R&D Day 2026 April 2, 2026 Bettering the Lives of People Impacted by Kidney Disease NASDAQ: AKBA 1 Cautionary note on 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 an ...

Core Insights - Maze Therapeutics' stock has seen a significant decline, attributed to recent trial results for its drug MZE829, which showed mixed efficacy in treating kidney disease AMKD [1][6]. Group 1: Clinical Trial Results - The trial for MZE829 demonstrated a mean reduction of 35.6% in urinary albumin-to-creatinine ratio (uACR) among broad AMKD patients, with 50% of patients achieving over a 30% reduction [1]. - Patients with focal segmental glomerulosclerosis (FSGS) experienced a notable mean reduction of 61.8% in uACR [2]. - In AMKD patients without diabetes, MZE829 resulted in a mean uACR reduction of 48.6%, while in diabetic patients, two out of five evaluable patients achieved at least a 30% reduction [4]. Group 2: Study Details and Financials - The HORIZON study enrolled 15 patients, with 12 evaluated for efficacy and all included in a safety analysis [5]. - Maze Therapeutics reported a cash balance of $360 million for 2025, which is expected to fund operations until 2028 [5]. Group 3: Analyst Ratings and Stock Performance - The stock currently holds a Buy rating with an average price target of $56.33, despite a recent drop of 31.17% to $33.72 [6]. - Recent analyst actions include HC Wainwright raising its target to $110, Truist Securities initiating coverage with a target of $68, and Wedbush increasing its target to $58 [6].

Core Viewpoint - Akebia Therapeutics, Inc. is hosting a virtual R&D Day on April 2, 2026, to discuss its clinical stage kidney disease programs and the current treatment landscape for these conditions [1][2]. Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [8]. Event Details - The R&D Day will feature discussions with scientific experts and company management on the unmet needs in kidney disease treatment and the differentiation of Akebia's product candidates [2]. - A live Q&A session will follow the formal presentation, and the event will be accessible via a webcast on Akebia's website [3]. Expert Contributions - Dr. James A. Tumlin, a nephrologist with extensive experience in kidney disease research, will participate in the event [4]. - Dr. V. Michael Holers, known for his research on the complement immune system, will also contribute to the discussions [5]. - Dr. Jonathan Barratt, focused on IgA nephropathy research, will provide insights into the pathogenesis and treatment of this condition [7]. Pipeline Overview - Akebia's pipeline includes: - Praliciguat, a soluble guanylate cyclase stimulator in Phase 2 clinical trials for Focal Segmental Glomerulosclerosis (FSGS) [6]. - AKB-097, a next-generation tissue-targeted complement inhibitor, set to enter a Phase 2 basket trial for rare kidney diseases in the second half of 2026 [6]. - AKB-9090, a HIF-PH inhibitor, entering a Phase 1 clinical trial for acute kidney injury associated with cardiac surgery in the first half of 2026 [6].

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]

Akebia Therapeutics Conference Summary Company Overview - **Company**: Akebia Therapeutics (NasdaqCM:AKBA) - **Focus**: Improving the lives of individuals affected by kidney disease - **Commercial Products**: - Auryxia: A phosphate binder nearing the end of its life cycle - VAFSEO: A HIF-PHI for treating anemia in chronic kidney disease patients on dialysis, launched about a year ago [4][5] Key Points on VAFSEO - **Initial Uptake**: Strong initial uptake observed post-launch, but faced challenges due to the unique nature of the dialysis market [7][8] - **Market Dynamics**: Dialysis providers control the prescription process, affecting product availability [8] - **Discontinuation Rates**: Higher than expected due to initial hemoglobin dips in patients; efforts are being made to improve patient retention [10][12] - **Dosing Strategy**: Transitioning to a three times weekly (TIW) dosing regimen has shown promising results in reducing discontinuation rates [12][13] - **Patient Access**: By the end of 2025, access to approximately 275,000 patients was achieved [13] - **Long-term Growth**: Data supporting VAFSEO's potential to become the standard of care for anemia in dialysis patients is anticipated [14][24] Clinical Trials and Studies - **VOCAL and VOICE Trials**: - VOCAL: A study comparing VAFSEO to Mircera, expected to show excellent hemoglobin control [20][29] - VOICE: A randomized comparison against Epogen, with results expected early in 2027 [29][31] - **Economic Perspective**: Demonstrating reduced hospitalization costs could enhance the economic proposition for dialysis organizations [31] Pipeline Developments - **Rare Kidney Disease Pipeline**: - Praliciguat: Phase II study initiated for FSGS, targeting rapid progression to end-stage kidney disease [5][40] - AKB-097: A tissue-targeted complement inhibitor, with a basket study planned for IgAN, C3G, and lupus nephritis [40][58] - **Mechanistic Rationale**: Praliciguat stimulates soluble guanylate cyclase, beneficial for podocytes and anti-inflammatory [42][44] - **Patient Focus**: Targeting primary FSGS and genetic mutation-related FSGS while excluding secondary causes [56] Financial Position - **Cash Reserves**: $166 million as of Q3, with at least two years of cash runway [69] Upcoming Catalysts - **Key Events**: - Continued monitoring of VAFSEO's market performance - Progress on Praliciguat and AKB-097 studies - Results from VOCAL and VOICE trials expected within the next 12 months [70][72] Conclusion - **Outlook**: The next 12 months are anticipated to be critical for Akebia, with significant clinical readouts and potential market shifts for VAFSEO and pipeline products [72]

Core Viewpoint - Unicycive Therapeutics, Inc. is actively participating in the biotech sector, focusing on developing therapies for kidney diseases, with significant upcoming events and investigational treatments under review [1][3]. Group 1: Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company dedicated to developing novel treatments for kidney diseases [3]. - The company's lead investigational treatment, oxylanthanum carbonate, is currently under review by the U.S. Food and Drug Administration (FDA) for treating hyperphosphatemia in patients with chronic kidney disease on dialysis [3]. - Unicycive's second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [3]. Group 2: Upcoming Events - Shalabh Gupta, M.D., the CEO of Unicycive, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on February 11, 2026, at 1:30 p.m. ET [1]. - A live and archived webcast of the event will be available on the Unicycive website under the Investors section [2].

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 - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [1][2] - The company will participate in two investor events in December 2025, including the Piper Sandler 37th Annual Healthcare Conference and a Noble Capital Markets Virtual Presentation [1] Company Overview - Unicycive's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2] - The second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [2] - UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers [2]

Summary of Akebia Therapeutics FY Conference Call Company Overview - **Company**: Akebia Therapeutics (NasdaqCM:AKBA) - **Focus**: Kidney disease treatment - **Products**: - **Auryxia**: A mature phosphate binder, past patent expiry - **Vafseo**: A hypoxia-inducible factor prolyl hydroxylase inhibitor approved for treating anemia in chronic kidney disease (CKD) patients on dialysis, launched at the beginning of the year [2][3] Financial Performance - **Recent Revenue**: Reported $14.3 million in revenue for the quarter, which was below expectations despite positive underlying metrics [5] - **Market Access**: Initially had access to about 40,000 patients, which has now grown to approximately 260,000 patients due to expanded access through major dialysis providers [6] Market Dynamics - **Dialysis Providers**: - **U.S. Renal Care**: Strong clinical advocacy, significant part of revenue base - **DaVita**: Expanded access from 100 to over 4,000 dialysis centers, indicating a successful pilot program [6][14] - **Fresenius**: More challenging engagement, but potential for significant patient access if they broaden availability [20] Clinical Insights - **Patient Management**: Emphasis on educating healthcare providers about the unique dosing and administration of Vafseo compared to traditional treatments [10][12] - **Clinical Data**: Recent data presented at ASN showed a 1% decrease in mortality and an 8% lower hospitalization rate for Vafseo compared to traditional treatments [19][23] Regulatory and Reimbursement Landscape - **TDAPA**: Transitional Drug Add-on Payment Adjustment allows billing for Vafseo outside the dialysis bundle for two years, providing a higher price point and facilitating access [25][26] - **Market Size**: The anemia treatment market in dialysis is estimated at $1 billion, with potential for Vafseo to capture a significant share if it becomes standard of care [26][29] Future Outlook - **Clinical Trials**: Ongoing studies (VOICE and VOCAL) aim to provide further evidence of Vafseo's efficacy and differentiate it from existing treatments [31][32] - **Pipeline Development**: Plans to explore additional indications for HIF-PHI, including acute kidney injury and retinopathy of prematurity [38][39] Financial Position - **Cash Reserves**: Ended the quarter with $166 million, indicating a solid balance sheet and guidance towards profitability [42]

Core Insights - Vertex Pharmaceuticals is presenting updates on its kidney programs at the American Society of Nephrology Kidney Week 2025 [1][2] - The company has three kidney programs in pivotal development and one in a proof-of-concept study [2] Company Overview - The presentation is led by Susie Lisa, Senior Vice President of Investor Relations, and includes an overview from CEO Dr. Reshma Kewalramani [1] - The company expresses gratitude for the participation of three physician thought leaders who will discuss recent data on kidney disease treatments [2] Research and Development - The RUBY-3 data in IgAN will be recapped by Dr. James A. Tumlin, a prominent figure in nephrology [3] - The RAINIER Phase III study of IgAN has recently completed full enrollment in record time, indicating strong progress in clinical trials [2]