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2016-03-03

Novavax, Inc.: Novavax Reports Fourth Quarter and Year-End 2015 Financial Results

GAITHERSBURG, Md., Feb. 29, 2016 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced its financial results for the fourth quarter and
twelve months ended December 31, 2015.

Recent Accomplishment:

* Novavax issued a total of $325 million Convertible Senior Notes, resulting
in net proceeds of approximately $276 million. These proceeds further
strengthen Novavax' balance sheet ahead of data from the pivotal Phase 3
Resolve(TM) clinical trial, expected in the third quarter of 2016, and in
support of discussions for the commercialization rights to its RSV F
Vaccine franchise outside North America, while minimizing dilution.

Novavax Fourth Quarter Achievements:

* Completed target enrollment of the Resolve trial of its RSV F Vaccine in
older adults (60 years of age and older). Resolve is a randomized,
observer-blinded, placebo-controlled trial of 11,850 older adults at 60
sites in the United States. The primary efficacy objective is the
prevention of moderate-severe RSV-associated lower respiratory tract
disease, as defined by the presence of multiple lower respiratory tract
symptoms.
* Completed enrollment of 1,330 older adults in a Phase 2 rollover clinical
trial of its RSV F Vaccine in older adults enrolled in the prior Phase 2
trial. The trial is a randomized, observer-blinded, placebo-controlled
rollover trial designed to enroll from the population of 1,600 older adults
who participated in the prior Phase 2 trial. The primary endpoints of the
trial will evaluate safety and serum anti-F IgG antibody concentrations in
response to immunization with the RSV F Vaccine.
* Initiated enrollment in a global pivotal Phase 3 clinical trial, known as
Prepare(TM), of its RSV F Vaccine in healthy pregnant women. Prepare is a
randomized, observer-blinded, placebo-controlled trial that utilizes a
group sequential design, thus, the eventual sample size may vary between
5,000 and 8,255 pregnant women over a period of two to four years. The
primary objective is to determine the efficacy of maternal immunization
with the RSV F Vaccine against symptomatic RSV lower respiratory tract
infection (LRTI) with hypoxemia in infants through the first 90 days of
life. Novavax previously announced it was awarded a grant up to $89 million
from the Bill&Melinda Gates Foundation to support development of this RSV F
Vaccine for infants via maternal immunization.
* Appointed Jeffrey Stoddard, M.D. to Vice President, Medical Affairs and
Mark Twyman to Vice President, Marketing and promoted Jody Lichaa to Vice
President, Quality Assurance.

2016 Anticipated Events:

* Announce top-line data from Resolve, the Phase 3 pivotal RSV F Vaccine in
older adults in third quarter of 2016; and
* Announce top-line data from the Phase 2 RSV F Vaccine rollover trial in
older adults in the second half of 2016.

Summary

"During the fourth quarter, we initiated two pivotal Phase 3 trials of our RSV
F Vaccine, and subsequently completed enrollment of our Resolve trial in
older adults. We expect to announce value-creating data from the Resolve
trial and the Phase 2 rollover trial in older adults in 2016," said Stanley
C. Erck, President and CEO. "In addition, we recently strengthened our
balance sheet through the successful completion of a convertible note
offering, providing the necessary resources for the continued execution of
our business plan."

Financial Results for the Three and Twelve Months Ended December 31, 2015

Novavax reported a net loss of $78.8 million, or $0.29 per share, for the
fourth quarter of 2015, compared to a net loss of $31.5 million, or $0.13 per
share, for the fourth quarter of 2014. For the twelve months ended December
31, 2015, the net loss was $156.9 million, or $0.60 per share, compared to a
net loss of $82.9 million, or $0.37 per share, for the same period in 2014.

Novavax revenue in the fourth quarter of 2015 decreased 13% to $5.9 million,
compared to $6.7 million for the same period in 2014. Revenue for the full
year 2015 increased 18% to $36.3 million, compared to $30.7 million in 2014.
The increase in full year revenue results from the recovery of additional
costs under the BARDA contract of $7.7 million for the settlement of indirect
rates for fiscal years 2011 and 2012 and $3.1 million relating to the
Company's prior Phase 2 clinical trial of our quadrivalent seasonal influenza
VLP vaccine candidate in Australia as collection of the amount became
reasonably assured in 2015. These increases in revenue were partially offset
by a decrease in revenue resulting from a lower level of development
activities under the BARDA contract and our prior PATH agreement, as compared
to 2014.

We have historically recorded certain reimbursable research and development
costs incurred under our government contracts in a line item titled "Cost of
government contracts revenue." Those costs are included in "Research and
development expenses" for all periods presented in this press release and in
the 2015 Annual Report on Form 10-K to be filed with the SEC.

Research and development expenses increased 128% to $75.9 million in the
fourth quarter of 2015, compared to $33.3 million for the same period in
2014. For the full year 2015, research and development expenses increased 72%
to $162.6 million, compared to $94.4 million in 2014. The increase in
research and development expenses for the full year 2015 was driven by costs
related to the initiation of our two pivotal Phase 3 clinical trials and
Phase 2 rollover trial of the RSV F Vaccine and higher employee-related
costs, including non-cash stock-based compensation, tied to the continued
growth of the company. This increase was partially offset by a lower level of
development activities under the BARDA contract.

General and administrative expenses increased 75% to $8.9 million in the
fourth quarter of 2015, compared to $5.1 million for the same period in 2014.
For the full year 2015, general and administrative expenses increased 55% to
$30.8 million, compared to $19.9 million in 2014. The increase in general and
administrative expenses for the full year 2015 resulted from increased
employee-related expenses, including non-cash stock-based compensation, tied
to the continued growth of the company and professional fees for
pre-commercialization activities.

As of December 31, 2015, the company had $230.7 million in cash and cash
equivalents and marketable securities compared to $168.1 million as of
December 31, 2014. Net cash used in operating activities for 2015 was $126.1
million, compared to $67.0 million for 2014. The factors contributing to the
change in operating cash usage were primarily due to increased costs relating
to our RSV F Vaccine and higher employee-related expenses, as well as the
timing of customer and vendor payments. Subsequent to year-end 2015, Novavax
completed its offering of Convertible Senior Notes mentioned above.

Conference Call

Novavax management will host its quarterly conference call today at 8:00 a.m.
EST. The dial-in number for the conference call is (877) 212-6076 (Domestic)
or (707) 287-9331 (International), passcode 45346424. 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 conference call will be available starting at 11:00 a.m. on
February 29, 2016 until midnight March 7, 2016. To access the replay by
telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International)
and use passcode 45346424. The replay will also be available as a webcast and
can be found on the "Investor Info"/"Events" on the Novavax website.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to
delivering novel products to prevent a broad range of infectious diseases.
Our recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the
foundation for groundbreaking innovation that improves global health through
safe and effective vaccines. Additional information about Novavax is
available on the Company's website,novavax.com.

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, 2015 to be 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.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)

--------------------------------------------------------------------------------------------------------------
| |
| Three Months Ended Twelve Months Ended |
| December 31, December 31, |
| 2015 2014 2015 2014 |
| (unaudited) |
| Revenue $ 5,853 $ 6,724 $ 36,250 $ 30,659 |
| |
| Expenses: |
| Research and development 75,903 33,332 162,644 94,422 |
| General and administrative 8,852 5,056 30,842 19,928 |
| Total expenses 84,755 38,388 193,486 114,350 |
| Loss from operations (78,902 ) (31,664 ) (157,236 ) (83,691 ) |
| Interest income (expense), net 95 118 419 129 |
| Other income (expense) 1 - (120 ) - |
| Realized gains on marketable securities - - - 615 |
| Net loss $ (78,806 ) $ (31,546 ) $ (156,937 ) $ (82,947 ) |
| |
| Basic and diluted net loss per share $ (0.29 ) $ (0.13 ) $ (0.60 ) $ (0.37 ) |
| Basic and diluted weighted average |
| number of common shares outstanding 269,863 ...

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