We came across a bullish thesis on Travere Therapeutics, Inc. on HalfBakedInnovations’s Substack by Biotech Distilled. In this article, we will summarize the bulls’ thesis on TVTX. Travere Therapeutics, Inc.'s share was trading at $30.07 as of February 9th. TVTX’s forward P/E was 26.32 respectively according to Yahoo Finance. 7 Best Dialysis and Kidney Disease Stocks to Buy yezry/Shutterstock.com Travere Therapeutics (TVTX) is a biotech company focused on rare kidney and metabolic diseases, with its lea ...

We came across a bullish thesis on Travere Therapeutics, Inc. on HalfBakedInnovations’s Substack by Biotech Distilled. In this article, we will summarize the bulls’ thesis on TVTX. Travere Therapeutics, Inc.'s share was trading at $30.07 as of February 9th. TVTX’s forward P/E was 26.32 respectively according to Yahoo Finance. 7 Best Dialysis and Kidney Disease Stocks to Buy yezry/Shutterstock.com Travere Therapeutics (TVTX) is a biotech company focused on rare kidney and metabolic diseases, with its lea ...

Heerma attributed fourth-quarter momentum to several factors, including FILSPARI’s differentiated profile as a once-daily oral, non-immunosuppressive therapy; simplified REMS monitoring requirements ; and the publication of KDIGO guidelines . He also said adoption is increasing in IgAN patients with proteinuria levels below 1.5 grams per gram, consistent with guideline direction toward earlier intervention and lower targets. When asked to quantify what proportion of fourth-quarter patient start forms came f ...

Travere Therapeutics (NasdaqGM:TVTX) Q4 2025 Earnings call February 19, 2026 04:30 PM ET Company ParticipantsBill Rote - Chief Research OfficerChris Cline - CFOEric Dube - President and CEOGavin Clark-Gartner - Managing Director of Biotechnology Equity ResearchJason Zemansky - Managing DirectorJula Inrig - Chief Medical OfficerNivi Nehra - VP of Corporate Communications and Investor RelationsPeter Heerma - Chief Commercial OfficerConference Call ParticipantsAlex Thompson - Managing Director and Senior Equit ...

Travere Therapeutics (NasdaqGM:TVTX) Q4 2025 Earnings call February 19, 2026 04:30 PM ET Company ParticipantsBill Rote - Chief Research OfficerChris Cline - CFOEric Dube - President and CEOGavin Clark-Gartner - Managing Director of Biotechnology Equity ResearchJason Zemansky - Managing DirectorJula Inrig - Chief Medical OfficerNivi Nehra - VP of Corporate Communications and Investor RelationsPeter Heerma - Chief Commercial OfficerConference Call ParticipantsAlex Thompson - Managing Director and Senior Equit ...

Travere Therapeutics (NasdaqGM:TVTX) Q4 2025 Earnings call February 19, 2026 04:30 PM ET Speaker3Good afternoon, and welcome to the Travere Therapeutics fourth quarter and full year 2025 financial results conference call. Today's call is being recorded. At this time, I would like to turn the conference call over to Nivi Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.Speaker4Thank you, operator. Good afternoon, and welcome to Travere Therapeutics' fourth quarter ...

Summary of Travere Therapeutics Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Focus**: Rare diseases, specifically targeting IgA nephropathy, FSGS, and homocystinuria (HCU) [2][3] Key Points Product Development and Regulatory Updates - **FILSPARI**: - Launched for IgA nephropathy, aiming to replace traditional treatments like RAS inhibitors and ARBs [3] - Achieved record commercial performance in the last quarter, marking the strongest quarter to date [3] - sNDA under review for FSGS, with a PDUFA date extended to April 13, 2026, due to additional information requests from the FDA [3][6] - Anticipated to be the first approved treatment for FSGS, addressing a significant unmet need [3][6] - **HCU**: - Manufacturing challenges resolved, with plans to restart Phase III HARMONY study [4] - HCU is a genetic metabolic disease with significant health risks if untreated, including cognitive and psychiatric defects [34][35] Market Dynamics and Competitive Landscape - **FSGS Market**: - High confidence in the approvability of sparsentan for FSGS due to strong clinical trial results [6][10] - Anticipated rapid uptake post-approval, driven by urgency and prior experience with FILSPARI in IgA nephropathy [12][31] - Expectation of complementary therapies rather than direct competition in the FSGS space [19] - **IgA Nephropathy**: - Increased competition in the market, but Travere believes that the introduction of new therapies will expand the overall market rather than diminish FILSPARI's growth [21][22] - Observing a trend towards earlier treatment and combination therapies in line with updated treatment guidelines [22] Financial Position and Future Outlook - **Financial Health**: - End of year cash position at $323 million, sufficient to support ongoing operations and product launches without immediate capital needs [45][46] - **Long-term Strategy**: - Plans to pursue additional assets post-FSGS approval, focusing on synergies with existing development and commercial expertise [43][44] Other Important Insights - **Patient Compliance**: High persistence rates observed for FILSPARI, attributed to its once-daily dosing and positive patient outcomes [27] - **REMS Program**: Adjustments to the REMS program have positively impacted prescribing behavior, allowing for quarterly testing instead of monthly [28][29] - **Payer Dynamics**: Early indications show payers are supportive of combination therapies, which may enhance FILSPARI's market position [24][25] Conclusion Travere Therapeutics is positioned for significant growth with its focus on rare diseases, particularly with the anticipated approval of FILSPARI for FSGS. The company is well-capitalized and strategically planning for future developments while navigating a competitive landscape in the rare disease market.

Summary of Travere Therapeutics FY Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 - **CEO**: Eric Dube Key Points Industry and Company Focus - Travere Therapeutics is focused on rare diseases, particularly in the areas of IgA nephropathy, FSGS (Focal Segmental Glomerulosclerosis), and homocystinuria (HCU) [2][3][32] Financial Performance - Achieved **$410 million** in net revenue for 2025, with **143% growth** compared to 2024 [3][4] - Revenue breakdown: **$323 million** from Filspari and **$88 million** from the Thiola portfolio [4] - **$103 million** revenue in Q4 2025, representing **108% growth** year-over-year [13] Product Updates - **Filspari**: - Reached an all-time high of **908 new patient start forms** in Q4 2025 for IgA nephropathy [3][12] - Positioned as a foundational therapy for IgA nephropathy, with a unique once-a-day pill formulation [10][11] - Clinical data shows a **50% reduction** in proteinuria compared to the standard of care [25] - Anticipated FDA approval for FSGS, with ongoing regulatory engagement [5][6][30] - **HARMONY Study**: - Phase III program for HCU reinitiated, focusing on enzyme replacement therapy [4][32] - Current treatment options are limited, with a significant unmet need for disease-modifying therapies [33] Regulatory Engagement - Ongoing discussions with the FDA regarding the FSGS supplemental new drug application (SNDA) [5][6] - Received additional information requests from the FDA focused on clinical benefits of Filspari, not related to safety or manufacturing [5][41] Market Opportunity - Approximately **70,000 patients** diagnosed with IgA nephropathy in the U.S., with a significant number still untreated [10] - Filspari is expected to capture a larger market share as awareness and clinical use grow [30][17] - The company has not yet reached **10%** of the addressable population for IgA nephropathy, indicating substantial growth potential [16][17] Clinical Insights - The KDIGO guidelines have been updated to reflect the urgency of treating IgA nephropathy, emphasizing the need for earlier intervention [9][15] - The PARASOL Group's findings indicate that reducing proteinuria is critical for lowering the risk of kidney failure in FSGS patients [21][23] Future Outlook - Travere is committed to redefining the standard of care in IgA nephropathy, FSGS, and HCU, with a strong financial foundation to support ongoing initiatives [37][52] - The company is prepared for rapid uptake of Filspari in FSGS upon approval, leveraging existing relationships with nephrologists [30][31] Patient-Centric Approach - The company emphasizes a patient-inspired approach, with personal connections to rare diseases among its team members [2] - Highlighted the story of a patient, Jennifer, to illustrate the impact of FSGS and the need for innovative therapies [38][39] Additional Important Information - The company has a strong commitment to the rare disease community and aims to provide hope and better treatment options for patients [39][52] - The upcoming PDUFA date for FSGS is critical, with expectations for timely communication regarding FDA decisions [40][41]

Core Insights - Travere Therapeutics anticipates approximately $127 million in U.S. net product sales for Q4 2025 and around $410 million for the fiscal year 2025, ending the year with about $323 million in cash and equivalents [1][6][7] Corporate Update - The company reported a record number of patients treated with FILSPARI for IgA Nephropathy (IgAN), emphasizing its foundational role in therapy [2] - Travere is preparing for the potential commercial launch of FILSPARI in Focal Segmental Glomerulosclerosis (FSGS), which would be the first approved medication for this condition [2][6] - The pivotal Phase 3 HARMONY Study of pegtibatinase is set to restart in Q1 2026 following manufacturing optimizations [5] Financial Performance - Preliminary U.S. net product sales of FILSPARI reached approximately $103 million in Q4 2025, marking a 108% year-over-year growth, with total sales for 2025 around $322 million [6] - The company received a $40 million milestone payment from CSL Vifor for market access achievements, with FILSPARI launched in several European countries [6] Regulatory and Development Milestones - The PDUFA target action date for the supplemental New Drug Application (sNDA) for FILSPARI in FSGS is set for January 13, 2026 [6] - The company is generating clinical evidence to support FILSPARI's role in IgAN through ongoing studies and presentations at medical meetings [6] - Chugai Pharmaceutical plans to submit a New Drug Application for sparsentan in Japan in 2026, with Travere eligible for additional milestone payments [6]

Summary of Travere Therapeutics FY Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Date**: December 02, 2025 - **Key Focus**: The company is focused on the ongoing launch of FILSPARI for IgA nephropathy, an SNDA with the FDA for FSGS, and enzyme replacement therapy for classical homocystinuria (HCU) [2][3][4] Core Points and Arguments FILSPARI Launch and Growth - **IgA Nephropathy**: The launch of FILSPARI is seeing strong growth, supported by the nephrology community and recent KDIGO guidelines that emphasize urgency in treating patients to prevent kidney failure [2] - **Patient Reach**: The company has reached a significant number of new patients this year, indicating robust market acceptance [2] FSGS SNDA and Regulatory Process - **SNDA Submission**: An SNDA for FSGS is under review, with a PDUFA date set for January 13, 2026. The process is straightforward, with no mid-cycle or late-cycle meetings planned [3][4] - **Labeling Expectations**: The company anticipates a broad indication for FSGS treatment without specific proteinuria cutoffs, as many patients present with high proteinuria levels [6][9] Market Potential and Patient Population - **Addressable Population**: The estimated addressable population for FSGS is around 30,000 patients, which could expand to 40,000-50,000 if secondary patients are included [10][9] - **Provider and Payer Dynamics**: Nephrologists are eager to prescribe FILSPARI, especially for secondary patients, despite challenges in identifying the etiology of FSGS. Payers may face difficulties in managing secondary populations due to the lack of specific ICD-10 codes [11][12][13] Manufacturing and Enrollment Challenges - **HCU Therapy**: The company faced manufacturing scale-up challenges but is now on track to resume enrollment in the phase three trial for pegtibatinase for HCU next year [3][26] - **Patient Support**: The company emphasizes the importance of patient support services to help patients reach target doses and maintain compliance [16][18] Financial Dynamics - **Revenue Growth**: Revenue from FILSPARI is outpacing patient start forms, attributed to the time required for reimbursement processes post-approval [19][20] - **Future Expectations**: The company expects a more stable dynamic between new patient prescriptions and reimbursements moving forward [21][23] Combination Therapy Considerations - **Combination with BAFF APRIL**: The company is optimistic about the potential for payers to approve FILSPARI in combination with BAFF APRIL therapies, especially for severe patients [24][25] HCU Study Design - **Enrollment Cadence**: The company plans to quickly ramp up enrollment for the HCU trial, having already identified interested patients and providers [26] - **Dietary Protocol**: A sub-study will explore how much protein can be introduced into patients' diets while maintaining control of homocysteine levels, which is a significant concern for patients [27][28] Other Important Points - **Eagerness for Approval**: There is a high level of eagerness among physicians to prescribe FILSPARI for FSGS, indicating a strong unmet need in the market [18] - **Patient-Centric Approach**: The company is focused on addressing patient needs, particularly in terms of dietary flexibility and treatment efficacy [27][28] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic priorities, market dynamics, and future expectations.