Latest news with #Spikevax®
Associated Press
01-05-2025
- Business
- Associated Press
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 / ACCESS Newswire / May 1, 2025 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the first quarter of 2025. 'In the first quarter, we continued to execute with financial discipline, significantly reducing our operating expenses, and further prioritized our investments in oncology,' said Stéphane Bancel, Chief Executive Officer of Moderna. 'Looking ahead, we are reiterating our 2025 financial framework and announcing a cost structure that is expected to reduce our annual operating expenses by approximately $1.5 billion by 2027. With several Phase 3 readouts approaching and continued momentum toward 10 product approvals, we remain confident in Moderna's long-term outlook.' Recent progress includes: Commercial Updates COVID-19: The Company reported $84 million in Spikevax® sales in the first quarter of 2025, which includes $29 million of U.S. sales and $55 million of international sales. As previously reported, Moderna entered into a tender opportunity in January to compete for COVID vaccine business in the EU. RSV: The Company reported $2 million in mRESVIA® sales in the first quarter of 2025. Moderna's RSV vaccine for adults aged 60 years and older has been recently approved in Australia, Switzerland, Taiwan and the UK. First Quarter 2025 Financial Results Revenue: Total revenue for the first quarter of 2025 was $108 million, compared to $167 million in the first quarter of 2024. 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 continued normalization of COVID into a seasonal commercial market, with demand expected to be concentrated in the second half of the year. Cost of Sales: Cost of sales for the first quarter of 2025 was $90 million, which included third-party royalties of $5 million, inventory write-downs of $42 million, unutilized manufacturing capacity and wind-down costs of $21 million, and losses on firm purchase commitments of $10 million. Compared to the same period in 2024, cost of sales decreased by $6 million, or 6%, reflecting lower sales volume and the seasonal nature of the Company's COVID vaccine business, with limited product sales in both periods. Despite the overall decrease in cost of sales, cost of sales as a percentage of net product sales increased to 104%, compared to 58% in the first quarter of 2024, reflecting the impact of lower net product sales. Research and Development Expenses: Research and development expenses for the first quarter of 2025 decreased by 19% to $856 million, compared to the first quarter in 2024. The decrease was primarily driven by lower clinical development costs across respiratory programs due to timing of trial activities and program wind-downs. This reduction was partially offset by increased investment in Moderna's individualized neoantigen therapy (mRNA-4157), which has been assigned the generic name intismeran autogene, and norovirus programs. Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of 2025 decreased by 23% to $212 million, compared to the first quarter in 2024. The decline was primarily driven by broad-based reductions across digital, facility, marketing, personnel-related expenses, and external consulting and service costs, as the Company continues to streamline operations and prioritize cost management. Income Taxes: The Company recognized an income tax provision of $7 million for the first quarter of 2025, compared to $10 million in the same period last year. In both periods, the income tax provision was not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets. Net Loss: Net loss was $(1.0) billion for the first quarter of 2025, compared to $(1.2) billion for the first quarter of 2024. Loss Per Share: Loss per share was $(2.52) for the first quarter of 2025, compared to $(3.07) for the first quarter of 2024. Cash Position: Cash, cash equivalents and investments as of March 31, 2025, were $8.4 billion, compared to $9.5 billion as of December 31, 2024. The decrease during the quarter was primarily driven by the operating loss for this quarter. 2025 Financial Framework Expectations for full year 2025 remain consistent with prior expectations. Revenue: The Company reiterates 2025 expected revenue of $1.5 to $2.5 billion. Moderna expects revenue of approximately $0.2 billion in the first half of the year, reflecting the seasonality of its respiratory business. Cost of Sales: Cost of sales for 2025 is expected to be approximately $1.2 billion. Research and Development Expenses: Full-year 2025 research and development expenses are anticipated to be approximately $4.1 billion. Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2025 are projected to be approximately $1.1 billion. Income Taxes: The Company continues to expect its full-year tax expense to be negligible. Capital Expenditures: Capital expenditures for 2025 are expected to be approximately $0.4 billion. Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately $6 billion. 2026 and 2027 Financial Updates Moderna is expanding its cost efficiency and prioritization programs and expects estimated GAAP operating costs of $5.4 to $5.7 billion in 2026, a reduction from the Company's previous estimate of $5.9 billion. The Company is announcing a new 2027 GAAP operating cost estimate of $4.7 to $5.0 billion, resulting in a reduction of $1.4 to $1.7 billion in estimated operating costs by 2027, compared to its 2025 estimate. Recent Progress and Upcoming Late-Stage Pipeline Milestones The Company continues to advance its research and development portfolio. Recently, Moderna updated its prioritized pipeline by adding its Phase 2 oncology candidate, checkpoint (mRNA-4359) therapy, and deprioritizing its flu/COVID combination vaccine (mRNA-1083) for adults aged 18-49. Respiratory vaccines: Latent and other vaccines: Oncology therapeutics: Rare disease therapeutics: Company Updates & Accolades Key 2025 Investor and Analyst Event Dates Investor Call and Webcast Information Moderna will host a live conference call and webcast at 8:00 a.m. ET on May 1, 2025. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under 'Events and Presentations' in the Investors section of the Moderna website. The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited, in millions, except per share data) 1Includes grant, collaboration, licensing and royalty, and other miscellaneous revenue. MODERNA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in millions) MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited, in millions) Spikevax® and mRESVIA® are registered trademarks of Moderna. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's 2025 financial framework, including its expected revenue range and ending cash balance; Moderna's advancement of up to 10 product approvals; Moderna's anticipated cost reductions by 2027; and anticipated milestones for Moderna's pipeline programs. In some cases, forward-looking statements can be identified by terminology such as 'will,' 'may,' 'should,' 'could,' 'expects,' 'intends,' 'plans,' 'aims,' 'anticipates,' 'believes,' 'estimates,' 'predicts,' 'potential,' 'continue,' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading 'Risk Factors' in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. ### Moderna Contacts Media: Chris Ridley Head of Global Media Relations +1 617-800-3651 [email protected] Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 [email protected] SOURCE: Moderna, Inc. press release
Yahoo
01-04-2025
- Business
- Yahoo
Moderna (NasdaqGS:MRNA) Faces Legal Spotlight Affecting Investor Sentiment with -8% Dip Over Last Month
Recent legal challenges have put Moderna in a spotlight, as Genevant Sciences and Arbutus Biopharma Corporation have filed lawsuits alleging patent infringements related to lipid nanoparticle technology across numerous countries, affecting products like Spikevax®. This ongoing legal tussle has impacted investor sentiment, contributing to the company's share price decline of 8% over the month. Compounding this, general market trends showed volatility with a 3% decline. Despite tech gains, broader market uncertainties, including tariffs and economic concerns, have weighed on stocks like Moderna, which hit a five-year low amid these broader market trends. Buy, Hold or Sell Moderna? View our complete analysis and fair value estimate and you decide. Trump has pledged to "unleash" American oil and gas and these 20 US stocks have developments that are poised to benefit. Over the last five years, Moderna's total shareholder return, including share price and dividends, amounted to an 18.16% decline. In a challenging landscape, legal and regulatory hurdles have played a significant role. One major event was the March 2025 lawsuits filed by Genevant Sciences and Arbutus Biopharma Corporation over patent infringements related to Moderna's lipid nanoparticle technology. Financial performance, notably in 2024, saw revenue fall to US$3.24 billion from US$6.85 billion in 2023, highlighting the drop in COVID-related product sales. The company's exclusion from the NASDAQ-100 Index in December 2024 further exemplified declining investor confidence. Efforts at diversification, such as Health Canada's approval of the mRESVIA vaccine for adults, signal positive potential. However, inventory write-downs and a net loss of $3.6 billion in 2024 underscore continuing challenges. Over the past year, Moderna underperformed both the U.S. market and Biotech industry, with the market posting a 6.1% increase and the Biotech industry experiencing an 11.9% decline. Our valuation report here indicates Moderna may be overvalued. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:MRNA. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
10-03-2025
- Business
- Yahoo
Moderna (NasdaqGS:MRNA) Sees 15% Jump Despite Recent Revenue Challenges
Moderna recently faced significant legal challenges with five international lawsuits from Genevant Sciences and Arbutus Biopharma targeting its LNP technology used in products like Spikevax®. These lawsuits, filed across 30 countries, underscore the competitive nature of mRNA technologies and potential financial implications, possibly influencing Moderna's stock, which rose 15% last week. The broader market environment is also relevant, with the S&P 500 and Nasdaq logging a third consecutive week of decline amid economic concerns, yet seeing late-week gains as the Fed signaled a stable economy and no immediate plans to raise interest rates. This market context, combined with Moderna's litigation news, might have swayed investor sentiment, contributing to its stark weekly gain despite weaker overall market performance. Additionally, contrasting with expectations, Moderna's recent revenue challenges, outlined in its latest earnings report, could have added to the stock's volatility during the week. Click here to discover the nuances of Moderna with our detailed analytical report. Over the past five years, Moderna's total shareholder return, including both share price appreciation and dividends, has been 67.18%. This contrasts with its underperformance relative to the US biotechs industry over the past year. Despite facing profitability challenges, with losses increasing by 20.2% annually, key milestones may have supported its longer-term performance. Notably, the approval of mRESVIA™ in November 2024, and a series of COVID-19 vaccine updates since 2021, reinforced Moderna's pioneering role in mRNA vaccine technologies. Furthermore, strategic alliances and manufacturing expansions, including a facility completed in Canada by late 2022, have been central to enhancing its production capabilities. The company's forward-looking endeavors, such as the initiation of Phase 3 trials for V940 and mRNA-1083 to broaden its vaccine portfolio, illustrate continuous efforts in vaccine development. Revenue challenges, however, have persisted, with a forecast of US$1.5-2.5 billion for 2025, indicating the evolving risk landscape. These elements together have shaped Moderna's longer-term performance amidst industry and economic variances. Analyze Moderna's fair value against its market price in our detailed valuation report—access it here. Analyze the downside risks for Moderna and understand their potential impact—click to learn more. Is Moderna part of your investment strategy? Use Simply Wall St to consolidate your holdings into a portfolio and gain insights with our comprehensive analysis tools. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:MRNA. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
03-03-2025
- Business
- Yahoo
Genevant Sciences and Arbutus Biopharma Initiate International Patent Infringement Enforcement Actions Against Moderna
BASEL, Switzerland and VANCOUVER, B.C. and WARMINSTER, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio (a subsidiary of Roivant Sciences, Ltd. (Nasdaq: ROIV)), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, Inc. and certain affiliates. Together, the enforcement actions target alleged infringing activities in 30 countries. Genevant and Arbutus are seeking monetary relief and injunctions against Spikevax® and, where applicable, additional Moderna products that Moderna has represented use the same LNP technology, including mRESVIA®. Where permitted to do so at this stage, Genevant and Arbutus submitted evidence from testing of commercial Moderna product samples sourced from the U.S. and Europe indicating that the samples contain LNPs falling under the protective scope of the claims of their lipid composition patents. The cases are: Canada: Federal Court of Canada File No. T-704-25, seeking a permanent injunction and damages or, if Genevant so elects, an accounting of Moderna's profits, attributable to infringement of Canadian Patent No. 2,721,333. Japan: Tokyo District Court Case No. 2025 (Wa) 70079, seeking a permanent injunction and reasonable royalty for infringement of Japanese Patent No. 5,475,753. Switzerland: filing a case seeking a permanent injunction and monetary relief, which upon later choice of Genevant and Arbutus can include surrender of profits, damages or a reasonable royalty, for infringement of EP 2 279 254. Unified Patent Court (UPC): Case 10280/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 2 279 254. UPC: Case 10284/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 4 241 767. The UPC actions together seek relief for: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, and Turkey. Today's actions expand on Arbutus and Genevant's ongoing enforcement proceeding in the U.S. District Court for the District of Delaware, seeking fair compensation for Moderna's alleged infringement of six U.S. patents in the manufacture and sale of Spikevax®. A jury trial is currently scheduled for September 2025. It is well established in the scientific literature that the most significant technological hurdle to developing and deploying medicines using mRNA is engineering a safe and effective way to deliver the mRNA to human cells. Scientists at Arbutus and Genevant have spent years developing and refining LNP delivery technology, which has been licensed for various applications to many different third parties, including Moderna. Arbutus and Genevant's LNP technology relies on microscopic particles built from four carefully selected types of fat-like molecules to shelter and protect mRNA molecules and to enable them to travel through the human body to a target cell and through the target cell's membrane before releasing the mRNA. Without this crucial delivery technology, mRNA would quickly degrade in the body and be ineffective. About Genevant Sciences Genevant Sciences is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant's scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant's LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) for the treatment of chronic hepatitis B (cHBV). Through its ownership stake in and license agreement with Genevant, Arbutus is also focused on maximizing opportunity for its in-house developed Lipid Nanoparticle (LNP) delivery technology. For more information, visit Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include, but are not limited to, statements about: Arbutus' plans with respect to the ongoing patent litigation matters. Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. CONTACT: Contact: Pete Zorn
Associated Press
03-03-2025
- Business
- Associated Press
Genevant Sciences and Arbutus Biopharma Initiate International Patent Infringement Enforcement Actions Against Moderna
BASEL, Switzerland and VANCOUVER, British Columbia and WARMINSTER, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust lipid nanoparticle (LNP) patent portfolio (a subsidiary of Roivant Sciences, Ltd. (Nasdaq: ROIV)), and Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company focused on infectious disease, today filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, Inc. and certain affiliates. Together, the enforcement actions target alleged infringing activities in 30 countries. Genevant and Arbutus are seeking monetary relief and injunctions against Spikevax® and, where applicable, additional Moderna products that Moderna has represented use the same LNP technology, including mRESVIA®. Where permitted to do so at this stage, Genevant and Arbutus submitted evidence from testing of commercial Moderna product samples sourced from the U.S. and Europe indicating that the samples contain LNPs falling under the protective scope of the claims of their lipid composition patents. The cases are: Canada: Federal Court of Canada File No. T-704-25, seeking a permanent injunction and damages or, if Genevant so elects, an accounting of Moderna's profits, attributable to infringement of Canadian Patent No. 2,721,333. Japan: Tokyo District Court Case No. 2025 (Wa) 70079, seeking a permanent injunction and reasonable royalty for infringement of Japanese Patent No. 5,475,753. Switzerland: filing a case seeking a permanent injunction and monetary relief, which upon later choice of Genevant and Arbutus can include surrender of profits, damages or a reasonable royalty, for infringement of EP 2 279 254. Unified Patent Court (UPC): Case 10280/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 2 279 254. UPC: Case 10284/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna's unfair profits, from infringement of EP 4 241 767. The UPC actions together seek relief for: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, and Turkey. Today's actions expand on Arbutus and Genevant's ongoing enforcement proceeding in the U.S. District Court for the District of Delaware, seeking fair compensation for Moderna's alleged infringement of six U.S. patents in the manufacture and sale of Spikevax®. A jury trial is currently scheduled for September 2025. It is well established in the scientific literature that the most significant technological hurdle to developing and deploying medicines using mRNA is engineering a safe and effective way to deliver the mRNA to human cells. Scientists at Arbutus and Genevant have spent years developing and refining LNP delivery technology, which has been licensed for various applications to many different third parties, including Moderna. Arbutus and Genevant's LNP technology relies on microscopic particles built from four carefully selected types of fat-like molecules to shelter and protect mRNA molecules and to enable them to travel through the human body to a target cell and through the target cell's membrane before releasing the mRNA. Without this crucial delivery technology, mRNA would quickly degrade in the body and be ineffective. About Genevant Sciences Genevant Sciences is a leading nucleic acid delivery company with world-class platforms, a robust lipid nanoparticle (LNP) patent portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. Genevant's scientists have pioneered LNP delivery of nucleic acids for over 20 years, and Genevant's LNP platform, which has been studied across more than a dozen discrete product candidates and is the delivery technology behind the first and only approved systemic RNA-LNP product (patisiran), enables a wide array of RNA-based applications, including vaccines, therapeutic protein production, and gene editing. For more information, please visit About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) for the treatment of chronic hepatitis B (cHBV). Through its ownership stake in and license agreement with Genevant, Arbutus is also focused on maximizing opportunity for its in-house developed Lipid Nanoparticle (LNP) delivery technology. For more information, visit Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include, but are not limited to, statements about: Arbutus' plans with respect to the ongoing patent litigation matters. Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
