Travere Therapeutics, Inc.

Welcome to the Travere Therapeutics Second Quarter 2023 Financial Results and Corporate Update Conference Call. Today's conference call is being recorded. At this time, I would like to turn the conference call over to the Vice President of Investor Relations, Naomi Eichenbaum. Please go ahead, Naomi.

Thank you. Good afternoon, and welcome to Travere Therapeutics Second Quarter 2023 Financial Results and Corporate Update Call. Thank you all for joining us. Today's call will be led by our Chief Executive Officer, Dr. Eric Dube. Eric will be joined in the prepared remarks by Dr. Jula 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 statements disclaimer on the company's press release issued earlier today, as well as the risk factor section in our Form 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 3rd, 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. In the first half of 2023, we made significant progress on our corporate strategy of delivering new treatment standards from our pipeline of innovative medicines for people living with rare disease. Our progress has been led by the ongoing successful launch of Filspari, or sparsentin. Filspari is the first and only non-immunosuppressive therapy approved for the reduction of proteinuria in adults with IgA nephropathy, or IGAN, at risk of rapid disease progression. We believe that PhilSparry holds the potential to help 30,000 to 50,000 addressable IGAM patients, and our field teams continue to hear from nephrologists that their experience with PhilSparry is reflective of an efficacy and safety profile demonstrated in the interim readout from the PROTECT study. In fact, last week, I spent a day in the field with a PhilSparry sales representative visiting commuting nephrologists. One physician shared a compelling patient story about a young woman with IGAM at risk of rapid disease progression and struggling with proteinuria levels above two grams per day, despite treatment with several therapies. After a few short weeks on Fils-Fari, her proteinuria level had significantly dropped below one gram per day. The physician noted that these types of results provide them with confidence to prescribe Fils-Fari to a greater number of their addressable patients with IGAN. We are encouraged to hear this positive feedback from the field, And the nephrologists are both re-prescribing and proactively identifying more eligible patients to use Filspari in their practices. These insights on physician feedback and demand provide us with confidence in the potential of Filspari to ultimately become a new treatment standard for IGAM. In the second quarter of 2023, we executed on our Filspari launch strategy and are observing strong performance on the two most important indicators of success. demand reflected in the growth of patient start forms, or PSFs, and patient access driven by increasing and broader payer coverage. In fact, we delivered the highest number of PSFs in the first quarter launch since launch among other rare renal launch benchmarks. Later this year, we expect to announce the complete results from the PROTECT study that we believe will have the potential to support traditional approval and the potential for a broader label of filspari in IGAN. The study is ahead of our initial guidance, and we now expect a top-line readout from PROTECT late in the third quarter or early in the fourth quarter. Looking beyond the U.S., we continue to work with our collaborator, CSLV4. Regulatory reviews in Europe are underway for sparsentin and IGAN, and we anticipate an opinion from the CHMP around the end of this year. Our top priority is ensuring a successful launch of Pilspari, and we believe that we are off to a strong start. In parallel, we have also continued to make progress on our other pipeline programs. We continue to believe that sparsentin may represent an important treatment option for patients with FSGS. In May, we reported top-line results from the Phase III duplex study of sparsentin and FSGS, in which sparsentin demonstrated significant and durable effects of proteinuria reduction, positive trends on EGFR, and a well-tolerated safety profile over two years of treatment. While the study did not achieve statistical significance on the EGFR endpoints, we are encouraged by the totality of data. We are scheduled to meet with the FDA to explore the potential for a future regulatory submission for sparsentin in FSGS and expect to provide an update on that discussion in the fall. Shifting to beg to that note, With the recent positive update from Cohort 6, we are even more confident that PEG-2-Batinase represents a significant opportunity for us to help patients with HCU and for our company to accelerate our growth in the coming years. Based on our growing body of market research, we understand there to be a population of approximately 3,500 addressable HCU patients in the U.S., a similar number in Europe, and a meaningful number of patients in additional geographies. Importantly, over time, we see this addressable patient population potentially increase by 50% or more with the introduction of an innovative new therapy and advancements in diagnostics. This is why we are excited to continue focusing our efforts on this program, and we are working towards initiating a pivotal study by year end. Outside of our innovative pipeline, we recently announced that we have entered into an agreement for the sale of our bile acid product portfolio for up to $445 million, consisting of $210 million up front and up to an additional $235 million in potential future sales-based milestone payments. This divestment, which is expected to close during the third quarter, will meaningfully strengthen our balance sheet and, most importantly, has clear strategic benefits for our organization. Strategically, it will enable us to focus even more clearly on the successful launch of Filspare and IGAN, pursuing a potential regulatory path for sparsentin and FSGS, the development of pectobatinase for the treatment of HCU. We believe successfully delivering on these priorities will position our medicines to become potential treatment standards, each in markets with billion-dollar potential. Overall, for the second quarter, I am incredibly proud of our team's performance. We continue to progress each of our strategic priorities and have made important advancements with our pipeline of innovative products. We have successfully delivered a strong first full quarter of the launch, laying the groundwork for our goal of enabling Filspari to ultimately become the foundational therapy in IGAD. Let me now turn the call over to Jula for a clinical update. Jula?