Financial Data and Key Metrics Changes - Q1 revenues were $100 million, with a net loss of $1 billion, reflecting the seasonal nature of the respiratory vaccine business [6][12] - Cash and investments at the end of the quarter totaled $8.4 billion, down from $9.5 billion at the end of Q4 [16] - R&D expenses decreased by 19% year over year to $856 million, driven by lower clinical development spending [14][19] - SG&A expenses were $212 million, down 23% year over year, reflecting broad-based cost reductions [15] Business Line Data and Key Metrics Changes - Net product sales were $86 million, primarily from COVID vaccine sales, with the U.S. accounting for about one-third of total sales [12][13] - Total revenue for the quarter was $108 million, a decrease of 35% year over year [13] - Cost of sales was $90 million, representing 104% of net product sales, up from 58% in the prior year [14] Market Data and Key Metrics Changes - Lower vaccination rates were observed compared to Q1 last year, indicating a transition of COVID into routine seasonal vaccination patterns [13] - The company expects total revenue in 2025 to be in the range of $1.5 billion to $2.5 billion, with first-half sales of approximately $200 million [17] Company Strategy and Development Direction - The company is focused on three priorities: expanding markets for commercial products, advancing its pipeline to drive sales growth, and executing with financial discipline [7][39] - The oncology portfolio is being expanded with the Checkpoint Medicine program, and the company aims to drive sales for approved products [8][39] - A commitment to achieve a breakeven target on a cash cost basis by 2028 has been established, with plans for significant cost reductions by 2027 [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for COVID vaccination, particularly in the upcoming fall season, despite the competitive market environment [52] - The company remains engaged with the FDA and anticipates continued productive exchanges regarding its product approvals [51] - The management is optimistic about the potential for new product approvals and the impact on sales growth [41][42] Other Important Information - The company plans to reduce annual GAAP expenses by over $6 billion from 2023 to 2027, representing a 55% reduction [22] - The Phase III FRU program has exceeded the required number of case accruals for an interim vaccine efficacy analysis [9] Q&A Session Summary Question: Comments on FDA interactions and potential risks to the vaccine business outlook - Management noted that interactions with the FDA have been productive and ongoing, with a focus on providing necessary data for product reviews [51][52] Question: Update on INT Phase III data expectations - Management believes that a 2026 readout for the Phase III melanoma study is still reasonable, pending event accruals [56][58] Question: Concerns about future market share changes in COVID revenue - Management indicated that script data shows a consistent market share of around 38%, and they are focused on managing working capital effectively [100][101] Question: Flu vaccine interim data expectations - Management did not provide specific guidance on total events for the flu vaccine analysis, stating that they will conduct the analysis once the season is over [105]

Financial Data and Key Metrics Changes - Q1 revenues were $100 million with a net loss of $1 billion, reflecting the seasonal nature of the respiratory vaccine business [7] - Cash and investments at the end of the quarter totaled $8.4 billion, down from $9.5 billion at the end of Q4 [16] - Net product sales were $86 million, primarily driven by COVID vaccine sales, with total revenue for the quarter at $108 million, a 35% decrease year over year [13][16] - R&D expenses were $856 million, a 19% decrease year over year, while SG&A expenses were $212 million, down 23% year over year [14][15] Business Line Data and Key Metrics Changes - The U.S. accounted for about one-third of total sales, with lower vaccination rates compared to Q1 last year due to the transition of COVID into routine seasonal vaccination patterns [12][13] - Cost of sales represented 104% of net product sales this quarter, up from 58% in the prior year, driven by lower volume and revenue mix [14] - The oncology portfolio was expanded with the Checkpoint Medicine program, which is expected to drive future sales growth [10][26] Market Data and Key Metrics Changes - The company received approvals for its vaccines in multiple international markets, including Australia, Taiwan, the UK, and Switzerland, enhancing its competitive position [9] - The company anticipates a total addressable market of over $30 billion for its upcoming product approvals [40] Company Strategy and Development Direction - The company is focused on three priorities: driving sales for approved products, advancing its late-stage pipeline, and delivering cost efficiency across the business [39] - The company plans to achieve significant cost reductions, targeting a cash cost of approximately $4.2 billion by 2027 to meet its breakeven target by 2028 [21][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for COVID vaccination, particularly in light of recent data showing high efficacy rates for their updated vaccine [53] - The company remains engaged with the FDA and continues to have productive exchanges regarding its ongoing product reviews [52] Other Important Information - The company is planning a total reduction in annual GAAP expenses of over $6 billion from 2023 to 2027, representing a 55% reduction [22] - The company is actively monitoring for additional cases of Guillain-Barré syndrome (GBS) in its trials and has lifted the clinical hold on its norovirus study [92] Q&A Session Summary Question: Comments on FDA interactions and potential risks to the vaccine business outlook - Management noted that interactions with the FDA have been productive and that they continue to see a need for COVID vaccination, especially among older Americans [52][53] Question: Update on INT Phase III data expectations - Management believes that a 2026 readout for the Phase III melanoma study is still reasonable based on historical event rates [57] Question: COVID strain selection process moving forward - The strain selection process will depend on guidance from regulatory bodies, with updates expected within the next month [75] Question: Concerns about future market share changes in COVID revenue - Management indicated that script data shows a consistent market share of around 38% and that inventory levels are being managed by customers [100] Question: Flu vaccine interim data expectations - Management did not provide specific guidance on total events for the flu vaccine analysis but indicated that a large number of cases are expected [105]

Financial Performance - Moderna's total revenue for 1Q25 was $0.108 billion, a decrease of 35% compared to $0.167 billion in 1Q24[14] - Net product sales decreased by 49%, from $0.167 billion in 1Q24 to $0.086 billion in 1Q25[14] - The company reported a net loss of $0.971 billion in 1Q25, compared to a net loss of $1.175 billion in 1Q24, representing a 17% decrease in net loss[14] - Operating expenses were reduced by 19%, or $0.275 billion, from $1.433 billion in 1Q24 to $1.158 billion in 1Q25[8, 14] - Cash, cash equivalents, and investments decreased by 12%, from $9.5 billion at the end of 2024 to $8.4 billion as of March 31, 2025[16] Financial Outlook - The company anticipates total revenue for the full year 2025 to be between $1.5 billion and $2.5 billion[17] - Moderna expects to reduce costs by $1.4 billion to $1.7 billion by 2027[18] - The company is targeting cash breakeven in 2028[2] Pipeline and Product Development - Moderna has filed for approval of its next-generation COVID vaccine and RSV vaccine for older adults[23, 29] - The company's flu vaccine (mRNA-1010) exceeded case accruals required for Phase 3 interim efficacy analysis[12] - Moderna is expanding its oncology portfolio, including Checkpoint AIM-T (mRNA-4359)[12]

Moderna Reports First Quarter 2025 Financial Results and Provides Business Updates Reports first quarter revenues of $0.1 billion, GAAP net loss of $(1.0) billion and GAAP EPS of $(2.52) Reiterates 2025 expected revenue range of $1.5 to $2.5 billion and 2025 year-end cash balance of approximately $6 billion Announces reduction of $1.4 to $1.7 billion in estimated GAAP operating costs by 2027 Advancing up to 10 products toward approval, including multiple oncology candidates CAMBRIDGE, MA / ACCESSWIRE / May ...

Financial Data and Key Metrics Changes - The meeting discussed the election of directors and the approval of executive compensation, indicating a stable governance structure and commitment to management accountability [10][13]. - The appointment of Ernst and Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was ratified, reflecting confidence in financial oversight [14][17]. Business Line Data and Key Metrics Changes - The company highlighted a robust pipeline with several dozen products in clinical development across various therapeutic areas, including respiratory viruses and oncology [20][23]. Market Data and Key Metrics Changes - The management emphasized the importance of driving the use of approved vaccines, which is critical for both patient outcomes and shareholder returns [20]. Company Strategy and Development Direction - The company is focused on three key priorities: driving the use of approved vaccines, aiming for the approval of ten products over the next few years, and delivering cost efficiencies across the business [20][21]. - Management expressed confidence in their ability to navigate the regulatory environment by maintaining constructive engagement with regulatory agencies [22]. Management's Comments on Operating Environment and Future Outlook - Management plans to provide a full update on quarterly performance and pipeline developments in the upcoming earnings call, indicating transparency and ongoing communication with investors [19][24]. - The company believes that focusing on science and data will demonstrate the potential of its medicines and their positive impact on patients [22]. Other Important Information - The meeting was conducted with a quorum present, allowing for the official business to proceed smoothly [7][10]. - The company will report final voting results and a current report to the SEC within four business days, ensuring compliance and transparency [17]. Q&A Session Summary Question: What is the status of the product pipeline beyond COVID vaccines? - The company has a robust pipeline with several dozen products in clinical development across various therapeutic areas, with updates to be provided in the upcoming earnings call [20][23]. Question: What actions are being taken to improve stock performance? - The company believes that executing on its three key priorities will deliver returns for shareholders [20]. Question: How is the company addressing the regulatory environment in the U.S.? - Management highlighted a strong record of working with administrations and emphasized the importance of focusing on science and data to demonstrate the potential of their medicines [22].

Core Viewpoint - The pandemic's fading impact has led to a significant decline in Moderna's stock, down 36% year to date, contrasting with the S&P 500's 9% drop, raising questions about its future despite ongoing developments in its pipeline [1] Group 1: Pandemic Performance - Moderna gained prominence with the emergency use authorization of its Spikevax vaccine in late 2021, becoming a household name during the pandemic [2] - The company's revenue surged from $803 million in 2020 to over $18.4 billion in 2021, with a net income of $12.2 billion [3] Group 2: Current Challenges - Moderna faces a significant challenge as it lacks other products to offset the decline in Spikevax sales as the pandemic subsides [4] - The lengthy development process for new vaccines means that the company has not yet seen substantial returns from its mRNA technology beyond Spikevax [5] Group 3: Future Prospects - Moderna is exploring a range of mRNA-based vaccines for various diseases, with many in mid- to late-stage clinical trials, indicating potential for future regulatory approvals [5] - The only other FDA-approved vaccine, mRESVIA for RSV, has seen disappointing sales since its rollout in mid-2024 [6] Group 4: Financial Outlook - The company is projected to end 2025 with $6 billion in cash, significantly lower than the $19 billion it held during the peak of the pandemic [8] - Concerns about potential dilutive secondary share issues or burdensome debt arrangements are raised if new products do not gain traction [9]

Group 1: Market Context - During stock-market corrections, investors are encouraged to take advantage of discounted stocks, as bull markets typically follow downturns, leading to potential long-term gains [1] - Companies often trade at steep discounts during corrections due to panic-selling by investors, creating opportunities for savvy investors [1] Group 2: Moderna - Moderna gained prominence by rapidly developing a COVID-19 vaccine but has faced revenue declines and returned to unprofitability as the pandemic recedes [3][8] - The company has made significant clinical advancements, including the approval of a vaccine for respiratory syncytial virus (RSV) and successful phase 3 studies for a combination COVID/influenza vaccine [5] - Moderna targets high unmet medical needs with a late-stage pipeline that includes a cytomegalovirus (CMV) vaccine and a personalized cancer vaccine, showcasing its innovative capabilities in the mRNA vaccine field [6][7] Group 3: Regeneron Pharmaceuticals - Regeneron Pharmaceuticals is experiencing uncertainty due to biosimilar competition for its key product Eylea, despite strong financial results last year [9][10] - The company’s Dupixent, an eczema treatment, has expanded its label to include chronic obstructive pulmonary disease (COPD), potentially adding billions in sales [11] - Regeneron is developing a new formulation of Eylea with a more convenient dosing schedule, which may mitigate losses from biosimilar competition [12] - The company has a promising pipeline in oncology, weight loss, and gene therapy for hearing loss, along with a new dividend and share-buyback program to reward shareholders [12][13]

In the latest trading session, Moderna (MRNA) closed at $27.19, marking a -0.75% move from the previous day. This change lagged the S&P 500's 0.74% gain on the day. On the other hand, the Dow registered a gain of 0.05%, and the technology-centric Nasdaq increased by 1.26%.The biotechnology company's stock has dropped by 14.73% in the past month, falling short of the Medical sector's loss of 7.7% and the S&P 500's loss of 4.77%.Investors will be eagerly watching for the performance of Moderna in its upcoming ...

Core Viewpoint - Moderna is expected to report first-quarter 2025 earnings on May 1, with a consensus estimate of $127 million in sales and a loss of $2.91 per share, reflecting a significant decline in revenue primarily due to lower demand for its COVID-19 vaccine [1][2]. Revenue Expectations - The majority of Moderna's revenue is anticipated to come from COVID-19 vaccine sales, estimated at $112 million, which indicates a substantial decrease from the previous year [1]. - Minimal sales are expected from the RSV vaccine mResvia, projected at $10 million, significantly lower than competitors' products [2]. Regulatory Filings and Approvals - Moderna submitted three regulatory filings to the FDA in Q4 2024, including requests for approval of mRNA-1283 (next-generation COVID-19 vaccine) and mRNA-1083 (COVID-19 plus influenza combination vaccine), with decisions expected by May 31 and June 12, respectively [3]. - mResvia is currently approved for older adults, and a label expansion for high-risk adults is under review [3]. Clinical Development Pipeline - The company is advancing over 40 mRNA-based investigational candidates across various clinical stages, including late-stage studies for mRNA-4157 (cancer therapy), mRNA-1647 (CMV vaccine), mRNA-1010 (influenza vaccine), and mRNA-1403 (norovirus vaccine) [4]. - mRNA-4157 is being evaluated in collaboration with Merck in pivotal phase III studies for melanoma and non-small cell lung cancer [5][6]. Earnings Performance - Moderna has consistently beaten earnings estimates over the past four quarters, with an average surprise of 31.79% [7]. - Year-to-date, Moderna's shares have declined by 34%, contrasting with a 6% decline in the broader industry [7]. Earnings Prediction - Current models do not predict a definitive earnings beat for Moderna, with an Earnings ESP of -8.13% and a Zacks Rank of 3 (Hold) [10].

Wall Street expects a year-over-year increase in earnings on lower revenues when Moderna (MRNA) reports results for the quarter ended March 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on May 1, 2025, might help the stock move higher if these key numbers are better than expectations. ...