PART I—FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a $273.9 million net loss for Q2 2025, a reversal from prior year's income, due to lower revenue and higher operating expenses [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $5.03 billion from $5.44 billion, primarily due to a decrease in cash and an increase in marketable securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,238,459 | $2,715,411 | | Marketable securities | $3,264,692 | $2,171,480 | | **Total Assets** | **$5,032,602** | **$5,436,940** | | **Liabilities & Equity** | | | | Total current liabilities | $113,866 | $149,411 | | Total liabilities | $216,696 | $249,742 | | Total shareholders' equity | $4,815,906 | $5,187,198 | | **Total Liabilities and Shareholders' Equity** | **$5,032,602** | **$5,436,940** | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 saw a $273.9 million net loss, a significant shift from prior year's $57.5 million net income, driven by lower revenue and higher operating expenses Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $2,170 | $7,990 | | Research and development | $152,919 | $120,507 | | General and administrative | $134,019 | $99,892 | | Loss from operations | ($284,922) | ($102,235) | | Gain on sale of Telavant net assets | — | $110,387 | | Net (loss) income | ($273,911) | $57,490 | | Net (loss) income per share, basic | ($0.33) | $0.13 | [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for Q2 2025 was $204.4 million, with significant cash used in investing activities for marketable securities Consolidated Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($204,383) | ($192,829) | | Net cash used in investing activities | ($1,085,716) | ($965) | | Net cash used in financing activities | ($187,768) | ($660,616) | | **Net change in cash, cash equivalents and restricted cash** | **($1,477,052)** | **($857,150)** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business, liquidity, and accounting policies, including a $110.4 million gain from Telavant sale and completion of a $1.5 billion share repurchase program - As of June 30, 2025, the Company had approximately **$4.5 billion** in cash, cash equivalents, and marketable securities. It incurred a net loss from continuing operations of **$273.9 million** for the quarter[43](index=43&type=chunk) - In June 2024, a one-time milestone related to the Telavant sale was achieved, resulting in the company recognizing a gain of **$110.4 million** for its pro rata portion[85](index=85&type=chunk) - The company completed its **$1.5 billion** share repurchase program as of June 30, 2025, having repurchased **20.3 million shares** for **$208.3 million** during the quarter. A **new $500 million** repurchase program was authorized in June 2025[93](index=93&type=chunk)[94](index=94&type=chunk) - The company's subsidiary, Immunovant, has a minimum purchase commitment of approximately **$43.1 million** with Samsung Biologics for the manufacturing of batoclimab[113](index=113&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the biopharmaceutical business, pipeline, $4.5 billion in cash, and Q2 2025 net loss driven by increased R&D and G&A expenses [Overview and Recent Developments](index=29&type=section&id=Overview%20and%20Recent%20Developments) Roivant advances its pipeline via 'Vant' subsidiaries, with key candidates in Phase 3, and completed a $1.5 billion share repurchase program Selected Product Candidate Pipeline | Product Candidate | Indication | Vant | Modality | Phase | | :--- | :--- | :--- | :--- | :--- | | Brepocitinib | Dermatomyositis | Priovant | Small Molecule | Phase 3* | | Brepocitinib | Non-Infectious Uveitis | Priovant | Small Molecule | Phase 3* | | IMVT-1402 | Graves' Disease | Immunovant | Biologic | Phase 2/3* | | Batoclimab | Thyroid Eye Disease | Immunovant | Biologic | Phase 3* | | Mosliciguat | Pulmonary Hypertension associated with Interstitial Lung Disease | Pulmovant | Inhaled | Phase 2 | - The company reported consolidated cash, cash equivalents, and marketable securities of **$4.5 billion** at June 30, 2025, supporting a cash runway into profitability[153](index=153&type=chunk) - Roivant completed its **$1.5 billion** share repurchase program, reducing outstanding shares by **over 15%** from March 31, 2024. A **new $500 million** share repurchase program was approved in June 2025[153](index=153&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Q2 2025 revenue decreased, R&D expenses rose by $32.4 million, and G&A expenses increased by $34.1 million due to executive compensation R&D Expense Breakdown (in thousands) | Program-specific costs | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Anti-FcRn franchise (all indications) | $56,012 | $40,793 | $15,219 | | Brepocitinib | $15,020 | $10,594 | $4,426 | | Mosliciguat | $8,385 | $2,980 | $5,405 | | **Total R&D Expenses** | **$152,919** | **$120,507** | **$32,412** | - G&A expenses increased by **$34.1 million**, primarily due to a **$34.2 million** increase in share-based compensation expense, largely from long-term equity incentive awards under the 2024 Senior Executive Compensation Program[176](index=176&type=chunk) - Interest income decreased by **$23.8 million** due to lower cash equivalent balances and lower interest rates[180](index=180&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $4.5 billion in cash and marketable securities, sufficient to fund operations, and completed a $1.5 billion share repurchase program - As of June 30, 2025, the company had cash, cash equivalents and marketable securities of approximately **$4.5 billion**[184](index=184&type=chunk) - The **$1.5 billion** common share repurchase program was completed as of June 30, 2025. A **new $500 million** program was authorized on June 24, 2025, with no purchases made under it as of the quarter's end[190](index=190&type=chunk)[191](index=191&type=chunk) Summary of Cash Flows (in thousands) | Activity | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($204,383) | ($192,829) | | Net cash used in investing activities | ($1,085,716) | ($965) | | Net cash used in financing activities | ($187,768) | ($660,616) | [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rates, foreign currency, and equity prices, with a hypothetical 10% change in key investments impacting financials by $28.4 million - The company's primary market risks are related to **interest rates**, **foreign currency**, and **equity prices**[206](index=206&type=chunk) - A hypothetical **10%** increase or decrease in the fair value of investments in Arbutus and Datavant would have impacted their fair value as of June 30, 2025 by approximately **$28.4 million**[209](index=209&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Based on an evaluation as of June 30, 2025, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were **effective at a reasonable assurance level**[212](index=212&type=chunk) - There were **no material changes** in the company's internal control over financial reporting during the fiscal quarter ended June 30, 2025[213](index=213&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company does not expect any current legal or regulatory proceedings to materially adversely affect its business or financial condition - The company does not currently expect any legal proceedings to have a **material adverse effect** on its business, operating results or financial condition[217](index=217&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its business model, financial position, product development, regulatory approval, and intellectual property [Risks Related to Our Business and Industry](index=42&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) Risks include limited operating history, 'Vant' structure complexities, reliance on in-licensed assets, capital allocation, and global economic instability - The company's **limited operating history** and the inherent uncertainties of biopharmaceutical development make it difficult to assess future prospects[220](index=220&type=chunk) - The **'Vant' structure** may result in increased costs, complexities, and key employee risks compared to a centralized model[236](index=236&type=chunk)[237](index=237&type=chunk) - Immunovant's rights to IMVT-1402 and batoclimab depend on the **HanAll Agreement**, and any termination or breach would severely impact their development and commercialization[228](index=228&type=chunk) - The company faces risks from its **significant holdings of cash and marketable securities**, including market volatility and potential for losses[249](index=249&type=chunk) [Risks Related to Our Intellectual Property](index=82&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on obtaining and enforcing IP rights, facing risks from patent challenges, litigation (e.g., Moderna, Pfizer/BioNTech), and AI-related IP complexities - The company relies on a combination of **patents**, **trade secrets**, and **confidentiality agreements** to protect its intellectual property, but these may not be sufficiently broad or enforceable[424](index=424&type=chunk) - The company's subsidiary GSG and Arbutus are in **active litigation against Moderna and Pfizer/BioNTech** for alleged patent infringement related to COVID-19 vaccines. The **jury trial in the Moderna case is scheduled for March 2026**[455](index=455&type=chunk)[456](index=456&type=chunk) - The company may not be able to protect its **intellectual property rights throughout the world**, as laws and enforcement vary by country, potentially allowing competitors to use its technologies in some jurisdictions[472](index=472&type=chunk)[473](index=473&type=chunk) - The use of **AI in drug discovery** introduces unresolved legal questions about inventorship and ownership under current patent laws, which could hinder the ability to protect AI-generated innovations[499](index=499&type=chunk) [Risks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters](index=96&type=section&id=Risks%20Related%20to%20Our%20Securities%2C%20Our%20Jurisdiction%20of%20Incorporation%20and%20Certain%20Tax%20Matters) Investor risks include stock price volatility, anti-takeover provisions, dilution from future issuances, and adverse tax consequences from Bermuda incorporation and CFC/PFIC status - The company's **largest shareholders** own a significant percentage of common shares, allowing them to exert substantial control over matters subject to shareholder approval[509](index=509&type=chunk) - As a **Bermuda-incorporated company**, shareholder rights are governed by Bermuda law, which may offer less protection than U.S. laws, and it may be difficult for U.S. investors to enforce judgments against the company[517](index=517&type=chunk)[518](index=518&type=chunk) - The company's non-U.S. subsidiaries are classified as **Controlled Foreign Corporations (CFCs)**, which may result in adverse U.S. federal income tax consequences for U.S. shareholders holding **10% or more** of the company's shares[527](index=527&type=chunk)[528](index=528&type=chunk) - The company believes it was not a **Passive Foreign Investment Company (PFIC)** for the taxable year ended March 31, 2025, but its status is an annual determination and could change, which would have adverse tax consequences for U.S. holders[529](index=529&type=chunk)[531](index=531&type=chunk)[532](index=532&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=102&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 20.0 million shares for $205.2 million, completing its $1.5 billion program, and authorized a new $500 million repurchase program Issuer Purchases of Equity Securities (Q1 2025) | Period | Total Common Shares Purchased | Average Price Paid per Share | Approximate Dollar Value of Shares that May Yet Be Purchased (in millions) | | :--- | :--- | :--- | :--- | | April 1 – 30, 2025 | 13,672,384 | $9.89 | $69.9 | | May 1 – 31, 2025 | 5,453,666 | $11.04 | $9.7 | | June 1 – 30, 2025 | 873,400 | $11.16 | $500.0 | | **Total** | **19,999,450** | | | - The company's **$1.5 billion** share repurchase program was **fully exhausted** as of June 30, 2025. A **new $500 million program** was authorized in June 2025[538](index=538&type=chunk) [Defaults Upon Senior Securities](index=103&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None - **None**[536](index=536&type=chunk) [Mine Safety Disclosures](index=103&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - **Not applicable**[536](index=536&type=chunk) [Other Information](index=103&type=section&id=Item%205.%20Other%20Information) None - **None**[536](index=536&type=chunk) [Exhibits](index=104&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including employment agreements, equity incentive plan documents, and officer certifications - The exhibits include various **employment agreements**, **equity plan documents**, and required **certifications** by the Principal Executive Officer and Principal Financial Officer[540](index=540&type=chunk)

[Overview and Business Update](index=1&type=section&id=Roivant%20Reports%20Financial%20Results%20for%20the%20First%20Quarter%20Ended%20June%2030%2C%202025%2C%20and%20Provides%20Business%20Update) Roivant reported strong financial results for Q1 2025, highlighted by significant clinical advancements and strategic share repurchases [Key Highlights](index=1&type=section&id=Key%20Highlights) Roivant achieved significant clinical progress, completed a **$1.5 billion** share repurchase, and maintains a strong **$4.5 billion** cash position - The Phase 3 VALOR study of brepocitinib in dermatomyositis (DM) is on track for a topline data readout in **H2 CY2025**[3](index=3&type=chunk) - Two potentially registrational studies for IMVT-1402 in Graves' disease (GD) and Sjögren's disease (SjD) were initiated in **June 2025**[3](index=3&type=chunk) - A **$1.5 billion** share repurchase program was completed, with **$208 million** bought back in the quarter, and a new **$500 million** program approved[3](index=3&type=chunk) - Consolidated cash, cash equivalents, restricted cash, and marketable securities totaled **$4.5 billion** as of **June 30, 2025**[3](index=3&type=chunk) [Major Upcoming Milestones](index=2&type=section&id=Major%20Upcoming%20Milestones) The company anticipates key clinical trial readouts for brepocitinib, batoclimab, and IMVT-1402, alongside progress in Genevant's LNP litigation Key Clinical Trial Readout Timeline | Subsidiary | Drug | Indication | Event | Expected Timing | | :--- | :--- | :--- | :--- | :--- | | Priovant | brepocitinib | Dermatomyositis (DM) | Phase 3 Topline Data | H2 CY2025 | | Priovant | brepocitinib | Non-infectious Uveitis (NIU) | Phase 3 Topline Data | H1 CY2027 | | Priovant | brepocitinib | Cutaneous Sarcoidosis (CS) | Phase 2 Topline Data | H2 CY2026 | | Immunovant | batoclimab | Graves' Disease (GD) | Remission Data | Sep 2025 | | Immunovant | Thyroid Eye Disease (TED) | Phase 3 Data | H2 CY2025 | | Immunovant | IMVT-1402 | Multiple Indications | Topline Results | CY2026 - CY2027 | | Pulmovant | mosliciguat | PH-ILD | Phase 2 Topline Data | H2 CY2026 | - Genevant's LNP litigation against Moderna has a jury trial scheduled for **March 2026**, with a judge's decision pending in the Pfizer/BioNTech case[6](index=6&type=chunk) [Financial Results for the First Quarter Ended June 30, 2025](index=3&type=section&id=First%20Quarter%20Ended%20June%2030%2C%202025%20Financial%20Summary) Roivant reported increased R&D and G&A expenses, leading to a significant loss from continuing operations for the quarter [Financial Summary Narrative](index=3&type=section&id=Financial%20Summary%20Narrative) Roivant's R&D and G&A expenses significantly increased year-over-year, resulting in a **$273.9 million** loss from continuing operations - Consolidated cash, cash equivalents, restricted cash, and marketable securities totaled approximately **$4.5 billion** as of **June 30, 2025**[7](index=7&type=chunk) Year-over-Year Expense Comparison (Three Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $152.9M | $120.5M | +$32.4M | | G&A Expenses | $134.0M | $99.9M | +$34.1M | - The increase in R&D costs was primarily driven by program-specific costs for the anti-FcRn franchise (up **$15.2 million**), mosliciguat (up **$5.4 million**), and brepocitinib (up **$4.4 million**)[9](index=9&type=chunk) - Loss from continuing operations was **$273.9 million**, or **$0.33 per share**, for the quarter ended **June 30, 2025**[14](index=14&type=chunk) - Non-GAAP loss from continuing operations was **$170.1 million**, compared to **$107.1 million** for the same period in **2024**[15](index=15&type=chunk) [Selected Balance Sheet Data](index=4&type=section&id=Selected%20Balance%20Sheet%20Data) Roivant's balance sheet as of **June 30, 2025**, shows **$5.03 billion** in total assets and **$4.82 billion** in shareholders' equity, with shifts in cash and marketable securities Selected Balance Sheet Data (in thousands) | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $1,248,609 | $2,725,661 | | Marketable securities | $3,264,692 | $2,171,480 | | Total assets | $5,032,602 | $5,436,940 | | Total liabilities | $216,696 | $249,742 | | Total shareholders' equity | $4,815,906 | $5,187,198 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Roivant reported a **$223.4 million** net loss for the quarter ended **June 30, 2025**, a significant decline from the prior year's net income due to increased expenses Condensed Consolidated Statements of Operations (unaudited, in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $2,170 | $7,990 | | Total operating expenses | $287,092 | $220,612 | | Loss from operations | $(284,922) | $(102,235) | | Loss from continuing operations, net of tax | $(273,911) | $(31,603) | | Net (loss) income attributable to Roivant | $(223,355) | $95,297 | | Net (loss) income per common share, basic | $(0.33) | $0.13 | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=6&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) Roivant's non-GAAP loss from continuing operations was **$170.1 million**, adjusted primarily for share-based compensation and changes in investment fair value GAAP to Non-GAAP Reconciliation Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Loss from continuing operations, net of tax (GAAP)** | **$(273,911)** | **$(31,603)** | | Share-based compensation | $82,178 | $47,373 | | Gain on sale of Telavant net assets | — | $(110,387) | | Change in fair value of investments | $19,125 | $(15,226) | | Other Adjustments | $2,485 | $2,739 | | **Adjusted loss from continuing operations (Non-GAAP)** | **$(170,124)** | **$(107,112)** | [Corporate Information](index=7&type=section&id=Corporate%20Information) This section provides details on investor communications, Roivant's business model, and standard forward-looking statement disclaimers [Investor Conference Call Information](index=7&type=section&id=Investor%20Conference%20Call%20Information) Roivant will host a conference call and webcast on **August 11, 2025**, to discuss Q1 financial results and provide a corporate update - A conference call and webcast will be held at **8:00 a.m. ET** on **Monday, August 11, 2025**, to discuss the financial results and business update[27](index=27&type=chunk) [About Roivant](index=8&type=section&id=About%20Roivant) Roivant is a biopharmaceutical company developing medicines through its "Vants" subsidiary model, focusing on key pipeline assets for inflammatory and autoimmune diseases - Roivant's key pipeline assets include brepocitinib (TYK2/JAK1 inhibitor), IMVT-1402 and batoclimab (FcRn targeting antibodies), and mosliciguat (sGC activator)[29](index=29&type=chunk) - The company utilizes a subsidiary model, creating "Vants" to develop and commercialize its medicines and technologies[29](index=29&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Roivant%20Forward-Looking%20Statements) This section contains forward-looking statements regarding clinical potential and future results, subject to risks and uncertainties, with no obligation for updates - The press release includes forward-looking statements regarding the clinical and therapeutic potential of product candidates, trial results, and commercial potential[31](index=31&type=chunk) - These statements are covered by the safe harbor provisions of the Securities Act and Exchange Act but are subject to significant risks and uncertainties[30](index=30&type=chunk)[32](index=32&type=chunk)

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]

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, batoclimab, brepocitinib, and mosliciguat, targeting various autoimmune and pulmonary conditions [3] Upcoming Events - Roivant will host a live conference call and webcast on August 11, 2025, at 8:00 a.m. ET to report its financial results for the first quarter ended June 30, 2025, and 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 Brepicitinib Investor Call Company and Industry - **Company**: Regan and Privyant - **Industry**: Pharmaceutical, specifically focusing on autoimmune diseases, particularly dermatomyositis (DM) Core Points and Arguments 1. **Brepicitinib Overview**: Brepicitinib is a dual selective Tyk2/JAK1 inhibitor, representing a new generation of treatments for inflammatory diseases, with potential to set a new standard of care for patients with high unmet medical needs, particularly in DM and other autoimmune conditions [4][5][6] 2. **Clinical Trials**: The VALOR study aims to improve treatment for over 40,000 patients with DM, with results expected in the second half of the year. The study is the largest DM trial ever conducted, enrolling 241 patients globally [4][22][45] 3. **Patient Burden**: DM is characterized by severe muscle weakness and debilitating skin conditions, leading to a high burden on patients. Current treatments, primarily high-dose steroids, are inadequate and carry significant side effects [10][12][14][16] 4. **Market Opportunity**: There is a significant commercial opportunity in DM, with several competitor programs in late-stage development, but brepicitinib is the only oral treatment in this space [49][50][51] 5. **Regulatory Engagement**: The company has had productive engagement with the FDA and plans to submit a New Drug Application (NDA) if the study results are positive [46] Important but Overlooked Content 1. **Steroid Burden**: The high use of steroids among DM patients leads to adverse health impacts, highlighting the need for new therapies that can reduce this burden while effectively treating the disease [14][15][40] 2. **Study Design**: The VALOR trial includes a strict steroid taper protocol to manage placebo response and demonstrate the drug's efficacy. A high success rate of 98% was achieved in tapering patients off steroids [40][41][86] 3. **Endpoints**: The primary endpoint of the study is the Total Improvement Score (TIS), which measures improvement rather than disease activity. This is crucial for understanding the drug's impact on patient quality of life [27][28][33] 4. **Patient Demographics**: The trial population is heavily treated, with many patients on multiple therapies, indicating a high level of disease severity and the need for effective new treatments [38][39] Conclusion - The upcoming results from the VALOR study are critical for establishing brepicitinib as a viable treatment option for DM, with the potential to significantly improve patient outcomes and address a substantial market need in the autoimmune disease space [44][58]

Summary of Roivant Sciences (ROIV) FY Conference - June 10, 2025 Company Overview - **Company**: Roivant Sciences (ROIV) - **Event**: Goldman Sachs Annual Health Care Conference Key Points Industry and Product Focus - **Primary Focus**: Roivant is focused on developing innovative therapies for autoimmune diseases, particularly in the areas of dermatomyositis (DM) and non-infectious uveitis (NIU) [4][30] - **Key Drug**: Brepicitinib, a dual inhibitor of JAK1 and TYK2, is being evaluated for its efficacy in DM and NIU [5][6] Clinical Trials and Data - **Phase III Trials**: Roivant is preparing for a significant period of clinical data releases and commercial launches over the next two to three years, starting with brepicitinib in DM and NIU [4][30] - **VALOR Study**: A 52-week placebo-controlled study for brepicitinib in DM is underway, with a focus on the total improvement score (TIS) as the primary endpoint [9][10] - **Dosing Strategy**: The study includes two doses of brepicitinib, with 30 mg being identified as highly efficacious based on previous studies [11][12] Market Opportunity - **DM Patient Population**: Estimated at around 40,000 patients, with a high unmet need for effective treatments beyond steroids and immunosuppressive therapies [32][30] - **Pricing Strategy**: Expected to be in the orphan drug pricing range, potentially between $200,000 and $600,000 annually, based on comparators like IVIG and FcRn therapies [37][30] Future Developments - **NIU Trials**: Roivant is also conducting pivotal studies in NIU, with promising Phase II data indicating a longer time to treatment failure compared to existing therapies [39][41] - **Indication Expansion**: The company is exploring additional indications for brepicitinib, including cutaneous sarcoidosis, with ongoing dose-ranging studies [57][66] Competitive Landscape - **Market Dynamics**: The myositis market is characterized by a concentrated prescriber base and a significant opportunity for novel therapies, especially given the limitations of current treatments [30][31] - **Graves' Disease**: Roivant is excited about the potential in Graves' disease, with a large patient population of approximately 330,000 who are refractory to existing therapies [97][98] Financial Strategy - **Capital Allocation**: Roivant has set aside approximately $2 billion for new opportunities and clinical development, alongside a stock buyback program totaling nearly $1.5 billion [104] Additional Insights - **Regulatory Environment**: The company is actively engaging with regulatory bodies to ensure smooth progression of its clinical trials and potential market entry [75][100] - **Investor Engagement**: There is a need for increased communication with the medical community and investors regarding the potential of NIU and other indications to enhance market understanding [55][56] Conclusion - Roivant Sciences is positioned for significant growth with its innovative therapies targeting high unmet needs in autoimmune diseases, backed by robust clinical data and strategic market positioning. The upcoming years are critical for execution and potential market launches.

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]

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]

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]

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]