Akebia Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Akibia's third quarter 2024 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 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 speaker today, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

Thank you, and welcome to TVA's third quarter 2024 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, November 7th, detailing our third quarter 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 today, we have John Butler, Chief Executive Officer, Nick Grundt, Chief Commercial Officer, and Eric Ostrowski, Chief Financial and 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 November 7th, 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 CEO John Butler.

Thanks, Mercedes, and thanks, everyone, for joining us today. You know, the Akiba team has spent the past 15 years working to bring Vapcio to patients. So I have to say, I get excited every time I have the opportunity to give an update on the progress we're making in the home stretch of that journey. We're building significant momentum as we prepare for U.S. market availability of Vapcio, Vatadustat, expected in January of 25. Our team's work has yielded tremendous progress on each of our three launch initiatives. First, at the prescriber level, we're driving demand. Second, we're focused on contracting effectively with dialysis organizations to have meaningful and have meaningful progress to share. And third, we've launched clinical initiatives to generate data that could demonstrate potential additional benefits of Vafsio for patients. I recently returned from the American Society of Nephrology or ASN Kidney Week As I mentioned previously, I considered this our coming out party. Team Akibia had a formidable presence, focused on engagement across the kidney community, building awareness and advocacy for Vafsio. It was impossible to miss us. Here are my takeaways. Over and over again, I heard from nephrologists that they're ready for a new choice in anemia management for their dialysis patients, and they want to ensure their patients have access. considering the traffic to our medical affairs booth, the interest in reviewing our existing clinical data and analyses on Vafsio is at an all-time high. We presented six posters on Vafsio data and our authors and partners spent their time delving into the findings and responding to physician questions. Now I'll let Nick share more detail on prescriber demand and commercial efforts, But overall, I'm extremely encouraged by the optimism that I felt amongst our team and within the broader kidney community, from caregivers and investigators, representatives from dialysis organizations, and patient advocacy groups. Akibia is committed to the kidney community, and we believe we have widespread support to make Vafcio successful. Now, prior to ASN Kidney Week, we also shared important updates regarding reimbursement, contracting, and access. In October, we secured TdapA reimbursement from CMS, and we also received Healthcare Common Procedure Coding System, or HCPCS codes, which allows dialysis organizations to submit for VAPCIA reimbursement in January of 25. And just to remind everyone, CMS created TdapA reimbursement system to encourage the use of innovative products for patients on dialysis. TDAPA creates positive economics for dialysis organizations that makes VAPCO a desirable addition to their formularies. While receiving TDAPA reimbursement payment was our expectation, we're pleased to have the assurance provided by this program as we engage in further contracting discussions. Now that we have the HCPCS codes, our key account managers can begin to educate dialysis organizations to ensure that these codes are known at each site to facilitate efficient Vafsio reimbursement. This quarter we've also made progress on our effort to secure access to Vafsio through commercial supply contracts with dialysis providers and group purchasing organizations. Nick will provide more details and speak to our goal of securing coverage for nearly 100% of patients on dialysis by the end of the year. Finally, we're progressing on plans to generate new clinical data. In September, we initiated our VASIO Outcomes In-Center Experience, or VOICE, trial in partnership with U.S. Renal Care, which will use three times per week dosing of VASIO and allow us to generate important data on key endpoints, such as mortality and hospitalization, that can further educate the physician community and support VASIO utilization. This study intends to enroll 2,200 patients across USRC sites and we expect the first patient to be enrolled in the next few weeks. Additionally, we're evaluating initiating complementary trials at other dialysis organizations. The interest among DOs is also encouraging as it suggests they're eager to understand how Vafsio can improve care for their patients as they gain real-world experience. We believe generating additional clinical data will help further our objective for Vafsio to become the new oral standard of care for the treatment of anemia due to chronic kidney disease. We look forward to working closely with USRC and other dialysis organizations to advance our understanding of additional potential benefits VAPCO treatment can bring to dialysis patients. Now, one final thought I'll share regarding ASN Kidney Week, based on conversations we continue to have with nephrologists, and that is that the unmet need for anemia treatment for patients with CKD who are not on dialysis is more significant than ever and represents an additional multi-billion dollar opportunity beyond the dialysis population. That is a resounding message from physicians. And at ASN, we reiterated our commitment to exploring a path for Vafcio label expansion into the non-dialysis CKD patient population. As we've said previously, we expect to provide a more detailed update on this initiative by the end of the year. Now, let me turn it over to Nick to talk more about our commercial activities. Thanks, John.