Full Press Release Details
Novavax Reports First Quarter 2018 Financial
MD, May 9, 2018 (GLOBE NEWSWIRE) - Novavax, Inc., (Nasdaq: NVAX) today announced its financial results for the first
quarter ended March 31, 2018.
Quarter and Subsequent Achievements:
had an extremely productive first quarter, including making important advances in our two lead clinical vaccine programs. We are
pleased to have reached the enrollment target for our Prepare Phase 3 RSV F Vaccine trial, which clears the path for following
these most recent participants and their babies, and subsequently announcing top-line results of our planned interim efficacy analysis
in the first quarter of 2019," said Stanley C. Erck, President and CEO of Novavax, Inc. "We also continue to make significant
progress on NanoFlu and plan to initiate a Phase 2 clinical trial in the third quarter of 2018."
Results for the First Quarter Ended March 31, 2018
reported a net loss of $46.4 million, or $0.14 per share, for the first quarter of 2018, compared to a net loss of $43.9 million,
or $0.16 per share, for the first quarter of 2017.
revenue in the first quarter of 2018 was $9.7 million, compared to $5.7 million in the same period in 2017. This 70% increase was
driven by higher revenue recorded under the BMGF grant corresponding to the increased enrollment in the Prepare trial.
and development expenses increased 18% to $44.5 million in the first quarter of 2018, compared to $37.7 million for the same period
in 2017. The increase was primarily due to increased development activities of the RSV F Vaccine for infants via maternal immunization.
income (expense), net for the first quarter of 2018 was ($2.9) million, compared to ($3.0) million for the same period of 2017.
of March 31, 2018, Novavax had $164.2 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 first quarter of 2018 was $66.1 million,
compared to $44.5 million for same period in 2017. The increase in cash usage was primarily due to approximately $16 million of
one-time payments, as well as the adoption of a new accounting standard that requires restricted cash to be included in the beginning
and ending balances on the statements of cash flows, thus increasing Novavax' cash usage in the first quarter of 2018 and
2017 by approximately $9 million and $6 million, respectively. We expect our cash used in operating activities to significantly
decrease for the subsequent quarters of 2018 as compared to the first quarter of 2018.
management will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877)
212-6076 (Domestic) or (707) 287-9331 (International),
passcode 3687883. A replay of the conference call will be available starting at 7:30
p.m. ET on May 9, 2018 until 7:30 p.m. ET on May 16, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic) or
(404) 537-3406 (International) and use passcode 3687883.
webcast of the conference call can also be accessed via a link on the home page of the Novavax website at www.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 August 9, 2018.
RSV is the most common cause of lower respiratory
tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide,
with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1
In the U.S., RSV is the leading cause of hospitalization of infants.2
Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.3
Currently, there is no approved RSV vaccine available.
About RSV F Vaccine for Infants via
Maternal Immunization
Novavax is developing a vaccine that targets
the fusion protein, or F protein, of the RSV virus. The F protein has highly conserved amino acid sequences, called antigenic sites,
which are the target of neutralizing antibodies and are believed to be ideal vaccine targets. Novavax' genetically engineered
novel F protein antigen exposes a range of these antigenic sites, and can evoke immune responses to them in human vaccine recipients.
In a previous Phase 2 clinical trial of the RSV F Vaccine, which assessed the transplacental transfer of maternal antibodies induced
by the vaccine, immunized women demonstrated meaningful fold rises in anti-F IgG, palivizumab-competing antibodies and microneutralization
titers. In addition, infants' antibody levels at delivery averaged 90-100% of the mothers' levels, indicating efficient
transplacental transfer of antibodies from mother to infant.
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 each year are attributed to influenza.4
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 2015 to $5.3 billion by 2025.5
2 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32
3 PLOS. "How immunity to respiratory syncytial
virus develops in childhood, deteriorates in adults." ScienceDaily. 21 April 2016. https://www.sciencedaily.com/releases/2016/04/160421145747.htm
4 Resolution of the World Health Assembly (2003)
5 Influenza Vaccines Forecasts. Datamonitor (2013)
NanoFlu is a recombinant hemagglutinin
(HA) protein nanoparticle influenza vaccine candidate 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.
Novavax, Inc. (Nasdaq:NVAX)
is a clinical-stage biotechnology company committed to delivering novel products to prevent infectious diseases. Its RSV and influenza
nanoparticle vaccine candidates are Novavax' most advanced clinical programs and are at the forefront of Novavax' efforts
to improve global health. For more information, please visit www.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, 2017 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenue | $ | 9,653 | $ | 5,680 | ||||
| Expenses: | ||||||||
| Research and development | 44,514 | 37,654 | ||||||
| General and administrative | 8,652 | 8,852 | ||||||
| Total expenses | 53,166 | 46,506 | ||||||
| Loss from operations | (43,513 | ) | (40,826 | ) | ||||
| Interest income (expense), net | (2,872 | ) | (3,039 | ) | ||||
| Other income (expense) | 33 | 11 | ||||||
| Net loss | $ | (46,352 | ) | $ | (43,854 | ) | ||
| Basic and diluted net loss per share | $ | (0.14 | ) | $ | (0.16 | ) | ||
| Basic and diluted weighted average number of common shares outstanding | 336,972 | 274,178 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| March 31, 2018 | December 31, 2017 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 113,402 | $ | 106,307 | ||||
| Marketable securities | 30,358 | 50,996 | ||||||
| Total restricted cash | 20,439 | 29,124 | ||||||
| Total current assets | 181,034 | 203,311 | ||||||
| Working capital | 136,130 | 129,636 | ||||||
| Total assets | 276,067 | 302,493 | ||||||
| Notes payable | 318,119 | 317,763 | ||||||
| Total stockholders' deficit | (99,369 | ) | (101,732 | ) |