Financial Performance - Net product sales for Q3 2025 reached $113.15 million, a 85.5% increase from $61.00 million in Q3 2024[18] - Total revenue for the nine months ended September 30, 2025, was $361.04 million, compared to $158.39 million for the same period in 2024, reflecting a 128.3% increase[18] - Operating income for Q3 2025 was $24.93 million, compared to an operating loss of $56.15 million in Q3 2024[18] - The company reported a net income of $25.71 million for Q3 2025, a significant improvement from a net loss of $54.81 million in Q3 2024[18] - For the nine months ended September 30, 2025, the net loss was $28,275 thousand, a significant improvement compared to a net loss of $261,281 thousand for the same period in 2024[26] - Basic net loss per share for the three months ended September 30, 2025, was $0.29, compared to a loss of $0.70 for the same period in 2024, showing an improvement in performance[138] Cash and Assets - Cash and cash equivalents increased to $110.93 million as of September 30, 2025, up from $58.54 million at the end of 2024[16] - Total assets decreased to $538.58 million as of September 30, 2025, down from $594.13 million at the end of 2024[16] - Total liabilities decreased to $465.02 million as of September 30, 2025, compared to $535.05 million at the end of 2024[16] - Cash and cash equivalents at the end of the period were $110,930 thousand, up from $36,409 thousand at the end of September 2024[26] - As of September 30, 2025, accounts receivable was $83.0 million, significantly up from $27.1 million at December 31, 2024, including a $40.0 million milestone payment[149] Expenses - Research and development expenses for Q3 2025 were $51.89 million, slightly up from $51.68 million in Q3 2024[18] - Selling, general and administrative expenses increased to $86.45 million in Q3 2025, compared to $65.62 million in Q3 2024[18] - Share-based compensation for the nine months ended September 30, 2025, was $33,404 thousand, compared to $27,699 thousand in 2024[26] - The Company reported amortization expense of $15.4 million for the three months ended September 30, 2025, compared to $10.8 million for the same period in 2024, indicating a year-over-year increase of approximately 43%[120] - Total share-based compensation for the three months ended September 30, 2025 was $11.263 million, compared to $8.021 million for the same period in 2024[147] Product Development and Regulatory Approvals - The FDA granted full approval for FILSPARI® (sparsentan) on September 5, 2024, to slow kidney function decline in adults with primary IgAN[30] - FILSPARI had previously received accelerated approval in February 2023 based on positive long-term results from the PROTECT Study[31] - The Company initiated the pivotal Phase 3 HARMONY Study for pegtibatinase in December 2023, with the first patients dosed in early 2024[37] - Renalys initiated an open label registration study of sparsentan in Japan in the second quarter of 2024, achieving full enrollment by January 2025[33] - The FDA accepted the supplemental New Drug Application (sNDA) for FILSPARI for the treatment of FSGS, with a target action date of January 13, 2026[36] Market and Sales - Over 98% of the Company's net product sales come from the United States, with product sales consisting of FILSPARI and tiopronin products[77] - Revenue from FILSPARI sales is recognized upon delivery to specialty pharmacies, with payment terms generally set at 30 days from shipment[78] - The company recognized $51.7 million in license and collaboration revenue for the three months ended September 30, 2025, including a market access milestone of $40.0 million from the CSL Vifor License Agreement[93] - The company received an upfront payment of $55.0 million under the CSL Vifor License Agreement and is eligible for up to $845.0 million in total potential value from regulatory and sales-based milestone payments[87] Investments and Securities - As of September 30, 2025, the company's marketable debt securities totaled $143.60 million, a decrease from $312.17 million as of December 31, 2024[96] - The Company does not intend to sell its investments in marketable debt securities, and unrealized losses are primarily due to fluctuations in short-term interest rates[102] - The investment portfolio is limited to investment-grade credit-rated securities, minimizing credit-related losses[240] Corporate Actions and Agreements - The Company entered into an exclusive licensing agreement with Renalys for sparsentan in January 2024, covering multiple Asian countries[33] - The Company completed the repurchase of $207.1 million aggregate principal amount of 2025 Notes for cash, resulting in a remaining principal amount of $68.9 million, which was repaid upon maturity on September 15, 2025[131] - The Company entered into a definitive stock purchase agreement with Chugai Pharmaceutical Co., Ltd. for the acquisition of full ownership of Renalys, which includes rights to develop sparsentan in Japan, South Korea, and Taiwan[156] Miscellaneous - Recent inflationary pressures have primarily increased labor costs, but have not impacted the current business outlook[242] - The Company has capitalized $181.5 million related to the Thiola intangible asset, which includes an up-front license fee and guaranteed minimum royalties[119] - The Company has not sold any shares under the $100.0 million At-the-Market Equity Offering agreement as of September 30, 2025[151]

FILSPARI in IgAN - FILSPARI is positioned to replace the historical standard of care in IgAN, supported by the 2025 KDIGO guidelines for earlier, first-line use in patients at risk of progression [13, 127] - In the U S, there are over 70,000 addressable patients with IgAN for FILSPARI [8, 15, 34, 38, 74] - FILSPARI demonstrated approximately 40% reduction in proteinuria after 110 weeks in the PROTECT study, with ~3x greater complete remission compared to irbesartan [48, 49] - FILSPARI treatment may potentially delay dialysis or transplant by 4 5 years compared to irbesartan [57] - U S net FILSPARI sales reached approximately $91 million in 3Q25, representing approximately 155% growth versus 3Q24 [32] FILSPARI in FSGS - There are up to 30,000 potential addressable patients with FSGS in the U S [8, 77] - In the DUPLEX study, sparsentan resulted in approximately 50% reduction in proteinuria [86] - Patients treated with sparsentan achieved approximately 1 6x greater partial remission compared to irbesartan [91] - The PDUFA target action date for FILSPARI in FSGS is January 13, 2026 [10, 13, 88] Pegtibatinase in HCU - Pegtibatinase has the potential to become the only disease-modifying treatment for classical HCU [13, 106, 127] - In the COMPOSE study, the highest dose cohort of pegtibatinase achieved a ~67% mean relative reduction in total homocysteine from baseline [111, 119]

Financial Performance - U.S. net product sales of FILSPARI grew 155% year-over-year to $90.9 million in Q3 2025, with 731 new patient start forms received during the quarter[1] - Total revenue for Q3 2025 was $164.9 million, including U.S. net product sales of $113.2 million and a $40 million market-access milestone from CSL Vifor[3] - 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[7] - Total net product sales for Q3 2025 reached $113.15 million, a significant increase from $61.00 million in Q3 2024, representing an 85.5% growth[40] - License and collaboration revenue surged to $51.71 million in Q3 2025, compared to just $1.90 million in Q3 2024, marking a 2,628% increase[40] - Total revenue for the nine months ended September 2025 was $361.04 million, up from $158.39 million in the same period of 2024, reflecting a 128.5% increase[40] - Operating income for Q3 2025 was $24.93 million, a turnaround from an operating loss of $56.15 million in Q3 2024[40] - Net income for Q3 2025 was $25.71 million, compared to a net loss of $54.81 million in Q3 2024, indicating a substantial improvement[40] - Non-GAAP net income for Q3 2025 was $52.77 million, compared to a net loss of $35.64 million in Q3 2024[42] Expenses - Research and development expenses for Q3 2025 were $51.9 million, slightly up from $51.7 million in Q3 2024, while total R&D expenses for the nine months ended September 30, 2025, decreased to $148.1 million from $155.4 million in 2024[4] - Selling, general, and administrative expenses for Q3 2025 were $86.5 million, compared to $65.6 million for the same period in 2024, largely due to preparations for a potential FSGS launch in January 2026[5] - Selling, general and administrative expenses increased to $86.45 million in Q3 2025 from $65.62 million in Q3 2024, a rise of 31.7%[40] Assets and Liabilities - As of September 30, 2025, total assets decreased to $538.6 million from $594.1 million as of December 31, 2024[36] - Cash and cash equivalents increased to $110.9 million from $58.5 million, while accounts receivable rose significantly to $83.0 million from $27.1 million[36] - Total current liabilities decreased to $135.1 million from $200.8 million, with accounts payable dropping to $18.2 million from $23.5 million[37] - Stockholders' equity increased to $73.6 million from $59.1 million, driven by an increase in additional paid-in capital to $1.55 billion[38] - The accumulated deficit widened to $1.48 billion from $1.45 billion, indicating ongoing financial challenges[38] Product Development and Regulatory - The FDA is reviewing the supplemental New Drug Application for FILSPARI in FSGS, with a target action date of January 13, 2026[13] - The company achieved a $40 million EU market access milestone, further strengthening its financial foundation[1] - The updated KDIGO guidelines include FILSPARI for earlier, first-line use in patients at risk of progression in IgAN[13] - The company is preparing for a potential FDA approval and commercial launch of FILSPARI for FSGS in Q1 2026[2] - The company has successfully manufactured the first commercial-scale batches of pegtibatinase and is engaging with the FDA to restart enrollment in the Phase 3 HARMONY Study in 2026[13] - The company is focused on the continued launch of FILSPARI for IgAN, with expectations for long-term growth trajectories[33] - There are plans for the potential approval of FILSPARI for FSGS, although the timing remains uncertain[33] - The company is restarting enrollment in the pivotal HARMONY Study of pegtibatinase, with anticipated timelines for progress[33] Risks and Monitoring - Risks include potential delays in FDA approval processes and challenges related to the commercial launch of FILSPARI[33] - The company is monitoring for adverse reactions related to FILSPARI, including hyperkalemia and hypotension, which have been observed in treated patients[29]

Group 1 - Travere Therapeutics (TVTX) is experiencing significant stock performance, having more than doubled since mid-June, making it a key stock to watch amid moderate market selling pressure [1] - The stock saw a notable increase of over 26% in mid-September following a favorable decision from the Food and Drug Administration (FDA) [1] - The IBD SmartSelect Composite Rating for Travere Therapeutics improved from 94 to 96, indicating a positive shift in its market position [2] Group 2 - Travere Therapeutics has achieved a Relative Strength (RS) Rating of 92, reflecting strong price performance and market competitiveness [4] - The company is on the verge of a breakout, supported by the FDA's decision that enhances the launch of its product Filspari [4] - Travere Therapeutics has consistently cleared key benchmarks, reaching an RS Rating of over 80, which signifies robust market strength [4]

Core Insights - Travere Therapeutics, Inc. will present 11 abstracts at the American Society of Nephrology Kidney Week 2025, including a late-breaking poster [1] Company Developments - The company will showcase a late-breaking analysis from the DUPLEX Study focused on focal segmental glomerulosclerosis (FSGS) [1] - The analysis indicates that patients treated with FILSPARI® (sparsentan) were more likely to achieve proteinuria levels below 0 [1]

Core Viewpoint - Travere Therapeutics (TVTX) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, thus affecting stock prices [4]. Company Performance and Outlook - The upgrade for Travere suggests an improvement in the company's underlying business, which should encourage investors to drive the stock price higher [5]. - Over the past three months, the Zacks Consensus Estimate for Travere has increased by 11.1%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Travere's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting strong potential for market-beating returns in the near term [10].

Core Insights - The updated KDIGO 2025 clinical practice guidelines for IgA Nephropathy emphasize the importance of achieving remission of proteinuria and slowing eGFR decline as key treatment goals [2][4] - FILSPARI (sparsentan) is highlighted as a first-line treatment option for IgA Nephropathy, demonstrating superior efficacy compared to traditional RASi therapies [3][4] Treatment Goals - The guidelines define remission of proteinuria as less than 0.5 g/day, ideally at less than 0.3 g/day, and emphasize the need to slow the decline of eGFR [2] - A treatment approach targeting both IgAN-induced nephron loss and IgA formation is recommended to meet these goals [2] FILSPARI's Role - FILSPARI is recognized as the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) and has shown proven efficacy in clinical trials, with more patients enrolled in the PROTECT study than in all prior RASi trials combined [3][4] - The PROTECT study demonstrated that patients receiving FILSPARI achieved a mean reduction in proteinuria of 49.8%, significantly higher than the 15.1% reduction seen in irbesartan-treated patients [7] Clinical Significance - The updated guidelines provide clarity for clinicians and patients, aiming to improve long-term kidney outcomes for those with IgA Nephropathy [4] - The inclusion of FILSPARI in the guidelines reflects its favorable benefit-risk profile and its role in reducing proteinuria and slowing kidney function loss [4][6] Company Background - CSL Vifor specializes in pharmaceuticals for iron deficiency and nephrology, focusing on strategic global partnerships and innovative therapies [8] - Travere Therapeutics is dedicated to developing treatments for rare diseases, emphasizing the urgent need for effective options in the IgA Nephropathy community [10]

Core Viewpoint - The article initiates coverage on Travere Therapeutics, Inc. (NASDAQ: TVTX) with a Buy Rating, highlighting the significant potential of its drug sparsentan [2] Company Overview - Travere Therapeutics is positioned in the pharmaceutical sector, focusing on innovative treatments [2] - The company is noted for its drug sparsentan, which is expected to have a substantial impact in its therapeutic area [2] Investment Analysis - The analysis suggests that Travere Therapeutics has a promising outlook due to the potential of sparsentan [2] - The article emphasizes the importance of deep-dive analysis in making informed investment decisions within the biotech sector [2]

Core Viewpoint - The article initiates coverage on Travere Therapeutics, Inc. (NASDAQ: TVTX) with a Buy Rating, highlighting the significant potential of its drug sparsentan [2]. Company Overview - Travere Therapeutics is positioned in the pharmaceutical sector, focusing on innovative treatments, particularly with its lead drug sparsentan [2]. Investment Potential - The analysis emphasizes the massive potential of sparsentan, suggesting that it could be a key driver for the company's growth and stock performance [2].

Core Insights - Travere Therapeutics (TVTX) received an encouraging update from the FDA regarding its supplemental new drug application (sNDA) for Filspari (sparsentan) in treating focal segmental glomerulosclerosis (FSGS), with a final decision expected on January 13, 2026, leading to a 26.2% increase in TVTX's shares [1][6] Company Overview - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S. and a similar number in the EU, characterized by kidney scarring and proteinuria, which can lead to kidney failure [2] - Filspari, if approved, would be the first treatment specifically indicated for FSGS, designed to address podocyte injury, a key factor in the disease's progression [3] Clinical Evidence - The sNDA for Filspari is supported by robust clinical data from the phase III DUPLEX and phase II DUET studies, showing significant reductions in proteinuria compared to Sanofi's Avapro [4][9] - The DUPLEX study demonstrated a 67% to 77% lower risk of kidney failure for patients achieving remission, although it did not meet the primary efficacy endpoint for eGFR slope [8][9] Market Performance - Year-to-date, TVTX stock has increased by 56.8%, significantly outperforming the industry average growth of 4.9% [5] Regulatory Developments - Filspari was previously granted full approval for IgA nephropathy (IgAN), making it the only non-immunosuppressive medication in that space [10] - The FDA recently streamlined the Risk Evaluation and Mitigation Strategies (REMS) for Filspari, reducing monitoring burdens and potentially accelerating physician adoption [13]