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
COVID-19 Program
- Secured funding for late-stage clinical development of
NVX‑CoV2373
- U.S. Government funding through Operation Warp Speed (OWS) up
to $1.6 billion
- Coalition for Epidemic Preparedness Innovations (CEPI) funding
increased up to a total of $399 million
- Cumulative $2 billion funding to date through OWS, CEPI and
Department of Defense (DoD)
- Advanced ongoing clinical trials for NVX‑CoV2373
- Phase 3 clinical trial in the United Kingdom (U.K.) initiated
- Trial expanded to 15,000 participants with full enrollment
expected by the end of November
- Enrollment approximately 9,000 participants, over 60% as of
today
- Event-driven interim data expected as soon as early first
quarter 2021
- Pivotal Phase 3 clinical trial in the U.S. expected to begin by
end of November
- U.S. Food and Drug Administration granted Fast Track
designation
- Conducted with support from the U.S. Government through
OWS
- Enrollment of up to 30,000 participants in the U.S. and Mexico,
with proportional representation among diverse populations most
vulnerable to COVID-19 distributed across race/ethnicity, age and
those living with co-morbidities
- Phase 2b clinical trial in South Africa initiated
- Includes two cohorts, one in healthy adults and one in
medically stable, HIV-positive adults, to allow for evaluation
across a diverse, representative study population
- Trial expanded to approximately 4,404 participants
- Enrollment over 50% as of today
- Supported in part by a $15 million grant from Bill &
Melinda Gates Foundation
- Phase 2 portion of Phase 1/2 clinical trial in the U.S. and
Australia initiated
- Enrollment completed with 1,288 healthy volunteers
- Presented favorable preliminary reactogenicity data during the
CDC Advisory Committee on Immunization Practices meeting
- Published Phase 1 data in The New England Journal of Medicine
from the Phase 1/2 clinical trial of NVX‑CoV2373 in healthy adults
18-59 years of age in September 2020
- Completed collaborations for global development, manufacture,
supply and commercialization of NVX‑CoV2373 with:
- Australian Federal Government to be supplied 40 million doses
- Novavax to supply doses beginning as early as the first half of
2021
- Government of Canada to be supplied up to 76 million doses
- U.K. Government for the purchase of 60 million doses and
support for the Phase 3 clinical trial to assess the efficacy in
the U.K. population
- Novavax to supply doses beginning as early as the first quarter
of 2021
- SK bioscience for development and supply in global markets
including the COVAX Facility
- Signed letter of intent with Republic of Korea’s Ministry of
Health and Welfare
- SK bioscience to manufacture the vaccine antigen component for
use in the final drug product
- AGC Biologics for manufacture of Matrix-M™ adjuvant in
Copenhagen, Denmark and Seattle, Washington in the U.S.
- 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
- Serum Institute of India (SII) for development and
commercialization in India and low- and middle-income countries
- Novavax and SII will split revenue from sale of product, net of
agreed costs
- SII to manufacture the antigen component
- FUJIFILM Diosynth Biotechnologies (FDB) to manufacture bulk
drug substance in North Carolina, Texas and in the U.K.
- Increased manufacturing capacity of NVX-CoV2373 to over two
billion doses annually, when all planned capacity has been brought
online anticipated by mid-2021
NanoFlu™ Program
- Formed a leadership team to advance NanoFlu to regulatory
licensure and accelerate all activities required to file a
biologics licensing application (BLA), including exploration of a
combined NanoFlu/NVX-CoV2373 vaccine that could be used in a
post-pandemic setting.
- Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President
and NanoFlu General Manager
- Published Phase 2 data in Clinical Infectious Diseases
Corporate
- Strengthened corporate leadership with additional executive
management promotions and hiring
- Gregory F. Covino as Chief Financial Officer
- John J. Trizzino as Chief Commercial Officer and Chief Business
Officer
- Filip Dubovsky, M.D. to Executive Vice President, Chief Medical
Officer
- Biegie Lee to Senior Vice President, Chief Information
OfficerClick here to read today’s leadership announcement
- Appointed Gregg Alton, J.D. to Novavax’ Board of Directors
- Provides extensive industry experience, including more than 20
years at Gilead Pharmaceuticals in an array of leadership roles
across a portfolio of responsibilities
- Expanded facilities to support global vaccine development
- 170,000 square feet in Gaithersburg, Maryland for
manufacturing, research and development, and general operational
purposes
- 9.7-acre parcel of land in Gaithersburg, Maryland to develop in
the future to accommodate growth
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.
Research 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.
Through 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 million.
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 (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.
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 February 9, 2021.
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.
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.
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 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
(in thousands)
|
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 |
) |
Contacts:
Investors Erika Trahan ir@novavax.com 240-268-2022
Media Brandzone/KOGS Communication Edna Kaplan
kaplan@kogspr.com 617-974-8659
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