Roivant Sciences (NasdaqGS:ROIV) 2025 Investor Day December 11, 2025 08:00 AM ET Company ParticipantsNone - Video Narrator 3Lindsay Androski - CEONone - Video Narrator 5Matt Gline - CEOUmer Raffat - Senior Managing DirectorNone - Video Narrator 9Richard Pulik - CFONone - Video Narrator 6None - Video Narrator 1None - Video Narrator 10Frank Torti - Vant ChairBen Zimmer - CEONone - Video Narrator 4Iris Gao - Equity Research Senior AssociateNone - Video Narrator 7Eric Venker - PresidentCorinne Jenkins - VPNone ...

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]

Core Insights - Pulmovant has received orphan drug designation for mosliciguat from Japan's Ministry of Health, Labour and Welfare, highlighting the significant unmet medical need for patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) [1][2] - Mosliciguat is a novel, once-daily, inhaled soluble guanylate cyclase (sGC) activator currently in Phase 2 clinical trials, aiming to provide a targeted treatment option for PH-ILD [1][3] Company Overview - Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases and is a subsidiary of Roivant [7] - The company’s lead candidate, mosliciguat, is designed to be a first-in-class inhaled treatment for PH-ILD, with a differentiated mechanism of action [7][5] Clinical Development - Mosliciguat is currently being evaluated in the Phase 2 PHocus clinical study, which is a randomized, double-blind, placebo-controlled trial involving approximately 120 adult patients [3][6] - The Phase 1b ATMOS study demonstrated that inhaled mosliciguat was well tolerated and resulted in a mean peak reduction in pulmonary vascular resistance (PVR) of up to 38% [5] Market Context - PH-ILD is a progressive and life-threatening condition affecting up to 200,000 patients in the U.S. and Europe, with limited or no approved treatment options available [4] - The orphan drug designation provides Pulmovant with regulatory benefits, including priority consultation and up to 10 years of market exclusivity post-approval [2][6]

Business Highlights - Roivant completed a $1.5 billion share repurchase program in June 2025, repurchasing approximately 149 million shares at an average price of $10.09, reducing the share count by over 15%[23] - The company expanded its pipeline by initiating 6 potentially registrational studies and 3 proof-of-concept (POC) studies[23] - Roivant increased shareholder exposure to clinical and litigation catalysts over the next 36 months[23] Brepocitinib Program - Topline data from the Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is expected in the second half of 2025[20, 27] - The VALOR study enrolled 241 adults with active DM, with 38% from the US, 32% from the EU, and 30% from the rest of the world[35] - Approximately 40% of subjects taking oral corticosteroids (OCS) at baseline in the VALOR study were able to eliminate OCS entirely by the end of the study[45] LNP Litigation - Summary judgment phase is ongoing in the US Moderna case, with a jury trial scheduled for March 2026[18, 27, 52] - Ongoing progress is expected in the Pfizer/BioNTech case following the Markman hearing, with a decision potentially in 2025[18, 27, 52] Financial Update - Research and development (R&D) expense was $153 million, with an adjusted R&D expense of $141 million (non-GAAP)[58] - General and administrative (G&A) expense was $134 million, with an adjusted G&A expense of $63 million (non-GAAP)[58] - Roivant had $4.5 billion in cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2025[58]

Core Insights - Roivant reported financial results for Q1 ended June 30, 2025, highlighting clinical progress and a completed $1.5 billion share repurchase program [1][2] - The company is preparing for the potential launch of brepocitinib, which targets high unmet medical needs [2][4] Recent Developments - The VALOR Phase 3 study for brepocitinib in dermatomyositis is on track for topline data readout in H2 2025, with the last patient visit completed in July [4][5] - Rapid enrollment is ongoing for brepocitinib in non-infectious uveitis and cutaneous sarcoidosis, with readouts expected in H1 2027 and H2 2026, respectively [4][5] - Immunovant initiated two potentially registrational studies for IMVT-1402 in Graves' disease and Sjögren's disease in June 2025 [5] Financial Summary - As of June 30, 2025, Roivant had consolidated cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.5 billion [6][8] - Research and development expenses increased by $32.4 million to $152.9 million compared to the same period in 2024, driven by program-specific costs and personnel-related expenses [9][10] - General and administrative expenses rose by $34.1 million to $134.0 million, primarily due to increased share-based compensation [12][14] Share Repurchase Program - Roivant completed its initial $1.5 billion share repurchase program, including $208 million in repurchases for the quarter, reducing outstanding shares by over 15% from March 31, 2024 [4][6] - A new $500 million share repurchase program was approved by the board in June 2025 [6] Upcoming Milestones - Topline data from the ongoing Phase 3 trial of brepocitinib in dermatomyositis is expected in H2 2025 [13] - Remission data from the batoclimab proof-of-concept study in Graves' disease will be reported at the American Thyroid Association Annual Meeting in September 2025 [13]