Financial Data and Key Metrics Changes - In Q4 2024, net product sales of FILSPARI reached approximately $50 million, representing nearly 40% growth compared to the previous quarter [30] - For the full year 2024, net product sales totaled $226.7 million, an increase of nearly 80% compared to 2023 [39] - The net loss for Q4 2024 was $60.3 million, or $0.73 per basic share, compared to a net loss of $90.2 million, or $1.18 per basic share in Q4 2023 [43] - Total revenue for Q4 2024 was $74.8 million, with $1.2 million recognized from license and collaboration revenue [41] Business Line Data and Key Metrics Changes - FILSPARI was the key growth driver, generating $132.2 million in net product sales for the full year 2024, outperforming benchmarks for the first full year of launch [39] - Thiola and Thiola EC contributed $23.9 million in net product sales for Q4 2024, with a slight decrease attributed to generic competition [40] Market Data and Key Metrics Changes - The company received 693 new patient start forms in Q4 2024, a 37% increase from the prior quarter, indicating growing adoption in the IgAN community [28] - The median starting proteinuria level for patients initiating FILSPARI is now below 1.5 grams per gram, signaling progress in targeting a broader patient population [32] Company Strategy and Development Direction - The company aims to solidify FILSPARI's foundational positioning in IgAN as the only non-immunosuppressive kidney-targeted therapy with demonstrated superiority over historical standards of care [12] - Plans include submitting a supplemental New Drug Application (sNDA) for a potential FSGS indication by the end of Q1 2025 [10] - The company is also focused on optimizing manufacturing for the pegtibatinase program and preparing for a potential launch in FSGS [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in FILSPARI's growth trajectory following full approval and highlighted the importance of updated KDIGO guidelines in driving physician behavior [33] - The company anticipates continued strength in demand for FILSPARI and expects to maintain disciplined investments to support growth [46] Other Important Information - The company had cash, cash equivalents, and marketable securities totaling $370.7 million as of December 31, 2024, including net proceeds from a successful financing [45] - The company expects to see a moderate increase in gross to net discounts compared to 2024, but anticipates significant growth in net product sales of FILSPARI in 2025 [46] Q&A Session Summary Question: What are you seeing in terms of patient uptake with the expanded FILSPARI label? - The company reported a 37% increase in new patient start forms, with more use in patients with lower proteinuria levels following full approval [55][56] Question: How might new competitors impact FILSPARI's uptake? - Management remains confident in FILSPARI's profile and growth outlook, noting that competition has not significantly affected sales thus far [63][66] Question: When might guidance for the IgAN setting be provided? - The company is monitoring uptake and will provide further updates but is not yet in a position to offer guidance [75] Question: What is the strategy for business development in the rare renal space? - The company is exploring opportunities to diversify its pipeline while prioritizing the launch of FILSPARI for FSGS [82] Question: What steps remain towards the ultimate goal for full removal of the REMS? - The first step is to modify the REMS to quarterly monitoring, with the next step being the potential removal of the REMS after sufficient patient exposure [90][127] Question: How will pricing be determined for FILSPARI in FSGS? - Pricing strategy will focus on ensuring broad access, with potential for linear pricing based on dosing [129][130] Question: How long will the accelerated approval path in IgAN remain open? - The FDA may eventually determine that the unmet need in IgAN has been sufficiently met, but specifics are difficult to predict [138] Question: Can you provide context on the conversion of patient start forms to patients on therapy? - The company has seen strong fulfillment and compliance rates, with improvements in the transition from patient start forms to therapy [97][100]

Drug Approvals and Efficacy - FILSPARI® (sparsentan) received full FDA approval on September 5, 2024, for slowing kidney function decline in adults with primary IgAN, following accelerated approval in February 2023 [493]. - In the PROTECT Study, FILSPARI demonstrated a significant reduction in kidney function decline with a mean eGFR slope of -3.0 mL/min/1.73 m²/year compared to -4.2 mL/min/1.73 m²/year for irbesartan, resulting in a treatment effect of 1.2 mL/min/1.73 m²/year (p=0.0168) [495]. - The FDA-approved label for FILSPARI includes two-year efficacy data showing a 3.8 mL/min/1.73 m² difference in mean change from baseline in eGFR between FILSPARI and irbesartan [495]. - FILSPARI has been granted seven years of Orphan Drug Exclusivity in the U.S. for both the reduction of proteinuria and slowing kidney function decline in adults with primary IgAN [496]. - The estimated prevalence of IgAN in the U.S. is up to 150,000 patients, with more than 70,000 potentially addressable under FILSPARI's full approval indication [498]. - In April 2024, the European Commission granted conditional marketing authorization for FILSPARI for adults with primary IgAN, with a regulatory milestone payment of $17.5 million expected upon full approval [501]. - The Phase 3 DUPLEX Study for sparsentan in FSGS showed that 42.0% of patients achieved FSGS partial remission of proteinuria compared to 26.0% for irbesartan (p=0.0094) [507]. - The FDA indicated that the two-year results from the DUPLEX Study alone were insufficient for an sNDA submission, prompting a collaborative effort to define alternative proteinuria-based endpoints for FSGS [508]. - The company plans to submit an sNDA for traditional approval of FILSPARI for FSGS by the end of Q1 2025, based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies [508]. Financial Performance - Total revenue for the year ended December 31, 2024, was $233.2 million, an increase of $87.9 million compared to $145.2 million in 2023, primarily driven by a $103.0 million increase in FILSPARI sales [549]. - FILSPARI sales reached $132.2 million in 2024, compared to $29.2 million in 2023, reflecting a full year of sales following its launch in February 2023 [550]. - Total net product sales increased by $99.2 million to $226.7 million in 2024, while license and collaboration revenue decreased by $11.2 million to $6.5 million [549]. - Operating expenses totaled $557.0 million in 2024, an increase of $23.6 million from $533.4 million in 2023, driven by restructuring costs and in-process research and development [552]. - The company recognized a non-recurring charge of $65.2 million in in-process research and development expense in March 2024 related to pegtibatinase [562]. - The loss from discontinued operations for the year ended December 31, 2024, was $0.9 million, a significant decrease from a gain of $264.9 million in 2023 due to the sale of the bile acid business [567]. - Cash used in operating activities from continuing operations decreased to $230.0 million in 2024 from $325.4 million in 2023, attributed to a $99.2 million increase in total net product sales [602]. - Cash provided by investing activities was $99.3 million in 2024, down from $151.6 million in 2023, due to a decrease in net purchases of marketable debt securities [603]. - Cash provided by financing activities was $139.4 million in 2024, compared to $220.1 million in 2023, influenced by a public offering that generated $134.7 million in net proceeds [604]. Corporate Actions and Workforce Management - The company implemented a 20% workforce reduction in December 2023, expected to result in annualized savings of approximately $25.0 million starting in 2024 [525]. - The company implemented a 20% workforce reduction in December 2023 to align resources for the FILSPARI launch and ongoing clinical studies [569]. - As of December 31, 2024, total non-recurring charges incurred due to restructuring amounted to $13.8 million [525]. - The company currently has four Phase 3 clinical trials in process, with ongoing non-clinical support trials that may impact future expenses [558]. Strategic Partnerships and Licensing - An exclusive licensing agreement with Renalys Pharma was established to bring sparsentan to patients in Japan and other Asian countries, with an open label registration study initiated in 2024 [502]. - The company has a license agreement with CSL Vifor that could yield up to $845.0 million in milestone payments and royalties for the commercialization of sparsentan [576]. - The company received an upfront cash payment of $210.0 million from the sale of its bile acid product portfolio to Mirum Pharmaceuticals [522]. - The company is eligible to receive up to $235.0 million in milestone payments based on specified annual net sales of the bile acid products sold to Mirum [523]. - The company received an upfront cash payment of $210.0 million from the sale of its bile acid business in August 2023, with potential additional payments of up to $235.0 million based on sales milestones [575]. - The company has a contingent payment obligation of up to $427.0 million related to the acquisition of Orphan Technologies Limited, based on development and regulatory milestones [590]. Research and Development - Pegtibatinase demonstrated a 55.1% mean relative reduction in total homocysteine (tHcy) from baseline in the highest dose cohort of 1.5 mg/kg during the Phase 1/2 COMPOSE Study [512]. - In the sixth cohort of the Phase 1/2 COMPOSE Study, treatment with 2.5 mg/kg of pegtibatinase resulted in a 67.1% mean relative reduction in tHcy from baseline [514]. - The pivotal Phase 3 HARMONY Study was initiated in December 2023 to evaluate the efficacy and safety of pegtibatinase for classical HCU [515]. - A voluntary pause of enrollment in the Phase 3 HARMONY Study was announced in September 2024 to address manufacturing scale-up improvements, with plans to restart enrollment in 2026 [516]. Market and Economic Conditions - The company is exposed to interest rate risk, with a potential $1.7 million impact on investments from a 100 basis point change in interest rates [605]. - Inflation has primarily impacted the company through increased labor costs, but it has not affected the current outlook or business objectives [608].

Core Insights - Travere Therapeutics reported a revenue of $74.79 million for Q4 2024, marking a 66% year-over-year increase and exceeding the Zacks Consensus Estimate of $73.44 million by 1.84% [1] - The company posted an EPS of -$0.73, an improvement from -$1.16 a year ago, but fell short of the consensus estimate of -$0.58, resulting in an EPS surprise of -25.86% [1] Revenue Breakdown - Revenue from Tiopronin products (Thiola) was $23.90 million, slightly below the estimated $24.03 million, reflecting a year-over-year decrease of 5.2% [4] - Total net product sales reached $73.55 million, surpassing the estimated $69.22 million [4] - Revenue from FILSPARI was $49.64 million, significantly exceeding the estimated $45.31 million, representing a remarkable year-over-year increase of 237.7% [4] - License and collaboration revenue was reported at $1.24 million, falling short of the average estimate of $4.77 million, indicating a year-over-year decline of 75.9% [4] Stock Performance - Over the past month, Travere's shares have returned +19.9%, outperforming the Zacks S&P 500 composite's +2.6% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Group 1 - Travere Therapeutics reported a quarterly loss of $0.73 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.58, representing an earnings surprise of -25.86% [1] - The company posted revenues of $74.79 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 1.84%, and showing a significant increase from $45.06 million in the same quarter last year [2] - Travere shares have increased approximately 33.9% since the beginning of the year, outperforming the S&P 500's gain of 4.5% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.54 on revenues of $70.16 million, and for the current fiscal year, it is -$1.40 on revenues of $345.91 million [7] - The Medical - Biomedical and Genetics industry, to which Travere belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Company to submit sNDA around the end of 1Q 2025 seeking traditional approval of FILSPARI® (sparsentan) for FSGS Net product sales of FILSPARI totaled $50 million in 4Q 2024; $132 million for full year 2024 Net product sales totaled $74 million in 4Q 2024; $227 million for full year 2024 SAN DIEGO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its fourth quarter and full year 2024 financial results and provided a corporate update. “Our strong execution in 2024 ma ...

Core Viewpoint - Travere Therapeutics, Inc. is set to report its fourth quarter and full year 2024 financial results on February 20, 2025, after the U.S. financial markets close, followed by a conference call and webcast to discuss the results and provide a business update [1] Company Information - Travere Therapeutics is a biopharmaceutical company focused on developing therapies for patients with rare diseases, emphasizing the urgent need for treatment options [3] - The company collaborates with the rare disease community to identify, develop, and deliver life-changing therapies, aiming to understand the diverse perspectives of rare patients [3]

Travere Therapeutics (TVTX) shares ended the last trading session 12.6% higher at $23.75. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 13.5% gain over the past four weeks.The sudden soaring of the stock price was observed following Travere's announcement that it has completed a Type C meeting with the FDA and intends to submit a supplemental new drug application (sNDA) for traditional approval of Filspari in tre ...

Core Insights - Travere Therapeutics has completed a Type C meeting with the FDA and plans to submit a supplemental New Drug Application (sNDA) for FILSPARI, targeting focal segmental glomerulosclerosis (FSGS) [1][2] - If approved, FILSPARI could be the first and only approved treatment for FSGS, a rare kidney disorder affecting over 40,000 patients in the U.S. [2][5] - The sNDA submission will rely on data from the Phase 3 DUPLEX and Phase 2 DUET studies, which have shown promising results in reducing proteinuria [1][6][7] Company Updates - The sNDA submission is expected around the end of the first quarter of 2025 [1] - The CEO of Travere Therapeutics expressed optimism about the sNDA submission and highlighted the urgent need for treatment options for FSGS [2] - A conference call and webcast will be held to discuss these updates, scheduled for February 11, 2025, at 8:30 a.m. ET [3][4] Study Insights - The Phase 3 DUPLEX study is noted as the largest interventional study in FSGS, achieving significant results in reducing proteinuria [6][7] - The Phase 2 DUET study demonstrated a greater than two-fold reduction in proteinuria compared to irbesartan, indicating the efficacy of FILSPARI [7] - Both studies support the importance of proteinuria reduction as a key endpoint in FSGS treatment, aligning with findings from the PARASOL workgroup [2][8] Disease Context - FSGS is characterized by progressive kidney scarring and is a leading cause of kidney failure, with no currently approved pharmacologic treatments [5] - The disorder affects both adults and children, highlighting the need for effective therapies [5]

EXHIBIT 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Provides Corporate Update and 2025 Outlook Received 693 new patient start forms for FILSPARI (sparsentan) in the fourth quarter of 2024; approximately $50 million in preliminary net product sales of FILSPARI for the fourth quarter ® sNDA requesting modification of liver monitoring for FILSPARI in IgAN accepted for review by FDA; PDUFA target action date of August 28, 2025 Company ...

Received 693 new patient start forms for FILSPARI® (sparsentan) in the fourth quarter of 2024; approximately $50 million in preliminary net product sales of FILSPARI for the fourth quarter sNDA requesting modification of liver monitoring for FILSPARI in IgAN accepted for review by FDA; PDUFA target action date of August 28, 2025 Company remains on track to provide regulatory update on sparsentan in FSGS by its fourth quarter 2024 earnings call SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Travere Therapeutic ...