Travere Therapeutics(TVTX)

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Travere Therapeutics (TVTX) FY Conference Transcript
2025-08-13 13:00
Summary of Travere Therapeutics (TVTX) FY Conference Call - August 13, 2025 Company Overview - **Company**: Travere Therapeutics - **Focus**: Development of therapies for rare diseases, particularly in rare nephrology and rare metabolics [3][4] Core Products - **Filspari**: - Approved for IgA nephropathy and in development for FSGS (Focal Segmental Glomerulosclerosis) - Unique as the only dual endothelin angiotensin receptor antagonist approved for these conditions [3][4] - **Pegtobatinib**: - Enzyme replacement therapy for classical homocystinuria (HCU) - Phase III study expected to begin enrollment next year [4][56] Commercial Performance - **Filspari Commercial Uptake**: - Accelerated approval received in February 2023, with a focus on becoming foundational care for IgA nephropathy [5][6] - Initial uptake was consistent with expectations, outperforming benchmark launches in the renal space [6] - Demand increased from approximately 500 patient start forms (PSFs) to around 700 PSFs following full approval in September [7][8] - 96% payer coverage achieved, with improvements in reimbursement timelines from 20-60 days to the lower end of that range [11][12] Regulatory Updates - **Supplemental NDA (sNDA)**: - Filed to modify Risk Evaluation and Mitigation Strategy (REMS) to remove embryo-fetal toxicity monitoring and adjust liver monitoring requirements [13][14] - Expectation for approval by PDUFA date of August 28 [17] Market Dynamics - **IgA Nephropathy Landscape**: - Recent approvals in the space (e.g., Tepalta, Venrafia) have not negatively impacted Filspari's market approach [23][24] - Over 70,000 addressable patients in the IgA nephropathy market, with KDIGO guidelines emphasizing ambitious treatment goals [25][26] - Filspari's unique position as the only non-immunosuppressive therapy approved for all patients at risk of progression [31] FSGS Market Potential - **FSGS Market Size**: - Potential to be larger than IgA nephropathy, with approximately half the patient population [47] - Nephrologists are more aware of the need for early treatment in FSGS, leading to a motivated patient and physician group [48] - Anticipated strong uptake due to existing experience with Filspari among nephrologists [49] Sales Strategy - **Sales Force Expansion**: - Incremental increase in sales force to maintain market share in IgA nephropathy and target pediatric nephrologists for FSGS [51][55] - Over 80% overlap in physicians treating both IgA nephropathy and FSGS patients [54] Future Outlook - **PDUFA Date for FSGS**: January 2026, with expectations for a strong narrative based on clinical data and alignment with recent Parasol workshop findings [35][42] - **Pegtobatinib**: Anticipated enrollment in Phase III study for HCU, targeting a patient population of 7,000-10,000 in the US [56] Conclusion - Travere Therapeutics is positioned for significant growth with Filspari and pegtobatinib, leveraging strong clinical data and market dynamics to enhance patient care in rare diseases [57][58]
Travere Therapeutics: Compelling FILSPARI Growth Is Hard To Ignore
Seeking Alpha· 2025-08-12 16:15
This is my second Travere Therapeutics (NASDAQ: TVTX ) article following 01/2024's "Travere Therapeutics: Restructuring Away From Disaster". In Restructuring, I rated Travere as a "Hold". Its referenced restructuring plan has worked quite well with shares trading up ~81%.Writing under the pseudonym "out of ignorance", I very much regard investing as a learning process. Investing failures are tuition paid. Investing successes enter the trove of lessons learned. In my Seeking Alpha articles I share my experie ...
Travere Therapeutics(TVTX) - 2025 Q2 - Earnings Call Transcript
2025-08-06 21:30
Financial Data and Key Metrics Changes - In Q2 2025, net product sales reached approximately $94.8 million, representing an 82% year-over-year growth [22][24] - FILSPARI net product sales in the U.S. were approximately $71.9 million, showing significant year-over-year growth [22][16] - The net loss for Q2 2025 was $12.8 million or $0.14 per basic share, compared to a net loss of $70.4 million or $0.91 per basic share for the same period in 2024 [25] Business Line Data and Key Metrics Changes - FILSPARI's performance in the IgA nephropathy market was highlighted, with strong demand from both new and repeat prescribers [5][16] - The commercial team reported 745 new patient start forms in Q2, a 43% increase compared to the same period last year [17] - THIOLA and THIOLA EC contributed $23 million in net product sales for the second quarter [22] Market Data and Key Metrics Changes - The company is preparing for a potential launch of FILSPARI for FSGS, with a PDUFA date set for January 13, 2026 [14] - The addressable patient population for FILSPARI in the U.S. is estimated at 70,000, with about 70% having elevated proteinuria levels below 1.5 grams per gram [81] Company Strategy and Development Direction - The company aims to establish FILSPARI as the foundational therapy for IgA nephropathy and is advancing its pipeline for rare diseases [5][10] - The strategy includes generating robust clinical evidence, broad access aligned with full approval indications, and real-world clinical experience [6][7] - The company is focused on expanding its commercial organization in preparation for the potential FSGS launch [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of FILSPARI, driven by robust underlying demand and the anticipated removal of certain REMS [26][20] - The management team highlighted the importance of early intervention in treatment and the growing recognition of FILSPARI's nephroprotective profile [18][19] - The company remains optimistic about its strategy and the feedback from the medical community [20] Other Important Information - The company recognized $19.6 million in licensing collaboration revenue, including a one-time milestone payment of $17.5 million from CSL Vifor [23] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling approximately $319.5 million [25] Q&A Session Summary Question: What do you anticipate the major topics could be for the FSGS AdCom? - Management indicated the need for educational components about the disease and the importance of proteinuria as a validated endpoint [31][34] Question: Can you comment on the cadence and level of engagement with the FDA regarding the REMS update for FILSPARI? - Management noted that interactions with the FDA have been progressing as expected, similar to previous experiences [38][40] Question: When will you gain insight into the timing of the advisory committee panel meeting? - Management stated that the advisory committee meeting is expected to take place sometime in Q4, given the PDUFA date of January 13 [45][47] Question: What would it take to remove the REMS entirely? - The strategy involves a two-step process, first seeking to lessen testing frequency and then pursuing full removal [51][52] Question: How are the new data from recent studies being received by the medical community? - The data have been received positively, with excitement about the nephroprotective effects of FILSPARI [54][56] Question: Can you comment on the dynamics and breakdown of growth contributions from stocking, new patients, and persistence rates? - Management confirmed that the revenue growth was performance-driven, with high persistence rates and strong demand [59][62] Question: What are the headwinds or bottlenecks in terms of uptake? - Management identified the urgency to treat patients as a key issue, but noted that the introduction of new treatment options is expected to help [105][106]
Travere Therapeutics(TVTX) - 2025 Q2 - Quarterly Report
2025-08-06 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _________________________________ FORM 10-Q _________________________________ ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-36257 TRAVERE THERAPEUTICS, INC. (Exact name of ...
Travere Therapeutics(TVTX) - 2025 Q2 - Quarterly Results
2025-08-06 20:06
Exhibit 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Reports Second Quarter 2025 Financial Results U.S. net product sales of FILSPARI (sparsentan) grew 165% year-over-year to $71.9 million in 2Q 2025; 745 new PSFs received in the quarter ® sNDA seeking full approval of FILSPARI for FSGS accepted for review; PDUFA target action date set for January 13, 2026 Total revenue for 2Q 2025 was $114.4 million, including net product sales of ...
Travere Therapeutics (TVTX) Earnings Call Presentation
2025-07-03 08:39
FILSPARI (sparsentan) for IgAN - FILSPARI is positioned as a foundational treatment for IgAN, targeting kidney injury by blocking ET-1 and ANG-II, with >70,000 addressable patients in the U S [9, 10, 22, 32, 64] - Clinical trials showed FILSPARI resulted in ~40% reduction in proteinuria after 110 weeks compared to irbesartan [43] - SPARTAN study showed ~70% reduction in proteinuria from baseline at week 24 in newly diagnosed patients [56] - U S commercial launch of FILSPARI outperformed benchmark launches, with ~$132 million in net sales in FY24, a ~78% growth over 2023 [61, 110] Sparsentan for FSGS - Travere plans to submit an sNDA for sparsentan in FSGS around the end of 1Q25 [11, 14] - DUPLEX study showed sparsentan resulted in a ~50% reduction in proteinuria [79] - DUPLEX study showed ~2 5x greater complete remission with sparsentan compared to irbesartan [84] - There are 15,000-30,000 potential addressable patients with FSGS in the U S [10, 70] Pegtibatinase for HCU - Pegtibatinase is a potential disease-modifying therapy for classical HCU, targeting the underlying genetic cause [14, 88, 95] - Phase 1/2 COMPOSE study showed a ~67% mean relative reduction in total homocysteine (tHcy) from baseline in the highest dose cohort [99, 106] - The company is on track to restart enrollment in the Phase 3 HARMONY Study in 2026 [14, 108]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
GlobeNewswire News Room· 2025-06-23 15:55
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving 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 [3] - 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 [3] 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 [4] - The firm has successfully recovered numerous multimillion-dollar damages for class members over its 85-year history [4]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
GlobeNewswire News Room· 2025-06-06 15:44
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving 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 [3] - Following the FDA announcement, Travere's stock price dropped by $4.35 per share, a decline of 20.57%, closing at $16.80 per share on May 16, 2025 [3] 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 [4] - The firm has successfully recovered numerous multimillion-dollar damages awards for class members over its 85-year history [4]
Travere Therapeutics (TVTX) 2025 Conference Transcript
2025-06-04 20:12
Summary of Travere Therapeutics (TVTX) Conference Call Company Overview - **Company**: Travere Therapeutics - **Focus**: Rare diseases, specifically targeting IgA nephropathy and FSGS (Focal Segmental Glomerulosclerosis) [3][4] Key Programs and Strategic Focus - **Filspari**: Launched for IgA nephropathy, aiming to be the foundational therapy [3] - **FSGS Program**: Supplemental NDA accepted with a PDUFA date of January 13, 2026 [3][5] - **Classical Homocystinuria (HCU)**: Phase three program set to initiate enrollment next year [4] Regulatory Insights - **Advisory Committee (AdCom)**: Requested by the FDA for FSGS; reasons include questions around endpoints and safety [5][6] - **Endpoints**: Proteinuria identified as a valid surrogate endpoint for kidney failure risk, contrary to eGFR [10][11] - **FDA Feedback**: Consistent with previous submissions; focus on phase three results in context of Parasol [12][13] Market Opportunity - **FSGS Patient Population**: Over 30,000 diagnosed patients in the U.S. not on dialysis, facing significant risk of kidney failure [19][20] - **Therapeutic Need**: Current therapies are ineffective for many patients; Filspari shows a consistent benefit in reducing proteinuria by approximately 50% [19][20] - **Rapid Uptake Expected**: Anticipated due to high unmet need and lack of alternative therapies [20][21] Commercial Dynamics - **IgA Nephropathy Launch**: Sustained growth with over 700 new patient start forms per quarter since full approval [25][26] - **Payer Access**: Improved since full approval; broad access expected to continue [36] - **Competitive Landscape**: Atrasentan from Novartis expected to grow the endothelin class, but Filspari maintains a broader indication [27][28][30] Pipeline and Future Plans - **HCU Program**: Enrollment expected to restart next year [50] - **Pipeline Expansion**: Focus on rare renal diseases; disciplined approach to new opportunities [51] - **Cash Position**: $322 million at the end of Q1; runway expected into 2028 and beyond [54] Upcoming Catalysts - **Key Dates**: PDUFA for REMS modification on April 28; advisory committee for FSGS pending [55] - **Market Access Milestones**: Anticipated payments from partners for approvals and commercial milestones [54][55] Additional Insights - **EMA Involvement**: Less than FDA but still engaged; confidence in EU regulatory pathway [15][16] - **Combination Therapy**: Filspari expected to be used in combination with SGLT2s for enhanced efficacy [34][42] This summary encapsulates the critical points discussed during the conference call, highlighting the company's strategic focus, regulatory insights, market opportunities, commercial dynamics, pipeline developments, and upcoming catalysts.
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
GlobeNewswire News Room· 2025-06-02 17:30
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving 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 [3] - Following this announcement, Travere's stock price dropped by $4.35, or 20.57%, closing at $16.80 per share on May 16, 2025 [3] Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of Travere for claims related to potential securities fraud [1] - The firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud [4]