Travere Therapeutics, Inc. (TVTX) Q2 2025 Earnings Call Transcript

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

Overview

The earnings call indicates strong financial performance with significant growth in FILSPARI sales and positive reception of new clinical data. The company is proactive in regulatory engagement and market expansion, with anticipated milestone payments enhancing financial flexibility. Despite some uncertainties in FDA timelines and competition, the market penetration potential and strategic investments suggest a positive outlook. The Q&A session did not reveal major risks, and the focus on educating healthcare providers and leveraging clinical data supports sustained growth. Overall, the sentiment leans positive, suggesting a stock price increase of 2% to 8%.

Key Financial Performance

FILSPARI net product sales $72 million in the U.S. in Q2 2025, representing significant year-over-year growth. This growth was driven by strong demand, expansion, and deepening of the prescriber base, as well as further efficiencies in the fulfillment process and solid therapy compliance and persistence.

U.S. net product sales $94.8 million in Q2 2025, reflecting an 82% growth over the same period last year. This growth was attributed to the strong performance of FILSPARI and contributions from THIOLA and THIOLA EC.

THIOLA and THIOLA EC net product sales $23 million in Q2 2025. These medicines continue to be meaningful options for patients living with cystinuria, though more generic competition is anticipated in the coming quarters.

License and collaboration revenue $19.6 million in Q2 2025, including a one-time $17.5 million milestone payment from CSL Vifor due to the conversion of conditional approval of FILSPARI to full approval in Europe earlier this year.

Research and development (R&D) expenses $49.4 million in Q2 2025, compared to $54.3 million in Q2 2024. The decrease is largely due to reduced clinical activity in the Phase III HARMONY study while optimizing manufacturing efforts.

Selling, general, and administrative (SG&A) expenses $76.2 million in Q2 2025, compared to $64.8 million in Q2 2024. The increase is attributed to higher amortization expenses related to FILSPARI royalties and increased investment to support its ongoing launch and preparation for a potential FSGS launch.

Net loss $12.8 million or $0.14 per basic share in Q2 2025, compared to $70.4 million or $0.91 per basic share in Q2 2024. The improvement reflects strong revenue growth and disciplined expense management.

Non-GAAP adjusted net income $11.9 million or $0.13 per basic share in Q2 2025, compared to a net loss of $50.1 million or $0.65 per basic share in Q2 2024. This improvement is due to increased revenue and controlled expenses.

Cash, cash equivalents, and marketable securities $319.5 million as of June 30, 2025. This includes the $17.5 million milestone payment from CSL Vifor and positions the company for financial flexibility.

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Operating Highlights

FILSPARI's performance in IgA nephropathy (IgAN): Strongest commercial quarter to date with $72 million in U.S. net product sales, driven by demand and prescriber expansion. FILSPARI is increasingly adopted as foundational care for IgAN due to its nephroprotective profile and ability to reduce proteinuria.

FILSPARI's potential in FSGS: sNDA review process for FSGS is advancing, with a PDUFA date of January 13, 2026. If approved, FILSPARI would be the first treatment for FSGS, representing a significant growth opportunity.

Pipeline advancements: Progress in the HARMONY study for pegtibatinase in classical homocystinuria, with plans to reinitiate enrollment next year.

International expansion of FILSPARI: Partners CSL Vifor and Renalis are expanding access to FILSPARI outside the U.S., with a $17.5 million milestone payment received for full approval in Europe.

Financial performance: Net product sales grew 82% year-over-year to $94.8 million in Q2 2025. FILSPARI contributed $71.9 million, with additional revenue from THIOLA and license collaborations.

Operational efficiencies: Improved fulfillment processes and therapy compliance contributed to FILSPARI's growth. SG&A expenses increased due to investments in FILSPARI's launch and preparation for FSGS.

Strategic positioning of FILSPARI: FILSPARI is positioned as a foundational therapy in IgAN, with potential label expansions to address broader patient segments. The company is preparing for FILSPARI's launch in FSGS, which could drive rapid uptake.

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Risk or Challenges

Regulatory Hurdles: The company is awaiting FDA decisions on the removal of embryo-fetal toxicity REMS and potential modification of liver monitoring REMS for FILSPARI. Any delays or unfavorable decisions could impact patient access and adoption.

Market Competition: Emerging treatment options for IgA nephropathy could challenge FILSPARI's market position, despite its current foundational role.

Supply Chain and Manufacturing: The company is scaling up manufacturing for pegtibatinase to support the Phase III HARMONY study and future commercial launch. Any delays or issues in manufacturing could disrupt timelines.

Economic Uncertainty: Potential seasonality in rare disease product demand could lead to variability in revenue, impacting financial stability.

Strategic Execution Risks: The company is preparing for a potential launch of FILSPARI in FSGS, which requires significant investment and organizational readiness. Failure to execute effectively could hinder market penetration.

Generic Competition: THIOLA and THIOLA EC are facing anticipated generic competition, which could reduce revenue from these products.

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Guidance & Outlook

FILSPARI in IgA Nephropathy: The company expects sustained growth in the IgA nephropathy market, driven by FILSPARI's positioning as a foundational therapy. Anticipated updates include modifications to liver monitoring REMS and removal of pregnancy testing REMS, which may simplify access. FILSPARI is expected to replace RAS inhibitors as the standard of care, with a growing emphasis on earlier intervention.

FILSPARI in FSGS: The sNDA review process for FILSPARI in FSGS is advancing, with a PDUFA date of January 13, 2026. If approved, FILSPARI would be the first treatment for FSGS, representing a significant growth opportunity. The company is preparing for a potential launch early next year.

HARMONY Study for Pegtibatinase: The company plans to reinitiate enrollment in the Phase III HARMONY study for pegtibatinase next year, supported by progress in manufacturing scale-up.

Revenue Growth: Continued revenue growth is expected, driven by demand for FILSPARI in IgA nephropathy. Additional milestone payments tied to market access achievements and sales-based achievements are anticipated to enhance financial flexibility.

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Shareholder Return Plan

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Key Q&A

Q:What are the major topics anticipated for the ADCOM regarding FSGS, and how does the company plan to address them?

A:The company anticipates educational components about the disease and pathophysiology, focusing on proteinuria as a validated endpoint and the challenges of eGFR in FSGS. They plan to educate nephrologists and cardiologists on the panel about the biologic plausibility of proteinuria and present strong clinical data showing sparsentan's significant reduction in proteinuria compared to an active comparator.

Q:What is the level of engagement with the FDA regarding the REMS update for FILSPARI?

A:The company has had active and engaged interactions with the FDA, similar to their previous experiences with the NDA for IgA nephropathy. They are monitoring the regulatory landscape and progressing as expected with their sNDAs for REMS modification and FSGS.

Q:When will the company gain insight into the timing of the Advisory Committee panel meeting?

A:The company does not yet know the date of the advisory committee meeting but anticipates it will occur in Q4, given the PDUFA date of January 13.

Q:What would it take to get the REMS potentially removed entirely, and on what timeline?

A:The company views REMS removal as a two-step process: first, lessening the testing frequency, and second, full removal. Historically, the FDA has required completion of a PMR involving 3,000 patients for 2 years. The company is in dialogue with the FDA to explore opportunities for earlier removal following the PDUFA date on the 28th of the month.

Q:How are the new data from the Spic and SPARTAN studies being received by the nephrology community, and is further real-world evidence anticipated?

A:The data have been received positively, showing safety and efficacy in combination with SGLT2 inhibitors and effects on disease-modifying biomarkers. The company plans to validate these findings with additional data from a large Phase III study and present them at future congresses.

Q:What is the breakdown of growth contributions from stocking, new patients, and persistence rates?

A:The revenue growth was performance-driven without stocking contributions. Persistence rates remain high, and growth is driven by a mix of new and continuing patients. The company expects this dynamic to be sustainable.

Q:What is the company's understanding of 'sustained CR' in FSGS, and how does it relate to their DUPLEX trial data?

A:'Sustained CR' can refer to either a single point in time or durability. In the DUPLEX trial, 85% of patients with complete remission stayed below baseline proteinuria levels, indicating durability. The company focuses on FDA requirements and has provided data consistent with these definitions.

Q:What is the conversion rate of patient start forms to patients on the drug, and how is market penetration evolving?

A:The conversion rate is at the top end of best practices for rare diseases. Market penetration is less than 10% of the addressable population, with significant room for growth. The company is entering a broader market segment with sustainable growth potential.

Q:How does the company view the impact of competition on patient start forms and market dynamics?

A:The company delivered its strongest quarter despite competition, seeing consistent demand and market growth. They believe the market is large enough for multiple products and expect to remain the market leader due to FILSPARI's strong profile and long-term data.

Q:What are the company's expectations for eGFR data presentation during the AdCom and FDA's focus on this metric?

A:The company does not anticipate eGFR to be a major focus during the AdCom, as the FDA has shifted to proteinuria as a surrogate endpoint. eGFR data is consistent with expectations but has not been a primary focus.

Q:What are the gross-to-net trends for IgAN, and what are the expectations for the rest of the year?

A:Gross-to-net trends improved in Q2 after typical beginning-of-year dynamics. The company expects incremental increases in discounts in Q3 and Q4 but remains aligned with guidance of low 20% for the year.

Q:What are the bottlenecks in drug uptake, and how does the company view the new patient segment?

A:The main bottleneck has been the urgency to treat patients earlier. The company sees an opportunity in the new patient segment with lower proteinuria levels, supported by REMS modifications aligning with clinical practice.

Q:What is the company's visibility on royalty revenue from the CSL launch in Europe?

A:The company defers to CSL Vifor for guidance but expects royalties to pick up as CSL gains reimbursement in individual countries.

Q:Review of Unclear Management Responses

A:Management avoided providing specific guidance on the timing of the Advisory Committee panel meeting, the exact timeline for REMS removal, and the expected cadence of patient start forms in the face of competition. They also deferred to CSL Vifor for details on European royalty revenue.

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Earnings Word Cloud

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