Travere Therapeutics, Inc.

Good afternoon and welcome to the Travere Therapeutics First Quarter 2025 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 First Quarter 2025 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Eric Dubé, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Dr. Jule Inric, our Chief Medical Officer, Peter Hirma, our Chief Commercial Officer, and Chris Klein, our Chief Financial Officer. Dr. Bill Roth, our Chief Research Officer, will join us for the Q&A. Before we begin, I'd 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 risk factors 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, May 1st, 2025. EntraViewer 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 entered the year determined to solidify Phil Sparry's foundational positioning in IG nephropathy, unlock additional growth for Phil Sparry through a potential new indication in FSGS, and continue advancing toward restarting enrollment in our Pivotal Harmony study of PEG-2-Batinase in HCU. And I'm pleased to report that we are making great progress with strong results in each of these three areas. Let me begin with Vilspari and IGAN. Following its full approval last fall, we saw momentum continue throughout the first quarter. Net sales at Vilspari grew 182% year over year and 13% versus the prior quarter, which reflects continued demand and strong uptake. We also continue to see high compliance rates, a growing patient base, and an expanding group of prescribing physicians, which illustrates the positive PhilSparry experience. This strengthens our confidence in the durability and long-term trajectory of growth. At a time of continued evolution in the IGAN treatment landscape, PhilSparry remains uniquely positioned as the only fully approved non-immunosuppressive kidney targeted therapy that has shown superiority over the historical standard of care. Recent market research continues to validate this positioning as nephrologists regularly highlight PhilSparry's strong clinical data, real-world effectiveness, and safety profile for chronic use, all of which underscores its role as a foundational therapy for IGAN. We continue to believe that PhilSparry can become foundational care outside of the US as well. Recently, the European Commission and the MHRA in the UK converted PhilSparry's conditional approvals to full approvals for the treatment of adults with IGAN, an important milestone that will enable our partner, CSLV4, to expand access to patients across Europe and the UK. Our partner, Renalis, also continues to make good progress, and they remain on track to report top-line data in the second half of this year from their pivotal study in IGAN to support a regulatory submission in Japan. Turning to FSGS, we have made excellent progress towards our role of bringing Filspari to a community that currently has no approved medication. After aligning with the FDA on our plan to submit an SNDA for an FSGS indication, we completed our submission in March. This reflects our team's dedication to a community that has been waiting for decades. We expect to receive notification of the FDA's acceptance of this filing later this month. If we are granted priority review, as expected, Filspari could be approved and ready to launch in FSGS as early as September. This would mark a historic milestone. Filspari would become the first and only approved medication indicated for patients with FSGS. We continue to believe that the opportunity in FSGS is potentially even larger than that in IGAN, given the urgent unmet need in this disease. Our team is advancing preparations to execute a successful launch so we can deliver Vilspari to the FSGS community quickly, if approved. We also remain very enthusiastic about PEG-2-Batinase, or PEG-T, our investigational therapy for classical homocysteineuria, or HCU. PEG-T has the potential to be the first disease-modifying treatment for HCU, and we continue to make strong progress towards restarting patient enrollment in the Phase III Harmony study next year. We remain committed to the HCU community and believe PEG-T has the potential to significantly improve the lives of these patients in the future. Looking ahead, we remain confident in our strategy with strong fundamentals and a clear focus on executing our key priorities. Let me now hand the call over to Jula for a clinical update. Jula?