Akebia Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the KBS 4th Quarter 2025 Financial Results Conference Call. At this time, all participants are in 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 automated message invites and your hand is raised. To withdraw your question, please press star 11 again. Please revise that today's conference is being recorded. I would like to hand the conference over to your first speaker today, Mercedes Carrasco, Senior Director of IR. Please go ahead.

Thank you, and welcome to Akebia's fourth quarter and full year 2025 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, February 26th, detailing our fourth quarter and full year 2025 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 Grundt, Chief Commercial Officer, and Eric Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer and Head of Research and Development, is available for Q&A dialing in from the annual dialysis conference in Kansas City today, where Akibia will present data on VASIO this weekend. 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 February 26th, as well in the risk factors and management discussion and analysis section of our most recent annual 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. 2025 was an important year for Akibia, marked by the commercial launch of Vafsio, Vatadustat, our oral HIF-PH inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis. Vapcio, along with our phosphate binder Orixia, generated $227 million in net product revenue in 2025, during which time we also progressed multiple post-marketing clinical trials and advanced and enhanced our growing pipeline. Let's start with Vapcio. 2025 got off to a very fast start before a number of challenges flattened demand in the second half of the year. We addressed those challenges head on, and we believe today we're starting to see the demand growth that we've expected. Most importantly, the body of evidence is growing that supports the potential for VAPCO to become standard of care in what is a billion-dollar U.S. market opportunity after the TdAPA period ends when we expect VAPCO will be priced roughly in parity with ESA pricing. While we didn't see the growth we expected in the second half of 2025, we built real excitement for Vasio. Today, just over a year into the launch, more than 1,000 prescribers at 24 different dialysis organizations have written a prescription for Vasio. And 290,000 patients have access to Vasio in dialysis clinics with a protocol in place. I'm particularly encouraged by the shifting dynamics we began to see in Q4 that are continuing in Q1 that suggest greater breadth of prescribers as well as improving adherence rates. Nick will provide more detail on these very encouraging trends in his remarks. Now, a key element of our strategy to have VAPCO become standard of care includes continuing to generate data supporting the benefits of managing anemia with a more physiologic approach compared to ESAs. At the ASN meeting in November, we presented a post-hoc hierarchical composite endpoint analysis of prospectively collected outcomes of death and hospitalization from our Phase III Innovate program and dialysis. This analysis demonstrated that patients treated with VASIO experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator. This coming weekend at the ADC in Kansas City, we're presenting a cost comparison of Vafsio versus darbopoietin based on Innovate data. In this analysis, Vafsio showed a 7.7% lower annual hospitalization rate, 16% reduction in hospitalization days, And based on Medicare cost data, approximately 15% lower Medicare hospitalization costs for patients treated with Vafsio versus darbopoietin. Reduced hospitalization translated into a cost savings of about $3,700 per patient per year, meaning a savings of almost $2 billion per year if all eligible patients were treated with Vafsio. These results are meaningful for dialysis providers, Medicare and other payers, and most importantly, for patients. Late this year, we'll have the results from the VOCAL study that we're conducting at the VITA clinics that's evaluating VASEO dose three times weekly. The trial also contains a sub-study of red blood cell characteristics, which we believe could make a compelling argument for VASEO. Fundamentally, when you manage hemoglobin levels with a more physiologic approach, you get a more physiologic and potentially better functioning red blood cell. The vocal data will be followed by results from the VOICE trial being run by USRC, evaluating VASIO versus standard of care on a hierarchical composite of all-cause mortality and hospitalization rates, data expected in early 2027. In my experience, in order to make a drug standard of care, particularly with nephrologists, you have to continue to deliver data that demonstrates the benefit of the product for their patients versus current treatment. Now, in addition to the launch of Valcio in 2025, we introduced our rare 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 disease community, and fits squarely within our corporate mission. We will host an R&D day for investors on April 2nd to discuss our mid-stage assets in detail, namely Perlisiguat and AKB097, as well as introduce our early HIF-PHI, AKB9090. Perlisiguat is an oral, once-daily soluble guanylate cyclase stimulator being evaluated in a Phase II clinical trial of focal segmental glomerulosclerosis, or FSGS. We expect to enroll up to approximately 60 patients in this trial, which will evaluate change from baseline in urine protein to creatinine ratio, or UPCR, at 24 weeks as the primary endpoint. Both the extensive preclinical work in FSGS disease models as well as previous clinical results for Priliciguat in diabetic kidney disease give us confidence in the potential for the therapy to impact FSGS. AKB097 is our tissue-targeted complement inhibitor that we acquired late last year. We believe this product candidate could have comparable efficacy to the most efficacious currently approved products in a well-characterized pathway. while the tissue targeting allows for the potential to, first, avoid the box warning for infection risk, and second, to deliver the drug in a more convenient dosing regimen. We believe this has best-in-class potential. We plan to initiate a Phase II open-label basket trial in the second half of this year. We will be looking at initial indications of IgA nephropathy, lupus nephritis, and C3 glomerulopathy. These diseases represent a multibillion-dollar market opportunity in areas of high unmet need. 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. As this is an open-label basket study, we expect to begin to report initial data in 2027. And lastly, we plan to initiate a phase one study in healthy volunteers of AKB 9090 in the first half of 2026, with top line results later this year. Our initial target disease area for 9090 is acute kidney injury associated with cardiac surgery. Our research and development team is working hard to deliver these important catalysts as quickly as possible. But of course, all of this work will be built on the success of Vafsio. Now let me turn it over to Nick, give more granularity on the launch.