Company profile

Ticker
MRNA, 0A45
Exchange
CEO
Stéphane Bancel
Employees
Incorporated
Location
Fiscal year end
Former names
Moderna Therapeutics, Inc.
SEC CIK
IRS number
813467528

MRNA stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

30 Oct 20
27 Nov 20
31 Dec 20

News

Quarter (USD) Sep 20 Jun 20 Mar 20 Sep 19
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from Moderna earnings reports.

Date Owner Security Transaction Code 10b5-1 $Price #Shares $Value #Remaining
24 Nov 20 Stephen Hoge Common Stock Sell Dispose S Yes 99.06 900 89.15K 1,734,597
24 Nov 20 Stephen Hoge Common Stock Sell Dispose S Yes 98.35 2,592 254.92K 1,735,497
24 Nov 20 Stephen Hoge Common Stock Sell Dispose S Yes 97.27 908 88.32K 1,738,089
24 Nov 20 Stephen Hoge Common Stock Sell Dispose S Yes 95.65 500 47.83K 1,738,997
24 Nov 20 Stephen Hoge Common Stock Sell Dispose S Yes 94.23 100 9.42K 1,739,497
23 Nov 20 Tal Zvi Zaks Common Stock Sell Dispose S Yes 101.21 6,724 680.54K 0
23 Nov 20 Tal Zvi Zaks Common Stock Sell Dispose S Yes 100.12 6,836 684.42K 6,724
23 Nov 20 Tal Zvi Zaks Common Stock Sell Dispose S Yes 99.31 1,440 143.01K 13,560
23 Nov 20 Tal Zvi Zaks Common Stock Option exercise Aquire M Yes 19.15 10,000 191.5K 15,000
23 Nov 20 Tal Zvi Zaks Common Stock Option exercise Aquire M Yes 12.21 5,000 61.05K 5,000
51.2% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 527 476 +10.7%
Opened positions 138 239 -42.3%
Closed positions 87 50 +74.0%
Increased positions 204 127 +60.6%
Reduced positions 128 84 +52.4%
13F shares
Current Prev Q Change
Total value 14.31B 13.93B +2.7%
Total shares 202.41M 217.02M -6.7%
Total puts 9.99M 5.63M +77.3%
Total calls 45.92M 6.66M +589.4%
Total put/call ratio 0.2 0.8 -74.3%
Largest owners
Shares Value Change
FMR 34.22M $2.42B -8.8%
Flagship Pioneering 30.87M $2.18B -22.6%
Vanguard 27.88M $1.97B +8.8%
BLK BlackRock 20.24M $1.43B +2.1%
Theleme Partners 7.65M $541.45M -10.5%
Baillie Gifford & Co 7.23M $511.21M +78.0%
STT State Street 6.58M $465.81M +9.2%
MS Morgan Stanley 5.03M $356.11M -21.2%
Geode Capital Management 3.36M $237.85M +1.1%
BLVGF Bellevue 3.34M $236.44M -0.1%
Largest transactions
Shares Bought/sold Change
Flagship Pioneering 30.87M -9M -22.6%
FMR 34.22M -3.31M -8.8%
Baillie Gifford & Co 7.23M +3.17M +78.0%
IVZ Invesco 689.48K -2.63M -79.2%
Vanguard 27.88M +2.25M +8.8%
FHI Federated Hermes 1.76M -1.79M -50.5%
MS Morgan Stanley 5.03M -1.35M -21.2%
Theleme Partners 7.65M -893.94K -10.5%
GS Goldman Sachs 1.82M -788.86K -30.3%
JHG Janus Henderson 103.9K -753.86K -87.9%

Financial report summary

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Risks
  • Risks related to our business and creating a new class of medicines
  • Our pursuit of mRNA-1273, a potential vaccine for the novel coronavirus (“SARS-CoV-2”), is at an early stage. We have not previously tested our rapid response capability and may be unable to produce a vaccine that successfully treats the virus in a timely manner, if at all.
  • If we are successful in producing a vaccine against SARS-CoV-2, we may need to devote significant resources to its scale-up and development, including for use by the U.S. government.
  • We will need to seek and secure significant funding through financings or from other sources. Clinical data or trial execution that creates delays, setbacks, or failures in one or more of our programs or modalities or the entire pipeline could result in an impaired ability or inability to finance or fund the Company in the future.
  • We attempt to distribute our technology, biology, execution, and financing risks across a wide variety of therapeutic areas, disease states, programs, and technologies. However, our assessment of, and approach to, risk may not be comprehensive or effectively avoid delays or failures in one or more of our programs or modalities. Failures in one or more of our programs or modalities could adversely impact other programs or modalities in our pipeline and have a material adverse impact on our business, results of operations, and ability to fund our business.
  • No mRNA drug has been approved in this new potential class of medicines, and may never be approved as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines.
  • We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
  • Our quarterly and annual operating results may fluctuate in the future. As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline and negatively impact our financing or funding ability as well as negatively impact our ability to exist as a standalone company.
  • Our business is highly dependent on the clinical advancement of our programs and modalities. Delay or failure to advance programs or modalities could adversely impact our business.
  • While we attempt to diversify our risks by developing one or more programs in each modality, there are risks that are unique to each modality and risks that are applicable across modalities. These risks may impair our ability to advance one or more of our programs in clinical development, obtain regulatory approval, or ultimately commercialize our programs, or cause us to experience significant delays in doing so, any of which may materially harm our business.
  • Risks related to the research, development, regulatory review, and approval of our existing and future pipeline
  • Preclinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to the clinic, any of which may affect our ability to obtain funding and may have a material adverse impact on our platform or our business.
  • Clinical development is lengthy and uncertain, especially with a new class of medicines such as mRNA medicines. Clinical trials of our investigational medicines may be delayed, and certain programs may never advance in the clinic or may be more costly to conduct than we anticipate, any of which could affect our ability to fund the Company and would have a material adverse impact on our platform or our business.
  • We may experience delays in identifying and enrolling participants in our clinical trials which would delay the progress of our investigational medicines and result in increased expenses.
  • mRNA medicines are a novel approach, and negative perception of the efficacy, safety, or tolerability of any investigational medicines that we develop could adversely affect our ability to conduct our business, advance our investigational medicines, or obtain regulatory approvals.
  • Because we are developing some of our development candidates or investigational medicines for the treatment of diseases in which there is little clinical experience and, in some cases, using new endpoints or methodologies, the FDA or other regulatory authorities may not consider the endpoints of our clinical trials to provide clinically meaningful results.
  • Some of our investigational medicines are classified as gene therapies by the FDA and the EMA, and the FDA has indicated that our investigational medicines will be reviewed within its Center for Biologics Evaluation and Research (“CBER”). Even though our mRNA investigational medicines are designed to have a different mechanism of action from gene therapies, the association of our investigational medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines, or negatively impact our platform or our business.
  • A breakthrough therapy designation or fast track designation by the FDA for a drug may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the drug will receive marketing approval.
  • We may fail to obtain and maintain orphan drug designations from the FDA for our future investigational medicines, as applicable.
  • Our investigational medicines may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Any clinical trials of our oncology-related products that we conduct with a seamless trial design may not be acceptable to regulatory authorities in the form submitted, or at all, which may delay our clinical development and limit or change the type of information we may gather from our clinical trials.
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, investigational medicines we may develop, and our ability to generate revenue will be materially impaired.
  • We may never obtain EMA or other foreign regulatory body approval for any of our investigational medicines, and even if we do, we may never be able to commercialize any of our investigational medicines in any other jurisdiction, which would limit our ability to realize their full market potential.
  • Our planned clinical trials or those of our strategic collaborators may reveal significant adverse events not seen in our preclinical or nonclinical studies and may result in a safety profile that could delay or terminate clinical trials, or delay or prevent regulatory approval or market acceptance of any of our investigational medicines.
  • Even if we obtain regulatory approval for an investigational medicine, our products will remain subject to regulatory scrutiny.
  • Our ability to generate product revenue is dependent on the success of one or more of our development candidates or investigational medicines, each of which is at an early-stage of development and will require significant additional development and clinical testing before we can seek marketing approval and begin commercial sales.
  • Risks related to the manufacturing of our development candidates, investigational medicines and our future pipeline
  • Our mRNA development candidates and investigational medicines are based on novel technologies and any development candidates and investigational medicines we develop may be complex and difficult to manufacture. We may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management, or shipping. If we or any of our third-
  • party manufacturers encounter such difficulties, our ability to supply material for clinical trials or any approved product could be delayed or stopped.
  • As our drug development pipeline increases and matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate. We will require increased capacity across our entire supply chain. Furthermore, we rely on many service providers, including those that provide manufacturing or testing services, all of whom have inherent risks in their operations that may adversely impact our operations.
  • We are subject to regulatory and operational risks associated with the physical and digital infrastructure at both our internal manufacturing facilities and at those of our external service providers.
  • There are risks inherent in pharmaceutical manufacturing operations that could affect our ability and the ability of our third-party manufacturers or contract manufacturing organizations to meet our delivery requirements or provide adequate amounts of material.
  • Our investigational medicines are inherently sensitive to shipping and storage conditions, which, in some cases, requires cold-chain logistics and could subject our investigational medicines to risk of loss or damage.
  • We are subject to significant regulatory oversight with respect to manufacturing our mRNA investigational medicines. Our manufacturing facilities or the manufacturing facilities of our third-party manufacturers or suppliers may not meet regulatory requirements. Failure to meet cGMP requirements set forth in regulations promulgated by the FDA, EMA, and other global health authorities could result in significant delays in and costs of our products.
  • Risks specific to certain investigational medicines
  • Our PCV investigational medicine is uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production.
  • Risks related to our reliance on third parties
  • We have in the past entered into, and in the future may enter into, strategic alliances with third parties to develop investigational medicines. If these strategic alliances are not successful, our business could be adversely affected.
  • Our strategic collaborators control aspects of our clinical trials, regulatory activities, and other aspects of our strategic alliances, which could result in delays and other obstacles in the development and commercialization of our proposed products and materially harm our results of operations.
  • We may seek to establish additional strategic alliances and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans. Certain of our strategic alliance agreements may restrict our ability to develop certain products.
  • We are dependent on single-source suppliers for some of the components and materials used in, and the processes required to develop, our development candidates and investigational medicines.
  • We rely on and expect to continue to rely on third parties to conduct aspects of our research, preclinical studies, protocol development, and clinical trials for our development candidates or investigational medicines. If these third parties do not perform satisfactorily, comply with regulatory requirements, or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our investigational medicines and our business could be substantially harmed.
  • Risks related to our intellectual property
  • Other companies or organizations may challenge our patent rights or may assert patent rights that prevent us from developing and commercializing our products.
  • If we become involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, substantial liability for damages, or be required to stop our product development and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary IP rights to product components and manufacturing processes for our development pipeline.
  • If we are not able to obtain and enforce patent protection for our discoveries, our ability to effectively compete using our development candidates will be harmed.
  • We license patent rights from third-party owners. If such owners do not properly or successfully obtain, maintain, or enforce the patents underlying such licenses, our competitive position and business prospects may be harmed.
  • If we fail to comply with our obligations in the agreements under which we license IP rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other IP.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Issued patents covering our development candidates and investigational medicines could be found invalid or unenforceable if challenged in court.
  • We may not be able to protect our IP rights throughout the world.
  • Our reliance on government funding and collaboration from government and quasi-governmental entities for certain of our programs adds uncertainty to our research and development efforts with respect to those programs and may impose requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs.
  • Risks related to commercialization of our pipeline
  • We have no sales, distribution, or marketing experience, and may invest significant financial and management resources to establish these capabilities. If we are unable to establish such capabilities or enter into agreements with third parties to market and sell our future products, if approved, we may be unable to generate any revenues.
  • The pharmaceutical market is intensely competitive. If we are unable to compete effectively with existing products, new treatment methods, and new technologies, we may be unable to commercialize successfully any products that we develop.
  • The commercial success of any current or future investigational medicine, if approved, will depend upon the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community.
  • We may market our products outside of the United States, and we will be subject to the risks of doing business outside of the United States.
  • The insurance coverage and reimbursement status of newly-approved products, particularly in a new class of medicines, is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • Recent federal legislation and actions by state and local governments may permit reimportation of drugs from foreign countries into the United States, including foreign countries where the drugs are sold at lower prices than in the United States, which could materially adversely affect our operating results.
  • Healthcare legislative reform discourse and potential or enacted measures may have a material adverse impact on our business and results of operations and legislative or political discussions surrounding the desire for and implementation of pricing reforms may adversely impact our business.
  • Due to the novel nature of our technology, we face uncertainty related to pricing and reimbursement for these investigational medicines.
  • If the market opportunities for our development candidates or investigational medicines are smaller than we believe they are, our revenue may be adversely affected and our business may suffer. Because the target patient populations for some of our programs are small, we must be able to successfully identify clinical trial participants and achieve a significant market share to maintain profitability and growth.
  • The market opportunities of some of our programs may be limited to those patients who are ineligible for or have failed prior treatments and for which the market opportunities may be small.
  • Our future success depends on our ability to retain key employees, consultants, and advisors and to attract, retain, and motivate qualified personnel. We may not be able to retain employees or executives who have vested stock options.
  • Our employees, principal investigators, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Employee litigation and unfavorable publicity could negatively affect our future business.
  • We have never generated any revenue from product sales and may never be profitable.
  • Our internal computer systems, or those of our strategic collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs and our manufacturing operations.
  • We may use our financial and human resources to pursue a particular research program or investigational medicine and fail to capitalize on programs or investigational medicines that may be more profitable or for which there is a greater likelihood of success.
  • If we are not successful in discovering, developing, and commercializing additional products beyond our current portfolio, our ability to expand our business and achieve our strategic objectives would be impaired.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any investigational medicine that we may develop.
  • We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
  • Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition, or results of operations.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters or other business interruptions such as cybersecurity attacks and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • If our products become subject to a product recall it could harm our reputation, business, and financial results.
  • The investment of our cash, cash equivalents, and investments is subject to risks which may cause losses and affect the liquidity of these investments.
  • Changes in tax law could adversely affect our business and financial condition.
  • If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements prove inaccurate, our actual results may vary from those reflected in our projections and accruals.
  • The amount of and our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations and uncertainty.
  • If we engage in future acquisitions, joint ventures, or strategic collaborations, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • The increasing use of social media platforms presents new risks and challenges.
  • We have broad discretion in the use of our cash, cash equivalents, and investments, and may not use them effectively.
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives. We are subject to financial reporting and other requirements for which our accounting and other management systems and resources may not be adequately prepared.
  • We are in the early stages of developing our policies and practices regarding pre-approval access and any policy we develop and implement may result in a negative perception of our Company and have a material adverse impact on our business.
  • As a general matter, we do not currently plan on providing forward-looking guidance regarding the expected timing of milestones in our business. We plan to report on the status of our programs, including the achievement of milestones and related data, on a retrospective basis, or as otherwise required by U.S. federal securities laws applicable to us, which may lead to speculation about our prospects that could have a material adverse effect on our business. If we do provide forward-looking guidance on the expected timing of milestones, we may not meet those timelines which may have a material averse effect on our business.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or development candidates or investigational medicines.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • Provisions in our amended and restated certificate of incorporation and by-laws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • Our amended and restated by-laws designate the Court of Chancery of the State of Delaware or the United States District Court for the District of Massachusetts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.
Content analysis ?
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Constraining
Legalese
Litigous
Readability
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