Financial Data and Key Metrics Changes - The company reported just under $5 billion in cash on the balance sheet as of March 31, 2025, with no debt [11][35] - The net cash usage for the quarter was approximately $150 million to $160 million, indicating a normal quarter for the business [35] - The company has repurchased $1.3 billion of its own stock, reducing the share count by nearly 15% [11][35] Business Line Data and Key Metrics Changes - The company is focused on multiple late-stage pipeline products, including brevacitinib for dermatomyositis and IMG1402 for various indications, with significant clinical execution and progress [6][7] - Brevacitinib is expected to be a first novel oral drug for dermatomyositis, with data anticipated in the second half of 2025 [5][12] - The company has multiple registrational studies ongoing, with potential for six or more blockbuster launches in the coming years [7][10] Market Data and Key Metrics Changes - The company is addressing a patient population with high unmet needs, particularly in dermatomyositis, where the only approved therapy is IVIG, which has significant liabilities [40] - The total addressable market for dermatomyositis is estimated to be between 40,000 to 70,000 patients, indicating potential for growth as treatment options improve [92] Company Strategy and Development Direction - The company is focused on capital allocation to support its pipeline to profitability, with $2 billion reserved for pipeline expansion and business development opportunities [11][12] - The company aims to maintain a leadership position in the FcRn category by prioritizing indications with high unmet needs and potential for best-in-class therapies [18][21] - The company is preparing for a busy data generation period over the next 36 months, with multiple potential blockbuster indications [10][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts, particularly for brevacitinib and IMG1402, which are expected to meet high expectations [10][30] - The company acknowledges the challenging market environment for many peers but feels well-positioned due to its strong capital position and pipeline [12][35] - Management highlighted the importance of data generation in driving future growth and patient outcomes [30] Other Important Information - The company is in the summary judgment phase of its LNP litigation against Moderna and Pfizer, with expectations for trial dates to be set soon [32][34] - The company is also awaiting a ruling in the Pfizer case, which is anticipated later this year [51][52] Q&A Session Summary Question: What are the expectations for the DM study? - Management indicated that a positive study with statistically significant separation from placebo is necessary for success, given the high unmet need in the patient population [39][40] Question: Can you provide an update on the LNP litigation? - Management stated that narrowing the case is a normal part of patent litigation, and parameters will be evident in the near future [44][46] Question: What are the plans for the upcoming readouts in 2026? - Management noted that both the open-label RA trial and the phase two CLE trial are designed to inform future program decisions, with a focus on safety and efficacy [53][55] Question: How will Brevacitinib be positioned if approved? - Management believes the entire market is addressable, with many patients being low-hanging fruit due to the lack of options [58][59] Question: What are the expectations for the placebo arm in the DM study? - Management referenced published data from similar studies that showed a well-behaved placebo arm, which is encouraging for their upcoming trial [66][67]

Financial Transactions - Roivant completed the sale of Dermavant to Organon for up to approximately $1.2 billion, including an upfront payment of $175 million and a $75 million milestone payment for FDA approval of VTAMA[36]. - Roivant repurchased a total of 128 million common shares for $1.3 billion, reducing common shares outstanding by 14% from March 31, 2024[36]. - Roivant received cash consideration of $183.6 million from the Dermavant Transaction, with an additional $75.0 million expected upon FDA approval of VTAMA for atopic dermatitis[54]. - Roivant is entitled to milestone payments of up to $950 million based on tiered net sales of VTAMA, with royalties ranging from low-to-mid single digit percentages for sales up to $1 billion and 30% for sales above $1 billion[54]. - Priovant paid Pfizer $10 million for a license agreement to develop and commercialize brepocitinib and TYK2 compounds[127]. - Priovant is obligated to pay Pfizer a mid tens-of-millions sales milestone payment if net sales exceed a mid hundreds-of-millions amount[128]. - Pulmovant made an initial payment of approximately $14 million to Bayer under a license agreement, with potential total payments of up to $280 million based on milestones[140]. Clinical Development and Pipeline - Brepocitinib showed potential best-in-indication results in the Phase 2 NEPTUNE study for non-infectious uveitis, with a treatment failure rate of only 35% at 12 months for the 45 mg dose arm[36]. - Batoclimab met its primary endpoint in the Phase 3 study for myasthenia gravis, achieving a 5.6 point mean improvement and a 93% MG-ADL Response Rate[40]. - Six INDs cleared for IMVT-1402, with studies initiated in five indications, including potentially registrational trials in Graves' disease and myasthenia gravis[40]. - Mosliciguat demonstrated up to approximately 38% reductions in pulmonary vascular resistance in the Phase 1b ATMOS study, with a Phase 2 study initiated for PH-ILD[40]. - Brepocitinib has shown statistically significant efficacy in multiple Phase 2 studies, including a 49.18% placebo-adjusted improvement in the SALT score for alopecia areata[61]. - The ongoing Phase 3 study of brepocitinib in dermatomyositis has enrolled 241 subjects, with topline data expected in the second half of 2025[69]. - The Phase 3 program for non-infectious uveitis has been initiated, with topline data anticipated in the first half of 2027[69]. - The company plans to initiate a potentially registrational trial for IMVT-1402 in Sjögren's disease (SjD) and a second trial in Graves' disease in the summer of 2025[97]. - The company has ongoing trials for IMVT-1402, with topline data expected in 2026 for several indications, including rheumatoid arthritis and myasthenia gravis[74]. Market and Patient Needs - The estimated prevalence of Graves' disease (GD) patients in the U.S. is approximately 880,000, with around 330,000 patients having relapsed on antithyroid drugs (ATDs) and opting not to pursue ablation[76]. - Myasthenia Gravis (MG) has an estimated prevalence of 59,000 to 116,000 cases in the U.S., with 35% of patients not well-controlled on current standard care, representing about 20,000 to 35,000 patients with significant unmet medical needs[77]. - The estimated prevalence of Chronic Cutaneous Lupus Erythematosus (CCLE) and Subacute Cutaneous Lupus Erythematosus (SCLE) is approximately 153,000 in the U.S., with about 50% of patients not adequately responding to first-line therapies, representing around 75,000 patients with significant unmet medical needs[81]. - The estimated prevalence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is approximately 58,000 patients in the U.S., with around 30% inadequately controlled on treatment, representing about 16,000 patients with significant unmet medical needs[79]. - The estimated prevalence of severe Rheumatoid Arthritis (RA) in the U.S. is approximately 490,000, with about 15% being autoantibody positive and inadequately responding to prior treatments, representing around 70,000 patients with significant unmet medical needs[86]. - PH-ILD is estimated to affect up to 200,000 patients in the U.S. and E.U., with a significant unmet need for new drugs[113]. Regulatory and Compliance - The FDA regulates drug approvals under the FDCA and PHSA, requiring substantial time and financial resources for compliance[164]. - The NDA or BLA process requires extensive preclinical and clinical testing, with no guarantee of timely approval[165]. - Clinical trials are conducted in three phases, with Phase 3 trials designed to demonstrate product effectiveness and safety[171]. - The FDA targets ten months for the initial review of a new molecular entity NDA or original BLA, and six months for priority review applications[179]. - The FDA may issue a Complete Response Letter detailing deficiencies in an NDA or BLA, which may require additional clinical data or trials[181]. - Orphan drug designation is granted for products intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S.[182]. - The FDA's fast-track program allows rolling review of sections of an NDA or BLA for products addressing serious conditions[186]. - Priority review reduces the FDA's target action date to six months for new molecular entity NDAs or original BLAs[187]. - Accelerated approval may be granted if a product shows meaningful advantages over existing therapies and meets specific criteria[188]. - Breakthrough therapy designation expedites development and review for products showing substantial improvement over existing therapies[189]. - The FDA requires manufacturers to comply with cGMP regulations for the production of clinical quantities of product candidates, which includes quality control and assurance measures[196]. - The FDA may impose restrictions on marketing or manufacturing, including suspension or withdrawal of product approval, if compliance with regulatory standards is not maintained[201]. Intellectual Property and Licensing - Genevant has over 550 issued patents and pending applications worldwide, focusing on nucleic acid delivery technologies[121]. - Genevant's LNP technology is included in the first FDA-approved systemic RNA-LNP product, Alnylam's Onpattro[129]. - Genevant has licensed rights to six patent families for brepocitinib, including at least 176 issued patents and 62 pending applications, expected to expire as early as 2035[148]. - ISG's in-licensed patent portfolio includes a patent family covering batoclimab with pending applications and issued patents in multiple countries, potentially expiring in 2035[149]. - ISG jointly owns rights to a patent family covering IMVT-1402, with a U.S. patent issued on March 12, 2024, potentially expiring in 2043[152]. - Pulmovant, Inc. holds exclusive rights to five patent families for mosliciguat, with 84 issued patents and 70 pending applications, expected to expire between 2033 and 2042[159]. - Genevant has licensed 28 patent families containing 463 issued patents and 108 pending applications, expected to expire between June 2025 and 2041[161]. Legislative and Market Environment - The ACA increased pharmaceutical manufacturers' rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs to 23.1% of average manufacturer price (AMP)[217]. - The Inflation Reduction Act (IRA) includes a drug price negotiation program for certain high-spend Medicare drugs, capping prices by a "maximum fair price"[222]. - The IRA imposes new manufacturer rebate obligations on certain drugs whose prices increase faster than inflation, potentially increasing government discount and rebate liabilities[222]. - The ACA established a new Patient-Centered Outcomes Research Institute to conduct comparative clinical effectiveness research, which may affect the market for certain pharmaceutical products[221]. - The Medicare sequester reductions under the Budget Control Act could trigger up to a 4% reduction in Medicare payments starting January 2025 if certain conditions are met[220]. - The American Rescue Plan Act of 2021 eliminated the Medicaid unit rebate AMP cap effective January 1, 2024, which could significantly impact Medicaid rebate liability for future products[220]. - The federal Physician Payments Sunshine Act requires manufacturers to report certain payments or transfers of value made to healthcare professionals, with extended obligations effective January 1, 2022[212]. - The company is subject to increasing scrutiny from federal and state enforcement bodies regarding compliance with healthcare laws, which could lead to significant penalties[215]. - Legislative changes and regulatory challenges to the ACA and other healthcare laws may continue to exert pressure on pharmaceutical pricing and profitability[218].

Financial Performance - Roivant reported consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $4.9 billion as of March 31, 2025[10]. - Revenue for the three months ended March 31, 2025, was $7,570 million, a decrease of 16.0% compared to $9,020 million for the same period in 2024[29]. - The net loss attributable to Roivant Sciences Ltd. for the three months ended March 31, 2025, was $206,475 million, compared to a net loss of $151,115 million for the same period in 2024[29]. - Loss from continuing operations, net of tax was $252.4 million for Q4 2025, compared to $95.0 million for Q4 2024, with a per share loss of $0.29[23]. - For the fiscal year ended March 31, 2025, loss from continuing operations was $729.8 million, compared to income of approximately $4.5 billion for the previous year[24]. Research and Development Expenses - Research and development (R&D) expenses increased by $37.7 million to $145.2 million for Q4 2025, compared to $107.6 million for Q4 2024, driven by program-specific costs and personnel-related expenses[11]. - For the fiscal year ended March 31, 2025, R&D expenses rose by $110.5 million to $550.4 million, primarily due to increases in program-specific costs and personnel-related expenses[13]. - Research and development expenses for the three months ended March 31, 2025, were $145,238 million, up 35.0% from $107,555 million in the prior year[31]. General and Administrative Expenses - General and administrative (G&A) expenses increased by $39.0 million to $147.1 million for Q4 2025, compared to $108.1 million for Q4 2024, mainly due to share-based compensation expenses[18]. - For the fiscal year ended March 31, 2025, G&A expenses increased by $175.3 million to $591.4 million, largely driven by share-based compensation and personnel-related expenses[20]. Share Repurchase and Outstanding Shares - Roivant repurchased $1.3 billion of the company's shares as of March 31, 2025, reducing outstanding shares by 14% from March 31, 2024[4]. - The weighted average shares outstanding for the three months ended March 31, 2025, were 707,298,861, compared to 802,859,062 for the same period in 2024[29]. Future Plans and Expectations - The company expects topline data from the ongoing Phase 3 trial of brepocitinib in dermatomyositis in the second half of calendar year 2025[9]. - Immunovant plans to initiate potentially registrational trials for IMVT-1402 in Sjögren's disease and Graves' disease in summer 2025[9]. - The company plans to host a live conference call on May 29, 2025, to report its financial results and provide a corporate update[35]. Pipeline and Corporate Strategy - Roivant's pipeline includes several product candidates, including brepocitinib and IMVT-1402, targeting various autoimmune indications[37]. - The company aims to improve patient lives by accelerating the development and commercialization of important medicines[37]. Risks and Uncertainties - The company acknowledges that actual results may differ materially from forward-looking statements due to various risks and uncertainties[40]. - Management's expectations and beliefs are based on current conditions and may change as new information becomes available[40]. - The company operates in a competitive and rapidly changing environment, which introduces new risks over time[40].

Business Updates - Roivant expects topline data for Brepocitinib in Dermatomyositis (DM) in the second half of 2025 [18, 28, 30, 70] - Immunovant anticipates topline results from Phase 3 trials of Batoclimab in Thyroid Eye Disease (TED) in the second half of 2025 [15, 18, 70] - Immunovant's IMVT-1402 has the potential to reach approximately 80% IgG reduction with continued weekly dosing of 600 mg [37] - Roivant is initiating a potentially registrational trial for IMVT-1402 in Sjögren's Disease (SjD) in Summer 2025 [18, 37, 51, 58] - A potentially registrational trial for IMVT-1402 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is actively enrolling [15, 18, 37, 52, 58] Financial Highlights - Roivant reported cash, cash equivalents, restricted cash, and marketable securities of $4.9 billion as of March 31, 2025 [25, 65] - The company repurchased 1284 million common shares for $13 billion in the fiscal year ended March 31, 2025 [26, 65] - For the year ended March 31, 2025, Roivant's revenue was $29 million, with an adjusted R&D expense of $508 million and an adjusted G&A expense of $348 million [65, 66] - The adjusted loss from continuing operations, net of tax, for the year ended March 31, 2025, was $624 million [65, 66] LNP Litigation - A US jury trial in the Moderna case is pending, with the summary judgment phase expected in the second or third quarter of 2025 [16, 62] - Ongoing progress is expected in the Pfizer/BioNTech case following the Markman hearing held in December 2024, with a ruling potentially in 2025 [16, 62, 70]

Core Insights - Roivant reported financial results for the fourth quarter and fiscal year ended March 31, 2025, highlighting significant progress in its clinical pipeline and financial position [1][34] - The company is focused on advancing its late-stage clinical programs, particularly brepocitinib and IMVT-1402, with several upcoming milestones expected in 2025 and 2026 [2][8] Financial Summary - As of March 31, 2025, Roivant had cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.9 billion, supporting its cash runway into profitability [9][14] - Research and development (R&D) expenses for the fourth quarter increased by $37.7 million to $145.2 million compared to the same period in 2024, driven by program-specific costs and personnel-related expenses [10][11] - For the fiscal year ended March 31, 2025, R&D expenses rose by $110.5 million to $550.4 million, primarily due to increases in program-specific costs and personnel-related expenses [12][13] - General and administrative (G&A) expenses for the fourth quarter increased by $39.0 million to $147.1 million, largely due to share-based compensation expenses [17][19] - The company reported a loss from continuing operations of $252.4 million for the fourth quarter, compared to a loss of $95.0 million in the same quarter of the previous year [22] Clinical Developments - Roivant's brepocitinib program is progressing well, with rapid enrollment in a Phase 3 study for non-infectious uveitis and a proof-of-concept trial for cutaneous sarcoidosis [5][6] - Immunovant announced positive results from its batoclimab studies, with significant improvements in Myasthenia Gravis Activities of Daily Living scores and responder rates in chronic inflammatory demyelinating polyneuropathy [4][6] - The company is actively enrolling potentially registrational trials for IMVT-1402 in multiple indications, including Graves' disease and Sjögren's disease, expected to start in summer 2025 [5][7] Share Repurchase and Equity - Roivant repurchased $1.3 billion of its shares as of March 31, 2025, reducing outstanding shares by 14% from the previous year [14][21] - The company reported a net loss attributable to Roivant of $206.5 million for the fourth quarter, compared to a net loss of $151.1 million in the same quarter of the previous year [28]

Company Overview - Roivant is a biopharmaceutical company focused on improving patient lives by accelerating the development and commercialization of important medicines [3] - The company's pipeline includes several product candidates such as IMVT-1402 and batoclimab for autoimmune indications, brepocitinib for various inflammatory conditions, and mosliciguat for pulmonary hypertension [3] Upcoming Events - Roivant will host a live conference call and webcast on May 29, 2025, at 8:00 a.m. ET to report its financial results for the fourth quarter and fiscal year ended March 31, 2025, and to provide a business update [1] Access Information - Interested parties can access the conference call by registering online, with details available on Roivant's investor website [2]

Summary of Roivant Sciences (ROIV) Conference Call Company Overview - **Company**: Roivant Sciences (ROIV) - **Event**: BofA Annual Healthcare Conference - **Date**: May 14, 2025 Key Points Immunovant and Clinical Focus - Roivant is transitioning its focus to IVD 1402, a next-generation program, after late-stage studies in betoclimab for MG and CIDP [8] - Eric Vanker has taken over as CEO of Immunovant, emphasizing patient enrollment in Graves' disease as the top priority [9] - Graves' disease is identified as a unique opportunity with a large patient population and high unmet need [11] Market Dynamics and Patient Population - Approximately 350,000 Graves' patients in the US are refractory to current treatments, primarily methimazole [25] - The current treatment landscape for Graves' disease has not seen a novel drug in 70 years, creating a significant opportunity for Roivant [29] - The company aims to address the operational challenges of enrolling patients in clinical trials due to the lack of recent novel therapies [30] Value Proposition of Therapy - The therapy aims to improve patient quality of life by reducing reliance on methimazole and potentially achieving drug-free remission [36] - Evidence from phase two data shows that 76% of patients on high doses achieved T3 and T4 normalization, with 56% able to discontinue anti-thyroid drugs [46] - The company is also exploring the potential to reduce the onset of Thyroid Eye Disease (TED) in hyperthyroid patients with proptosis [38] Regulatory and Clinical Trial Insights - The FDA has shown enthusiasm for new therapies in Graves' disease, indicating a supportive regulatory environment [51] - The first GRAVE study will treat patients for six months before randomization to assess remission rates [41] - The company is optimistic about the potential for accelerated approval based on positive clinical outcomes [85] Myasthenia Gravis (MG) and CIDP Challenges - Roivant acknowledges the challenges of entering the MG market, dominated by Argenx, and recognizes the need for deeper clinical data to compete effectively [58] - The company aims to shift the focus in MG from treatment response to deeper remission endpoints, which could favor their drug's profile [61] Dermatomyositis and Other Programs - Roivant is preparing for a phase three trial in dermatomyositis, with expectations for regulatory approval based on statistical significance [78] - The company is also developing a pulmonary hypertension program, with data expected in the second half of next year [87] Legal Matters - Roivant is involved in litigation regarding intellectual property related to lipid nanoparticles used in COVID vaccines, with a jury trial scheduled for September 2025 [90] - Potential damages from the case could be substantial, given the scale of global COVID vaccine sales [93] Additional Insights - The company is focused on executing its current indications before exploring new opportunities, indicating a disciplined approach to R&D investment [66] - Roivant is evaluating its pipeline continuously and may announce new indications as they progress [66] This summary encapsulates the key discussions and insights from the Roivant Sciences conference call, highlighting the company's strategic focus, market opportunities, and ongoing challenges in the biopharmaceutical landscape.

Corporate Strategy & Leadership - Eric Venker, MD, was appointed CEO, and Tiago Girao was appointed CFO, signaling a management transition[12] - Immunovant is focused on executing in six announced indications currently underway, including Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE)[12] - The current cash balance provides runway for announced indications into Graves' readout expected in 2027[11] IMVT-1402 Clinical Development & Potential - IMVT-1402 is expected to reach approximately 80% IgG reduction with continued weekly dosing of 600 mg, based on Phase 1 data[20] - A potentially registrational trial for IMVT-1402 in Sjögren's Disease (SjD) is expected to start in Summer 2025[12, 20] - A proof-of-concept study in Cutaneous Lupus Erythematosus (CLE) has been initiated for IMVT-1402, with early positive data[12, 20] - IMVT-1402 has strong patent protection covering composition of matter, method of use, and methods for manufacturing to 2043[20] Market Opportunity & Competitive Landscape - Approved FcRn products generated over $2.4 billion in net sales in their second year post-launch, more than double TNF agents at a similar timepoint[22] - In the US, approximately 90,000 people with Sjögren's Disease with anti-Ro/SSA antibodies represent a target addressable population[26, 38] - In the US, approximately 75,000 people with Cutaneous Lupus Erythematosus uncontrolled on standard of care represent a target addressable population[26, 49] - Up to 50% of SCLE/CCLE patients failing standard of care, represent an untapped market opportunity[54]

NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced next phase of growth including changes to its leadership team and the expanded development of IMVT-1402 into two new indications, SjD and CLE. Eric Venker, M.D., Roivant's President and an Immunovant Director, has been appointed as Immunovant's CEO. Dr. Venker brings over two decades of clinical practice and ...

Core Insights - Immunovant, Inc. is entering a new growth phase with leadership changes and expanded development of IMVT-1402 into Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) [1][2] Leadership Changes - Eric Venker, M.D. has been appointed as the new CEO of Immunovant, bringing over 20 years of clinical and operational experience [2][6] - Pete Salzmann, M.D. has retired from his role as CEO and Director, while Tiago Girao has been appointed as the new CFO [2][6] - The board of directors has seen changes with George Migausky stepping down and Robert Susman and Jacob Bauer joining [3] Strategic Transition - The leadership changes are part of a broader strategic transition, with Roivant increasing its operational involvement and oversight of Immunovant [2][6] - Development activities for batoclimab are concluding, while those for IMVT-1402 are ramping up [2][6] Clinical Development Updates - The IND for IMVT-1402 in SjD has been cleared, marking it as the fifth indication for the drug, with a study expected to initiate in summer 2025 [6] - A proof-of-concept study for IMVT-1402 in CLE has been initiated, based on promising efficacy data from previous studies [6] - Current cash reserves are sufficient to support the announced indications through the expected readout for Graves' Disease in 2027 [6] Market Needs - Sjögren's Disease is characterized by severe dryness and has no approved therapies specifically targeting it, indicating a significant market opportunity for new treatments [7] - Cutaneous Lupus Erythematosus (CLE) has a high unmet need, with up to 50% of patients not optimally managed by existing therapies, and no new therapies approved in over 50 years [8]