Travere Therapeutics, Inc. (TVTX) Q3 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call highlights strong financial performance and strategic developments. FILSPARI's growth in IgA nephropathy and potential FSGS approval, along with positive REMS adjustments, suggest a positive outlook. The Q&A reveals consistent demand and effective communication strategies. Despite some management vagueness, the overall sentiment is positive, with expectations of revenue growth and strategic expansions. The market reaction is likely positive, considering these factors.

Key Financial Performance

FILSPARI net product sales $90.9 million in the third quarter, representing an increase of more than 155% year-over-year. The growth was driven by consistent demand and deepening engagement among new and experienced prescribers.

Total revenue $164.9 million for the quarter, which includes $51.7 million of license and collaboration revenue. This growth was supported by a $40 million market access milestone achieved by CSL Vifor and $9.3 million in noncash revenue from the relinquishment of the option to acquire Renalys.

Research and Development (R&D) expenses $51.9 million in the third quarter of 2025, compared to $51.7 million for the same period in 2024. The expenses remained relatively stable year-over-year.

Selling, General and Administrative (SG&A) expenses $86.5 million in the third quarter of 2025, compared to $65.6 million for the same period in 2024. The increase was primarily due to investments in preparations for a potential launch in FSGS, increased amortization expense related to FILSPARI royalties, and increased investment in supporting commercial efforts for FILSPARI in IgA nephropathy.

Net income $25.7 million or $0.29 per basic share in the third quarter of 2025, compared to a net loss of $54.8 million or $0.70 per basic share for the same period in 2024. The improvement was driven by strong revenue growth and disciplined financial investments.

Cash, cash equivalents, and marketable securities Approximately $254.5 million as of September 30, 2025. This balance reflects the repayment of $69 million in 2025 convertible notes and does not yet include the $40 million milestone payment from Vifor or proceeds from the acquisition of Renalys by Chugai.

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Operating Highlights

FILSPARI's growth in IgA nephropathy: FILSPARI delivered sustained commercial excellence, with $91 million in net product sales in Q3 2025, representing a 155% year-over-year increase. It is now included in KDIGO guidelines as a first-line treatment for IgA nephropathy, simplifying care with reduced monitoring requirements.

FILSPARI in FSGS: Pending FDA approval in January 2026, FILSPARI could become the first approved medication for FSGS, addressing a significant unmet need. The company is prepared for a rapid launch upon approval.

Pegtibatinase development: Successfully manufactured the first commercial-scale batches of pegtibatinase, with plans to restart the pivotal HARMONY study in 2026. Pegtibatinase shows potential as a disease-modifying therapy for classical HCU.

Global expansion of FILSPARI: Strong progress in Europe and the U.K. through CSL Vifor, achieving a $40 million market access milestone. In Japan, Renalys completed enrollment in a registrational trial for IgA nephropathy and plans to initiate Phase III trials for sparsentan in FSGS and Alport syndrome.

Financial performance: Generated $164.9 million in total revenue in Q3 2025, including $113.2 million in U.S. net product sales and a $40 million milestone payment from CSL Vifor. Net income reached $25.7 million, a significant improvement from a net loss in the prior year.

Operational efficiencies: Repayment of $69 million in convertible notes, strengthening the financial position. No near-term need for additional capital to execute core objectives.

Strategic focus on rare diseases: Continued focus on advancing therapies for rare kidney diseases and classical HCU, with a strong emphasis on data generation, regulatory engagement, and global partnerships.

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Risk or Challenges

Regulatory Approval Challenges: The company is awaiting FDA approval for FILSPARI in FSGS, which represents a critical milestone. Any delays or negative outcomes in the approval process could significantly impact the company's strategic objectives and financial performance.

Market Competition: FILSPARI's success in IgA nephropathy and potential approval in FSGS could face competitive pressures from other therapies in the market, which may affect its market share and revenue growth.

Supply Chain and Manufacturing Risks: The company has faced challenges in scaling up the manufacturing of pegtibatinase, which could delay the restart of the pivotal HARMONY study in 2026 and impact the development timeline for this investigational therapy.

Economic and Financial Risks: Although the company has a strong financial foundation, higher discounts anticipated in the fourth quarter and increased SG&A expenses for potential FSGS launch preparations could strain financial resources.

Clinical and Data Risks: The success of FILSPARI in FSGS and pegtibatinase in HCU depends on clinical trial outcomes and real-world data. Any unfavorable results could hinder regulatory approvals and market adoption.

Patient Access and Compliance: While modifications to the REMS program for FILSPARI have improved access, any unforeseen issues in patient compliance or payer coverage could limit the therapy's adoption and revenue potential.

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Guidance & Outlook

FDA approval for FSGS: Pending FDA approval in January 2026, FILSPARI is expected to become the first and only approved medication for FSGS, representing a significant opportunity for Travere. The company is prepared for a rapid launch upon approval.

FILSPARI's growth in IgA nephropathy: FILSPARI continues to grow as a foundational nephroprotective therapy, with strong commercial performance and increasing adoption among nephrologists. The company anticipates sustained growth in this segment.

Pegtibatinase development for HCU: The company plans to restart enrollment in the pivotal Phase III HARMONY study for pegtibatinase in 2026, aiming to address a substantial gap for patients with classical HCU.

Global expansion of FILSPARI: FILSPARI's global footprint is expanding, with regulatory approvals and market access milestones achieved in Europe, the U.K., and Japan. The company expects further growth in these regions.

KDIGO guidelines and FILSPARI: The updated KDIGO guidelines include FILSPARI as a first-line treatment for IgA nephropathy, reinforcing its role as a foundational therapy and supporting its long-term growth potential.

FSGS market opportunity: The FSGS market is expected to present a significant growth opportunity, with a more rapid uptake anticipated compared to the IgA nephropathy launch, due to the high unmet need and progressive nature of the disease.

Financial outlook: The company is financially well-positioned, with no near-term need for additional capital, enabling it to sustain growth in IgA nephropathy, execute a potential FSGS launch, and advance the pegtibatinase program.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:With the new label approved in August, can you quantify the early impact of the REMS adjustment? Are you seeing new prescribers or a new patient base? Are there any competitive impacts?

A:The REMS modification has been positively received by the nephrology community, leading to a continuation of new prescribers and expansion within experienced prescribers. The shift from monthly to quarterly monitoring has helped expand the patient population. Competitive dynamics have not significantly impacted demand, which remains consistent.

Q:Do you have a sense of the typical baseline proteinuria level at the start of prescribing FILSPARI? Are you detecting any off-label use in the FSGS setting?

A:Baseline proteinuria levels at the start of prescribing are consistently below 1.5 grams per gram, with about 65% of the patient population falling in this range. There is limited off-label prescribing in the FSGS setting, but the company does not promote this.

Q:How do we think about the quarter-over-quarter declines in patient start forms despite the strong performance? Any considerations on gross to net or inventory?

A:The decline in patient start forms is attributed to seasonality, though the impact was less pronounced this year. Strong demand in September and October indicates robust performance. Gross to net for Q3 had a less than $2 million benefit, and the company expects higher gross to net in Q4, maintaining guidance of around 20% for the year.

Q:What can we expect in terms of communication leading up to the FSGS PDUFA date in January?

A:The company will not comment on ongoing FDA interactions and will enter a quiet period as the PDUFA date approaches. Updates will be provided on January 13.

Q:How are practitioners learning about the reduced REMS and KDIGO guidelines?

A:Key opinion leaders were already familiar with the KDIGO guidelines, and the full publication has helped disseminate information to community nephrologists. The company is actively communicating the REMS modification to physicians, which has been well-received.

Q:Is the scale-up for pegtibatinase manufacturing complete?

A:The first commercial batches have been completed, enabling engagement with the FDA and the restart of the Phase III study next year. Additional manufacturing campaigns will continue to build stock for launch and further characterization work.

Q:Should the revenue growth seen this quarter be extrapolated going forward? How much is the Q4 gross to net impact?

A:Revenue growth has been driven by refined pull-through processes and strong compliance and persistence. Gross to net for Q3 was slightly lower than Q2, and an increase is expected in Q4, with the annual gross to net guidance remaining at around 20%.

Q:What are the advantages of a dual ERA mechanism in FSGS compared to single agents like atrasentan?

A:A dual ERA mechanism targets both endothelin and angiotensin II, providing greater nephroprotective potential and more significant proteinuria reduction. FILSPARI has shown a 50% reduction in proteinuria, durable for up to 2 years, and achieves more complete remissions compared to single agents.

Q:Are there any changes in time lines for the development of sparsentan in Japan, South Korea, and Taiwan?

A:There are no changes in time lines. The company is impressed with the speed and quality of work from Renalys and expects similar performance from Chugai Pharmaceuticals.

Q:How is the company preparing for a potential FSGS launch, and what are the SG&A expectations?

A:The company is building on its existing prescriber base, with an incremental increase in its commercial footprint. SG&A expenses are expected to rise incrementally in Q4 and further around the time of launch to ensure a strong start.

Q:Have time lines for the complete removal of the REMS changed?

A:Time lines have not changed. The FDA requires exposure across about 3,000 patients for 2 years. The company will continue to engage with the FDA to align on next steps.

Q:Can you comment on off-label FSGS use and dosing?

A:The company has limited insight into off-label FSGS use and dosing. Upon approval, physicians will be educated on the appropriate label and target dose.

Q:What are the expectations for R&D expenses going forward, especially with the restart of the pegtibatinase study?

A:R&D expenses will increase with the restart of the pegtibatinase study, focusing on fast enrollment and quality. Investments in sparsentan will ramp down, but evidence generation efforts and transplant studies will continue.

Q:Review of Unclear Management Responses

A:Management avoided providing specific guidance on sequential increases in new patient start forms for Q4, stating only that demand is expected to remain above 700 quarterly. They also did not provide detailed insights into off-label FSGS dosing or specific gross to net impacts by quarter.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

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