Travere Therapeutics, Inc.

You're currently on hold for this Travier Therapeutics second quarter financial results and corporate update. 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. Thank you. Good day and welcome to the Travere Therapeutics Second Quarter Financial Results and Corporate Update. Today's conference is being recorded. At this time, I'd like to turn the conference over to the CFO, Chris Klein. Please go ahead, sir. Thank you.

Thank you, Caroline. Good morning and welcome to Travere Therapeutics Second 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 Hammer, our Chief Commercial Officer, and our Chief Financial Officer, Laura Clegg. 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 statement disclaimer on the company's press release issued earlier today, as well as the risk factor section in our forms 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 4, 2022. and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, I'll now turn the call over to Eric. Eric?

Thank you, Chris, and good morning, everyone. Yesterday afternoon, we provided a comprehensive regulatory update on our sparsentin and PEG-debatinase programs, which is where I will begin. First, the FDA recently communicated to us in our mid-cycle review meeting for the sparsentin, NDA, and IgA nephropathy that the review process remains on track for our PDUFA target action date of November 17th. This strengthens our confidence that we are on the path to a potential approval of sparsentin for IgG nephropathy later this year. As such, we are continuing our efforts to ready the organization for the first launch of sparsentin and I am very pleased with the progress we've made to date. The second update is that we completed our planned Type A interactions with the FDA to discuss the potential for accelerated approval of sparsentin for FSGS, and we received the final meeting minutes. Following a collaborative interaction, rather than submitting for accelerated approval this year, the FDA has recommended that we pursue traditional approval based on two-year EGFR slope data following the completion of the duplex study next year. While it is disappointing, that we will not be filing for accelerated approval this year, it does not change our belief that sparsentin has the potential to become a new treatment standard for FSGS as well as IJ nephropathy if approved. Of note, while the FDA reiterated again that we should not disclose detailed data from the ongoing study in order to assure trial integrity, they did align with us on sharing a few important elements with stakeholders. The first, is that the FDA recognizes the significant unmet need as well as the challenges in studying FSGS given its heterogeneity. There have been few clinical trials completed to date to provide insight into this disease. In many respects, we are leading the way and our duplex study is on track to deliver the largest controlled data set to date in the field. The second point is that the EGFR data since the interim analysis in the duplex study was first reported in February of 2021, we have continued to progress in a manner consistent with the profile of sparsentin. And the third is that the FDA has indicated that the duplex study as designed maintains the potential to support full approval pending completion of the study. And the FDA recommends that we pursue traditional approval based on two-year EGFR slope. These are important points as they support the fact that sparsentin is acting consistent with what we know from the history of its development and that we have confidence that the duplex study will ultimately enable us to pursue a submission for approval for FSGS. We expect to have the two-year EGFR slope and additional data available in the first half of next year. Assuming sparsentin is approved for IJ nephropathy and we see supportive two-year results from duplex, we will be in a position to submit a supplemental NDA or SNDA in the second half of next year. With this update in the U.S., we and our partners at B4 Pharma have pivoted from a joint indication submission for both IJ nephropathy and FSGS in Europe to apply for conditional marketing authorization of sparsentin for IJ nephropathy on its own this year. Pending the completion and support of data for full approval from the duplex study, we are targeting an application for approval of FSGS in Europe by the end of next year. The last update that we provided yesterday afternoon was that the FDA has granted breakthrough therapy designation to our PEG to BATNACE program for HCU. This is an exciting achievement and meaningful step forward for our program, particularly as we work to establish the biomarker pathway for a pivotal study in the US and abroad for this devastating disease. I will now turn the call over to Jula for a bit more on the regulatory updates and clinical activity. Jula?