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TRAVERE ™ THERAPEUTICS Travere Therapeutics Reports Second Quarter 2021 Financial Results July 29 , 2021 Company expects to submit an application for conditional marketing authorization of sparsentan for FSGS in Europe before year - end 2021 Pivotal PROTECT Study of sparsentan in IgA nephropathy on track to report topline data from interim 36 - week proteinuria endpoint in August 2021 Net product sales of $ 54.6 million for the second quarter of 2021 SAN DIEGO , July 29 , 2021 ( GLOBE NEWSWIRE ) -- Travere Therapeutics , Inc. ( NASDAQ : TVTX ) today reported its second quarter 2021 financial results and provided a corporate update . • Following interactions with the European Medicines Agency ( EMA ) during the second quarter of 2021 , the Company expects to submit an application for conditional marketing authorization ( CMA ) of sparsentan for the treatment of focal segmental glomerulosclerosis ( FSGS ) in Europe before year - end 2021 • The Phase 3 PROTECT Study of sparsentan in IgA nephropathy ( IgAN ) completed patient enrollment in the second quarter of 2021 ; topline data from the 36 - week interim proteinuria analysis are on track for August 2021 • Net product sales for the second quarter 2021 were $ 54.6 million , compared to $ 48.4 million for the same period in 2020 • Cash , cash equivalents and marketable securities , as of June 30 , 2021 , totaled $ 522.8 million " We remain steadfast in our commitment to advancing toward our goal of delivering sparsentan as a potential new treatment standard for people living with FSGS and IgAN , ” said Eric Dube , Ph.D. , chief executive officer of Travere Therapeutics . “ We are encouraged by recent interactions with EMA , and we remain on - track to submit an application for conditional marketing authorization for FSGS in Europe later this year . As previously announced , we've adjusted our U.S. timelines for FSGS and look forward to our upcoming Type A meeting with the FDA to further our collaborative discussions on the potential to stay on an accelerated approval pathway . Next month , we are looking forward to the upcoming topline results from our Phase 3 PROTECT Study of sparsentan in IgA nephropathy , which if successful , would contribute to the growing body of evidence for sparsentan in rare kidney disorders , and potentially support submissions for accelerated approval in the U.S. and conditional marketing authorization in Europe . " Quarter Ended June 30 , 2021 Net product sales for the second quarter of 2021 were $ 54.6 million , compared to $ 48.4 million for the same period in 2020. For the six months ended June 30 , 2021 , net product sales were $ 102.0 million , compared to $ 96.2 million for the same period in 2020. The increase in net product sales was attributable to growth across the Company's commercial products . Research and development ( R & D ) expenses for the second quarter of 2021 were $ 51.8 million , compared to $ 30.8 million for the same period in 2020 . For the six months ended June 30 , 2021 , R & D expenses were $ 99.8 million , compared to $ 61.0 million for the same period in 2020. The difference is largely attributable to the fully enrolled , ongoing pivotal DUPLEX and PROTECT studies of sparsentan , as well the continued development of the pegtibatinase program in classical homocystinuria ( HCU ) . On a non - GAAP adjusted basis , R & D expenses were $ 48.7 million for the second quarter of 2021 , compared to $ 28.2 million for the same period in 2020 . Selling , general and administrative ( SG & A ) expenses for the second quarter of 2021 were $ 35.0 million , compared to $ 35.0 million for the same period in 2020. For the six months ended June 30 , 2021 , SG & A expenses were $ 71.7 million , compared to $ 68.1 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 $ 24.0 million for the second quarter of 2021 , compared to $ 25.8 million for the same period in 2020 . Total other expense , net , for the second quarter of 2021 was $ 3.6 million , compared to $ 2.9 million for the same period in 2020. The difference is largely attributable to a reduction in interest income . Net loss for the second quarter of 2021 was $ 39.0 million , or $ 0.64 per basic share , compared to a net loss of $ 26.1 million , or $ 0.58 per basic share for the same period in 2020. For the six months ended June 30 , 2021 , net loss was $ 92.9 million , compared to $ 25.3 million for the same period in 2020. On a non - GAAP adjusted basis , net loss for the second quarter of 2021 was $ 23.3 million , or $ 0.39 per basic share , compared to a net loss of $ 9.9 million , or $ 0.22 per basic share for the same period in 2020 . As of June 30 , 2021 , the Company had cash , cash equivalents and marketable securities of $ 522.8 million . Program Updates Sparsentan - FSGS • In February 2021 , the Company announced that the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in FSGS achieved its pre - specified interim FSGS partial remission of proteinuria endpoint ( FPRE ) 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