Travere Therapeutics, Inc.

and welcome to the Travere Therapeutics conference call. Today's conference is being recorded. At this time, I'd like to turn the conference over to the Senior Vice President of Investor Relations, Chris Klein. Please go ahead, sir.

Great. Thank you, Justin. Good afternoon, and welcome to Travere Therapeutics' first 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 for the prepared remarks by Dr. Jule Enrig, our Chief Medical Officer, Peter Herma, our Chief Commercial Officer, and our Chief Financial Officer, Laura Clay. 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 major in this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Security Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risk. 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 reforms 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, May 5th, 2022, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. I'll now turn the call over to Eric.

Eric? Thank you, Chris, and good afternoon. I'm very pleased with our progress to start 2022. During the first quarter, we made significant headway on our key priorities of advancing our pipeline of potential first-in-class treatments for people living with rare disease and preparing our organization for potential launches of sparsentin if approved. Most notably during the quarter, we achieved an on-time submission of our new drug application, or NDA, for accelerated approval of sparsentin in IgA nephropathy. We look forward to receiving notice later this month from the FDA regarding the acceptance of the NDA as well as the timeline for review. If the NDA is accepted and we are granted priority review, we would anticipate a launch in IgA nephropathy as early as the end of this year if sparsentin is approved. We are also on track to submit additional EGFR data from the ongoing duplex study to the FDA this quarter. Consistent with our prior guidance, we will be providing an update following our regulatory interactions, but we will not be providing incremental updates before then. As a reminder, we believe the potential outcomes that are either the FDA is supportive of a submission of accelerated approval for FSGS, in which case we will be preparing to submit an MDA under Subpart H in the coming months, or that the FDA recommends that we instead wait until full completion of the study in the first half of next year, and we would subsequently expect to submit for full approval in 2023. Together with our European partner, B4 Pharma, we also remain prepared to submit a combined IgA nephropathy and FSGS MAA submission for conditional approval of sparsentin in Europe, pending alignment with the regulatory path in the U.S. I am also pleased with the further positive reception of the data from our ongoing Phase 1-2 COMPOSE study of PEG-debatinase following its presentation at SIND last month. PEG-debatinase represents an exciting potential new treatment for people living with classical homocystinuria, or HCU. And we look forward to continuing to progress our discussions with regulators on the design of a pivotal program. On the commercial side of the business, our performance for the quarter was strong and in line with expectations in a challenging environment. As many of you will recall during our end of year update, we outlined that in 2022, we do not anticipate overall growth in net product sales due to the generic dynamics for Fiola. Our first quarter performance is consistent with that guidance. Demand across all products in the quarter increased. In fact, we are seeing a return to pre-pandemic levels for overall demand. And the bile acid portfolio continues to perform well. But as expected, the dynamics for the evolving competitive landscape in Cystinuria are beginning to put pressure on the net revenue from our Sciola business. This shift is accounted for in our planning, and I continue to be incredibly impressed by our team's ability to maintain continuity of the business and support for the patient community despite these challenges. Notably, Peter and the commercial organization continue to do a fantastic job of building upon the strengths and expertise of our current sales team in nephrology to prepare for a launch of sparsentin in the U.S. as early as the end of the year if approved. As a result of our progress to date, both in the clinic and from a commercial preparation perspective, I remain confident that if approved, sparsentin can become a new treatment standard for the many patients with rare kidney disease currently facing a rapid progression to dialysis. Finally, during the quarter, we strengthened our financial foundation through the convertible refinancing transactions enacted in March. These transactions resulted in us being able to effectively extend the maturity on the vast majority of our convertible notes from 2025 to 2029 and add modest incremental cash to the balance sheet. Let me now turn the call over to Jula for a clinical update. Jula?