Roivant Sciences(ROIV)

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Roivant and Priovant to Host Investor Video Conference at 1:00 PM ET on Tuesday, June 17 on Brepocitinib and the Unmet Medical Need in Dermatomyositis
Globenewswire· 2025-06-09 20:05
Core Viewpoint - Roivant and Priovant Therapeutics are hosting a live investor video conference to discuss brepocitinib and its potential impact on patients with dermatomyositis [1] Company Overview - Priovant Therapeutics focuses on developing novel therapies for autoimmune diseases with high morbidity and limited treatment options, with brepocitinib as its lead asset [3] - Brepocitinib is a dual selective inhibitor of TYK2 and JAK1, designed to suppress key cytokines linked to autoimmunity through a single oral therapy [3] - Roivant is a biopharmaceutical company that accelerates the development and commercialization of important medicines, with a diverse pipeline including brepocitinib and other therapies targeting autoimmune conditions [4] Product Development - Brepocitinib has been dosed in over 1,400 subjects and has shown positive results in seven Phase 2 studies, currently being evaluated in Phase 3 trials for dermatomyositis and non-infectious uveitis, and Phase 2 for cutaneous sarcoidosis [3]
Roivant Sciences (ROIV) 2025 Conference Transcript
2025-06-05 21:22
Summary of Roivant Sciences (ROIV) Conference Call Company Overview - Roivant Sciences is a clinical stage biopharma company focused on developing valuable medicines with a portfolio of late-stage programs [4][5] - The company has approximately $5 billion in cash, primarily from a previous transaction involving an anti T1 antibody [6] Key Programs and Pipeline - **Anti FcRn Franchise**: Developed through subsidiary Immunovant, focusing on indications like Graves' disease and myasthenia gravis (MG) [5][59] - **JAK1/TYK2 Inhibitor**: Targeting dermatomyositis, non-infectious uveitis, and cutaneous sarcoidosis [5] - **PHLD Program**: Known as Mosley Siguat, with significant data expected in the near future [5] - Upcoming phase three readout for dermatomyositis expected in the second half of the year, which could lead to a commercial launch [7][24] Market Opportunities - The dermatomyositis market is estimated to have around 40,000 to 70,000 patients, with the potential for Roivant to be the first oral novel medication in this space [27][28] - The company anticipates a significant commercial opportunity, with pricing expected to be competitive with existing therapies like IVIG [52][51] Business Development (BD) Strategy - The current biotech market presents opportunities for Roivant as valuations decrease and expectations shift [11][12] - The company is exploring indication expansions organically, particularly in the FcRn and JAK1/TYK2 areas [13][14] - Roivant is open to various therapeutic areas, including immunology, respiratory, and rare diseases, while being cautious about competitive dynamics in oncology and gene therapy [20] Regulatory and Clinical Considerations - The company is focused on achieving orphan drug designation for its dermatomyositis treatment, which provides benefits in user fees and FDA engagement [41][42] - The primary endpoint for the phase three trial is a statistically significant improvement in the Total Improvement Score (TIS) [30][40] - Placebo effects are a concern, but the company is implementing strategies to mitigate these risks, including a mandatory steroid taper in the trial protocol [34][39] Immunovant and Future Prospects - Immunovant's lead drug, IMG1402, is in pivotal trials for multiple indications, with promising data supporting deeper IgG suppression leading to better clinical outcomes [59][60] - The company aims to redefine success metrics in MG, moving towards deeper clinical responses rather than just baseline improvements [63][65] - Roivant holds a 58% stake in Immunovant and is optimistic about the potential for multiple blockbuster indications [72][74] Legal Matters - Roivant is involved in patent litigation against Pfizer and Moderna regarding their COVID-19 vaccines, with expectations for a trial in the near future [76][77] Conclusion - Roivant Sciences is positioned for significant growth with a robust pipeline and strategic focus on valuable therapeutic areas, while navigating challenges in the current biotech landscape and legal environment [4][11][76]
Roivant Sciences Ltd. (ROIV) Reports Q4 Loss, Lags Revenue Estimates
ZACKS· 2025-05-29 13:16
Group 1: Roivant Sciences Ltd. Performance - Roivant Sciences Ltd. reported a quarterly loss of $0.22 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.16, representing an earnings surprise of -37.50% [1] - The loss per share has improved slightly from a loss of $0.23 per share a year ago [1] - In the previous quarter, the company had a loss of $0.13 per share against an expected loss of $0.24, resulting in a positive surprise of 45.83% [1] Group 2: Montes Archimedes Acquisition Performance - Montes Archimedes Acquisition reported revenues of $7.57 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 88.76%, and down from $28.93 million year-over-year [2] - The company has surpassed consensus revenue estimates two times over the last four quarters [2] - The stock has underperformed, losing about 10.2% since the beginning of the year compared to the S&P 500's gain of 0.1% [3] Group 3: Earnings Outlook and Estimates - The current consensus EPS estimate for Montes Archimedes Acquisition is -$0.25 on revenues of $3.89 million for the coming quarter, and -$1.01 on revenues of $28.53 million for the current fiscal year [7] - The estimate revisions trend for the company is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the top 30% of Zacks industries, which historically outperforms the bottom 50% by a factor of more than 2 to 1 [8] Group 4: Industry Context - Beyond Air, Inc., another company in the same industry, is expected to report a quarterly loss of $0.14 per share, reflecting a year-over-year change of +61.1%, with revenues expected to be $1.39 million, up 195.7% from the year-ago quarter [9]
Roivant Sciences(ROIV) - 2025 Q4 - Earnings Call Transcript
2025-05-29 13:02
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, which is considered 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 and IMG1402, with significant clinical execution and progress across all main clinical franchises [7][8] - Brevacitinib is expected to be a market therapy within the next couple of years, with pivotal studies ongoing in multiple indications [8][12] - The company has initiated studies in dermatomyositis and cutaneous sarcoidosis, with data readouts expected in the near future [14][18] 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 [40] - The estimated market for dermatomyositis is between 40,000 to 70,000 patients in the U.S., with approximately 34,000 currently treated [100] Company Strategy and Development Direction - The company aims to capitalize on its strong cash position to drive profitability and pipeline expansion, with $2 billion reserved for future opportunities [11][12] - The focus is on indications with high unmet needs and potential for first-in-class therapies, particularly in the FcRn space [19][88] - The company is preparing for a busy data generation period over the next 36 months, with multiple potential blockbuster launches anticipated [10][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts and the potential for significant market opportunities, particularly in immunology [10][31] - The company acknowledges the challenging market environment but feels well-positioned compared to peers [12][35] - Management emphasized the importance of capital allocation and the strategic focus on high unmet medical needs [11][12] Other Important Information - The company is in the summary judgment phase of its LNP litigation against Moderna and Pfizer, with a trial expected to follow [32][34] - The company is also awaiting a ruling in the Pfizer case, which is anticipated later this year [51] 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 in the DM study [39][40] Question: Can you provide an update on the LNP litigation against Moderna? - Management noted that narrowing the case is a normal part of patent litigation and that parameters will be evident in the near future [43][44] Question: What is the status of the pending Pfizer Markman decision? - Management stated that the timing of the Markman decision is at the judge's discretion and is hopeful for a ruling later this year [51] Question: How is the company planning to position Brevacitinib if approved? - Management views the entire market as addressable and believes many patients represent low-hanging fruit due to the lack of options [60] Question: What are the expectations for the placebo response in the DM study? - Management referenced published data from similar studies that showed a well-behaved placebo response, which is encouraging [70] Question: What is the observable population for dermatomyositis in the U.S.? - Management estimates the DM market to be between 40,000 to 70,000 patients, with around 34,000 currently treated [100]
Roivant Sciences(ROIV) - 2025 Q4 - Earnings Call Transcript
2025-05-29 13:00
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]
Roivant Sciences(ROIV) - 2025 Q4 - Annual Report
2025-05-29 11:53
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].
Roivant Sciences(ROIV) - 2025 Q4 - Annual Results
2025-05-29 11:33
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].
Roivant Sciences(ROIV) - 2025 Q4 - Earnings Call Presentation
2025-05-29 11:05
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]
Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025, and Provides Business Update
Globenewswire· 2025-05-29 11:00
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]
Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025 and Provide Business Update on Thursday, May 29, 2025
Globenewswire· 2025-05-15 20:10
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]