Travere Therapeutics Q1 2024 Financial Results

Travere Therapeutics Inc. has reported outstanding financial results for the first quarter of 2024, highlighting significant progress in the commercialization and regulatory milestones of its product FILSPARI® (sparsentan) for the treatment of IgA nephropathy (IgAN). Eric Dube, Ph.D., president and CEO, announced the strong beginning to the year, emphasizing increased demand and revenue for FILSPARI, alongside key regulatory achievements that affirm the company's potential for substantial growth in 2024 and beyond.

During Q1 2024, Travere received 511 new patient start forms (PSFs) for FILSPARI, bringing the total to 1,963 since the product's launch. Net product sales for FILSPARI reached $19.8 million for the quarter. This progress follows the recent FDA Priority Review for the supplemental New Drug Application (sNDA) to transition FILSPARI from accelerated to full approval for IgAN in the U.S., with a PDUFA target date set for September 5, 2024.

In Europe, FILSPARI gained conditional marketing authorization (CMA) from the European Commission for IgAN, with the first market launches anticipated in the second half of 2024. This authorization, covering EU member states as well as Iceland, Liechtenstein, and Norway, is expected to trigger significant milestone payments, including $17.5 million upon conversion to full approval.

Travere also noted the dosing of the first patients in the pivotal Phase 3 HARMONY Study of pegtibatinase for classical homocystinuria (HCU), with topline data anticipated in 2026. Additionally, the company's cash, cash equivalents, and marketable securities totaled $441.0 million as of March 31, 2024, indicating robust financial health.

Financially, Travere reported net product sales of $40.0 million for Q1 2024, compared to $24.2 million for the same period in 2023. The increase is attributed primarily to the commercial launch of FILSPARI. Research and development (R&D) expenses decreased to $49.4 million from $58.2 million, reflecting lower personnel and development costs as the Phase 3 programs progressed. Selling, general, and administrative (SG&A) expenses were slightly reduced to $64.2 million from $66.0 million during the same timeframe.

A notable expense was a $65 million milestone related to the first patient dosed in the HARMONY Study, which is expected to be paid in Q2 2024. Travere's total other income, primarily from increased interest income, amounted to $3.5 million, compared to $0.9 million in Q1 2023. The net loss for Q1 2024, including discontinued operations, was $136.1 million or $1.76 per share, compared to a net loss of $86.3 million or $1.27 per share for Q1 2023.

Among other updates, the company highlighted ongoing discussions with the nephrology community and regulatory bodies regarding its data from the DUPLEX Study. Travere is preparing for potential regulatory engagements with the FDA concerning sparsentan in Focal Segmental Glomerulosclerosis (FSGS).

Furthermore, in January 2024, Travere entered an exclusive licensing agreement with Renalys Pharma to introduce sparsentan in Japan and other Asian countries. Following discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, an Investigational New Drug (IND) Application for a Phase 3 trial was submitted in April 2024, with topline data expected in the second half of 2025.

Presentations at prominent conferences such as the World Congress of Nephrology and the American Nephrology Nurses Association (ANNA) National Symposium showcased various study data, reinforcing FILSPARI's clinical benefits.

In 2024, the company anticipates the inclusion of FILSPARI in the draft Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for Glomerular Diseases. To ensure patient access and safety, FILSPARI will be available under a Risk Evaluation and Mitigation Strategy (REMS) program due to potential hepatotoxicity and embryo-fetal toxicity.

Overall, Travere Therapeutics is poised for significant advancements in 2024, driven by its strategic initiatives, strong financial results, and the ongoing development and commercialization of its innovative therapies.