Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices by Travere Therapeutics, Inc. and its officers or directors [1] Group 1: Company Developments - On May 15, 2025, Travere announced that the FDA plans to hold an advisory committee meeting regarding its supplemental New Drug Application for FILSPARI, aimed at treating focal segmental glomerulosclerosis [2] - Following the FDA announcement, Travere's stock price dropped by $4.35, or 20.57%, closing at $16.80 per share on May 16, 2025 [2] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [3]

Group 1 - The biotech forum has seen significant discussions around profitable buy-write or covered call strategies on selected biotech stocks in recent months [1] - Travere Therapeutics, Inc. (NASDAQ: TVTX) is highlighted for its impressive sales growth in Q1, despite a recent pullback in stock price and a notable reduction in losses [2] - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat for trade ideas and weekly market commentary [2]

Summary of Travere Therapeutics (TVTX) Conference Call Company Overview - **Company**: Travere Therapeutics - **Focus**: Rare diseases, specifically targeting rare kidney diseases (FSGS and IgA nephropathy) and classical homocystinuria (HCU) [2][3] Key Priorities and Developments 1. **Launch of Filspari for IgA Nephropathy**: - Full approval received in September 2024, leading to a significant increase in demand [3] - New treatment guidelines (QADIGO) expected to enhance accessibility and usage [3][4] - Demand growth observed with a 40% increase in new patient starts post-approval [14] 2. **FSGS Therapy Development**: - Submitted supplemental New Drug Application (sNDA) for potential first therapy for FSGS, with expected FDA notification this month [4][11] - Anticipated PDUFA date in September if priority review is granted [4] 3. **HCU Program**: - Reinitiating enrollment in Phase III program following commercial manufacturing scale-up [4] Treatment Landscape - **IgA Nephropathy**: - New therapies are changing patient outcomes, allowing for prolonged kidney function [5] - Filspari shows superiority over traditional RAS inhibitors in improving kidney function and reducing proteinuria [6][8] - Combination therapy is emphasized due to the dual nature of the disease affecting both the immune system and kidneys [7] - **FSGS**: - High unmet need with rapid progression to kidney failure, especially in children [10] - Proteinuria is identified as a key predictor of kidney failure, leading to a shift in regulatory acceptance of proteinuria as an endpoint for clinical trials [12][42] Market Dynamics - **Growth Potential**: - Majority of IgA nephropathy patients have proteinuria levels below 1.5, representing a significant market opportunity [15] - The evolving treatment guidelines are expected to drive earlier and more aggressive interventions [19][20] - **Regulatory Environment**: - FDA is becoming more open to using proteinuria as a clinical trial endpoint, which could facilitate innovation in FSGS treatments [42] Financial Position - **Capitalization**: - Company reported a cash balance of $322 million at the end of the last quarter, positioning it well for future growth initiatives [48] Future Directions - **Pipeline Expansion**: - Interest in developing therapies for other rare diseases, particularly within the rare kidney disease space [48][52] - Focus on building evidence for combination therapies and establishing Filspari as a foundational treatment [28][31] Conclusion - Travere Therapeutics is strategically positioned to capitalize on its recent approvals and ongoing clinical programs, with a strong emphasis on addressing unmet needs in rare kidney diseases. The company is focused on expanding its pipeline and enhancing treatment accessibility while navigating a rapidly evolving regulatory landscape.

Group 1 - Travere Therapeutics reported $81.73 million in revenue for Q1 2025, a year-over-year increase of 97.6% [1] - The EPS for the same period was -$0.47, improving from -$1.76 a year ago, with a surprise of +14.55% compared to the consensus estimate of -$0.55 [1] - The revenue exceeded the Zacks Consensus Estimate of $79.35 million, resulting in a surprise of +3.00% [1] Group 2 - Key metrics indicate that Travere's stock has returned +16% over the past month, while the Zacks S&P 500 composite has decreased by -0.7% [3] - The stock currently holds a Zacks Rank 4 (Sell), suggesting potential underperformance against the broader market in the near term [3] Group 3 - Revenue from Tiopronin products (Thiola) was $19.98 million, slightly below the average estimate of $20.90 million, representing a year-over-year change of -0.8% [4] - Total net product sales reached $75.86 million, exceeding the estimated $69.96 million [4] - Revenue from FILSPARI was $55.88 million, surpassing the average estimate of $49.31 million, with a year-over-year increase of +181.7% [4] - License and collaboration revenue was reported at $5.87 million, above the average estimate of $4.20 million, reflecting a year-over-year change of +322.4% [4]

Group 1 - Travere Therapeutics reported a quarterly loss of $0.47 per share, better than the Zacks Consensus Estimate of a loss of $0.55, and improved from a loss of $1.76 per share a year ago, representing an earnings surprise of 14.55% [1] - The company posted revenues of $81.73 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 3%, and showing significant growth from year-ago revenues of $41.37 million [2] - Travere shares have increased by approximately 19.5% since the beginning of the year, contrasting with the S&P 500's decline of -5.3% [3] Group 2 - The earnings outlook for Travere is uncertain, with current consensus EPS estimates at -$0.45 for the coming quarter and -$1.47 for the current fiscal year, alongside revenues of $83.04 million and $356.83 million respectively [7] - The Zacks Rank for Travere is currently 4 (Sell), indicating expectations of underperformance in the near future due to unfavorable estimate revisions [6] - The Medical - Biomedical and Genetics industry, to which Travere belongs, is currently in the top 32% of Zacks industries, suggesting a favorable environment for stocks within this sector [8]

Financial Data and Key Metrics Changes - The company reported net product sales of $75.9 million for the first quarter, representing a 90% increase year-over-year and continued sequential growth [26][30] - Net sales for VILSPARI grew 182% year-over-year and 13% compared to the previous quarter, reflecting strong demand and uptake [7][26] - The net loss for the first quarter was $41.2 million, or $0.47 per basic share, compared to a net loss of $136.1 million, or $1.76 per basic share for the same period in 2024 [30] Business Line Data and Key Metrics Changes - VILSPARI generated approximately $56 million in net product sales in the first quarter, driven by an increasing prescriber base and deepening penetration among experienced prescribers [19][20] - Thiola and Thiola EC contributed $20 million in net product sales for the first quarter [26] - The company anticipates continued strong demand for VILSPARI in IgA nephropathy, with projected net product sales growth throughout the year [31] Market Data and Key Metrics Changes - The European Commission and MHRA in the UK converted FILSPARI's conditional approvals to full approvals for the treatment of adults with IgA nephropathy, enabling broader access across Europe and the UK [8] - Approximately 75% of nephrologists are now targeting proteinuria below 0.5 grams per gram, with nearly a third targeting even more ambitious goals of 0.3 grams [23] Company Strategy and Development Direction - The company aims to solidify VILSPARI's foundational positioning in IgA nephropathy and unlock additional growth through a potential new indication in FSGS [6] - The company is preparing for a potential launch of VILSPARI for FSGS, which is expected to be a significant opportunity, potentially larger than in IgA nephropathy [10][24] - The company is committed to advancing its investigational therapy PEG T for classical homocystinuria (HCU) and plans to restart patient enrollment in the Phase III HARMONY study next year [11][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategy with strong fundamentals and a clear focus on executing key priorities [11] - The company is monitoring legislative developments and geopolitical uncertainties but believes that any potential tariffs on pharmaceutical products would not have a material impact on VILSPARI [31] - Management highlighted the importance of the upcoming finalization and publication of the KDIGO guidelines, which are expected to reinforce the shift to earlier and more ambitious treatments [23][100] Other Important Information - The company expects to receive a $17.5 million milestone payment from CSL V4 due to the recent conversion of FILSPARI's conditional approval to full approval in Europe [30] - The company has maintained broad coverage across payers, with criteria easing following the label expansion at full approval [21] Q&A Session Summary Question: Can you elaborate on any interactions with the agency regarding the sNDA for FSGS? - Management reported that interactions with the FDA have been progressing as expected, with consistency in the review process compared to previous experiences with the IGAN indication [34][35] Question: What do you think the label for FSGS will look like? - The expectation is that the indication statement will be for the treatment of FSGS in patients ages eight and up, based on the broad inclusion criteria of the duplex study [39][42] Question: How is the recent approval of Novartis' therapy impacting your sales reps in the field? - Management noted that it is early to assess the impact, but continued demand growth has been observed, indicating confidence in FILSPARI's profile [48][51] Question: Can you provide more detail on gross to net comments? - Management indicated that gross to net discounts are expected to be in the low twenties, with a more even distribution throughout the year compared to the previous year [56][58] Question: What is the split between new versus repeat prescribers for FILSPARI? - The split is slightly skewed towards experienced prescribers, with a healthy continuation of new prescribers as well [82]

Financial Performance - Total revenue for Q1 2025 was $81.732 million, a 97% increase from $41.374 million in Q1 2024[19]. - Net product sales reached $75.861 million, up 90% from $39.984 million in the same period last year[19]. - Operating loss for Q1 2025 was $42.674 million, compared to a loss of $139.237 million in Q1 2024, indicating a significant improvement[19]. - The company reported a net loss of $41.226 million for Q1 2025, a decrease from a net loss of $136.061 million in Q1 2024[19]. - For the three months ended March 31, 2025, the net loss from continuing operations was $41,226 thousand, a decrease from a net loss of $135,958 thousand in the same period of 2024, representing a 70.7% improvement[25]. - For the three months ended March 31, 2025, the company reported a net loss of $41.2 million, or $(0.47) per share, compared to a net loss of $136.1 million, or $(1.76) per share for the same period in 2024[131]. - Revenue for the three months ended March 31, 2025, was $81.7 million, a significant increase from $41.4 million in the same period of 2024[149]. Cash and Assets - Cash and cash equivalents increased to $61.897 million as of March 31, 2025, up from $58.535 million at the end of 2024[16]. - Total assets decreased to $548.799 million as of March 31, 2025, down from $594.125 million at the end of 2024[16]. - Total liabilities were $515.976 million as of March 31, 2025, compared to $535.048 million at the end of 2024, reflecting a reduction in liabilities[16]. - As of March 31, 2025, the company had cash equivalents and marketable debt securities totaling approximately $322.2 million[233]. - The company’s inventory decreased from $41.9 million as of December 31, 2024, to $38.0 million as of March 31, 2025[141]. - Accounts receivable increased to $34.4 million as of March 31, 2025, up from $27.1 million as of December 31, 2024[142]. Expenses - Research and development expenses for Q1 2025 were $46.889 million, slightly down from $49.420 million in Q1 2024[19]. - Selling, general and administrative expenses increased to $72.838 million in Q1 2025, compared to $64.223 million in Q1 2024[19]. - The company recognized a total of $13.8 million in restructuring costs as of December 31, 2024, primarily related to one-time termination benefits[65]. - Total share-based compensation for continuing operations was $11.5 million for the three months ended March 31, 2025, compared to $9.8 million for the same period in 2024[140]. Product Development and Regulatory Approvals - FILSPARI® received full FDA approval on September 5, 2024, for slowing kidney function decline in adults with primary IgAN, following positive long-term results from the PROTECT Study[29][30]. - The company completed a Type C meeting with the FDA in February 2025 and submitted an sNDA for FILSPARI for the treatment of FSGS, supported by results from the Phase 3 DUPLEX Study[34]. - Renalys Pharma initiated an open label registration study of sparsentan in Japan in the second quarter of 2024, with full enrollment achieved by January 2025[32]. - Pegtibatinase is currently in a voluntary enrollment pause in the Phase 3 HARMONY Study to address manufacturing scale-up issues, with ongoing support for currently enrolled patients[37]. - The company focuses on expanding its product pipeline through licenses and acquisitions to address serious unmet medical needs in rare diseases[28]. Sales and Revenue Recognition - The company sells its products primarily in the United States, which represents over 98% of net product sales[70]. - Revenue from product sales is recognized upon delivery, with payment terms generally within 30 days from shipment[71]. - FILSPARI sales reached $55.881 million in Q1 2025, compared to $19.834 million in Q1 2024, reflecting a significant growth[78]. - The company recognized $5.9 million in license and collaboration revenue for Q1 2025, up from $1.4 million in Q1 2024[80]. Debt and Financing - The Company completed a repurchase of $207.1 million of 2025 Notes for a total of $213.8 million, resulting in a $7.6 million loss on extinguishment of debt[123]. - The 2025 Notes bear an annual interest rate of 2.50% and will mature on September 15, 2025[117]. - The total remaining principal amount outstanding under the 2025 Notes was $68.9 million as of March 31, 2025[123]. - The Company received net proceeds of $306.4 million from the issuance of the 2029 Notes after deducting $9.9 million in commissions and offering expenses[114]. - The effective interest rate on the 2029 Notes is 2.74%[116]. - The initial conversion rate for the 2029 Notes is 31.3740 shares per $1,000 principal amount, equating to an initial conversion price of approximately $31.87 per share[115]. - The Company incurred approximately $9.9 million in debt issuance costs related to the 2029 Notes, which are being amortized over the expected life of the notes[116]. - The total interest expense recognized for the three months ended March 31, 2025, was $2.9 million, compared to $2.8 million for the same period in 2024[126]. Marketable Securities and Investments - As of March 31, 2025, the company's marketable debt securities totaled $260.345 million, down from $312.166 million as of December 31, 2024[90]. - Unrealized losses on available-for-sale marketable debt securities as of March 31, 2025, totaled $19, with a fair value of $81.960 million[92]. Contingent Liabilities and Agreements - The company has contingent cash payments of up to $427.0 million related to the acquisition of Orphan Technologies Limited, based on certain development and commercialization milestones[133]. - The Renalys License Agreement allows the company to receive up to $120 million in milestone payments and tiered royalties on net sales in specified Asian countries[82].

Financial Data and Key Metrics Changes - The company reported net product sales of $75.9 million for Q1 2025, representing a 90% increase year-over-year and continued sequential growth [27] - Net sales for VILSPARI grew 182% year-over-year and 13% compared to the previous quarter, reflecting strong demand and uptake [6][20] - The net loss for Q1 2025 was $41.2 million, or $0.47 per basic share, compared to a net loss of $136.1 million, or $1.76 per basic share, for the same period in 2024 [32] Business Line Data and Key Metrics Changes - VILSPARI maintained strong momentum with $55.9 million in net product sales for Q1 2025, despite higher gross-to-net discounts due to insurance coverage changes [27][28] - Thiola and Thiola EC contributed $20 million in net product sales for the first quarter [28] - The company expects to receive a $17.5 million milestone payment from CSL V4 due to the conversion of VILSPARI's conditional approval to full approval in Europe [32] Market Data and Key Metrics Changes - The European Commission and MHRA in the UK converted FILSPARI's conditional approvals to full approvals for the treatment of adults with IgA nephropathy, enabling broader access across Europe and the UK [7] - Approximately 75% of nephrologists are now targeting proteinuria below 0.5 grams per gram, with nearly a third targeting even more ambitious goals of 0.3 grams [25] Company Strategy and Development Direction - The company aims to solidify VILSPARI's foundational positioning in IgA nephropathy and unlock additional growth through a potential new indication in FSGS [5] - The company is preparing for a potential launch of VILSPARI for FSGS, which is expected to be a significant opportunity, potentially larger than in IgA nephropathy [10][26] - The company is committed to advancing its investigational therapy PEG T for classical homocystinuria (HCU) and plans to restart patient enrollment in the Phase III HARMONY study next year [10][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategy with strong fundamentals and a clear focus on executing key priorities [11] - The company anticipates continued strong demand for FILSPARI and IgA nephropathy, projecting meaningful growth in net product sales throughout the year [33] - Management is monitoring legislative developments and geopolitical uncertainties but believes that potential tariffs on pharmaceutical products would not have a material impact on VILSPARI [33] Other Important Information - The company reported a decrease in R&D expenses to $46.9 million for Q1 2025, down from $49.4 million in the same period in 2024 [29] - Selling, general, and administrative expenses increased to $72.8 million for Q1 2025, compared to $64.2 million for the same period in 2024, largely due to increased investment in the FILSPARI launch [30] Q&A Session Summary Question: Can you elaborate on any interactions with the agency regarding the sNDA for FSGS? - Management indicated that interactions with the FDA have been consistent and progressing as expected, similar to previous experiences with the IGAN indication [36][38] Question: What do you think the label for FSGS will look like? - The expectation is that the indication will be for the treatment of FSGS in patients ages eight and up, based on the broad inclusion criteria of the duplex study [42][45] Question: How is the recent approval of Novartis' therapy impacting your sales reps in the field? - Management noted that it is early to assess the impact, but continued demand for FILSPARI has been observed, indicating confidence in its efficacy profile [50][52] Question: What is the impact of the removal of the REMS program on new patient starts in IGAN? - Management stated that REMS has not been an obstacle to performance and anticipates that modifications will enhance convenience for patients and physicians [76][78] Question: What is the split between new versus repeat prescribers for FILSPARI? - The split is slightly skewed towards experienced prescribers, with a healthy continuation of new prescribers as well [86]

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025EU approval is based on the complete data set from the phase-III PROTECT studyST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the ...

Core Viewpoint - Travere Therapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for FILSPARI, aiming for it to be the first FDA-approved treatment for focal segmental glomerulosclerosis (FSGS), a rare kidney condition [1][2] Company Overview - Travere Therapeutics is focused on developing therapies for rare diseases, emphasizing the urgent need for effective treatment options for conditions like FSGS [2][8] - FILSPARI is currently approved for slowing kidney function decline in adults with IgA nephropathy and is a non-immunosuppressive oral medication [2][9] Clinical Studies - The sNDA submission is supported by results from the Phase 3 DUPLEX Study and the Phase 2 DUET Study, which are among the largest interventional studies in FSGS [1][6] - The DUPLEX Study achieved its interim endpoint with statistical significance at 36 weeks, showing significant proteinuria reduction and a lower rate of end-stage kidney disease compared to the active control [6][7] - The DUET Study demonstrated a greater than two-fold reduction in proteinuria compared to irbesartan, with a consistent safety profile across trials [7] Regulatory Process - The FDA has 60 days to determine whether to accept the sNDA for review, with an expected notice in the second quarter of 2025 [3] - The FDA has indicated that REMS monitoring for embryo-fetal toxicity is no longer necessary, and the company plans to submit a modification to the REMS [4] Disease Context - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S., characterized by progressive scarring of the kidney and leading to kidney failure [5] - There are currently no FDA-approved pharmacologic therapies for FSGS, highlighting the significance of FILSPARI's potential approval [5]