Full Press Release Details
Moderna Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Updates
Q4 2021 revenues of $7.2 billion; GAAP net-income of $4.9 billion and GAAP diluted EPS of
Full year 2021 revenues of $18.5 billion; GAAP net-income of $12.2 billion
and GAAP diluted EPS of $28.29
Moderna increased its 2022 signed advance purchase agreements to approximately $19 billion,
with additional signed options of approximately $3 billion; numerous discussions ongoing with governments for the fall of 2022 and 2023
Moderna received full U.S. FDA approval for COVID-19 vaccine, Spikevax
Moderna announces new bivalent booster candidate (mRNA-1273.214) combining Omicron-specific booster candidate (mRNA-1273.529) and the
Moderna COVID-19 vaccine (mRNA-1273)
Company now has 44 programs in development
Moderna announces a new $3 billion share repurchase plan
CAMBRIDGE, Mass. (ACCESS WIRE) February 24, 2022 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 of fiscal year 2021.
now approved in more than 70 countries around the world protecting hundreds of millions of people and real-world evidence from multiple independent studies has confirmed its strong effectiveness, said St phane Bancel, Chief Executive
Officer of Moderna. In 2021, we delivered 807 million doses with approximately 25% of those doses going to low- and middle-income countries, and we will continue to scale in 2022 to help end the COVID-19 pandemic. Moderna has experienced exponential growth and we have more than doubled the size of our team over the last year with a global team of 3,000. We also have announced plans to scale to 21 commercial
subsidiaries across the world, including four new locations in Asia and six new locations in Europe. We continue to expand and advance our industry-leading mRNA pipeline with 44 programs in development. We look forward to clinical readouts from our
therapeutics development candidates later in 2022 in rare genetic diseases and oncology. We are entering 2022 with a remarkable team and strategic priorities to continue advancing mRNA vaccines and therapeutics to impact human health.
Updates and recent progress include:
COVID-19 Vaccine Development
Respiratory Vaccines
Moderna now has 44 programs in development across 41 development
candidates1, of which 25 are currently in active clinical trials. The Company s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more
than 100 peer reviewed manuscripts.
Summary of Program Highlights by Modality2
Vaccines: Moderna is developing vaccines against viral diseases where there is an unmet medical need, including vaccines against respiratory infections and vaccines against latent viruses.
Vaccines against acute respiratory infections
COVID-19 vaccine development
Additional vaccines against respiratory infections
Vaccines against latent viruses
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.
Exploratory Modalities
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.
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.
Inhaled Pulmonary Therapeutics
Information about each
development candidate in Moderna s pipeline can be found at investors.modernatx.com.
Fourth Quarter and Full Year 2021 Financial Results
2022 Financial Framework
Commercial Outlook in 2023 & Beyond
Moderna s Capital Allocation Priorities
2021 Commercial Network
Moderna is building a global commercial network to enable Moderna s entire portfolio, which will facilitate the commercialization of its pipeline
without a large pharmaceutical partner. The Company now has active commercial subsidiaries in the following geographies in the Americas: Canada, the United States; Europe: France, Germany, Italy, Spain, Switzerland, and the United Kingdom;
Asia Pacific: Australia, Japan, and South Korea. In addition, Moderna works with distributors or partners in other geographies.
2022 New Commercial Networks
In 2022, the Company plans to further expand its commercial network
to enable Moderna s entire portfolio by establishing or activating commercial subsidiaries in the following geographies in Asia: Hong Kong, Malaysia, Singapore and, Taiwan; and in Europe: Belgium, Denmark, Netherlands, Norway, Poland,
and Sweden. In addition, Moderna will continue to work with distributors or partners in other geographies.
Corporate Social Responsibility
Key 2022 Investor and Analyst Event Dates
Investor Call and Webcast Information
a live conference call and webcast at 8:00 a.m. ET on Thursday, February 24, 2022. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5682797. 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.
In over 10 years since its
inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad
intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad
range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna s capabilities have come together to allow the
authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the
development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the
past seven years. To learn more, visit www.modernatx.com.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in millions, except per share data)
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales | $ | 6,935 | $ | 200 | $ | 17,675 | $ | 200 | ||||||||
| Grant revenue | 262 | 341 | 735 | 529 | ||||||||||||
| Collaboration revenue | 14 | 30 | 61 | 74 | ||||||||||||
| Total revenue | 7,211 | 571 | 18,471 | 803 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 952 | 8 | 2,617 | 8 | ||||||||||||
| Research and development | 648 | 759 | 1,991 | 1,370 | ||||||||||||
| Selling, general and administrative | 201 | 79 | 567 | 188 | ||||||||||||
| Total operating expenses | 1,801 | 846 | 5,175 | 1,566 | ||||||||||||
| Income (loss) from operations | 5,410 | (275 | ) | 13,296 | (763 | ) | ||||||||||
| Interest income | 7 | 4 | 18 | 25 | ||||||||||||
| Other expense, net | (7 | ) | (29 | ) | (6 | ) | ||||||||||
| Income (loss) before income taxes | 5,410 | (271 | ) | 13,285 | (744 | ) | ||||||||||
| Provision for income taxes | 542 | 1 | 1,083 | 3 | ||||||||||||
| Net income (loss) | $ | 4,868 | $ | (272 | ) | $ | 12,202 | $ | (747 | ) | ||||||
| Earnings (loss) per share: | ||||||||||||||||
| Basic | $ | 12.03 | $ | (0.69 | ) | $ | 30.31 | $ | (1.96 | ) | ||||||
| Diluted | $ | 11.29 | $ | (0.69 | ) | $ | 28.29 | $ | (1.96 | ) | ||||||
| Weighted average common shares used in calculation of earnings (loss) per share: | ||||||||||||||||
| Basic | 405 | 397 | 403 | 381 | ||||||||||||
| Diluted | 431 | 397 | 431 | 381 |
CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA
(Unaudited, in millions)
| December 31, 2021 | December 31, 2020 | |||||||
| Cash, cash equivalents and investments | $ | 17,570 | $ | 5,247 | ||||
| Total assets | 24,669 | 7,337 | ||||||
| Total liabilities | 10,524 | 4,776 | ||||||
| Total stockholders equity | 14,145 | 2,561 | ||||||
| Total liabilities and stockholders equity | 24,669 | 7,337 | ||||||
| Years Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| Net cash provided by operating activities | $ | 13,620 | $ | 2,027 | ||||
| Cash used for purchases of property and equipment | (284 | ) | (68 | ) | ||||
| Cash used for repurchase of common stock | (857 | ) |
Forward-Looking Statements
This presentation 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 vaccines against COVID-19, including efforts to develop variant-specific and multivalent vaccines against variant strains of SARS-CoV-2 and for booster doses; the ability of the Moderna COVID-19 Vaccine and booster doses to provide protection against COVID-19 and variants of concern, including Omicron; the need for boosters against COVID-19; the Company s plan to submit for EUA for
at-risk adolescents; the Company s plan to submit data regarding use of its COVID-19 vaccine in adolescents and pediatrics to regulators; the conduct and timing of
clinical trials for programs in the Company s pipeline, including its vaccine candidates against seasonal flu, combination flu and COVID-19, hMPV + PIV3, RSV + hMPV, CMV, RSV, HIV, Zika virus, Nipah
virus, EBV, triplet, IL-12, KRAS, VEGF-A, IL-2, PA, MMA, the Company s checkpoint cancer vaccine, as well as the
Company s personalized cancer vaccine candidate; the ability of the Company s next-generation flu candidates to potentially improve immunity; the ability of an mRNA vaccine against HSV-2 to deliver
similar efficacy as existing treatments and to improve compliance and quality of life; the potential for the Company s HSV-2 vaccine candidate to provide cross protection against HSV-1; the commercial opportunity for an HSV-2 vaccine; the potential market associated with commercial vaccines; the Company s capital allocation priorities, including
its intention to reinvest in the business, accelerate investment, seek external investment opportunities and return capital to shareholders; anticipated vaccine deliveries under advance purchase agreements and options in 2022 and the associated
dollar amounts to be received, which should not be construed as expected 2022 revenue and the anticipated timing for those deliveries; contracts for COVID-19 vaccine sales in 2023; the likelihood that options
for purchases of the Company s COVID-19 vaccine will be exercised; expected cost of sales as a percentage of product sales for fiscal year 2022; expected full year operating expenses and capital
investments in 2022; the Company s expected effective tax rate for 2022; new manufacturing and commercial capacity expected to come online in 2022, including the Company s plans to expand its commercial network globally through the
establishment of subsidiaries in new locations; anticipated deliveries of COVID-19 vaccine to the COVAX facility in 2022; the Company s plans to build a facility in Africa; the Company s pledge to
achieve net-zero carbon emissions by 2030; and the Company s commercial rights to its development candidates. 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 presentation 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 most recent Annual
Report on Form 10-K 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 presentation 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.
Director, Corporate Communications
Senior Vice President & Head of Investor Relations