Travere Therapeutics (NasdaqGM:TVTX) 2026 Conference February 11, 2026 04:00 PM ET Company ParticipantsChris Cline - CFOEric Dube - President and CEOConference Call ParticipantsVamil Divan - Biopharma AnalystVamil DivanAll right, I think we're ready to get started. So, thanks everyone for joining us for this year's Biotech Summit here at Guggenheim. I'm Vamil Divan, one of the biopharma analysts here. Next up in this room, we have the Travere Therapeutics team. Next to me, Eric Dube, the President and CEO, ...

Core Viewpoint - Block & Leviton is investigating Travere Therapeutics, Inc. for potential securities law violations following a significant drop in its stock price after the FDA extended the review timeline for its drug application [1][2]. Group 1: Company Overview - Travere Therapeutics, Inc. experienced a trading halt after its shares fell over 30% on January 13, 2026, due to the FDA's extension of the review timeline for the supplemental New Drug Application for FILSPARI [2]. - The FDA set a new PDUFA target action date of April 13, 2026, citing that additional responses from Travere constituted a major amendment and required further data to assess clinical benefit [2]. Group 2: Investigation Details - Block & Leviton is examining whether Travere Therapeutics adequately disclosed the risks associated with the review extension and if prior communications regarding the regulatory timeline were misleading [2][4]. - The firm is open to representing investors who have lost money in Travere's stock, regardless of whether they have sold their shares [3][4]. Group 3: Investor Actions - Investors who have incurred losses are encouraged to contact Block & Leviton for potential recovery options [5]. - Whistleblowers with non-public information about Travere Therapeutics are invited to assist in the investigation, with the possibility of receiving rewards from the SEC [6]. Group 4: Firm Credentials - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [7].

Company Overview - Travere Therapeutics, Inc. is a biotechnology company focused on developing and commercializing therapies for rare diseases, leveraging a diversified portfolio of approved products and a clinical pipeline targeting high-need indications [6] - The company generates revenue from commercialized rare disease therapies, including Chenodal, Cholbam, and Thiola/Thiola EC, and has additional pipeline assets such as Sparsentan and TVT-058 in clinical development [8] Financial Performance - As of January 16, 2026, Travere Therapeutics' stock price was $27.87, with a market capitalization of $2.46 billion [4] - The company reported a total revenue of $435.83 million for the trailing twelve months (TTM), with a net income of -$88.54 million [4] - In the third quarter, sales of the FILSPARI drug increased by 155% year over year to $90.9 million, contributing to total revenue of $164.9 million, up from $62.9 million the previous year [10] Investment Activity - Palisades Investment Partners, LLC initiated a new position in Travere Therapeutics, acquiring 137,768 shares valued at approximately $5.26 million [2] - This new position represents 1.99% of Palisades Investment Partners' $264.72 million in reportable U.S. equity assets as of December 31, 2025 [3] - The stock price of Travere Therapeutics increased by 50.89% over the past year, outperforming the S&P 500 by 34.01 percentage points [3] Market Position and Growth Potential - Travere Therapeutics is well-positioned to address unmet medical needs in the rare disease market, supported by strategic partnerships and clinical research initiatives [6] - The company's focus on rare metabolic and renal disorders, along with the potential expansion of FILSPARI's use pending FDA approval, suggests strong growth prospects [11]

Core Viewpoint - Block & Leviton is investigating Travere Therapeutics, Inc. for potential securities law violations following a significant drop in its stock price after the FDA extended the review timeline for its drug FILSPARI [2][4]. Group 1: Company Overview - Travere Therapeutics, Inc. is facing scrutiny after its shares were halted from trading due to a more than 30% decline in intraday trading on January 13, 2026 [2]. - The U.S. FDA has set a new PDUFA target action date of April 13, 2026, for the supplemental New Drug Application for FILSPARI, indicating that additional data is required to assess clinical benefits [2]. Group 2: Investigation Details - Block & Leviton is examining whether Travere Therapeutics adequately disclosed the risks associated with the FDA review extension and if prior communications were misleading [2][4]. - The firm is considering filing an action to recover losses for investors who have been affected by the stock price decline [4]. Group 3: Investor Eligibility - Any investor who purchased common stock of Travere Therapeutics and experienced a loss may be eligible to participate in the investigation, regardless of whether they have sold their shares [3]. Group 4: Whistleblower Information - Individuals with non-public information about Travere Therapeutics are encouraged to assist in the investigation or report to the SEC under the whistleblower program, with potential rewards of up to 30% of any successful recovery [6]. Group 5: Firm Reputation - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [7].

Core Viewpoint - Block & Leviton is investigating Travere Therapeutics, Inc. for potential securities law violations following a significant drop in share price after the FDA extended the review timeline for a key drug application [1][2]. Group 1: Company Overview - Travere Therapeutics, Inc. experienced a trading halt after its shares fell over 30% on January 13, 2026, due to the FDA's extension of the review timeline for the supplemental New Drug Application for FILSPARI [2]. - The FDA set a new PDUFA target action date of April 13, 2026, citing that additional responses from Travere constituted a major amendment and required further data to assess clinical benefit [2]. Group 2: Investigation Details - Block & Leviton is examining whether Travere Therapeutics adequately disclosed the risks associated with the review extension and if prior communications regarding the regulatory timeline were misleading [2][4]. - The firm is considering filing an action to recover losses for investors who have been affected by the decline in share value [4]. Group 3: Investor Eligibility - Any individual who purchased common stock of Travere Therapeutics and has experienced a decline in share value may be eligible to participate in the investigation, regardless of whether they have sold their investment [3]. Group 4: Whistleblower Information - Individuals with non-public information about Travere Therapeutics are encouraged to assist in the investigation or report to the SEC under the whistleblower program, potentially receiving rewards of up to 30% of any successful recovery [6]. Group 5: Firm's Reputation - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [7].

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.

Summary of Travere Therapeutics Conference Call Company Overview - **Company**: Travere Therapeutics (NasdaqGM:TVTX) - **Industry**: Biotech, focusing on rare kidney diseases - **Key Product**: FILSPARI, approved for IgA nephropathy and pending approval for FSGS [2][4] Core Points and Arguments Product Development and Approval - FILSPARI is redefining treatment for IgA nephropathy and is expected to be the first approved therapy for FSGS with a PDUFA date set for January 13, 2026 [2][4] - The FDA has canceled the advisory committee meeting for FSGS, indicating a smooth review process [4][5] - The company has had consistent interactions with the FDA, similar to those experienced during the IgA nephropathy review [8][4] Clinical Data and Efficacy - The two-year trial for FSGS showed a consistent benefit on proteinuria, although it missed the confirmatory endpoint of eGFR [12][13] - A post-hoc analysis indicated that achieving proteinuria levels below 0.7 grams correlates with lower rates of kidney failure, showing an 86% reduction in kidney failure risk [14][15] - The treatment effect of sparsentan versus irbesartan translates into a 24% reduced rate of kidney failure [15] Market Opportunity and Strategy - Travere is seeking a broad indication for FSGS treatment, which could address approximately 30,000 patients in the U.S. [20][21] - The company plans to expand its sales force from 80+ to maximize opportunities in both IgA nephropathy and FSGS [24] - Pricing strategy aims for broad access, leveraging strong health economic analysis for FSGS [28][30] Competitive Landscape - FILSPARI is positioned as a category leader with a differentiated profile and long-term efficacy data [34][35] - The company anticipates competition from biologics but believes that FILSPARI's nephroprotective profile will maintain its market position [40][41] Financial Position - As of Q3, Travere has approximately $300 million in cash, with no immediate capital needs [56] - The company is focused on growth in IgA nephropathy, launching FSGS, and advancing the pegtibatinase program [56] Other Important Content - The company is preparing for potential post-marketing requirements from the FDA but currently does not anticipate any significant issues [23] - There is a strong emphasis on the importance of long-term data for nephrologists, which has positively influenced FILSPARI's uptake [40] - Travere is also interested in business development opportunities but prioritizes the successful launch of FSGS [54]

Core Insights - Armistice Capital sold 2,152,000 shares of Travere Therapeutics, reducing its position by approximately $29.3 million in the third quarter [2][7] - Following the sale, Armistice holds 6.7 million shares valued at $160.7 million, representing 2% of its assets under management (AUM) [3][4] - Travere Therapeutics' stock price increased by 100% over the past year, significantly outperforming the S&P 500, which rose nearly 14% in the same period [4] Company Overview - Travere Therapeutics has a market capitalization of $3.2 billion and reported a revenue of $435.8 million for the trailing twelve months (TTM) [5] - The company incurred a net loss of $88.5 million in the TTM [5] - As of the latest market close, Travere's share price was $35.44 [5] Business Focus - Travere Therapeutics specializes in therapies for rare diseases, with marketed products including Chenodal, Cholbam, and Thiola, and is advancing clinical candidates like Sparsentan and TVT-058 [6][9] - The company targets high unmet medical needs in the biotechnology sector, leveraging clinical expertise and strategic partnerships for growth [9] Recent Performance - Travere Therapeutics reported a strong quarter with total revenue reaching $164.9 million, driven by a 155% year-over-year increase in FILSPARI's U.S. sales [10] - The company achieved a GAAP net income of $25.7 million, a significant turnaround from a $54.8 million loss a year earlier [10] Investment Perspective - Despite the sale of shares, Armistice Capital remains heavily invested in Travere, which still accounts for 5% of its AUM and is its second-largest holding [11] - The sale appears to be a disciplined portfolio management decision following a significant share price rebound rather than a change in investment thesis, especially with an upcoming FDA decision in FSGS [11] - Long-term investors may find Travere appealing due to its accelerating commercial uptake, improving profitability, and upcoming regulatory catalysts [12]

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]