vafseo against standard erythropoiesis-stimulating agents (ESA) [1][2] - Vafseo was approved by the FDA in March 2024 and became available in the U.S. in January 2025 for treating anemia in adults on dialysis for at least three months [4] Study Design and Objectives - The VOCAL trial will enroll approximately 350 patients across 18 DaVita hemodialysis clinics, utilizing a 1:1 randomization method [2] - The study duration will be up to 33 weeks, including screening, treatment, and safety follow-up [2] - Primary endpoint is the change in hemoglobin levels, with secondary endpoints including serious adverse events, target hemoglobin range, and RBC transfusion rates compared to ESA treatment [2] Sub-Study and Research Focus - A sub-study will involve around 28 patients from three clinics, focusing on the impact of Vafseo on red blood cell (RBC) quality [3] - The sub-study aims to analyze RBC phenotypes, including deformability and resistance to oxidative stress, in collaboration with Vitalant Research Institute [3] Company Overview - Akebia Therapeutics is a biopharmaceutical company dedicated to improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5] - Vafseo is a once-daily oral medication that stimulates endogenous erythropoietin production to manage anemia [6] Regulatory and Safety Information - Vafseo is indicated for treating anemia due to CKD in adults on dialysis for at least three months, but it has not been shown to improve quality of life or fatigue [7] - The drug carries warnings for increased risks of death, myocardial infarction, stroke, and thrombotic events [8][10]

Vafseo Launch and Market Opportunity - Vafseo (vadadustat) has launched as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis[8] - The U S market opportunity for Vafseo in the dialysis patient population is approximately $1 billion[8] - Akebia is pursuing label expansion of Vafseo for the late-stage non-dialysis CKD population, representing a multi-billion-dollar U S market opportunity[8] - Contracts are secured covering nearly 100% of U S dialysis patients for Vafseo[12, 20] Clinical and Patient Considerations - Current standard of care for dialysis patients (ESAs) has remained unchanged for 30 years, with nearly 25% of patients falling below target hemoglobin levels[13] - Approximately 20% of patients on dialysis are ESA hyporesponders, leading to higher hospitalization and mortality rates[13] - Market research indicates that over 2 out of 3 nephrologists identify an unmet need for anemia treatment in CKD, particularly for oral options and ESA-resistant patients[14] VOICE Trial and Label Expansion - The VOICE trial, with over 650 subjects enrolled as of January 10, 2025, is designed to demonstrate non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization[23, 24] - A Phase 3 clinical trial for Vafseo in late-stage CKD patients not on dialysis is planned to begin in mid-2025[8, 46] Non-Dialysis Market - In patients with pre-hemodialysis Hb <9 0 g/dL (n=4855), 73 4% did not receive ESA pre-HD[26] - The U S non-dialysis market opportunity for anemia treatment is approximately $1 billion, driven by predominantly private and unbundled government payment structures[40, 41] HIF-based Pipeline - Akebia is advancing a HIF-based pipeline targeting high unmet needs, including ROP (rare disease) with a ~$1 5B+ U S market opportunity and ~30K patients[50]

Vafseo Launch and Market Opportunity - Vafseo (vadadustat) has launched as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis[8] - The U S market opportunity for Vafseo in the dialysis patient population is approximately $1 billion[8] - Akebia is pursuing label expansion of Vafseo for the late-stage non-dialysis CKD population, representing a multi-billion-dollar U S market opportunity[8] - Contracts are secured covering nearly 100% of U S dialysis patients for Vafseo[12, 20] Clinical and Patient Considerations - Current standard of care for dialysis patients (ESAs) has remained unchanged for 30 years, with nearly 25% of patients falling below target hemoglobin levels[13] - Approximately 20% of patients on dialysis are ESA hyporesponders, leading to higher hospitalization and mortality rates[13] - Market research indicates that over 2 out of 3 nephrologists identify an unmet need for anemia treatment in CKD, particularly for oral options and ESA-resistant patients[14] Vafseo Advantages and Ongoing Trials - Vafseo is an oral HIF-PH inhibitor with the potential to become standard of care, offering a unique mechanism of action and convenient oral dosing[15] - The VOICE trial, with a target enrollment of ~2,200 patients, is underway to demonstrate Vafseo's non-inferiority for all-cause mortality and superiority for a 10% reduction in all-cause hospitalization[24] Non-Dialysis Market and Future Plans - In patients with pre-hemodialysis Hb <9 0 g/dL (n=4855), 73 4% did not receive ESA pre-HD[26] - A Phase 3 clinical trial is planned to begin in mid-2025 for Vafseo in patients with late-stage CKD anemia not on dialysis, targeting ~1,500 U S subjects[8, 46] Pipeline and Financial Outlook - Akebia expects its existing cash resources and cash from operations to be sufficient to fund its current operating plan for at least two years[8] - Akebia is advancing a HIF-based pipeline targeting high unmet needs, including ROP (~$1 5B+ U S market opportunity), ARDS (~$2B U S market opportunity), and CS associated AKI (~$1 5B+ U S market opportunity)[50]