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Novavax Reports Second Quarter 2021 Financial Results and Operational Highlights Filed regulatory submissions for EUA in India, Indonesia and the Philippines, in partnership with Serum Institute of India Demonstrated gre

Key Takeaway: Novavax Reports Second Quarter 2021 Financial Results and Operational Highlights GAITHERSBURG, Md., August 5, 2021 -- Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial resul

Full Press Release Details

Novavax Reports Second Quarter 2021 Financial
Results and Operational Highlights
GAITHERSBURG, Md., August 5, 2021 -- Novavax,
Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its
financial results and operational highlights for the second quarter ended June 30, 2021.
"We are highly encouraged by the filing of
regulatory submissions in multiple markets, made in partnership with Serum Institute of India. We view these submissions as the first
of many filings to come, which will allow NVX-CoV2373 to be made available at a global scale," said Stanley C. Erck, President and
Chief Executive Officer, Novavax. "Our clinical successes over the second quarter reaffirm our confidence in NVX-CoV2373's
differentiated efficacy profile. We continue to see the circulation of new variants and inequitable access to vaccine globally, demanding
that we bring our COVID-19 vaccine to market as swiftly as possible."
Second Quarter 2021 and Recent Highlights
COVID-19 Vaccine Clinical and Non-Clinical Development
COVID-19 Vaccine Regulatory
COVID-19 Vaccine Manufacturing
Novavax to manufacture and distribute 350 million doses
SII to manufacture and distribute the remaining balance of the 1.1 billion doses to low- and middle-income countries
/ NVX-CoV2373 Combination Vaccine (qNIV/CoV2373)
Vaccine / Matrix-M Adjuvant Collaboration
Financial Results for the Three Months Ended
Novavax reported a net loss of $352 million, or
$4.75 per share, for the second quarter of 2021, compared to a net loss of $18 million, or $0.30 per share, for the second quarter of
Novavax revenue in the second quarter of 2021
was $298 million, compared to $36 million in the same period in 2020. This increase was due to increased development activities relating
to NVX-CoV2373 for services performed under the U.S. government and Coalition for Epidemic Preparedness Innovations agreements.
Research and development expenses increased to
$571 million in the second quarter of 2021, compared to $35 million in the same period in 2020. The increase was primarily due to the
development of NVX-CoV2373.
General and administrative expenses increased
to $73 million in the second quarter of 2021, compared to $18 million for the same period in 2020. The increase was primarily due to increased
employee-related costs, stock-based compensation expenses, and professional fees supporting our NVX-CoV2373 program.
As of June 30, 2021, Novavax had $2.1 billion
in cash, cash equivalents and restricted cash, compared to $806 million as of December 31, 2020. Net cash provided by operating activities
for the first six months of 2021 was $807 million, compared to $93 million for the same period in 2020. The increase in cash provided
was primarily due to $1.1 billion in payments under advance purchase agreements recorded as deferred revenue and the timing of payments
Through utilization of At-the-Market (ATM) offerings
during the first six months of 2021, Novavax raised net proceeds of $565 million.
Novavax will host its quarterly conference call
today at 4:30 p.m. ET. The dial-in numbers for the conference call are (866) 652-5200 (Domestic) or (412) 317-6060 (International). Participants
will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET
on August 5, 2021 until 7:30 p.m. ET on November 12, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412)
317-0088 (International) and use passcode 10158313.
A webcast of the conference call can also be accessed
on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until November 12, 2021.
NVX-CoV2373 is a protein-based vaccine candidate
engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created
using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated
with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing
antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies,
NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection
and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.
NVX-CoV2373 is being evaluated in two pivotal
Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the
Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated
100% protection against moderate and severe disease and 90.4% efficacy overall. It is also being tested in two ongoing Phase 2 studies
that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative
participants and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation
in the U.S. and Australia.
NVX-CoV2373 is stored and stable at 2 - 8 C,
allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in
NanoFlu is a recombinant hemagglutinin
(HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino
acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax'
patented saponin-based Matrix-M adjuvant.
About Matrix-M Adjuvant
Novavax' patented saponin-based
Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into
the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology
company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent
serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering
to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage
clinical trials for NVX-CoV2373, its vaccine candidate against SARSCoV-2, the virus that causes COVID-19. NanoFlu , its quadrivalent
influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced
for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance
the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com
and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
herein relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and other Novavax
vaccine product candidates, timing of future regulatory filings and actions, anticipated manufacturing capacity, and future availability
of NVX-CoV2373 at a global scale are forward-looking statements. Novavax cautions that these forward-looking statements are subject to
numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.
These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization
requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities;
difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on
the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple
commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K
for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission
(SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are
encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com,
for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the
date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial
risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration
to these risks and uncertainties.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 2021 2020
Revenue $ 298,017 $ 35,538 $ 745,246 $ 38,915
Expenses:
Research and development 570,685 34,846 1,163,356 51,741
General and administrative 73,161 17,719 136,351 27,098
Total expenses 643,846 52,565 1,299,707 78,839
Loss from operations (345,829 ) (17,027 ) (554,461 ) (39,924 )
Interest income (expense), net (5,599 ) (3,106 ) (10,076 ) (6,074 )
Other income (expense) 2,659 2,612 (3,934 ) 2,613
Net loss before income tax expense (348,769 ) (17,521 ) (568,471 ) (43,385 )
Income tax expense 3,548 -- 6,565 --
Net loss $ (352,317 ) $ (17,521 ) $ (575,036 ) $ (43,385 )
Basic and diluted net loss per share $ (4.75 ) $ (0.30 ) $ (7.82 ) $ (0.84 )
Basic and diluted weighted average number of common shares outstanding 74,118 58,618 73,580 51,401
SELECTED CONSOLIDATED BALANCE SHEET DATA
Last updated: Aug 5, 2021