Travere Therapeutics (TVTX) Q3 2025: Filspari US Sales Surge 155% as FSGS Launch Readiness Accelerates
Travere Therapeutics delivered a pivotal Q3 with Filspari, dual ERA/ARB kidney therapy, driving US sales up more than 155% year-over-year, cementing its position in IgA nephropathy and setting the stage for a potential first-in-class launch in FSGS. Execution was supported by key regulatory tailwinds, expanded guideline endorsements, and disciplined capital deployment, with management signaling confidence in pipeline and commercial readiness to capture rare kidney disease leadership in 2026.
Summary
- Label and Guideline Tailwinds: REMS simplification and KDIGO guideline inclusion are expanding Filspari's eligible patient pool.
- Commercial Foundation Strengthens: Deepening prescriber engagement and payer access underpin sustained Filspari momentum.
- FSGS Launch Poised: Operational ramp and overlapping prescriber base set up rapid FSGS entry if approval is secured.
Performance Analysis
Travere’s Q3 was defined by the outperformance of Filspari, a dual endothelin and angiotensin receptor antagonist for rare kidney diseases. US net product sales for Filspari reached $90.9 million, representing a year-over-year increase exceeding 155%, and accounted for the majority of the company’s $113.2 million in total US net product sales. This growth was driven by robust demand, high compliance, and the impact of the August REMS (Risk Evaluation and Mitigation Strategy) program modification, which reduced liver monitoring frequency and removed embryo-fetal toxicity requirements, streamlining patient onboarding and retention.
License and collaboration revenue also surged, aided by a $40 million milestone from CSL Vifor tied to European market access, and $9.3 million in non-cash revenue related to the Rinalis/Chugai transaction. SG&A spending increased, reflecting investments in the impending FSGS launch and ongoing support for Filspari’s commercial expansion. Net income swung to $25.7 million from a loss in the prior year, with non-GAAP net income at $52.8 million. Cash and equivalents stood at $254.5 million, not yet reflecting the recent milestone payment or proceeds from the Rinalis acquisition.
- Filspari Demand Resilience: New patient start forms remained robust, with September marking the highest daily rate since launch, and trends continuing strong into October.
- Seasonality Impact Muted: Despite typical summer seasonality, Filspari demand was less affected than in prior years, even as competitive entries launched.
- Pipeline Progress: First commercial-scale batches of PEG-tobatinase were manufactured, positioning the Harmony phase 3 study for restart in 2026.
Travere’s performance reflects both commercial execution and strategic positioning, with Filspari’s consistent uptake and payer access setting a foundation for future launches and pipeline investment.
Executive Commentary
"The core driver of our performance is Silspari's continued growth in IgA nephropathy, where we delivered sustained commercial excellence in the third quarter. Physicians continue to confidently adopt Silspari as a foundational nephroprotective therapy for their patients. This confidence reflects consistent real-world outcomes, robust long-term data reinforcing Silspari's differentiated profile, and its recent inclusion in the CADEGO guidelines for earlier first-line use to optimize nephroprotection in IGANS."
Dr. Eric Hubei, President and Chief Executive Officer
"This quarter, we delivered another strong set of financial results with continued significant revenue growth and disciplined financial investment. We also further strengthened our financial foundation by repaying our remaining 2025 convertible notes. Importantly, we're doing all of this from a position of financial strength with no near-term need for additional capital to execute on our core objectives."
Chris Klein, Chief Financial Officer
Strategic Positioning
1. Filspari: Foundational Therapy in IgA Nephropathy
Filspari’s adoption as a first-line therapy for IgA nephropathy (IGAN) has been catalyzed by its inclusion in the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines and the REMS program modification. The new guidelines validate dual ERA/ARB therapy as standard of care, and the reduced monitoring burdens have expanded access to lower-risk and newly diagnosed patients. Prescriber confidence is reinforced by real-world data and long-term outcomes, supporting Filspari’s differentiated positioning.
2. FSGS Launch Readiness
Preparations for a potential FSGS (focal segmental glomerulosclerosis) indication are well advanced. The prescriber overlap with IGAN allows for operational leverage, while incremental SG&A investments are focused on expanding the commercial footprint and early uptake. Management expects a more rapid adoption curve in FSGS given the urgent unmet need and physician familiarity with Filspari. The regulatory process is on track, with no advisory committee required and launch readiness for January if approved.
3. Global Value Creation and Partnerships
Travere’s international strategy is bearing fruit, with CSL Vifor driving European expansion, a $40 million milestone achieved, and Rinalis completing IGAN trial enrollment in Japan. The planned acquisition of Rinalis by Chugai is expected to accelerate Asian market development for sparsentan, further validating Travere’s global rare kidney disease platform.
4. Pipeline Execution: PEG-tobatinase for HCU
Manufacturing scale-up for PEG-tobatinase, a potential disease-modifying therapy for classical homocystinuria (HCU), has been achieved. The Harmony phase 3 trial is set to restart in 2026, with long-term data showing sustained, clinically meaningful reductions in homocysteine and methionine. This program represents a potential new pillar of growth beyond nephrology.
Key Considerations
Travere’s Q3 demonstrates the compounding benefits of commercial execution, regulatory wins, and pipeline advancement, but also surfaces operational and strategic complexities as the business scales.
Key Considerations:
- REMS Program Tailwind: The shift to quarterly liver monitoring is expanding Filspari’s eligible patient base and lowering barriers for prescribers and patients.
- Guideline Endorsement Impact: KDIGO’s foundation-of-care endorsement is likely to drive both earlier and broader Filspari adoption, supporting durable volume growth.
- SG&A Leverage and Investment: Incremental SG&A increases are targeted at FSGS launch readiness, but management is leveraging existing infrastructure to maximize efficiency.
- Gross-to-Net Dynamics: Q3 included a modest one-time gross-to-net benefit, but higher discounts are expected in Q4, with annual guidance near 20% gross-to-net adjustment.
- Pipeline Execution Risk: The restart of the Harmony trial for PEG-tobatinase is a key 2026 event, with manufacturing scale-up largely de-risked but ongoing supply and regulatory steps ahead.
Risks
Key risks include regulatory uncertainty for FSGS approval, evolving competitive dynamics in both IGAN and FSGS, and execution risk around the PEG-tobatinase pivotal trial restart. Payer pressure and gross-to-net variability remain ongoing headwinds, while the need to maintain commercial momentum amid new launches and guideline-driven practice changes could challenge operational focus. The company’s ability to scale SG&A efficiently and avoid dilutionary capital raises will be closely watched.
Forward Outlook
For Q4 2025, Travere expects:
- Continued Filspari demand growth, with new patient starts tracking above 700 per quarter
- Higher gross-to-net discounts, with annual adjustment around 20%
For full-year 2025, management maintained guidance for:
- Durable revenue growth in Filspari and stable cash position
Management highlighted several factors that will shape near-term results:
- Potential FSGS approval and launch in January 2026
- Restart of PEG-tobatinase Harmony trial enrollment
Takeaways
Travere’s Q3 marks a pivotal inflection point, with Filspari’s commercial strength, regulatory tailwinds, and pipeline progress positioning the company for rare kidney disease leadership.
- Filspari Anchors Growth: Label expansion and guideline inclusion are driving both volume and prescriber depth, with competitive launches having minimal impact to date.
- FSGS Launch Leverage: Overlapping prescriber base and commercial infrastructure should enable rapid scale if approval is secured, with SG&A investments tracking operational needs.
- Pipeline Execution in Focus: The restart of the Harmony study and ongoing global partnerships are critical for sustaining long-term growth and diversification beyond nephrology.
Conclusion
Travere Therapeutics exits Q3 with commercial momentum, regulatory clarity, and a strengthened financial base. The company is well-positioned to capitalize on its leadership in rare kidney diseases, with Filspari’s trajectory and pipeline execution as key determinants of future value.
Industry Read-Through
Travere’s Q3 demonstrates the outsized impact of regulatory simplification and guideline endorsement on rare disease drug adoption. The REMS reduction and KDIGO inclusion have proven to be powerful volume accelerators, a dynamic likely to play out across other specialty pharma and rare disease launches. The overlap between IGAN and FSGS prescribers highlights the importance of franchise-building in nephrology, while the company’s global partnership model sets a template for value creation in markets with complex regulatory and commercial pathways. Competitors in kidney disease and rare metabolic disorders should monitor Travere’s execution for signals on payer access, real-world data leverage, and the operational demands of scaling in orphan indications.