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Moderna Reports Second Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Moderna COVID-19 Vaccine mRNA-1273: Final blinded analysis of Phase 3 COVE study shows 93% efficacy; Efficacy remains durabl

Key Takeaway: Moderna Reports Second Quarter Fiscal Year 2021 Financial Results and Provides Business Updates Moderna COVID-19 Vaccine mRNA-1273: Final blinded analysis of Phase 3 COVE study shows 93% Efficacy remains durable through six months after second dose Moderna booster candidates d

Full Press Release Details

Moderna Reports Second Quarter Fiscal Year 2021 Financial Results and Provides Business Updates
Moderna COVID-19 Vaccine mRNA-1273: Final blinded analysis of Phase 3 COVE study shows 93%
Efficacy remains durable through six months after second dose
Moderna booster candidates demonstrate robust antibody responses to COVID-19 variants of concern in
Dosing started in Phase 1 studies for quadrivalent seasonal flu vaccine candidate (mRNA-1010) and IL-2 mRNA program for
autoimmune disorders (mRNA-6231)
Moderna has mRNA candidates in clinical development across five therapeutic areas: infectious
disease, cardiovascular, oncology, rare disease and autoimmune disorders
Q2 total revenue of $4.4 billion, net income of
$2.8 billion and diluted earnings per share of $6.46
Moderna establishes new Charitable Foundation to promote public health,
healthcare and educational opportunities, particularly in underserved populations
CAMBRIDGE, Mass., August 5,
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 second quarter of fiscal year
I am proud of the progress our teams at Moderna have made in the past quarter in advancing our development pipeline while addressing a global
pandemic and quickly establishing global manufacturing and commercial organizations, said St phane Bancel, Chief Executive Officer of Moderna. We now have mRNA candidates in clinical trials across five therapeutic areas including
infectious diseases, cardiovascular, oncology, rare disease and autoimmune disorders. We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months, but recognize that the Delta variant is a significant new threat so
we must remain vigilant.
Looking forward, Bancel said, We have begun preparing late stage studies for our flu vaccine and RSV vaccine, which
received fast track designation from the FDA a few days ago and are looking forward towards our vision of a single dose annual booster that provides protection against COVID-19, flu and RSV for adults. I look forward to the start of our Phase 3
trial for CMV this year and to clinical proof of concept data in the coming quarters from our therapeutics pipeline. We believe this is just the beginning.
Updates and recent progress include:
COVID-19 Vaccine Development
Autoimmune Disorders
currently has 23 mRNA development programs in its portfolio with 15 having entered clinical studies. The Company s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 80 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, 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.
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.
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 at investors.modernatx.com.
Second Quarter 2021 Financial Results
Key 2021 Investor and Analyst Event Dates
Investor Call and Webcast Information
a live conference call and webcast at 8:00 a.m. ET on Thursday, August 5, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5749439. 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 webcast and slides are available directly at:
https://investors.modernatx.com/events/event-details/moderna-2q-2021-earnings-call. 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
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. Today, 23 development programs are
underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in millions, except per share data)
Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
Revenue:
Product sales $ 4,197 $ $ 5,930 $
Grant revenue 139 38 333 42
Collaboration revenue 18 29 28 33
Total revenue 4,354 67 6,291 75
Operating expenses:
Cost of sales 750 943
Research and development 421 152 822 267
Selling, general and administrative 121 37 198 61
Total operating expenses 1,292 189 1,963 328
Income (loss) from operations 3,062 (122 ) 4,328 (253 )
Interest income 3 7 7 15
Other expense, net (2 ) (2 ) (12 ) (3 )
Income (loss) before income taxes 3,063 (117 ) 4,323 (241 )
Provision for income taxes 283 322
Net income (loss) $ 2,780 $ (117 ) $ 4,001 $ (241 )
Earnings (loss) per share:
Basic $ 6.93 $ (0.31 ) $ 9.98 $ (0.66 )
Diluted $ 6.46 $ (0.31 ) $ 9.30 $ (0.66 )
Weighted average common shares used in calculation of earnings (loss) per share:
Basic 402 381 401 367
Diluted 431 381 430 367
CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA
(Unaudited, in millions)
June 30, December 31,
2021 2020
Cash, cash equivalents and investments $ 12,197 $ 5,247
Total assets 16,153 7,337
Total liabilities 9,449 4,776
Total stockholders equity 6,704 2,561
Total liabilities and stockholders equity 16,153 7,337
Six Months Ended June 30,
2021 2020
Net cash provided by (used in) operating activities $ 7,034 $ (130 )
Cash used for purchases of property and equipment (65 ) (25 )
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 for a Biologics License Application for mRNA-1273; 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; 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 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; 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; plans to conduct a share repurchase program; plans to establish a charitable foundation; and plans to establish the Moderna International Business Services Center. 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 Investor Relations
Last updated: Aug 5, 2021