Travere Therapeutics(TVTX) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported net product sales of $75.9 million for the first quarter, representing a 90% increase year-over-year and continued sequential growth [26][30] - Net sales for VILSPARI grew 182% year-over-year and 13% compared to the previous quarter, reflecting strong demand and uptake [7][26] - The net loss for the first quarter was $41.2 million, or $0.47 per basic share, compared to a net loss of $136.1 million, or $1.76 per basic share for the same period in 2024 [30] Business Line Data and Key Metrics Changes - VILSPARI generated approximately $56 million in net product sales in the first quarter, driven by an increasing prescriber base and deepening penetration among experienced prescribers [19][20] - Thiola and Thiola EC contributed $20 million in net product sales for the first quarter [26] - The company anticipates continued strong demand for VILSPARI in IgA nephropathy, with projected net product sales growth throughout the year [31] Market Data and Key Metrics Changes - The European Commission and MHRA in the UK converted FILSPARI's conditional approvals to full approvals for the treatment of adults with IgA nephropathy, enabling broader access across Europe and the UK [8] - Approximately 75% of nephrologists are now targeting proteinuria below 0.5 grams per gram, with nearly a third targeting even more ambitious goals of 0.3 grams [23] Company Strategy and Development Direction - The company aims to solidify VILSPARI's foundational positioning in IgA nephropathy and unlock additional growth through a potential new indication in FSGS [6] - The company is preparing for a potential launch of VILSPARI for FSGS, which is expected to be a significant opportunity, potentially larger than in IgA nephropathy [10][24] - The company is committed to advancing its investigational therapy PEG T for classical homocystinuria (HCU) and plans to restart patient enrollment in the Phase III HARMONY study next year [11][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategy with strong fundamentals and a clear focus on executing key priorities [11] - The company is monitoring legislative developments and geopolitical uncertainties but believes that any potential tariffs on pharmaceutical products would not have a material impact on VILSPARI [31] - Management highlighted the importance of the upcoming finalization and publication of the KDIGO guidelines, which are expected to reinforce the shift to earlier and more ambitious treatments [23][100] Other Important Information - The company expects to receive a $17.5 million milestone payment from CSL V4 due to the recent conversion of FILSPARI's conditional approval to full approval in Europe [30] - The company has maintained broad coverage across payers, with criteria easing following the label expansion at full approval [21] Q&A Session Summary Question: Can you elaborate on any interactions with the agency regarding the sNDA for FSGS? - Management reported that interactions with the FDA have been progressing as expected, with consistency in the review process compared to previous experiences with the IGAN indication [34][35] Question: What do you think the label for FSGS will look like? - The expectation is that the indication statement will be for the treatment of FSGS in patients ages eight and up, based on the broad inclusion criteria of the duplex study [39][42] Question: How is the recent approval of Novartis' therapy impacting your sales reps in the field? - Management noted that it is early to assess the impact, but continued demand growth has been observed, indicating confidence in FILSPARI's profile [48][51] Question: Can you provide more detail on gross to net comments? - Management indicated that gross to net discounts are expected to be in the low twenties, with a more even distribution throughout the year compared to the previous year [56][58] Question: What is the split between new versus repeat prescribers for FILSPARI? - The split is slightly skewed towards experienced prescribers, with a healthy continuation of new prescribers as well [82]