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]

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 - 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]

Financial Data and Key Metrics Changes - In Q3 2025, the company generated U.S. net product sales of $113.2 million, with FILSPARI contributing approximately $90.9 million, representing an increase of more than 155% year-over-year [22][23] - Net income for Q3 2025 was $25.7 million, or $0.29 per basic share, compared to a net loss of $54.8 million, or $0.70 per basic share for the same period in 2024 [25] - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled approximately $254.5 million [26] Business Line Data and Key Metrics Changes - FILSPARI's net sales reached approximately $91 million in Q3 2025, driven by consistent demand and engagement among prescribers [16] - The company saw 731 new patient start forms during the quarter, with September recording the highest daily patient start form rate since launch [16][18] - Thiola and Thiola EC contributed $22.3 million in U.S. net product sales [23] Market Data and Key Metrics Changes - The FDA approved a modification to the FILSPARI REMS program, which simplifies care for physicians and patients, reinforcing FILSPARI's long-term safety profile [5][14] - The KDIGO guidelines included FILSPARI as a first-line option for patients at risk of IgA nephropathy progression, validating its role as foundational treatment [9][10] Company Strategy and Development Direction - The company is preparing for a potential FDA approval in FSGS, aiming to launch FILSPARI as the first approved medication for this condition [7][19] - The focus on expanding FILSPARI's global footprint and addressing urgent needs in rare kidney diseases is central to the company's mission [6][28] - The company plans to advance the manufacturing scale-up of pegtibatinase to support the pivotal HARMONY study restart in 2026 [4][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining FILSPARI's growth in IgA nephropathy and executing a successful launch in FSGS if approved [27][28] - The company is well-positioned financially, with no near-term need for additional capital, allowing it to focus on core objectives [26][27] Other Important Information - The company repaid its remaining 2025 convertible notes, strengthening its financial foundation [22] - The recent acquisition of Renalys by Chugai Pharmaceutical is expected to create value and validate FILSPARI's potential globally [22][23] Q&A Session Summary Question: Impact of REMS adjustment and competitive dynamics - Management noted consistent demand since full approval last year, with the REMS modification positively received by the nephrology community, leading to a continuation of new prescribers [31][32][35] Question: Typical baseline proteinuria level at start of prescribing - The company indicated that about 65% of the patient population has proteinuria levels below 1.5 grams per gram, with a trend towards lower levels at initiation [37][39] Question: Communication leading up to FSGS PDUFA date - Management stated that they will enter a quiet period as they approach the PDUFA date and will provide updates on January 13 [47] Question: Awareness of REMS and KDIGO changes among practitioners - The company is actively communicating the REMS modification to physicians, while key opinion leaders are already familiar with the KDIGO guidelines [49][51] Question: Off-label use in FSGS setting - Limited prescribing and use in FSGS have been observed, but the company does not promote this [38] Question: Future R&D expenses and timelines for sparsentan development - Management expects additional investments for pegtibatinase as clinical operations ramp up, with no change in timelines for sparsentan development in Japan and other regions [78]

Core Insights - The company is focused on the successful launch of FILSPARI in IgA nephropathy as its top priority for the year [1] - There have been positive performance results in the first half of the year, with plans for exciting updates in the latter half [1] - The company has modified the liver monitoring REMS and removed the pregnancy testing REMS to simplify patient access [1] - The second priority involves ongoing work with the FDA for potential approval in FSGS [2]

Summary of Travere Therapeutics Conference Call Company Overview - **Company**: Travere Therapeutics - **Focus**: Rare kidney diseases, specifically IgA nephropathy and FSGS (Focal Segmental Glomerulosclerosis) Key Priorities - **FILSPARI Launch**: Continued success in the launch of FILSPARI for IgA nephropathy, with positive performance in the first half of the year and updates to simplify patient access [3][4] - **FDA Approval for FSGS**: Ongoing work with the FDA for potential approval of FILSPARI in FSGS, which is seen as a transformational opportunity for patients lacking approved treatments [3][4] Parasol Initiative - **Overview**: A public-private partnership aimed at defining clinical endpoints for FSGS trials, involving patient advocacy groups and global regulators [6] - **Conclusions**: - eGFR is important but not feasible as a trial endpoint due to variability [7] - Proteinuria reduction can predict kidney failure risk, establishing its importance as a clinical endpoint [9] FDA Interactions - **Advisory Committee Meeting**: Anticipated discussions will focus on clinical data in the context of the Parasol initiative [10][11] - **eGFR Data**: No current focus on eGFR in discussions with the FDA, with emphasis on proteinuria data instead [17] Commercial Strategy for FSGS - **Market Opportunity**: FSGS is expected to be a larger opportunity than IgA nephropathy due to established unmet needs [22][23] - **Prescriber Overlap**: Over 80% of physicians treating IgA nephropathy also treat FSGS patients, facilitating market entry [25] - **Sales Force Expansion**: Incremental expansion of the sales force is planned to ensure competitiveness in both IgA nephropathy and FSGS [26] Pricing Strategy - **Linear Pricing**: Pricing for FSGS will be linear with IgA nephropathy, with a higher dose for sicker patients [29][31] Market Dynamics - **Patient Population**: Approximately 30,000 addressable patients for FSGS at launch, with potential for growth as more patients are diagnosed [32] - **IgA Market Growth**: Strong growth trajectory observed in the IgA market, with a 40% increase in new patient starts post-full approval [36] Competitive Landscape - **Novartis Competition**: Initial positive signals despite competition from Novartis, with FILSPARI maintaining a strong position due to its dual mode of action and established physician relationships [40][41] - **B-cell Modulating Agents**: Upcoming therapies are viewed as complementary rather than direct competition, with a focus on combination therapies [46][48] Future Outlook - **KDIGO Guidelines**: Anticipated publication of updated guidelines will support more aggressive treatment targets and reinforce FILSPARI's position [53] - **Cash Runway**: Sufficient cash runway into 2028, supporting ongoing launches and development programs [59] Additional Insights - **Patient Compliance**: High compliance and persistence rates observed, indicating strong patient support and efficacy of FILSPARI [52] - **Long-term Vision**: Aiming for a future where no patient with IgA nephropathy experiences kidney failure, emphasizing the importance of combination therapies [49]

Group 1 - The core viewpoint of the article is that Travere Therapeutics has successfully implemented its restructuring plan, resulting in a significant increase in share price by approximately 81% [1]. Group 2 - The author emphasizes the importance of learning from both investment failures and successes, viewing investing as a continuous educational process [2]. - The focus of the author's research has been primarily on healthcare stocks over the past five years [2].