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Novavax Reports First Quarter 2021 Financial Results and Operational Highlights Significant progress in PREVENT-19 study; final data expected in the second quarter of 2021 Initiated pediatric extension of PREVENT-19 in t

Key Takeaway: Novavax Reports First Quarter 2021 Financial Results and Operational Highlights May 10, 2021 -- Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational high

Full Press Release Details

Novavax Reports First Quarter 2021 Financial
Results and Operational Highlights
May 10, 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 first quarter ended March 31, 2021.
"Novavax made great strides over the first
quarter to pave the path for our COVID-19 vaccine candidate, NVX-CoV2373, notably achieving statistically significant efficacy across
our Phase 3 UK and Phase 2b South Africa trials," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In
parallel, we have secured additional manufacturing and supply agreements, expanding our global supply chain to over 10 countries. In the
coming months, we look forward to delivering on critical milestones, including announcing final data from our PREVENT-19 Phase 3 trial,
completing our regulatory submissions, evaluating NVX-CoV2373 in younger populations and continuing to develop our booster strategy to
address the evolving COVID-19 pandemic. As we continue our dialogue with regulatory authorities for authorization, we remain committed
to promptly delivering our vaccine globally, ensuring equitable access and expansive distribution."
First Quarter 2021 and Recent Highlights
Clinical Development
Manufacturing and Supply
COVID-19 Regulatory Pathway
Malaria R21 Vaccine / Matrix-MTM
Adjuvant Collaboration
Corporate Highlights
Financial Results for the Three Months Ended
Novavax reported a net loss of $223 million, or
$3.05 per share, for the first quarter of 2021, compared to a net loss of $26 million, or $0.58 per share, for the first quarter of 2020.
Novavax revenue in the first quarter of 2021 was
$447 million, compared to $3 million in the same period in 2020. This significant 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
$593 million in the first quarter of 2021, compared to $17 million in the same period in 2020. The significant increase was primarily
due to the development of NVX-CoV2373.
General and administrative expenses increased
to $63 million in the first quarter of 2021, compared to $9 million for the same period in 2020. The increase was primarily due to increased
employee-related costs, stock-based compensation expenses, and supporting our NVX-CoV2373 program.
As of March 31, 2021, Novavax had $2 billion in
cash, cash equivalents, marketable securities and restricted cash, compared to $806 million as of December 31, 2020. Net cash provided
by operating activities for the first three months of 2021 was $663 million, compared to net cash used in operating activities of $23
million for same period in 2020. The increase in cash provided was primarily due to $772 million in payments under advance purchase agreements
recorded as deferred revenue and the timing of payments to third parties.
Through utilization of At-the-market (ATM) offerings
during the first quarter 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 May 10, 2021 until 11:59 p.m. ET on May 17, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088
(International) and use passcode 10155684.
A webcast of the conference
call can also be accessed on the Novavax website at https://ir.novavax.com/events. A replay of the webcast will be available on the Novavax
website until August 10, 2021.
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 adjuvanted with Novavax' patented saponin-based Matrix-M 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.
is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy
of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the
U.S. and Mexico that began in December 2020. 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 100% protection against severe disease 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.
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 10-dose vials.
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.
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 SARS-CoV-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
Statements herein relating to the future of Novavax
and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking
statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed
or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the
Novavax Annual Report on Form 10-K for the year ended December 31, 2020, 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 sec.gov, 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) (unaudited)
Three Months Ended
March 31,
2021 2020
Revenue $ 447,229 $ 3,377
Expenses:
Research and development 592,671 16,895
General and administrative 63,190 9,379
Total expenses 655,861 26,274
Loss from operations (208,632 ) (22,897 )
Interest income (expense), net (4,477 ) (2,967 )
Other income (expense) (6,593 ) --
Net loss before income tax expense $ (219,702 ) $ (25,864 )
Income tax expense 3,017 --
Net loss $ (222,719 ) $ (25,864 )
Basic and diluted net loss per share $ (3.05 ) $ (0.58 )
Basic and diluted weighted average
number of common shares outstanding 73,035 44,421
SELECTED CONSOLIDATED BALANCE SHEET DATA
March 31, 2021 December 31, 2020
(unaudited)
Cash and cash equivalents $ 1,995,482 $ 553,398
Marketable securities 2,250 157,649
Total restricted cash 33,588 95,340
Total current assets 2,246,784 1,248,203
Working capital 1,038,229 668,531
Total assets 2,608,366 1,582,479
Notes payable 322,390 322,035
Total stockholders' equity 1,039,127 627,209
Erika Schultz | 240-268-2022
Alexandra Roy | 617-221-9197
Laura Keenan | 202-709-7521
Amy Speak | 617-420-2461
Last updated: May 10, 2021