Travere Therapeutics, Inc.

Good afternoon and welcome to the Travere Therapeutics fourth quarter and full year 2024 financial results conference call. Today's call is being recorded. At this time, I would like to turn the conference call over to Victoria Prescott, Manager of Investor Relations. Please go ahead, Victoria.

Thank you, Chloe. Good afternoon and welcome to Travere Therapeutics. fourth quarter and full year 2024 financial results and corporate update call. Thank you all for joining. Today's call will be led by Dr. Eric Dubé, our president and chief executive officer. Eric will be joined in the prepared remarks by Dr. Jula Inric, our chief medical officer, Peter Hirma, our chief commercial officer, and our chief financial officer. Dr. Bill Roth, senior vice president of research and development, will join us for the Q&A. Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance and achievements, to differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factor section in our Forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, February 20, 2025. and trivia specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, let me now turn the call over to Eric.

Thank you, Victoria, and good afternoon, everyone. We just completed a remarkable year, one marked by execution, innovation, and a relentless commitment to patients with rare kidney and metabolic diseases. Our exceptional progress cumulated culminated in the full FDA approval of PhilSparry for IGN nephropathy in September, a major milestone for our company and the patients we serve. In the fourth quarter, net sales at PhilSparry grew by nearly 40% compared to the third quarter, and we saw a meaningful inflection in demand following full approval. This is a testament to our sound commercial execution. alongside Pilspari's strong profile with robust long-term efficacy, including preservation of kidney function and two-year safety data. It also speaks to the ability for physicians to now prescribe Pilspari to more of their patients with IGAN with a broader label and supportive draft Cadego guidelines. I'm also excited about the progress we've been making in expanding Pilspari's potential beyond IGAN. As we highlighted last week, We recently completed our Type C interactions with the FDA and plan to submit our SMDA for a potential FSGS indication around the end of this quarter. This submission, supported by compelling data from our duplex and duet studies that we believe are further validated by the findings from the Paracel group, could lead to the first-ever FDA-approved therapy for patients with FSGS by year end. We continue to believe that FSGS represents an even greater potential opportunity to help patients, and we look forward to the submission and review process. In addition, we remain committed to generating further evidence to support PhilSparry's foundational positioning in IGAM and broad use, which Jule will touch on shortly. Also in the pipeline, we continue to believe in the disease-modifying potential for PEG-2-batinase and the hope it can bring to the HCU community. We are continuing to optimize our manufacturing scale-up of our PEG to Batinase program, and I am pleased with our recent progress. Looking ahead into 2025, our strategic priorities are clear and focused. We will leverage our recent full approval and broader label to further solidify Pilspare's foundational positioning again as the only non-immunosuppressive kidney-targeted therapy that has demonstrated superiority over historical standard of care. With the unique profile and unsurpassed clinical data, we believe that Filspare will be utilized as a new foundational therapy in IGAN, now and into the future, replacing the traditional role that RAS inhibitors have played. We will also focus on submitting a high-quality SMDA for FSGS, working with the FDA throughout the review process and preparing for a potential launch later this year. And lastly, with PEG to Batinase, we aim to maintain the momentum in our CMC efforts to enable reopening enrollment in our Phase 3 Harmony Study, and we are on track to achieve that next year. Following our successful financing near the end of the year, we are well capitalized to execute on these key strategic priorities. Let me now turn the call over to Jula for the clinical update. Jula?