Exhibit 99.1
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Tricia J. Richardson
Novavax, Inc.
240-268-2031 |
NOVAVAX REPORTS THIRD QUARTER 2007 FINANCIAL RESULTS AND PROGRESS
WITH VACCINE DEVELOPMENT PROGRAMS
ROCKVILLE, MD (November 12, 2007) — /PRNewswire-FirstCall/ — Novavax Inc. (NASDAQ: NVAX) today
reported financial results for the third quarter ended September 30, 2007 and reviewed its recent
accomplishments and upcoming milestones. Novavax reported a net loss of $9.0 million, or the
equivalent of $0.15 loss per share, compared with a $5.0 million net loss, or the equivalent of
$0.08 loss per share in the third quarter of 2006.
For the nine months ended September 30, 2007, the Company reported a net loss of $25.5 million or
$0.42 loss per share, as compared to a loss of $16.9 million or $0.29 loss per share for the nine
months ended September 30, 2006. The increase in net loss was principally due to increases in
research and development costs related to advancing the Company’s two lead virus-like particle
(“VLP”)-based vaccine candidates against pandemic and seasonal influenza.
“Financial results for the third quarter and year to date were in line with our expectations and
reflect our continued progress across all of our drug development activities, particularly with our
two flu vaccine programs. With the initiation of human clinical trials for H5N1 pandemic flu VLP
vaccine, we are now a clinical-stage vaccine company and on target to announce scheduled top line
results from this Phase I/IIa trial in December 2007,” said Novavax President and Chief Executive
Officer, Dr. Rahul Singhvi.
Key recent accomplishments were as follows:
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Enrolled all seventy stage ‘A’ participants in the Phase I/IIa clinical trial of our novel
pandemic vaccine from which scheduled top line results will be reported in December. The
first subject was enrolled in this study in July. |
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Advanced our trivalent seasonal flu vaccine program into preclinical studies. This
program is on target for an IND filing in the second quarter of 2008. |
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Announced a new vaccine candidate for the prevention of Shingles caused by the Varicella
Zoster Virus, expanding our vaccine product pipeline to three. |
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Continued progress in building a GMP pilot-plant facility at our Rockville, Maryland
headquarters to allow manufacturing of Phase I-III clinical supplies of our VLP vaccine
candidates. |
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Announced in conjunction with Allergan the wind down of manufacturing of the production of
Estrasorb ®. Estrasorb ® was acquired by Allergan as a result of their
acquisition of Esprit Pharma in October 2007. |
Some of the key milestones anticipated during the fourth quarter of 2007 are:
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The announcement of a fourth vaccine candidate. |
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Pre-clinical results for our trivalent seasonal flu VLP vaccine candidate. |
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Completion of construction of our GMP pilot manufacturing facility for production of our
VLP vaccine candidates. |
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Scheduled results from our Phase I/IIa H5N1 pandemic flu vaccine trial. |
Third Quarter Financial Results
Revenues for the third quarter ended September 30, 2007 were $1.3 million, an increase of $0.1
million over the $1.2 million reported in the comparable 2006 period. Revenues consist of
ESTRASORB® sales and royalties paid by Esprit
Pharma, Inc. of $0.5 million as well as
contract research and development revenues of $0.7 million in the third quarter of 2007 as compared
to $0.6 million of research and development revenues for the same period in 2006.
Cost of products sold for the three-month period ended September 30, 2007 was $1.1 million as
compared to $1.2 million for the same period in 2006. Included in the cost of products sold was
$0.6 million in idle capacity costs at our manufacturing facility compared to $0.7 million of such
costs in the comparable 2006 quarter. The company also incurred $0.8 million in excess inventory
costs over market for the third quarter as compared to $0.3 million in the comparable 2006 period,
which reflects its current production costs over the sales transfer price of ESTRASORB®.
Research and development costs for the third quarter increased to $5.6 million compared to $2.9
million for the comparable 2006 three-month period. The increase in R&D was primarily due to higher
spending to support the continuing development of the Company’s influenza vaccines as well as
licensing fees paid to Wyeth Holdings as a result of a licensing agreement signed in July 2007.
General and administrative expenses were $3.1 million for the third quarter of 2007, as compared to
$2.6 million for the same period last year. The increase in expenses was principally due to
increased facility expenses of $0.4 million resulting from the new leased facility in Rockville,
Maryland.
As of September 30, 2007, Novavax had $52.3 million in cash, cash-equivalents, and short-term
investments as compared to $73.6 million at December 31, 2006, a decrease of $21.3 million. The
decrease of $21.3 million was principally due to operating losses incurred for the year to date
period of 2007, partially offset by non-cash expenses of $3.4 million.
Conference Call
The Company will hold an investor conference call at 10:00 a.m. Eastern Time on November 12, 2007
to discuss its financial results. The call will be hosted by Novavax President and Chief Executive
Officer Dr. Rahul Singhvi and other members of senior management. The dial-in number for the
conference call in the United States and Canada is (800) 810 0924; international callers may dial
(913) 981 4900.
A live audio webcast of the conference call will be available at www.novavax.com. Please connect
to this website at least 15 minutes prior to the conference call to ensure adequate time for any
software download that may be needed to hear the webcast. A replay of the webcast will be available
for 90 days after the webcast and a replay of the conference call will also be available by
telephone beginning 1pm EST. November 12, 2007 through midnight November 19, 2007. To access the
replay, dial (888) 203 1112 and enter pass code 5883744.
About Novavax
Novavax Inc. is committed to leading the global fight against infectious disease by creating novel,
highly potent vaccines that are safer and more effective than current preventive options. Using the
company’s
proprietary virus-like particle (VLP) and Novasome® adjuvant technologies, Novavax is developing
vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases.
Novavax’s particulate vaccines closely match disease-causing viruses while lacking the genetic
material to cause disease, which provides potential for greater immune protection at lower doses
than current vaccines. With an exclusive portable manufacturing system that allows for rapid
mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.
Additional information about Novavax is available at www.novavax.com and in the company’s various
filings with the Securities and Exchange Commission.
Forward Looking Statements
Statements herein relating to future financial or business performance, conditions or strategies
and other financial and business matters, including expectations regarding product sales, operating
expenses, and clinical developments are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements
are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that
may cause actual results to differ materially from the results discussed in the forward-looking
statements or historical experience include risks and uncertainties, including the failure by
Novavax to secure and maintain relationships with collaborators; risks relating to the early stage
of Novavax’s product candidates under development; uncertainties relating to clinical trials; risks
relating to the commercialization, if any, of Novavax’s proposed product candidates; dependence on
the efforts of third parties; dependence on intellectual property; competition for clinical
resources and patient enrollment from drug candidates in development by other companies with
greater resources and visibility, and risks that we may lack the financial resources and access to
capital to fund our operations. Further information on the factors and risks that could affect
Novavax’s business, financial conditions and results of operations, is contained in Novavax’s
filings with the U.S. Securities and Exchange Commission, which are available at
http://www.sec.gov. These forward-looking statements speak only as of the date of this press
release, and Novavax assumes no duty to update forward-looking statements.
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
(unaudited)
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenues: |
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Net product sales |
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$ |
453 |
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$ |
571 |
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$ |
678 |
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$ |
1,668 |
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Contract research and development |
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710 |
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582 |
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1,146 |
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1,459 |
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Royalties and milestone fees |
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152 |
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40 |
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318 |
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208 |
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Total revenues |
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1,315 |
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1,193 |
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2,142 |
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3,335 |
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Operating costs and expenses: |
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Cost of products sold |
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1,096 |
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1,170 |
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3,269 |
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3,564 |
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Excess inventory costs over market |
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757 |
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264 |
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1,317 |
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1,256 |
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Research and development |
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5,634 |
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2,903 |
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13,487 |
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8,336 |
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General and administrative |
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3,085 |
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2,550 |
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11,044 |
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7,946 |
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Total operating costs and expenses |
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10,572 |
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6,887 |
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29,117 |
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21,102 |
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Loss from operations |
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(9,257 |
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(5,694 |
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(26,975 |
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(17,767 |
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Other income (expense) |
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Interest income |
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749 |
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1,021 |
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2,559 |
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2,239 |
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Interest expense |
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(458 |
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(341 |
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(1,132 |
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(1,392 |
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Net loss |
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$ |
(8,966 |
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$ |
(5,014 |
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$ |
(25,548 |
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$ |
(16,920 |
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Basic and diluted loss per share |
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$ |
(0.15 |
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$ |
(0.08 |
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$ |
(0.42 |
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$ |
(0.29 |
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Basic and diluted weighted
average number of
common shares outstanding |
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61,399,445 |
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61,500,942 |
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61,311,478 |
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58,444,933 |
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As of September 30, |
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As of December 31, |
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2007 |
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2006 |
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Cash, cash equivalents and
short-term investments |
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$ |
52,260 |
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$ |
73,595 |
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Total current assets |
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55,317 |
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77,342 |
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Total assets |
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99,706 |
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121,877 |
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Working capital |
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49,700 |
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72,003 |
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Long term debt |
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21,817 |
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22,458 |
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Stockholders’ equity |
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71,883 |
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94,001 |
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