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TRAVERE ™ THERAPEUTICS Travere Therapeutics Reports First Quarter 2021 Financial Results May 6 , 2021 Pivotal PROTECT Study of sparsentan in IgA nephropathy nears completion of patient enrollment ; topline proteinuria data expected 3Q21 Net product sales of $ 47.4 million for the first quarter of 2021 SAN DIEGO , May 06 , 2021 ( GLOBE NEWSWIRE ) results and provided a corporate update . -- Travere Therapeutics , Inc. ( NASDAQ : TVTX ) today reported its first quarter 2021 financial • Following achievement of the pre - specified interim FSGS partial remission of proteinuria endpoint ( FPRE ) in the ongoing Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis ( FSGS ) , the Company is engaging with regulators in pursuit of submissions for accelerated approval • The Phase 3 PROTECT Study of sparsentan in IgA nephropathy ( IgAN ) is nearing completion of patient enrollment and remains on - track to report topline data from the 36 - week proteinuria analysis in the third quarter of 2021 • Net product sales for the first quarter 2021 were $ 47.4 million , compared to $ 47.8 million for the same period in 2020 • Cash , cash equivalents and marketable securities , as of March 31 , 2021 , totaled $ 520.9 million " I am pleased with our start to 2021. Our organization is fully aligned and executing on the priorities that will enable us to develop our pipeline and ultimately deliver new treatments to people living with rare diseases , " said Eric Dube , Ph.D. , chief executive officer of Travere Therapeutics . " To begin this year , our Phase 3 DUPLEX Study of sparsentan achieved its interim proteinuria endpoint . We are in the process of engaging with the FDA and EMA in pursuit of the accelerated approval pathway for FSGS , and we look forward to providing a regulatory update in the first half of the year as previously announced . During the first quarter , we saw strong patient enrollment in our pivotal PROTECT Study of sparsentan in IgA nephropathy . This has positioned us to randomize the last patient in the study in the near future and report topline results from the interim proteinuria analysis in the third quarter of this year . Finally , we continued to strengthen our commercialization capabilities . This led to reaching new patients with our approved products despite the ongoing pandemic and has further prepared our organization to be successful with future potential launches from our pipeline . " First Quarter 2021 Financial Results Net product sales for the first quarter of 2021 were $ 47.4 million , compared to $ 47.8 million for the same period in 2020. The company estimated a favorable impact of approximately $ 1.5 million to $ 2.0 million in the first quarter of 2020 as a result of increased demand at the onset of the COVID - 19 pandemic . For the full year 2021 , the Company continues to anticipate mid - single - digit percentage growth in net product sales compared to 2020 . Research and development ( R & D ) expenses for the first quarter of 2021 were $ 47.9 million , compared to $ 30.2 million for the same period in 2020 . The difference is largely attributable to increased patient enrollment in the ongoing pivotal DUPLEX and PROTECT studies of sparsentan , as well the addition of the pegtibatinase ( TVT - 058 ) program in classical homocystinuria ( HCU ) . On a non - GAAP adjusted basis , R & D expenses were $ 44.7 million for the first quarter of 2021 , compared to $ 27.8 million for the same period in 2020 . Selling , general and administrative ( SG & A ) expenses for the first quarter of 2021 were $ 36.8 million , compared to $ 33.1 million for the same period in 2020. The difference is largely attributable to increased headcount as a result of the Company's operational growth , and professional fees . On a non - GAAP adjusted basis , SG & A expenses were $ 26.3 million for the first quarter of 2021 , compared to $ 24.0 million for the same period in 2020 . Total other expense , net , for the first quarter of 2021 was $ 6.0 million , compared to $ 3.1 million for the same period in 2020. The difference is largely attributable to a reduction in interest income . Net loss for the first quarter of 2021 was $ 53.9 million , or $ 0.96 per basic share , compared to a net income of $ 0.8 million , or $ 0.02 per basic share for the same period in 2020. On a non - GAAP adjusted basis , net loss for the first quarter of 2021 was $ 31.2 million , or $ 0.55 per basic share , compared to a net loss of $ 8.5 million , or $ 0.20 per basic share for the same period in 2020 . As of March 31 , 2021 , the Company had cash , cash equivalents and marketable securities of $ 520.9 million . This includes net proceeds of approximately $ 189 million from a common stock offering completed in February 2021 . Program Updates Sparsentan • In February 2021 , the Company announced that the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in FSGS achieved its pre - specified interim FPRE endpoint with statistical significance . FPRE is a clinically meaningful endpoint defined as urine protein - to - creatinine ratio ( UP / C ) ≤1.5 g / g and a > 40 percent reduction in UP / C from baseline . After 36 weeks of treatment , 42.0 percent of patients receiving sparsentan achieved FPRE , compared to 26.0 percent of irbesartan- treated patients ( p = 0.0094 ) . Preliminary results from the interim analysis suggest that to date in the study , sparsentan has been generally well - tolerated and has shown a comparable safety profile to irbesartan . Based on the data from the interim analysis , the Company is continuing its engagement with regulators in the first half of 2021 to discuss the ongoing study and the pursuit of an NDA submission under the Subpart H accelerated approval pathway in the U.S. , as well as an