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Moderna(MRNA) - 2025 Q1 - Quarterly Report
2025-05-01 20:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _ to _ Commission File Number: 001-38753 Moderna, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 81-3467528 (State or Other Jurisdiction o ...
Moderna: Regulatory Hurdles And Market Challenges Prompt Downgrade To Sell
Seeking Alpha· 2025-05-01 17:30
With a background as an RN and an MBA, Stephen analyzes healthcare and tech stocks by combining clinical insight with rigorous valuation methods. He specializes in scenario-based DCF modeling, sensitivity analysis, and Monte Carlo simulations to uncover asymmetric risk-reward. His focus is on translating complex science and market dynamics into actionable investment theses. His influences include Superforecasting and Fooled by Randomness.Stay up to date with Stephen's latest thoughts and investment insights ...
Moderna Expands Cost-Cutting Program By Up To $1.7 Billion, FDA Approval For Flu/COVID-19 Combo Shot Delayed Into 2026
Benzinga· 2025-05-01 17:14
Moderna Inc. MRNA reported on Thursday a first-quarter EPS loss of $(2.52), missing the consensus of $(3.12), down from an EPS loss of $(3.07) a year ago.The COVID-19 vaccine maker reported quarterly sales of $108 million, down from $167 billion a year ago, beating the consensus of $106.20 million.The decline was primarily driven by lower net product sales, which totaled $86 million in the quarter.The reduction in product sales reflects lower vaccination rates compared to the same period last year and the c ...
Moderna Beats on Q1 Earnings, Lags on Revenues, Focuses on Cost Cuts
ZACKS· 2025-05-01 16:26
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]
Moderna (MRNA) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-01 12:40
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 ...
Moderna(MRNA) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:00
Moderna (MRNA) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 Good day, and thank you for standing by. Welcome to the Moderna first quarter '20 '20 '5 conference call. At this time, all participants are in a listen only mode. After the speakers' presentation, there'll be a question and answer session. To ask a question during the session, you need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Pl ...
Moderna(MRNA) - 2025 Q1 - Earnings Call Transcript
2025-05-01 12:00
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]
Moderna(MRNA) - 2025 Q1 - Earnings Call Presentation
2025-05-01 11:16
© 2025 Moderna, Inc. All rights reserved. Forward-looking statements and disclaimer First Quarter 2025 Financial Results May 1, 2025 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's ability to drive use of Spikevax and mRESVIA and expand markets for its products; Moderna's 2025 financial framework; Moderna's ability to deliver cost efficiency across the business, including a ...
Moderna(MRNA) - 2025 Q1 - Quarterly Results
2025-05-01 10:31
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 ...
Moderna(MRNA) - 2025 FY - Earnings Call Transcript
2025-04-30 12:00
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].