Travere Therapeutics (NasdaqGM:TVTX) 2025 Conference November 18, 2025 10:00 AM ET Company ParticipantsPeter Heerma - Chief Commercial OfficerEric Dube - CEOConference Call ParticipantsMaury Raycroft - AnalystMaury RaycroftHi everyone, my name is Maury Raycroft, and I'm one of the biotech analysts at Jefferies. It's with great pleasure that I'd like to welcome the Travere management team. We've got Eric Dube, the CEO, and Peter Heerma, the Chief Commercial Officer. Thanks so much for joining us today. We're ...

Key Points New York City-based Armistice Capital sold 2,152,000 shares of Travere Therapeutics for an estimated $29.3 million in the third quarter. At quarter-end, the fund reporting holding 6.7 million shares of Travere Therapeutics valued at $160.7 million. The position now represents 2% of fund assets, making it Armistice's second-largest holding. These 10 stocks could mint the next wave of millionaires › On Friday, New York City-based Armistice Capital disclosed it sold 2,152,000 shares of Tr ...

Summary of Travere Therapeutics Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Event**: Conference at TD Cowen's I&I Summit on November 13, 2025 Key Industry and Company Insights Focus on FSGS (Focal Segmental Glomerulosclerosis) - Upcoming PDUFA date is January 13, 2026, for sparsentan in treating FSGS [7] - Recent data presented at ASN Kidney Week showed significant continuity in achieving the 0.7 gram per gram UPCR target across DUPLEX and RADAR studies [3][4] - Achieving the 0.7 proteinuria reduction correlates with a lower rate of kidney failure, with an 85% reduction in risk for patients reaching this target [5][6] - Sparsentan demonstrated a 26% difference in treatment effect compared to irbesartan over two years [6] Regulatory Engagement - Consistent engagement with the FDA, with no unusual issues noted during the SNDA review process [7][14] - Anticipation of a draft label approximately one month before the PDUFA date [7] Pediatric Indication - Requested indication for patients aged eight years and older, with ongoing studies to support safety and efficacy in pediatric patients [21][22] - Potential for expanding the age range through the EPIC study, which includes patients under eight [22] Market Dynamics and Launch Strategy - The addressable patient community for FSGS is about half that of IgAN, but there is greater urgency for treatment [24] - The launch of sparsentan is expected to be faster due to existing payer coverage policies from the IgAN launch and the availability of two-year data [26][27] - Anticipated pricing dynamics suggest a higher cost due to a double dose for adult patients [28][29] Competitive Landscape - Travere Therapeutics is positioned as a first mover in the FSGS space, with expectations that other companies will follow with their own treatments [31] - The company is optimistic about the need for multiple treatment options, particularly for combination therapies [31] Financial Position - As of the third quarter, the company reported $255 million in cash, with pro forma cash of approximately $300 million after a recent milestone [39] - No immediate need for capital, but continued investments are planned for FILSPARI and the FSGS launch [39][40] Future Outlook - Continued growth in revenue is expected, driven by high patient adherence and a stable base of continuing patients [36] - The company is optimistic about the upcoming FSGS approval and the potential for rapid uptake in the market [27][37] Additional Important Points - The company is preparing for a quiet period leading up to the PDUFA date [19] - Discussions regarding the potential full REMS removal are planned post-FSGS approval [37] - The competitive landscape in IgAN is evolving, with a focus on combination therapies to enhance treatment efficacy [34][35]

Summary of Travere Therapeutics FY Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Market Cap**: Approximately $3 billion [39] Industry Focus - **Primary Focus**: Rare kidney diseases, specifically IgA nephropathy and Focal Segmental Glomerulosclerosis (FSGS) - **Key Products**: Filspari (for IgA nephropathy) and pegtibatinase (for classical homocystinuria) Key Points and Arguments FSGS Developments - **Unmet Need**: FSGS represents a high unmet need in nephrology, with no approved medications currently available [6][21] - **FDA Review**: A PDUFA date for the FSGS supplemental new drug application (SNDA) is set for January 13, 2026, with expectations that the review process is on track [3][44] - **Patient Population**: Approximately 30,000 addressable patients for FSGS compared to 70,000 for IgA nephropathy, with a faster progression rate in FSGS [14] - **Treatment Urgency**: The urgency to treat FSGS patients is higher due to rapid progression to kidney failure [14] Competitive Landscape - **Market Dynamics**: Travere is optimistic about paving the way for other companies to enter the FSGS space, viewing potential competitors as complementary rather than direct threats [22] - **Current Competitors**: Limited direct competition exists, with only one other therapy in phase three trials [22] IgA Nephropathy Insights - **Market Growth**: The number of approved therapies for IgA nephropathy has increased to four, enhancing treatment options for patients [24] - **Guideline Changes**: New KDIGO guidelines recommend aggressive treatment strategies, which are positively impacting prescribing patterns [25][26] Financial Position - **Cash Reserves**: The company ended the quarter with $255 million in cash, with a pro forma basis nearing $300 million, indicating a strong financial position [42] - **Investment Plans**: Plans to invest in evidence generation, operationalizing phase three for pegtibatinase, and supporting FSGS uptake [42][43] Future Catalysts - **Upcoming Events**: Key upcoming events include the PDUFA date for FSGS on January 13, 2026, and updates on IgA nephropathy performance and pegtibatinase study restart [44] Pegtibatinase Program - **Patient Population**: Estimated 7,000-10,000 patients in the U.S. with classical homocystinuria, with potential for higher numbers due to missed diagnoses [37] - **Manufacturing Challenges**: The program faced manufacturing challenges but is now on track to reinitiate phase three enrollment next year [38] Additional Important Insights - **Regulatory Environment**: The FDA is focused on spurring innovation in the rare kidney space, which is encouraging for Travere's upcoming applications [12] - **Payer Considerations**: The lack of specific diagnostic codes for FSGS may complicate payer responses, but the high cost of untreated patients may lead to broader acceptance [20][21] This summary encapsulates the critical insights and developments discussed during the Travere Therapeutics FY Conference Call, highlighting the company's strategic direction and the evolving landscape of rare kidney disease treatments.

Core Insights - Travere Therapeutics announced late-breaking data from the Phase 3 DUPLEX Study, showing that FILSPARI (sparsentan) significantly improved proteinuria outcomes in patients with focal segmental glomerulosclerosis (FSGS) compared to irbesartan [1][2][3] Study Findings - In the DUPLEX Study, 37.5% of patients treated with FILSPARI achieved a urine protein-to-creatinine ratio (UPCR) below 0.7 g/g, compared to 21.4% for those on irbesartan, indicating a relative risk (RR) of 1.8 [3] - At week 108, 19% of FILSPARI-treated patients reached the UPCR threshold versus 11.2% for irbesartan, with an RR of 1.7 [3] - Patients achieving UPCR below 0.7 g/g had a lower likelihood of reaching kidney failure (3.6% vs. 11.2%, RR 0.52) [3][4] Long-term Risk Analysis - In the DUPLEX-aligned RaDaR cohort, achieving UPCR below 0.7 g/g at 24 months was linked to a significantly lower risk of kidney failure over an additional 60 months (hazard ratio [HR] 0.14) [4] - A similar lower risk was observed for patients who achieved UPCR below 0.7 g/g at any time during the 24-month period (HR 0.27) [4] - The analysis indicated that a 26% relative reduction in UPCR for FILSPARI-treated patients correlates to a 24% reduction in the 5-year risk of kidney failure (HR 0.76) [8] Background on FSGS - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S., characterized by progressive scarring and often leading to kidney failure [7] - There are currently no FDA-approved pharmacologic therapies specifically for FSGS [7] Company Overview - Travere Therapeutics is focused on developing therapies for rare diseases, with FILSPARI currently indicated for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) [9][28]

Core Viewpoint - Travere Therapeutics, Inc. (NASDAQ:TVTX) has demonstrated significant financial improvement, with a notable increase in stock performance driven by strong earnings and sales growth in its kidney disease treatment, Filspari [1][3]. Financial Performance - The company reported a net income of $25.7 million in Q3, a turnaround from a net loss of $54.8 million in the same quarter last year [2]. - Total revenues surged by 162% year-on-year, reaching $164.8 million, up from $62.9 million, primarily due to robust sales of Filspari [3]. Product Performance - Filspari generated $90.9 million in sales in the US alone, reflecting a 155% growth year-on-year [3]. - The CEO highlighted the drug's growing role as a foundational therapy in IgAN, indicating strong commercial execution and increasing confidence among healthcare providers and patients [4]. Future Outlook - The company is optimistic about the progress of its supplemental New Drug Application (sNDA) review for FSGS and is preparing for potential FDA approval early next year [5]. - Travere is also making strides in restarting the pivotal HARMONY Study of pegtibatinase, positioning itself for long-term growth [5].

Core Insights - Travere Therapeutics, Inc. (NASDAQ:TVTX) achieved a record high stock price, driven by strong earnings and positive outlook for the upcoming month [1][3] Financial Performance - The company reported a net income of $25.7 million in Q3, a significant turnaround from a net loss of $54.8 million in the same quarter last year [2] - Total revenues increased by 162% year-on-year, reaching $164.8 million, primarily due to robust sales of its kidney disease treatment, Filspari [3] - Filspari generated $90.9 million in sales in the US, reflecting a 155% growth compared to the previous year [3] Management Commentary - The President and CEO of Travere Therapeutics highlighted the strong commercial performance and the growing acceptance of Filspari as a foundational therapy in IgAN [4] - The company is optimistic about the progress of its supplemental New Drug Application (sNDA) review for FSGS and is preparing for potential FDA approval early next year [5] - Travere is also making strides in restarting the pivotal HARMONY Study of pegtibatinase, positioning itself for long-term growth [5]

Core Insights - Travere Therapeutics reported strong sales growth driven by its drug Filspari, which treats IgA nephropathy, achieving $90.9 million in sales for the September quarter, a 155% increase year-over-year, surpassing forecasts of $79 million [1][5] - The FDA has relaxed monitoring requirements for Filspari, reducing liver function checks from monthly to quarterly for the first year of treatment [2] - KDIGO guidelines now position Filspari as a potential foundational treatment for IgA nephropathy, enhancing its competitive standing [3] Financial Performance - Travere's total sales reached $164.9 million, exceeding market expectations of $105.2 million to $106 million [5] - The company reported a surprising profit of $0.28 per share, a turnaround from a loss of $0.70 per share in the same quarter last year, while analysts had predicted a loss of $0.30 [6] Market Reaction - Travere's stock surged 18.6% to close at $35.16, breaking out of a consolidation phase with a previous entry point at $28.69 [4] - The stock has been in a profit-taking zone after rising 20% to 25% above its entry point [4] Future Prospects - Travere is seeking FDA approval for Filspari in treating focal segmental glomerulosclerosis (FSGS), with a decision expected by January 13 [7] - The company has seen a slight decline in new patient start forms for Filspari, with 731 forms filled, down 2% from the previous quarter [5][6] - Analyst Laura Chico raised the price target for Travere stock from $32 to $37, maintaining an outperform rating [7] Stock Ratings - Travere Therapeutics holds a high IBD Digital Composite Rating of 98, indicating it outperforms 98% of all stocks based on fundamental and technical measures [8]

Core Insights - Two stocks in the health care sector are showing signs of being overbought, which may concern momentum-focused investors [1][2] Company Performance - **Alphatec Holdings Inc (NASDAQ: ATEC)** reported better-than-expected third-quarter financial results and raised its FY25 sales guidance above estimates, with a stock gain of approximately 12% over the past month and a 52-week high of $17.14. The RSI value is 82.5, indicating overbought conditions, while the stock closed at $16.33 after a 1% decline [7] - **Travere Therapeutics Inc (NASDAQ: TVTX)** also reported better-than-expected third-quarter sales results, with a stock gain of around 24% over the past month and a 52-week high of $30.97. The RSI value is 80.9, also indicating overbought conditions, and the stock closed at $29.65 after a 1.1% decline [7]

Core Insights - Travere Therapeutics reported a revenue of $164.86 million for Q3 2025, marking a year-over-year increase of 162.1% and significantly surpassing the Zacks Consensus Estimate of $103.39 million by 59.45% [1] - The company achieved an EPS of $0.28, a notable improvement from -$0.70 a year ago, resulting in an EPS surprise of 190.32% compared to the consensus estimate of -$0.31 [1] Revenue Breakdown - Revenue from Tiopronin products (Thiola) was $22.25 million, slightly below the estimated $22.64 million, reflecting a year-over-year decrease of 12.3% [4] - Total net product sales reached $113.15 million, exceeding the average estimate of $99.66 million, representing an 85.5% increase year-over-year [4] - Revenue from FILSPARI was $90.9 million, surpassing the estimated $77.02 million, with a year-over-year growth of 155.2% [4] - License and collaboration revenue amounted to $51.71 million, significantly exceeding the average estimate of $4.23 million, indicating a remarkable year-over-year increase of 2625.8% [4] Stock Performance - Travere's shares have returned 20.9% over the past month, outperforming the Zacks S&P 500 composite's 3.6% change [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential for continued outperformance in the near term [3]