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Moderna Reports Third Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Q3 total revenue of $5.0 billion, net income of $3.3 billion and diluted EPS of $7.70 U.S. FDA granted Priority Review to the

Key Takeaway: Moderna Reports Third Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Q3 total revenue of $5.0 billion, net income of $3.3 billion and diluted EPS of $7.70 U.S. FDA granted Priority Review to the Biologics License Application for Moderna s COVID-19 Int

Full Press Release Details

Moderna Reports Third Quarter Fiscal Year 2021 Financial Results and Provides Business Updates
Q3 total revenue of $5.0 billion, net income of $3.3 billion and diluted EPS of $7.70
U.S. FDA granted Priority Review to the Biologics License Application for Moderna s COVID-19
Interim data from Phase 2/3 KidCOVE study of mRNA-1273 in children ages 6 to under 12 years shows vaccine efficacy of 100%
two weeks after first dose of mRNA-1273 at 50 g dose level
First participants dosed in Phase 3 study of cytomegalovirus
(CMV) vaccine candidate (mRNA-1647)
Introducing inhaled pulmonary therapeutics modality: Vertex and
Moderna cystic fibrosis mRNA therapeutic (VXc-522) IND-enabling first-in-human studies
Company continues to scale with 37 programs in development, including 21 in ongoing clinical studies
CAMBRIDGE, Mass. (BUSINESS WIRE) November 4, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA
(mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the third quarter of fiscal year 2021.
humbled to have helped hundreds of millions of people around the world with our COVID-19 vaccine and yet we know our work is not done. We will not rest until our vaccine is available to anyone who needs it,
and we are working hard to ensure our vaccine is available in low-income countries with approximately 10% of our 2021 volume and significantly more of our 2022 volume going to
low-income countries. It is promising to see the real-world evidence showing that the Moderna COVID-19 vaccine shows sustainably high, durable efficacy, said
St phane Bancel, Chief Executive Officer of Moderna. Looking ahead, we are focused on advancing the many other programs in our pipeline. We recently dosed the first participants in the Phase 3 study of our CMV vaccine. CMV is a latent
virus that remains in the body for life after infection and can lead to lifelong medical conditions. We are also focused on addressing respiratory viruses in addition to COVID-19, including seasonal flu and
RSV. We look forward to sharing data from the Phase 1 study of our flu vaccine candidate soon and we are preparing to start our Phase 2 study. We are also preparing to start the Phase 2/3 study of our RSV vaccine candidate. RSV causes
hospitalizations and deaths in our most vulnerable populations of young children and older adults. In addition, we continue to progress our therapeutics pipeline and we look forward to clinical proof of concept data. I would like to thank the
Moderna team for their scientific passion and commitment to our mission. I am more energized than ever by the impact our mRNA platform will have on human health.
Updates and recent progress include:
COVID-19 Vaccine Development
Respiratory Vaccines
Moderna continues to scale, now with 37 programs in development across 34 development candidates1, including 21 in ongoing clinical studies. The Company s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published nearly 100 peer
reviewed manuscripts.
Summary of Program Highlights by Modality
Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need including complex vaccines with multiple antigens for common diseases, vaccines against latent
viruses, and 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.
Vaccines against acute respiratory infections
COVID-19 vaccine development
vaccines against acute 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.
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.
Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies
directly into tumors.
Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.
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.
Third Quarter 2021 Financial Results
Updated Financial Framework
2022 Revenue Drivers
We expect several dynamics will
drive 2022 revenues:
Based on these three
revenue drivers, the Company believes 2022 sales could be in the range of $17 billion to $22 billion. The Company continues to have discussions for 2022 APAs with governments and international organizations, including COVAX, the Pan
American Health Organization (PAHO) and the African Union.
Corporate Social Responsibility
Key 2022 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, November 4, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 9177025. 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 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant
that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 September 30, Nine Months Ended September 30,
2021 2020 2021 2020
Revenue:
Product sales $ 4,810 $ $ 10,740 $
Grant revenue 140 145 473 187
Collaboration revenue 19 12 47 45
Total revenue 4,969 157 11,260 232
Operating expenses:
Cost of sales 722 1,665
Research and development 521 344 1,343 611
Selling, general and administrative 168 48 366 109
Total operating expenses 1,411 392 3,374 720
Income (loss) from operations 3,558 (235 ) 7,886 (488 )
Interest income 4 6 11 21
Other expense, net (10 ) (3 ) (22 ) (6 )
Income (loss) before income taxes 3,552 (232 ) 7,875 (473 )
Provision for income taxes 219 1 541 1
Net income (loss) $ 3,333 $ (233 ) $ 7,334 $ (474 )
Earnings (loss) per share:
Basic $ 8.27 $ (0.59 ) $ 18.25 $ (1.26 )
Diluted $ 7.70 $ (0.59 ) $ 17.00 $ (1.26 )
Weighted average common shares used in calculation of earnings (loss) per share:
Basic 404 395 402 376
Diluted 434 395 431 376
CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA
(Unaudited, in millions)
September 30, December 31,
2021 2020
Cash, cash equivalents and investments $ 15,348 $ 5,247
Total assets 20,923 7,337
Total liabilities 10,799 4,776
Total stockholders equity 10,124 2,561
Total liabilities and stockholders equity 20,923 7,337
Nine Months Ended September 30,
2021 2020
Net cash provided by operating activities $ 10,310 $ 763
Cash used for purchases of property and equipment (164 ) (44 )
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 the Moderna COVID-19 Vaccine (mRNA-1273); its 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 ability of the Moderna COVID-19 vaccine to
provide protection against COVID-19 over time and to trigger an antibody response against variants of concern; the Company s plans to submit results from its ongoing KidCOVE study to regulatory agencies;
the development of additional COVID-19 vaccine candidates that may be refrigerator stable; the conduct and timing of clinical trials for programs in the Company s pipeline, including its vaccine
candidates against seasonal flu, CMV, RSV, HIV, Nipah virus and EBV, as well as the Company s personalized cancer vaccine candidate; expected enrollment in the Company s Phase 3 study of its CMV vaccine; anticipated timing for the
submission of an IND for the Company s partnered cystic fibrosis program with Vertex; the potential to combine different vaccines into a single dose; the number of doses of the Moderna COVID-19 vaccine
that the Company anticipates being able to manufacture and deliver in 2021 and 2022, and investments to facilitate that manufacturing; anticipated doses to be delivered under advance purchase agreement in 2021 and 2022 and the associated dollar
amounts to be received, which should not be construed as expected 2021 or 2022 revenue; potential exercises for options to deliver vaccines, entry into the booster market for COVID-19 vaccine and the outcome
of discussions for future sales of vaccine with governments and international organizations; anticipated deliveries to the African Union and COVAX in 2021 and 2022; the construction of manufacturing facilities in Canada and Africa; the anticipated
cost of sales associated with the Moderna COVID-19 vaccine; the Company s commercial rights to its development candidates; future research and development expenses; future sales, general and
administrative expenses, and capital expenditures, as well as other expenses; orders for the Company s Moderna COVID-19 vaccine; the Company s future tax rate; and the Company s efforts to
achieve net-zero carbon emissions. 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 those other 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 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.
Director, Corporate Communications
Senior Vice President & Head of
Last updated: Nov 4, 2021