Akebia Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the KBS first quarter 2025 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 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker for today, Ms. Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

Thank you, and welcome to Atebia's first quarter 2025 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, May 8th, detailing our first quarter 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 also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, Nicholas Grund, Chief Commercial Officer, and Eric Ostrowski, Chief Financial and Chief Business Officer. 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 are included in the financial results press release that we issued on May 8th, as well as in the risk factors and management discussion and analysis section of our most annual report and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thanks to everyone for joining us this morning. Well, during our last call, we shared initial progress on our VAFCO Vata-Dustat US product launch, and I'm extremely pleased to report we continued our strong performance. We delivered US net product revenues of $12 million versus our guidance of 10 to 11 million in the first quarter. I believe our strong early performance is a reflection of nephrologists' desire for a new treatment option to treat anemia in CKD patients on dialysis. Though I continue to express caution that we're in the early stages of product introduction, it is one of the strongest launches I've ever seen in the dialysis market. I want to acknowledge the excellent job our commercial and medical affairs teams are doing, educating dialysis providers, prescribers, anemia managers, and other members of the patient care team about Vafsio. The complexity of selling a product in the dialysis market should never be underestimated, but our strategy to build prescriber demand and quickly transition patients onto Vafsio is playing out as planned. Importantly, we're also encouraged to see that patients are staying on therapy as evidenced by the growing number of refills being written And as expected, we're also seeing the utilization of higher doses as patients' doses are titrated to achieve and maintain appropriate hemoglobin levels. As we've said in the past, we have commercial contracts in place with dialysis organizations covering nearly 100% of dialysis patients. The top five dialysis organizations have now ordered Vafsio. However, nearly all the revenues still coming from the small to midsize dialysis organizations who treat approximately 150,000 patients collectively. One of the large dialysis providers is planning a large pilot to operationalize its protocol. We expect that pilot to begin in the third quarter. The other large provider is earlier in their process. but I'm encouraged that they're making the product available on an exception basis for patients. Given that each LDO treats over 200,000 patients, bringing one on board with a broad protocol will more than double the number of patients with access to Vasio. Now shifting gears, the voice study in collaboration with U.S. Renal Care continues to march towards full enrollment and now has about 75% of patients enrolled. As you recall, the target enrollment is approximately 2,200 subjects. In just five months of enrollment, this is tremendous progress. We believe voice could generate data on the benefits associated with Vafsio treatment, including potential improvements in hospitalization, which is critical information for prescribers and dialysis organizations. We also continue to pursue an approval of Vafsio in a non-dialysis patient population, and remain on track with our goal to initiate our Phase III VALOR trial in NDD in the second half of 2025. We're planning to meet with the FDA to further discuss the VALOR trial, which will study the use of Atadustat in treating anemia in CKD patients who are not on dialysis. We'll continue to update you on our progress as appropriate. While the VASCO launch and initiating VALOR remain our top priorities, We'll also update you throughout 2025 about our plans to advance our pipeline of HIF-PH inhibitors and other assets. We are working towards having multiple product candidates enter the clinic this year. Akibia is an incredibly strong position. The team has worked very hard to get us here. Now, first, Nick is going to give you a detailed view of our launch progress, and then Eric will talk to you about our strong first quarter results and enhanced financial position. Now, let me turn it over to Nick to give you more color on the VAPCO launch.