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TRAVERE THERAPEUTICS Travere Therapeutics Reports Third Quarter 2021 Financial Results and Organizational Progress October 28 , 2021 Recently reported positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgA nephropathy Following pre - NDA interactions with FDA , NDA submission of sparsentan in IgA nephropathy for accelerated approval under Subpart H expected in the first quarter of 2022 Based on FDA interactions , accelerated approval submission of sparsentan FSGS planned for mid - 2022 , pending additional supportive eGFR data from the ongoing DUPLEX Study Joint collaboration with Vifor Pharma to commercialize sparsentan in Europe ; combined IgA nephropathy and FSGS MAA submission for sparsentan in Europe expected mid - 2022 Net product sales of $ 54.2 million for the third quarter of 2021 SAN DIEGO , Oct. 28 , 2021 ( GLOBE NEWSWIRE ) Travere Therapeutics , Inc. ( NASDAQ : TVTX ) today reported its third quarter 2021 financial results and provided a corporate update . • In August 2021 , the Company reported that the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgA nephropathy ( IgAN ) met its pre - specified interim primary efficacy endpoint , demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment , compared to the active control irbesartan ( p < 0.0001 ) • In its recent pre - New Drug Application ( NDA ) interactions with the U.S. Food and Drug Administration ( FDA ) , the Company confirmed that the interim results from the ongoing PROTECT Study of sparsentan in IgAN support an application for accelerated approval under Subpart H in the U.S .; NDA submission is expected in the first quarter of 2022 • In September 2021 , the Company announced alignment with FDA on a pathway to proceed with a Subpart H NDA submission for accelerated approval of sparsentan in focal segmental glomerulosclerosis ( FSGS ) in mid - 2022 , pending additional supportive estimated glomerular filtration rate ( eGFR ) data from the ongoing DUPLEX Study • The Company has formalized plans for a combined IgAN and FSGS Marketing Authorization Application ( MAA ) for sparsentan in Europe ; submission is expected in mid - 2022 • In September 2021 , the Company entered into a joint collaboration and licensing agreement with Vifor Pharma for the commercialization of sparsentan in Europe , Australia and New Zealand • Ruth Williams - Brinkley joined the Board of Directors , bringing to Travere more than 35 years of executive leadership in care delivery and health plan operations • Net product sales for the third quarter 2021 were $ 54.2 million , compared to $ 51.1 million for the same period in 2020 • Cash , cash equivalents and marketable securities , as of September 30 , 2021 , totaled $ 551.2 million , which includes the $ 55.0 million upfront payment from the joint collaboration and licensing agreement with Vifor Pharma " The third quarter was pivotal for our sparsentan development programs . In August , we announced impressive topline interim results from the ongoing Phase 3 PROTECT Study of sparsentan in IgA nephropathy , and we recently concluded successful pre - NDA interactions with the FDA that put us on track for an NDA submission for accelerated approval in the first quarter of next year , " said Eric Dube , Ph.D. , chief executive officer of Travere Therapeutics . " We also made regulatory progress that positions us for additional submissions mid - next year , including a potential NDA submission for accelerated approval of sparsentan for FSGS , and a combined IgA nephropathy and FSGS MAA submission for conditional marketing authorization in Europe . We look forward to continuing our strong execution through the balance of 2021 , and to building upon the strength of our existing commercial organization to prepare for multiple potential launches of sparsentan , if approved . " Quarter Ended September 30 , 2021 Net product sales for the third quarter of 2021 were $ 54.2 million , compared to $ 51.1 million for the same period in 2020. For the nine months ended September 30 , 2021 , net product sales were $ 156.2 million , compared to $ 147.3 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 third quarter of 2021 were $ 48.4 million , compared to $ 32.3 million for the same period in 2020 . For the nine months ended September 30 , 2021 , R & D expenses were $ 148.2 million , compared to $ 93.4 million for the same period in 2020. The difference is largely attributable to the fully enrolled and ongoing pivotal DUPLEX and PROTECT studies of sparsentan , as well as the continued development of the pegtibatinase program in classical homocystinuria ( HCU ) . On a non - GAAP adjusted basis , R & D expenses were $ 45.2 million for the third quarter of 2021 , compared to $ 29.5 million for the same period in 2020 . Selling , general and administrative ( SG & A ) expenses for the third quarter of 2021 were $ 36.1 million , compared to $ 32.0 million for the same period in 2020. For the nine months ended September 30 , 2021 , SG & A expenses were $ 107.8 million , compared to $ 100.1 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 $ 25.5 million for the third quarter of 2021 , compared to $ 22.9 million for the same period in 2020 .