Travere Therapeutics, Inc.

and welcome to the Travere Therapeutics First Quarter 2024 Financial Results and Corporate Update Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to the Manager of Investor Relations, Anne Croteau. Please go ahead, Anne.

Thank you, Rachel. Good afternoon and welcome to Travere Therapeutics First Quarter 2024 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube. Eric will be joined in the prepared remarks by Dr. Jule Enrig, 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 guaranteed for performance. They involve known and unknown risk, 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 files with the SEC. In addition, any forward-looking statements represent our views only as of the date such as statements are made, May 6, 2024, and Trevier 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, Anne, and good afternoon, everyone. This year, our organization is focused on executing on the key priorities that will drive sustainable growth for Travere in 2024 and the years ahead. I am pleased to report that we made significant progress on all fronts. Our commercial launch at Filspari in the U.S. is continuing to reach new highs. We successfully achieved multiple regulatory milestones with Filspari, and the first patients were dosed in the Pivotal Harmony study of PEG-2-batinase. I'll begin with the Filspari launch in the U.S. Following a strong close to 2023, our team continued to elevate performance in quarter one. Importantly, this was demonstrated across all key aspects of the launch. Increased patient demand, new and repeat prescribers, faster time to reimbursement, and broader payer access. We continue to have the highest demand amongst recent rare renal benchmarks. and we achieved 35% growth in revenue over last quarter despite the typical new year headwinds with gross to net adjustments. Notably, we are seeing the strength continue in the second quarter. This reflects strong execution by our commercial team, but also the underlying demand for a superior foundational treatment. Peter will provide further detail on the quarter one performance and our outlook shortly. To start 2024, our regulatory team achieved important milestones in our journey to deliver Filspari to more patients globally. Today, we are very pleased to report that our submission to convert Filspari from accelerated approval to full approval has been granted priority review by the FDA. This marks a critical step forward for full approval, which we expect would include a label enabling us to breach a broader set of patients living with IgA nephropathy in the U.S. Outside of the U.S., our partners made important progress with a recent conditional marketing authorization, or CMA, of Filspari for IGAN in Europe and submission of an IND for a Phase III trial in IGAN patients in Japan. Jula will provide further detail on our regulatory engagements and milestones for the rest of the year. We also made good progress on our PEG to Batenase program, which provides an opportunity for significant growth for Trevere beyond Filspari. This program is the only late-stage development candidate for HCU and the only medicine in development for HCU that has the potential to be disease-modifying. With successful efforts, we anticipate that PEG-2-batonase could become a new treatment standard in the market that we expect to grow well beyond $1 billion. We initiated the Phase III Harmony study at the end of last year, and we are pleased to have dosed our first patients in the study. Overall, we remain on track to report phase three top-line results in 2026. Now, let me turn the call over to Jula for her update. Jula?