Group 1 - The conference call features Stephen Hoge, President of Moderna, discussing the company's commercial business and pipeline developments [1] - There is a focus on the outlook for 2025, with particular attention to how changes in the administration may impact the business [2] - Moderna reaffirmed its revenue and cost guidance for the current year during the last quarterly call, indicating progress with the next-generation COVID vaccine approval, mRNA-1283 [3]

Moderna (MRNA) 2025 Conference June 05, 2025 10:30 AM ET Speaker0 Everyone, thank you. Good morning, and thank you for joining us on our next discussion here at the Jefferies Healthcare Conference. I have the pleasure of having the President of Moderna, Stephen Hoag, up here with us. Obviously, timely. A lot's going on in the world, both from a regulatory administrative standpoint. We had Marty Makary here yesterday. Obviously, a lot going on with your commercial business, the pipeline, all of that. So I lo ...

Core Insights - Moderna (MRNA) received FDA approval for its next-generation COVID-19 vaccine, mRNA-1283, branded as mNexspike, with a narrower usage label than initially sought [1][8] - The approval aligns with the FDA's updated guidance focusing on vaccinating high-risk populations, specifically older adults aged 65 and individuals aged 12-64 with underlying health conditions [2][8] - mNexspike is Moderna's third FDA-approved product, joining Spikevax and mResvia [3] Product Details - mNexspike offers improved shelf life and storage benefits, making it advantageous for distribution in areas with limited cold-chain infrastructure [4] - Clinical data indicates that a 10 μg dose of mNexspike has a 9.3% higher relative vaccine efficacy compared to a 50 μg dose of Spikevax [4] Market Launch - Moderna plans to commercially launch mNexspike during the 2025-26 vaccination season [5] Stock Performance - Year-to-date, Moderna's stock has decreased by 35%, contrasting with a 4% decline in the industry [6] Recent Developments - Negative sentiment surrounds Moderna's stock due to the U.S. government terminating contracts worth $766 million for the development of an mRNA-based bird flu vaccine [9] - The FDA's new guidelines for COVID-19 vaccine boosters limit eligibility for healthy individuals under 65, potentially reducing demand [10] - Moderna voluntarily withdrew a regulatory filing for its COVID-19/influenza vaccine after the FDA requested additional efficacy data, delaying potential approval [10] Competitive Landscape - Other players in the COVID-19 vaccine market include Pfizer (PFE) with its mRNA vaccine Comirnaty and Novavax (NVAX) with its non-mRNA vaccine Nuvaxovid [11][12] - Novavax's Nuvaxovid has received full FDA approval for older adults and high-risk individuals aged 12-64, but is not yet approved for those under 12 [12]

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth?Moderna (NASDAQ: MRNA ) shares are down over 35% year-to-date, over 80% on a one-year basis, and since reaching their pandemic era high of over $450 per share, they are down 94%.The group is for both novice and expe ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

智通财经6月2日电，美国食品药品监督管理局（FDA）批准Moderna公司新一代新冠疫苗后，Moderna 公司股价上涨7.1%。 ...

Company Overview - Moderna is focused on building a diverse portfolio of products utilizing mRNA technology, targeting areas such as infectious diseases, cancer, rare diseases, and autoimmune diseases [3]. Strategic Priorities - The company has outlined three main priorities for the year: 1. To drive sales through approved products, specifically COVID-19 and RSV vaccines [3]. 2. To launch new products to diversify and grow the top line, with up to 10 launches planned over the next few years and several Biologics License Applications (BLAs) already filed [4]. 3. To resize the company from a cost perspective in response to the transition from pandemic-related sales [4].

Moderna (MRNA) recently announced that the U.S. government has terminated the previously-awarded contract for the late-stage development of an mRNA-based bird flu vaccine, as well as the right to purchase this vaccine.The Biden administration had awarded two contracts to Moderna over the past year. This includes $590 million in funding earlier this year to advance vaccine development, including the expansion of clinical studies for up to five additional pandemic influenza subtypes. Another contract worth $1 ...

Financial Data and Key Metrics Changes - The company achieved a 20% cost reduction in Q1 2025 compared to Q1 2024, with a target of around $4 billion in cash costs by 2027, down from $9 billion two years ago [7][6][8] Business Line Data and Key Metrics Changes - The company is focusing on driving sales from its two approved products, COVID and RSV, while planning up to 10 new product launches in the coming years [6][5] - The company is reducing its manufacturing footprint and resizing its operations across all lines of the P&L [8][7] Market Data and Key Metrics Changes - The U.S. COVID vaccine market for the 2024-2025 season was around 40 million doses, with a potential increase in demand for high-risk populations [21][20] - The company is also expanding its sales outside the U.S., with contracts in Canada, the UK, and Australia expected to contribute significantly starting this year [59][60] Company Strategy and Development Direction - The company aims to stabilize its COVID and RSV business while diversifying its product portfolio, including a focus on oncology and autoimmune diseases [5][61] - The strategy includes leveraging existing infrastructure for new product launches to minimize costs [8][7] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for increased COVID vaccine demand among high-risk populations, which could lead to a larger market than previously anticipated [23][20] - The company is closely monitoring regulatory changes and their potential impacts on its business, particularly regarding the FDA and CDC [15][17] Other Important Information - The company is experiencing a shift in the regulatory landscape, with the FDA potentially taking a more active role in product recommendations [39][41] - Recent comments from the HHS director regarding mRNA technology have raised concerns, but management emphasized the extensive testing and safety of their products [42][44] Q&A Session Summary Question: How does the company view the impact of regulatory changes on its business? - Management noted that the company does not rely on PBMs for vaccine sales, which insulates it from potential PBM reforms [13] - The company is not significantly impacted by Medicaid reforms, as its primary business is with Medicare [15] Question: What is the company's strategy for the upcoming flu and COVID combo vaccine? - The company is adjusting its filing strategy to include efficacy data for the flu component, which may affect the timing of the launch [72][74] Question: How does the company plan to manage risks associated with its revenue generation? - Management indicated that the guidance for revenue does not include new product launches, which could provide upside if successful [70][71]

路透社称，莫德纳公司今年1月曾获得拜登政府5.9亿美元的拨款，用于推进禽流感疫苗研发，并支持其扩展临床研究，以涵盖另外5种流感亚型。此 外，美国卫生与公众服务部去年还曾向该公司拨款1.76亿美元，用于完成一款基于mRNA、针对H5N1型禽流感疫苗的后期开发和试验工作。这两项 拨款合计金额超过7亿美元。 【环球网报道 记者 张倩】据路透社、美国Axios新闻网报道，美国制药公司莫德纳当地时间5月28日宣布，特朗普政府已取消与该公司签署的一份用 于推进人用禽流感疫苗后期研发的合同，由此引发争议，有专家批评此举"可能放弃迅速应对禽流感疫情暴发的工具"。 报道称，美卫生与公共服务部发言人称，经过全面的内部审查，卫生部已确定该项目并未达到继续进行联邦投资所需的科学标准和安全预期。而莫 德纳公司表示，仍计划探索替代方案以推进疫苗后期开发与生产。 报道提到，对于这一消息，美国约翰·霍普金斯大学健康安全中心高级学者阿梅什·阿达利亚批评称，"取消（合同）意味着政府放弃了一项可能能够 以最有效、最迅速的方式抗击禽流感疫情暴发的工具。" 5月23日，总部位于巴黎的世界动物卫生组织发布首份年度《世界动物卫生状况报告（2025）》。报 ...