BASEL, Switzerland and LONDON and NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 29, 2025, to report its financial results for the fourth quarter and fiscal year ended March 31, 2025, 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 & Present ...

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.

Immunovant Corporate Update 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 allocation, research and development p ...

Core Insights - Immunovant, Inc. reported positive topline results from its Phase 3 study of batoclimab in Myasthenia Gravis (MG) and initial results from its Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [1][2] Phase 3 Study in MG - The Phase 3 study was a randomized, quadruple-blind, placebo-controlled trial assessing batoclimab's efficacy and safety in adults with moderate to severe MG [3] - The primary endpoint was the mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12, with significant improvements observed in both dosing arms [8] - The higher dose (680mg weekly) achieved a 5.6 point improvement in MG-ADL with a 74% mean IgG reduction, while the lower dose (340mg weekly) showed a 4.7 point improvement with a 64% mean IgG reduction [7][8] Phase 2b Study in CIDP - The Phase 2b study is also a randomized, quadruple-blind, placebo-controlled trial designed to evaluate batoclimab's efficacy and safety in active CIDP [4] - Initial results from Period 1 indicated a mean improvement of 1.8 points in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score, with an 84% responder rate among patients achieving an IgG reduction greater than 70% [9] Efficacy and Safety Results - In the MG study, deeper IgG reductions correlated with better clinical outcomes across various assessments [7] - Safety and tolerability profiles were consistent with previous batoclimab studies, indicating a favorable safety profile [10] Future Plans - Immunovant plans to initiate potentially registrational studies for both MG and CIDP with its lead asset IMVT-1402, having received clearance for Investigational New Drug (IND) applications [11] - The company does not intend to seek regulatory approval for batoclimab in MG or CIDP at this time, focusing instead on leveraging data from these studies to inform its programs with IMVT-1402 [12]

Group 1 - Immunovant, Inc. will host an investor webcast on March 19, 2025, at 8:00 a.m. ET to review results from its Phase 3 study of batoclimab in myasthenia gravis (MG) and initial results from its Phase 2b study in chronic inflammatory demyelinating polyneuropathy (CIDP) [1] - The webcast will feature Pete Salzmann, M.D., MBA, Chief Executive Officer of Immunovant, alongside Matt Gline, Chief Executive Officer of Roivant [2] - The live webcast will be accessible on Roivant's investor website, with an archived version available post-event [3] Group 2 - Roivant is a biopharmaceutical company focused on accelerating the development and commercialization of impactful medicines, with a pipeline that includes IMVT-1402 and batoclimab targeting autoimmune diseases, brepocitinib for dermatomyositis and other conditions, and mosliciguat for pulmonary hypertension [4]

Core Viewpoint - Roivant Sciences Ltd. has successfully replaced the entire Board of Directors of Arbutus Biopharma Corporation, following a request from Roivant's CEO, Matthew Gline, and now holds 20.5% of Arbutus's common shares [1][2]. Group 1: Board Restructuring - On February 21, 2025, Roivant's CEO requested the resignation of all members of Arbutus's Board of Directors, which was agreed upon, leading to their resignation on February 24, 2025 [2]. - The number of directors has been reduced from seven to five, with new members including Lindsay Androski, Robert Alan Beardsley, Joseph Bishop, Matthew Gline, and Anuj Hasija [2]. - Lindsay Androski has been appointed as President and CEO of Arbutus, with Ms. Androski, Mr. Gline, and Mr. Bishop being employees of Roivant Sciences, Inc. [2]. Group 2: Ownership and Future Actions - Roivant currently owns 38,847,462 shares of Arbutus, representing 20.5% of the total common shares [1]. - Roivant may consider purchasing additional securities of Arbutus or disposing of its holdings based on various factors including Arbutus's business prospects and market conditions [3]. - The company reserves the right to adjust its holdings in Arbutus at its discretion [3]. Group 3: Regulatory Compliance - The news release is issued under the early warning provisions of Canadian securities legislation, with an Early Warning Report to be filed by Roivant [5]. - A copy of the Early Warning Report will be available on Arbutus's SEDAR+ profile [5].

Core Viewpoint - Roivant Sciences Ltd. (ROIV) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook driven by an upward trend in earnings estimates [1] Group 1: Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which significantly influence stock prices [4] - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4] - Montes Archimedes Acquisition's rating upgrade reflects an improvement in its underlying business, likely pushing its stock price higher [5] Group 2: Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with a strong historical performance of Zacks Rank 1 stocks averaging a +25% annual return since 1988 [7] - The system maintains a balanced distribution of 'buy' and 'sell' ratings across over 4000 stocks, ensuring that only the top 20% receive a 'Strong Buy' or 'Buy' rating [9][10] Group 3: Specific Company Insights - Montes Archimedes Acquisition is projected to earn -$0.64 per share for the fiscal year ending March 2025, reflecting a year-over-year change of 33.3% [8] - Over the past three months, the Zacks Consensus Estimate for Montes Archimedes Acquisition has increased by 23.1%, indicating a positive trend in earnings estimates [8]

Financial Results and Business Update for the Quarter Ended December 31, 2024 February 10, 2025 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 positio ...

Financial Data and Key Metrics Changes - The company reported a cash balance of $5.2 billion as of December 31, 2024, which includes $500 million authorized for additional share buybacks and $1 billion bought back so far [12][43] - R&D expenses were reported at $142 million, adjusted to $131 million, while G&A expenses were also $142 million, adjusted to $71 million [42] Business Line Data and Key Metrics Changes - The company is focused on clinical execution, with six INDs cleared at Abutavant, and trials beginning or initiated by March 2026 [9][10] - A new indication for brepasitinib in cutaneous sarcoidosis has been initiated, with a proof of concept study expected to provide data in the second half of next year [14][26] Market Data and Key Metrics Changes - The company anticipates significant data releases in 2025, including results from MG and CIDP studies, which are expected to bolster confidence in their clinical outcomes [27][28] - The competitive landscape in dermatomyositis is evolving, with the company positioned to potentially be the first to market with a new mechanism if their data is successful [102] Company Strategy and Development Direction - The company aims to validate its API CRM franchise as a best-in-class franchise, with multiple important milestones set for 2025 [6][7] - The strategy includes focusing on indications with high unmet needs tailored to their unique mechanism, particularly in orphan immunology [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2025 being a pivotal year with numerous important milestones, including a jury trial scheduled for September regarding LNP litigation with Moderna and Pfizer BioNTech [7][41] - The management highlighted the potential for ten or more blockbuster launches in the future, driven by their robust pipeline and cash position [11][12] Other Important Information - The company has removed all debt following the sale of dermaVant to Organon, receiving approximately $259 million [12][43] - The company is actively evaluating additional indications for brepasitinib, with a focus on competitive dynamics and patient population size [110][114] Q&A Session Summary Question: Can you review the bateclimab efficacy bars for success ahead of the release of results? - Management indicated that they are looking for a clear dose response between the two doses, which would provide confidence for future studies [49][50] Question: Can you discuss the LNP litigation and the range of outcomes? - Management noted that there could be a range of outcomes regarding liability, depending on the court's interpretation of the contracts involved [55][62] Question: What are the expectations for the BREPO Phase three readout and the competitive landscape? - Management expressed confidence in their positioning, stating that if successful, they would be ahead of any competitors in dermatomyositis [102][103]

Financial Performance - Revenue for the three months ended December 31, 2024, was $9,018 thousand, down 42.3% from $15,562 thousand for the same period in 2023[28]. - Net income attributable to Roivant Sciences Ltd. for the three months ended December 31, 2024, was $169,381 thousand, a decrease of 96.7% compared to $5,096,184 thousand for the same period in 2023[28]. - The company reported a net loss from continuing operations of $208,945 thousand for the three months ended December 31, 2024, compared to a net income of $5,131,180 thousand for the same period in 2023[28]. - Comprehensive income attributable to Roivant Sciences Ltd. for the three months ended December 31, 2024, was $195,474 thousand, compared to $5,071,472 thousand for the same period in 2023[31]. - For the nine months ended December 31, 2024, the company reported a net loss of $104.4 million compared to a net income of $4.4 billion for the same period in 2023[38]. - The company reported a net loss attributable to Roivant Sciences Ltd. of $169.4 million for the three months ended December 31, 2024, compared to a net income of $5.1 billion for the same period in 2023[175]. - The company incurred a net loss from continuing operations of $477.4 million for the nine months ended December 31, 2024, compared to net income of approximately $4.6 billion for the same period in 2023[203]. Assets and Liabilities - Total current assets decreased from $6,731,828 thousand as of March 31, 2024, to $5,363,968 thousand as of December 31, 2024, a decline of approximately 20.3%[26]. - Total liabilities decreased significantly from $773,953 thousand as of March 31, 2024, to $256,375 thousand as of December 31, 2024, a reduction of approximately 66.9%[26]. - The company’s total assets decreased from $7,222,482 thousand as of March 31, 2024, to $5,792,345 thousand as of December 31, 2024, a decline of approximately 19.8%[26]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of approximately $5.1 billion and retained earnings of $460.4 million[203]. Cash Flow and Investments - Cash and cash equivalents decreased from $6,494,953 thousand as of March 31, 2024, to $1,990,683 thousand as of December 31, 2024, a decline of about 69.4%[26]. - The company incurred a net cash used in operating activities of $666.9 million for the nine months ended December 31, 2024, compared to $656.8 million for the same period in 2023[38]. - The company reported a net cash used in investing activities of $2.84 billion for the nine months ended December 31, 2024, compared to a net cash provided by investing activities of $5.2 billion in 2023[38]. - Cash flow from investing activities changed to a net cash used of approximately $2.8 billion for the nine months ended December 31, 2024, from net cash provided of approximately $5.2 billion for the same period in 2023, primarily due to purchases of marketable securities[221]. Shareholder Equity and Repurchase Programs - As of September 30, 2024, total shareholders' equity stands at $5,580,042, a decrease from $6,448,529 on June 30, 2024, reflecting a net loss of $279,924 during the quarter[34]. - The company repurchased 71,251,083 common shares for $648,385, and an additional 9,023,658 shares for $106,054 in the latest reporting period[34]. - The share repurchase program allows for repurchases of common shares up to $1.5 billion, with approximately $648.4 million spent to repurchase 71,251,083 shares from Sumitomo Pharma Co., Ltd.[101]. Research and Development - Research and development expenses accrued as of December 31, 2024, totaled $53.5 million, an increase from $37.7 million as of March 31, 2024[97]. - Research and development expenses increased by $33.4 million to $141.6 million for the three months ended December 31, 2024, compared to $108.1 million for the same period in 2023, mainly due to increased program-specific costs[180]. - Research and development expenses increased by $72.8 million to $405.2 million for the nine months ended December 31, 2024, compared to $332.4 million for the same period in 2023[183]. Discontinued Operations - The company completed the acquisition of Dermavant Sciences Ltd. by Organon in October 2024, classifying its results as discontinued operations[51]. - For the three months ended December 31, 2024, the net revenue from discontinued operations was $3.5 million, a decrease of 83.8% compared to $21.6 million in the same period of 2023[90]. - The company reported a loss from discontinued operations, net of tax, of $327.0 million for the three months ended December 31, 2024, compared to a loss of $58.5 million in the same period in 2023[90]. - For the nine months ended December 31, 2024, income from discontinued operations was $373.0 million, compared to a loss of $227.6 million for the same period in 2023, indicating a change of $600.6 million[201][202]. Accounting and Financial Reporting - The management's discussion and analysis is based on unaudited condensed consolidated financial statements prepared in accordance with U.S. GAAP[223]. - The preparation of financial statements requires estimates, judgments, and assumptions that affect reported amounts of assets and liabilities[223]. - Actual results may differ from estimates under different assumptions or conditions, indicating the inherent uncertainty in financial reporting[223]. - Critical accounting policies involve subjective estimates and judgments likely to materially impact financial condition and results of operations[224].