Travere Therapeutics, Inc.

and welcome to the Travere Therapeutics Second 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 Vice President of Corporate Communications and Investor Relations, Nivi Naira. Please go ahead, Nivi.

Thank you, Rachel. Good afternoon, and welcome to Travere Therapeutics Second 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 Dubé. 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, Senior Vice President of Research and Development, will join us for the Q&A session. 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, August 1, 2024, and Trevere 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, Nivi, and good afternoon, everyone. In the second quarter, we continued to make significant progress on our key priorities. At the center of our growth is PhilSparry, which is becoming a foundational therapy for IG nephropathy, giving patients hope for a better future. Our launch performance continues to strengthen. During the second quarter, we set new highs in demand and revenue, and we are on track to outperform benchmark launches in year two. MilSpar is the only rare renal launch to consistently deliver quarter-over-quarter growth in new patient start forms through the first six quarters of launch, which speaks to high demand from physicians and patients and our ability to achieve our goals. This strength is being driven by positive trends in all of our key growth factors, including increasing breadth and depth of prescribers, strong payer coverage, and continuing improvements in our pull-through process. From a regulatory perspective, our S&DA review process for full approval in IGAN continues as planned, and we are eagerly preparing for full potential approval next month. To date, our educational and promotional focus has been on the rapid and profound impact on proteinuria and the results from our interim readout from PROTECT. We are excited about the opportunity to build further momentum in the launch that an updated label would provide, including the ability to educate on two-year data from the most rigorous study conducted in IGAN. We anticipate that a broader label would enable us to reach more patients. Specifically, we estimate PhilSparry's addressable IGAN patient population in the future could nearly double over the time from the current level. And the two-year data should build even more conviction in prescribing Filspari since it will potentially provide an opportunity for our teams to clearly highlight long-term durable proteinuria reduction, long-term kidney function preservation, and two-year safety data. And our teams are ready. We also continue to make progress in bringing Filspari to IGAN patients in other parts of the world. Our partner in Europe, CSLB4, is preparing for the first launch of Pilspari in that region very soon. In Japan, Rinalis recently dosed the first patient in their pivotal study, which is expected to have results in the second half of 2025, and to support a submission to Japanese regulators for approval. As for the additional priorities to expand our growth, we are encouraged by the ongoing work regarding FSGS endpoints by the Paracel Group, and we remain hopeful that we will be able to identify a regulatory path to bring PhilSparry to patients diagnosed with FSGS. We plan to engage with regulators later this year and to provide an update following those discussions. And finally, PEG-2-Batinase continues enrollment activities in furtherance of a planned top-line readout in 2026. As we outlined at the start of the year, 2024 is a year of execution for Travere. As we move into the second half of the year, I am proud of our teams and how they have continued to execute exquisitely across our priorities, all while keeping the needs of patients front of mind. I'll now turn the call over to Jula for an update on our development activities. Jula?