Full Press Release Details
Novavax Reports Third Quarter 2015 Financial
Gaithersburg, Md., November 9, 2015 -
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 third quarter and nine months ended
Novavax Third Quarter and Subsequent
Today's Announcement
Near-term Anticipated Events
"The initiation of the first Phase
3 trial of our RSV F Vaccine in older adults underscores our accomplishments to date and positions the company to bring the first
RSV vaccine to market. Our recent data announcements demonstrate the safety and robust immunogenicity of the RSV F Vaccine across
all three target populations: older adults; infants via maternal immunization; and pediatrics," said Gregory Glenn, M.D.,
Senior Vice President, Research and Development. "Our Phase 2 trial of the RSV F Vaccine in older adults was the first to
demonstrate efficacy of an active RSV immunization in any clinical trial population. In addition, data from pregnant women in
their third trimester provided an important safety data and proof-of-concept for maternal immunization, with a high level of transplacental
"During the third quarter, we delivered
positive results from five key clinical programs including our RSV F Vaccine for older adults, infants via maternal immunization
and pediatrics, as well as our Seasonal Influenza Vaccine, and our Ebola GP Vaccine. These results, coupled with today's
initiation of our Phase 3 trial of our RSV F Vaccine in older adults, demonstrate Novavax' ability to successfully advance
our clinical stage programs along aggressive timelines," said Stanley C. Erck, President and CEO. "With successful
phase 2 results, and consistent execution, the Company is well-positioned to begin our second phase 3 trial in pregnant women
in the first quarter of 2016."
Financial Results for the Three and
Nine Months Ended September 30, 2015
Novavax reported a net loss of $33.1 million,
or $0.12 per share, for the third quarter of 2015, compared to a net loss of $19.7 million, or $0.08 per share, for the third
quarter of 2014. For the nine months ended September 30, 2015, the net loss was $78.1 million, or $0.30 per share, compared to
a net loss of $51.4 million, or $0.23 per share, for the same period in 2014.
Novavax revenue in the third quarter of
2015 decreased 21% to $6.5 million, compared to $8.2 million for the same period in 2014. This decrease results from a lower level
of development activities under the HHS BARDA contract in the third quarter of 2015 as compared to the same period in 2014.
The cost of government contracts revenue
in the third quarter of 2015 decreased 32% to $2.7 million, compared to $4.0 million for the same period in 2014. The decrease
in cost of government contracts revenue was associated with a lower level of development activities under the HHS BARDA contract
in the third quarter of 2015 as compared to the same period in 2014.
Research and development expenses increased
45% to $27.9 million in the third quarter of 2015, compared to $19.2 million for the same period in 2014. The increase in research
and development expenses was driven by activities relating to the RSV Vaccine and higher employee-related expenses, including
non-cash stock-based compensation, tied to the continued growth of the company.
General and administrative expenses increased
90% to $9.1 million in the third quarter of 2015, compared to $4.8 million for the same period in 2014. The increase in general
and administrative expenses 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 September 30, 2015, the company
had $290.2 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 the nine months of 2015 was $71.3 million, compared to $47.2 million for the same period
in 2014. The factors contributing to the change in operating cash usage were primarily due to increased costs relating to our
RSV F Vaccine, Ebola GP Vaccine and higher employee-related expenses, as well as the timing of customer and vendor payments.
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 (U.S. or Canada) or 707-287-9331
(International). 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 November 9, 2015 until midnight November 16, 2015. To access the replay by telephone, dial
855-859-2056 (Domestic) or 404-537-3406 (International) and use passcode 70778771. The replay will also be available as a webcast
and can be found on the "Investor Info"/"Events" on the Novavax website.
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 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, 2014 and our Quarterly Reports on Form
10-Q for the quarters ended March 31, 2015 and June 30, 2015, 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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Revenue | $ | 6,525 | $ | 8,214 | $ | 30,397 | $ | 23,935 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of government contracts revenue | 2,747 | 4,027 | 8,054 | 12,150 | ||||||||||||
| Research and development | 27,917 | 19,219 | 78,686 | 48,940 | ||||||||||||
| General and administrative | 9,060 | 4,757 | 21,991 | 14,871 | ||||||||||||
| Total costs and expenses | 39,724 | 28,003 | 108,731 | 75,961 | ||||||||||||
| Loss from operations | (33,199 | ) | (19,789 | ) | (78,334 | ) | (52,026 | ) | ||||||||
| Interest income (expense), net | 130 | 81 | 324 | 10 | ||||||||||||
| Other income (expense) | (51 | ) | (19 | ) | (121 | ) | ||||||||||
| Realized gains on marketable securities | 615 | |||||||||||||||
| Net loss | $ | (33,120 | ) | $ | (19,727 | ) | $ | (78,131 | ) | $ | (51,401 | ) | ||||
| Basic and diluted net loss per share | $ | (0.12 | ) | $ | (0.08 | ) | $ | (0.30 | ) | $ | (0.23 | ) | ||||
| Basic and diluted weighted average | ||||||||||||||||
| number of common shares outstanding | 269,554 | 238,304 | 259,703 | 221,578 |
SELECTED CONSOLIDATED BALANCE SHEET
| September 30, 2015 | December 31, 2014 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 138,144 | $ | 32,335 | ||||
| Marketable securities | 152,042 | 135,721 | ||||||
| Total current assets | 310,102 | 188,158 | ||||||
| Working capital | 285,229 | 154,042 | ||||||
| Total assets | 404,634 | 276,002 | ||||||
| Total notes payable and capital lease obligation | 664 | 1,173 | ||||||
| Total stockholders' equity | 367,016 | 229,618 |
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
Todd Davenport, Ph.D.