Travere Therapeutics NASDAQ: TVTX reported second-quarter results marked by record FILSPARI demand and revenue, driven by continued growth in IgA nephropathy and an early launch in focal segmental glomerulosclerosis, or FSGS.
The company generated $161.4 million in U.S. net product sales during the quarter and $169.6 million in total revenue, including licensing and collaboration revenue. FILSPARI accounted for $141.1 million of U.S. net product sales, up approximately 96% from a year earlier, while Thiola EC contributed $20.3 million.
Chief Commercial Officer Peter Heerma said FILSPARI demand reached a record level, with more than 2,000 new patient start forms across IgA nephropathy and FSGS. He said the quarter represented the first full period in which FILSPARI was commercially available for both indications following the April approval for FSGS.
FSGS Launch Gains Early Momentum
Travere said the FSGS launch has exceeded its expectations, with early adoption, payer access, fulfillment and revenue metrics tracking ahead of what the company experienced during the initial IgA nephropathy launch.
Heerma said FSGS uptake was supported by the lack of previously approved medicines for the progressive kidney disease, along with established nephrology relationships and launch preparation. Shipments began within the first week after approval, according to the company.
Management emphasized that prescribing activity has been broad rather than concentrated among a limited group of physicians. Most FSGS prescribers have written FILSPARI for one patient so far, despite having additional FSGS patients in their practices, which the company said supports its view that the market remains at an early stage of adoption.
“We did not see evidence of a bolus,” Chief Executive Officer Eric Dube said in response to an analyst question about whether early demand reflected a one-time wave of previously identified patients. He said the company instead saw rapid uptake based on high anticipation among patients and nephrologists and expects continued demand.
Travere said first-pass approval rates in FSGS are ahead of those seen at a comparable point in the IgA nephropathy launch. Heerma added that conversion from patient start forms to paid prescriptions has been faster than it was initially in IgA nephropathy, though he did not disclose specific conversion metrics.
The company expects some quarter-to-quarter variability in patient starts, including potential summer seasonality, but said the FSGS launch has foundational elements already in place that were not available during the earlier IgA nephropathy rollout.
IgA Nephropathy Demand Continues to Rise
In IgA nephropathy, Travere said demand increased sequentially despite the arrival of additional treatment options. Heerma said FILSPARI remains the most widely utilized approved treatment option in the indication, supported by repeat prescriptions and adoption by new physicians.
Chief Medical Officer Jula Inrig said discussions with nephrologists continue to support FILSPARI’s role as a foundational kidney-directed therapy. She said physicians are increasingly focused on reducing proteinuria to less than 0.3 grams per day and slowing eGFR decline, while using immune-modulating therapies for patients when clinically appropriate.
Management said it has not seen payer pushback that prevents the use of FILSPARI alongside other branded therapies. Inrig said physicians have expressed uncertainty because nephrology has had less experience using multiple branded agents, but the company continues to hear that clinicians want to combine therapies when needed to pursue proteinuria remission and eGFR stabilization.
Travere also said most FILSPARI prescriptions are new to branded therapies rather than switches from other branded products. Heerma described the typical treatment transition as a move from generic RAS inhibition to FILSPARI before physicians consider other branded modalities.
Pipeline and Financial Position
The company said enrollment is continuing in the pivotal Phase III HARMONY study of pegtibatinase for classical homocystinuria, or HCU. Travere continues to expect top-line HARMONY results in the second half of 2027. The company described pegtibatinase as a potential disease-modifying therapy designed to address the underlying CBS enzyme deficiency in HCU.
Travere also completed enrollment in a post-transplant study evaluating FILSPARI in recurrent FSGS and recurrent IgA nephropathy, with data anticipated in 2027. In the second half of 2026, the company plans to initiate a Phase IV open-label study of FILSPARI in adult and pediatric FSGS patients of African ancestry who are at high risk of disease progression.
In July, Travere closed an exclusive licensing agreement with Everest Medicines for civorebrutinib, an investigational oral covalent reversible BTK inhibitor. The company plans to open an investigational new drug application in the U.S. and engage with the Food and Drug Administration on development pathways across rare immune-mediated kidney diseases, including primary membranous nephropathy, immune-mediated FSGS and minimal change disease.
Total GAAP research and development and selling, general and administrative expenses were $156.4 million in the quarter, including about $22.2 million in non-cash stock-based compensation and depreciation expense. R&D spending increased primarily due to HARMONY enrollment activities and pegtibatinase manufacturing, while SG&A rose with the FSGS launch and continued IgA nephropathy investments.
As of June 30, Travere held approximately $489.2 million in cash, cash equivalents and marketable securities. The balance included approximately $158 million of net proceeds from a convertible refinancing transaction. After the quarter ended, the company paid Everest Medicines a previously disclosed $112.5 million upfront payment related to the civorebrutinib agreement.
Dube said Travere continues to see the potential for more than $3 billion in peak annual FILSPARI sales across IgA nephropathy and FSGS, though the company did not revise that estimate following the early FSGS launch performance.
About Travere Therapeutics (NASDAQ:TVTX)
Travere Therapeutics, Inc NASDAQ: TVTX is a biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of therapies for rare kidney and genetic disorders. The company's mission is to address unmet needs in conditions with limited treatment options by focusing on diseases that affect small patient populations. Travere combines research, development and commercial capabilities to bring innovative medicines to market.
The company's lead product is sparsentan, a dual endothelin angiotensin receptor antagonist that has received accelerated approval from the U.S.
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