Full Press Release Details
Novavax Reports Third Quarter 2020 Financial
and Operational Results
Md., November 9, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation
vaccines for serious infectious diseases, today announced its financial results and operational highlights for the third quarter
ended September 30, 2020.
"Novavax continued to deliver remarkable
progress this quarter, with our most notable achievement being the initiation of a 15,000-person pivotal Phase 3 trial in the U.K.
of NVX-CoV2373, our COVID-19 vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax.
"With multiple clinical trials ongoing worldwide, we expect initial efficacy data potentially by early first quarter 2021.
In the U.S., we made significant progress in large-scale manufacturing and expect to launch a pivotal Phase 3 trial by the end
of November. We also announced a newly formed team to lead the NanoFlu program to licensure in the U.S. and look forward to providing
updates as the team finalizes its strategy."
Third Quarter 2020 and Recent Highlights
Click here to read today's
leadership announcement
Financial Results for the Three and
Nine Months Ended September 30, 2020
Novavax reported a net loss of $197.3 million,
or $3.21 per share, for the third quarter of 2020, compared to a net loss of $18.0 million, or $0.74 per share, for the third quarter
of 2019. For the nine months ended September 30, 2020, the net loss was $240.7 million, or $4.39 per share, compared to a net loss
of $100.9 million, or $4.43 per share, for the same period in 2019.
Novavax revenue in the third quarter of
2020 was $157.0 million, compared to $2.5 million in the same period in 2019. This significant increase was due to increased development
activities relating to NVX-CoV2373 under the CEPI agreement, participation in OWS and the DOD contract.
and development expenses increased to $294.1 million in the third quarter of 2020, compared to $18.6 million in the same period
in 2019. The increase was primarily due to increased development activities relating to NVX-CoV2373, including
an expense of $187.2 million associated with its manufacturing supply agreements for NVX-CoV2373. Of the $187.2 million expense,
approximately $122 million was non-cash in the period, and is based on Novavax' determination that certain supply agreements
contain an embedded lease under U.S. accounting principles. Given that determination, Novavax recognized a financing lease liability
and a right-of-use (ROU) asset. As Novavax is in the research and development phase of its vaccine development, the ROU asset was
expensed in the third quarter, as it did not have an alternative use. Research and development expenses also increased due to increased
employee-related costs, primarily stock-based compensation expense.
General and administrative expenses increased
to $56.9 million in the third quarter of 2020, compared to $7.9 million for the same period in 2019. This increase was primarily
due to increased employee-related costs, primarily stock-based compensation expenses, and increased professional fees relating
to the integration of Novavax CZ and supporting our NVX-CoV2373 program.
As of September 30, 2020, Novavax had $571.6
million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019.
Net cash provided by operating activities for the first nine months of 2020 was $86.0 million, compared to net cash used in operating
activities of $112.9 million for same period in 2019.
utilization of At-the-market (ATM) offerings during the third quarter of 2020, Novavax raised net proceeds of $53.3 million and
$445.6 million since the beginning of the year. In addition, in the second quarter of 2020, Novavax entered into an agreement to
sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated
with RA Capital Management (RA Capital) in a private placement. Novavax received gross proceeds of $200
Novavax will host its quarterly conference
call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International),
passcode 8059421. A replay of the conference call will be available starting at 7:30 p.m. ET on November 9, 2020 until 7:30 p.m.
ET on November 16, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and
use passcode 8059421.
conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "For
Investors"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website
until February 9, 2021.
is a vaccine candidate engineered from the genetic sequence 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 contains 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 cannot replicate, nor can it cause COVID-19.
In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted
by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373
was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.
NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase
2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for
its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations
(CEPI) and almost $1.7 billion from the U.S. government.
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
late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization
of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple clinical trials
for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the
United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu , its
quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.
Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response
and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary
recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles
in order to address urgent global health needs.
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, 2019, and Quarterly Report on Form 10-Q
for the period ended September 30, 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.
| NOVAVAX, INC. |
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
| (in thousands, except per share information) |
| (unaudited) |
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue | $ | 157,024 | $ | 2,507 | $ | 195,939 | $ | 9,846 | ||||||||
| Expenses: | ||||||||||||||||
| Research and development | 294,087 | 18,611 | 345,828 | 84,502 | ||||||||||||
| Gain on Catalent transaction | -- | (9,016 | ) | -- | (9,016 | ) | ||||||||||
| General and administrative | 56,879 | 7,899 | 83,977 | 26,236 | ||||||||||||
| Total expenses | 350,966 | 17,494 | 429,805 | 101,722 | ||||||||||||
| Loss from operations | (193,942 | ) | (14,987 | ) | (233,866 | ) | (91,876 | ) | ||||||||
| Interest income (expense), net | (4,320 | ) | (3,061 | ) | (10,394 | ) | (8,973 | ) | ||||||||
| Other income (expense) | 952 | 5 | 3,565 | (15 | ) | |||||||||||
| Net loss | $ | (197,310 | ) | $ | (18,043 | ) | $ | (240,695 | ) | $ | (100,864 | ) | ||||
| Basic and diluted net loss per share | $ | (3.21 | ) | $ | (0.74 | ) | $ | (4.39 | ) | $ | (4.43 | ) | ||||
| Basic and diluted weighted average | ||||||||||||||||
| number of common shares outstanding | 61,554 | 24,327 | 54,810 | 22,761 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| September 30, 2020 | December 31, 2019 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 334,171 | $ | 78,823 | ||||
| Marketable securities | 169,860 | -- | ||||||
| Total restricted cash | 67,565 | 3,357 | ||||||
| Total current assets | 671,217 | 97,247 | ||||||
| Working capital | 431,999 | 71,452 | ||||||
| Total assets | 944,020 | 172,957 | ||||||
| Notes payable | 321,679 | 320,611 | ||||||
| Total stockholders' equity (deficit) | 106,440 | (186,017 | ) |
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