Financial Performance - Net sales and revenues for the second quarter of 2025 decreased by 16% to $12,763 million compared to $15,235 million in 2024, and year-to-date sales decreased by 22% to $21,272 million from $27,420 million[107]. - Net income attributable to Deere & Company for the second quarter of 2025 was $1,804 million, a decrease of 24% from $2,370 million in 2024, and year-to-date net income decreased by 35% to $2,673 million from $4,121 million[107]. - Total consolidated net income attributable to Deere & Company for the six months ended April 27, 2025, was $2,673 million, down from $4,121 million in the same period of 2024, representing a decrease of about 35%[156]. - Net income for the first six months of 2025 was $2,667 million, a decrease of 35.1% compared to $4,116 million in 2024[161]. Segment Performance - Production and Precision Agriculture segment net sales decreased by 21% to $5,230 million in the second quarter of 2025, with operating profit down 30% to $1,148 million[111]. - Small Agriculture and Turf segment net sales decreased by 6% to $2,994 million in the second quarter of 2025, with operating profit slightly up by 1% to $574 million[116]. - Construction and Forestry net sales decreased by 23% to $2,947 million for the three months ended April 27, 2025, and by 30% to $4,941 million for the six months ended April 27, 2025, compared to the same periods in 2024[121]. - Operating profit for Construction and Forestry dropped 43% to $379 million for the three months ended April 27, 2025, and 64% to $444 million for the six months ended April 27, 2025, primarily due to lower shipment volumes and unfavorable price realization[121]. Cost and Expenses - The cost of sales to net sales ratio increased to 68.1% in the second quarter of 2025 from 67.3% in 2024, primarily due to higher overhead costs and tariffs[108]. - The cost of sales for equipment operations was $7,609 million in Q2 2025, compared to $9,157 million in Q2 2024, reflecting a reduction of approximately 17%[154]. - Total costs and expenses for the six months ended April 27, 2025, were $18,040 million, down from $22,087 million in the same period of 2024, a decrease of about 18%[156]. Cash Flow and Financing - Cash provided by operating activities was $568 million for the first six months of 2025, down from $944 million in the same period last year[135]. - The company forecasts lower operating cash flows from equipment operations in 2025 compared to 2024, driven by a decrease in net income adjusted for non-cash provisions[129]. - Cash flows from operating activities decreased to $568 million in 2025 from $944 million in 2024, reflecting a decline of 39.8%[161]. - Net cash used for investing activities was $779 million in 2025, compared to a cash outflow of $1,670 million in 2024, indicating a significant improvement[161]. - Net cash provided by financing activities was $(821) million in 2025, a decrease from $(1,162) million in 2024, showing a reduction in cash outflow[161]. Market Outlook - The company expects agriculture and turf equipment sales volumes for the remainder of 2025 to be lower than the prior year due to reduced demand driven by high interest rates and market uncertainty[93]. - The construction equipment industry sales are forecasted to decline in the U.S. and Canada from 2024 levels, influenced by macroeconomic uncertainty and high mortgage rates[105]. - The company anticipates continued challenges in the agricultural market due to lower sales volumes, higher sales incentives, and elevated receivable write-offs in 2025[99]. - The company continues to face challenges from higher interest rates, supply chain disruptions, and geopolitical instability affecting its operations and market demand[149]. Research and Development - Research and development expenses for the first six months of 2025 were $1,075 million, a decrease of 2% from $1,098 million in 2024, reflecting continued investment in technology solutions[108]. - Research and development expenses for equipment operations were $549 million in Q2 2025, slightly down from $565 million in Q2 2024[154]. Balance Sheet - Total assets for Deere & Company reached $106.303 billion as of April 2025, compared to $107.320 billion in October 2024, reflecting a decrease of approximately 0.94%[159]. - Total liabilities decreased to $81.925 billion in April 2025 from $84.395 billion in October 2024, a reduction of approximately 2.8%[159]. - Stockholders' equity rose to $24.287 billion in April 2025, up from $22.836 billion in October 2024, indicating an increase of about 6.3%[159]. - The ratio of interest-bearing debt to stockholder's equity was 8.7 to 1 as of April 27, 2025, compared to 8.1 to 1 a year earlier[131]. - The company has access to $11.9 billion in worldwide lines of credit, with $4,866 million unused as of April 27, 2025[143]. Inventory and Borrowings - Inventories increased by $777 million during the first six months of 2025, primarily due to seasonal increases, but decreased by $573 million compared to a year ago[138]. - Inventories stood at $7.870 billion in April 2025, compared to $7.093 billion in October 2024, marking an increase of about 10.9%[159]. - The company's short-term borrowings decreased to $911 million in April 2025 from $1.055 billion in October 2024, a decline of about 13.6%[159]. Stockholder Returns - The company repurchased common stock amounting to $838 million in 2025, down from $2,422 million in 2024, indicating a reduction of 65.4%[161]. - Dividends paid increased to $1,827 million in 2025 from $1,888 million in 2024, a decrease of 3.2%[161].

Financial Performance - Net sales for the three months ended April 30, 2025 were $131.8 million, representing a $2.6 million or 1.9% decrease from the prior year period[113]. - The Watch and Accessory Brands segment net sales were $114.8 million, a decrease of $2.3 million or 2.0% compared to the prior year, primarily due to a $6.8 million or 17.0% decrease in the owned brands category[114]. - The licensed brands category saw an increase in net sales of $6.2 million or 8.3%, partially offsetting the decline in owned brands[114]. - Net sales for the U.S. Watch and Accessory Brands segment were $38.6 million, a decrease of $0.5 million or 1.4% compared to the prior year, primarily due to an unfavorable sales mix[115]. - International net sales in the Watch and Accessory Brands segment were $76.2 million, down $1.8 million or 2.3%, impacted by foreign currency fluctuations of $1.2 million[116]. - Net income attributable to Movado Group, Inc. was $1.4 million for the three months ended April 30, 2025, compared to $2.0 million in the prior year[130]. Cost and Expenses - The Company recorded $4.6 million in accruals for severance and employee-related charges during fiscal year 2025 as part of a cost-savings initiative[107]. - The Company expects annual savings of approximately $10.0 million from the cost-savings initiatives implemented[107]. - Gross profit for the three months ended April 30, 2025, was $71.4 million, representing 54.1% of net sales, a decrease from 54.3% in the prior year[118]. - SG&A expenses increased by $0.3 million or 0.4% to $71.1 million, driven by a $2.7 million rise in foreign exchange losses[119]. - The Company recorded an operating loss of less than $0.1 million in the Watch and Accessory Brands segment, compared to an operating income of $1.7 million in the prior year[120]. - The U.S. locations of the Watch and Accessory Brands segment reported an operating loss of $7.0 million, an improvement from an $8.1 million loss in the prior year[121]. - International locations recorded operating income of $7.0 million, down from $9.8 million in the prior year, due to higher SG&A expenses[124]. Cash Flow and Investments - Cash used in operating activities was $7.2 million, an improvement from $18.1 million used in the prior year[133]. - The Company had $203.1 million in cash and cash equivalents as of April 30, 2025, down from $225.4 million in the prior year[131]. - The Company committed to invest up to $21.5 million in minority investments, having funded approximately $14.1 million through fiscal 2025 and an additional $1.3 million in the first three months of fiscal 2026[143]. - Cash paid for interest was $0.1 million for both the three-month periods ended April 30, 2025, and April 30, 2024[142]. Tariffs and Foreign Exchange - The U.S. government imposed a baseline special tariff of 10% on products from all countries, which is expected to increase the Company's cost of sales[104]. - The total U.S. special tariff on Chinese watch bands and jewelry has increased to 37.5% due to recent tariff implementations[105]. - Fluctuations in foreign currency exchange rates negatively impacted net sales by $1.2 million compared to the prior year period[113]. Shareholder Returns - The Company declared a cash dividend of $0.35 per share, totaling $7.8 million, for both the three-month periods ended April 30, 2025, and April 30, 2024[144]. - The Company expects to continue declaring cash dividends in the future, subject to the Board of Directors' discretion[144]. Debt and Financial Obligations - As of April 30, 2025, the Company had unsecured lines of credit totaling 6.5 million Swiss Francs, equivalent to $7.9 million, with no borrowings against these lines[140]. - The Company had no floating rate debt as of April 30, 2025, and reported no weighted average borrowings during the three months ended April 30, 2025[153]. - The Company has guaranteed obligations to third parties totaling $1.5 million as of April 30, 2025, related to its foreign subsidiaries[141]. Hedging and Future Contracts - As of April 30, 2025, the Company's net forward contracts hedging portfolio included 30.5 million U.S. dollars equivalent and 34.6 million Euros equivalent, with various expiry dates[151]. - The Company did not hold any future contracts in its gold hedge portfolio as of April 30, 2025, meaning changes in gold purchase prices will directly affect the cost of sales[152]. Share Repurchase - During the three months ended April 30, 2024, the Company repurchased 39,000 shares at a total cost of $1.1 million, averaging $27.85 per share[145].

Financial Performance - National Grid's fiscal year ended March 31, 2025, with significant developments reported in the strategic and financial reviews [11]. - The company reported a consolidated revenue of £X billion for the fiscal year, representing a Y% increase compared to the previous year [16]. - The underlying operating profit for 2024/25 was reported at £4,934 million, reflecting a 10% year-on-year increase [26]. - The company achieved an asset growth of £5,357 million, which is a 12% year-on-year increase [26]. - The dividend per share increased to 60.0p, representing a 3% year-on-year growth [26]. - Underlying operating profit increased by 12% to £5.4 billion at constant currency, driven by increased regulated revenues and flat controllable costs [75]. - Group RoE for 2024/25 was 9.0%, down from 10.5% in the prior year, impacted by lower gearing due to the Rights Issue [187]. - Underlying EPS grew by 2% year-on-year, driven by strong performance in New York, New England, and UK ET [176]. Capital Investment and Growth - National Grid announced a record capital investment of £9.85 billion for the year, contributing to a total investment of approximately £60 billion over five years, nearly doubling the previous investment level [25]. - Capital investment reached a record £9.85 billion over the past year, which is 20% higher than the previous year, reflecting strong activity across all regulated businesses [75]. - The company plans to invest approximately £60 billion over the next five years to expand its networks and connect new clean energy sources [120]. - The company has a target to achieve around £51 billion in green capital investment between April 2024 and March 2029 [184]. - The company delivered £7.7 billion of green capital investment in 2024/25, a £1.7 billion increase from the previous year [184]. Strategic Focus and Sustainability - National Grid's capital investment and asset growth strategies are highlighted, indicating a focus on infrastructure development [13]. - Future outlook includes continued investment in renewable energy and infrastructure to support energy transition [12]. - The company is committed to achieving net-zero emissions by 2030, with significant investments planned in renewable energy projects [15]. - The company is committed to aligning its greenhouse gas emissions reduction targets with the Science Based Targets initiative (SBTi) 1.5°C pathway [120]. - The strategic report emphasizes the importance of climate-related financial disclosures and regulatory compliance [13]. Operational Efficiency and Cost Management - The company has set a target to reduce operational costs by E% through efficiency improvements and digital transformation initiatives [16]. - The company is committed to leveraging advanced technologies and innovative practices to improve the efficiency of energy network operations [25]. Employee Engagement and Community Support - Employee engagement index reached 80% in the latest survey, indicating strong workforce morale [27]. - The company has launched a £13.8 million Grid for Good Energy Affordability Fund to support communities struggling with high living costs [83]. - In the UK, the company has assisted 21,000 customers in saving a total of £22 million through its fuel poverty programme [124]. Regulatory and Market Position - The company is classified as a large accelerated filer under the Securities Exchange Act [9]. - The financial statements are prepared in accordance with International Financial Reporting Standards [11]. - The company is actively working with regulators and governments to establish price controls and rate cases that reflect the growing demand for grid connections [120]. - The company submitted its RIIO-T3 business plan to Ofgem, which will nearly double the power transfer capacity across the UK [153]. Network Reliability and Safety - National Grid's network reliability was maintained at 99.9%, consistent with the previous year [26]. - The company reported a lost time injury frequency rate of 0.10 per 100,000 hours worked, a 25% year-on-year improvement [26]. - Network reliability for 2023/24 is reported at 99.9% with a capital investment of £8.24 billion and an underlying EPS of 72.1p, restated to 10.5% ROE [110].

Customer Concentration - In 2024, the company's largest three customers accounted for 14%, 13%, and 11% of total sales, compared to 15%, 14%, and 8% in 2023[28]. - In 2024, the top three customers represented 38% of the company's sales, compared to 37% in 2023 and 39% in 2022, indicating a relatively concentrated customer base[101]. Acquisitions and Expansions - The company completed the acquisition of Punto Verde, a distributor in Ecuador, on October 5, 2023, which included product registrations and customer lists[24]. - The company acquired AgNova in Australia, expanding its specialty crop protection solutions[56]. - AgriCenter acquired Punto Verde in Ecuador, enhancing distribution capabilities in the region[58]. - The company completed the purchase of Agrinos, a biological input supplier, enhancing its product offerings[57]. - The establishment of AgNova Technologies NZ Limited aims to expand business in the Australasia region[58]. Financial Performance - The Company experienced a net loss of $126,340 (or $4.50 per share) in 2024, compared to a net income of $7,519 (or $0.26 per share) in 2023[137]. - Total net sales decreased by approximately 6% to $547,306 in 2024, with U.S. crop sales down 15% and international sales up 1%[138]. - Gross margin dropped to 22% in 2024 from 31% in the prior year, attributed to high costs of sales which increased by 7%[134]. - Operating expenses rose by 42% to $221,872 in 2024, primarily due to non-cash asset impairment charges and transformation strategy costs[135]. - The Company incurred nonrecurring charges of $117,355 during 2024 related to business transformation and asset impairments[131]. - Sales of the granular insecticide Aztec dropped by 40% in 2024, significantly impacting overall sales performance[133]. - Comprehensive loss was $139,170 in 2024, compared to a comprehensive income of $13,738 in 2023, driven by a negative foreign currency translation adjustment of $13,824[149]. Operational Challenges - The company faces regulatory risks that could increase operational costs or limit product marketing capabilities[62]. - The company is dependent on a limited number of suppliers for certain raw materials, which poses a risk to achieving projected sales[71]. - Disruptions in the global supply chain continue to present risks, potentially affecting raw material availability and costs[72]. - The company is subject to increased scrutiny and potential litigation related to product liability, particularly concerning pesticides[68]. - Climate change has led to unpredictable weather conditions that may reduce the demand for the Company's products, affecting revenues and profitability[78]. Human Capital and Employee Engagement - Employee engagement and competitive compensation are key elements of the company's human capital strategy, aimed at optimizing retention[53]. - The company employed 755 employees as of December 31, 2024, down from 845 in 2023, reflecting seasonal business adjustments[46]. Research and Development - The company has been investing in molecular research and development for its green solutions portfolio since 2021[22]. - The company has developed a portfolio of intellectual property, including patents and trademarks, to protect its proprietary formulations[34]. - The company has a history of investing in technology, particularly in natural oil technology and biorationals, as part of its growth strategy, although there is no guarantee of successful commercialization[97]. Financial Management and Liquidity - The Company relies on customer prepayments to meet working capital needs, and any material change in this program could adversely affect liquidity[90]. - The Company believes its cash flows and credit facility availability will meet its working capital and capital expenditure requirements for at least the next 12 months[164]. - The Company recorded inventory adjustments of $21,417 in 2024, compared to $2,700 in 2023[169]. - The Company recorded intangible asset impairment charges of $9,345 in 2024, with no such charges in 2023[170]. - The Company recorded goodwill impairment charges of $27,049 during the year ended December 31, 2024[176]. Market Conditions and Competition - The competitive nature of the agricultural chemical markets is increasing, with a rise in generic products and consolidation among competitors, potentially eroding the Company's market position[81]. - The company faces competition from generic competitors operating at thinner gross margins, which may impact pricing and profitability[99]. - The Company has successfully implemented price increases on its products in response to inflationary pressures, although there has been a drop in demand due to customer destocking directives[183]. Regulatory and Compliance Issues - The company’s products are subject to registration by the U.S. Environmental Protection Agency, with compliance costs impacting operating expenses[35][38]. - The Company has identified material weaknesses in its internal control over financial reporting as of December 31, 2024, which could adversely affect its financial performance and investor confidence[82]. - The Company’s internal control over financial reporting received an adverse opinion due to a material weakness identified as of December 31, 2024[188]. Economic Factors - The Company is exposed to fluctuations in the global economy, including inflation, foreign currency exchange rates, and commodity prices, which could negatively impact sales volume and financial results[77]. - Domestic inflation trends and increased interest rates could lead to higher costs and potentially recessionary periods, adversely impacting the Company's financial performance[94]. - A 10% change in the exchange rate between the US Dollar and local currencies could result in a positive or negative change of approximately $6,800[182].

Exhibit 99.1 Li Auto Inc. Announces Unaudited First Quarter 2025 Financial Results Quarterly total revenues reached RMB25.9 billion (US$3.6 billion) Quarterly deliveries reached 92,864 vehicles BEIJING, China, May 29, 2025 — Li Auto Inc. ("Li Auto" or the "Company") (Nasdaq: LI; HKEX: 2015), a leader in China's new energy vehicle market, today announced its unaudited financial results for the quarter ended March 31, 2025. Operating Highlights for the First Quarter of 2025 | | 2025 Q1 | 2024 Q4 | 2024 Q3 | 2 ...

Exhibit 99.1 Multiple brokerage accounts by one client are counted as one brokerage account. The number of users refers to the number of user accounts registered with Futu. Non-GAAP adjusted net income is defined as net income excluding share-based compensation expenses. · Total number of funded accounts increased 41.6% year-over-year to 2,673,119 as of March 31, 2025. · Total number of brokerage accounts increased 30.0% year-over-year to 4,955,319 as of March 31, 2025. · Total number of users increased 16. ...

Financial Performance - Net sales for the fourth quarter of fiscal 2025 decreased by $52.9 million, or 11.7%, to $400.4 million compared to the same quarter of the prior fiscal year[3]. - Net income for the fourth quarter of fiscal 2025 was $25.6 million, a decrease of 4.6% year-over-year, representing 6.4% of net sales[5]. - Adjusted EBITDA for the fourth quarter of fiscal 2025 decreased by $7.6 million, or 13.9%, to $47.1 million, or 11.8% of net sales[5]. - For the fiscal year ended April 30, 2025, net sales decreased by 7.5% to $1,709.6 million from the prior fiscal year[4]. - Net income for the fiscal year 2025 was $99.5 million, a decrease of 14.4% year-over-year, representing 5.8% of net sales[5]. - Adjusted EBITDA for the fiscal year 2025 was $208.6 million, or 12.2% of net sales, down from $252.8 million, or 13.7% of net sales in the prior fiscal year[5]. - Net income for the three months ended April 30, 2025, is $25.566 million, a decrease from $26.798 million in the same period last year[28]. - Adjusted EBITDA for the twelve months ended April 30, 2025, is $208.630 million, compared to $252.773 million for the same period in 2024[28]. - Net sales for the three months ended April 30, 2025, are $400.395 million, a decline from $453.278 million in Q2 fiscal 2024[28]. Cash Flow and Liquidity - Cash provided by operating activities for the fiscal year was $108.4 million, with free cash flow totaling $65.7 million[8]. - As of April 30, 2025, the company had $48.2 million in cash and access to $314.2 million under its revolving credit facility[7]. - Free cash flow for the twelve months ended April 30, 2025, is $65.684 million, down from $138.509 million in the previous year[33]. - Cash provided by operating activities for the twelve months ended April 30, 2025, is $108.447 million, down from $230.750 million in the previous year[33]. Future Outlook - The company expects net sales for fiscal 2026 to range from low-single digit declines to low-single digit increases[12]. - The targeted Adjusted EBITDA range for fiscal 2026 is set at $175 million to $200 million[12]. Restructuring and Adjustments - The company incurred restructuring charges of $2.956 million in Q2 fiscal 2025, related to workforce reductions and facility closures[29]. - The company has adjusted its definition of Adjusted EPS to exclude changes in the fair value of foreign exchange forward contracts starting Q2 fiscal 2025[25]. Earnings Per Share - Adjusted EPS per diluted share for Q2 fiscal 2025 is $1.61, down from $1.78 in Q2 fiscal 2024, while GAAP EPS is $1.71 compared to $1.69 in the prior year[31]. - The net income margin for Q2 fiscal 2025 is 6.4%, compared to 5.9% in the same quarter last year[28]. Leverage - Net leverage as of April 30, 2025, is 1.56, indicating the company's leverage position after accounting for cash and cash equivalents[36].

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].

Drug Development - Immunovant is focused on developing IMVT-1402, a potential best-in-class FcRn inhibitor, to address autoimmune diseases driven by high levels of pathogenic IgG antibodies [502]. - In a Phase 1 clinical trial, IMVT-1402 demonstrated deep, dose-dependent IgG reductions, with expectations to achieve approximately 80% IgG reductions with 600 mg weekly dosing [504]. - The company has initiated studies in five indications for IMVT-1402, including potentially registrational trials in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy [506]. - Batoclimab's Phase 3 study in myasthenia gravis achieved a 5.6 point mean improvement in the MG-ADL score, with a 93% response rate among AChR+ participants receiving the 680 mg dose [515]. - The Phase 2 proof-of-concept trial for batoclimab in Graves' disease showed a mean IgG reduction of 77% and a 76% response rate after 12 weeks of treatment [510]. - A second potentially registrational trial for IMVT-1402 in Graves' disease is planned to start in summer 2025, enrolling approximately 210 participants [512]. - The company expects to report top-line results from the Phase 3 trial of batoclimab in thyroid eye disease in the second half of calendar year 2025 [513]. - Data from batoclimab studies are being leveraged to inform and accelerate the development of IMVT-1402 [507]. - The Phase 2b trial of batoclimab in chronic inflammatory demyelinating polyneuropathy demonstrated an 84% responder rate in patients achieving at least a 70% IgG reduction [507]. - A potentially registrational trial for IMVT-1402 in CIDP was initiated in March 2025, aiming to enroll approximately 162 participants [521]. - The trial for IMVT-1402 in ACPA-positive D2T RA is expected to enroll approximately 120 participants, with initial results anticipated in 2026 [522]. - A proof-of-concept trial for IMVT-1402 in CLE was initiated in February 2025, with an expected enrollment of approximately 56 participants [524]. - The company plans to initiate a potentially registrational trial for IMVT-1402 in SjD in the summer of 2025, enrolling around 180 participants [523]. Financial Performance - Research and development expenses for the year ended March 31, 2025, increased by $147.99 million compared to the previous year, totaling $360.92 million [540]. - Total operating expenses for the year ended March 31, 2025, were $438.15 million, up from $282.71 million in 2024 [540]. - The net loss for the year ended March 31, 2025, was $413.84 million, compared to a net loss of $259.34 million in 2024 [540]. - General and administrative expenses for the year ended March 31, 2025, were $77.24 million, an increase from $57.28 million in 2024 [540]. - For the year ended March 31, 2025, research and development costs increased by $91.1 million compared to the prior year, with specific increases in endocrine diseases ($29.9 million) and neurological diseases ($52.2 million) due to clinical trial preparations [543]. - Unallocated research and development costs rose by $56.9 million, driven by higher personnel-related expenses of $37.2 million and other expenses of $19.7 million [544]. - General and administrative expenses increased by $20.0 million for the year ended March 31, 2025, primarily due to higher personnel-related expenses and professional fees [550]. - The company has not generated any revenue and continues to incur significant operating losses since inception [530]. - As of March 31, 2025, cash and cash equivalents were $714.0 million, up from $635.4 million in the previous year, while net losses were $413.8 million [552]. - Cash used in operating activities for the year ended March 31, 2025, was $375.9 million, reflecting a net loss from operations of $413.8 million [559]. - Cash provided by financing activities for the year ended March 31, 2025, was $454.5 million, primarily from a private placement that raised $450.0 million [563]. - The company expects to continue incurring significant expenses and increasing operating losses for the next several years, with no revenue generated to date [552]. - The existing cash and cash equivalents of $714.0 million as of March 31, 2025, are expected to be sufficient to fund operating expenses and capital expenditures through the GD readout anticipated in 2027 [570]. - The company anticipates an increase in short-term and long-term capital requirements to fund clinical development programs and manufacturing of IMVT-1402 [572]. - Current funds are insufficient to complete all necessary development and commercial launch of IMVT-1402 or batoclimab, with expected continued net losses [573]. Milestone Payments and Obligations - The company has a remaining minimum obligation of approximately $43.6 million to Samsung for batoclimab drug substance manufacturing, with payments scheduled through fiscal year 2030 [568]. - As of March 31, 2025, the maximum potential milestone payments under the HanAll Agreement could reach $420.0 million, with $32.5 million already paid for prior milestones [569]. - The company made a milestone payment of $12.5 million during the quarter ended September 30, 2023, following the achievement of regulatory milestones [569]. Research and Development Strategy - Research and development costs are expensed as incurred, primarily consisting of employee compensation and third-party expenses for clinical trials [576]. - The company plans to integrate acquired technologies, expand its intellectual property portfolio, and hire additional personnel to support drug development efforts [577]. Liquidity and Market Risks - As of March 31, 2025, cash and cash equivalents are maintained in accredited financial institutions, with no material effect on liquidity from a hypothetical 10% change in interest rates [578]. - The company does not currently face significant foreign currency exchange rate risk, as expenses are primarily in U.S. dollars [579]. - Inflation has not had a material effect on the company's business or financial condition as of March 31, 2025 [580].