Core Insights - Travere Therapeutics announced late-breaking data from the Phase 3 DUPLEX Study, showing that FILSPARI (sparsentan) significantly improved proteinuria outcomes in patients with focal segmental glomerulosclerosis (FSGS) compared to irbesartan [1][2][3] Study Findings - In the DUPLEX Study, 37.5% of patients treated with FILSPARI achieved a urine protein-to-creatinine ratio (UPCR) below 0.7 g/g, compared to 21.4% for those on irbesartan, indicating a relative risk (RR) of 1.8 [3] - At week 108, 19% of FILSPARI-treated patients reached the UPCR threshold versus 11.2% for irbesartan, with an RR of 1.7 [3] - Patients achieving UPCR below 0.7 g/g had a lower likelihood of reaching kidney failure (3.6% vs. 11.2%, RR 0.52) [3][4] Long-term Risk Analysis - In the DUPLEX-aligned RaDaR cohort, achieving UPCR below 0.7 g/g at 24 months was linked to a significantly lower risk of kidney failure over an additional 60 months (hazard ratio [HR] 0.14) [4] - A similar lower risk was observed for patients who achieved UPCR below 0.7 g/g at any time during the 24-month period (HR 0.27) [4] - The analysis indicated that a 26% relative reduction in UPCR for FILSPARI-treated patients correlates to a 24% reduction in the 5-year risk of kidney failure (HR 0.76) [8] Background on FSGS - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S., characterized by progressive scarring and often leading to kidney failure [7] - There are currently no FDA-approved pharmacologic therapies specifically for FSGS [7] Company Overview - Travere Therapeutics is focused on developing therapies for rare diseases, with FILSPARI currently indicated for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) [9][28]

Core Viewpoint - Travere Therapeutics, Inc. (NASDAQ:TVTX) has demonstrated significant financial improvement, with a notable increase in stock performance driven by strong earnings and sales growth in its kidney disease treatment, Filspari [1][3]. Financial Performance - The company reported a net income of $25.7 million in Q3, a turnaround from a net loss of $54.8 million in the same quarter last year [2]. - Total revenues surged by 162% year-on-year, reaching $164.8 million, up from $62.9 million, primarily due to robust sales of Filspari [3]. Product Performance - Filspari generated $90.9 million in sales in the US alone, reflecting a 155% growth year-on-year [3]. - The CEO highlighted the drug's growing role as a foundational therapy in IgAN, indicating strong commercial execution and increasing confidence among healthcare providers and patients [4]. Future Outlook - 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].

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]

Core Insights - Travere Therapeutics reported strong sales growth driven by its drug Filspari, which treats IgA nephropathy, achieving $90.9 million in sales for the September quarter, a 155% increase year-over-year, surpassing forecasts of $79 million [1][5] - The FDA has relaxed monitoring requirements for Filspari, reducing liver function checks from monthly to quarterly for the first year of treatment [2] - KDIGO guidelines now position Filspari as a potential foundational treatment for IgA nephropathy, enhancing its competitive standing [3] Financial Performance - Travere's total sales reached $164.9 million, exceeding market expectations of $105.2 million to $106 million [5] - The company reported a surprising profit of $0.28 per share, a turnaround from a loss of $0.70 per share in the same quarter last year, while analysts had predicted a loss of $0.30 [6] Market Reaction - Travere's stock surged 18.6% to close at $35.16, breaking out of a consolidation phase with a previous entry point at $28.69 [4] - The stock has been in a profit-taking zone after rising 20% to 25% above its entry point [4] Future Prospects - Travere is seeking FDA approval for Filspari in treating focal segmental glomerulosclerosis (FSGS), with a decision expected by January 13 [7] - The company has seen a slight decline in new patient start forms for Filspari, with 731 forms filled, down 2% from the previous quarter [5][6] - Analyst Laura Chico raised the price target for Travere stock from $32 to $37, maintaining an outperform rating [7] Stock Ratings - Travere Therapeutics holds a high IBD Digital Composite Rating of 98, indicating it outperforms 98% of all stocks based on fundamental and technical measures [8]

Core Insights - Two stocks in the health care sector are showing signs of being overbought, which may concern momentum-focused investors [1][2] Company Performance - **Alphatec Holdings Inc (NASDAQ: ATEC)** reported better-than-expected third-quarter financial results and raised its FY25 sales guidance above estimates, with a stock gain of approximately 12% over the past month and a 52-week high of $17.14. The RSI value is 82.5, indicating overbought conditions, while the stock closed at $16.33 after a 1% decline [7] - **Travere Therapeutics Inc (NASDAQ: TVTX)** also reported better-than-expected third-quarter sales results, with a stock gain of around 24% over the past month and a 52-week high of $30.97. The RSI value is 80.9, also indicating overbought conditions, and the stock closed at $29.65 after a 1.1% decline [7]

Core Insights - Travere Therapeutics reported a revenue of $164.86 million for Q3 2025, marking a year-over-year increase of 162.1% and significantly surpassing the Zacks Consensus Estimate of $103.39 million by 59.45% [1] - The company achieved an EPS of $0.28, a notable improvement from -$0.70 a year ago, resulting in an EPS surprise of 190.32% compared to the consensus estimate of -$0.31 [1] Revenue Breakdown - Revenue from Tiopronin products (Thiola) was $22.25 million, slightly below the estimated $22.64 million, reflecting a year-over-year decrease of 12.3% [4] - Total net product sales reached $113.15 million, exceeding the average estimate of $99.66 million, representing an 85.5% increase year-over-year [4] - Revenue from FILSPARI was $90.9 million, surpassing the estimated $77.02 million, with a year-over-year growth of 155.2% [4] - License and collaboration revenue amounted to $51.71 million, significantly exceeding the average estimate of $4.23 million, indicating a remarkable year-over-year increase of 2625.8% [4] Stock Performance - Travere's shares have returned 20.9% over the past month, outperforming the Zacks S&P 500 composite's 3.6% change [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential for continued outperformance in the near term [3]

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]

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]

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]