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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Moderna, Inc.    MRNA

MODERNA, INC.

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Moderna : Announces Supply Agreement with United Kingdom Government to Supply mRNA Vaccine against COVID-19 if Approved for Use

11/18/2020 | 09:44am EST

CAMBRIDGE - Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the government of the United Kingdom to supply mRNA-1273, its COVID-19 vaccine candidate, beginning in March 2021 if it is approved for use by UK regulatory authorities.

This agreement comes as the UK continues its efforts to secure access to safe and effective COVID-19 vaccines.

'We appreciate the collaboration with the UK Government as with many other governments and other key partners around the world,' said Stephane Bancel, CEO of Moderna. 'For almost a decade, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. We are proud of our progress including the positive first interim analysis from our Phase 3 COVE study recently released. As we advance the clinical development of mRNA-1273, this continues to be a pivotal moment for us all.'

Yesterday, Moderna announced that the independent, U.S.NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

On October 27, 2020, Moderna received confirmation that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom started the rolling review process of mRNA-1273.

The investments in this proprietary platform have enabled Moderna to expeditiously create, manufacture and clinically develop mRNA-1273 in support of the global response to the current COVID-19 pandemic. Moderna continues to scale up its global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021. The Company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United States. This is a dedicated supply chain to support Europe and countries other than the United States that enter into purchase agreements with Moderna.

About the Phase 3 COVE Study

The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 -microg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID's COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna's partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution of the COVE study.

The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of 30,000 participants ages 18 and older in the U.S. on October 22, including those at high risk of the severe complications of COVID-19 disease. The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study. The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.

About mRNA-1273

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID's Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of mRNA-1273 in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine. mRNA-1273 currently is not approved for use by any regulatory body.

BARDA is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract No. W911QY-20-C-0100.

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 regarding the Company's development of a potential vaccine (mRNA-1273) against the novel coronavirus, mRNA-1273's efficacy and its ability to prevent infection or mitigate symptoms of COVID-19, the safety profile for mRNA-1273, further changes to mRNA-1273's efficacy as the study continues, the Company's plans to seek regulatory approval for the use of mRNA-1273 in the U.S. and other jurisdictions, and the Company's anticipated production of mRNA-1273. 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. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Contact:

Colleen Hussey

Tel: 617-335-1374

Email: Colleen.Hussey@modernatx.com

(C) 2020 Electronic News Publishing, source ENP Newswire

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Financials (USD)
Sales 2020 512 M - -
Net income 2020 -571 M - -
Net cash 2020 2 597 M - -
P/E ratio 2020 -107x
Yield 2020 -
Capitalization 51 846 M 51 846 M -
EV / Sales 2020 96,2x
EV / Sales 2021 4,40x
Nbr of Employees 1 100
Free-Float 90,0%
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Number of Analysts 16
Average target price 137,27 $
Last Close Price 131,02 $
Spread / Highest target 41,2%
Spread / Average Target 4,77%
Spread / Lowest Target -47,3%
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Managers and Directors
NameTitle
Stéphane Bancel Chief Executive Officer & Director
Stephen Hoge President
Noubar B. Afeyan Chairman
David W. Meline Chief Financial Officer
Juan Andres Chief Technical Operations & Quality Officer
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