Travere Therapeutics (NasdaqGM:TVTX) FY Conference Transcript

Summary of Travere Therapeutics FY Conference Call Company Overview - Company: Travere Therapeutics (NasdaqGM:TVTX) - Date: December 02, 2025 - Key Focus: The company is focused on the ongoing launch of FILSPARI for IgA nephropathy, an SNDA with the FDA for FSGS, and enzyme replacement therapy for classical homocystinuria (HCU) [2][3][4] Core Points and Arguments FILSPARI Launch and Growth - IgA Nephropathy: The launch of FILSPARI is seeing strong growth, supported by the nephrology community and recent KDIGO guidelines that emphasize urgency in treating patients to prevent kidney failure [2] - Patient Reach: The company has reached a significant number of new patients this year, indicating robust market acceptance [2] FSGS SNDA and Regulatory Process - SNDA Submission: An SNDA for FSGS is under review, with a PDUFA date set for January 13, 2026. The process is straightforward, with no mid-cycle or late-cycle meetings planned [3][4] - Labeling Expectations: The company anticipates a broad indication for FSGS treatment without specific proteinuria cutoffs, as many patients present with high proteinuria levels [6][9] Market Potential and Patient Population - Addressable Population: The estimated addressable population for FSGS is around 30,000 patients, which could expand to 40,000-50,000 if secondary patients are included [10][9] - Provider and Payer Dynamics: Nephrologists are eager to prescribe FILSPARI, especially for secondary patients, despite challenges in identifying the etiology of FSGS. Payers may face difficulties in managing secondary populations due to the lack of specific ICD-10 codes [11][12][13] Manufacturing and Enrollment Challenges - HCU Therapy: The company faced manufacturing scale-up challenges but is now on track to resume enrollment in the phase three trial for pegtibatinase for HCU next year [3][26] - Patient Support: The company emphasizes the importance of patient support services to help patients reach target doses and maintain compliance [16][18] Financial Dynamics - Revenue Growth: Revenue from FILSPARI is outpacing patient start forms, attributed to the time required for reimbursement processes post-approval [19][20] - Future Expectations: The company expects a more stable dynamic between new patient prescriptions and reimbursements moving forward [21][23] Combination Therapy Considerations - Combination with BAFF APRIL: The company is optimistic about the potential for payers to approve FILSPARI in combination with BAFF APRIL therapies, especially for severe patients [24][25] HCU Study Design - Enrollment Cadence: The company plans to quickly ramp up enrollment for the HCU trial, having already identified interested patients and providers [26] - Dietary Protocol: A sub-study will explore how much protein can be introduced into patients' diets while maintaining control of homocysteine levels, which is a significant concern for patients [27][28] Other Important Points - Eagerness for Approval: There is a high level of eagerness among physicians to prescribe FILSPARI for FSGS, indicating a strong unmet need in the market [18] - Patient-Centric Approach: The company is focused on addressing patient needs, particularly in terms of dietary flexibility and treatment efficacy [27][28] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic priorities, market dynamics, and future expectations.