Full Press Release Details
Novavax Reports First Quarter 2017 Financial
MD, May 8, 2017 - Novavax, Inc., (Nasdaq: NVAX) today announced its financial results for the first quarter ended March 31,
Quarter Achievements:
continued to make significant progress in the execution of our two key clinical trials of our RSV F vaccine for both infant via
maternal immunization and in older adults. We look forward to reporting important clinical data from our older adult trial
in the next 90 days. We've also been in discussion with the FDA about conducting an informational analysis of the Prepare
trial that would provide an indication of our vaccine's potential efficacy. From these discussions, we believe we can conduct
this analysis in late 2017," said Stanley C. Erck, President and CEO. "In
addition, we are seeing the continued adoption and use of our proprietary adjuvant, Matrix-M, in a number of internal and partnered
Results for the Three Months Ended March 31, 2017
reported a net loss of $43.9 million, or $0.16 per share, for the first quarter of 2017, compared to a net loss of $77.3 million,
or $0.29 per share, for the first quarter of 2016.
revenue in the first quarter of 2017 increased 35% to $5.7 million, compared to $4.2 million for the same period in 2016, primarily
due to increased revenue recorded under the BMGF grant relating to our ongoing Prepare clinical trial.
and development expenses decreased 45% to $37.7 million in the first quarter of 2017, compared to $69.0 million for the same period
in 2016. The decrease was primarily due to reduced costs associated with the clinical trials and development activities
of our RSV F Vaccine and lower employee-related costs.
and administrative expenses decreased 16% to $8.9 million in the first quarter of 2017, compared to $10.5 million for the same
period in 2016. The decrease was primarily due to lower professional fees for pre-commercialization activities.
income (expense), net for the first quarter of 2017 was ($3.0) million, compared to ($1.9) million for the same period in 2016.
of March 31, 2017, the company had $211.2 million in cash and cash equivalents and marketable securities compared to $235.5 million
as of December 31, 2016. Net cash used in operating activities for the first quarter of 2017 was $38.6 million, compared to $69.8
million for same period in 2016. The decrease in cash usage was primarily due to decreased costs relating to our RSV F Vaccine
and lower employee-related costs.
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 15607801. A replay of the conference call will be available starting at 7:30 p.m. ET on May 8, 2017 until 7:30 pm ET on
May 15, 2017. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode
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 through
the "Investor Info"/"Events" tab on the Novavax website until July 3, 2017.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles
and Matrix-M 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.
Respiratory syncytial virus (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, and globally, is second only to malaria as a cause of death
in children under 1 year of age.23 Despite the induction of post-infection immunity, repeat infection and lifelong
susceptibility to RSV is common. Currently, there is no approved RSV vaccine available.45
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, 2016 and the Report on Form 10-Q for the
period ended March 31, 2017, both 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.
al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic
review and meta-analysis. Lancet, 2010; 375: 1545-1555.
al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics,
2013; 132(2): E341-348.
Group: http://www.ovg.ox.ac.uk/rsv
W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child,
al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In
CONDENSED CONSOLIDATED STATEMENTS OF
(in thousands, except per share information)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2017 | 2016 | |||||||
| Revenue | $ | 5,680 | $ | 4,218 | ||||
| Expenses: | ||||||||
| Research and development | 37,654 | 68,952 | ||||||
| General and administrative | 8,852 | 10,528 | ||||||
| Total expenses | 46,506 | 79,480 | ||||||
| Loss from operations | (40,826 | ) | (75,262 | ) | ||||
| Interest income (expense), net | (3,039 | ) | (1,957 | ) | ||||
| Other income (expense) | 11 | (33 | ) | |||||
| Net loss | $ | (43,854 | ) | $ | (77,252 | ) | ||
| Basic and diluted net loss per share | $ | (0.16 | ) | $ | (0.29 | ) | ||
| Basic and diluted weighted average | ||||||||
| number of common shares outstanding | 274,178 | 270,179 |
SELECTED CONSOLIDATED BALANCE SHEET DATA
| March 31, 2017 | December 31, 2016 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 95,847 | $ | 144,353 | ||||
| Marketable securities | 115,331 | 91,126 | ||||||
| Total current assets | 258,449 | 287,830 | ||||||
| Working capital | 201,951 | 221,424 | ||||||
| Total assets | 361,504 | 394,301 | ||||||
| Total notes payable and capital lease obligation | 316,714 | 316,376 | ||||||
| Total stockholders' deficit | (29,099 | ) | (5,546 | ) |
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations
Todd Davenport, Ph.D.