Akebia Therapeutics, Inc.

day and thank you for standing by. Welcome to Akibia's first quarter 2026 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mercedes Carrasco. Please go ahead.

Thank you, and welcome to Akebia's first quarter 2026 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, May 7th, detailing our first quarter 2026 financial results, and that release is available on the investor section of our website. For your convenience, a replay of today's call will be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, Nick Grund, Chief Commercial Officer, and Eric Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer, will also be available during Q&A. I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on May 7th, as well as in the risk factors and management discussion and analysis section of our most recent annual and quarterly report filed with the SEC. With that, I'd like to introduce our CEO, 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 three 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 Vafsio. Second, continue to build the clinical evidence to make Vastio a 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 Vastio launch, revenues were nearly $16 million in Q1, representing our highest quarter of VastioNet 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 AFSEO. We believe this growth is being driven by dialysis organizations that have chosen to implement an observed dosing protocol. Nick's 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 Vasya 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 Vafsio continues to grow. The post hoc hierarchical composite endpoint analysis from our phase three Innovate program in dialysis was recently published in the Journal of the American Society of Nephrology. The analysis demonstrated that patients treated with Vafsio 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 Vatadustat versus darbopoietin. That analysis showed that patients in the INOVATE trial treated with Vatadustat 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 support the potential benefits of managing anemia with VASIO 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 VASIO, those three times weekly, and it contains a sub-study of red blood cell characteristics, which we believe will further differentiate VASIO's clinical profile versus ESA's. VOCAL top-line data will be followed by results from the VOICE trial being run by U.S. Renal Care, evaluating VASIO 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, they further support the findings of the recently published WIN statistics analysis. Both voice and vocal utilize a three times weekly dosing regimen aligned with in-center dialysis treatment. Most dialysis 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 VASIO 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. We were joined by leading medical experts, Dr. Jim Tomlin, Michael Holers, and Jonathan Barrett. During that event, we reviewed the preclinical data in focal segmental glomerular sclerosis, or FSGS models, and prior clinical data in diabetic kidney disease for Prolisiglot, 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 Prolisiglot 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. AKB097, whose generic name is Ebrebifus or Ebre, 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 EBRY 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 EBRY to be delivered at a lower dose in a more convenient dosing regimen. As Dr. Barrett articulated during our R&D Day presentation, EBRI is a second-generation complement inhibitor. We believe these characteristics support the potential for EBRI 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 EBRI 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 EBRI. And as a reminder, as the basket studies open label, we expect to begin reporting initial data in 2027. Lastly, this quarter, we were pleased to announce the initiation of a phase one study of AKB9090, 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 Vafsio 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 Vafsio launch.