Akebia Therapeutics, Inc.

Hello and welcome to Acabia's first quarter 2024 financial results conference call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce Senior Director, Investor Relations, Mercedes Carrasco.

Thank you, and welcome to TBI's first quarter 2024 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, May 9th, detailing our first quarter financial results and that release is available on the investor section of our website. For our convenience, a replay of today's call will be available on our website after we conclude. Joining me for the call today, we have John Butler, Chief Executive Officer and Principal Financial Officer, and Nick Grund, Chief Commercial 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 May 9th, 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. The forward-looking statements on this call speak only as to the original date of this call and accept as required by law We do not undertake any obligation to update or revise any of these statements. With that, I'd like to introduce our CEO, John Butler.

Thanks Mercedes, and thanks everyone for joining us today. This is our first quarterly call since the approval of AFSEO in late March. Though only about six weeks ago, I'm extremely encouraged by our early progress. I'm excited by the reaction of the dialysis market. Prescribers, dialysis providers, and patient groups as well as the excitement from the folks at Akibia to get this product into the hands of patients. We celebrated the milestone and win for the kidney community for a moment, then immediately kicked into high gear to initiate our launch. On our Vafsio approval call, I outlined three things we have to execute effectively to drive a successful launch and ensure long-term growth of Vafsio in dialysis. First, drive demand from prescribers. Second, contract effectively with dialysis providers. And third, demonstrate potential additional benefits of Vafsio for dialysis patients and the folks who serve them. Nick will go into more detail, but I'll share that our commercial and medical affairs teams have already engaged with thousands of physicians. I'm extremely encouraged by the physicians' interest and enthusiasm, particularly when I speak to investigators who have experience using the product. We believe the Vasio label supports widespread adoption, and that's how we're presenting the product to the market. We've developed our launch strategy and tactics that best position Vasio to potentially become a new oral standard of care for dialysis patients with anemia due to chronic kidney disease. As I speak to potential Vasio prescribers, besides describing their clear interest in using the product for their dialysis patients, They asked me to please not give up on working towards an approval for non-dialysis patients. We will not give up on this patient population. The FDA in the Vataduce.crl suggested we return and discuss appropriate subpopulations where the benefit risk is positive. Now, this may include conducting a new clinical trial to supplement the data we already have in the patient population we plan to discuss. One potential subgroup we're exploring are CKD patients with anemia not on dialysis with a GFR below 15. We believe these patients would benefit from treatment with Vafsio. Over 70% of these patients are not treated today, and they routinely have a higher mortality rate than patients who had their anemia controlled before dialysis. And they continue to have a higher mortality rate 12 months after starting dialysis. a once-a-day oral option may be ideal for this patient population. We plan to engage the FDA this year to discuss a path forward for these patients. And it's critical that we take this population into account as we determine our WAC pricing for Vafseo. We are carefully considering pricing and will announce the WAC by next month. So now let me ask Nick to give us more detail on launch execution.