Travere Therapeutics (TVTX) investor relations material

Strategic priorities and pipeline progress

• Focused on three priorities: FILSPARI launch in IgA nephropathy, sNDA for FSGS, and pegtibatinase for HCU.

• FILSPARI launch in IgA nephropathy shows strong growth, supported by new KDIGO guidelines.

• sNDA for FSGS under FDA review with a PDUFA date of January 13; broad label requested to address all FSGS types.

• Pegtibatinase phase 3 enrollment to restart next year after resolving manufacturing scale-up; higher manufacturing scale achieved.

• Sufficient capital to support all three programs.

Regulatory and market access updates

• No mid- or late-cycle FDA meetings for sNDA; advisory committee canceled, indicating no major concerns.

• Draft labeling discussions expected about a month before PDUFA date; company entering quiet period after current conferences.

• Broad FSGS label could expand addressable population from 30,000 to 40,000–50,000 patients.

• Payers unlikely to restrict access by FSGS subtype due to diagnostic challenges; focus remains on diagnosis and proteinuria levels.

• High physician eagerness for FILSPARI in FSGS, with some institutions preparing to prescribe quickly upon approval.

Clinical and commercial insights

• Over 90% of FSGS trial patients achieved and maintained the 800 mg dose; tolerability issues were generally self-limiting.

• Patient support services and education will be leveraged to ensure high compliance and persistence in FSGS, as seen in IgA nephropathy.

• FILSPARI revenue in IgA nephropathy outpaced new patient starts due to reimbursement timing, now stabilizing.

• Combination therapy with FILSPARI and immune-targeted agents expected, especially in severe cases; payers have approved similar combinations.