Intismeran autogene (mRNA-4157) - mRNA-4157 is designed to target an individual patient's unique tumor mutation [6] - mRNA-4157 is in Phase 3 study for adjuvant melanoma, which is fully enrolled [6] - mRNA-4157 is in two adjuvant Phase 3 studies for NSCLC, for those with and without prior neoadjuvant treatment [6] - mRNA-4157 is in randomized Phase 2 study for adjuvant high-risk muscle invasive bladder cancer and adjuvant renal cell carcinoma, the latter of which is fully enrolled [6] - mRNA-4157 is in randomized Phase 2 study for high-risk non-muscle invasive bladder cancer (HR NMIBC) [6] - mRNA-4157 is in Phase 1 basket study for solid tumors: Melanoma, Gastric, PDAC, NSCLC [6] Off-the-shelf cancer antigen therapies - mRNA-4359 targets immunosuppressive cells and mechanisms [10] - mRNA-4359 is in Phase 2, with additional indications planned [10, 11] - mRNA-4106 is in Phase 1 [10] - mRNA-4359 encodes for PD-L1 and IDO, targeting both immunosuppressive cells and cancer cells, and is applicable to many different cancer types [15] T-cell engagers - The company is developing two approaches with secreted T-cell engaging antibodies to target surface and intracellular proteins [19] In vivo cell therapy - mRNA-4203 (partnered with Immatics) has an IND open [28]

Core Insights - Moderna is focusing on its oncology pipeline as a key area of interest for investors moving forward [3][4]. Company Overview - The conference call is part of Barclays' 8th annual speaking science conference series, aimed at discussing scientific concepts, clinical program progress, and company strategy [1][2]. Oncology Pipeline - Rose Loughlin, EVP of Research, is presenting a comprehensive slide deck regarding Moderna's oncology pipeline, indicating its importance in the company's future development [3][5]. - The oncology space is highlighted as a significant focus for Moderna, with expectations of substantial investor interest [3].

Summary of Moderna (MRNA) Update / Briefing June 16, 2025 Company Overview - **Company**: Moderna (MRNA) - **Focus**: Oncology pipeline and commercial strategy Key Points on Oncology Pipeline 1. **Oncology as a Key Focus**: The company emphasizes the importance of oncology in its future development, with a focus on individualized therapies and cancer antigen therapies [3][4] 2. **Lead Program - Intisiran Auto Gene (INT)**: This individualized neoantigen therapy has shown a 49% reduction in the risk of recurrence or death in a Phase 2 study for adjuvant melanoma, with pivotal study data expected in 2026 [7][39] 3. **Expansion of INT**: The company is exploring INT in various cancer settings, including combinations with pembrolizumab and as a monotherapy [7][8] 4. **Off-the-Shelf Cancer Antigen Therapies**: These therapies are designed for broader patient use and are currently in development, with lead programs mRNA-4106 and mRNA-4359 targeting specific tumor antigens and training the immune system [10][11] 5. **T Cell Engagers**: The company is developing multiplexed T cell engagers that can target multiple proteins on cancer cells, enhancing the immune response [16][17] 6. **In Vivo Cell Therapies**: Moderna is pursuing innovative approaches to enhance the efficacy of cell therapies, including engineered T cells that can be modified within the patient's body [20][24] Clinical Development and Data 1. **Phase 2 and Phase 3 Studies**: The company is preparing for Phase 3 trials based on encouraging Phase 2 data, with a focus on event-driven trial designs [34][40] 2. **Control Arm Performance**: The performance of the pembrolizumab control arm in Phase 2 is reported to be in line with historical data, addressing investor concerns about patient allocation [32][36] 3. **Safety and Tolerability**: The safety profile of mRNA-4359 and INT is favorable, with low-grade adverse events and no dose-limiting toxicities reported [15][62] Market and Competitive Landscape 1. **Partnerships and Collaborations**: Moderna is closely monitoring competitive developments, including BioNTech's recent acquisition of CareVac and their oncology programs [78] 2. **Regulatory Environment**: The company is navigating a changing political landscape that affects vaccine development and approval processes, particularly in the context of COVID-19 and RSV vaccines [82][86] Financial Guidance and Market Outlook 1. **Revenue Guidance**: Moderna has provided a broad revenue guidance range of $1.5 billion to $2.5 billion for the year, considering potential declines in vaccination rates and other market factors [96] 2. **Future Approvals**: The company is optimistic about upcoming FDA approvals and the potential for expanded indications for its vaccines, particularly for high-risk populations [85][89] Additional Insights 1. **Combination Therapies**: The company is exploring combination therapies with checkpoint inhibitors and other agents, aiming to enhance overall response rates and progression-free survival (PFS) [65][66] 2. **Clinical Trial Design**: The design of clinical trials is being carefully considered, with a focus on achieving statistically significant outcomes that can support regulatory filings [50][52] This summary captures the essential points discussed during the call, highlighting Moderna's strategic focus on oncology, clinical development progress, market positioning, and financial outlook.

Company Performance - Moderna's stock closed at $26.68, showing a decrease of -2.45% from the previous day's closing price, which was less than the S&P 500's daily loss of 1.13% [1] - Over the past month, Moderna's shares increased by 15.65%, outperforming the Medical sector's gain of 3.07% and the S&P 500's gain of 3.55% [1] Financial Projections - The upcoming earnings per share (EPS) for Moderna is projected to be -$2.97, indicating a 10.81% increase from the same quarter last year [2] - Revenue for the same quarter is estimated at $131 million, reflecting a significant decline of 45.64% compared to the equivalent quarter last year [2] - For the full year, the Zacks Consensus Estimates project an EPS of -$9.78 and revenue of $2.08 billion, representing changes of -10.26% and -35.72% from the prior year, respectively [3] Analyst Forecasts - Investors are advised to monitor any recent revisions to analyst forecasts for Moderna, as these revisions indicate the changing nature of near-term business trends [4] - Positive revisions in estimates suggest analysts' confidence in the company's performance and profit potential [4] Zacks Rank and Industry Position - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), currently places Moderna at a rank of 3 (Hold) [6] - Over the past month, the Zacks Consensus EPS estimate for Moderna has increased by 1.28% [6] - The Medical - Biomedical and Genetics industry, which includes Moderna, has a Zacks Industry Rank of 78, placing it in the top 32% of over 250 industries [7]

Core Viewpoint - The approval of Moderna's RSV vaccine for younger adults indicates a potential easing of the previous administration's resistance to mRNA vaccine technology, allowing the company to target a larger market segment [1][2]. Group 1: Regulatory Approvals - The U.S. FDA has approved Moderna's RSV vaccine for adults under 60 who are at high risk of respiratory syncytial virus (RSV) infection, expanding its market reach [1]. - This approval follows the FDA's earlier authorization of the same vaccine for individuals aged 60 and above, marking the second mRNA vaccine product for Moderna after its COVID-19 vaccine [1][2]. Group 2: Competitive Landscape - Competitors such as Pfizer and GlaxoSmithKline have also received approvals for their RSV vaccines targeting high-risk populations, with Pfizer allowed to sell to those under 60 and GlaxoSmithKline to those aged 50 to 59 [1][2]. - The global market now features three adult RSV vaccines: Moderna's mRNA-1345, Pfizer's Abrysvo™, and GlaxoSmithKline's Arexvy™, each utilizing different technological platforms and formulations [2][3]. Group 3: Vaccine Technology and Efficacy - Moderna's mRNA-1345 vaccine employs a single mRNA strand encoding the pre-F protein, encapsulated in lipid nanoparticles, which allows for rapid updates and high neutralizing antibody titers with a single injection [3]. - In contrast, Pfizer and GlaxoSmithKline utilize recombinant protein vaccines with adjuvants, which may offer better immune persistence but require more complex manufacturing processes [3].

Core Viewpoint - Moderna has faced a significant decline in stock value, approximately 80% over the past three years, due to reduced demand for its coronavirus vaccine, despite recent positive developments in its product pipeline and cost-cutting measures [1][2][10]. Group 1: Company Performance - Moderna's revenue peaked at $18.4 billion in 2022 from its coronavirus vaccine, but demand has since dropped, leading to a decline in sales [5][10]. - The company has received approval for a second product, its respiratory syncytial virus (RSV) vaccine, but initial sales have been disappointing [2][6]. - Moderna aims to achieve between $1.4 billion and $1.7 billion in GAAP operating cost reductions by 2027 [7]. Group 2: Product Pipeline and Future Goals - Moderna has a robust late-stage pipeline with goals for up to 10 product approvals in the coming years, including multiple cancer vaccines [8][9]. - Currently, there are seven cancer-vaccine candidates in phase 2 or phase 3 studies, which could provide multiple revenue streams if successful [9]. - The company continues to focus on advancing its mRNA technology across various treatment areas, including latent viruses and cancer vaccines [4][5]. Group 3: Market Challenges and Investor Sentiment - Despite positive developments, investor sentiment remains cautious due to the ongoing decline in coronavirus vaccine sales and early disappointments in the RSV market [10][12]. - Uncertainty surrounding government vaccine policies may also pose challenges for Moderna's stock performance [11]. - Long-term prospects for revenue growth remain, particularly as key product approvals approach, suggesting potential for future stock appreciation [13][14].

Company Overview - Moderna has developed a robust mRNA platform over many years, focusing on infectious disease vaccines, oncology, and rare genetic diseases, with potential expansion into autoimmune diseases [3]. Current Business Status - The company aims to drive revenue growth with existing products as its top priority [4]. - The second priority is to launch new products, although specific details on these launches were not provided in the excerpts [4]. Market Context - The current environment includes factors such as COVID-19 demand, regulatory changes from HHS and FDA, and drug pricing dynamics, all of which impact Moderna's business strategy [2].

Summary of Moderna (MRNA) FY Conference June 11, 2025 Company Overview - **Company**: Moderna (MRNA) - **Industry**: Biotechnology, specifically focusing on mRNA technology for vaccines and therapeutics Key Points and Arguments Business Strategy - **Current Focus**: Drive revenue growth with existing products, launch new products, and reduce costs to align with post-pandemic operations [5][6][7] - **Product Pipeline**: Approximately 10 products expected to launch in the next few years, including respiratory vaccines targeting high-risk populations [6][8] - **Cost Management**: Significant reduction in cash costs from $6.3 billion last year to a projected $5.5 billion this year, with further reductions expected [26][31] Market Dynamics - **COVID-19 Vaccine Demand**: The U.S. population of around 100 million at high risk for respiratory diseases presents a potential market for COVID-19 vaccines [12][13] - **Sales Performance**: Last year, 40 million COVID vaccine doses were administered in the U.S., indicating a potential stabilization in demand [13] - **International Sales**: Factories in Canada, the UK, and Australia are expected to significantly contribute to sales starting in 2026, with a potential for $1 billion in sales from these regions [16][18][19] Regulatory Environment - **FDA Guidelines**: Recent FDA guidelines are seen as constructive, focusing on high-risk populations for vaccine distribution [11][12] - **Approval Timelines**: Moderna has successfully navigated regulatory challenges, with recent product approvals on schedule [56] Product Development - **Respiratory Vaccine Portfolio**: Focus on finalizing a comprehensive respiratory vaccine portfolio, including COVID, RSV, and flu vaccines [8][15] - **Oncology Pipeline**: Ongoing development in oncology, with several products in clinical trials, including a phase three study for melanoma expected in 2026 [22][60] - **CMV Vaccine**: Optimism surrounding the CMV vaccine, with encouraging phase two data and a significant medical need for this product [70][71] Financial Outlook - **Revenue Guidance**: Projected revenue for 2025 is between $2 billion and $2.5 billion, with expectations for growth in subsequent years as new products launch [32][39] - **Profitability Goals**: Aiming for profitability by 2028, with a focus on managing costs and expanding the product portfolio [31][50] Risks and Challenges - **Market Risks**: Potential reduction in market size and sales due to changing guidelines and competition [39][44] - **Regulatory Delays**: Dependence on timely approvals from local authorities for new factories could impact sales [44][45] Partnerships and Collaborations - **Business Development**: Actively seeking partnerships with pharmaceutical companies and financial partners to advance product development without incurring additional capital expenditures [46][50] Additional Insights - **Technological Advancements**: Utilizing AI and technology to enhance productivity and streamline operations [29][30] - **Retail Strategy**: Building a diverse product portfolio to enhance negotiation leverage with retail pharmacies, which are facing financial challenges [38][36] This summary encapsulates the key discussions and insights from the Moderna FY Conference, highlighting the company's strategic direction, market opportunities, and challenges ahead.

Core Insights - Moderna's stock has experienced a decline of over 80% in the past year, primarily due to reduced vaccine sales and a disappointing outlook [1][2] - The company reported a significant drop in revenue, with a decrease of 83% from $18.9 billion in 2022 to $3.1 billion over the last twelve months [3] - Moderna's narrow product portfolio has made it vulnerable to demand fluctuations, especially as it transitions from a pandemic-driven market to a seasonal vaccine market [5][7] Financial Performance - Moderna's operating income over the past four quarters was -$3.7 billion, resulting in an operating margin of -118.8% [6] - The operating cash flow during the same period was -$3.1 billion, indicating a low cash flow margin of -97.2% [6] - The company's sales forecast for 2025 was cut by $1 billion, and the break-even target was delayed by two years due to development setbacks [4] Market Transition - The demand for Moderna's COVID-19 vaccine has significantly decreased as the pandemic has shifted to an endemic stage, impacting sales [2][7] - The company is attempting to diversify its revenue sources, but the rapid decline in COVID-19 vaccine sales has outpaced its efforts to compensate for these losses [7] - Promising clinical trial results for a skin cancer vaccine exist, but its rollout is still years away pending regulatory approvals [5]

2025.06. 10 本文字数：989，阅读时长大约1.5分钟 导读 ： 美国疾控中心的免疫实践咨询委员会负责审查疫苗数据并提出建议，以确定哪些人有资格接种疫苗，以及保 险公司是否应该承保。 作者 | 第一财经 钱童心 封面图来源 | 央视新闻 当地时间6月9日，美国卫生与公众服务部（HHS）部长罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）宣 布，他将解除为美国疾病控制与预防中心（CDC）提供咨询的免疫实践咨询委员会（ACIP）所有17 名成员的职务，这些人将被迫"退休"。 肯尼迪周一在媒体上发表评论文章称："需要彻底清除所有成员，才能重建公众对疫苗科学的信心。" 不过，ACIP的专家提出了不同的建议。在该小组专家顾问的建议下，美国CDC表示，如果家长和医 生同意需要，新冠疫苗仍然是健康儿童的一种选择。 在美国，CDC也可独立于FDA，对已经审批上市的疫苗接种范围提出更严格的推荐建议。例如， FDA已经批准默沙东的HPV疫苗用于9至45岁的女性和男性。但CDC仅建议9至26岁的患者使用该疫 苗，因为该疫苗对27至45岁人群的公共健康获益较低。 肯尼迪上任后推行的包括加强对疫苗监管审查等一 ...