Moderna Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Provides Business Updates
February 25, 2021 at 07:00 AM EST
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the fourth quarter and fiscal year 2020 and highlighted pipeline progress.
“2020 was a historic year for Moderna. The team rose to the challenge to address the devastating COVID-19 pandemic in less than one year with our authorized vaccine. It is encouraging and humbling that more than 32 million doses of our vaccine have been administered in the U.S. and that millions of people around the world have been vaccinated with our vaccine to date. 2020 demonstrated the power of harnessing mRNA to make medicines and also demonstrated the speed and scalability of the Moderna platform that we have built over the last 10 years,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I believe that 2021 will be an inflection year for Moderna. We previously believed that mRNA would lead to approved medicines, and we were limited in our ambitions by the need for regular capital raises and keeping several years of cash to manage financing risk. We now know that mRNA vaccines can be highly efficacious and authorized for use, and we are a cash-flow generating commercial company. We opened commercial subsidiaries in 8 countries in 2020 and plan to add Japan, South Korea and Australia in 2021. We plan to accelerate and significantly increase our investments in science and grow our development pipeline faster. By executing on our 2021 priorities, we will advance our mission of delivering on the promise of mRNA science to create a new generation of transformative medicines for patients. This is just the beginning.”
New updates and recent progress include:
COVID-19 Vaccine Development
Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered clinical studies. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 65 peer-reviewed papers.
Summary of Program Highlights by Modality
Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company’s global public health portfolio is focused on epidemic and pandemic diseases for which funding has been sought from governments and non-profit organizations.
COVID-19 Vaccine Development
Vaccines requiring complex antigens and against highly prevalent infections
Vaccines against respiratory infections
Public health vaccines
Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.
Cancer Vaccines: These programs focus on stimulating a patient’s immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.
Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.
Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.
Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.
Information about each development candidate in Moderna’s pipeline can be found on the investor relations page of its website: investors.modernatx.com.
Fourth Quarter and Full Year 2020 Financial Results (Unaudited)
Moderna’s COVID-19 Vaccine Supply Agreements & Regulatory Updates
Moderna has confirmed the following supply agreements of committed orders:
“I would like to thank Tal for his tremendous impact on Moderna’s success over the last six years. Tal joined us when we were a pre-clinical company. His guidance and contributions were important in helping Moderna get to where we are today. Through his leadership over the past year in Moderna’s response to the COVID-19 pandemic, Tal has made a contribution that extends beyond Moderna to all of society. I have enjoyed having him as my partner and wish him all the best as he embarks on the next leg of his career,” said Stéphane Bancel.
2020 Commercial Network
The Company started to build a global commercial network. This infrastructure will enable Moderna’s entire portfolio, which means that Moderna can commercialize its entire pipeline without a large pharmaceutical partner. The Company now has subsidiaries, distributors or partners in the following geographies:
2021 Financial Considerations
2021 New Commercial Networks
In 2021, the Company plans to further expand its commercial network to enable Moderna’s entire portfolio.
Key 2021 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 Thursday, February 25, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 4066945. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. 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.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company’s development of the Moderna COVID-19 Vaccine (mRNA-1273); the number of doses of the Moderna COVID-19 Vaccine that the Company anticipates being able to manufacture in 2021 and 2022 and on a quarterly basis, and investments to facilitate that manufacturing; the Company’s efforts to continue developing vaccines against COVID-19, including efforts to develop vaccines against variant strains of SARS-CoV-2 and for booster doses; the Company’s establishment of additional subsidiaries and development of its commercial network; the status of developments for programs in the Company’s pipeline, including with respect to the timing, enrollment and potential results of clinical trials; future growth prospects for the Company; the efficacy of mRNA vaccines and their potential for regulatory approval or authorization; expected timing of execution of the Purchase Agreement by the European Commission for additional vaccine doses; future research and development expenses; sales, general and administrative expenses; and capital expenditures, as well as other expenses; orders for the Company’s Moderna COVID-19 Vaccine, both inside and outside the U.S.; anticipated doses to be delivered under advance purchase agreement in 2021 and the associated dollar amounts to be received, which should not be construed as expected 2021 revenue; the anticipated cost of sales associated with the Moderna COVID-19 Vaccine; the Company’s future tax rate; and personnel recruitment efforts. 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: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q 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 www.sec.gov. 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 hereof.
1 On February 18, 2021, the European Commission advised Moderna it had successfully tendered for the provision of 150 million doses of COVID-19 Vaccine Moderna in 2021 and an option to purchase an additional 150 million doses in 2022; this tender is subject to execution of the Purchase Agreement, which is expected February 26, 2021, following an opt out period for individual Member States.