Travere signals readiness for rapid FILSPARI launch in FSGS as Q3 2025 revenue hits $164.9M

Earnings Call Insights: Travere Therapeutics (TVTX) Q3 2025

MANAGEMENT VIEW

* President and CEO Eric Dube emphasized "exceptional progress across our three key priorities: delivering strong commercial execution in IgA nephropathy, preparing for a potential FDA approval in FSGS, and successfully advancing the manufacturing scale-up of pegtibatinase to support restarting enrollment in the pivotal HARMONY study in 2026." He highlighted the sustained growth of FILSPARI in IgA nephropathy and noted its inclusion in the KDIGO guidelines for earlier first-line use.
* Dube pointed to the FDA's approval of a modification to the FILSPARI REMS program, stating "This change not only simplifies care for physicians and patients, but also reinforces FILSPARI's long-term safety profile." He underscored the company's preparedness for a rapid launch in FSGS, pending approval, calling it "a transformational opportunity for Travere."
* Chief Medical Officer Jula Inrig cited the updated KDIGO guidelines as "a strong external validation of FILSPARI's role as foundational treatment" and described new data from the SPARTAN and PROTECT trials, asserting the product's consistent benefit across patient populations.
* Chief Commercial Officer Peter Heerma reported "FILSPARI net product sales reached approximately $91 million in the third quarter, representing another quarter of strong growth, driven by consistent demand and deepening engagement among new and experienced prescribers." Heerma also highlighted 731 new patient start forms during the quarter, with record daily rates in September.
* Chief Financial Officer Chris Cline stated, "In the third quarter, we generated U.S. net product sales of $113.2 million. FILSPARI continued to grow significantly in the third quarter, generating $90.9 million in U.S. net product sales, which represents an increase of more than 155% year-over-year."

OUTLOOK

* Management reiterated readiness for a potential FDA approval and launch of FILSPARI in FSGS in January 2026, emphasizing execution plans and commercial preparedness.
* Dube confirmed "our teams are fully prepared to execute a rapid launch upon approval, building upon the commercial foundation we've established in IgA nephropathy."
* Cline described a strong financial foundation and no near-term need for additional capital, with confidence in "our ability to execute on our key priorities and continue advancing our mission for patients."

FINANCIAL RESULTS

* Travere reported total revenue of $164.9 million for the quarter, including $113.2 million in U.S. net product sales and $51.7 million of license and collaboration revenue. FILSPARI U.S. net product sales totaled $90.9 million.
* The quarter included a $40 million market access milestone from CSL Vifor and $9.3 million in noncash revenue from the relinquishment of the option to acquire Renalys.
* Net income for the third quarter of 2025 was $25.7 million or $0.29 per basic share, shifting from a net loss of $54.8 million in the same period last year. On a non-GAAP adjusted basis, net income was $52.8 million or $0.59 per basic share.
* As of September 30, 2025, cash, cash equivalents and marketable securities totaled approximately $254.5 million.

Q&A

* Joseph Schwartz, Leerink Partners: Asked about the impact of the REMS adjustment and competitive dynamics. Peter Heerma responded, "I think overall, I would say we see very consistent demand since we had our full approval last year. And that consistency have not been impacted by launches of new products that came into the marketplace."
* Laura Chico, Wedbush: Inquired about baseline proteinuria levels and off-label use in FSGS. Heerma shared that "the baseline proteinuria levels are well below 1.5 gram per gram" and Dube confirmed "we do see some limited prescribing and use in FSGS."
* Anupam Rama, JPMorgan: Questioned quarter-over-quarter declines in patient start forms and considerations on gross to net. Heerma noted strong September and October trends, while Cline explained, "there was less than $2 million benefit" from gross to net in Q3 and guided for higher discounts in Q4.
* Tyler Van Buren, TD Cowen: Asked about communication ahead of the FSGS PDUFA date. Dube stated, "It's been our practice not to comment on ongoing FDA interactions...we'll be entering a quiet period as we approach the PDUFA date."
* Multiple analysts probed on competitive dynamics, the impact of updated guidelines and REMS changes, SG&A expectations, and pegtibatinase manufacturing progress.

SENTIMENT ANALYSIS

* Analysts were largely positive, focusing on performance momentum, competitive positioning, and pipeline progress, with questions reflecting curiosity about sustainability and expansion rather than skepticism.
* Management maintained a confident and upbeat tone throughout, particularly when discussing commercial execution, regulatory milestones, and financial strength. Heerma's and Dube's language emphasized continued growth and readiness for rapid expansion.
* Compared to the previous quarter, both analysts and management displayed increased confidence, with fewer defensive responses and a greater focus on operational execution.

QUARTER-OVER-QUARTER COMPARISON

* Guidance language in Q3 shifted to emphasize immediate readiness for a potential FSGS launch, compared to preparatory language in Q2.
* FILSPARI revenue and total revenue increased significantly versus Q2, where FILSPARI net product sales were $71.9 million and total revenue was $114.4 million.
* Management tone became more assertive about competitive positioning and less cautious about potential headwinds.
* Analyst focus shifted from regulatory and launch uncertainties to questions about market expansion and real-world performance metrics.
* SG&A rose, attributed to preparations for the FSGS launch, while R&D expenses remained stable quarter-over-quarter.

RISKS AND CONCERNS

* Management acknowledged the need to monitor gross to net impacts, with expectations of higher discounts in Q4.
* Ongoing competition in the IgA nephropathy space was addressed, with management repeatedly stating that demand "has not been impacted by launches of new products."
* Pending FDA decisions remain a critical event risk, with Dube reiterating the company will "enter a quiet period" ahead of the PDUFA date.
* The scaling up of pegtibatinase manufacturing continues, though the company reported "first commercial scale batches" are completed, with further work ongoing to build stock for launch.

FINAL TAKEAWAY

Travere Therapeutics management underscored strong Q3 performance driven by FILSPARI's commercial momentum and regulatory advancements, expressing confidence in sustaining growth in IgA nephropathy and executing a rapid launch in FSGS if approved. With financial strength, expanded clinical validation, and operational readiness, the company signaled a commitment to advancing innovative therapies for rare kidney diseases and maintaining its leadership position in the evolving treatment landscape.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/tvtx/earnings/transcripts]

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* Travere Therapeutics, Inc. (TVTX) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4836081-travere-therapeutics-inc-tvtx-q3-2025-earnings-call-transcript]
* Travere Therapeutics: Buy Rating On Back Of Filspari Expansion Towards FSGS [https://seekingalpha.com/article/4822585-travere-therapeutics-buy-rating-on-back-of-filspari-expansion-towards-fsgs]
* Travere: No AdCom, No Problem - Targeting Big Revenues With FSGS Approval [https://seekingalpha.com/article/4821665-travere-no-adcom-no-problem-targeting-big-revenues-with-fsgs-approval]
* Travere Therapeutics Q3 2025 Earnings Preview [https://seekingalpha.com/news/4510573-travere-therapeutics-q3-2025-earnings-preview]
* Travere rises as FDA says no AdCom required for Filspari label expansion [https://seekingalpha.com/news/4493651-travere-says-no-fda-adcom-filspari-review]