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Core Insights - Moderna Inc. reported a first-quarter EPS loss of $(2.52), which was better than the consensus estimate of $(3.12) but worse than the $(3.07) loss from the previous year [1] - Quarterly sales were $108 million, down from $167 billion a year ago, but exceeded the consensus of $106.20 million [1] - The decline in product sales was attributed to lower vaccination rates and the normalization of COVID-19 into a seasonal market, with demand expected to peak in the second half of the year [2] Financial Performance - The company reported $84 million in Spikevax sales, with $29 million from the U.S. and $55 million from international markets in the first quarter of 2025 [3] - Cost of sales for the fourth quarter of 2024 was $739 million, which included third-party royalties of $45 million, inventory write-downs of $193 million, and wind-down costs of $259 million [4] Guidance and Future Outlook - Moderna reiterated its 2025 revenue outlook of $1.5 billion to $2.5 billion, compared to a consensus of $2.14 billion, expecting approximately $0.2 billion in the first half of the year [5] - The company announced a new GAAP operating cost estimate for 2027 of $4.7 to $5 billion, reducing estimated operating costs by $1.4 to $1.7 billion compared to its 2025 estimate [6] - Moderna submitted its flu/COVID combination vaccine (mRNA-1083) for regulatory approval, targeting approval in 2026 due to an extended review timeline [7] Market Reaction - Following the earnings report, Moderna's stock price decreased by 4.52% to $27.25 [7]

Core Viewpoint - Moderna reported a narrower loss of $2.52 per share in Q1 2025, compared to a loss of $3.07 in the same period last year, but total revenues of $108 million fell short of expectations and declined approximately 35% year over year due to lower product sales [1][2][3] Financial Performance - Total revenues for Q1 2025 were $108 million, missing the Zacks Consensus Estimate of $127 million [1] - Product sales decreased by 49% year over year to $86 million, primarily due to lower sales of the COVID-19 vaccine Spikevax [2] - Spikevax sales were $84 million in the quarter, down from $167 million in the previous year, attributed to lower vaccination rates and the normalization of COVID into a seasonal market [3] - mResvia sales were only $2 million, significantly below the estimated $70 million, due to late approval and recommendations [4] - The company generated $22 million from grants, collaborations, licensing, and royalty revenues, with no revenues recorded in the year-ago period [6] Cost Management - Selling, general and administrative (SG&A) expenses were $212 million, down 23% year over year due to cost-cutting measures [7] - Research & development (R&D) expenses decreased by 19% to $856 million, driven by reduced clinical spending [7] Financial Guidance - Moderna reiterated its total revenue guidance for 2025, expecting revenues between $1.5 billion and $2.5 billion, with around $0.2 billion expected in the first half of the year [8] - Full-year R&D expenses are projected to be around $4.1 billion, while SG&A expenses are expected to be approximately $1.1 billion [9] - Capital expenditure is anticipated to be around $0.4 billion in 2025 [9] Pipeline Developments - Moderna submitted three regulatory filings to the FDA in Q4 2024, including for mRNA-1283 (next-generation COVID-19 vaccine) and mResvia for high-risk adults [12] - A third filing for the COVID-19 and influenza combination vaccine, mRNA-1083, is pending further data, which may delay launch plans [13] - The company has over 40 mRNA-based investigational candidates in various clinical stages, including cancer therapies [16] - Moderna is co-developing intismeran autogene with Merck, evaluating it in pivotal phase III studies for melanoma and non-small cell lung cancer [17][18] - The company plans to start a registrational study for mRNA-3705, a therapeutic candidate for methylmalonic acidemia, later this year [19]

Core Viewpoint - The vaccine sector is experiencing a decline in stock prices following reports of a significant policy change by the FDA, which will require all new vaccines to undergo placebo-controlled clinical trials before approval [1][2]. Group 1: Market Reaction - Major vaccine companies such as GSK, Sanofi, Merck, AstraZeneca, Pfizer, BioNTech, Moderna, and Novavax have seen stock declines ranging from over 1% to more than 3.7% [1]. - Specifically, Moderna's stock dropped over 3.7%, while BioNTech fell more than 2.5% [1]. Group 2: Regulatory Changes - The FDA plans to implement a new policy requiring all new vaccines to include a placebo group in clinical trials, marking a significant shift in the vaccine approval process [1]. - This policy mandates that new vaccines must undergo safety testing with a control group receiving an inactive substance, such as saline, for comparison [1]. Group 3: Scope of the New Policy - There is uncertainty regarding the definition of "new vaccines," but it is reported that the policy is unlikely to apply to flu vaccines, which have a long-established safety record [2]. - The HHS has not clarified whether vaccines that have already completed safety studies will be subject to re-evaluation under this new policy, focusing mainly on COVID-19 vaccines in their response [2].

Moderna (MRNA) came out with a quarterly loss of $2.52 per share versus the Zacks Consensus Estimate of a loss of $2.92. This compares to loss of $3.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 13.70%. A quarter ago, it was expected that this biotechnology company would post a loss of $2.69 per share when it actually produced a loss of $2.50, delivering a surprise of 7.06%.Over the last four quarters, the company has sur ...

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].