Core Viewpoint - Travere Therapeutics Inc's stock is experiencing a significant decline due to new FDA questions regarding its Filspari application, overshadowing strong fourth-quarter sales performance [1] Group 1: Stock Performance - The stock is down 32.8%, trading at $22.92, marking its largest single-day percentage loss since September 2023 [1][2] - Today's decline has brought the stock to its lowest levels since September 2025, moving away from its record high of $42.03 reached on December 24 [2] - Year-over-year, the stock still maintains a 25.9% increase [2] Group 2: Options Activity - Options trading has surged, with 6,295 calls and 23,000 puts exchanged, which is 21 times the average daily options volume [3] - The most popular option is the January 16, 2026, 17.50-strike put, with new positions being opened [3] - The stock has been placed on the short sell restricted (SSR) list today [3] Group 3: Market Sentiment - The put/call volume ratio for Travere Therapeutics is 1.49, indicating a higher than usual interest in puts, ranking above 93% of readings from the past year [4]

Group 1 - U.S. stock futures are lower, with Dow futures down approximately 0.2% [1] - Travere Therapeutics Inc expects total U.S. net product sales of $127 million for Q4 and $410 million for 2025 [1] - Travere Therapeutics will restart its Phase 3 HARMONY study in Q1 2026 [1] Group 2 - Travere Therapeutics shares fell 28.2% to $24.50 in pre-market trading [2] - Lulu's Fashion Lounge Holdings Inc shares decreased 10.4% to $10.89 after a significant rise of 79% on Monday [3] - Other stocks such as Graf Global Corp, Ready Capital Corp, and Baidu Inc also experienced declines in pre-market trading [3]

Core Viewpoint - Travere Therapeutics emphasizes its commitment to rare diseases, driven by personal connections among its team members, including the CEO, who is a rare cancer survivor [3]. Group 1: Company Overview - Travere Therapeutics is represented by CEO Eric Dube at the 44th Annual JPMorgan Healthcare Conference, highlighting the company's focus on rare diseases [1][2]. - The company adopts a patient-inspired approach in its operations, reflecting the personal experiences of its employees with rare diseases [3]. Group 2: Performance and Priorities - Travere announced updates regarding its performance expectations for 2025 and outlined three key priorities for the company [4].

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]

Financial Performance - U.S. net product sales for FILSPARI in Q4 2025 reached approximately $103 million, representing 108% year-over-year growth[5] - Total U.S. net product sales for the fiscal year 2025 are expected to be approximately $410 million[1] - The company ended 2025 with approximately $323 million in cash, cash equivalents, and marketable securities[1] - A $40 million milestone payment was received from CSL Vifor in October 2025 following market access achievements[5] Product Development and Approvals - The PDUFA target action date for FILSPARI's sNDA seeking full approval in FSGS is January 13, 2026[5] - The pivotal Phase 3 HARMONY Study of pegtibatinase is set to restart in Q1 2026 after optimization of the manufacturing process[6] - Chugai Pharmaceutical is expected to submit a New Drug Application for sparsentan in Japan in 2026[5] - If approved, FILSPARI would be the first and only medication approved for FSGS, a rare kidney disorder[5] - The company is preparing for a New Drug Application for sparsentan for the treatment of IgAN in Japan, indicating market expansion efforts[21] Market Launch and Acceptance - The company is making continued progress with the FILSPARI launch in IgAN, with preliminary estimates of metrics related to this launch[21] - The company anticipates potential approval and commercial launch of FILSPARI in FSGS, although there are risks regarding the timing and outcome of the sNDA[21] - The ongoing commercial launch of FILSPARI in IgAN is facing risks related to market acceptance, including efficacy, safety, and pricing[21] Clinical Evidence and Research - The company anticipates continued generation of clinical evidence to support FILSPARI's role as foundational therapy in IgAN throughout 2026[5] - The company is focused on the Phase 3 HARMONY Study, with expectations to restart study activities, although timelines may be subject to change[21] Risks and Challenges - There are uncertainties regarding the company's ability to raise additional funding required for product development due to macroeconomic conditions[21] - Risks associated with the manufacturing scale-up and successful execution of commercial strategies for FILSPARI are present[21] - The company faces potential disruptions to clinical trials and commercialization activities due to global and macroeconomic conditions[21] - The company is dependent on contractors for clinical drug supply and commercial manufacturing, which introduces additional risks[21] - The company is monitoring serum potassium levels in patients treated with FILSPARI, especially when used with other agents that increase serum potassium[22]

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]

Travere Therapeutics Corporate Overview January 2026 Forward-Looking Statements This presentation contains forward-looking statements, including but not limited to statements about: continued progress with the FILSPARI launch in IgAN; statements regarding our products and products in development as potential foundational treatments and/or treatment standards; additional development and regulatory milestones, including expected data from additional studies and the expected timing thereof; plans and expectati ...

Summary of Key Points from the Conference Call Industry Overview - **Industry**: US Biopharmaceuticals - **Performance**: Biopharma ended 2025 positively with NBI up 32% and DRG up 21%, outperforming SPX at 17% [1] - **Outlook for 2026**: Optimism exists despite macro concerns like inflation and tariffs, with easing drug pricing worries, increased M&A activity, new product cycles, and modest expectations positioning the sector favorably [1] Core Insights and Arguments - **Valuation**: Biotech/Pharma P/E multiples are around 19x, which is lower compared to Financials at 18x and Utilities at 20x, indicating potential undervaluation [1] - **Catalysts**: Companies like Insmed (+152%), BridgeBio (+179%), and Travere (+119%) have shown strong performance driven by value-driving catalysts [1] Company-Specific Highlights Insmed - **Performance**: Insmed was a top performer in 2025, driven by Brinsupri's launch and TPIP's phase 2 results [2] - **2026 Outlook**: Continued upside is expected as Brinsupri's uptake alleviates skepticism over the $5B NCFB opportunity [2] BridgeBio - **Focus for 2026**: The debate will center around Attruby, with positive channel checks suggesting potential for accelerated sales [2] - **Key Data**: Anticipation for PROPEL3 readout in January, which could significantly impact the stock [10] Travere - **Performance**: Outperformance in 2025 attributed to commercial success in IgAN [3] - **Approval Outlook**: Filspari's potential approval for FSGS is a major debate, with FDA signals indicating a favorable outlook [9] Cytokinetics - **Market Entry**: Myqorzo's approval for oHCM is expected to face challenges in market execution against established competitors [15][40] - **Upcoming Data**: ACACIA readout in 2Q26 is crucial for assessing the drug's competitive position [19] Tyra - **Expansion**: Tyra is expanding dabogratinib's development into LG-UTUC, which could offer greater regulatory flexibility and market opportunity [43] - **Market Potential**: Management believes an oral option could be a game changer in a relatively underserved market [43] Acumen - **Pipeline Development**: Acumen's EBD program is expected to provide optionality, with initial non-clinical data anticipated early in 2026 [13] - **Key Event**: ALTITUDE-AD is a defining event for Acumen, with expectations for significant data to outperform competitors [33] Additional Important Insights - **M&A Activity**: The biopharma sector is seeing increased M&A activity as companies prepare for patent expirations [1] - **Regulatory Environment**: The FDA's involvement in various drug approvals and feedback mechanisms is crucial for shaping market expectations [9][10] - **Investor Sentiment**: There remains a cautious sentiment among investors, particularly regarding the approval of new drugs and their market uptake [9][19] This summary encapsulates the key points from the conference call, highlighting the overall industry outlook, company-specific developments, and critical upcoming events that could influence market dynamics in the biopharmaceutical sector.

Core Viewpoint - Travere Therapeutics, Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 4:30 p.m. PT, highlighting its ongoing commitment to engaging with investors and stakeholders in the healthcare sector [1]. Company Information - Eric Dube, Ph.D., serves as the president and chief executive officer of Travere Therapeutics [1]. - A live webcast of the presentation will be available on the Investor page of Travere's website, with a replay accessible for up to 30 days post-event [1].

Core Viewpoint - Travere Therapeutics has seen a significant stock increase of nearly 14% following positive analyst updates, indicating strong investor interest and potential for future growth [1]. Group 1: Analyst Insights - Jefferies analyst Maury Raycroft identified Travere as a potential takeover candidate for 2026, highlighting its drug Filspari as a key asset that could become a blockbuster [2]. - Cantor Fitzgerald's update suggests that the FDA is showing signs of flexibility regarding the approval of Filspari, which is favorable for the company's prospects in the kidney treatment market [6]. Group 2: Drug Approval Status - Filspari has been submitted for FDA approval to treat focal segmental glomerulosclerosis (FSGS), with a decision deadline set for January 13, 2026 [4]. - In early 2024, Travere received full FDA approval for Filspari to treat immunoglobulin A nephropathy (IgAN), marking a significant milestone for the company [4]. Group 3: Financial Metrics - Travere Therapeutics has a current market capitalization of $3.2 billion, with a stock price of $40.28 following a 13.91% increase [5]. - The stock has a 52-week range of $12.91 to $42.13, indicating substantial volatility and potential for growth [5].