Akebia Therapeutics, Inc.

Good day and welcome to a KBS fourth quarter 2024 financial results call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would now like to turn the call over to Mercedes Carrasco, Senior Director, Investor Relations. Please go ahead.

Thank you. And welcome to PBS fourth quarter and full year 2024 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, March 13th, detailing our fourth quarter and full year 2024 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, Nick 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 is included in the financial results press release that we issued on March 13th, as well as in the risk factors and management discussion and analysis section of our most recent annual 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, it's March 13th, which is World Kidney Day. As a company whose mission is to better the lives of people impacted by kidney disease, this holds a special meaning. One of the enduring themes of Rural Kidney Day is driving innovation in the care of kidney disease. I am proud of the role Akibia plays and will continue to play in delivering that innovation. As a matter of fact, as you know, we are just in the early days of bringing an important new treatment to the care of patients on dialysis. It is a pleasure to have the opportunity this morning to discuss the excellent progress we've made in the launch of Vapcio, our HIF-PH inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis. We're in the earliest stage of our launch. The data we will review today represents the first seven weeks of prescribing. And of course, there's always some volatility at this stage. But even at this early stage, we're very excited about what we're seeing in the market. Now, let me be clear. We do not plan to provide quarterly revenue guidance going forward. But we thought it was important to share early performance metrics. especially since we have only about two weeks left in the quarter. With that said, I am very pleased to report that we expect $10 to $11 million in net product revenue for Vafsio in the first quarter, a very strong start and well ahead of current analyst estimates. Our goal is to make Vafsio standard of care for patients with anemia due to chronic kidney disease. That goal has two parts. First, a successful dialysis launch Second, an approval of Vafseo for the non-dialysis patient population. I'll address both, but let's drill down on the launch first. Previously, I outlined the three initiatives we had to execute to work towards a successful launch and sustained growth. Create access through effective contracting, drive demand at the prescriber level, and generate data to identify potential additional benefits. When the first prescriptions were written for Vapcio on January 13th, we had commercial supply contracts in place with the dialysis providers who care for nearly 100% of dialysis patients in the U.S., which we believe is a first for a drug with transitional drug add-on payment adjustment or TDAPA reimbursement. Of course, having a contract in place is just the first step to broad access. We have also worked with the dialysis organizations to have protocols in place and finalize other operational elements like distribution and ordering details. We've been successful working through this process in many dialysis organizations, and these are the DOs driving early prescribing. For some time, we've said we expect our early use and adoption to come from the medium and small dialysis organizations who care for about 150,000 patients collectively. This has been the case. and an appropriate area of focus, but we're also pleased with the progress we're making across the broader market. Now, access without corresponding prescriber demand does not get product to patients. If you recall, as we prepared for product introduction, I spoke about the coiled spring strategy. Secure contracts and build prescriber demand to start transitioning patients onto VAPCO as quickly as possible upon availability. I believe that strategy is playing out in the excellent pull through to patient prescriptions we've seen in the early launch metrics. Nick will give you a sense of both prescribers and prescriptions through the end of February. With the pieces for a successful launch in place and impressive early traction, our team also focused on the third initiative. Continuing to build evidence is what we believe ultimately allows a product to become standard of care. The voice study in collaboration with us, renal care is an important effort to generate significant data, potentially demonstrating additional benefits of treatment. Positive results from voice would potentially show a significant reduction in hospitalization versus the essays data that we believe will be critical for physicians as they make anemia treatment decisions. Dr. Block, the lead investigator, began study enrollment at the beginning of December, and as of last week, he has enrolled over half of the total target of 2,200 patients. Finally, to become standard of care for all patients with anemia due to CKD, we need to be able to have the product approved for the non-dialysis population. I was in the field with one of our key account managers one day last month, and every physician I spoke to proactively told me, that they wanted to use the product for their NDD patients. We plan to work to enable them to do that as quickly as possible. Now, in our latest communication from the FDA, they offered the opportunity to meet with them to discuss the protocol for our planned phase three clinical trial, VALOR, which will study the use of Atadustat in treating anemia in late-stage CKD patients who are not on dialysis. We believe taking the time for this meeting will be helpful to the success of the program in the long run. We expect to initiate the Valor study in U.S. non-dialysis patients in the second half of this year. We will continue to update you as appropriate as we get closer to initiating this important study. Treatment of non-dialysis patients is clearly a significant potential opportunity for Akibia and for patients, and it's a primary focus for our development organization. In parallel, our commercial organization is completely focused on dialysis launch success. Now, let me turn it over to Nick to give more details on the early days of our launch.