Moderna(MRNA)
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FDA May Not Renew Pfizer's Authorization For Covid Shots In Younger Children, Moderna Prepares To Boost Supply
Benzinga· 2025-08-11 17:55
Core Viewpoint - Pfizer's COVID-19 vaccine for children under five may lose FDA authorization, potentially leading to supply shortages, with Moderna stepping in to fill gaps [1][2][3] Group 1: FDA Authorization and Vaccine Availability - The FDA may not renew the emergency use authorization for Pfizer's pediatric COVID-19 vaccine for the 2025 respiratory season, which could remove the only vaccine available for children under five [2][3] - Pfizer anticipates full FDA approval for its COVID-19 vaccine for children aged 5 to 11 this fall, but options for the youngest age group would be limited without authorization [3] Group 2: Current Vaccine Landscape - Moderna's pediatric vaccine, approved in July, is only available for children with specific health conditions, while Novavax's pediatric shot is available for children 12 and older with similar conditions [4] - The CDC is in discussions with Moderna to increase vaccine supply for young children in anticipation of potential gaps [4] Group 3: Vaccination Rates and Public Health Concerns - Health experts express concern that narrowing vaccine access could further decrease already low vaccination rates, with only 5.6% of children aged six months to four years vaccinated and 15% of children aged 5 to 17 [5] - Despite low uptake, the vaccines are noted to be highly effective in preventing hospitalization and death [5] Group 4: Regulatory Changes and Controversies - The U.S. Health and Human Services Secretary announced that the COVID-19 vaccine will no longer be recommended for pregnant women and healthy children on the CDC's immunization schedule [6] - The FDA has implemented stricter clinical trial requirements for healthy adults and limited annual booster approvals to older and high-risk Americans [7] - A lawsuit has been filed against Robert F. Kennedy Jr. for changes to COVID-19 vaccine recommendations, which plaintiffs argue undermine science and public health [8]
全球制药行业成本压力上升,多家企业宣布减员计划
Di Yi Cai Jing Zi Xun· 2025-08-08 12:12
Core Viewpoint - The global pharmaceutical industry is experiencing a downturn in the capital market due to uncertain policies from the Trump administration, leading to increased cost pressures and a trend of cost-cutting measures among major companies [2][3]. Market Performance - The S&P 500 healthcare sector index has declined by approximately 5% this year, while the overall S&P 500 index has increased by over 7% [2]. - The price-to-earnings (P/E) ratio for the healthcare sector has dropped from nearly 20 times to about 16 times over the past year [3]. Company Actions - Merck has announced a cost-cutting and layoff plan aimed at saving $3 billion annually by 2027, with an expected cost increase of $200 million due to tariffs [3]. - Pfizer has initiated a significant cost reduction plan, targeting net savings of approximately $4.5 billion by the end of 2025 and $7.2 billion by the end of 2027 [4]. - Moderna is facing financial challenges, with its stock price down over 75% in the past year, and plans to cut its workforce by 10% [5]. Future Growth Strategies - Companies are focusing on advancing their drug pipelines to drive future growth, with Novo Nordisk highlighting ongoing clinical trials for key products [6]. - The pharmaceutical industry is facing a wave of patent expirations in the coming years, with nearly $200 billion in sales from drugs set to lose patent protection before 2030 [7]. Mergers and Acquisitions - There has been a notable decrease in large-scale acquisitions in the pharmaceutical sector, with companies now favoring smaller deals to achieve higher returns [8]. - Chinese companies are increasingly attracting interest from global pharmaceutical firms, with licensing deals valued at $35 billion in the first half of the year [9].
深度|全球制药行业成本压力上升,多家企业宣布减员计划
Di Yi Cai Jing Zi Xun· 2025-08-08 08:45
Group 1: Industry Overview - The global pharmaceutical industry is experiencing a downturn in capital markets due to uncertain policy impacts from the Trump administration, leading to increased cost pressures from tariffs and drug price reductions [1][3] - The S&P 500 healthcare sector index, with a total market value of nearly $5 trillion, has declined by approximately 5% this year, while the S&P 500 index has increased by over 7% [1] - The healthcare sector's price-to-earnings (P/E) ratio has dropped from nearly 20 times a year ago to about 16 times, indicating a cooling market [3] Group 2: Company Actions and Financial Performance - Merck has announced a cost-cutting and layoff plan aimed at saving $3 billion annually by 2027, with an expected cost increase of $200 million due to current tariff levels [3] - Pfizer has initiated a significant cost reduction plan, targeting net savings of approximately $4.5 billion by the end of 2025 and $7.2 billion by the end of 2027 [4][5] - Moderna is facing financial challenges, with its stock price down over 75% in the past year, and plans to cut its workforce by 10% to reduce costs [5][6] Group 3: Future Growth and R&D Focus - Companies are actively pushing their drug pipelines forward, with Novo Nordisk highlighting ongoing clinical trials for oral semaglutide and Alzheimer's treatments [7] - Moderna is developing a melanoma vaccine currently in phase three clinical trials, but it may not be available until 2027 or later [7] - The pharmaceutical industry is facing a wave of patent expirations, with nearly $200 billion in sales from drugs expected to lose patent protection before 2030 [8] Group 4: M&A Activity and Market Trends - Merck announced a $10 billion acquisition of UK biotech company Verona to fill gaps from expiring patents, while Pfizer has engaged in a licensing agreement with Chinese company 3SBio for a cancer therapy worth approximately $6 billion [9] - The number of large-scale acquisitions in the pharmaceutical market has significantly decreased, with companies now favoring smaller acquisitions for potentially higher returns [9][10] - Chinese companies have become attractive partners for global pharmaceutical firms, with licensing deals valued at $35 billion in the first half of the year [10]
美国卫生部撤回mRNA疫苗开发拨款;马斯克:特斯拉正在训练新的FSD模型;超微电脑跌超16%,AMD跌超4%【美股盘前】
Mei Ri Jing Ji Xin Wen· 2025-08-06 13:38
每经记者|宋欣悦 每经编辑|陈柯名 兰素英 ④ 【AMD二季度"增收不增利",盘前跌超5%】美芯片巨头AMD盘前跌超5%。消息面上,公司最新公布的财报显示,其二季度的营收超出预期,不过, 二季度营业利润率仅为12%,上年同期为22%。二季度调整后净利润7.81亿美元,同比下降31%。 ⑤ 【马斯克:特斯拉正在训练新的FSD模型】8月6日,马斯克在X上发文称,特斯拉正在训练新的FSD模型,新模型的参数规模约为当前版本的十倍,如 果一切顺利则可能会在下个月底准备好面向公众发布。 ⑥ 【大幅下调营收指引,超微电脑盘前跌超16%】超微电脑盘前跌超16%。消息面上,超微电脑公布的第四财季报告显示,公司预计下季度营收在60亿 ~70亿美元之间,调整后每股收益在0.40~0.52美元之间。2026财年营收预期从此前的400亿美元下调至330亿美元,降幅达17.5%。 ⑦ 【诺和诺德减肥药Wegovy第二季度销售额飙升67%】周三,丹麦制药巨头诺和诺德公布了其2025年第二季度财报。财报显示,其核心产品Wegovy二季 度销售额同比大增67%,至195.3亿丹麦克朗。 ⑧ 【美国卫生部撤回mRNA疫苗开发拨款,众多疫苗大厂" ...
突然!美国决定:撤销!
券商中国· 2025-08-06 10:06
Core Viewpoint - The U.S. government has decided to cancel approximately $500 million in funding for mRNA vaccine development, marking a significant shift away from mRNA technology in public health strategy [2][3]. Group 1: Decision Details - U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced the cancellation of the mRNA vaccine development project, which includes the termination of 22 contracts related to mRNA technology by the Biomedical Advanced Research and Development Authority (BARDA) [2][3]. - The decision is influenced by consultations with top experts from the National Institutes of Health (NIH) and the FDA, concluding that the risks of mRNA technology outweigh its benefits for respiratory viruses like COVID-19 and influenza [3][4]. - The U.S. Department of Health and Human Services plans to redirect the canceled funds to "safer and broader vaccine platforms" that remain effective even with viral mutations [3]. Group 2: Expert Opinions - Many experts argue that mRNA vaccines have a significant advantage in rapid development and adaptability, which is crucial for responding to emerging viruses and variants [6]. - Dr. Peter Hotez criticized the decision as undermining national biosecurity and promoting a "pseudo-scientific agenda" [6]. - Dr. Paul Offit expressed concern that the decision was made without scientific evidence, potentially exposing the nation to unnecessary risks [6]. Group 3: Industry Impact - The cancellation of contracts with companies like Moderna and others indicates a broader shift in the U.S. government's approach to vaccine development, which may affect future innovations in the biomedical field [5][6]. - The U.S. Department of Health and Human Services is also terminating contracts with Emory University and Tiba Biotech, which were working on mRNA-based antiviral platforms [6].
Moderna Q2 Earnings Review: Downsizing Triggers Selloff, But I'm Long-Term Bullish
Seeking Alpha· 2025-08-04 13:33
Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has compiled detailed reports on more than 1,000 companies [1]
异动盘点0804|英诺赛科涨超8%,优必选涨超5%;亚马逊跌超8%,Rocket股价走高涨超11%,Reddit涨超17%
贝塔投资智库· 2025-08-04 04:03
Group 1: Market Performance - Dongyue Group (00189) saw a rise of over 1%, with expectations for increased refrigerant demand as the new cooling season begins, despite a seasonal decline in August [1] - Hong Kong's banking stocks experienced a rally, with Agricultural Bank (01288) up over 2%, and other banks like ICBC (01398) and China Merchants Bank (03968) also gaining over 1%. The overall asset quality of listed banks remains stable, and profit growth is expected to continue [1] - In the gold sector, Lingbao Gold (03330) rose over 3%, with other companies like Chifeng Jilong Gold (06693) and Shandong Gold (01787) also seeing significant gains, driven by lower-than-expected U.S. job growth data which increased interest in gold [3] Group 2: Company Announcements - InnoCare (02577) surged over 8% after being named the only Chinese chip company in NVIDIA's 800VDC power architecture collaboration, indicating a significant partnership in AI data centers [2] - Derun Shipping (02510) announced a profit forecast of approximately $180 million to $200 million for the six months ending June 30, 2025, representing a 220% to 255% increase compared to the previous year [2] - China Eastern Education (00667) reported an expected profit increase of no less than 45% for the first half of the year, driven by a 7% increase in new student registrations and effective cost control [3] Group 3: Financial Results - Amazon (AMZN.US) reported second-quarter earnings that exceeded expectations, with AWS revenue growing 17% year-over-year, but the third-quarter profit guidance fell short of market expectations [5] - Coinbase (COIN.US) saw a 16.7% drop after reporting second-quarter revenue of $1.5 billion, which was below analyst expectations, despite a significant profit increase due to investments [5] - Moderna (MRNA.US) experienced a decline of over 10% due to delays in vaccine shipments, leading to a downward revision of its revenue forecast for 2025 [7]
莫德纳宣布裁员10%!疫苗巨头员工数将降至5000人以下,股价一年跌超75%
Jin Rong Jie· 2025-08-02 16:17
Core Insights - Moderna announced a global workforce reduction of approximately 10%, which translates to nearly 800 employees, bringing the total number of employees below 5,000 by the end of the year [1][3] - The decision to cut jobs is driven by a significant decline in vaccine sales revenue, with the company's stock price dropping over 75% in the past year and market capitalization plummeting from nearly $200 billion to around $11 billion, a decrease of over 90% [3] Financial Pressure and Strategic Adjustments - To address the revenue decline, Moderna has implemented several cost-cutting measures, including a plan to reduce annual operating expenses by approximately $1.5 billion by 2027 [3] - The company also canceled plans to build an mRNA drug manufacturing facility in Japan due to changes in the global and Japanese business environment, indicating a strategic retreat from non-core business investments [3] Market Environment Challenges - Changes in U.S. health policy have directly impacted Moderna's business, including the withdrawal of long-term vaccination recommendations for children and pregnant women, which has narrowed the market for its latest vaccine [4] - The termination of a contract for developing an avian flu vaccine further constricts the company's business scope [4] - Moderna's second major product, the respiratory syncytial virus vaccine, has not gained significant market attention, leading to a downward revision of the company's revenue expectations for the year [4] - The timeline for achieving breakeven has been pushed from 2026 to 2028 due to underperformance in sales [4] - Despite these challenges, the CEO remains optimistic, highlighting that Moderna currently has three approved products and up to eight more expected to be approved within the next three years [4]
Here's What Key Metrics Tell Us About Moderna (MRNA) Q2 Earnings
ZACKS· 2025-08-01 23:01
Core Insights - Moderna reported revenue of $142 million for the quarter ended June 2025, a decrease of 41.1% year-over-year, with an EPS of -$2.13 compared to -$3.33 in the same quarter last year [1] - The revenue exceeded the Zacks Consensus Estimate of $127.17 million by 11.66%, while the EPS also surpassed the consensus estimate of -$2.99 by 28.76% [1] Revenue Breakdown - Product sales in the United States were $88 million, significantly higher than the average estimate of $28.31 million, but represented a year-over-year decline of 45.7% [4] - Product sales in the Rest of the World reached $26 million, below the average estimate of $42.95 million, but showed an 18.2% increase year-over-year [4] - Net product sales totaled $114 million, exceeding the average estimate of $81.42 million, but reflected a 38% decrease compared to the previous year [4] - Other revenue amounted to $28 million, slightly above the average estimate of $25.13 million, but indicated a 50.9% decline year-over-year [4] - Grant revenue was reported at $5 million, compared to the average estimate of $6.16 million [4] - Licensing and royalty revenue was $2 million, significantly lower than the average estimate of $10.65 million [4] - Collaboration revenue reached $4 million, below the average estimate of $7.5 million [4] Stock Performance - Over the past month, Moderna's shares have returned -3.1%, contrasting with the Zacks S&P 500 composite's increase of 2.3% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]
Moderna(MRNA) - 2025 Q2 - Quarterly Report
2025-08-01 20:03
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a net loss of $825 million in Q2 2025, an improvement from Q2 2024, with total assets decreasing to $12.0 billion due to cash used in operations [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$12.01 billion** by June 30, 2025, from **$14.14 billion**, driven by reduced cash and investments, with equity declining to **$9.40 billion** Condensed Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$12,010** | **$14,142** | | Cash and cash equivalents | $1,279 | $1,927 | | Total investments | $6,226 | $7,592 | | **Total Liabilities** | **$2,611** | **$3,241** | | Total current liabilities | $1,572 | $2,206 | | **Total Stockholders' Equity** | **$9,399** | **$10,901** | | Retained earnings | $8,249 | $10,045 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 total revenue decreased 41% to **$142 million**, resulting in a net loss of **$825 million**, which narrowed from Q2 2024 due to a 43% reduction in R&D expenses Statement of Operations Summary (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $142 | $241 | $250 | $408 | | Research and development | $700 | $1,221 | $1,556 | $2,284 | | Total operating expenses | $1,049 | $1,604 | $2,207 | $3,037 | | Loss from operations | $(907) | $(1,363) | $(1,957) | $(2,629) | | Net loss | $(825) | $(1,279) | $(1,796) | $(2,454) | | Net loss per share (basic and diluted) | $(2.13) | $(3.33) | $(4.64) | $(6.41) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities for H1 2025 was **$1.96 billion**, an improvement from 2024, with investing activities providing **$1.29 billion**, resulting in a **$648 million** decrease in cash Cash Flow Summary for Six Months Ended June 30 (in millions) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,956) | $(2,263) | | Net cash provided by investing activities | $1,294 | $1,767 | | Net cash provided by financing activities | $13 | $48 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(648)** | **$(448)** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business, accounting policies, and financial components, highlighting three commercial products, declining sales, key collaborations, increased inventory write-downs, and patent litigation - The company has three commercial products: **Spikevax** (original COVID vaccine), **mRESVIA** (RSV vaccine), and **mNEXSPIKE** (next-gen COVID vaccine) It has a pipeline of **30 development candidates** across **39 programs**[30](index=30&type=chunk) Net Product Sales by Product (in millions) | Product | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | COVID | $114 | $184 | $198 | $351 | | RSV | $— | $— | $2 | $— | | **Total** | **$114** | **$184** | **$200** | **$351** | - A development and commercialization funding arrangement with Blackstone for the mRNA-based influenza vaccine program resulted in a reduction of R&D expenses by **$160 million** and **$250 million** for the three and six months ended June 30, 2025, respectively[55](index=55&type=chunk)[56](index=56&type=chunk) - Inventory write-downs increased to **$38 million** in Q2 2025 and **$80 million** in H1 2025, compared to **$14 million** and **$44 million** in the respective prior-year periods, mainly due to excess demand forecasts and shelf-life expiration[64](index=64&type=chunk) - The company is involved in significant patent-infringement litigation with multiple parties, including **Pfizer/BioNTech**, **Arbutus**, **Alnylam**, and **GSK**[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - As of June 30, 2025, **$1.7 billion** remains under the board's authorization for share repurchases No shares were repurchased during the first six months of 2025[100](index=100&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a **41%** Q2 2025 revenue decline due to lower COVID vaccine sales, with net loss narrowing from reduced R&D and SG&A expenses, and highlights key regulatory approvals and sufficient liquidity [Business Highlights and Recent Program Developments](index=31&type=section&id=Business%20Highlights%20and%20Recent%20Program%20Developments) Moderna achieved key regulatory milestones with FDA approvals for **mNEXSPIKE** and expanded **mRESVIA**, reported positive Phase 3 flu vaccine results, and advanced CMV, Norovirus, and oncology programs - In May 2025, the FDA approved **mNEXSPIKE (mRNA-1283)**, the company's next-generation COVID-19 vaccine, for individuals 12 and older at risk, based on a Phase 3 study showing non-inferiority and higher relative efficacy compared to Spikevax[109](index=109&type=chunk) - In June 2025, the FDA expanded the approval of **mRESVIA**, the RSV vaccine, to include adults aged 18-59 at increased risk, building on the initial approval for adults 60 and older[110](index=110&type=chunk) - The seasonal flu vaccine candidate (**mRNA-1010**) achieved its primary superiority endpoint in a Phase 3 study, showing **26.6%** relative vaccine efficacy compared to a licensed standard-dose vaccine The company is preparing for FDA submission[115](index=115&type=chunk) - The pivotal Phase 3 study for the CMV vaccine candidate (**mRNA-1647**) is fully enrolled with a final analysis anticipated in 2025[115](index=115&type=chunk) [Results of Operations Analysis](index=35&type=section&id=Results%20of%20Operations%20Analysis) Q2 2025 total revenue decreased **41%** to **$142 million** due to lower product sales, while cost of sales rose to **105%**, and operating expenses significantly reduced with R&D down **43%** Q2 2025 vs Q2 2024 Performance (in millions) | Metric | Q2 2025 | Q2 2024 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $114 | $184 | $(70) | (38)% | | Total revenue | $142 | $241 | $(99) | (41)% | | Cost of sales | $119 | $115 | $4 | 3% | | Research and development | $700 | $1,221 | $(521) | (43)% | | Selling, general and administrative | $230 | $268 | $(38) | (14)% | | Net loss | $(825) | $(1,279) | $454 | 35% | - The decrease in Q2 and H1 2025 revenue was largely due to lower sales volume and a lower average selling price for the COVID vaccine in the U.S. market[126](index=126&type=chunk)[127](index=127&type=chunk) - Cost of sales as a percentage of net product sales increased to **105%** in Q2 2025, compared to **62%** in Q2 2024, primarily due to the impact of lower net product sales against largely fixed manufacturing costs[130](index=130&type=chunk) - The **43%** decrease in Q2 2025 R&D expenses was driven by lower clinical manufacturing and trial expenses, investment reprioritization, and a **$62 million** benefit from the Blackstone funding arrangement[132](index=132&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, Moderna held **$7.5 billion** in cash and investments, a **$2.0 billion** decrease from December 2024, primarily due to operating cash outflow, but believes it has sufficient funding for 12 months Financial Position (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,279 | $1,927 | | Total Investments | $6,226 | $7,592 | | **Total Cash & Investments** | **$7,505** | **$9,519** | | Working Capital | $4,599 | $5,893 | - Net cash used in operating activities for the first six months of 2025 was **$2.0 billion**, driven by a net loss of **$1.8 billion** and changes in working capital[147](index=147&type=chunk) - The company believes its cash, cash equivalents, and investments as of June 30, 2025, will be sufficient to fund operations and capital expenditures for at least the next **12 months**[155](index=155&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No material changes occurred in the company's market risks or their management during the first six months of 2025 compared to the 2024 Form 10-K disclosure - There have been no material changes to the company's market risk or its management of such risks for the three and six months ended June 30, 2025[158](index=158&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[159](index=159&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[160](index=160&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company provides updates on ongoing patent litigation, including the Arbutus trial rescheduled to March 2026, new GSK lawsuits, and a favorable appeal decision with Alnylam - The patent infringement trial with **Arbutus Biopharma** and **Genevant Sciences** has been rescheduled to begin on **March 9, 2026**[164](index=164&type=chunk) - In July 2025, **GlaxoSmithKline (GSK)** filed two new patent infringement lawsuits against Moderna in the **Unified Patent Court (UPC)** related to liposomes for RNA delivery, seeking monetary and injunctive relief[165](index=165&type=chunk) - In a case with **Alnylam Pharmaceuticals**, the Federal Circuit Court of Appeals decided an appeal in Moderna's favor on **June 4, 2025**, regarding a judgment of non-infringement[166](index=166&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred in the company's risk factors compared to those previously disclosed in the 2024 Annual Report on Form 10-K - There have been no material changes from the risk factors previously disclosed in the 2024 Form 10-K[167](index=167&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No shares were repurchased during Q2 2025, with **$1.7 billion** remaining under the board's share repurchase authorization, which has no expiration date - No shares were repurchased during the three months ended June 30, 2025[168](index=168&type=chunk) - As of June 30, 2025, **$1.7 billion** of the Board's authorization for share repurchases remains outstanding with no expiration date[168](index=168&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement during the fiscal quarter - No directors or officers adopted or terminated a **Rule 10b5-1** trading plan or a non-Rule 10b5-1 trading arrangement during the quarter[170](index=170&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including officer certifications and XBRL data files