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Sep 30, 2023
Travere Q3 2023 Earnings Report
Travere reported an increase in FILSPARI demand and net product sales, along with advancements in their sparsentan programs and the sale of their bile acid product portfolio.
Key Takeaways
Travere Therapeutics reported Q3 2023 financial results, highlighted by the growth in FILSPARI prescriptions and sales, advancements in clinical programs, and the completion of the sale of the bile acid product portfolio. Net product sales reached $33.9 million, with FILSPARI contributing $8 million.
Received 430 new patient start forms for FILSPARI in Q3 2023, indicating growing demand.
FILSPARI net product sales totaled $8 million for Q3 2023.
Phase 3 PROTECT and DUPLEX Studies of sparsentan presented at ASN Kidney Week and published in The Lancet and NEJM.
Completed the sale of the bile acid product portfolio for up to $445 million, strengthening the financial foundation.
Revenue by Segment
Forward Guidance
Travere anticipates providing regulatory updates in the fourth quarter for both sparsentan programs and expects to initiate a pivotal study for pegtibatinase by year-end.
Positive Outlook
- On track to provide regulatory update in Q4 regarding sNDA submission for full approval of FILSPARI for IgAN in the U.S.
- Anticipates a review opinion by the Committee for Medicinal Products for Human Use (CHMP) on the potential approval of the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN in Europe around year-end.
- On track to provide a regulatory update in Q4 regarding the potential path forward for an sNDA for sparsentan for the treatment of FSGS in the U.S.
- Plans to engage with the European Medicines Agency to determine the potential for a subsequent variation to the CMA of sparsentan for the treatment of FSGS, subject to a review decision on the pending application for CMA of sparsentan in IgAN.
- Remains on track to initiate a pivotal study for pegtibatinase by the end of 2023.
Challenges Ahead
- Uncertainty regarding the FDA's acceptance of the Phase 3 PROTECT Study results for full approval of sparsentan.
Revenue & Expenses
Visualization of income flow from segment revenue to net income
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