Novavax Reports Third Quarter 2018 Financial Results
Novavax, Inc., (Nasdaq: NVAX) today announced its financial results
and operational highlights for the third quarter and nine months
ended September 30, 2018.
“We remain on track to meet our 2018 objectives,
as we continue to execute on our clinical milestones for ResVax and
NanoFlu,” said Stanley C. Erck, President and Chief Executive
Officer of Novavax, Inc. “In Prepare, our Phase 3 trial of ResVax,
we will complete monitoring of the efficacy endpoints by year-end,
which would allow us to announce top-line efficacy results in the
first quarter of 2019. For NanoFlu, we have completed enrollment of
our Phase 2 clinical trial and anticipate top-line results in the
first quarter of 2019. Based on this progress, we expect to conduct
an End-of-Phase 2 meeting with the FDA in the first half of 2019
and to initiate a pivotal Phase 3 clinical trial later in the
year.”
Third Quarter 2018 Operational
Highlights
ResVax™ Program
- Novavax expects to report top-line results from its final
efficacy analysis in the first quarter of 2019 and, assuming
successful results, expects to submit the Biologics License
Application (BLA) and Marketing Authorization Application (MAA) by
the first quarter of 2020.
NanoFlu™ Program
- In September 2018, Novavax initiated a Phase 2 clinical trial
in older adults of quadrivalent formulations of NanoFlu, its
nanoparticle seasonal influenza vaccine candidate, and in October
2018, Novavax completed enrollment of approximately 1,375 healthy
older adults across clinical sites in the U.S. This randomized,
observer-blinded, active-controlled trial will assess the safety
and tolerability of different doses and formulations of NanoFlu,
both adjuvanted with Matrix-M™ and unadjuvanted, as compared to two
U.S.-licensed comparators. Phase 2 clinical trial top-line results
are expected in the first quarter of 2019.
- During a pre-IND meeting in 2018, the FDA acknowledged and
agreed that the accelerated approval pathway for seasonal influenza
vaccines could be available for NanoFlu. Novavax plans to discuss
the Phase 2 data and the proposed Phase 3 study design, and reach
agreement on the use of accelerated approval, with the FDA during
an End-of-Phase 2 meeting in the first half of 2019. Novavax will
bring forward the selected dose/formulation of the Phase 2 clinical
trial into its future pivotal Phase 3 immunogenicity clinical
trial.
Corporate
- Novavax announced the appointment of Rachel King, Co-Founder
and Chief Executive Officer of GlycoMimetics, Inc., to its Board of
Directors. In addition to extensive experience as an executive in
the biotechnology industry, Mrs. King has also worked in the
venture capital side of life sciences, and has held executive
positions within a global multinational pharmaceutical
company.
Key Upcoming Anticipated
Events
- Final efficacy results of the Prepare trial are expected in the
first quarter of 2019.
- Top-line data from the Phase 2 clinical trial of NanoFlu are
expected in the first quarter of 2019.
- An End-of-Phase 2 meeting for NanoFlu is expected in the first
half of 2019.
Financial Results for the Three and Nine
Months Ended September 30, 2018
Novavax reported a net loss of $44.6 million, or
$0.12 per share, for the third quarter of 2018, compared to a net
loss of $44.6 million, or $0.15 per share, for the third quarter of
2017. For the nine months ended September 30, 2018, the net loss
was $135.4 million, or $0.37 per share, compared to a net loss of
$132.9 million, or $0.47 per share, for the same period in
2017.
Novavax revenue in the third quarter of 2018 was
$7.7 million, compared to $8.4 million in the same period in 2017.
This 7% decrease was driven by the completion of enrollment of the
Prepare trial in the second quarter of 2018.
Research and development expenses decreased 1%
to $41.3 million in the third quarter of 2018, compared to $41.9
million for the same period in 2017.
General and administrative expenses increased 2%
to $8.3 million in the third quarter of 2018, compared to $8.1
million for the same period in 2017.
Interest income (expense), net for the third
quarter of 2018 was ($2.7) million, compared to ($3.0) million for
the same period of 2017.
As of September 30, 2018, Novavax had $145.6
million in cash, cash equivalents, marketable securities and
restricted cash, compared to $186.4 million as of December 31,
2017. Net cash used in operating activities for the third quarter
of 2018 was $33.5 million, compared to $44.2 million for same
period in 2017. The decrease in cash usage was primarily due to
receiving a $15 million payment under the BMGF grant in the third
quarter of 2018, whereas no payment was received in the same period
of 2017.
Conference Call
Novavax will host its quarterly conference call
today at 4:30 p.m. ET. The dial-in numbers for the conference call
is (877) 212-6076 (Domestic) or (707) 287-9331 (International),
passcode 3639227. A replay of the conference call will be available
starting at 7:30 p.m. ET on November 7, 2018 until 7:30 pm ET on
November 14, 2018. To access the replay by telephone, dial (855)
859-2056 (Domestic) or (404) 537-3406 (International) and use
passcode 3639227.
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 “Investor Info”/“Events” tab on the
Novavax website. A replay of the webcast will be available on the
Novavax website until February 7, 2019.
About RSV in Infants
Globally, RSV (respiratory syncytial virus) is
the leading viral cause of severe lower respiratory tract disease
in infants and young children.1 It is the second leading cause of
death in children under one year of age.2 Estimated annual
hospitalizations of 1.4 million and an estimated 27,300 in-hospital
deaths were due to RSV acute lower respiratory infection in
children under six months of age.3 RSV results in a total global
economic burden of $6.2 billion annually.
In the U.S., RSV is the leading cause of
hospitalization of infants, with estimated annual hospitalizations
of up to 76,000.4,[5],[6] While RSV can impact all infants, babies
under six months of age are among those at highest risk, as
approximately 77% of all first-year RSV infections occur before six
months.7 In the U.S., the total economic burden is $2.7 billion
annually.
About ResVax™
ResVax is an RSV fusion (F) protein recombinant
nanoparticle vaccine with aluminum phosphate as an adjuvant. It is
being developed to protect infants from RSV disease via maternal
immunization, which may offer the best method of protection from
RSV disease in infants through the first months of life. Currently,
ResVax is being evaluated in Prepare™, a global Phase 3 clinical
trial in 4,636 pregnant women, at least 3,000 of whom have received
the vaccine, and their infants. Prepare is supported by an $89.1
million grant from the Bill & Melinda Gates Foundation
(BMGF).
About Influenza
Influenza is a world-wide infectious disease
that causes illness in humans with symptoms ranging from mild to
life-threatening or even death. Serious illness occurs not only in
susceptible populations such as infants, young children and older
adults, but also in the general population largely because of
infection by continuously evolving strains of influenza which can
evade the existing protective antibodies in humans. An estimated
one million deaths globally each year are attributed to influenza.8
Current estimates for seasonal influenza vaccine growth in the top
seven markets (U.S., Japan, France, Germany, Italy, Spain and UK),
show a potential increase from approximately $3.2 billion in
2012-13 season to $5.3 billion by the 2021-22 season.9
About NanoFlu™and Matrix M™
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, which 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. In October 2018, Novavax
completed enrollment in its Phase 2 clinical trial in older adults
of quadrivalent formulations of NanoFlu in 1,375 healthy older
adults across clinical sites in the U.S.
About Accelerated Approval
Accelerated approval may be granted for certain
biological products that have been studied for their safety and
effectiveness in treating serious or life-threatening illnesses and
that provide meaningful therapeutic benefit over existing
treatments. Such an approval will be based on adequate and
well-controlled clinical trials establishing that the biological
product has an effect on a surrogate endpoint that is reasonably
likely to predict clinical benefit. For seasonal influenza
vaccines, the hemagglutination inhibition (HAI) antibody response
may be an acceptable surrogate marker of activity that is
reasonably likely to predict clinical benefit. To be considered for
accelerated approval, a biologics license application for a new
seasonal influenza vaccine should include results from one or more
well-controlled studies designed to meet immunogenicity endpoints
and a commitment to conduct confirmatory post-marketing studies of
clinical effectiveness in preventing influenza.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a late-stage
biotechnology company that drives improved health globally through
the discovery, development, and commercialization of innovative
vaccines to prevent serious infectious diseases. ResVax™, its RSV
vaccine for infants via maternal immunization, is the only vaccine
in a Phase 3 clinical program and is designed to prevent the second
leading cause of death in children under one year of age worldwide.
Novavax is also advancing NanoFlu™, its quadrivalent influenza
nanoparticle vaccine, to address key factors that can lead to the
poor effectiveness of currently approved flu vaccines. Novavax is a
leading innovator of recombinant vaccines; its proprietary
recombinant technology platform combines the power and speed of
genetic engineering to efficiently produce a new class of highly
immunogenic nanoparticles addressing 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, 2017 and the Quarterly Report on
Form 10-Q for the period ended September 30, 2018 as filed with the
Securities and Exchange Commission (SEC). We caution investors not
to place considerable reliance on the 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 |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
7,735 |
|
|
$ |
8,352 |
|
|
$ |
28,161 |
|
|
$ |
20,764 |
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
41,326 |
|
|
|
41,862 |
|
|
|
130,382 |
|
|
|
118,779 |
|
|
General and
administrative |
|
8,309 |
|
|
|
8,118 |
|
|
|
25,185 |
|
|
|
25,911 |
|
|
|
Total expenses |
|
49,635 |
|
|
|
49,980 |
|
|
|
155,567 |
|
|
|
144,690 |
|
Loss from
operations |
|
(41,900 |
) |
|
|
(41,628 |
) |
|
|
(127,406 |
) |
|
|
(123,926 |
) |
Interest income
(expense), net |
|
(2,651 |
) |
|
|
(2,989 |
) |
|
|
(8,119 |
) |
|
|
(9,021 |
) |
Other income
(expense) |
|
(19 |
) |
|
|
10 |
|
|
|
111 |
|
|
|
20 |
|
Net loss |
$ |
(44,570 |
) |
|
$ |
(44,607 |
) |
|
$ |
(135,414 |
) |
|
$ |
(132,927 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted
net loss per share |
$ |
(0.12 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.47 |
) |
Basic and diluted
weighted average |
|
|
|
|
|
|
|
|
number of common
shares outstanding |
|
382,315 |
|
|
|
296,435 |
|
|
|
365,236 |
|
|
|
284,767 |
|
|
SELECTED CONSOLIDATED BALANCE SHEET DATA |
(in thousands) |
|
|
September 30,2018 |
|
December 31, 2017 |
|
(unaudited) |
|
|
Cash and cash equivalents |
$ |
56,496 |
|
|
$ |
106,307 |
|
Marketable securities |
|
70,612 |
|
|
|
50,996 |
|
Total restricted cash |
|
18,540 |
|
|
|
29,124 |
|
Total current assets |
|
160,541 |
|
|
|
203,311 |
|
Working capital |
|
113,826 |
|
|
|
129,636 |
|
Total assets |
|
250,478 |
|
|
|
302,493 |
|
Notes payable |
|
318,830 |
|
|
|
317,763 |
|
Total stockholders’
deficit |
|
(126,679 |
) |
|
|
(101,732 |
) |
|
|
|
|
Contacts:
InvestorsNovavax, Inc.Erika Trahanir@novavax.com240-268-2000
Westwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaSam BrownMike Beyermikebeyer@sambrown.com312-961-2502
1 Nair, H., et al. (2010) Lancet. 375:1545-1555
2 Losano R., et al. (2012/Dec15) Lancet. 380: 2095
3 Ting S/Nair H. Lancet. (2017). Sep2;390:946
4 Leader S., et al. (2003) J Pediatr. 143: S127
5 Hall CB. N Engl J Med (2009). 360:588
6 CDC-Stockman LJ. Pediatr Infect Dis J (2012). 31:5
7 Hall CB. (2013) Pediatrics. 132:e341
8 Resolution of the World Health Assembly. (2003)
WHA56.19.28
9 Influenza Vaccines Forecasts. Datamonitor (2013)
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