Akebia Therapeutics (NasdaqCM:AKBA) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Company ParticipantsAshleigh Acker - Biotechnology Equity Research AssociateErik Ostrowski - CFO and Chief Business OfficerJohn Butler - President, CEO, and DirectorMercedes Carrasco - Senior Director of Investor and Corporate CommunicationsNicholas Grund - Chief Commercial OfficerSteven Burke - Chief Medical OfficerConference Call ParticipantsJulian Harrison - Managing Director and Biotechnology AnalystMichael Cherny - ...

Akebia Therapeutics (NasdaqCM:AKBA) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Company ParticipantsErik Ostrowski - CFO and Chief Business OfficerJohn Butler - President, CEO, and DirectorMercedes Carrasco - Senior Director of Investor and Corporate CommunicationsNicholas Grund - Chief Commercial OfficerSteven K. Burke - Senior Vice President, Chief Research and Development OfficerConference Call ParticipantsJulian Harrison - Managing Director and Biotechnology AnalystManagi Nassar - Senior Equity ...

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 Insights - Akebia Therapeutics has initiated a Phase 2 clinical trial for praliciguat, targeting biopsy-confirmed FSGS, a rare kidney disease affecting approximately 40,000 patients in the U.S. [2] - The trial aims to evaluate the efficacy and safety of praliciguat, with a primary endpoint of change in urine protein-to-creatinine ratio (UPCR) at Week 24 [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]. - The company has a mid-stage pipeline for rare kidney diseases, with praliciguat being a key component [2]. Clinical Trial Details - The Phase 2 trial is randomized, double-blind, placebo-controlled, and multicenter, involving approximately 60 patients already on maximally tolerated doses of ACE inhibitors or ARBs [2]. - Participants will be randomized 1:1 to receive either praliciguat or placebo for an initial 24-week period, followed by an open-label phase for an additional 24 weeks [2]. Safety and Efficacy - No significant safety issues were reported for praliciguat in previous Phase 1 and Phase 2 studies, indicating a favorable safety profile [3]. - Adverse events were infrequent and consistent with the known blood pressure-lowering effects of praliciguat [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 has established a rare kidney disease pipeline, focusing on two main product candidates: AKB-097, a complement inhibitor, and praliciguat, an sGC stimulator [2][3] - The company plans to initiate Phase 2 clinical trials for both AKB-097 and praliciguat in 2026, targeting multiple rare kidney disease indications [1][3] Group 1: Product Candidates - AKB-097 is a tissue-targeted C3d-Factor H fusion protein complement inhibitor acquired from Q32 Bio, expected to address a range of complement-mediated rare kidney diseases [2][5] - Praliciguat is an oral sGC stimulator, with initial clinical trials focusing on focal segmental glomerulosclerosis (FSGS), a rare kidney disease [2][8] Group 2: Clinical Trials - The Phase 2 basket trial for AKB-097 is set to begin in the second half of 2026, with initial data expected in 2027 [6][3] - The Phase 2 trial for praliciguat will enroll up to 60 patients in the U.S., with the primary efficacy endpoint being the change in urine protein-to-creatinine ratio over 24 weeks [10][11] Group 3: Financial Aspects - Akebia paid an upfront fee of $7 million to Q32 Bio for the acquisition of AKB-097, with additional payments tied to development milestones and royalties on net sales [7]