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Mar 31, 2024
Travere Q1 2024 Earnings Report
Reported first quarter financial results and provided a corporate update.
Key Takeaways
Travere Therapeutics reported strong first quarter 2024 results, marked by new highs in demand and revenue for FILSPARI in IgAN. The FDA granted Priority Review for FILSPARI's sNDA, and the European Commission granted conditional marketing authorization. The company is also progressing with the HARMONY Study of pegtibatinase in HCU.
FDA grants Priority Review for FILSPARI sNDA for IgAN, with a PDUFA target action date of September 5, 2024.
Received 511 new patient start forms (PSFs) for FILSPARI in Q1 2024, totaling 1,963 PSFs since launch.
Net product sales of FILSPARI totaled $19.8 million for the first quarter of 2024.
European Commission granted conditional marketing authorization (CMA) to FILSPARI for IgAN in Europe, with the first launch anticipated in H2 2024.
Revenue by Segment
Forward Guidance
Travere Therapeutics anticipates significant growth in 2024 and beyond, driven by the ongoing commercial launch of FILSPARI and the potential approval of pegtibatinase for HCU.
Positive Outlook
- Potential full approval of FILSPARI for IgAN in the U.S.
- Anticipated launch of FILSPARI for IgAN in certain European markets in H2 2024.
- Progress in clinical studies, including the Phase 3 HARMONY Study for pegtibatinase.
- Potential for pegtibatinase to become the only disease-modifying therapy for HCU.
- Potential inclusion of FILSPARI into the KDIGO guidelines.
Challenges Ahead
- Risks associated with the regulatory review and approval process.
- Market acceptance of commercial products, including efficacy, safety, price, reimbursement, and benefit over competing therapies.
- Risks associated with the successful development and execution of commercial strategies.
Revenue & Expenses
Visualization of income flow from segment revenue to net income
Historical Earnings Impact
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Avg. Return Before/After Earnings
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