Moderna(MRNA) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents Moderna, Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis for the three months ended March 31, 2025, and 2024 Item 1. Financial Statements (Unaudited) This section presents Moderna, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the accounting policies, business operations, and specific financial line items for the three months ended March 31, 2025, and 2024 Condensed Consolidated Balance Sheets This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time Condensed Consolidated Balance Sheets Data | | March 31, 2025 (millions) | December 31, 2024 (millions) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $1,623 | $1,927 | | Investments (current) | $4,352 | $5,098 | | Accounts receivable, net | $78 | $358 | | Inventory | $128 | $117 | | Total current assets | $6,766 | $8,099 | | Investments, non-current | $2,418 | $2,494 | | Property, plant and equipment, net | $2,212 | $2,196 | | Total assets | $12,704 | $14,142 | | Liabilities | | | | Accounts payable | $226 | $405 | | Accrued liabilities | $1,001 | $1,427 | | Deferred revenue (current) | $125 | $153 | | Total current liabilities | $1,604 | $2,206 | | Total liabilities | $2,638 | $3,241 | | Stockholders' Equity | | | | Total stockholders' equity | $10,066 | $10,901 | | Total liabilities and stockholders' equity | $12,704 | $14,142 | Condensed Consolidated Statements of Operations This statement details the company's revenues, expenses, and net loss over a specific period Condensed Consolidated Statements of Operations Data | | Three Months Ended March 31, 2025 (millions) | Three Months Ended March 31, 2024 (millions) | Change (YoY) | | :--- | :--- | :--- | :--- | | Net product sales | $86 | $167 | (49)% | | Other revenue | $22 | $0 | 100% | | Total revenue | $108 | $167 | (35)% | | Cost of sales | $90 | $96 | (6)% | | Research and development | $856 | $1,063 | (19)% | | Selling, general and administrative | $212 | $274 | (23)% | | Total operating expenses | $1,158 | $1,433 | (19)% | | Loss from operations | $(1,050) | $(1,266) | (17)% | | Net loss | $(971) | $(1,175) | (17)% | | Basic and diluted net loss per share | $(2.52) | $(3.07) | (18)% | Condensed Consolidated Statements of Comprehensive Loss This statement presents the net loss and other comprehensive income or loss components, reflecting changes in equity not resulting from transactions with owners Condensed Consolidated Statements of Comprehensive Loss Data | | Three Months Ended March 31, 2025 (millions) | Three Months Ended March 31, 2024 (millions) | | :--- | :--- | :--- | | Net loss | $(971) | $(1,175) | | Other comprehensive income, net of tax: | | | | Net increase from available-for-sale securities | $15 | $22 | | Pension and postretirement obligation adjustments | $2 | $0 | | Gains on foreign currency translation | $3 | $0 | | Total other comprehensive income | $20 | $22 | | Comprehensive loss | $(951) | $(1,153) | Condensed Consolidated Statements of Stockholders' Equity This statement outlines changes in the company's equity accounts, including common stock, additional paid-in capital, and retained earnings, over a period Condensed Consolidated Statements of Stockholders' Equity Data | | Balance at Dec 31, 2024 (millions) | March 31, 2025 (millions) | Balance at Dec 31, 2023 (millions) | March 31, 2024 (millions) | | :--- | :--- | :--- | :--- | :--- | | Common Stock (Shares) | 386 | 387 | 382 | 383 | | Additional Paid-In Capital | $866 | $982 | $371 | $487 | | Accumulated Other Comprehensive Income (Loss) | $(10) | $10 | $(123) | $(101) | | Retained Earnings | $10,045 | $9,074 | $13,606 | $12,431 | | Total Stockholders' Equity | $10,901 | $10,066 | $13,854 | $12,817 | | Changes (3 months ended March 31, 2025): | | | | | | Stock-based compensation | | $115 | | | | Other comprehensive income, net of tax | | $20 | | | | Net loss | | $(971) | | | Condensed Consolidated Statements of Cash Flows This statement summarizes the cash inflows and outflows from operating, investing, and financing activities over a specific period Condensed Consolidated Statements of Cash Flows Data | | Three Months Ended March 31, 2025 (millions) | Three Months Ended March 31, 2024 (millions) | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,037) | $(989) | | Net cash provided by investing activities | $730 | $118 | | Net cash provided by financing activities | $4 | $14 | | Net decrease in cash, cash equivalents and restricted cash | $(303) | $(857) | | Cash, cash equivalents and restricted cash, end of period | $1,626 | $2,071 | Notes to Condensed Consolidated Financial Statements These notes provide essential details and explanations supporting the condensed consolidated financial statements, clarifying accounting policies and specific financial line items 1. Description of the Business This section describes Moderna's core business as a biotechnology company developing mRNA medicines across various franchises and highlights its key commercial products and pipeline - Moderna is a biotechnology company developing mRNA medicines across four franchises: respiratory virus vaccines, latent and other virus vaccines, oncology therapeutics, and rare disease therapeutics[27] - The company's first commercial product is Spikevax (mRNA-1273), its COVID vaccine[28] - mRESVIA (mRNA-1345), an mRNA RSV vaccine, was approved by the FDA in May 2024 for adults aged 60 years and older, marking the second approved product[28] - Moderna has a diverse pipeline of 31 development candidates across 41 programs, with 38 currently in clinical studies[28] 2. Summary of Basis of Presentation and Recent Accounting Standards This section outlines the accounting principles used in preparing the financial statements and discusses recent accounting standard updates and their impact - Financial statements are prepared in accordance with U.S. GAAP and SEC rules for interim reporting, consistent with the 2024 Form 10-K[29] - Effective January 1, 2025, the estimated useful life of certain manufacturing equipment was revised from five years to a range of five to twelve years, reflecting expanded internal manufacturing capabilities[32] - The company anticipates seasonal fluctuations in demand for COVID and RSV vaccines, with higher sales expected during fall and winter[30] Other Comprehensive Income Components | Component | Balance at Dec 31, 2024 (millions) | Other Comprehensive Income (millions) | Balance at Mar 31, 2025 (millions) | | :--- | :--- | :--- | :--- | | Unrealized Gains on Available-for-Sale Debt Securities | $10 | $15 | $25 | | Pension and Postretirement Obligation Adjustments | $(12) | $2 | $(10) | | Losses on Foreign Currency Translation | $(8) | $3 | $(5) | | Total | $(10) | $20 | $10 | 3. Net Product Sales This section details the company's net product sales, breaking them down by geographic location and product, and explains the factors influencing sales performance Net Product Sales by Geographic Location | Geographic Location | 2025 (millions) | 2024 (millions) | | :--- | :--- | :--- | | United States | $31 | $100 | | Europe | $0 | $0 | | Rest of world | $55 | $67 | | Total | $86 | $167 | Net Product Sales by Product | Product | 2025 (millions) | 2024 (millions) | | :--- | :--- | :--- | | COVID | $84 | $167 | | RSV | $2 | $0 | | Total | $86 | $167 | - Net product sales decreased by $81 million (49%) YoY, mainly due to lower COVID vaccine sales in the U.S. market driven by reduced vaccination rates[121] - Deferred revenue related to customer deposits for the COVID vaccine was $154 million as of March 31, 2025, with $96 million expected to be realized within one year[43][119] 4. Other Revenue This section provides a breakdown of other revenue streams, including grant, collaboration, and licensing income, and explains significant changes year-over-year Other Revenue by Type | Revenue Type | 2025 (millions) | 2024 (millions) | | :--- | :--- | :--- | | Grant revenue | $1 | $0 | | Collaboration revenue | $1 | $0 | | Licensing and royalty revenue | $8 | $0 | | Other revenue | $12 | $0 | | Total other revenue | $22 | $0 | - Other revenue increased by $22 million (100%) YoY, mainly due to an increase in licensing and royalty and other revenue[123] - In April 2024, Moderna entered a non-exclusive out-licensing agreement for mRNA COVID-related IP in Japan, receiving an upfront payment of $50 million, of which $30 million was recognized as other revenue[48] - Moderna was awarded up to $176 million and $590 million by BARDA in June 2024 and January 2025, respectively, to accelerate development of mRNA-based pandemic influenza vaccines[47] 5. Collaboration Agreements and Research and Development Funding Arrangement This section describes key collaboration agreements and funding arrangements that impact the company's research and development activities and expenses - Moderna collaborates with Merck on personalized mRNA cancer vaccines (INT), with costs and profits generally shared equally worldwide[51] - For Q1 2025, expenses related to the INT collaboration, net of Merck's reimbursements, were $104 million, compared to $76 million in Q1 2024[51] - Moderna has a funding arrangement with Blackstone Life Sciences for up to $750 million to support mRNA-based influenza vaccine development[53] - Funding from Blackstone is recognized as a reduction to R&D expenses; $90 million was recorded as a reduction in Q1 2025[54] 6. Financial Instruments This section details the company's financial instruments, including cash, cash equivalents, and investments, and their fair value measurements Financial Instruments Fair Value | Category | March 31, 2025 (millions) | December 31, 2024 (millions) | | :--- | :--- | :--- | | Cash and cash equivalents | $1,623 | $1,927 | | Certificates of deposit | $102 | $52 | | U.S. treasury bills | $731 | $786 | | U.S. treasury notes | $2,870 | $3,036 | | Corporate debt securities | $2,975 | $3,580 | | Government debt securities | $92 | $138 | | Total Estimated Fair Value | $8,393 | $9,519 | - The company held 180 available-for-sale securities in an unrealized loss position as of March 31, 2025, but does not intend to sell them before recovery of carrying values[58] - Net losses on equity investments from changes in fair value were $8 million in Q1 2025, down from $13 million in Q1 2024[62] 7. Inventory This section provides a breakdown of inventory components and discusses inventory write-downs and losses on firm purchase commitments Inventory Components | Category | March 31, 2025 (millions) | December 31, 2024 (millions) | | :--- | :--- | :--- | | Raw materials | $75 | $63 | | Work in progress | $39 | $26 | | Finished goods | $14 | $28 | | Total inventory | $128 | $117 | | Inventory, non-current | $134 | $150 | - Inventory write-downs were $42 million in Q1 2025, compared to $30 million in Q1 2024, primarily due to inventory in excess of expected demand and shelf-life expiration[64] - Losses on firm purchase commitments were $10 million in Q1 2025, related to excess raw material purchase commitments[64] 8. Property, Plant and Equipment, Net This section details the company's property, plant, and equipment, including land, buildings, and manufacturing equipment, along with accumulated depreciation Property, Plant and Equipment, Net Data | Category | March 31, 2025 (millions) | December 31, 2024 (millions) | | :--- | :--- | :--- | | Land and land improvements | $59 | $59 | | Building and building improvements | $759 | $743 | | Manufacturing and laboratory equipment | $361 | $344 | | Construction in progress | $1,078 | $1,057 | | Total | $2,778 | $2,723 | | Less: Accumulated depreciation | $(566) | $(527) | | Property, plant and equipment, net | $2,212 | $2,196 | - Depreciation and amortization expense for Q1 2025 was $38 million, compared to $35 million in Q1 2024[66] 9. Other Balance Sheet Components This section provides further detail on various balance sheet items such as accounts receivable and accrued liabilities Accounts Receivable, Net | Category | March 31, 2025 (millions) | December 31, 2024 (millions) | | :--- | :--- | :--- | | Accounts receivable | $249 | $698 | | Less: Wholesalers chargebacks, discounts and fees | $(171) | $(340) | | Accounts receivable, net | $78 | $358 | Accrued Liabilities | Category | March 31, 2025 (millions) | December 31, 2024 (millions) | | :--- | :--- | :--- | | Provisions related to product sales | $337 | $370 | | Manufacturing | $128 | $109 | | Compensation-related | $120 | $312 | | Development operations | $120 | $120 | | Clinical trials | $88 | $94 | | Loss on future firm purchase commitments | $20 | $60 | | Total accrued liabilities | $1,001 | $1,427 | - Research and development funding receivable increased to $32 million as of March 31, 2025, from $0 at December 31, 2024[69] 10. Leases This section describes the company's lease arrangements for facilities and equipment, including current and non-current lease liabilities - Moderna leases facilities and equipment, including its headquarters (Moderna Science Center) and manufacturing campus (Moderna Technology Center)[76][77] - The company completed the acquisition of the Moderna Technology Center campus in December 2024[77] Lease Liabilities | Category | March 31, 2025 (millions) | December 31, 2024 (millions) | | :--- | :--- | :--- | | Operating lease liabilities (current) | $15 | $14 | | Financing lease liabilities (current) | $28 | $23 | | Operating lease liabilities (non-current) | $667 | $671 | | Financing lease liabilities (non-current) | $35 | $39 | | Total lease liabilities | $745 | $747 | 11. Commitments and Contingencies This section outlines the company's legal proceedings, indemnification arrangements, and non-cancelable purchase commitments - Moderna is involved in various ordinary course legal proceedings, but no material loss is probable or estimable at this time[81] - The company has standard indemnification arrangements with officers, directors, employees, landlords, and business partners[82][83][84] - As of March 31, 2025, non-cancelable purchase commitments for raw materials and manufacturing agreements totaled $454 million, expected to be paid through 2027[86] - Non-cancelable purchase commitments for research and development and other goods/services totaled $191 million, expected to be paid through 2028[86] - The company has cancelable open purchase orders of $2.6 billion for clinical operations and contract manufacturing, assuming no cancellation[87] 12. Stock-Based Compensation and Share Repurchase Programs This section details the company's stock-based compensation expenses and information regarding its share repurchase programs Stock-Based Compensation Expense | Category | 2025 (millions) | 2024 (millions) | | :--- | :--- | :--- | | Options | $39 | $40 | | Restricted Stock Units (RSUs) | $71 | $55 | | Performance Stock Units (PSUs) | $1 | $3 | | Employee Stock Purchase Plan (ESPP) | $4 | $3 | | Total | $115 | $101 | - As of March 31, 2025, $1.1 billion of unrecognized compensation cost related to unvested stock-based compensation is expected to be recognized over a weighted-average period of 2.3 years[92] - The company revised its Black-Scholes option pricing model assumptions, including expected term and volatility, effective Q1 2025, without material impact on financial statements[93] - $1.7 billion remains authorized for common stock repurchases under the 2022 Repurchase Programs, with no shares repurchased in Q1 2025[94] 13. Income Taxes This section presents the company's income tax provision, effective tax rate, and factors influencing tax expense Income Tax Data | Category | 2025 (millions) | 2024 (millions) | | :--- | :--- | :--- | | Loss before income taxes | $(964) | $(1,165) | | Provision for income taxes | $7 | $10 | | Effective tax rate | (0.7)% | (0.9)% | - The effective tax rate for Q1 2025 was higher than the statutory rate due to a global valuation allowance, limiting recognition of tax benefits from losses[95] - The company is under audit in various state and foreign jurisdictions, with no proposed adjustments to tax positions as of March 31, 2025[97] 14. Loss per Share This section provides the calculation of basic and diluted net loss per share, including the weighted-average common shares outstanding Loss per Share Data | Category | 2025 (millions, except per share) | 2024 (millions, except per share) | | :--- | :--- | :--- | | Net loss | $(971) | $(1,175) | | Basic and diluted weighted-average common shares outstanding | 386 | 382 | | Basic and diluted EPS | $(2.52) | $(3.07) | - Common stock equivalents of 49 million shares (2025) and 35 million shares (2024) were excluded from diluted EPS calculation as their inclusion would have been anti-dilutive[98] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides a comprehensive discussion and analysis of Moderna's financial condition and results of operations for the three months ended March 31, 2025, compared to the same period in 2024. It covers an overview of the business, key highlights, recent program developments, detailed financial performance, liquidity, capital resources, and critical accounting policies Overview This section provides a high-level summary of Moderna's business, its transition to a commercial enterprise, and its product pipeline - Moderna is a biotechnology company focused on mRNA medicines, with a platform enabling a robust pipeline across four franchises[101] - The company has transitioned from a research-stage company to a commercial enterprise with a diverse clinical portfolio and integrated manufacturing capabilities[102] - Approved products include Spikevax (COVID vaccine) and mRESVIA (RSV vaccine), with mRESVIA approved by the FDA in May 2024 for adults aged 60 and older[103] - The development pipeline includes 31 candidates across 41 programs, with 38 in clinical studies[102] Business Highlights This section summarizes key achievements and financial metrics for the reporting period, including regulatory approvals and sales performance - mRESVIA (RSV vaccine) received regulatory approvals in the U.S., European Union, Australia, UK, Switzerland, and Taiwan, and is commercially available[104] - Moderna was awarded a multi-year tender agreement in January 2025 to supply its mRNA COVID vaccine to 17 EU countries, Norway, and North Macedonia[105] Key Financial Metrics | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net product sales | $86 million | $167 million | | Loss per share | $(2.52) | $(3.07) | Recent Program Developments This section details the progress and status of Moderna's various vaccine and therapeutic candidates in its development pipeline - Next-generation COVID vaccine (mRNA-1283) filed for FDA approval with a PDUFA goal date of May 31, 2025[107] - RSV vaccine (mRNA-1345) for high-risk adults aged 18-59 filed for FDA approval with a PDUFA goal date of June 12, 2025[113] - Seasonal flu + COVID vaccine (mRNA-1083) approval targeted for 2026 due to need for Phase 3 flu efficacy data; deprioritized for adults aged 18-49[113] - Pivotal Phase 3 study for CMV vaccine (mRNA-1647) is fully enrolled, with final efficacy data anticipated in 2025, despite not meeting early efficacy criteria in December 2024[113] - Individualized Neoantigen Therapy (INT, mRNA-4157) Phase 3 clinical trial for adjuvant melanoma is fully enrolled, with two Phase 3 studies for NSCLC and Phase 2 studies for bladder cancer and renal cell carcinoma ongoing/enrolling[113] - Checkpoint adaptive immune modulation therapy (AIM-T, mRNA-4359) added to oncology pipeline, with Phase 1/2 study ongoing and Phase 2 study enrolling for melanoma and NSCLC[113] - Development of mRNA-1011/1012, mRNA-1020/1030, and preclinical PKU candidate (mRNA-3210) has been paused or discontinued due to strategic prioritization[109][113] Results of operations This section provides a detailed analysis of the company's financial performance, including revenue, operating expenses, and net loss Consolidated Results of Operations | | 2025 (millions) | 2024 (millions) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $86 | $167 | $(81) | (49)% | | Other revenue | $22 | $0 | $22 | 100% | | Total revenue | $108 | $167 | $(59) | (35)% | | Total operating expenses | $1,158 | $1,433 | $(275) | (19)% | | Loss from operations | $(1,050) | $(1,266) | $216 | (17)% | | Net loss | $(971) | $(1,175) | $204 | (17)% | Revenue This section analyzes the company's net product sales and other revenue streams, explaining the drivers of changes year-over-year - Net product sales decreased by $81 million (49%) YoY, primarily due to lower sales of the COVID vaccine in the U.S. market[121] - RSV vaccine sales contributed $2 million in Q1 2025, compared to none in Q1 2024[117] - Other revenue increased by $22 million (100%) YoY, driven by licensing and royalty revenue[123] - Demand for COVID and RSV vaccines is expected to follow a seasonal pattern, with full-year 2025 net product sales anticipated to be lower than 2024 due to reduced vaccination rates and increased competition[122] Operating expenses This section details the components of operating expenses, including cost of sales, research and development, and selling, general and administrative expenses - Total operating expenses decreased by $275 million (19%) YoY[116] - Cost of sales decreased by $6 million (6%) YoY to $90 million, but increased to 104% of net product sales (from 58% in Q1 2024) due to lower sales volume and fixed manufacturing costs[125] - Cost of sales for Q1 2025 included $42 million in inventory write-downs, $21 million in unutilized manufacturing capacity/wind-down costs, and $10 million in losses on firm purchase commitments[124] - Research and development expenses decreased by $207 million (19%) YoY, primarily due to a $134 million decrease in clinical trial and manufacturing expenses across several vaccine programs[127] - Selling, general and administrative expenses decreased by $62 million (23%) YoY, driven by broad-based reductions in digital, facility, marketing, personnel, and consulting costs[129] Interest income This section discusses the company's interest income and the factors influencing its changes Interest Income Data | Metric | 2025 (millions) | 2024 (millions) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Interest income | $90 | $120 | $(30) | (25)% | - The decrease in interest income was primarily due to lower average investment balances[131] Other expense, net This section explains other non-operating expenses and income, including losses on investments and interest expense Other Expense, Net Data | Category | 2025 (millions) | 2024 (millions) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Loss on investments | $(7) | $(15) | $8 | (53)% | | Interest expense | $(1) | $(6) | $5 | (83)% | | Other income, net | $4 | $2 | $2 | 100% | | Total other expense, net | $(4) | $(19) | $15 | (79)% | - The decrease in total other expense, net, was primarily driven by lower interest expense and reduced losses on equity investments[132] Income taxes This section analyzes the company's income tax provision and effective tax rate Income Tax Provision | Metric | 2025 (millions) | 2024 (millions) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Provision for income taxes | $7 | $10 | $(3) | (30)% | - The decrease was primarily due to the continued maintenance of the global valuation allowance, limiting the ability to recognize tax benefits from losses[133] Liquidity and capital resources This section assesses the company's ability to meet its short-term and long-term financial obligations, including cash, investments, and working capital Financial Assets and Working Capital | Category | March 31, 2025 (millions) | December 31, 2024 (millions) | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $1,623 | $1,927 | $(304) | (16)% | | Investments (current) | $4,352 | $5,098 | $(746) | (15)% | | Investments (non-current) | $2,418 | $2,494 | $(76) | (3)% | | Total Financial Assets | $8,393 | $9,519 | $(1,126) | (12)% | | Working capital | $5,162 | $5,893 | $(731) | (12)% | - The decrease in financial assets was primarily due to $1.0 billion net cash outflow from operating activities and $117 million in property and equipment purchases[134] - Net cash used in operating activities increased by $48 million (5%) YoY to $1.0 billion, mainly due to changes in accounts receivable, partially offset by a decrease in net loss and accrued liabilities[141] - Net cash provided by investing activities increased by $612 million (519%) YoY to $730 million, primarily due to a decrease in purchases of marketable securities[144] - The company believes its cash, cash equivalents, and investments, along with expected product sales, will be sufficient to fund operations and capital expenditures for at least the next 12 months[148] Critical accounting policies and significant judgments and estimates This section discusses the accounting policies that require management's most difficult, subjective, or complex judgments - No material changes in critical accounting policies and estimates for Q1 2025 compared to the 2024 Form 10-K[149] Contractual Obligations This section outlines the company's material contractual obligations and commitments - No material changes to contractual obligations and commitments as of March 31, 2025, beyond disclosures in Notes 10 and 11[150] Item 3. Quantitative and Qualitative Disclosures about Market Risk There have been no material changes to Moderna's market risks or its management of such risks for the three months ended March 31, 2025, as previously summarized in the 2024 Form 10-K - No material changes to market risk or risk management for Q1 2025 compared to the 2024 Form 10-K[151] Item 4. Controls and Procedures This section details the evaluation of Moderna's disclosure controls and procedures, concluding their effectiveness at a reasonable assurance level. It also confirms no material changes in internal control over financial reporting during the quarter and acknowledges the inherent limitations of all control systems Disclosure Controls and Procedures This section confirms the effectiveness of the company's disclosure controls and procedures as of the reporting period - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of March 31, 2025[152] Changes in Internal Control over Financial Reporting This section reports on any material changes in the company's internal control over financial reporting during the quarter - No material changes in internal control over financial reporting during Q1 2025[153] Inherent Limitations on Effectiveness of Controls This section acknowledges that all control systems have inherent limitations, providing only reasonable assurance, not absolute, against misstatements - Control systems provide only reasonable assurance, not absolute, due to inherent limitations such as faulty judgment, human error, circumvention, or management override[154] PART II. OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings Moderna is involved in various legal proceedings, including patent infringement lawsuits against Pfizer/BioNTech (where a German court ruled in Moderna's favor on one patent, subject to appeal), and new lawsuits filed by Arbutus and Genevant concerning lipid nanoparticle patents for Spikevax and mRESVIA. GSK also has ongoing patent infringement cases against Moderna - Moderna is involved in patent infringement proceedings against Pfizer Inc. and BioNTech SE in the U.S. and Europe[156] - In March 2025, the Dusseldorf Regional Court in Germany ruled that Pfizer and BioNTech violated one of Moderna's European patents related to its COVID vaccine technology, with damages to be determined[157] - Arbutus Biopharma Corporation and Genevant Sciences GmbH filed five international lawsuits in March 2025, asserting infringement of lipid nanoparticle patents by Spikevax and/or mRESVIA[158] - GlaxoSmithKline Biologicals SA (GSK) has filed two complaints against Moderna in the U.S. District Court for the District of Delaware, asserting patent infringement by Spikevax or mRESVIA, with trials set for July and August 2027[159] Pfizer/BioNTech Patent Litigation This section details the ongoing patent infringement lawsuits between Moderna and Pfizer/BioNTech in the U.S. and Germany - U.S. litigation against Pfizer/BioNTech is stayed pending IPRs; PTAB found challenged claims in two Moderna patents unpatentable in March 2025, subject to appeal[156] - Dusseldorf Regional Court in Germany ruled that Pfizer and BioNTech violated one of Moderna's European patents related to its COVID vaccine technology, with damages to be determined[157] Proceedings Related to Patents Owned by Arbutus This section describes the international patent infringement lawsuits filed by Arbutus and Genevant against Moderna concerning lipid nanoparticle technology - Arbutus and Genevant filed five international lawsuits in March 2025, asserting that Spikevax and/or mRESVIA infringe certain lipid nanoparticle patents[158] - Lawsuits were filed in Canadian Federal Court, Tokyo District Court, Swiss Federal Patent Court, and two actions in the Unified Patent Court, seeking monetary and injunctive relief[158] Proceedings Related to Patents Owned by GSK This section outlines the patent infringement complaints filed by GlaxoSmithKline against Moderna in the U.S. District Court - GSK filed two complaints against Moderna in the U.S. District Court for the District of Delaware, asserting that Spikevax or mRESVIA infringe GSK's patents[159] - Trial dates for these cases are set for July 19, 2027 (Spikevax) and August 23, 2027 (mRESVIA)[159] Item 1A. Risk Factors There have been no material changes to the risk factors previously disclosed in the 2024 Form 10-K - No material changes from the risk factors previously disclosed in the 2024 Form 10-K[160] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds As of March 31, 2025, $1.7 billion remains authorized under the Board of Directors' share repurchase program, with no shares repurchased during Q1 2025 - $1.7 billion remains authorized for common stock repurchases under the 2022 Repurchase Programs, with no expiration date[161] - No shares were repurchased during the three months ended March 31, 2025[161] Item 5. Other Information On March 13, 2025, director Abbas Hussain adopted a Rule 10b5-1 trading plan to sell up to 313 shares of common stock on June 11, 2025, to satisfy tax obligations related to equity award vesting - Director Abbas Hussain adopted a Rule 10b5-1 plan on March 13, 2025, to sell up to 313 shares on June 11, 2025, for tax obligations from equity award vesting[163] Item 6. Exhibits This section lists the exhibits filed or incorporated by reference as part of this Form 10-Q, including certifications, XBRL documents, and the cover page interactive data file Exhibit Index | Exhibit No. | Exhibit Index | | :--- | :--- | | 31.1* | Certification of Principal Executive Officer | | 31.2* | Certification of Principal Financial Officer | | 32.1+ | Certification pursuant to 18 U.S.C. Section 1350 | | 101.INS* | XBRL Instance Document | | 101.SCH* | XBRL Taxonomy Extension Schema Document | | 101.CAL* | XBRL Taxonomy Extension Calculation Document | | 101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB* | XBRL Taxonomy Extension Label Linkbase Document | | 101.PRE* | XBRL Taxonomy Extension Presentation Link Document | | 104* | Cover Page Interactive Data File | SIGNATURES This section contains the official signatures of the company's principal executive and financial officers, certifying the accuracy of the report - The report was signed by Stéphane Bancel (CEO) and James M. Mock (CFO) on May 1, 2025[170]