Financial Data and Key Metrics Changes - For Q4 2025, the company reported U.S. net product sales of $126.6 million, with total net product sales for the full year reaching $410.5 million, marking significant year-over-year growth [24][29] - FILSPARI generated approximately $103 million in net product sales for Q4 2025, resulting in $322 million for the full year, representing a 144% year-over-year growth [19][24] - The company achieved a net income of $2.7 million for Q4 2025, compared to a net loss of $60.3 million for the same period in 2024 [29] Business Line Data and Key Metrics Changes - FILSPARI saw record demand with 908 new patient starts in Q4 2025, driven by strong physician adoption and confidence in its role as a foundational therapy in IgA nephropathy [18][19] - Thiola and Thiola EC contributed $23.3 million in U.S. net product sales during Q4 2025, totaling $88.5 million for the full year [25] Market Data and Key Metrics Changes - The company noted that over 96% of the patient population has a pathway to reimbursement for FILSPARI, maintaining a strong position in payer boundaries despite new competition [37] - There is increasing adoption of FILSPARI among patients with proteinuria levels below 1.5 grams per gram, which represents approximately two-thirds of the addressable IgA nephropathy population [21] Company Strategy and Development Direction - The company aims to solidify FILSPARI's foundational role in IgA nephropathy, successfully deliver the first approved medicine for FSGS, and advance enrollment in the Phase 3 HARMONY Study [9][30] - The strategy includes building a durable, growing rare disease company grounded in execution and scientific rigor, with a focus on delivering meaningful progress for patients [9][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical profile of FILSPARI as a potential FSGS therapy, despite a shift in the FDA's PDUFA action date to April 13, 2026 [8][12] - The company anticipates continued strong demand for FILSPARI and expects meaningful net product sales growth in 2026, despite modestly higher gross to net discounts [30][31] Other Important Information - The company has resumed activating clinical trial sites for the Phase 3 HARMONY study for pegtibatinase, which is designed to evaluate sustained total homocysteine control in classical homocystinuria [16] - The company reported a total of approximately $322.8 million in cash, cash equivalents, and marketable securities as of December 31, 2025 [29] Q&A Session Summary Question: Can you provide more detail on the IgA performance and how the product is being prescribed? - Management noted that demand was driven by modifications in REMS requirements and the publication of KDIGO guidelines, with the majority of utilization occurring in community-based nephrologists [35][37] Question: Have you had more significant data requests from the FDA? - Management confirmed ongoing engagement with the FDA and stated that they are on track for the April 13 action date, without providing specific details on the nature of the requests [46] Question: What proportion of new patient starts came from patients with proteinuria less than 1.5 grams per gram? - Management indicated that there is an increasing proportion of patient start forms with proteinuria levels below 1.5, although specific percentages were not disclosed [50][53] Question: What are your plans for communicating with the investor community as you approach the FSGS PDUFA? - Management stated they will enter a quiet period and provide updates following any material communication from the FDA regarding the PDUFA action [85] Question: Can you set expectations for first quarter demand relative to Q4 2025? - Management expressed confidence in strong demand exceeding 900 new patient starts but cautioned about variability in a rare disease market [90]

Financial Data and Key Metrics Changes - For Q4 2025, Travere reported U.S. net product sales of $126.6 million, with total net product sales for the full year reaching $410.5 million, marking significant year-over-year growth [21][22] - FILSPARI generated approximately $103 million in net product sales for Q4 2025, resulting in $322 million for the full year, representing a 144% year-over-year growth [17][21] - Net income for Q4 2025 was $2.7 million, or $0.03 per basic share, compared to a net loss of $60.3 million, or $0.73 per basic share, for the same period in 2024 [25] Business Line Data and Key Metrics Changes - FILSPARI saw record demand with 908 new patient starts in Q4 2025, driven by strong physician adoption and confidence in its role as a foundational therapy for IgA nephropathy [16][17] - Thiola and Thiola EC contributed $23.3 million in U.S. net product sales during Q4 2025, totaling $88.5 million for the full year [22] Market Data and Key Metrics Changes - The demand for FILSPARI continued strongly into Q1 2026, indicating robust growth potential despite new competition entering the market [19][39] - The company reported that over 96% of the patient population has a pathway to reimbursement for FILSPARI, maintaining a strong position in payer boundaries [33] Company Strategy and Development Direction - Travere aims to solidify FILSPARI's foundational role in IgA nephropathy, successfully deliver the first approved medicine for FSGS, and advance enrollment in the Phase 3 HARMONY Study [7][28] - The company is focused on building a durable, growing rare disease company grounded in execution and scientific rigor, with a commitment to delivering meaningful progress for patients [7][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical profile of FILSPARI as a potential FSGS therapy, despite a shift in the FDA's PDUFA target action date to April 13, 2026 [6][9] - The company anticipates continued growth in net product sales from FILSPARI and IgA nephropathy, with a strong balance sheet and no near-term need for additional capital [26][27] Other Important Information - The company has resumed site activation for the pivotal Phase 3 HARMONY study for pegtibatinase, which is expected to become the first disease-modifying therapy for classical homocystinuria [13][15] - Travere's strong commercial execution in Q4 2025 was evidenced by record demand and revenue, positioning the company well for sustainable growth [19][20] Q&A Session Summary Question: Can you provide more detail on the IgA performance and how the product is being prescribed? - Management noted that the strong demand in Q4 was driven by modifications in REMS requirements and the publication of KDIGO guidelines, with the majority of utilization occurring in community-based nephrologists [31][33] Question: Have you had more significant data requests from the FDA? - Management confirmed ongoing engagement with the FDA and provided requested information, remaining on track for the April 13 PDUFA date [41][42] Question: What proportion of new patient starts came from patients with proteinuria less than 1.5 grams? - Management indicated that there is an increasing proportion of patient start forms with proteinuria levels below 1.5 grams, although specific percentages were not provided [46][49] Question: What are your plans for communicating with the investor community as you approach the FSGS PDUFA? - Management stated they will enter a quiet period and provide updates following the FDA's decision, similar to previous communications [78][80] Question: Can you set expectations for Q1 as it relates to new patient starts? - Management expressed confidence in strong demand exceeding 900 new patient starts, but noted variability is expected in rare disease markets [84][85]

Financial Data and Key Metrics Changes - The company reported its strongest quarter to date, with a 40% growth in demand uptake for Filspari since receiving full approval [4][8] - The revenue growth in Q2 outpaced patient start forms, indicating a lag in payer authorization updates following the full approval [10][11] - The company expects continued revenue growth due to strong patient compliance and persistence, with less than 10% of the addressable population currently reached [13] Business Line Data and Key Metrics Changes - The launch of Filspari for IgA nephropathy has seen consistent new patient starts, averaging around 700 since Q4 of the previous year [8] - The REMS modification has simplified monitoring for patients, which is expected to enhance patient access and compliance [5][20] - The company has an accepted sNDA for FSGS, with anticipation of approval by January next year [6] Market Data and Key Metrics Changes - Over 70% of patients are managed by community nephrologists, indicating a strong prescriber base for Filspari [27] - The competitive landscape includes Atarsentan, which has a more limited label, while Filspari has shown superior long-term data [29][41] - The draft QDIGO guidelines suggest earlier and more aggressive intervention for IgA nephropathy, which could increase the patient population eligible for Filspari [30][32] Company Strategy and Development Direction - The company aims to position Filspari as a foundational treatment for IgA nephropathy and FSGS, emphasizing its dual mechanism of action [28][35] - There is a focus on generating robust data for combination therapies, particularly with SGLT2 inhibitors and potential B cell therapies [45][47] - The company is committed to addressing the needs of the rare disease community, with plans to reinitiate Phase III trials for peg debatinase next year [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing engagement with the FDA regarding the approval process for FSGS, highlighting consistency in communication [48][54] - The company anticipates a powerful year ahead for the rare disease community, with hopes of providing new therapies for conditions like FSGS and HCU [64][66] - Management emphasized the importance of hope for families affected by rare diseases, indicating a strong commitment to advancing treatment options [64] Other Important Information - The company has made significant progress in modifying REMS requirements, which is expected to facilitate broader patient access [5][20] - The competitive positioning of Filspari is strengthened by its comprehensive clinical data and favorable payer access [41][42] Q&A Session Summary Question: What were the key accomplishments over the past year? - Management highlighted the successful launch and strong uptake of Filspari for IgA nephropathy as a major achievement [4] Question: How is the prescriber base evolving? - The majority of patients are managed by community nephrologists, with a strong competitive position in that segment [27] Question: What is the outlook for revenue growth? - Continued growth is expected due to high patient compliance and the potential to reach a larger addressable population [13] Question: How does the company plan to compete with new entrants? - The company believes in the superior profile of Filspari, emphasizing its dual mechanism of action and strong clinical data [29] Question: What are the timelines for potential REMS removal? - The company plans to engage with the FDA for a potential sNDA submission for full REMS removal after the PDUFA date for FSGS [25] Question: How does the company view combination therapies? - Management sees value in generating evidence for combination therapies and anticipates that physicians will likely use these in practice [47]