FILSPARI™(sparsentan) granted accelerated approval by FDA for the reduction of proteinuria in IgA nephropathy (IgAN) on February 17th, 2023; commercial launch underway
Total net product sales of $50.3 million for the first quarter of 2023, including $3.0 million for FILSPARI
SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its first quarter 2023 financial results and provided a corporate update.
- On February 17, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to FILSPARI™ (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g
- Review decision by the European Medicines Agency (EMA) on the potential approval of the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN in Europe expected in second half 2023
- Net product sales of FILSPARI totaled $3.0 million for the first quarter of 2023
- Total revenue for the first quarter of 2023 was $57.0 million, consisting of $50.3 million in net product sales and $6.7 million in licensing and collaboration revenue
- Cash, cash equivalents, and marketable securities, as of March 31, 2023, totaled $561.5 million, including net proceeds of $216.0 million from a common stock offering completed in the first quarter, as well as the Company’s payment of a $23 million milestone related to the approval of FILSPARI
“We began the new year with the first FDA approval from our rare disease pipeline. The accelerated approval of FILSPARI marks the first and only non-immunosuppressive treatment indicated for the reduction of proteinuria in patients with IgAN and we are very pleased with the progress in the first quarter, which represents the first six weeks of the commercial launch,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Our field team started to engage with nephrologists on the next business day following the approval, and within the first two weeks, FILSPARI was available and had been shipped to the first patient. We continue to receive positive feedback from the IgAN community that further supports our confidence in the potential for FILSPARI to ultimately become the future foundational treatment for patients with IgAN. As we look ahead, we are focused on continued progress with the FILSPARI launch, as well as achieving additional development and regulatory milestones as we continue to advance our pipeline throughout the year.”
Financial Results for the Quarter Ended March 31, 2023
Net product sales for the first quarter of 2023 were $50.3 million, compared to $46.4 million for the same period in 2022. The increase is primarily attributable to the first reported sales of FILSPARI and growth in sales of the bile acid portfolio.
Research and development (R&D) expenses for the first quarter of 2023 were $59.9 million, compared to $56.6 million for the same period in 2022. The difference is largely attributable to the continued advancement of the Company’s sparsentan and pegtibatinase clinical programs, including clinical trial expenses, manufacturing, and increased headcount. On a non-GAAP adjusted basis, R&D expenses were $53.0 million for the first quarter of 2023, compared to $53.2 million for the same period in 2022.
Selling, general, and administrative (SG&A) expenses for the first quarter of 2023 were $72.2 million, compared to $46.8 million for the same period in 2022. The difference is largely attributable to the onboarding of the FILSPARI field team and supporting staff, as well as launch related activities following the accelerated approval of FILSPARI in February 2023. On a non-GAAP adjusted basis, SG&A expenses were $55.8 million for the first quarter of 2023, compared to $35.0 million for the same period in 2022.
Total other income, net, for the first quarter of 2023 was $0.8 million, compared to total other expense, net, of $9.8 million for the same period in 2022. The difference is largely attributable to changes in interest expense and a loss on early extinguishment of debt related to the Company’s convertible note transactions effected in March 2022.
Net loss for the first quarter of 2023 was $86.3 million, or $1.27 per basic share, compared to a net loss of $76.0 million, or $1.20 per basic share for the same period in 2022. On a non-GAAP adjusted basis, net loss for the first quarter of 2023 was $56.2 million, or $0.82 per basic share, compared to a net loss of $51.6 million, or $0.82 per basic share for the same period in 2022.
As of March 31, 2023, the Company had cash, cash equivalents, and marketable securities of $561.5 million. This includes net proceeds of approximately $216 million from a common stock offering completed in March 2023, as well as a $23 million milestone payment made to Ligand Pharmaceuticals as a result of the accelerated approval of FILSPARI in February 2023.
Program Updates
FILSPARI™ (sparsentan) – IgAN
- On February 17, 2023, the U.S. FDA granted accelerated approval to FILSPARI to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. The approval of FILSPARI is based on clinically meaningful and statistically significant improvements in proteinuria compared to irbesartan, an active comparator, in the pivotal and ongoing Phase 3 PROTECT Study, the largest head-to-head interventional study to date in IgAN.
- FILSPARI became commercially available the week of February 27, 2023. In the first six weeks since approval, commercial progress with the launch has resulted in:
- Net product sales of $3.0 million
- 146 new patient start forms (PSFs) received
- In April 2023, the interim analysis of efficacy and safety data from the ongoing pivotal, Phase 3 PROTECT Study evaluating FILSPARI in adults with IgAN were published in The Lancet. Select new data from the interim analysis included:
- During the double-blind treatment period, a significantly greater proportion of patients on FILSPARI achieved complete remission (urine protein excretion