Travere Therapeutics(TVTX) - 2022 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q2 2022, total revenue was reported at $54.2 million, consisting of approximately $51 million in net product sales and $3.2 million in collaboration revenue, compared to $54.6 million in net product sales for the same period in 2021 [31] - The company reported a GAAP net loss of $67 million for Q2 2022, with a non-GAAP net loss of $41.3 million after adjusting for noncash expenses and income tax [31][32] - Cash and cash equivalents at the end of Q2 2022 stood at $553.2 million, which is expected to support operations into 2024 [33] Business Line Data and Key Metrics Changes - The sparsentan program is on track for a potential approval for IgA nephropathy by the PDUFA target action date of November 17, 2022, while the FSGS program is pursuing traditional approval based on 2-year eGFR slope data [7][11] - The pegtibatinase program received breakthrough therapy designation from the FDA, indicating significant unmet need and promising data [12][22] Market Data and Key Metrics Changes - The company is preparing for the launch of sparsentan for IgA nephropathy, with strong engagement from the nephrology community and patient advocacy groups [16][27] - The bile acid portfolio, led by Cholbam, performed well during the quarter, with expectations for growth in the second half of the year [24] Company Strategy and Development Direction - The company aims to position sparsentan as a foundational therapy for IgA nephropathy and FSGS, focusing on medical education and engagement with nephrologists [13][30] - The strategy includes applying for conditional marketing authorization of sparsentan for IgA nephropathy in Europe, with a review decision anticipated in the second half of 2023 [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential approval of sparsentan for IgA nephropathy and the ability to submit a supplemental NDA for FSGS based on supportive data from the DUPLEX study [11][36] - The company is focused on ensuring broad access to sparsentan, with plans to price it competitively to achieve its vision of making it a new treatment standard [72] Other Important Information - The company completed its recruitment of the field force to support the potential launch of sparsentan, with team members having significant nephrology experience [26] - The company anticipates increases in R&D and SG&A expenses as it prepares for the potential launch of sparsentan [32][33] Q&A Session Summary Question: What 2-year data from DUPLEX was the FDA able to look at? - The FDA reviewed a descriptive look at the composite of all available eGFR data for the sparsentan arm and the irbesartan treatment arm, without breaking it down by duration in the study [42] Question: Are you expecting the initial patient bolus to start sparsentan post-approval? - Initial uptake is expected to be strong once physicians gain experience with sparsentan, despite the conservative nature of nephrologists as prescribers [46] Question: Has the FDA quantified what the threshold is for FSGS approval? - The FDA has not set a specific threshold but acknowledged the high bar for accelerated approval due to the challenges in studying FSGS [50] Question: Can you elaborate on the heterogeneity of the FSGS patients enrolled in DUPLEX? - The trial enrolled a wide spectrum of FSGS patients, including those with primary FSGS and genetic patients, representing the largest trial of FSGS patients to date [59] Question: Have you thought about pricing to balance patient benefit with value? - The company has not disclosed specific pricing yet but is studying the burden of disease and the value proposition of sparsentan [70][72]