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Sep 30, 2022
Travere Q3 2022 Earnings Report
Travere Therapeutics reported third quarter financial results
Key Takeaways
Travere Therapeutics reported a net product sales of $50.8 million and total revenue of $53.5 million for the third quarter of 2022. The company's cash, cash equivalents and marketable securities totaled $506.3 million as of September 30, 2022. The EMA accepted for review the Conditional Marketing Authorization application for sparsentan for IgAN in Europe and a new PDUFA target action date for sparsentan in IgAN was set for February 17, 2023.
EMA accepted for review the Conditional Marketing Authorization application for sparsentan for IgAN in Europe; review decision expected in second half of 2023
New PDUFA target action date for sparsentan in IgAN set for February 17, 2023
Breakthrough Therapy Designation granted to pegtibatinase development program for classical homocystinuria (HCU)
Cash, cash equivalents and marketable securities totaled $506.3 million
Revenue by Segment
Forward Guidance
Travere is focused on advancing its IgA nephropathy and FSGS programs, positioning sparsentan as a dual-acting, non-immunosuppressive treatment option for rare kidney disorders. The company anticipates potential approvals of sparsentan for IgA nephropathy in the U.S. and Europe next year and looks forward to the upcoming readout of the DUPLEX Study of sparsentan in FSGS in the first half of next year, as well as the potential to advance pegtibatinase into a pivotal trial for HCU in 2023.
Positive Outlook
- Potential approvals of sparsentan for IgA nephropathy in the U.S. and Europe next year
- Upcoming readout of the DUPLEX Study of sparsentan in FSGS in the first half of next year
- Potential to advance pegtibatinase into a pivotal trial for HCU in 2023
- Built upon strong commercial foundation to establish a field team with extensive nephrology experience in the U.S.
- Advancing IgA nephropathy and FSGS programs
Challenges Ahead
- Risk of FDA not granting accelerated approval of sparsentan for IgAN within the extended target action date
- Risk that the Phase 3 PROTECT Study of sparsentan in IgAN will not demonstrate that sparsentan is safe or effective
Historical Earnings Impact
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Avg. Return Before/After Earnings
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