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5/4/2026
Hello, and welcome to Trevier Therapeutics' first quarter 2026 financial results conference call. Today's call is being recorded. At this time, I would like to turn the conference call over to Nivi Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi. Thank you, Operator.
Good afternoon, and welcome to Trevier Therapeutics' first quarter 2026 financial results and corporate update call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Dr. Jula Enrich, our Chief Medical Officer, Peter Hirma, our Chief Commercial Officer, and Chris Klein, our Chief Financial Officer. Dr. Bill Rote, our Chief Research Officer, will join us for the Q&A. Before we begin, I'd 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 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 4th, 2026. Interview 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, Nidhi. Good afternoon, and thank you for joining us. This has been a tremendous start to the year for TREVIR. We've made significant progress across our three strategic priorities. We achieved the first FDA approval in FSGS. We reported a new high in demand for Filspari and IJ nephropathy, and we dosed the first new patient in the phase three Harmony study of PEG-2-batinase following restart of enrollment. April 13th marked a pivotal point for the FSGS community and Travere. Achieving the first full FDA approval for Filspari and FSGS established it as the first and only approved medicine for this rare and devastating kidney condition. With the potential to help more than 30,000 people living with FSGS without nephrotic syndrome, This approval is a significant indication expansion for Filspari and meaningfully increases the opportunity ahead for us. The first quarter also marked another period of exceptional commercial performance in IG nephropathy. We delivered another quarter of record new patient start forms. As we look ahead, We are already building upon our experience gained from the successful launch of Filspari and IgA nephropathy and are executing a strong launch in FSGS. Across IgA nephropathy and FSGS, we are now estimating that more than 100,000 patients in the U.S. could be eligible for Filspari. Together, we believe this represents a $3 billion potential peak sales opportunity for PhilSparry, reinforcing a compelling long-term growth trajectory for the company. We are also advancing our pipeline to support further sustainable growth. We recently dosed the first new patient in our Pivotal Phase III Harmony study, evaluating PEG to Batinase and classical homocysteineuria following the restart of enrollment. Importantly, Achieving this milestone puts us on track to deliver top-line results in the second half of 2027. Based on the data we've generated to date, we believe this program has the potential to become the first disease-modifying therapy for the HCU community. We expect there are approximately 7,000 to 10,000 people living with HCU globally who would be addressable for PEG to batinase. I'm incredibly proud of our team's accomplishments and look forward to accelerating Travere's growth as we expand our reach and serve more patients across the rare disease community. With that, I'll turn it over to Jula for a medical update. Jula?
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