Loading...
•
Dec 31, 2021
Travere Q4 2021 Earnings Report
Travere reported mixed Q4 2021 results with increased net product sales but a net loss.
Key Takeaways
Travere Therapeutics reported Q4 2021 financial results, featuring a rise in net product sales to $54.6 million compared to $51.0 million in the same period of 2020. However, the company experienced a net loss of $51.6 million, or $0.84 per basic share, compared to a net loss of $121.6 million, or $2.37 per basic share for the same period in 2020.
Net product sales for Q4 2021 increased to $54.6 million, compared to $51.0 million for the same period in 2020.
The company is on-track to submit a New Drug Application (NDA) for accelerated approval of sparsentan in IgA nephropathy (IgAN) in the first quarter of 2022.
The company reported positive topline results from the ongoing Phase 1/2 COMPOSE Study of pegtibatinase in classical homocystinuria.
As of December 31, 2021, the Company had cash, cash equivalents and marketable securities of $552.9 million.
Revenue by Segment
Forward Guidance
Travere Therapeutics is focused on regulatory submissions and advancing its pipeline.
Positive Outlook
- On-track to submit NDA for sparsentan in IgA nephropathy in Q1 2022.
- Preparing NDA submission for sparsentan in FSGS and combined IgAN and FSGS MAA mid-year 2022.
- Engaging with regulators to establish next steps for pegtibatinase pivotal development program.
- Company expects to submit a combined IgAN and FSGS MAA in mid-2022 for conditional marketing authorization of sparsentan in Europe.
- Topline results from the confirmatory endpoint analysis are expected in the second half of 2023.
Challenges Ahead
- There is no guarantee that the FDA will grant accelerated approval of sparsentan for IgAN or FSGS or that sparsentan will be approved at all.
- There is also no guarantee that the results from the ongoing clinical study of pegtibatinase will be positive.
- The Company faces risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates
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...