Core Insights - The discussion revolves around the key accomplishments of the past year and the investment case for the upcoming year, indicating a focus on performance evaluation and future outlook [1] Group 1 - The speaker, Mohit Bansal, initiates a conversation about the previous year's performance and asks for insights on key accomplishments [1] - There is an emphasis on understanding what factors would contribute to a positive outlook for the next year, suggesting a strategic approach to investment planning [1] - The mention of a year-over-year comparison indicates a focus on growth and progress within the company or industry [1]

Core Insights - The company is focused on the successful launch of FILSPARI in IgA nephropathy as its top priority for the year [1] - There have been positive performance results in the first half of the year, with plans for exciting updates in the latter half [1] - The company has modified the liver monitoring REMS and removed the pregnancy testing REMS to simplify patient access [1] - The second priority involves ongoing work with the FDA for potential approval in FSGS [2]

Summary of Travere Therapeutics Conference Call Company Overview - **Company**: Travere Therapeutics - **Focus**: Rare kidney diseases, specifically IgA nephropathy and FSGS (Focal Segmental Glomerulosclerosis) Key Priorities - **FILSPARI Launch**: Continued success in the launch of FILSPARI for IgA nephropathy, with positive performance in the first half of the year and updates to simplify patient access [3][4] - **FDA Approval for FSGS**: Ongoing work with the FDA for potential approval of FILSPARI in FSGS, which is seen as a transformational opportunity for patients lacking approved treatments [3][4] Parasol Initiative - **Overview**: A public-private partnership aimed at defining clinical endpoints for FSGS trials, involving patient advocacy groups and global regulators [6] - **Conclusions**: - eGFR is important but not feasible as a trial endpoint due to variability [7] - Proteinuria reduction can predict kidney failure risk, establishing its importance as a clinical endpoint [9] FDA Interactions - **Advisory Committee Meeting**: Anticipated discussions will focus on clinical data in the context of the Parasol initiative [10][11] - **eGFR Data**: No current focus on eGFR in discussions with the FDA, with emphasis on proteinuria data instead [17] Commercial Strategy for FSGS - **Market Opportunity**: FSGS is expected to be a larger opportunity than IgA nephropathy due to established unmet needs [22][23] - **Prescriber Overlap**: Over 80% of physicians treating IgA nephropathy also treat FSGS patients, facilitating market entry [25] - **Sales Force Expansion**: Incremental expansion of the sales force is planned to ensure competitiveness in both IgA nephropathy and FSGS [26] Pricing Strategy - **Linear Pricing**: Pricing for FSGS will be linear with IgA nephropathy, with a higher dose for sicker patients [29][31] Market Dynamics - **Patient Population**: Approximately 30,000 addressable patients for FSGS at launch, with potential for growth as more patients are diagnosed [32] - **IgA Market Growth**: Strong growth trajectory observed in the IgA market, with a 40% increase in new patient starts post-full approval [36] Competitive Landscape - **Novartis Competition**: Initial positive signals despite competition from Novartis, with FILSPARI maintaining a strong position due to its dual mode of action and established physician relationships [40][41] - **B-cell Modulating Agents**: Upcoming therapies are viewed as complementary rather than direct competition, with a focus on combination therapies [46][48] Future Outlook - **KDIGO Guidelines**: Anticipated publication of updated guidelines will support more aggressive treatment targets and reinforce FILSPARI's position [53] - **Cash Runway**: Sufficient cash runway into 2028, supporting ongoing launches and development programs [59] Additional Insights - **Patient Compliance**: High compliance and persistence rates observed, indicating strong patient support and efficacy of FILSPARI [52] - **Long-term Vision**: Aiming for a future where no patient with IgA nephropathy experiences kidney failure, emphasizing the importance of combination therapies [49]

Financial Data and Key Metrics Changes - The company reported its strongest quarter to date, with a 40% growth in demand uptake for Filspari since receiving full approval [4][8] - The revenue growth in Q2 outpaced patient start forms, indicating a lag in payer authorization updates following the full approval [10][11] - The company expects continued revenue growth due to strong patient compliance and persistence, with less than 10% of the addressable population currently reached [13] Business Line Data and Key Metrics Changes - The launch of Filspari for IgA nephropathy has seen consistent new patient starts, averaging around 700 since Q4 of the previous year [8] - The REMS modification has simplified monitoring for patients, which is expected to enhance patient access and compliance [5][20] - The company has an accepted sNDA for FSGS, with anticipation of approval by January next year [6] Market Data and Key Metrics Changes - Over 70% of patients are managed by community nephrologists, indicating a strong prescriber base for Filspari [27] - The competitive landscape includes Atarsentan, which has a more limited label, while Filspari has shown superior long-term data [29][41] - The draft QDIGO guidelines suggest earlier and more aggressive intervention for IgA nephropathy, which could increase the patient population eligible for Filspari [30][32] Company Strategy and Development Direction - The company aims to position Filspari as a foundational treatment for IgA nephropathy and FSGS, emphasizing its dual mechanism of action [28][35] - There is a focus on generating robust data for combination therapies, particularly with SGLT2 inhibitors and potential B cell therapies [45][47] - The company is committed to addressing the needs of the rare disease community, with plans to reinitiate Phase III trials for peg debatinase next year [61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing engagement with the FDA regarding the approval process for FSGS, highlighting consistency in communication [48][54] - The company anticipates a powerful year ahead for the rare disease community, with hopes of providing new therapies for conditions like FSGS and HCU [64][66] - Management emphasized the importance of hope for families affected by rare diseases, indicating a strong commitment to advancing treatment options [64] Other Important Information - The company has made significant progress in modifying REMS requirements, which is expected to facilitate broader patient access [5][20] - The competitive positioning of Filspari is strengthened by its comprehensive clinical data and favorable payer access [41][42] Q&A Session Summary Question: What were the key accomplishments over the past year? - Management highlighted the successful launch and strong uptake of Filspari for IgA nephropathy as a major achievement [4] Question: How is the prescriber base evolving? - The majority of patients are managed by community nephrologists, with a strong competitive position in that segment [27] Question: What is the outlook for revenue growth? - Continued growth is expected due to high patient compliance and the potential to reach a larger addressable population [13] Question: How does the company plan to compete with new entrants? - The company believes in the superior profile of Filspari, emphasizing its dual mechanism of action and strong clinical data [29] Question: What are the timelines for potential REMS removal? - The company plans to engage with the FDA for a potential sNDA submission for full REMS removal after the PDUFA date for FSGS [25] Question: How does the company view combination therapies? - Management sees value in generating evidence for combination therapies and anticipates that physicians will likely use these in practice [47]

Summary of Trevere Therapeutics Conference Call Company Overview - **Company**: Trevere Therapeutics - **Key Products**: Sparsentan (Filspari), Pegobatinase Key Industry Insights - **Industry**: Biopharmaceuticals, specifically focusing on treatments for kidney diseases such as IgA nephropathy and FSGS (Focal Segmental Glomerulosclerosis) Core Points and Arguments 1. **FDA Approval of REMS Modification**: The FDA approved a modification to the Risk Evaluation and Mitigation Strategy (REMS) for Sparsentan, allowing liver function tests to be conducted every three months instead of monthly, and removing embryo-fetal toxicity testing requirements [3][4][5] 2. **Commercial Significance**: The modification is expected to broaden the patient population eligible for Sparsentan, particularly those with proteinuria levels below 1.5, which constitutes about 70% of the addressable patient population [7][8][9] 3. **Patient Monitoring Alignment**: The new monitoring schedule aligns with standard nephrology practices, making it easier for physicians to prescribe Sparsentan [5][10] 4. **Market Opportunity**: There are approximately 70,000 patients in the U.S. with IgA nephropathy who could benefit from Sparsentan, with current penetration being less than 10% of this population [29][30] 5. **QADIGO Guidelines Impact**: The upcoming QADIGO guidelines are expected to reinforce the need for aggressive treatment targets for proteinuria, further supporting the use of Sparsentan [23][24][25] 6. **Combination Therapy Future**: The company emphasizes the importance of combination therapies, as current treatments alone (like ACE inhibitors) are often insufficient [31][32] 7. **Clinical Data**: Sparsentan has shown a significant reduction in proteinuria, with a 70% reduction in treatment-naive patients, indicating its effectiveness when initiated early [42][44] 8. **FSGS Development**: The company is preparing for an advisory committee meeting regarding the FSGS indication, focusing on the importance of proteinuria as a primary endpoint based on findings from the Parasol initiative [56][63][66] Additional Important Insights 1. **Manufacturing Challenges**: Trevere faced manufacturing challenges with Pegobatinase but is on track to resume Phase 3 enrollment next year [79][80] 2. **Patient Education**: The company is actively working to educate nephrologists about the urgency of treating IgA nephropathy earlier, as many patients are often undertreated [33][34] 3. **Regulatory Engagement**: Trevere has maintained consistent engagement with the FDA regarding its clinical data and the potential for future submissions [64][66] 4. **Market Dynamics**: The company acknowledges the increasing competition in the rare disease space but believes that the introduction of new therapies will ultimately benefit patients [32][33] This summary encapsulates the key points discussed during the conference call, highlighting Trevere Therapeutics' strategic direction, product positioning, and market opportunities within the biopharmaceutical industry.

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]

Group 1 - The core viewpoint of the article is that Travere Therapeutics has successfully implemented its restructuring plan, resulting in a significant increase in share price by approximately 81% [1]. Group 2 - The author emphasizes the importance of learning from both investment failures and successes, viewing investing as a continuous educational process [2]. - The focus of the author's research has been primarily on healthcare stocks over the past five years [2].

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]

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 ...

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 ...