Travere Therapeutics(TVTX)
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Travere Therapeutics (TVTX) Beats Q3 Earnings and Revenue Estimates
ZACKS· 2025-10-30 22:56
Core Insights - Travere Therapeutics reported quarterly earnings of $0.28 per share, exceeding the Zacks Consensus Estimate of a loss of $0.31 per share, and showing a significant improvement from a loss of $0.7 per share a year ago, resulting in an earnings surprise of +190.32% [1] - The company achieved revenues of $164.86 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 59.45%, compared to revenues of $62.9 million in the same quarter last year [2] - Travere's stock has increased by approximately 72.1% since the beginning of the year, significantly outperforming the S&P 500's gain of 17.2% [3] Earnings Outlook - The future performance of Travere's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook, including current consensus earnings expectations for upcoming quarters [4] - The trend of estimate revisions for Travere was favorable prior to the earnings release, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Future Estimates - The current consensus EPS estimate for the upcoming quarter is -$0.27 on revenues of $115.04 million, and for the current fiscal year, it is -$1.17 on revenues of $413.87 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Travere belongs, is currently ranked in the top 38% of over 250 Zacks industries, suggesting a favorable outlook for stocks within this sector [8]
Travere Therapeutics(TVTX) - 2025 Q3 - Earnings Call Transcript
2025-10-30 21:30
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]
Travere Therapeutics(TVTX) - 2025 Q3 - Quarterly Report
2025-10-30 20:46
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]
Travere Therapeutics(TVTX) - 2025 Q3 - Earnings Call Presentation
2025-10-30 20:30
Travere Therapeutics Corporate Overview October 2025 2 rare for life. We are in At Travere Therapeutics, we are a biopharmaceutical company that comes together every day to help patients, families, and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent — that is why our global team works with the rare disease community to identify, develop, and deliver life-changing therapies. Forward-Looking Statements This presentation co ...
Travere Therapeutics(TVTX) - 2025 Q3 - Quarterly Results
2025-10-30 20:06
Exhibit 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Reports Third Quarter 2025 Financial Results U.S. net product sales of FILSPARI (sparsentan) grew 155% year-over-year to $90.9 million in 3Q 2025; 731 new PSFs received during the quarter ® Total revenue for 3Q 2025 was $164.9 million, including U.S. net product sales of $113.2 million Retired remaining $69 million of 2025 convertible notes and achieved $40 million EU market acces ...
Biotech Leader Travere Therapeutics Eyes Buy Point After More Than Doubling
Investors· 2025-10-23 16:01
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]
Travere Therapeutics to Present Abstracts at American Society of Nephrology (ASN) Kidney Week 2025
Businesswire· 2025-10-17 13:01
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]
What Makes Travere (TVTX) a New Strong Buy Stock
ZACKS· 2025-10-15 17:01
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].
CSL Vifor and Travere Therapeutics Recognize Updated KDIGO Clinical Practice Guidelines for IgA Nephropathy
Prnewswire· 2025-09-26 06:30
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]
Travere Therapeutics: Buy Rating On Back Of Filspari Expansion Towards FSGS (NASDAQ:TVTX)
Seeking Alpha· 2025-09-12 19:47
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]