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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For Quarter Ended Commission File No.
JUNE 30, 1998 0-26770
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NOVAVAX, INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 22-2816046
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
8320 GUILFORD ROAD, COLUMBIA, MD 21046
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(Address of principal executive offices) (Zip code)
(301) 854-3900
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Registrant's telephone number, including area code
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
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The number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date:
Common Shares Outstanding at August 10, 1998
12,321,368
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NOVAVAX, INC AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(unaudited)
June 30, December 31,
1998 1997
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ASSETS
Current Assets:
Cash and Cash Equivalents $ 8,344,316 $ 3,847,107
Accounts receivable 69,949 217,150
Receivable from former parent - 32,835
Prepaid expenses and other current assets 107,200 205,952
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Total current assets 8,521,465 4,303,044
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Property and equipment, net of accumulated
depreciation of $607,899 and $539,463 in
1998 and 1997, respectively 993,741 889,175
Patent costs, net of accumulated amortization of
$613,349 and $549,397 in 1998 and 1997, 1,572,434 1,573,454
respectively
Other assets 16,960 57,598
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Total assets $ 11,104,600 $ 6,823,271
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Capital lease obligations, current portion $ 32,230 $ 10,744
Accounts payable 150,484 237,884
Accrued payroll 83,863 40,010
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Total current liabilities 266,577 288,638
Capital lease obligations, less current portion 26,324 12,863
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Total liabilities 292,901 301,501
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Stockholders' Equity:
Preferred stock, $.01 par value, 2,000,000
shares authorized; 6,500 designated as Series A Custom
Convertible Preferred Stock; 6,500 shares issued and
outstanding at June 30, 1998; none issued and outstanding
at December 31, 1997. 5,997,599 -
Common stock, $.01 par value, 30,000,000
shares authorized; 12,148,376 issued and 12,131,036
outstanding at June 30, 1998; 12,031,757 and
12,012,013 shares issued and outstanding at
December 31, 1997 121,483 120,318
Additional paid-in capital 38,289,972 38,020,621
Accumulated deficit (33,335,218) (31,342,780)
Deferred compensation on stock options granted (20,472) (25,620)
Treasury stock, 17,340 and 19,744 shares at June 30, 1998
and December 31, 1997, cost basis (241,665) (250,769)
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Total stockholders' equity 10,811,699 6,521,770
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Total liabilities and stockholders' equity $ 11,104,600 $ 6,823,271
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The accompanying notes are an integral part of the consolidated financial
statements.
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NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED JUNE 30,
1998 1997 1998 1997
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Revenues:
Contract Revenue $ 120,055 $ 149,733 $ 324,719 $ 149,733
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Operating expenses:
General and administrative 724,395 601,567 1,261,316 1,243,820
Research and development 673,619 760,833 1,267,998 1,362,456
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Total operating expenses 1,398,014 1,362,400 2,529,314 2,606,276
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Loss from operations (1,277,959) (1,212,667) (2,204,595) (2,456,543)
Interest income, net 119,120 78,726 212,157 112,980
Net loss (1,158,839) (1,133,941) (1,992,438) (2,343,563)
Preferred stock deemed dividend - - (455,048) -
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Net loss applicable to common stockholders $ (1,158,839) $ (1,133,941) $ (2,447,486) $ (2,343,563)
============== ============= ============== ==============
Net loss per common share (basic and diluted): $ (0.10) $ (0.10) $ (0.20) $ (0.21)
============== ============= ============== ==============
Weighted average number of common 12,096,877 11,891,507 12,066,715 11,389,929
shares outstanding (basic and diluted) ============== ============= ============== ==============
The accompanying notes are an integral part of the consolidated financial
statements.
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NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED JUNE 30, 1998 AND 1997
(unaudited)
1998 1997
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Cash flows from operating activities:
Net loss $ (1,992,438) $(2,343,563)
Reconciliation of net loss to net cash used by operating activities:
Non-cash compensation expense 5,148 288,822
Depreciation and amortization 132,388 135,339
Issuance of stock to 401(k) plan 10,236 15,969
Changes in operating assets and liabilities:
Accounts receivable 147,201 (92,654)
Prepaid expenses and other assets 139,390 93,414
Payable to/receivable from former parent 32,835 (6,176)
Accounts payable and accrued expenses (44,679) (138,753)
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Net cash used by operating activities (1,569,919) (2,047,602)
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Cash flows from investing activities:
Proceeds from the sale of marketable securities - 500,820
Capital expenditures (122,657) (36,324)
Deferred patent costs (62,932) (115,147)
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Net cash provided by (used by) investing activities (185,589) 349,349
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Cashflows from financing activities:
Payment of capital lease obligations (15,398) (6,087)
Proceeds from the private placement of preferred stock 5,997,599 -
Proceeds from the private placement of common stock - 5,002,718
Proceeds from the exercise of options 270,516 66,862
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Net cash provided by financing activities 6,252,717 5,063,493
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Net change in cash and cash equivalents 4,497,209 3,365,241
Cash and cash equivalents at beginning of the period 3,847,107 2,481,258
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Cash and cash equivalents at end of the period $ 8,344,316 $ 5,846,499
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The accompanying notes are an integral part of the consolidated financial
statements.
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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Basis of Presentation
The accompanying consolidated financial statements include the accounts of
Novavax its wholly owned subsidiaries, Micro-Pak, Inc., Micro Vesicular
Systems, Inc. and Lipovax, Inc. All significant intercompany accounts and
transactions have been eliminated. These statements have been prepared by
Novavax, Inc. without audit, pursuant to the rules and regulations of the
Securities and Exchange Commission, and reflect all adjustments, which, in the
opinion of management, are necessary for a fair presentation of the results for
the interim periods presented. All such adjustments are of a normal recurring
nature.
Certain information in footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles
has been condensed or omitted pursuant to such rules and regulations, although
the Company believes the disclosures are adequate to make the information
presented not misleading. It is suggested that these financial statements are
read in conjunction with the financial statements and the notes thereto
included in the Company's Annual Report on Form 10-K/A for the year ended
December 31, 1997.
2. Net Loss Per Share
In 1997, the Company retroactively adopted SFAS No. 128, Earnings per Share.
Basic earnings per share are computed by dividing the net loss available to
common stockholders by the weighted average number of common shares outstanding
during the period. Diluted earnings per share are computed by dividing net
earnings available to common stockholders by the weighted average number of
common shares outstanding after giving effect to all potentially dilutive
common shares that were outstanding during the period.
Potential dilutive common shares are not included in the computation of diluted
earnings per share if they are antidilutive. Net loss per share as reported
was not adjusted for potential common shares, as they are antidilutive.
3. New Accounting Standards
The Financial Accounting Standards Board has issued a new standard that became
effective in reporting periods beginning after December 15, 1997. SFAS No.
130, Reporting Comprehensive Income, requires additional reporting with respect
to certain changes in assets and liabilities that previously were not required
to be reported as results of operations for the period. The Company's adoption
of SFAS No. 130 resulted in no additional reporting as the Company has no other
items of comprehensive income or loss.
The Financial Accounting Standards Board has issued a new standard that became
effective in reporting periods beginning after December 15, 1997. SFAS No.
131, Disclosures about Segments of an Enterprise and Related Information, which
became effective for reporting periods beginning after December 15, 1997.
Interim reporting is not required
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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
under SFAS No. 131 prior to adoption. SFAS No. 131 requires financial and
descriptive information with respect to "operating segments" of an entity based
on the way management disaggregates the entity for making internal operating
decisions. The Company will begin making the disclosures required by SFAS No.
131, if any, with financial statements for the period ending December 31, 1998.
There will be no financial impact from the adoption of SFAS No. 131 as the
standard affects disclosure only.
The Financial Accounting Standards Board has issued a new standard that became
effective in reporting periods beginning after June 15, 1999. SFAS No. 133,
Accounting for Derivative Instruments and Hedging Activities, requires that
every derivative instrument be recorded in the balance sheet as either an asset
or liability measured at its fair value. The statement requires that changes
in the derivative's fair value be recognized in earnings unless specific hedge
accounting criteria are met. The Company believes that the effect, if any, of
the adoption of SFAS No. 133 will not be material.
4. Employee Benefit Plan
Effective January 1, 1997, the Company established the Novavax, Inc. 401(k)
Profit Sharing Plan (the "Plan"). The Plan is a discretionary defined
contribution plan and covers all employees who were employed by the Company on
or after January 1, 1997 and who have completed three months of service to the
Company. Under the provisions of the Plan, employees may contribute up to
$9,500 of their annual base compensation on the tax-deferred basis. The Board
of Directors determines the Company's matching contribution in any year. As of
June 30, 1998 and 1997, the Company accrued contributions of Company stock
valued at $10,236 and $15,969, respectively.
5. Financing Transactions
On February 10, 1997, Novavax signed a definitive agreement to privately place
1,200,000 common shares with Anaconda Opportunity Fund L.P. Novavax also
granted warrants to purchase an additional 600,000 shares at a price of $6.00
per share and 600,000 shares at a price of $8.00 per share. The warrants have
a three-year term. The transaction was closed on March 14, 1997 at an aggregate
price of $5,100,000. Proceeds net of all related transaction costs were
$5,002,718.
On January 23, 1998, the Company entered into Subscription Agreements to
effectuate the private placement of 6,500 shares of Series A Custom Convertible
Preferred Stock, $.01 par value per share (the "Preferred Stock"). The closing
occurred on January 28, 1998 (the "Issuance Date") at an aggregate purchase
price of $6,500,000. Proceeds net of all related transaction costs were
$5,997,599.
The Preferred Stock was convertible into shares of Common Stock during a period
of 90 days following the Issuance Date, at a conversion price equal to 100% of
the average of the two lowest consecutive trade prices of the Common Stock as
reported on the American
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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Stock Exchange for the 25 trading days immediately preceding the conversion
date (the "Two Day Average Trading Price"). Effective April 28, 1998 and for
the period thereafter the conversion price is equal to 94% of the Two Day
Average Trading Price (the "Conversion Price").
From the Issuance Date, there is ceiling price of $6.33 and within the first
180 days after the Issuance Date, the Conversion Price has applicable floor
prices based on conversion dates. The floor prices range from $5.67 to $4.32.
These applicable floor prices expired at the close of business on July 28,
1998. The maximum number of shares as measured by the conversion terms most
beneficial to the holders of the Preferred Stock at the time of closing
resulted in a deemed dividend in the amount of $455,048 for the six months
ended June 30, 1998.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
The following discussion may contain statements that are not purely historical.
Certain statements contained herein or as may otherwise be incorporated by
reference herein constitute "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements include but are not limited to statements regarding year 2000
readiness, future product development and related clinical trials and
statements regarding future research and development. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors
which may cause the actual results, performance or achievements of the Company,
or industry results, to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking
statements.
Such factors include, among other things, the following: general economic and
business conditions; competition; unexpected changes in technologies and
technological advances; ability to obtain rights to technology; ability to
obtain and enforce patents; ability to commercialize and manufacture products;
statements regarding establishment of commercial-scale manufacturing
capabilities, and statements regarding future collaborations with industry
partners; results of preclinical studies; results of research and development
activities; business abilities and judgment of personnel; availability of
qualified personnel; changes in, or failure to comply with, governmental
regulations; ability to obtain adequate financing in the future; and other
factors referenced herein.
All forward-looking statements included in this document are based on
information available to the Company on the date hereof, and the Company
assumes no obligation to update any such forward-looking statements.
Accordingly, past results and trends should not be used by investors to
anticipate future results or trends.
The following is a discussion of the historical consolidated financial
condition and results of operations of Novavax and its subsidiaries and should
be read in conjunction with the consolidated financial statements and notes
thereto set forth in this Form 10-Q. Additional information concerning factors
that could cause actual results to differ materially from those in the
forward-looking statements is contained from time to time in the Company's SEC
filings, including but not limited to the Company's report on Form 10-K/A for
the year ended December 31, 1997.
RESULTS OF OPERATIONS
The Company has incurred net losses since its inception from the development of
its technologies for human pharmaceuticals, vaccines and vaccine adjuvants.
Novavax expects the losses to increase in the near-term as it conducts
additional human clinical trials and seeks regulatory approval for its product
candidates. The Company also expects to continue to incur substantial
operating losses over the extensive time period required to develop the
Company's products, or until such time as revenues, to offset the costs, are
sufficient to fund its continuing operations.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 1998 COMPARED TO 1997
The net loss was $1,158,839 for the quarter ended June 30, 1998. This compares
to a net loss in the prior year of $1,133,941. The net loss increase of
$24,898 was due primarily to increases in general and administrative expenses
of $122,828 partially offset by decreases in research and development expenses
of $87,214.
Revenues of $120,055 for services related to vaccine and adjuvant technologies
were recognized during the three months ended June 30, 1998. Revenues of
$149,733 were recorded for the same period in the prior year.
General and administrative expenses were $724,395 for the three months ended
June 30, 1998 compared to $601,567 incurred for the same period in 1997. The
net change of $122,828 was primarily caused by the hire of a Vice President of
Business Development, increases in legal expenses and costs associated with
strategic alliance development offset by a decrease in the non-cash
compensation expense related to non-employee options and warrants granted
during 1996.
Research and development expenses were $673,619 and $760,833 for the three
months ended June 30, 1998 and 1997, respectively. Total research and
development expenses exclusive of non-cash charges related to the below-market
priced stock options issued December 12, 1995 were $671,687 and $644,116 for
the periods ended June 30, 1998 and 1997, respectively. This increase of
$27,571 is related to the timing of clinical trial activities and the nature of
those trials, including the number of products, the number of patients and the
duration of the trials.
Net interest income of $119,120 was recorded in the three months ended June 30,
1998 compared with net interest income of $78,726 in the three months ended
June 30, 1997. The $40,394 increase is due to higher average cash balances
during the first quarter 1998, when compared to average cash balances during
the same period in 1997.
SIX MONTHS ENDED JUNE 30, 1998 COMPARED TO 1997
The net loss before the preferred stock deemed dividend of $455,048 was
$1,992,438 for the six months ended June 30, 1998. This compares to a net loss
in the prior year of $2,343,563. The reduction of $351,125 was due primarily
to increases in revenue of $174,986, decreases in research and development
expenses of $94,458 and increases in interest income of $99,177.
The net loss applicable to common stockholders of $2,447,486 for the six months
ended June 30, 1998, was $103,923 more than the net loss of $2,343,563 in the
six months ended June 30, 1997 and reflects those items mentioned in the above
paragraph along with a preferred stock deemed dividend of $455,048.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Revenues of $324,719 for services related to vaccine and adjuvant technologies
were recognized during the six months ended June 30, 1998 compared to $149,733
recorded for that same period in the prior year. The increase of $174,986 was
due primarily to a subcontract to supply new chemical structures designed to
inactivate viruses, bacteria and bacterial spores.
General and administrative expenses were $1,261,316 for the six months ended
June 30, 1998 or $17,496 higher than the $1,243,820 of general and
administrative expenses incurred for the same period in 1997. The net increase
was primarily caused by the hire of a Vice President of Business Development
increases in legal expenses and costs associated with strategic alliance
development offset by a decrease in the non-cash compensation expense related
to non-employee options and warrants granted during 1996.
Research and development expenses were $1,267,998 and $1,362,456 for the six
months ended June 30, 1998 and 1997, respectively. Total research and
development expenses exclusive of non-cash charges related to the below-market
priced stock options issued December 12, 1995 were $1,264,131 and $1,129,021
for the periods ended June 30, 1998 and 1997, respectively. This increase of
$135,110 is related to the timing of clinical trial activities and the nature
of those trials, including the number of products, the number of patients and
the duration of the trials.
Net interest income of $212,157 was recorded in the six months ended June 30,
1998 compared with net interest income of $112,980 in the six months ended June
30, 1997. The $99,177 increase is due to higher average cash balances during
the first six months 1998, when compared to average cash balances during the
same period in 1997.
YEAR 2000
The Company is evaluating and working to resolve the potential impact of the
year 2000 on the Company's computerized information systems' ability to
accurately process information that may be date-sensitive. Any of the
Company's programs that recognize a date using "00" as the year 1900 rather
than the year 2000, could result in errors or system failures. The Company
primarily uses personal computers for administrative and accounting systems.
Additionally, the Company has certain laboratory equipment with
microprocessors. Along with a review of the hardware and software employed by
the Company, our business partners and suppliers have been surveyed to
determine their year 2000 readiness.
The Company does not believe that the costs of addressing this issue will have
a material impact on the Company's financial position. Nor, has the Company
been given any indication that its business partners and suppliers will not be
year 2000 compliant by the year 2000. The Company plans to continue, on a
timely basis, to monitor and address any significant year 2000 issues.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
LIQUIDITY AND CAPITAL RESOURCES
Novavax's capital requirements depend on numerous factors, including but not
limited to the progress of its research and development programs, the progress
of preclinical and clinical testing, the time and costs involved in obtaining
regulatory approvals, the costs of filing, prosecuting, defending and enforcing
any patent claims and other intellectual property rights, competing
technological and market developments, and changes in Novavax's development of
commercialization activities and arrangements. The Company has three product
candidates in development. Future activities including clinical development and
the establishment of commercial-scale manufacturing capabilities are subject to
the Company's ability to raise funds through equity financing, or collaborative
arrangements with corporate partners.
The Company used $1,755,508 of its cash resources during the six month period
ended June 30, 1998 to fund the activities of its research and development
programs and costs associated with obtaining regulatory approvals, pre-clinical
and clinical testing. In addition to revenues of $324,719, Novavax received
proceeds of $270,516 from the exercise of stock options and proceeds, net of
all related transaction costs, of $5,997,599 from the sale of 6,500 shares of
Series A Convertible Preferred Stock. The closing of the Preferred Stock
private placement occurred on January 28, 1998 at an aggregate price of
$6,500,000.
Cash and cash equivalents on June 30, 1998 totaled $8,344,316. Novavax
estimates that based on historical and projected levels of spending, existing
cash resources will be sufficient to finance its operations for approximately
19 to 22 months from June 30, 1998. Past spending levels are not necessarily
indicative of future spending. Future expenditures for product development
especially related to outside testing and human clinical trials are
discretionary and, accordingly, can be adjusted to available cash. As the
Company continues to progress in its clinical development activities and
commercial scale-up of product manufacturing, it anticipates increases in
spending associated with these activities.
Moreover, the Company will seek to establish one or more collaborations with
industry partners to defray the costs of clinical trials and other related
activities. Novavax will also consider sources of additional funds through
public or private equity or debt financings, collaborative arrangements with
pharmaceutical companies or from other sources. There can be no assurance that
additional funding or bank financing will be available at all or on acceptable
terms to permit successful commercialization of Novavax's technologies and
products. If adequate funds are not available, Novavax may be required to
significantly delay, reduce the scope of or eliminate one or more of its
research or development programs, or seek alternative measures including
arrangements with collaborative partners or others that may require Novavax to
relinquish rights to certain of its technologies, product candidates or
products.
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NOVAVAX, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION
Item 1 - Legal Proceedings
None
Item 2 - Changes in Securities
None
Item 3 - Defaults upon Senior Securities
None
Item 4 - Submission of Matters to a Vote of Security Holders
At the Company's Annual Meeting of Stockholders held on May 14, 1998, the
following proposals were adopted by the vote specified below:
1. PROPOSAL I: To Elect one Class III director, Mitchell J. Kelly, to serve on
the Board of Directors for a three-year term expiring at the Annual Meeting
of Stockholders in 2001.
For 8,201,333
Against -0-
Abstain 1,953,381
2. PROPOSAL II: To approve an amendment to the 1995 Novavax, Inc. Stock Option
Plan increasing the number of shares of Common Stock authorized for
issuance thereunder by 400,000 shares from 4,000,000 shares to 4,400,000.
For 7,871,708
Against 2,238,791
Abstain 44,215
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NOVAVAX, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION
Item 4 - Submission of Matters to a Vote of Security Holders (continued)
3. PROPOSAL III: To ratify the issuance of Series A Custom Convertible
Preferred Stock by the Company and to approve the issuance by the Company
of Common Stock aggregating 20% or more of the outstanding Common stock
upon conversion of the Company's Series A Custom Convertible Preferred
Stock, if necessitated by reductions in the Common Stock trading price at
the time of conversion, in accordance with the terms of the Series A Custom
convertible Preferred Stock.
For 4,334,163
Against 2,173,567
Abstain 44,272
Delegate No Vote 3,602,712
4. PROPOSAL IV: To ratify the appointment of Coopers & Lybrand L.L.P. as
independent auditors of the Company for the current fiscal year ending
December 31, 1998. Subsequent to the voting, Coopers & Lybrand L.L.P.
merged with Price Waterhouse L.L.P. and the legal company name is now
PricewaterhouseCoopers LLP.
For 8,488,933
Against 1,649,288
Abstain 16,493
Item 5 - Other information
None
Item 6 - Exhibits and Reports on Form 8-K
(a) Exhibits:
Exhibit 27 - Financial Data Schedule
(b) Reports on Form 8-K:
None
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NOVAVAX, INC. AND SUBSIDIARIES
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
NOVAVAX, INC.
(Registrant)
Date: August 13, 1998 By: /s/ BRENDA L. FUGAGLI
----------------------------------------------
Brenda L. Fugagli
Senior Vice President, Chief Financial Officer
(Principal Financial and Accounting Officer)
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