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]