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Sep 30, 2021
Travere Q3 2021 Earnings Report
Travere reported financial results and organizational progress for Q3 2021.
Key Takeaways
Travere Therapeutics reported net product sales of $54.2 million for the third quarter of 2021. The company is on track for an NDA submission for accelerated approval in the first quarter of next year.
Positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan in IgA nephropathy were reported.
NDA submission of sparsentan in IgA nephropathy for accelerated approval under Subpart H is expected in the first quarter of 2022.
Accelerated approval submission of sparsentan in FSGS is planned for mid-2022, pending additional supportive eGFR data from the ongoing DUPLEX Study.
A joint collaboration with Vifor Pharma will commercialize sparsentan in Europe; a combined IgA nephropathy and FSGS MAA submission for sparsentan in Europe is expected mid-2022.
Forward Guidance
Travere expects to continue strong execution through the balance of 2021, and to build upon the strength of their existing commercial organization to prepare for multiple potential launches of sparsentan, if approved.
Positive Outlook
- NDA submission for accelerated approval in the first quarter of next year.
- Potential NDA submission for accelerated approval of sparsentan for FSGS.
- Combined IgA nephropathy and FSGS MAA submission for conditional marketing authorization in Europe.
- Preliminary eGFR data available at the time of the interim analysis are indicative of a potential clinically meaningful treatment effect after two years of treatment.
- The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance.
Challenges Ahead
- The company faces risks associated with market acceptance of its commercial products including efficacy, safety, price, reimbursement and benefit over competing therapies.
- The company faces the risk that the Phase 3 DUPLEX Study of sparsentan in FSGS will not demonstrate that sparsentan is safe or effective or serve as a basis for accelerated approval of sparsentan as planned.
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