Travere Therapeutics, Inc.

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

Thank you. Good afternoon and welcome to Travere Therapeutics Third Quarter 2023 Financial Results and Corporate Update Call. Thank you all for joining. 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 Enrig, our Chief Medical Officer, Peter Herma, our Chief Commercial Officer, and Chris Klein, our Chief Financial Officer. Dr. Bill Root, 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 and 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 factors section in our Forms 10-Q and 10-K filed with the SBC. In addition, any forward-looking statements represent our views only as of the date such statements are made, November 7, 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. During the third quarter, we executed our key corporate priorities to further strengthen our leadership position in the rare disease community. Notably, during the quarter, we made progress with our launch of Filspari and IGAN and reported two-year data from the PROTECT study that we believe will position Filspari to play an important foundational role in the IGAN treatment landscape. Additionally, we completed a successful end of phase two meeting for our PEG-debatinase program putting us on track for the phase three study initiation of PEG to betonase by year end. And we completed the divestiture of the bile acid product portfolio, enabling us to further focus on our key priorities. Regarding the ongoing launch of Philspari, we continued to execute our strategy for Philspari to become a new foundational treatment in IGAN. In the third quarter, we helped to reach even more patients. And every week we hear stories from physicians and patients of how well PhilSparry is working for them. Over the course of a quarter, we identified that additional patient education and support could improve the performance of the launch, specifically in onboarding new patients after a patient start form has been submitted, and we quickly adjusted. Notably, we are seeing early positive trends from these adjustments through October, and Peter will provide additional details shortly. Overall, we have built a solid foundation of physician demand, with growth in new patient start forms and payer coverage. And together with the initial signs of a positive impact from our enhancements in the quarter, we have confidence in the successful future of the TIL SPARI launch. We are just returning from ASN Kidney Week, the largest nephrology congress of the year. It was truly exciting and humbling to have both of our phase three studies of sparsentin in IGAN and FSGS presented as late breaker oral presentations and published simultaneously in the Lancet and New England Journal of Medicine, world-renowned peer-reviewed scientific journals. Key opinion leaders who were at the Congress spoke positively about these groundbreaking results and recognized the role of sparsentin in providing deep and durable reductions in proteinuria and kidney function preservation compared to an active comparator for patients with IGAN and FSGS. This, in conjunction with the Lancet publication on the PROTECT study, should further lay the groundwork for potential inclusion into KDGO guidelines for IGAN and should enable SILSFARI to become a new foundational therapy for this disease. Consistent with previous guidance regarding our U.S. regulatory engagements, we remain on track to provide updates for both FSGS and IGAN this quarter. In parallel, our team is compiling the Supplemental New Drug Application, or SNDA, for IGAN. so that we're in a position to submit in the first half of 2024 for full approval in the U.S. In Europe, the Conditional Marketing Authorization Evaluation for sparseness in the NIGAN is progressing. Together with our partner CSLB4, we continue to anticipate a review opinion around year-end for the CHMP. Regarding our exciting PEG to BATNAGE program, we are on track for an expected Phase III study initiation by year-end. In late October, FDA hosted a patient-focused drug development panel on classical HCU. We are grateful for the HCU patients and their caregivers for sharing their stories about living with HCU. The need for better therapies, the ability to improve diet, and improve testing was incredibly clear, and we feel the sense of urgency to execute our phase three program. Our confidence and the potential For PEG-2-Batinase to become the first and only disease-modifying therapy for people living with classical HCU continues to grow, and we're looking forward to sharing additional updates on the program in the near term. Lastly, during the quarter, we completed the sales of bioasset portfolio to Merum Pharmaceuticals. This transaction further strengthens our balance sheet and our focus on our key priorities of achieving success with Tilspari and advancing PEG-2-Batinase into Phase III. Let me now turn the call over to Jula for a clinical update. Jula?