Travere Therapeutics, Inc.

Good afternoon and welcome to the Travere Therapeutics Third 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 Nivi Nera, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.

Thank you, Operator. Good afternoon and welcome to Travere Therapeutics' Third Quarter 2025 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Dr. Eric Hubei, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Dr. Jula Enrich, our Chief Medical Officer, Peter Hirma, our Chief Commercial Officer, and Chris Klein, our Chief Financial Officer. Dr. Bill Rote, 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 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, October 30th, 2025. Interviewers 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, Nivi, and good afternoon, everyone. The third quarter marked exceptional progress across our three key priorities. delivering strong commercial execution in IgA nephropathy, preparing for a potential FDA approval in FSGS, and successfully advancing the manufacturing scale-up of PEG-2-batinase to support restarting enrollment in the Pivotal Harmony Study in 2026. The core driver of our performance is Silspari's continued growth in IgA nephropathy, where we delivered sustained commercial excellence in the third quarter. Physicians continue to confidently adopt Silspari as a foundational nephroprotective therapy for their patients. This confidence reflects consistent real-world outcomes, robust long-term data reinforcing Silspari's differentiated profile, and its recent inclusion in the CADEGO guidelines for earlier first-line use to optimize nephroprotection in IGANS. Additionally, in August, the FDA approved a modification to the Filspare REMS program, removing the embryo fetal toxicity REMS and reducing the liver monitoring frequency to quarterly, which aligns with routine clinical practice and our clinical trial experience. This change not only simplifies care for physicians and patients, but also reinforces Filspare's long-term safety profile. Our U.S. performance continues to be complemented by strong progress from our partners globally. In Europe and the UK, CSLv4 is expanding access following full regulatory approvals, and the progress has culminated in the recent achievement of a meaningful market access milestone. In Japan, Rinalis completed enrollment in its registrational trial in IGAN and remains on track to deliver top-line data in quarter four. The company also reached an agreement with the PMDA of Japan to initiate two phase three trials for sparsentin in FSGS, and Alport syndrome, and recently announced its planned acquisition by Chugai, a leading innovator in renal and rare disease research in Japan. Together, these milestones underscore PhilSparry's expanding global footprint and the growing excitement around its long-term potential to transform care for rare kidney diseases. Beyond our progress in IGEN, addressing the urgent need for an approved medication in FSGS is both central to our mission and represents the next pillar of growth for Trevir. Today, there are no FDA-approved medicines for this disease. Patients often experience rapid disease progression with many reaching kidney failure within just a few years of diagnosis, often requiring a transplant. Even then, The disease recurs in approximately half of transplant recipients. The consequences are devastating for patients and their families. Earlier and more effective treatment is desperately needed, which is why the opportunity to bring Silspari forward in FSGS is so meaningful for this community who have waited far too long. In September, the FDA communicated that an advisory committee is no longer needed for our SMDA and FSGS. We've been pleased with the progress of our review and our ongoing engagement with the agency to date. Pending approval, Bilspari will become the first and only approved medication for FSGS, representing a landmark moment for this community, and given the urgent need for an effective approved medication, a transformational opportunity for Trevere. Our teams are fully prepared to execute a rapid launch upon approval. building upon the commercial foundation we've established in IG nephropathy. Beyond Filspari, we have successfully manufactured the first commercial scale batches of PEG-2-batinase and are looking forward to an expected restart of the pivotal Harmony study of PEG-2-batinase in classical HCU next year. PEG-T remains a promising, potentially disease-modifying investigational therapy that could address a substantial gap for patients living with this rare metabolic disorder. I'll now turn the call over to Jula for a clinical update. Jula?