Travere Therapeutics, Inc.

You are currently on hold for the Travere Therapeutics third quarter 2022 financial results and corporate update call. At this time, we are assembling today's audience and plan to be underway shortly. We appreciate your patience and please remain on the line. Good day and welcome to the Travere Therapeutics Third Quarter 2022 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, Kari.

Good afternoon, and welcome to Trivia Therapeutics' third quarter 2022 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 Dubé. Eric will be joined in the prepared remarks by Dr. Jula Enrich, our Chief Medical Officer, Tia Herma, our Chief Commercial Officer, and Chris Klein, our Chief Financial Officer. Dr. Bill Roach, 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 10Q and 10K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, October 27th, 2022. And Trevier specifically disclaims any observation 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 welcome to Tavir. And good afternoon, everyone. During the third quarter, we continued to execute toward our vision of being a leader in the global rare disease community. We did this through the continued development of our pipeline with the objective of positioning it for sustainable, diversified growth for years to come, and by strengthening our organization to support broad access to our approved medicines while being in a position to meet the need of patients as our potential new therapies become available. Notably, during the quarter, we continued our efforts to position sparsentin to become the first non-immunosuppressive therapy for IJ nephropathy and FSGS as a potential new treatment standard if approved. A couple of weeks ago, we provided a regulatory update on our NDA for sparsentin in IJ nephropathy that is currently under priority review with the FDA for subpart H accelerated approval. In that update, we were pleased to report that we had received a draft label on time. that no advisory committee is expected, and no new data or trials have been requested as part of the review process. During our late cycle meeting interactions, the FDA did unexpectedly ask us to incorporate liver monitoring into our planned REMS. I am pleased to report that we have submitted our proposed updated REMS, and we recently received confirmation of the expected three-month extension of our PDUFA target action date which is now February 17, 2023. Perhaps most notably, we have been very pleased with the continued enthusiasm for the strength of our clinical data supporting the profile of sparsensis. We have continued to hear this from the nephrology community since the update was provided a couple of weeks ago. I would also like to highlight that while the submission of a revised REMS has resulted in an extension of our PDUFA target action date, Our teams were well prepared and in a strong position to launch this November. This is a great testament to Peter and his teams, and to the whole organization, as it is no small feat to prepare for the launch of a potential new treatment standard. We will utilize the added time to further enhance our understanding for how we can best support patients and providers in the IJ and nephropathy community, and be even more prepared for a successful launch. Outside of the U.S., we were very pleased to have the EMA accept for review the conditional marketing authorization application for sparsentin for the treatment of IgA nephropathy. We look forward to working closely with our partner CSLV4 throughout the review process, and we expect a review decision on a potential approval in the second half of 2023. Lastly, on sparsentin, we continue to be pleased with the progress of our ongoing pivotal duplex study in FSGS. and we look forward to top-line data from the two-year endpoints in the first half of next year. If the data are supportive of an FSGS regulatory submission and assuming approvals in IgA nephropathy, we would anticipate being in a position to submit an SNDA in the second half of next year and a subsequent variation to our European CMA application. Elsewhere in the pipeline, our PEG to Batinase program for classical homocystinuria, or HCU, continues to advance. Jula will be going into a bit more detail shortly, but we're pleased with our regulatory interaction during the quarter, which enabled us to advance on the path towards utilizing a total homocysteine biomarker as a primary endpoint in a Phase III study. Let me now turn the call over to Jula for the clinical update. Jula?