Travere Therapeutics, Inc.

and welcome to the Travere Therapeutics Fourth Quarter and Full Year 2022 Financial Results and Corporate Update. 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.

Thank you, Rachel. Good afternoon, and welcome to Travere Therapeutics Fourth Quarter and Full Year 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 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 fact 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 statements. Please see the forward-looking statements, disclaimers on the company's press release issued earlier today, as well as the risk factors section in our Forms 10Q and 10K with the SEC. In addition, any forward-looking statements represent our views as of only the date such statements are made, February 23, 2023, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. During today's call, we will be covering certain financial results for the quarter and for the year ended December 31, 2022, including certain non-GAAP financial results. Please refer to the company's press release issued earlier today again, among other things, a reconciliation of the differences between the non-GAAP financial results and the most direct comparable GAAP financial results. You can access the press release on our website at Travere.com. With that, let me turn the call over to Eric. Eric?

Thank you, Naomi, and good afternoon, everyone. 2022 was a year of many achievements that have further strengthened our position as a leader in the rare disease community. This is founded in our mission to identify, develop, and deliver life-changing therapies to people living with rare disease. Throughout last year, we advanced our pipeline, prepared our organization for launch, and continue to reach the patients that currently rely on our approved medicines. Perhaps most importantly, our work culminated in the recent accelerated approval of PhilSparry for the reduction of proteinuria in adults with primary IgA nephropathy, or IGAN, at risk of rapid disease progression. Filspare is the first and only non-immunosuppressive medicine approved for IGAN, which has demonstrated a three-fold superior proteinuria reduction compared to a standard-of-care herbosartan. As you heard us talk about on a recent approval call, we have high aspirations for Filspare, as we believe it will become the foundational treatment option for IGAN patients who are at risk of rapid progression. Importantly, we have the deep market insights, the product profile, the team, and the strategy to achieve that goal. If we are successful, we will be able to positively impact many patients in the U.S. with this important new medicine. We are only a few days into the launch in the U.S., but we're encouraged by the initial engagement with physicians, patients, and payers. And Peter will go into it in a bit more detail shortly. We still have more exciting milestones to come with Vilspari in 2023. Beyond setting the launch trajectory in the U.S., We are anticipating a review decision from the EMA in the second half of 2023 for the conditional marketing authorization application for sparsentin in the treatment of IGAM in Europe. We will continue to work closely with our partner CSLB4 throughout the review process. And we also look forward to the two-year data from the ongoing PROTECT study. As a reminder, the interim results from the study supported the accelerated approval of Nelspari last week. As such, we are awaiting with anticipation the two-year data set, which is planned for the fourth quarter of this year. Based upon the interim results, we believe the preliminary EGFR data available at the time of the interim analysis were indicative of a potentially clinically meaningful treatment effect after two years of treatment, and that we'll be able to utilize those data for a traditional approval submission in 2024. Additionally, from Sparsentin, We expect to have top-line data from the two-year endpoint in the ongoing duplex study in FSGS during the second quarter of this year. If the results from duplex are supportive of an FSGS regulatory submission, we would anticipate being in a position to submit an SNDA in the second half of this year, and would also target submitting, together with CSLV4, a subsequent variation to our European CMA application by end of year. This would represent an incredible opportunity for us to help patients with FSGS one of the leading causes of kidney failure due to glomerular disease. Beyond sparsentin, we continue to advance our novel PEG-debatinase program for classical homocystinuria, or HCU. Later this year, we anticipate being in position to provide additional data from the ongoing COMPOSE study, as well as plans for a potential Phase III program after we complete our regulatory engagements. 2022 was a remarkable year for Travere, and I am proud of our organization's accomplishments and perseverance to ultimately get us to our first approval from our pipeline of therapies targeting rare diseases. We have started off 2023 with a key milestone that has been years in the making, and we have much more to come as we continue working towards our mission of delivering life-changing therapies to people living with rare disease. Let me now turn the call over to Jula for a clinical update. Jula?