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].

Moderna, Inc. (NASDAQ:MRNA) Goldman Sachs 46th Annual Global Healthcare Conference June 11, 2025 8:40 AM ET Company Participants Stéphane Bancel - CEO & Director Conference Call Participants Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division Salveen Jaswal Richter Great. Good morning, everyone. Thank you so much for joining us. Really pleased to have Stéphane Bancel, CEO of Moderna, with us. Question-and-Answer Session Salveen Jaswal Richter Maybe to start here, Stéphane, in the context o ...

Moderna (MRNA) FY Conference June 11, 2025 08:40 AM ET Speaker0 So much for joining us. Really pleased to have Stephane Benzel, CEO of Moderna, with us. Maybe just start here, Stephane. You know, in the context of the current environment, both from a COVID demand and regulatory standpoint and the overall health care policy that we're seeing flow through from HHS and FDA and then there's the drug pricing dynamics. But just walk us through today where Moderna's business stands from a revenue and expenses stan ...

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 ...

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。 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系列政策正在对疫苗厂商构成新的威胁。FDA上个月 表示，计划要求制药商在65岁以下健康成年人中对新冠加强疫苗进行临床试验，并与安慰 ...