Loading...
•
Dec 31, 2022
Travere Q4 2022 Earnings Report
Travere reported Q4 2022 financial results, marked by FILSPARI's FDA approval and progress in clinical programs.
Key Takeaways
Travere Therapeutics reported a total revenue of $55.9 million for Q4 2022, with net product sales of $52.3 million. The company's net loss for the quarter was $65.8 million, or $1.03 per basic share. FILSPARI received FDA accelerated approval, and the company is advancing its clinical programs with key milestones expected in 2023.
FILSPARI received U.S. FDA accelerated approval for IgAN.
EMA review decision for sparsentan in IgAN is anticipated in the second half of 2023.
DUPLEX Study of sparsentan in FSGS is on track to report topline data in the second quarter of 2023.
Net product sales were $52.3 million for the fourth quarter of 2022.
Revenue by Segment
Forward Guidance
Travere Therapeutics anticipates a review decision by the EMA on the potential approval of sparsentan for IgAN in Europe in the second half of 2023. Topline results from the two-year confirmatory endpoints in the ongoing Phase 3 PROTECT Study are expected in the fourth quarter of 2023. The company also anticipates additional data from its novel pegtibatinase program for HCU and the potential initiation of a Phase 3 program this year.
Positive Outlook
- Potential approval of sparsentan for IgAN in Europe in the second half of 2023
- Topline results from the two-year confirmatory endpoints in the ongoing Phase 3 PROTECT Study expected in the fourth quarter of 2023
- Additional data from the COMPOSE Study in mid-2023
- Potential initiation of a pivotal Phase 3 clinical trial of pegtibatinase in patients with HCU in the second half of 2023
- Complete the ongoing Phase 3 RESTORE Study in CTX during 2023
Challenges Ahead
- No specific negatives provided in the earnings report.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...