Travere Therapeutics, Inc.

Good day and welcome to the Travere Therapeutics first quarter 2023 financial results and corporate update conference call. Today's conference is being recorded. At this time, I would like to turn the conference call over to Vice President of Investor Relations, Naomi Eichenbaum. Please go ahead, Naomi.

Thank you. Good afternoon and welcome to Travere Therapeutics first quarter 2023 financial results and corporate update call. Today's call will be led by our Chief Executive Officer, Dr. Eric Dubé. Eric will be joined in the prepared remarks by Dr. Jule Inrig, our Chief Medical Officer, Peter Herma, our Chief Commercial Officer, and Chris Klein, our Chief Financial Officer. Dr. Bill Rote, Senior Vice President of Research and Development, will join us for the Q&A session. 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 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 4th, 2023. And Travere 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. Eric?

Thank you, Naomi. And good afternoon, everyone. The first quarter of 2023 has been one of critical milestones representing significant progress across the organization. These advancements have positioned Trevere for sustained growth led by the ongoing launch of Filspari in IgA nephropathy and bolstered by the continued progression of our pipeline. The most notable achievements in the quarter was the U.S. accelerated approval of Filspari, or sparsentin, for the reduction of proteinuria in adults with primary IgA nephropathy, or IgAN, at risk of rapid disease progression. The approval of Filspari marked the first and only non-immunosuppressive therapy for the reduction of proteinuria in IGAN. While we are only in the early stages, the commercial launch is progressing very well and in line with our expectations. Today, we'll focus on the important takeaways from the first six weeks, but I am very pleased with the early demand and the commercial organization's execution, which instills confidence that we will effectively position Filspari to meet or exceed our internal goals for the year. Furthermore, we were very excited to see the interim results from the PROTECT study published in The Lancet. These data further elucidate the clinical profile of Philspari, demonstrating a greater than three-fold reduction of proteinuria from baseline after 36 weeks of treatment compared to the active control Herbisartan. The compelling data set support our confidence in a positive outcome from the two-year secondary endpoints in the fourth quarter of this year. Overall, it was a great quarter for our efforts to establish the foundation for Filspari to become a new treatment standard in IGAN for the addressable population. Earlier this week, we were disappointed to report that our Phase III duplex study of sparsentin and FSGS did not achieve the primary efficacy EGFR endpoints. FSGS is a very difficult disease to study. Despite this, sparsentin still managed to demonstrate a consistent profile characterized by sustained proteinuria reduction and a well-tolerated safety profile over two years. We will continue to analyze the data sets and engage with the FDA and EMA to explore the potential for future regulatory submissions in FSGS. Once we've completed this, we'll provide an update on our direction. With regard to PEG-2-batinase, we continue to be highly encouraged by the forward momentum in our program for classical homocysteineuria, or HCU. As many of you will recall, HCU is a serious and progressive metabolic disorder that can lead to thrombotic events, serious vision problems due to lens dislocations, bone malformation, and a constellation of mental and psychiatric complications. Importantly, PEG-2-batinase is well-positioned to potentially become the first and only disease-modifying approach to treat HCU. We have made recent strides in our program and remain on track to report data from Cohort 6 in the second quarter. We are incredibly grateful to the patients, family members, and physicians who have supported us in our pursuit of therapeutic advancements for diseases with high unmet needs Our team remains committed to our mission of improving the lives of those living with rare disease, delivering for our patients, for the rare disease community, and our shareholders. Now let me turn the call over to Jula for a clinical update. Jula?