BASEL, Switzerland and LONDON and NEW YORK, Jan. 23, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Friday, February 6, 2026, to report its financial results for the second quarter ended December 31, 2026, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in ...

Summary of Roivant Sciences FY Conference Call Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Event**: FY Conference Call on January 12, 2026 - **Speaker**: CEO Matt Gline Key Points Company Positioning and Strategy - Roivant is entering a new era with a significantly simplified business model focused on a smaller subset of products, emphasizing clinical execution and pipeline potential [3][4] - The company aims to shape its own destiny with a high priority on delivering results from its clinical programs [3] Financial Strength - Roivant reported a cash balance of **$4.4 billion**, positioning it well for future growth without the need for additional fundraising [5][9] - The company has a strong track record with **12 positive phase III studies** and **8 FDA approvals**, indicating robust past performance and a solid pipeline [9] Clinical Development Highlights - **Brepocitinib**: Positive data for dermatomyositis (DM) with plans to file an NDA by early 2026, marking it as the first novel oral therapeutic for DM [4][5] - **IMVT-1402**: Progressing in pivotal studies for Graves' disease, with expectations for significant disease-modifying benefits [4] - Upcoming data releases include registrational programs for brepocitinib in non-infectious uveitis (NIU) and phase IIb data for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) [6][7] Market Opportunities - The company sees a potential **$15 billion-plus portfolio** across various indications, with significant opportunities in DM, NIU, and Graves' disease [19][70] - Brepocitinib is expected to capture market share from existing therapies, particularly for patients currently on high-dose steroids or IVIG [41][42] Competitive Landscape - Roivant is positioned to be among the first non-prostacyclin novel mechanisms in PH-ILD, competing against established treatments [6][57] - The company is optimistic about the potential for brepocitinib to outperform existing treatments in DM, especially given the enthusiasm from physicians [41][46] Legal and Regulatory Environment - Ongoing litigation with Moderna regarding lipid nanoparticle technology, with a jury trial scheduled for March 2026 [5][60] - The outcome of this case may have implications for other ongoing litigations and the company's overall strategy [62] Future Outlook - Roivant anticipates a transformative next 36 months with multiple commercial launches and pivotal study readouts [11][19] - The company is focused on executing its clinical programs and expanding its pipeline to drive future value [19][29] Unique Business Model - Roivant's model combines talent from various backgrounds, emphasizing creative clinical development and a focus on delivering value to patients [10][30] - The company aims to differentiate itself by maintaining high standards for partnerships and transactions, driven by a focus on profitability [36] Conclusion - Roivant Sciences is positioned for significant growth with a strong financial foundation, a focused pipeline, and a commitment to innovative clinical development. The upcoming years are expected to be pivotal for the company as it seeks to capitalize on its opportunities in the biotech space [19][70]

If You Didn't Buy Roivant in 2025, Now Is the Time J.P. Morgan Healthcare Conference January 12, 2026 Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial p ...

Roivant Sciences Investor Day Summary Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Event**: 2025 Investor Day held on December 11, 2025 - **Context**: First Investor Day since 2022, highlighting significant progress and future plans [1][4] Key Points and Arguments Business Transformation - Roivant is undergoing a transformation, marking a new decade focused on simplified operations and the development and commercialization of promising programs [5][6] - The company emphasizes a shift from its previous decade, aiming for a more streamlined approach [6] Clinical Execution and Pipeline Opportunities - Roivant has made substantial progress in clinical milestones, with multiple pipeline programs showing potential for blockbuster indications [6][7] - The company has a well-capitalized position with $4.4 billion in cash and cash equivalents, allowing for funding into profitability [7][8] - Roivant has a strong track record with 12 positive phase three studies and eight FDA approvals, with three commercial launches anticipated [8][9] Unique Talent Model - The leadership team is primarily homegrown, fostering a unique organizational culture that emphasizes rapid adaptation and alignment of incentives with project success [9][10] Focus on Execution - Roivant is committed to executing clinical programs effectively, with recent updates indicating accelerated timelines for NDA filings and clinical data readouts [12][13][14] Commercial Opportunities - The company is targeting high-value indications with significant unmet medical needs, particularly in the areas of dermatomyositis (DM), non-infectious uveitis (NIU), and cutaneous sarcoidosis [16][17][18] - The commercial strategy is designed to capitalize on the current biotech landscape, focusing on tractable indications with limited competition [21][22] Specific Programs and Indications Brepocitinib (Brepo) - Brepo is a dual inhibitor of JAK1 and TYK2, with potential applications in DM, NIU, and cutaneous sarcoidosis [25][26] - The NDA filing for DM is expected by early 2026, with significant enthusiasm from the clinical community [12][26] - The NIU program is particularly promising, with a high unmet need and a market of potentially under 200,000 patients [33][34] Non-Infectious Uveitis (NIU) - NIU is a leading cause of blindness among working-age populations, necessitating aggressive treatment strategies [34][35] - The company has observed significant systemic therapy use among NIU patients, indicating a strong market opportunity for new therapies [39][40] Cutaneous Sarcoidosis - Roivant is pursuing cutaneous sarcoidosis as a significant indication, with a small proof-of-concept study underway [48][49] - The potential market includes around 40,000 patients in the U.S., with a high urgency for effective treatments [51][52] Financial Performance and Shareholder Value - Roivant has returned cash to shareholders since going public, increased its cash balance, and doubled its share price [18] - The company has repurchased $1.5 billion of stock since its IPO, with an additional $500 million authorized for buybacks [8][9] Market Context and Future Outlook - The current biotech environment presents unique opportunities for Roivant, with a shift towards successful commercialization of innovative therapies [20][21] - The company is well-positioned to navigate macroeconomic and regulatory changes, with a focus on executing its pipeline effectively [21][22] Conclusion - Roivant Sciences is poised for significant growth with a robust pipeline, strong financial backing, and a commitment to addressing high unmet medical needs in the biotech sector [6][7][8]

December 11, 2025 New York City Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, potential uses of cash and capital allocat ...

Core Insights - Roivant is at a transformational moment with opportunities for three major product launches, each representing a pipeline-in-a-product opportunity with blockbuster potential [2] - The company is hosting an Investor Day to discuss pipeline updates and long-term value creation strategies [1][9] Program-Specific Highlights and Updates - Brepocitinib is expected to have its NDA filing for dermatomyositis in early 2026, with a commercial launch anticipated in early 2027 [6][7] - The Phase 3 trial for brepocitinib in non-infectious uveitis is fully enrolled, with topline data expected in the second half of 2026 [6][7] - A proof-of-concept trial for brepocitinib in cutaneous sarcoidosis is also fully enrolled, with topline data expected in the first half of 2026 [6][7] - IMVT-1402's potentially registrational trial in difficult-to-treat rheumatoid arthritis is expected to provide topline data in 2026 [6][7] - The ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease is on track, with topline data expected in the second half of 2026 [5][8] Financial and Strategic Developments - Roivant's financing efforts alongside key institutional investors generated approximately $550 million for Immunovant, extending its cash runway to the launch of IMVT-1402 in Graves' disease [6][7] - The company is well-positioned to generate shareholder value through its late-stage pipeline and long-term strategy [2][6]

Summary of Roivant Sciences Conference Call Company Overview - Roivant Sciences is a public biopharma company with a market cap of approximately $14.5 billion, primarily focused on developing late-stage drugs for underserved patient populations [4][5] Key Developments in 2025 - The company has made significant progress in its drug portfolio, particularly in two main programs: - **FCRN Franchise**: Demonstrated potential best-in-class drug efficacy in myasthenia gravis and chronic inflammatory demyelinating polyneuropathy (CIDP) [5] - **Brepocitinib**: A dual inhibitor of TYK2 and JAK1, showing promising phase three data in treating dermatomyositis, an orphan disease with high unmet need [5][6] Brepocitinib Insights - Brepocitinib is positioned as a novel treatment option for dermatomyositis, with data showing extraordinary benefits and successful achievement of all primary and secondary endpoints [6] - The drug is expected to be filed for NDA in the first half of 2026, with a gradual launch trajectory anticipated [8][9] - The current treated patient population for dermatomyositis is estimated at 40,000 to 70,000, indicating a significant market opportunity [9] Market Dynamics and Adoption - The drug is expected to be used broadly among treated patients, particularly those who are refractory to existing treatments like IVIG [14] - There is a strong familiarity among doctors with JAK inhibitors, which may facilitate the adoption of Brepocitinib [17][18] Future Indications and Studies - Roivant plans to expand Brepocitinib's indications, with ongoing studies in non-infectious uveitis (NIU) and cutaneous sarcoid, both expected to yield data in the coming years [19][20][26] - The company is also exploring the potential of mosliciguat for pulmonary hypertension associated with interstitial lung disease (PH-ILD), with promising phase one data [29][36] Clinical Catalysts for 2026 - Key upcoming catalysts include: - Cutaneous sarcoid study results - Multiple studies in the FCRN franchise - Phase two B study for mosliciguat in PH-ILD - Jury trial with Moderna related to ongoing litigation [29][30] Investor Sentiment and Market Perception - There is a perception that the market is underappreciating the potential of Brepocitinib in dermatomyositis and NIU, as well as the opportunities presented by mosliciguat [31][33] - The company aims to leverage its existing pipeline to achieve significant market cap growth, potentially reaching $30 billion to $50 billion [58][59] Business Development Strategy - Roivant is cautious about pursuing new business development opportunities, focusing on enhancing the success of its existing programs before engaging in new transactions [58][61] Conclusion - Roivant Sciences is positioned for significant growth with its innovative drug pipeline, particularly in addressing unmet medical needs in orphan diseases. The upcoming clinical data and market strategies will be critical in shaping investor sentiment and market performance in the coming years [4][5][29]

Core Viewpoint - Roivant is set to host a live conference call on November 10, 2025, to report its financial results for Q2 2025 and provide a business update [1]. Company Overview - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines [3]. - The company's pipeline includes several key product candidates: - Brepocitinib, a small molecule inhibitor of TYK2 and JAK1 for treating dermatomyositis, non-infectious uveitis, and cutaneous sarcoidosis [3]. - IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn for various IgG-mediated autoimmune conditions [3]. - Mosliciguat, an inhaled sGC activator for pulmonary hypertension associated with interstitial lung disease [3]. - Roivant employs a strategy of creating nimble subsidiaries, referred to as "Vants," to develop and commercialize its medicines and technologies [3]. - In addition to therapeutics, Roivant also incubates discovery-stage companies and health technology startups that complement its biopharmaceutical business [3].

Group 1 - Roivant has been recognized as one of the 2025 Fortune Best Workplaces in BioPharma, ranking 28th in the small & medium category, marking its first appearance on this prestigious list [1][3] - The award is based on survey responses from nearly 40,000 employees at Great Place To Work Certified companies in the biotechnology and pharmaceutical industry, reflecting a comprehensive picture of workplace experiences [2][4] - The selection process involved over 1.3 million survey responses from employees across the U.S., with rankings derived from 60 employee experience questions within the Great Place To Work Trust Index™ Survey [5] Group 2 - The recognition highlights Roivant's commitment to fostering an empowering, high-performance, and talent-oriented culture, as stated by the CEO [3] - The Best Workplaces in BioPharma list is highly competitive, with companies evaluated on their ability to provide positive outcomes for employees across various demographic identifiers [4][5] - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines, with a diverse pipeline targeting various medical conditions [10][11]

Core Insights - Roivant Sciences Ltd. is highlighted as a promising investment opportunity in the healthcare sector, particularly in the biopharmaceutical space [1][4] Company Overview - Roivant Sciences Ltd. (NASDAQ:ROIV) is a clinical-stage biopharmaceutical company that accelerates the development of medicines through its subsidiaries, known as "Vants" [2] - The company focuses on in-licensing drug candidates from larger pharmaceutical firms and advancing them toward commercialization [2] Pipeline and Recent Developments - The current pipeline includes mosliciguat for pulmonary hypertension, brepocitinib for inflammatory diseases, and IMVT-1402 targeting autoimmune conditions [2] - A significant milestone for Roivant is the advancement of mosliciguat, which has received orphan drug designation in Japan, providing regulatory benefits and potential market exclusivity [3] - The Pulmovant subsidiary is positioned to address an underserved market in pulmonary hypertension with limited treatment options [3] Strategic Focus and Market Position - Roivant's brepocitinib program is progressing toward critical Phase 3 data readouts, which is fostering optimism among investors and analysts [4] - The company's strategic focus on rare and immune-mediated diseases enhances its attractiveness as a high-potential biotech investment [4]