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XOMA(XOMA) - 2025 Q4 - Earnings Call Transcript
2026-03-18 13:02
Financial Data and Key Metrics Changes - In 2025, XOMA Royalty reported total GAAP income and revenue of $52.1 million, a significant increase from $28.5 million in 2024 [21] - Total cash receipts grew by 9% to $50.5 million, with royalty receipts reaching approximately $34 million, marking a 68% increase compared to 2024 [21] - Full-year GAAP net income was $31.7 million, compared to a GAAP net loss of $13.8 million in 2024 [23] Business Line Data and Key Metrics Changes - The company added 22 assets to its portfolio in 2025, including five in phase II or phase III trials, with a total cash outlay of only $25 million upfront [14] - Royalty receipts came from four programs in 2025, two more than in 2024, and six programs achieved clinical, regulatory, and business development events, leading to approximately $17 million in cash milestone payments [21] Market Data and Key Metrics Changes - The portfolio has expanded significantly, doubling the number of assets in active development from roughly 60 in 2023 to over 120 in 2025 [12] - The company has established a diverse and growing source of recurring receipts, with seven commercially available programs [5] Company Strategy and Development Direction - XOMA Royalty aims to build a diversified portfolio of biotechnology royalty and milestone assets while maintaining disciplined capital allocation [11] - The company is focused on innovative transactions and underappreciated opportunities, positioning itself as a unique source of capital for biotech innovation [20] - The strategy includes a balance between returning capital to shareholders and investing in new portfolio assets to increase breadth [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for royalty receipts, particularly from VABYSMO, OJEMDA, and MIPLYFFA, which are expected to ramp up significantly [32] - The company is approaching an inflection point where royalty receipts alone could cover operating expenses by 2027 [28] - Management remains optimistic about the potential for future milestone payments and royalty growth from a robust late-stage pipeline [9] Other Important Information - The company maintained a lean operating structure, achieving positive cash flow from operations and returning $16 million of capital through share buybacks [5] - XOMA Royalty ended the year with approximately $83 million in unrestricted cash and cash equivalents, providing ample firepower for future investments [27] Q&A Session Summary Question: Growth prospects for royalty receipts on approved products - Management indicated strong growth prospects, particularly from VABYSMO, which had double-digit growth last year, and positive expectations for OJEMDA and MIPLYFFA [32] Question: Confidence in Tremfya economic opportunity - Management expressed confidence in the breach claim related to Tremfya, citing historical relationships and potential royalty rates [34] Question: Prioritization of capital deployment between share buybacks and new deals - Management emphasized a philosophy of reducing equity base to increase cash flow per share while balancing external opportunities [46] Question: Size of the opportunity for Rezolute's ersodetug program - Management estimated the combined opportunity for the two indications to be approaching $1 billion, with a favorable split between congenital and tumor hyperinsulinism [48]
XOMA(XOMA) - 2025 Q4 - Earnings Call Transcript
2026-03-18 13:02
Financial Data and Key Metrics Changes - In 2025, XOMA Royalty reported total GAAP income and revenue of $52.1 million, a significant increase from $28.5 million in 2024 [21] - Total cash receipts grew by 9% to $50.5 million, with royalty receipts reaching approximately $34 million, marking a 68% increase compared to 2024 [21] - Full-year GAAP net income was $31.7 million, compared to a GAAP net loss of $13.8 million in 2024 [23] Business Line Data and Key Metrics Changes - The company added 22 assets to its portfolio in 2025, including 7 commercially available programs, enhancing its recurring revenue sources [4][5] - The growth in royalty receipts was driven by VABYSMO and OJEMDA, along with contributions from MIPLYFFA following its approval [21] - Six programs achieved clinical, regulatory, and business development events, leading to approximately $17 million in cash milestone payments [21] Market Data and Key Metrics Changes - The company is seeing promising launches from several commercial-stage programs, with potential geographic expansions anticipated [6] - The portfolio includes 14 programs in registrational stage, indicating multiple catalysts for potential top-line royalty growth in the coming years [8] Company Strategy and Development Direction - XOMA Royalty aims to build a diversified portfolio of biotechnology royalty and milestone assets while maintaining disciplined capital allocation [11] - The company executed a strategic revenue share transaction with Takeda, adding potential royalty and milestone payments across 9 programs [10] - The focus remains on innovative transactions and underappreciated opportunities to expand the portfolio without diluting shareholder value [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for royalty receipts, particularly from VABYSMO, OJEMDA, and MIPLYFFA [32] - The company is approaching an inflection point where royalty receipts alone could cover operating expenses by 2027 [28] - Management remains optimistic about the potential for future cash flow growth from the expanding portfolio and ongoing clinical developments [29] Other Important Information - The unrestricted cash position increased to over $80 million, providing ample resources for future investments [12] - The company maintained a flat share count compared to 2023, avoiding shareholder dilution while achieving positive operating cash flows [13] Q&A Session Summary Question: Growth prospects for royalty receipts on approved products - Management indicated strong growth prospects, particularly from VABYSMO, with double-digit growth and positive expectations for OJEMDA and MIPLYFFA [32] Question: Confidence in Tremfya economic opportunity - Management expressed confidence in the breach claim related to Tremfya, citing historical relationships and potential royalty rates [34] Question: Prioritization of capital deployment between share buybacks and new deals - Management emphasized a balance between returning capital to shareholders and investing in new opportunities, favoring internal investments to enhance cash flow per share [45] Question: Size of the opportunity for Rezolute's program for ersodetug - Management estimated the combined market opportunity for the two indications to be around $1 billion, with a favorable split between congenital and tumor hyperinsulinism [48]
XOMA(XOMA) - 2025 Q4 - Earnings Call Presentation
2026-03-18 12:00
CORPORATE PRESENTATION NASDAQ COMMON: XOMA NASDAQ PERPETUAL PREFERRED SHARES: XOMAP, XOMAO THE ROYALTY AGGREGATOR FOR BIOTECH COMPANIES Q1 2026 DISCLAIMERS Certain statements in this presentation are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding: future potential monetization opportunities, active transactions with significant financial implications, collaborations poised for s ...
XOMA Corporation (NasdaqGM:XOMA) 2026 Conference Transcript
2026-03-11 16:22
Summary of XOMA Corporation Conference Call Company Overview - **Company**: XOMA Corporation (NasdaqGM:XOMA) - **Industry**: Biotechnology - **Key Leadership**: CEO Owen Hughes, CFO Jeff Trigilio, Chief Investment Officer Brad Sitko Core Points and Arguments - **Portfolio Strategy**: XOMA aims to increase optionality within its portfolio, focusing on building a robust pipeline to withstand the binary nature of biotech. The company has 15 assets in phase 3 development, with 2 recent failures attributed to a higher-than-expected placebo effect. Despite this, the company's valuation remains stable, indicating confidence in its portfolio's potential [6][7]. - **Asset Growth**: Over the past three years, XOMA has added approximately 80 assets while reducing its share count, demonstrating effective capital management and a strategy to leverage future returns without diluting equity [8]. - **Tremfya Economics**: XOMA has a claim related to the commercialization of Tremfya, which it believes is integral to the drug's development. Although a recent arbitration was unsuccessful, the company sees potential in pursuing Johnson & Johnson for royalties, with a market cap of $450-$500 million and significant potential financial upside if successful [9][12][14]. - **Litigation Outlook**: The company is optimistic about the potential for a settlement or favorable ruling in its ongoing litigation, which could provide additional funding for business development and shareholder returns [19][22][27]. - **Takeda Transaction**: In 2025, XOMA completed a significant transaction with Takeda, exchanging one asset for nine additional assets, enhancing its portfolio and optionality. This deal is part of a broader strategy to diversify risk and increase net present value (NPV) [34][35]. Financial Highlights - **2025 Financial Performance**: XOMA reported over $50 million in top-line revenue, with $33 million from royalty receipts. The company achieved free cash flow positivity and repurchased $16 million of stock, indicating strong financial health [42][43]. - **Future Projections**: The company anticipates continued growth in royalties from approved therapies, with expectations of covering operational expenses and financial obligations through royalties alone by 2027. XOMA has over $620 million in net operating losses (NOLs) and capitalized R&D deductions, allowing it to maintain a low effective tax rate [51][52]. Upcoming Catalysts - **Clinical Trials**: XOMA has several upcoming catalysts, including the phase 2b readout for volixibat and a phase 3 trial for ersodetug, both of which could significantly impact the company's financials and market position [79][85]. - **Vabysmo Royalties**: Currently generating approximately $25 million annually from Vabysmo royalties, with expectations for continued growth. The drug's performance will influence the company's ability to pay off loans and return cash flows to shareholders [89][90]. Additional Insights - **Business Model**: XOMA's strategy focuses on acquiring non-dilutive capital and building a diversified portfolio to mitigate risks associated with biotech investments. The company emphasizes the importance of maintaining a flat share count while pursuing growth opportunities [60][64]. - **Market Positioning**: The company recognizes the challenges in biotech, including the unpredictability of clinical success and market dynamics. XOMA aims to leverage its unique assets and partnerships to create sustainable revenue streams [55][56]. This summary encapsulates the key points discussed during the conference call, highlighting XOMA's strategic direction, financial performance, and future opportunities within the biotechnology sector.
Mirum Pharmaceuticals (NasdaqGM:MIRM) 2026 Conference Transcript
2026-03-11 15:02
Summary of Mirum Pharmaceuticals Conference Call Company Overview - **Company**: Mirum Pharmaceuticals (NasdaqGM:MIRM) - **Event**: 2026 Conference on March 11, 2026 Key Points Financial Guidance and Commercial Strategy - Mirum Pharmaceuticals reiterated its revenue guidance for 2026, projecting between **$630 million and $650 million** [4] - The company is focused on funding R&D programs while maintaining durable trends in commercial performance [4] Upcoming Data Events - Key data events scheduled for Q2 2026 include: - **VISTAS PSC** top-line data, pivotal for potential NDA filing by year-end [4] - **Brelovitug** Phase 2b interim readout from the AZURE-1 study [5] - **EXPAND** top-line readout in Q4 2026 [5] EXPAND Program - The EXPAND program targets ultra-rare cholestasis conditions, with a significant portion of patients expected to be pediatric [7][9] - The potential market for LIVMARLI is projected to reach **at least $1 billion**, with EXPAND contributing approximately one-third of that [9] Geographic Expansion - LIVMARLI is currently available in **low- to mid-30 countries**, with most international sales driven by Alagille syndrome [11] - Opportunities for growth exist in regions like the Middle East and Latin America, where sales have been limited [11] Adult PFIC Market - The adult PFIC market is still in early stages, with increased genetic testing among providers expected to drive growth [12] - The company anticipates continued patient diagnosis and treatment persistence, contributing to long-term growth [13] PSC and PBC Opportunities - Approximately **60%** of diagnosed PSC patients are reported to experience meaningful itch, indicating a significant market for antipruritic therapies [19] - The company plans to conduct market development work to raise awareness of pruritus among healthcare professionals and patients [20] Launch Timeline - Following the release of top-line results, Mirum plans to engage with the FDA for pre-submission interactions, aiming for an NDA filing in the second half of 2026 and potential approval in 2027 [24] - Significant revenue contributions from new products are expected to begin in **2028** [25] Brelovitug Market Development - The company is focused on shifting testing paradigms for hepatitis delta, with a goal to increase diagnosis rates through reflex testing [30][32] - The estimated diagnosed and insured population for delta is around **15,000**, with a full prevalence of approximately **40,000** [33] Competitive Positioning - Brelovitug is positioned as a highly active regimen with a strong safety profile, focusing on endpoints linked to improved patient outcomes [37] - The company anticipates a **$750 million** floor guidance for brelovitug, based on conservative assumptions regarding market penetration [39] Future Growth and Business Development - Mirum remains active in seeking new rare disease programs, maintaining a high bar for potential acquisitions to ensure financial strength [47][48] Additional Insights - The company emphasizes the importance of patient experience and education in driving treatment uptake and market growth [18][21] - Mirum's strategy includes leveraging existing teams and distributor networks to expand market access, particularly in regions with lower GDP [44]
Mirum Pharmaceuticals (NasdaqGM:MIRM) 2026 Conference Transcript
2026-03-10 15:12
Mirum Pharmaceuticals Conference Call Summary Company Overview - **Company**: Mirum Pharmaceuticals (NasdaqGM:MIRM) - **Focus**: Rare disease medicines, with a strategy centered on developing high-impact therapies for patients with rare diseases [4][5] Financial Performance - **Revenue Guidance**: Expected top line revenue for 2026 is between $630 million and $650 million, reflecting strong performance across three approved medicines [5][29] - **Growth Drivers**: The company anticipates four pivotal readouts over the next 18 months, indicating a pivotal year for growth [5][46] Product Pipeline and Commercial Opportunities LIVMARLI - **Indications**: Approved for Alagille syndrome and PFIC, with ongoing expansion into additional indications through the EXPAND study [8][30] - **Mechanism**: LIVMARLI reduces circulating bile acid levels, significantly alleviating symptoms such as pruritus in patients [8][9] - **Market Dynamics**: Steady growth in Alagille syndrome patient starts; PFIC adoption is dynamic due to increased genetic testing [10][13] - **Sales Growth**: LIVMARLI sales are expected to contribute significantly to the overall revenue, with projections indicating it could become a billion-dollar brand [45][94] Cholbam and CTEXLI - **Sales Performance**: Revenue for Cholbam and CTEXLI has grown to over $160 million, driven by increased awareness and diagnosis efforts [23][24] - **Market Strategy**: Focus on both raising awareness and identifying new patients for these rare conditions [24][26] Brelovitug - **Indication**: Targeting Hepatitis D, a rare and progressive liver disease with significant unmet need [52] - **Clinical Data**: Phase 2 data showed promising results, with a 100% virologic response at 48 weeks [57] - **Enrollment**: Rapid enrollment in registration studies indicates strong interest and potential for success [58] Volixibat - **Indications**: Targeting primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) [78][87] - **Unique Approach**: Using pruritus as a primary endpoint for PSC, which has no approved therapies, represents a novel strategy [78][79] - **Market Potential**: Approximately 30,000 PSC patients in the U.S., with two-thirds experiencing pruritus, indicating a substantial launch population [81][83] Strategic Focus and Future Outlook - **Investment Strategy**: The company aims to balance investments in pipeline development while maintaining a positive cash flow position [98] - **Market Position**: Mirum expects to have a competitive edge in the PSC market due to the lack of approved therapies, allowing for a strong market presence for several years [96][94] - **Long-term Vision**: The company is focused on building value through new medicines and disciplined business development efforts [98][99] Conclusion - Mirum Pharmaceuticals is positioned for significant growth with a robust pipeline and strong commercial performance. The focus on rare diseases and innovative treatment approaches, combined with a solid financial outlook, presents a compelling investment opportunity.
Mirum Pharmaceuticals (NasdaqGM:MIRM) FY Conference Transcript
2026-03-02 19:12
Summary of Mirum Pharmaceuticals FY Conference Call Company Overview - **Company**: Mirum Pharmaceuticals (NasdaqGM:MIRM) - **Focus**: Building a leader in rare diseases by developing and commercializing best-in-class medicines [2][4] Financial Highlights - **2025 Revenue Guidance**: Expected revenues between $630 million and $650 million [2] - **2026 Guidance**: Strong performance anticipated, exceeding consensus estimates [4] Product Pipeline - **Approved Medicines**: Three approved medicines currently available [2] - **Upcoming Trials**: Four pivotal trials expected to unblind over the next 18 months, including: - PSC trial with volixibat in Q2 2026 - Interim analysis for Chenodal with 50 patients - AZURE-1 and AZURE-4 trials for Chenodal in the second half of 2026 - EXPAND trial with LIVMARLI for ultra-rare cholestatic indications [3] Commercial Performance - **LIVMARLI Uptake**: - Strong performance in Alagille syndrome with approximately 50% market penetration and an annual incidence of about 100 patients [4] - Achieving over 80% market share in Alagille [4] - Positive reception in PFIC, capturing at least 50% of treatment-naive patients [4][5] - **Ex-US Market**: Good visibility in major Western European countries, with growth expected in Alagille and PFIC [7] Expansion Opportunities - **EXPAND Study**: Initiated due to high demand from compassionate use requests; includes various ultra-rare indications [8] - **Market Potential**: Estimated peak sales for LIVMARLI could exceed $1 billion, with a third of sales from Alagille, PFIC, and the EXPAND population [10] Intellectual Property - **Patent Expiration**: Expected to extend to 2040 for dosing patents and 2043 for tablet patents [13] Volixibat Development - **Target Population**: Aimed at adults with PSC and PBC, with expectations for a clinically meaningful difference of at least 1.75 placebo-adjusted [15][20] - **Interim Results**: Positive interim results for PBC with significant pruritus benefits observed [21] Strategic Acquisitions - **Bluejay Therapeutics**: Acquired to enhance the hepatitis delta program, with a potential patient population of at least 15,000 diagnosed patients [31][33] Competitive Landscape - **Hepatitis Delta Treatment**: Brelovitug expected to have advantages in convenience and tolerability compared to competitors [35] - **Market Dynamics**: Anticipated increase in diagnosis rates with the introduction of new therapies [33] Future Outlook - **Regulatory Submissions**: NDA filing expected in the second half of 2026 following positive trial results [20] - **Commercial Strategy**: Plans to expand marketing efforts for volixibat and other therapies, focusing on community gastroenterologists and hepatologists [38] Conclusion - **Growth Potential**: Mirum Pharmaceuticals is positioned for significant growth in the rare disease market, with a robust pipeline and strategic acquisitions enhancing its portfolio [41]
Mirum's Q4 Earnings Lag, Higher Product Sales Drive Y/Y Revenues
ZACKS· 2026-02-26 16:51
Core Insights - Mirum Pharmaceuticals (MIRM) reported a loss of 11 cents per share in Q4 2025, missing the Zacks Consensus Estimate of earnings of 2 cents, but improved from a loss of 49 cents per share in the same quarter last year [1][10] - Revenues for Q4 totaled $148.9 million, representing a 50.5% year-over-year increase, surpassing the Zacks Consensus Estimate of $141 million, driven by strong sales of Livmarli and newly acquired bile acid medicines [2][8] Financial Performance - The company recorded no license and other revenues in the year-ago quarter, while research and development expenses rose by 16.1% year-over-year to $51.1 million [6] - Selling, general and administrative expenses increased by 30.5% to $74.1 million compared to the previous year [9] - For the full year 2025, Mirum generated revenues of $521.3 million, up from $336.9 million in 2024, with a loss of 47 cents per share, an improvement from a loss of $1.85 in the prior year [10] Product and Pipeline Updates - Livmarli is approved for treating cholestatic pruritus in patients with Alagille syndrome and certain patients with progressive familial intrahepatic cholestasis [3] - A new tablet formulation of Livmarli was launched in the U.S. in June 2025, aimed at providing convenience for older patients [4] - Mirum acquired Travere Therapeutics' bile acid products in August 2023, adding Cholbam and Ctexli to its portfolio [4] - The company expects worldwide net product sales of approximately $630-$650 million in 2026 and aims to achieve positive cash flow in 2027 [11] Clinical Trials and Research - Mirum is conducting a phase III EXPAND study for Livmarli to treat pruritus in rare cholestatic conditions, with enrollment expected to complete in the first half of 2026 [12] - The lead pipeline candidate, volixibat, is being evaluated in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with top-line data expected in 2026 [13] - The company initiated the phase II BLOOM study for MRM-3379, a PDE4D inhibitor for Fragile X syndrome, and completed the acquisition of Bluejay Therapeutics, adding brelovitug to its pipeline [14] Stock Performance - Mirum's shares have increased by 45.5% over the past six months, outperforming the industry average rise of 23% [5]
Mirum(MIRM) - 2025 Q4 - Earnings Call Transcript
2026-02-25 22:32
Financial Data and Key Metrics Changes - In 2025, the company achieved $521 million in net product sales, a 55% increase from $336 million in 2024 [5][14] - The fourth quarter of 2025 saw net product sales of $149 million, compared to $99 million in the same quarter of the previous year [14] - The company ended 2025 with $391 million in cash equivalents, up from $293 million at the end of 2024 [15] Business Line Data and Key Metrics Changes - LIVMARLI net product sales were $245 million in the U.S. and $115 million internationally, with bile acid medicines contributing an additional $161 million [5] - The commercial cash contribution margin in 2025 was approximately 55%, a significant increase from the prior year [15] Market Data and Key Metrics Changes - The company expects net product sales for 2026 to be between $630 million and $650 million, indicating continued growth [6] - The company anticipates a return to positive cash flow in 2027, following increased R&D expenses in 2026 [16] Company Strategy and Development Direction - The company is focused on advancing its pipeline with multiple clinical and regulatory milestones, including the approval of Ctexli for CTX and a tablet formulation of LIVMARLI [6][7] - The addition of the phase III brelovitug program for chronic hepatitis delta virus aligns with the company's strategy to address significant unmet needs in rare diseases [7][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in entering 2026, highlighting a strong commercial business and a robust pipeline with four potentially pivotal readouts expected in the next 18 months [17] - The company is committed to disciplined execution and delivering impactful medicines for patients with rare diseases [9][17] Other Important Information - The company completed two private placements concurrent with the closing of the Bluejay acquisition, generating gross proceeds of $268.5 million [15] - The company is on track to report top-line data from the volixibat VISTA study in PSC in the second quarter of 2026 [10][11] Q&A Session Summary Question: Volixibat pricing strategy - Management indicated that pricing considerations for volixibat will be based on data closer to launch, noting its unique positioning due to the lack of approved medicines for PSC [19][20] Question: Risk factors in PSC trial - Management acknowledged the episodic nature of pruritus in PSC patients and emphasized the study design's focus on enrolling patients with persistent pruritus to limit variability [25][28] Question: Similarities between VISTA and VANTAGE study designs - Management highlighted commonalities in studying cholestatic pruritus and confirmed that patients with moderate to severe pruritus will be selected for both studies [35][36] Question: FDA interactions regarding safety database for volixibat - Management confirmed that the current VISTA study has a sufficient safety database and plans to interact with the FDA regarding the submission plan after top-line data [40] Question: Market for hepatitis delta virus (HDV) - Management noted the evolving landscape for HDV treatments and expressed optimism about brelovitug's potential as a best-in-class option [70][71] Question: R&D spending increase for HDV studies - Management anticipates a $150 million increase in R&D spending related to the brelovitug program, with significant investments in CMC [72]
Mirum(MIRM) - 2025 Q4 - Earnings Call Transcript
2026-02-25 22:32
Financial Data and Key Metrics Changes - In 2025, the company achieved $521 million in net product sales, a 55% increase from $336 million in 2024, exceeding the upper end of guidance [5][14] - The total net product sales for Q4 2025 was $149 million, compared to $99 million in Q4 2024 [14] - The commercial cash contribution margin in 2025 was approximately 55%, significantly up from the previous year [15] Business Line Data and Key Metrics Changes - LIVMARLI net product sales were $245 million in the U.S. and $115 million internationally, with bile acid medicines contributing an additional $161 million [5] - The company expects net product sales for 2026 to be between $630 million and $650 million, indicating continued growth [6] Market Data and Key Metrics Changes - The company is seeing strong demand in international markets, particularly for LIVMARLI and its bile acid medicines [5] - The integration of the Bluejay acquisition has progressed smoothly, enhancing the company's operational capabilities [8] Company Strategy and Development Direction - The company is focused on advancing its pipeline with significant clinical and regulatory milestones, including the approval of CTEXLI and the enrollment completion of the VISTAS study for volixibat [6][7] - The addition of the phase III brelovitug program for chronic hepatitis delta virus aligns with the company's strategy to address serious rare diseases [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in entering 2026, highlighting a pivotal year with multiple potential registrational readouts expected [6][17] - The company anticipates a return to positive cash flow in 2027, supported by disciplined spending and a strong balance sheet [16] Other Important Information - The company ended 2025 with $391 million in cash equivalents, up from $293 million at the end of 2024 [15] - R&D expenses are expected to increase in 2026 due to investments in the brelovitug clinical program and preparations for BLA submission [16] Q&A Session Summary Question: Regarding volixibat's commercial opportunity and pricing strategy - Management indicated that pricing decisions will be made closer to launch, considering the unique positioning of volixibat in the market [19][20] Question: Concerns about pruritus variability in PSC patients - Management acknowledged the episodic nature of pruritus in PSC and emphasized careful patient selection and monitoring in the study design [25][28] Question: Differences between VISTAS and VANTAGE study designs - Management highlighted the commonality in studying cholestatic pruritus while noting the differences in disease etiology between PSC and PBC [33][35] Question: FDA interactions regarding safety database requirements for volixibat - Management confirmed that the current VISTAS study has a sufficient safety database and plans to interact with the FDA post-top-line data [40] Question: Market expectations for HDV and R&D spending - Management discussed the evolving treatment landscape for HDV and anticipated a $150 million increase in R&D spend related to brelovitug [70][72]