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 second quarter ended June 30, 2020.
“Novavax’ unprecedented development activities
for NVX-CoV2373 and progress continued through the second quarter,”
said Stanley C. Erck, President and Chief Executive Officer of
Novavax. “Since identifying a candidate vaccine to address the
COVID-19 pandemic in March, we’ve secured significant funding,
implemented global manufacturing capacity and completed and
reported our successful Phase 1 trial. We’ve also expanded our
senior leadership team to advance our efforts to bring NVX-CoV2373
to market as rapidly as possible and grow our infrastructure to
support commercial stage operations.”
Second Quarter 2020 and Recent
Highlights
COVID-19 Program
- Announced Phase 1 data from its Phase 1/2 randomized,
observer-blinded, placebo-controlled clinical trial of NVX-CoV2373
in healthy adults 18-59 years of age-- Neutralization levels
numerically superior to convalescent serum-- Significantly higher
immune response with 2-dose, Matrix-MTM adjuvanted vaccine-- Strong
T cell responses-- Reassuringly safe and tolerable vaccine
profile-- Presentation included on Novavax website here-- Data
submitted for peer-review publication and posted to online preprint
server at medRxiv.org
- Demonstrated protection and high immunogenicity in animal
models-- Presented data from non-human primate models that
demonstrate protection in challenge studies, enhancement of
multifunctional T cells, and production of anti-S IgG and
neutralizing antibodies-- Data submitted for peer-review
publication and posted to online preprint server at medRxiv.org
- Secured $2 billion in funding for development and
commercialization of NVX-CoV2373-- Coalition for Epidemic
Preparedness Innovations (CEPI) funding up to $388 million-- U.S.
Department of Defense (DoD) funding up to $60 million-- U.S.
Government funding through Operation Warp Speed (OWS) up to $1.6
billion
- Completed collaborations for global development and
commercialization of NVX-CoV2373-- Partnered with Takeda
Pharmaceutical Company Limited for development, manufacture and
commercialization in Japan -- Novavax to receive payments
based on achievement of certain development and commercial
milestones -- Novavax shares in proceeds from vaccine sales--
Partnered with Serum Institute of India for development and
commercialization in India and low- and middle-income countries
(LMIC) -- Novavax and Serum Institute will split revenue from
sale of product, net of agreed costs
- Secured global manufacturing capacity for NVX-CoV2373--
Acquired Praha Vaccines in a cash transaction of approximately $167
million -- Includes biologics manufacturing facility and
related assets in Czech Republic -- Facility expected to
provide annual capacity approaching 1 billion antigen doses
starting in 2021-- Entered into agreements with FUJIFILM Diosynth
Biotechnologies’ (FDB) to manufacture bulk drug substance at
facilities in North Carolina and Texas -- Large scale
manufacturing initiated at FDB North Carolina site-- Entered into
manufacturing arrangements with AGC Biologics and PolyPeptide Group
for large-scale production of Novavax’ Matrix-M adjuvant in both
U.S. and Europe
NanoFlu™ Program
- Successful pivotal NanoFlu Phase 3 clinical trial announced in
March 2020-- Added important immunogenicity data regarding
development of robust T cell mediated responses-- All results
expected to support future BLA submission using U.S. FDA
accelerated approval pathway-- Company exploring pathways to
manufacture for required lot consistency clinical trial
- Phase 2 and Phase 3 data submitted for peer-review publications
and posted to online preprint server at medRxiv.org
Corporate
- Strengthened leadership with
numerous executive management promotions and hiring
- Appointed David M. Mott to Novavax’
Board of Directors-- Brings more than three decades of global
management, board and investment experience across multiple private
and public biopharmaceutical companies
Financial Results for the Three and Six
Months Ended June 30, 2020
Novavax reported a net loss of $17.5 million, or
$0.30 per share, for the second quarter of 2020, compared to a net
loss of $39.6 million, or $1.69 per share, for the second quarter
of 2019. For the six months ended June 30, 2020, the net loss was
$43.4 million, or $0.84 per share, compared to a net loss of $82.8
million, or $3.77 per share, for the same period in 2019.
Novavax revenue in the second quarter of 2020
was $35.5 million, compared to $3.4 million in the same period in
2019. This significant increase was due to increased development
activities relating to NVX-CoV2373 under the CEPI agreement.
Research and development expenses increased 15%
to $34.8 million in the second quarter of 2020, compared to $30.4
million in the same period in 2019. The increase was primarily due
to increased development activities relating to NVX-CoV2373 under
the CEPI agreement, partially offset by decreased employee-related
and other costs and development activities of ResVax as compared to
the same period in 2019.
General and administrative expenses increased
84% to $17.7 million in the second quarter of 2020, compared to
$9.6 million for the same period in 2019. This increase was
primarily due to increased professional fees relating to the
Novavax CZ acquisition and supporting our NVX-CoV2373 program and
increased employee-related expenses.
As of June 30, 2020, Novavax had $609.5 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 six months of 2020
was $92.5 million, compared to net cash used in operating
activities was $80.6 million for same period in 2019.
Novavax has continued to strengthen its balance
sheet. Recent activities include:
- In June, 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 million.
- Through utilization of at-the-market (ATM) offerings during the
second quarter of 2020, Novavax raised net proceeds of $206.3
million and a total of $392.3 million since the beginning of the
year.
Conference Call
Novavax will host its quarterly conference call
today at 4:30 p.m. ET. The dial-in numbers for the conference call
are (866) 923-9367 (Domestic) or (707) 287-9331 (International),
passcode 3048947. A replay of the conference call will be available
starting at 7:30 p.m. ET on August 10, 2020 until 7:30 p.m. ET on
August 17, 2020. To access the replay by telephone, dial (855)
859-2056 (Domestic) or (404) 537-3406 (International) and use
passcode 3048947.
A webcast of the 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 November 10, 2020.
About NVX-CoV2373
NVX‑CoV2373 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. In
preclinical trials, NVX‑CoV2373 demonstrated indication of
antibodies that block binding of spike protein to receptors
targeted by the virus, a critical aspect for effective vaccine
protection. In its Phase 1 portion of the 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. Novavax was awarded $1.6 billion by the federal
government as part of Operation Warp Speed (OWS), a U.S. government
program to deliver millions of doses of a safe, effective vaccine
for COVID-19 to the U.S. population. The OWS funding is being used
by Novavax to complete late-stage clinical development, including a
pivotal Phase 3 clinical trial; establish large-scale
manufacturing; and deliver 100 million doses of NVX‑CoV2373
beginning as early as late 2020. The Coalition for Epidemic
Preparedness Innovations (CEPI) is also investing up to $388
million, and Department of Defense (DoD) is investing up to $60
million of funding to advance clinical development of
NVX‑CoV2373.
About NanoFlu™
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™
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.
About Novavax
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 undergoing clinical trials for NVX-CoV2373, its vaccine
candidate against SARS-CoV-2, the virus that causes COVID-19.
NVX‑CoV2373 was generally well-tolerated and elicited robust
antibody responses numerically superior to that seen in human
convalescent sera in its Phase 1 portion of the Phase 1/2 clinical
trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine,
met all primary objectives in its pivotal Phase 3 clinical trial in
older adults. Both vaccine candidates incorporate Novavax’
proprietary saponin-based Matrix-M™ adjuvant in order 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
8-K for the period ended June 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.
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NOVAVAX, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except per share information) |
(unaudited) |
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
|
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Revenue |
$ 35,538 |
|
$ 3,357 |
|
$ 38,915 |
|
$ 7,339 |
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Expenses: |
|
|
|
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|
|
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Research and
development |
34,846 |
|
30,417 |
|
51,741 |
|
65,890 |
|
General and
administrative |
17,719 |
|
9,606 |
|
27,098 |
|
18,338 |
|
|
Total expenses |
52,565 |
|
40,023 |
|
78,839 |
|
84,228 |
Loss from
operations |
(17,027) |
|
(36,666) |
|
(39,924) |
|
(76,889) |
Interest income
(expense), net |
(3,106) |
|
(2,929) |
|
(6,074) |
|
(5,912) |
Other income
(expense) |
2,612 |
|
(8) |
|
2,613 |
|
(20) |
Net loss |
$ (17,521) |
|
$ (39,603) |
|
$ (43,385) |
|
$ (82,821) |
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Basic and diluted net
loss per share |
$ (0.30) |
|
$ (1.69) |
|
$ (0.84) |
|
$ (3.77) |
Basic and diluted
weighted average |
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number of common
shares outstanding |
58,618 |
|
23,473 |
|
51,401 |
|
21,966 |
SELECTED CONSOLIDATED BALANCE SHEET
DATA(in thousands)
|
June 30, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
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Cash and cash equivalents |
$ |
424,395 |
|
$ |
78,823 |
|
Marketable securities |
|
77,902 |
|
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-- |
|
Total restricted cash |
|
107,179 |
|
|
3,357 |
|
Total current assets |
|
636,381 |
|
|
97,247 |
|
Working capital |
|
423,050 |
|
|
71,452 |
|
Total assets |
|
932,227 |
|
|
172,957 |
|
Notes payable |
|
321,323 |
|
|
320,611 |
|
Total stockholders’ equity
(deficit) |
|
184,526 |
|
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(186,017 |
) |
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Contacts:
Investors Novavax, Inc. Silvia Taylor and Erika Trahan
ir@novavax.com 240-268-2022
Media Brandzone/KOGS Communication Edna Kaplan kaplan@kogspr.com
617-974-8659
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