UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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þ
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QUARTERLY REPORT UNDER SECTION 13 or 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the Quarterly Period Ended June 30, 2008
or
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1034
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Commission File No. 0-26770
NOVAVAX, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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22-2816046
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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9920 Belward Campus Drive, Rockville, MD
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20850
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(Address of principal executive offices)
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(Zip code)
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(240) 268-2000
(Registrants 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.
þ
Yes
o
No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
o
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Accelerated filer
þ
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
o
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
o
Yes
þ
No
The number of shares outstanding of each of the issuers classes of common stock, as of the latest
practicable date:
Shares of Common Stock Outstanding at July 29, 2008: 62,049,252
NOVAVAX, INC.
Form 10-Q
For the Quarter Ended June 30, 2008 and 2007 (unaudited)
Table of Contents
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Page No.
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PART I. FINANCIAL INFORMATION
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Item 1
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Financial Statements
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Consolidated Balance Sheets as of June 30, 2008 (unaudited)
and December 31, 2007
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1
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Consolidated Statements of Operations for the three-month and
six-months ended June 30, 2008 and 2007 (unaudited)
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2
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Consolidated Statements of Stockholders Equity as of
June 30, 2008 (unaudited)
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3
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Consolidated Statements of Cash Flows for the six months ended
June 30, 2008 and 2007 (unaudited)
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4
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Notes to the Consolidated Financial Statements (unaudited)
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5
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Item 2
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Managements Discussion and Analysis of Financial
Condition and Results of Operations
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30
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Item 3
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Quantitative and Qualitative Disclosures about Market Risk
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51
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Item 4
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Controls and Procedures
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53
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PART II. OTHER INFORMATION
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Item 1
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Legal Proceedings
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54
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Item 1A
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Risk Factors
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54
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Item 4
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Submission of Matters to a Vote of Security Holders
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60
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Item 6
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Exhibits
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61
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SIGNATURES
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62
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i
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
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June 30,
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December 31,
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2008
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2007
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(unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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23,513
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$
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4,350
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Short-term investments classified as available for sale
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8,875
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9,200
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Short-term investments classified as held to maturity
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3,497
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32,939
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Accounts and other receivables, net of allowance for
doubtful accounts of $211 and $168 as of June 30, 2008 and
December 31, 2007, respectively
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327
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667
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Inventory
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47
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25
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Prepaid expenses and other current assets
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1,339
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1,304
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Current assets of discontinued operations
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711
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531
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Total current assets
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38,309
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49,016
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Property and equipment, net
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7,940
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5,721
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Goodwill
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33,141
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33,141
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Assets held for sale
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899
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899
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Non-current assets of discontinued operations
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280
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1,634
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Other non-current assets
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208
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880
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Total assets
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$
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80,777
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$
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91,291
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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$
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729
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$
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1,490
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Accrued expenses
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3,690
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2,980
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Current portion of notes payable
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333
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1,120
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Deferred rent
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652
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Current liabilities of discontinued operations
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3,625
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616
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Total current liabilities
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9,029
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6,206
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Convertible notes
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21,574
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21,369
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Non-current portion of notes payable
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220
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260
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Deferred rent
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2,733
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391
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Total liabilities
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33,556
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28,226
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Stockholders equity:
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Preferred stock, $.01 par value, 2,000,000 shares authorized;
no shares issued and outstanding
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Common stock, $.01 par value, 100,000,000 shares authorized;
62,423,015 shares issued and 61,999,252 outstanding at
June 30, 2008, and 62,356,977 issued and 61,949,881
outstanding at December 31, 2007
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624
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624
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Additional paid-in capital
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265,901
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264,618
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Accumulated deficit
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(216,854
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)
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(199,727
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)
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Treasury stock, 423,763 shares at June 30, 2008 and 407,096
shares at December 31, 2007, cost basis
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(2,450
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)
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(2,450
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)
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Total stockholders equity
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47,221
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63,065
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Total liabilities and stockholders equity
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$
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80,777
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$
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91,291
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The accompanying notes are an integral part of these consolidated financial statements.
1
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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Six months ended
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June 30,
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June 30,
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2008
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2007
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2008
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2007
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Revenues:
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Net product sales
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$
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$
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(327
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)
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$
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$
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(123
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)
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Contract research and development
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325
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68
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783
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309
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Royalties, milestone and licensing fees
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17
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43
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17
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59
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Total revenues
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342
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(216
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)
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800
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245
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Operating costs and expenses:
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Cost of products sold
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101
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151
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Research and development
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5,380
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3,992
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9,814
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7,645
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General and administrative
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3,166
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3,362
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6,410
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7,959
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Total operating costs and expenses
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8,546
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7,455
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16,224
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15,755
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Loss from continuing operations before
interest (expense) income, net
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(8,204
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)
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(7,671
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)
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(15,424
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)
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(15,510
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)
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Interest (expense) income, net
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(110
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)
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531
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7
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1,135
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Loss from continuing operations
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(8,314
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)
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(7,140
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)
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(15,417
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)
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(14,375
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)
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Loss from discontinued operations
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(1,058
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)
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(1,054
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)
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(1,710
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)
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(2,207
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)
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Net loss
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$
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(9,372
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)
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$
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(8,194
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)
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$
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(17,127
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)
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$
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(16,582
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)
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Basic and
diluted net loss per share:
Loss per share from continuing operations
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$
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(0.14
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)
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$
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(0.12
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)
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$
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(0.25
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)
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$
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(0.23
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)
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Loss per share from discontinued operations
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$
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(0.02
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)
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$
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(0.02
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)
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$
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(0.03
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)
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$
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(0.04
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)
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Net loss per share
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$
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(0.15
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)
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$
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(0.13
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)
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$
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(0.28
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)
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$
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(0.27
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)
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Basic and diluted weighted average number
of common shares outstanding
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61,329,699
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61,311,954
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61,286,169
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61,266,765
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The accompanying notes are an integral part of these consolidated financial statements.
2
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
For the six months ended June 30, 2008
(in thousands, except share information)
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Additional
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Common Stock
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Paid-in
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Accumulated
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Treasury
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Total
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Shares
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Amount
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Capital
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Deficit
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Stock
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Stockholders Equity
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Balance, December 31, 2007
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62,356,977
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$
|
624
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$
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264,618
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|
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$
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(199,727
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)
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$
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(2,450
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)
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$
|
63,065
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|
|
|
|
|
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|
|
|
|
|
|
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Non-cash compensation
costs for stock options
(unaudited)
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|
|
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365
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|
|
|
|
|
|
|
|
|
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365
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|
Exercise of stock options
(unaudited)
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|
20,571
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|
35
|
|
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|
|
|
|
|
|
|
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|
35
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|
Amortization of
restricted stock for
compensation (unaudited)
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85
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|
|
|
|
|
|
|
|
|
|
|
85
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|
Net loss (unaudited)
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|
|
|
|
|
|
|
|
|
|
|
|
|
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(7,755
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)
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|
|
|
|
|
|
(7,755
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)
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2008
(unaudited)
|
|
|
62,377,548
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|
|
|
624
|
|
|
|
265,103
|
|
|
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(207,482
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)
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|
|
(2,450
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)
|
|
|
55,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash compensation
costs for stock options
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
612
|
|
|
|
|
|
|
|
|
|
|
|
612
|
|
Exercise of stock options
(unaudited)
|
|
|
45,467
|
|
|
|
|
|
|
|
102
|
|
|
|
|
|
|
|
|
|
|
|
102
|
|
Amortization of
restricted stock for
compensation (unaudited)
|
|
|
|
|
|
|
|
|
|
|
84
|
|
|
|
|
|
|
|
|
|
|
|
84
|
|
Net loss (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,372
|
)
|
|
|
|
|
|
|
(9,372
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2008
(unaudited)
|
|
|
62,423,015
|
|
|
$
|
624
|
|
|
$
|
265,901
|
|
|
$
|
(216,854
|
)
|
|
$
|
(2,450
|
)
|
|
$
|
47,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
3
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six months ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Operating Activities:
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(15,417
|
)
|
|
$
|
(14,375
|
)
|
Reconciliation of net loss from continuing operations to net
cash used
in operating activities:
|
|
|
|
|
|
|
|
|
Amortization of intangible assets
|
|
|
|
|
|
|
66
|
|
Depreciation
|
|
|
420
|
|
|
|
343
|
|
Amortization of debt discount
|
|
|
204
|
|
|
|
|
|
Provision for bad debts
|
|
|
|
|
|
|
218
|
|
Reserve for notes and accrued interest receivable
|
|
|
270
|
|
|
|
940
|
|
Retirement of capital assets
|
|
|
73
|
|
|
|
|
|
Impairment of long lived assets
|
|
|
148
|
|
|
|
|
|
Amortization of net discounts on short-term investments
|
|
|
(178
|
)
|
|
|
(1,367
|
)
|
Amortization of deferred financing costs
|
|
|
129
|
|
|
|
129
|
|
Deferred rent
|
|
|
2,995
|
|
|
|
281
|
|
Non-cash stock compensation
|
|
|
1,146
|
|
|
|
868
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
577
|
|
|
|
(102
|
)
|
Inventory
|
|
|
(22
|
)
|
|
|
115
|
|
Prepaid expenses and other assets
|
|
|
250
|
|
|
|
142
|
|
Accounts payable and accrued expenses
|
|
|
953
|
|
|
|
349
|
|
Other assets
|
|
|
(12
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities from continuing operations
|
|
|
(8,464
|
)
|
|
|
(12,393
|
)
|
Net cash provided by (used in) operating activities from
discontinued operations
|
|
|
1,292
|
|
|
|
(256
|
)
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(7,172
|
)
|
|
|
(12,649
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(4,273
|
)
|
|
|
(872
|
)
|
Purchases of short-term investments
|
|
|
(15,650
|
)
|
|
|
(53,211
|
)
|
Proceeds from maturities of short-term investments
|
|
|
45,595
|
|
|
|
67,133
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities from continuing
operations
|
|
|
25,672
|
|
|
|
13,050
|
|
Net cash provided by (used in) investing activities from
discontinued operations
|
|
|
1,354
|
|
|
|
(2
|
)
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
27,026
|
|
|
|
13,048
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities:
|
|
|
|
|
|
|
|
|
Principal payments of notes payable
|
|
|
(828
|
)
|
|
|
(486
|
)
|
Proceeds from the exercise of stock options
|
|
|
137
|
|
|
|
89
|
|
Bank overdraft
|
|
|
|
|
|
|
174
|
|
|
|
|
|
|
|
|
Net cash used in financing activities
|
|
|
(691
|
)
|
|
|
(223
|
)
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
19,163
|
|
|
|
176
|
|
Cash and cash equivalents at beginning of period
|
|
|
4,350
|
|
|
|
7,161
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
23,513
|
|
|
$
|
7,337
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash interest payments
|
|
$
|
654
|
|
|
$
|
532
|
|
|
|
|
|
|
|
|
Debt discount from modification of convertible debt
|
|
$
|
|
|
|
$
|
852
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash activities:
|
|
|
|
|
|
|
|
|
Equipment purchases included in accounts payable
|
|
$
|
201
|
|
|
$
|
225
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
4
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Organization
Novavax, Inc., a Delaware corporation (Novavax or the Company), was incorporated in 1987,
and is a clinical-stage biotechnology company creating novel vaccines to address a broad range of
infectious diseases worldwide using advanced, proprietary virus-like-particle (VLP) technology.
The Company produces these VLP based, potent, recombinant vaccines utilizing new and efficient
manufacturing approaches. VLPs are genetically engineered three-dimensional nanostructures, which
incorporate immunologically important, lipids and recombinant proteins. The Companys VLPs
resemble the virus but lack the genetic material to replicate the virus. The Companys proprietary
production technology uses insect cells rather then chicken eggs or mammalian cells. The Companys
current product targets include vaccines against the H5N1, H9N2 and other subtypes of avian
influenza with pandemic potential, human seasonal influenza, Varicella Zoster, which causes
shingles, and a fourth undisclosed disease target.
On July 31, 2007, the Company began Phase I clinical trials for its H5N1 pandemic influenza
vaccine. In December 2007, the Company announced favorable interim results for its pandemic
influenza vaccine that demonstrated immunogenicity and safety. The Company began subject
enrollment for the Phase I/IIa trial in March 2008 to gather additional patient immunogenicity and
safety data, as well as determining a final dose through completion of this clinical trial. It is
anticipated that initial immunogenicity and safety data will be available in the third quarter of
2008 with study completion by the end of 2008 to include ongoing safety data collection.
The Companys vaccine products currently under development or in clinical trials will require
significant additional research and development efforts, including extensive pre-clinical and
clinical testing and regulatory approval, prior to commercial use. There can be no assurance that
the Companys research and development efforts will be successful or that any potential products
will prove to be safe and effective in clinical trials. Even if developed, these vaccine products
may not receive regulatory approval or be successfully introduced and marketed at prices that would
permit the Company to operate profitably. The commercial launch of any vaccine product is subject
to certain risks including but not limited to, manufacturing scale-up and market acceptance.
The Company also has a drug delivery platform based on its micellar nanoparticle (MNP)
technology, proprietary oil and water nano emulsions used for the topical delivery of drug. The
MNP technology was the basis for the development of the Companys first Food and Drug
Administration (FDA) approval estrogen replacement product known as Estrasorb. In October 2007,
Allergan, Inc. (Allergan) purchased Esprit Pharma, Inc. (Esprit) and subsequently entered into
an agreement with Novavax, which among other things terminated the license and supply agreement for
Estrasorb. In February 2008, the Company sold its assets related to Estrasorb in the United
States, Canada and Mexico to Graceway Pharmaceuticals, LLC (Graceway). In connection with the
sale of Estrasorb assets to Graceway, Novavax terminated the Estrasorb license agreement with
Allergan. The Company is seeking to divest its non-vaccine MNP technology through sales and
licenses.
No assurance can be given that the Company can generate sufficient product revenue to become
profitable or generate positive cash flow from operations at all or on a sustained basis. The
Companys efforts to divest the remaining non-vaccine MNP technology discussed above may not be
successful because the Company may not be able to identify a potential licensee or buyer, and even
if the Company does identify a licensee or buyer, the price and terms may not be acceptable to the
Company.
5
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim consolidated financial statements include the accounts of
the Company and its wholly owned subsidiary (Fielding Pharmaceutical Company). All significant
inter-company accounts and transactions have been eliminated in consolidation. They have been
prepared pursuant to the rules and regulations of the Securities and Exchange Commission. The
financial statements reflect all adjustments that are in the opinion of management, necessary for a
fair statement of such information. All such adjustments are of a normal recurring nature.
Although Novavax believes that the disclosures are adequate to make the information presented
herein not misleading, certain information and footnote disclosures, including a description of
significant accounting policies, which are normally included in financial statements prepared in
accordance with accounting principles generally accepted in the United States of America, have been
condensed or omitted pursuant to such rules and regulations. Certain information and disclosures
required by accounting principles generally accepted in the United States for complete consolidated
financial statements are not included herein. The interim statements should be read in conjunction
with financial statements and notes thereto included in the Companys latest Annual Report on Form
10-K. The results of operations for the three and six months ended June 30, 2008 are not
necessarily indicative of the results for any subsequent quarter or the entire fiscal year ending
December 31, 2008.
Reclassifications
Certain amounts appearing in the consolidated financial statements for the three and six
months ended June 30, 2007 have been reclassified to conform to the current periods presentation.
As discussed in Note 3, the results of the operations and the assets and liabilities related to the
Philadelphia, Pennsylvania manufacturing facility have been accounted for as discontinued operations.
Liquidity Matters
The Company has incurred losses since its inception and, as of June 30, 2008, has an
accumulated deficit of $217 million. The Company does not expect to generate significant revenue
in the near future. In July 2008, the Company raised additional funds through a registered direct
offering with aggregate net proceeds of $17.6 million. Based on the Companys assessment of the
availability of capital and its business operations as currently contemplated, including the
Companys clinical development plans, in the absence of new financings, any potential redemption of
its 4.75% convertible senior notes, licensing arrangements or partnership agreements, the Company
believes it will have adequate capital resources through September 2009. If the Company is unable
to obtain additional capital, it will continue to assess its capital resources and the Company may
be required to delay, reduce the scope of, or eliminate one or
6
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Liquidity Matters (continued)
more of its product research and development programs, downsize its organization, or reduce its general
and administrative infrastructure.
Use of Estimates
The preparation of the consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Revenue Recognition
During 2005, Novavax began to transition from a specialty pharmaceutical company, which
included the sale and marketing of products serving the womens health space, to an innovative,
biopharmaceutical company focused on the development of vaccines. For the three and six months
ended June 30, 2008 and 2007, product revenues resulted primarily from the sale of Estrasorb, the
Companys Food and Drug Administration approved estrogen replacement product. As discussed under
Significant Transactions-Graceway Agreements
, the Company entered into agreements with Graceway
Pharmaceuticals, LLC in February 2008, pursuant to which Novavax produced additional units of
Estrasorb with final delivery in July 2008.
The Company recognizes revenue in accordance with the provisions of Staff Accounting Bulletin
No. 104,
Revenue Recognition
(SAB No. 104). For product sales, revenue is recognized when all of
the following criteria are met: persuasive evidence of an arrangement exists, delivery has
occurred, the sellers price to the buyer is fixed or determinable and collectability is reasonably
assured. The Company recognizes these sales, net of allowances for returns and rebates. Through
December 31, 2007, a large part of the Companys product sales were to Allergan or to distributors
who resold the products to their customers. With the exception of sales to Allergan and Graceway,
the Company provided rebates to members of certain buying groups who purchased from the Companys
distributors, to distributors that sold to their customers at prices determined under a contract
between the Company and the customer, and to state agencies that administer various programs such
as the federal Medicaid and Medicare programs. Rebate amounts were usually based upon the volume
purchased or by reference to a specific price for a product. The Company estimated the amount of
the rebate that would be paid, and recorded the liability as a reduction of revenue when the
Company recorded the sale of the products. Settlement of the rebate generally occurred from three
to twelve months after the sale. The Company regularly analyzed the historical rebate trends and
made adjustments to record reserves for changes in trends and terms of rebate programs. In a
similar manner, the Company estimates amounts for returns based on historical trends, distributor
7
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Revenue Recognition (continued)
inventory levels, product prescription data and generic competition and makes adjustments to the
recorded reserves based on such information.
Under the license and supply agreements with Allergan (
See Significant Transactions-Graceway
Agreements)
the Company no longer has responsibility for rebates related to Estrasorb or for
returns of Estrasorb made subsequent to entering into the license agreement on October 19, 2005.
For upfront payments and licensing fees related to contract research or technology, the
Company follows the provisions of SAB No. 104 in determining if these payments and fees represent
the culmination of a separate earnings process or if they should be deferred and recognized as
revenue as earned over the life of the related agreement. Milestone payments are recognized as
revenue upon achievement of contract-specified events and when there are no remaining performance
obligations. Revenue earned under research contracts is recognized in accordance with the terms
and conditions of such contracts for reimbursement of costs incurred and defined milestones.
A roll-forward of the sales return allowances is as follows (in thousands):
|
|
|
|
|
Balance, December 31, 2006
|
|
$
|
238
|
|
Returns received from 2006 sales (unaudited)
|
|
|
(38
|
)
|
|
|
|
|
Balance, March 31, 2007 (unaudited)
|
|
|
200
|
|
Provision for 2007 sales (unaudited)
|
|
|
44
|
|
Additional provision for planned discontinuation of Gynodiol (unaudited)
|
|
|
158
|
|
Returns received from 2004 sales (unaudited)
|
|
|
(19
|
)
|
|
|
|
|
Balance, June 30, 2007 (unaudited)
|
|
$
|
383
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2007
|
|
$
|
354
|
|
Returns received from 2005 sales (unaudited)
|
|
|
(33
|
)
|
Returns received from 2006 sales (unaudited)
|
|
|
(11
|
)
|
|
|
|
|
Balance, March 31, 2008
(unaudited)
|
|
|
310
|
|
Adjustment to provision for Estrasorb and other products (unaudited)
|
|
|
(144
|
)
|
Returns received from 2007 sales (unaudited)
|
|
|
(12
|
)
|
Adjustment to provision for planned discontinuation of Gynodiol (unaudited)
|
|
|
(42
|
)
|
|
|
|
|
Balance, June 30, 2008 (unaudited)
|
|
$
|
112
|
|
|
|
|
|
8
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Inventor
y
Inventory consists of raw materials, work-in-process and finished goods, and are priced at the
lower of cost or market, using the first-in-first out method, and were as follows:
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
(in thousands)
|
|
Raw materials
|
|
$
|
|
|
|
$
|
226
|
|
Work-in-process
|
|
|
151
|
|
|
|
|
|
Finished goods
|
|
|
299
|
|
|
|
140
|
|
Reserve for inventory
|
|
|
|
|
|
|
(52
|
)
|
|
|
|
|
|
|
|
|
|
|
450
|
|
|
|
314
|
|
Less: inventory reclassified
to current assets of
discontinued operations
|
|
|
(403
|
)
|
|
|
(289
|
)
|
|
|
|
|
|
|
|
|
|
$
|
47
|
|
|
$
|
25
|
|
|
|
|
|
|
|
|
The Company utilizes Statement of Financial Accounting Standard No. 151,
Inventory Costs an
amendment of ARB No. 43, Chapter 4
(SFAS No. 151). Under SFAS No. 151, the Company allocates
fixed production overhead costs to inventories based on the anticipated normal capacity of its
manufacturing facility at the time. Included in cost of products sold in discontinued operations
for the three and six months ended June 30, 2008 is $162,000 or $0.00 per share and $781,000, or
$0.01 per share, respectively, of idle capacity costs, which amounts represent the excess of fixed
production overhead costs over that allocated to inventories, as compared to $609,000, or $0.01 per
share and $1,400,000, or $0.02 per share for the three and six months ended June 30, 2007.
During both the three and six months ended June 30, 2008, $465,000 of inventory costs in
excess of market value were included in the loss from discontinued operations in the accompanying
consolidated statement of operations related to the supply agreement with Esprit and Graceway, as
compared to $476,000, and $560,000 for the three and six months ended June 30, 2007, respectively.
Under the terms of the supply Agreement, with both Esprit and Graceway, the Company sold Estrasorb
at a price which was below its manufacturing costs.
In June 2007, the Company decided to discontinue the sale of Gynodiol. In connection with its
decision, the Company recorded an inventory reserve totaling $52,000. During the six months ended
June 30, 2008, the Company destroyed the remaining Gynodiol inventory and wrote-off the remaining
inventory balance against this reserve.
Based on the termination of the supply Agreement with Allergan, the Company had planned to
close the leased Philadelphia, Pennsylvania manufacturing facility at the end of 2007 and transfer
production to a third party. However, in February 2008, the Company entered into an
9
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Inventory (continued)
agreement with Graceway to sell its manufacturing equipment and other assets related to Estrasorb
in the United States, Canada and Mexico. In addition to the sale of assets, the Company agreed to
produce additional quantities of Estrasorb on behalf of Graceway. The production began in March
2008 and was completed in July 2008. The Company expects to close this leased facility by
mid-August 2008.
Net Loss per Share
The Company calculates net loss per share in accordance with SFAS No. 128,
Earnings per Share.
Basic loss per share is computed based on the weighted average number of common shares outstanding
during the period. The dilutive effect of common stock equivalents is included in the calculation
of diluted earnings per share only when the effect of the inclusion would be dilutive. For the
three and six months ended June 30, 2008 and 2007, there were no common stock equivalents included
in the calculations of earnings per share as they were all anti-dilutive.
Short-term investments
For short-term investments classified as held to maturity securities, the Company has the
positive intent and ability to hold them until maturity. These investments are recorded at face
value less any premiums or discounts. Income related to these securities is reported as a
component of interest income. These premiums or discounts are then amortized or accreted over the
remaining maturity periods of the investments. Included in net interest income on the consolidated
statement of operations for the three and six months ended June 30, 2008 is $31,000 and $178,000 of
amortization/accretion of premiums/discounts related to these short-term investments. Included in
net interest income on the consolidated statement of operations for the three and six months ended
June 30, 2007 is $669,000 and $1,367,000 of amortization/accretion of premiums/discounts related to
these short-term investments. As of June 30, 2008, short-term investments classified as held to
maturity have original maturity dates of less than one year and were comprised of $3,497,000 of
corporate bonds. As of December 31, 2007, short-term investments classified as held to maturity
were comprised of $1,997,000 of certificates of deposit, $22,057,000 of corporate bonds and
$8,885,000 of government agency bonds.
Short-term investments classified as available for sale are carried at fair value. Fair value
is based on quoted market price. At June 30, 2008, the Company held $8,875,000 of high grade,
interest-bearing auction rate securities which were comprised of taxable municipal bonds and
preferred shares, compared to $9,200,000 as of December 31, 2007 which was comprised of taxable
municipal bonds. The Company has classified these auction rate securities as short-term
investments available for sale on its consolidated balance sheets. Auction rate securities are
variable rate bonds tied to short-term interest rates with maturities on the face of the securities
between 2010 and 2042. The Company did not record any unrealized gains or losses for its
10
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Short-term Investments (unaudited)
available for sale securities, as cost approximates market for these securities. These auction
rate securities have interest rate resets through a modified Dutch auction, at predetermined
short-term intervals. Interest paid during a given period is based upon the interest rate
determined during the prior auction. Auctions for these investments may fail to settle on their
respective settlement dates.
Failures in auction rate securities have raised concerns about the liquidity of such
investments. When auctions are not successful, the investment rate increases as does the risk of
illiquidity. The principal amount of the Companys auction rate securities will not be accessible
until a successful auction occurs, the issuer calls or restructures the underlying security, or the
underlying security matures and is paid by a buyer outside the auction process. The Company has
determined that it has both the ability and intent to hold these auction rate securities until the
market recovers. The Company does not anticipate having to sell these securities in order to
operate its business and, based upon available information, anticipates being able to recover the
original cost basis of all the auction rate securities remaining on its balance sheet. Impairment
assessments are made at the individual security level. When the fair value of an investment is
less than its cost at the balance sheet date, a determination is made as to whether the impairment
is other than temporary and, if it is other than temporary, an impairment loss is recognized. The
Company has determined that there were no declines in the fair values of its short-term investments
as of June 30, 2008.
Property and Equipment
Property and equipment are recorded at cost. Depreciation of furniture, fixtures and equipment
is provided under the straight-line method over the estimated useful lives of the assets, generally
three to ten years. Amortization of leasehold improvements is provided over the shorter of the
estimated useful lives of the improvements or the term of the respective lease. Repairs and
maintenance costs are expensed as incurred.
Property and equipment are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
June 30, 2008
|
|
|
December 31, 2007
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
(in thousands)
|
|
Construction in progress
|
|
$
|
4,653
|
|
|
$
|
1,601
|
|
Furniture, machinery and equipment
|
|
|
4,269
|
|
|
|
4,124
|
|
Leasehold improvements
|
|
|
7,848
|
|
|
|
7,759
|
|
Computer software and hardware
|
|
|
380
|
|
|
|
346
|
|
|
|
|
|
|
|
|
|
|
|
17,150
|
|
|
|
13,830
|
|
Less accumulated depreciation and amortization
|
|
|
(9,210
|
)
|
|
|
(8,109
|
)
|
|
|
|
|
|
|
|
|
|
$
|
7,940
|
|
|
$
|
5,721
|
|
|
|
|
|
|
|
|
11
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Property and Equipment
Construction in progress is related to costs incurred in the construction the Companys Good
Manufacturing Practice (GMP) pilot manufacturing facility which started during the third quarter
of 2007. Construction on the GMP pilot manufacturing facility was completed during the second
quarter of 2008, however, the assets will not be placed in service until the validation of the
facility and related equipment is completed.
On June 27, 2008, the Company received $3.0 million from the landlord of its corporate
headquarters as reimbursement of its leasehold improvements for its GMP pilot manufacturing
facility (See Note 4).
Accounting for Facility Exit Costs
In July 2004, the Company entered into a ten-year lease agreement for a 32,900 square foot
facility in Malvern, Pennsylvania. In April 2006, the Company entered into a sublease agreement
with Sterilox Technologies, Inc. (now known as Puricore, Inc., Puricore) to sublease 20,469
square feet of the Malvern corporate headquarters at a price per square foot above the base lease
amount.
Consistent with the strategic focus to further develop vaccines, the Company moved its
corporate headquarters to Rockville, Maryland, in January 2007. This move allowed the Company to
add additional space for its vaccine operations which had previously been based in Rockville, but
at another physical location. As a result, the Company entered into an amendment to the sublease
agreement with Puricore to sublease an additional 7,500 square feet of the Malvern facility at a
premium price per square foot. This sublease as amended, expires on September 30, 2009. As a
result of the premium price received on the sublease agreement, as amended, there were no facility
exit costs associated with the move to Rockville, Maryland.
Goodwill and Other Intangible Assets
Goodwill originally resulted from business acquisitions. Assets acquired and liabilities
assumed were recorded at their fair values; the excess of the purchase price over the identifiable
net assets acquired was recorded as goodwill. Other intangible assets are a result of product
acquisitions, non-compete arrangements, and internally-discovered patents. In accordance with SFAS
No. 142,
Goodwill and Other Intangible Assets
(SFAS No. 142), goodwill and intangible assets
deemed to have indefinite lives are not amortized but are subject to impairment tests annually, or
more frequently should indicators of impairment arise. The Company utilizes a discounted cash flow
analysis that includes profitability information, estimated future operating results, trends and
other information in assessing whether the value of indefinite-lived intangible assets can be
recovered. Under SFAS No. 142, goodwill impairment is deemed to exist if the carrying value of a
reporting unit exceeds its estimated fair value.
12
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Goodwill and Other Intangible Assets (continued)
The Company most recently performed the annual impairment test as of December 31, 2007, which
indicated that the estimated fair value of the goodwill exceeded its carrying value and,
accordingly, no impairment was identified.
Other intangible assets were amortized on a straight-line basis over their estimated useful
lives, ranging from five to seventeen years, through December 31, 2007. The Company did not record
any amortization expense for the three and six months ended June 30, 2008. Amortization expense
was $33,000 and $66,000 for the three and six months ended June 30, 2007.
As of June 30, 2008 and December 31, 2007, the Companys intangible assets and related
accumulated amortization consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
Gross
|
|
Amortization
|
|
Net
|
|
|
|
|
(unaudited)
|
|
|
Goodwill-Company
acquisition
|
|
$
|
33,141
|
|
|
$
|
|
|
|
$
|
33,141
|
|
During the third quarter of 2007, the Company began efforts to divest its
remaining non-vaccine MNP technology,
which included patent technology included as intangible assets on the Companys consolidated
balance sheet. In connection with the planned divestiture, the Company evaluated the
recoverability of the carrying value of the patents and reclassified $846,000 into assets held for
sale. The Company has determined that the estimated fair value of the patents exceeds their
carrying value, and accordingly no impairment charge is included in the consolidated statement of
operations for the three and six months ended June 30, 2008.
Fair Value Measurements
On January 1, 2008 the Company adopted Statement of Financial Accounting Standards No. 157,
Fair Value Measurements
(SFAS No. 157), which clarifies the definition of fair value, establishes
a framework for measuring fair value, and expands the disclosures on fair value measurements. In
February 2008, the FASB issued Staff Position 157-2,
Effective Date of FASB Statement No. 157
(FSP
157-2) that deferred the effective date of SFAS No. 157 for one year for nonfinancial assets and
liabilities recorded at fair value on a non-recurring basis. SFAS No. 157 defines fair value as
the exchange price that would be received for an asset or paid to transfer a liability (an exit
price) in the principal or most advantageous market for the asset or liability in an orderly
transaction between market participants on the measurement date. SFAS No. 157 also establishes a
fair value hierarchy, which is outlined below, that requires an entity to maximize the use of
observable inputs and minimize the use of unobservable inputs when measuring fair value.
13
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Fair Value Measurements (continued)
Level 1
Quoted prices in active markets for identical assets or liabilities. The Companys Level
1 assets include corporate bonds.
Level 2
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or
liabilities, or other inputs that are observable or can be corroborated by observable market data
for substantially the full term of the assets or liabilities. The Companys Level 2 assets and
liabilities primarily include assets held for sale.
Level 3
Unobservable inputs that are supported by little or no market activity and that are
financial instruments whose value is determined using pricing models, discounted cash flow
methodologies, or similar techniques, as well as instruments for which the determination of fair
value requires significant judgment or estimation. The Companys Level 3 assets are comprised of
goodwill and auction rate securities.
If the inputs used to measure the financial assets and liabilities fall within more than one
of the different levels described above, the categorization is based on the lowest level input that
is significant to the fair value measurement of the instrument.
Financial assets and liabilities measured a fair market value on a recurring basis as of June
30, 2008 are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at
|
|
|
|
June 30, 2008 using
|
|
|
|
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
Quoted
|
|
|
|
|
|
|
|
|
|
|
|
|
Prices in
|
|
|
|
|
|
|
|
|
|
|
|
|
Active
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
Markets for
|
|
|
Other
|
|
|
Significant
|
|
|
|
|
|
|
Identical
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
|
|
|
Assets
|
|
|
Inputs
|
|
|
Inputs
|
|
|
Assets
|
|
Assets
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
At Fair Value
|
|
Auction rate securities
|
|
$
|
|
|
|
$
|
|
|
|
$
|
8,875
|
|
|
$
|
8,875
|
|
Corporate bonds
|
|
|
3,497
|
|
|
|
|
|
|
|
|
|
|
|
3,497
|
|
Assets held for sale
|
|
|
|
|
|
|
899
|
|
|
|
|
|
|
|
899
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
33,141
|
|
|
|
33,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,497
|
|
|
$
|
899
|
|
|
$
|
42,016
|
|
|
$
|
46,412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-Based Compensation
The Company has various stock incentive and option plans, which are described in Note 9 of the
Notes to the Consolidated Financial Statements to the Companys 2007 Annual Report on
14
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued)
Form 10-K, that provide for the grant of options and restricted stock to eligible employees,
officers, directors and consultants of the Company.
The Company accounts for its stock options in accordance with Statement of Financial
Accounting Standard No. 123 (revised),
Accounting for Stock-Based Compensation
(SFAS No. 123R).
This standard requires the Company to measure the cost of employee services received in exchange
for equity share options granted based on the grant-date fair value of the options. The cost is
recognized as compensation expense over the vesting period of the options. Under the modified
prospective method, compensation cost included in operating expenses was $612,000 and $977,000 for
the three and six months ended June 30, 2008, and $364,000 and $601,000 for the three and six
months ended June 30, 2007.
As of June 30, 2008, there were 6,762,432 stock options outstanding. At June 30, 2008, the
aggregate fair value of the remaining compensation cost of unvested options, as determined using a
Black-Scholes option valuation model, was approximately $14,464,000 (net of estimated forfeitures).
This unrecognized compensation cost of unvested options is expected to be recognized over a
weighted average period of 6.87 years. During the three and six months ended June 30, 2008, the
Company granted 66,750 and 850,900 stock options, respectively, with a fair value of approximately
$112,000 and $1,370,000 (net of estimated forfeitures), respectively, and 231,033 and 344,650
options were forfeited during the three and six months ended June 30, 2008, respectively. During
the three and six months ended June 30, 2007, the Company granted 258,000 and 1,199,900 stock
options respectively, with a fair value of approximately $544,000 and $3,153,000 (net of estimated
forfeitures), respectively, and 436,836 and 741,561 options were forfeited during the three and six
months ended June 30, 2007.
The weighted average fair value of stock options on the date of grant and the assumptions used
to estimate the fair value of stock options issued during the three and six months ended June 30,
2008 and 2007, using the Black-Scholes option valuation model, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
Weighted average fair
value of options
granted
|
|
$
|
2.62
|
|
|
$
|
2.11
|
|
|
$
|
2.61
|
|
|
$
|
2.63
|
|
Expected life (years)
|
|
|
4.12
|
|
|
|
4.03-5.94
|
|
|
|
3.62-6.37
|
|
|
|
4.03-5.94
|
|
Expected volatility
|
|
|
84.75-84.89
|
%
|
|
|
86-90
|
%
|
|
|
81.14-87.78
|
%
|
|
|
86-94
|
%
|
Risk free interest rate
|
|
|
3.29
|
%
|
|
|
4.45-4.61
|
%
|
|
|
1.97-3.29
|
%
|
|
|
4.45-4.61
|
%
|
Expected dividend
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Expected forfeiture rate
|
|
|
21.96
|
%
|
|
|
20.34
|
%
|
|
|
21.96
|
%
|
|
|
20.34
|
%
|
15
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued)
The expected life of options granted was based on the Companys historical share option
exercise experience using the historical expected term from vesting date. The expected volatility
of the options granted during the three and six months ended June 30, 2008 and 2007 was determined
using historical volatilities based on stock prices over a look-back period corresponding to the
expected life. The risk-free interest rate was determined using the yield available for
zero-coupon U.S. government issues with a remaining term equal to the expected life of the options.
The forfeiture rate for the three and six months ended June 30, 2008 and 2007 was determined using
historical rates since the inception of the plans. The Company has never paid a dividend, and as
such the dividend yield is zero.
Restricted Stock
The Company did not grant any shares of restricted common stock for the three and six months
ended June 30, 2008. During the three and six months ended June 30, 2007, the Company granted
100,000 and 160,000 shares of restricted common stock, respectively, under the 2005 Plan totaling
$277,000 and $443,000, respectively, in value at the date of grant to officers, a director and a
consultant of the Company, which vest upon the achievement of certain milestones or over a period
of up to three years.
Non-cash compensation expense related to all restricted stock issued has been recorded as
compensation cost in accordance with SFAS No. 123R using the straight-line method of amortization.
For the three and six months ended June 30, 2008, $84,000 and $169,000 respectively, of non-cash
stock compensation expense was included in total operations costs and expenses and additional
paid-in capital was increased accordingly. For the three and six months ended June 30, 2007,
$121,000 and $267,000 respectively, of non-cash stock compensation expense was included in total
operating costs and expenses and additional paid-in capital was increased accordingly.
Segment Information
The Company currently operates in one business segment, which is the creation of
differentiated value-added vaccines that leverage the Companys proprietary virus-like particle
technology and the development of a drug delivery platform using MNP technology. The Company is
managed and operated as one business. A single management team reports to the Chief Executive
Officer who comprehensively manages the entire business. The Company does not operate separate
lines of business with respect to its products and product candidates. Accordingly, the Company
does not have separately reportable segments as defined by SFAS No. 131,
Disclosure about Segments
of an Enterprise and Related Information.
16
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Recent Accounting Pronouncements
SFAS No. 157
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. 157,
Fair Value Measurements
(SFAS No. 157). SFAS No. 157
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles and expands disclosures about fair value measurements. SFAS No. 157 applies
under other accounting pronouncements that require or permit fair value measurements, but does not
require any new fair value measurements. In February 2008, the FASB issued Staff Position 157-2,
Effective Date of FASB Statement No. 157
(FSP 157-2) that defers the effective date of SFAS No.
157 for one year for nonfinancial assets and liabilities recorded at fair value on a non-recurring
basis those fiscal years. The adoption of SFAS No. 157 for financial assets and liabilities did
not have a material impact on the Companys financial condition, results of operations or
liquidity.
SFAS No. 159
In February 2007, the FASB issued Statement of Financing Accounting Standards No. 159,
The
Fair Value Option for Financial Assets and Financial Liabilities
(SFAS No. 159). This Statement
establishes a fair value option which permits entities to choose to measure many financial
instruments and certain other items at fair value at specified election dates. Any unrealized
gains and losses on items for which the fair value option has been elected will be reported in
earnings. SFAS No. 159 is effective for our fiscal year beginning January 1, 2008. The Company
did not elect the fair value option under SFAS No. 159 for any of its financial instruments upon
adoption.
EITF 07-1
In December 2007, the FASB issued EITF Issued No. 07-1,
Accounting for Collaborative
Arrangements,
which is effective for calendar year companies on January 1, 2009. The Task Force
clarified the manner in which costs, revenues and sharing payments made to, or received by, a
partner in a collaborative arrangement should be presented in the income statement and set for the
certain disclosures that should be required in the partners financial statements. Novavax is
currently assessing the potential impact of implementing this standard on its financial condition,
results of operations and liquidity.
SAB 110
In December 2007, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin 110 (SAB 110), which permits, under certain circumstances, to continue to use the
simplified method of estimating the expected term of plain options as discussed in SAB No. 107 and in accordance
with SFAS No. 123R. The guidance in this release is effective January 1,
2008. The adoption of this standard on the consolidated financial statements did not have an
impact on the Companys financial condition, results of operation or liquidity.
17
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
SFAS No. 141R
In December 2007, the FASB issued SFAS No. 141 (revised 2007),
Business Combinations
(SFAS
No. 141R). For calendar year companies, the standard is applicable to new business combinations
occurring on or after January 1, 2009. SFAS No. 141R requires an acquiring entity to recognize all
the assets acquired and liabilities assumed in a transaction at the acquisition-date
fair value with limited exceptions. Most significantly, SFAS No. 141R will require that
acquisition costs generally be expensed as incurred, certain acquired contingent liabilities will
be recorded at fair value, and acquired in-process research and development will be recorded at
fair value as an indefinite-lived intangible asset at the acquisition date. The Company does not
expect the adoption of SFAS No. 141R to have a material impact on its financial condition, results
of operations or liquidity.
SFAS No. 160
In December 2007, the FASB also issued SFAS No. 160,
Noncontrolling interests in Consolidated
Financial Statements An Amendment of ARB No. 51
(SFAS No. 160), which is effective for fiscal
years, and interim periods within those fiscal years, beginning on or after December 15, 2008. The
standard establishes new accounting and reporting standards for the noncontrolling interest in a
subsidiary and for the deconsolidation of subsidiary. The Company does not expect the adoption of
SFAS No. 160 to have a material impact on its financial condition, results of operations or
liquidity.
SFAS No. 161
In March 2008, the FASB issued Statement of Financial Accounting Standards No. 161,
Disclosures about Derivate Instruments and Hedging Activities
(SFAS No. 161), which is effective
January 1, 2009. SFAS No. 161 requires enhanced disclosures about derivative instruments and
hedging activities to allow for a better understanding of their effects on an entitys financial
position, financial performance, and cash flows. Among other things, SFAS No. 161 requires
disclosure of the fair values of derivative instruments and associated gains and losses in a
tabular format. The adoption of SFAS No. 161 is not expected to have a material impact on the
Companys financial condition, results of operations, or liquidity.
18
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
EITF 07-3
In June 2007, the FASB ratified a consensus opinion reached by the Emerging Issues Task Force
(EITF) on EITF Issue 07-3,
Accounting for Nonrefundable Advance Payments for Goods or Services
Received for Use in Future Research and Development Activities
(EITF 07-3). The guidance in EITF
07-3 requires the Company to defer and capitalize nonrefundable advance payments made for goods or
services to be used in research and development activities until the goods have been delivered or
the related services have been performed. If the goods are no longer expected to be delivered nor
the services expected to be performed, the Company would be required to expense the related
capitalized advance payments. The consensus in EITF 07-3 is effective for fiscal years, and
interim periods within those fiscal years, beginning after December 15, 2007, and is to be applied
prospectively to new contracts entered into on or after December 15, 2007. Early adoption is not
permitted. Retrospective application of EITF 07-3 is also not permitted. The Company adopted EITF
07-3 effective January 1, 2008. The impact of applying this consensus will be evaluated based on
the terms of the Companys future research and development contractual arrangements entered into on
or after December 15, 2007.
SFAS No. 162
In May 2008, the FASB issued SFAS No. 162,
Hierarchy of Generally Accepted Accounting
Principles
(SFAS No. 162). SFAS No. 162 identifies the sources of accounting principles and the
framework for selecting the principles used in the preparation of financial statements. SFAS No.
162 is effective 60 days following the SECs approval of the Public Company Accounting Oversight
Board amendments to AU Section 411,
The Meaning of Present Fairly in Conformity with Generally
Accepted Accounting Principles.
The implementation of this standard is not expected to have a
material impact on our consolidated financial position and results of operations.
FSP EITF 03-6-1
In June 2008, the FASB issued FSP EITF 03-6-1,
Determining Whether Instruments Granted in
Share-Based Payment Transactions Are Participating Securities
(FSP EITF 03-6-1). FSP EITF 03-6-1
clarified that all outstanding unvested share-based payment awards that contain rights to
nonforfeitable dividends participate in undistributed earnings with common shareholders. Awards of
this nature are considered participating securities and the two-class method of computing basic and
diluted earnings per share must be applied. FSP EITF 03-6-1 is effective for fiscal years
beginning after December 15, 2008. The Company is currently assessing the impact of FSP EITF
03-6-1 on its consolidated financial position and results of operations.
19
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
EITF 07-5
In June 2008, the FASB ratified EITF Issue No. 07-5,
Determining Whether an Instrument (or an
Embedded Feature) Is Indexed to an Entitys Own Stock
(EITF 07-5). EITF 07-5 provides that an
entity should use a two step approach to evaluate whether an equity-linked financial instrument (or
embedded feature) is indexed to its own stock, including evaluating the instruments contingent
exercise and settlement provisions. It also clarifies on the impact of foreign currency
denominated strike prices and market-based employee stock option valuation instruments on the
evaluation. EITF 07-5 is effective for fiscal years beginning after December 15, 2008. The
Company is currently assessing the impact of EITF 07-5 on its consolidated financial position and
results of operations.
EITF 08-3
In June 2008, the FASB ratified EITF Issue No. 08-3,
Accounting for Lessees for Maintenance
Deposits Under Lease Agreements
(EITF 08-3). EITF 08-3 provides guidance for accounting for
nonrefundable maintenance deposits. It also provides revenue recognition accounting guidance for
the lessor. EITF 08-3 is effective for fiscal years beginning after December 15, 2008. The
Company is currently assessing the impact of EITF 08-3 on its consolidated financial position and
results of operations.
Significant Transactions
G
raceway Agreements
In February 2008, the Company entered into an asset purchase agreement with Graceway
Pharmaceuticals, LLC (Graceway), pursuant to which Novavax sold Graceway its assets related to
Estrasorb in the United States, Canada and Mexico. The assets sold include certain patents related
to the micellar nanoparticle technology (the MNP Technology), trademarks, know-how, manufacturing
equipment, customer and supplier relations, goodwill and other assets. Novavax retained the rights
to commercialize Estrasorb outside of the United States, Canada and Mexico.
In February 2008, Novavax and Graceway also entered into a supply agreement, pursuant to which
Novavax agreed to manufacture additional units of Estrasorb with final delivery completed in July
2008. Graceway is paying a preset transfer price per unit of Estrasorb for the supply of this
product. Because Novavax has delivered the required quantity of Estrasorb, Novavax must clean the
manufacturing equipment and prepare the equipment for transport. Graceway will remove the equipment
from the manufacturing facility and Novavax will then exit the facility by mid-August, 2008.
During the three and six months ended June 30, 2008, the Company received payment for the
manufacture and delivery of the additional units of Estrasorb delivered during the quarter.
20
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
G
raceway Agreements (Continued)
In February 2008, Novavax and Graceway also entered into a license agreement, pursuant to
which Graceway granted Novavax an exclusive, non-transferable (except for certain allowed
assignments and sublicenses), royalty-free, limited license to the patents and know-how that
Novavax sold to Graceway pursuant to the asset purchase agreement. The license allows Novavax to
make, use and sell licensed products and services in certain, limited fields. The license and
supply agreements with Allergan, Inc., successor-in-interest to Esprit Pharma, Inc., were
terminated in February 2008 and October 2007, respectively.
In connection with the closing of the transaction, Novavax received an upfront payment from
Graceway. The Company has determined that the Graceway agreements should be accounted for as a
single arrangement with multiple elements as defined in EITF 00-21,
Revenue Arrangements with
Multiple Deliverables
(EITF 00-21). Under EITF 00-21, in an arrangement with multiple
deliverables, the delivered
item(s)
should be considered a separate unit of accounting if it has
stand-alone value and the fair value of the undelivered performance obligations can be determined.
If the fair value of the undelivered performance obligations can be determined, such obligations
would be accounted for separately as performed. If the fair value of undelivered performance
obligations cannot be determined, the arrangement is accounted for as a single unit of accounting.
The Company has evaluated the deliverables related to the Graceway supply and asset purchase
agreements under the criteria of EITF 00-21 to determine whether they meet the requirements for
separation within a multi-element arrangement. The Company has concluded that the deliverables
should not be treated as separate units of accounting, as there is no objective and reliable
evidence of the fair value of the undelivered items related to the manufacture of the additional
Estrasorb lots and the cleaning and preparation of the equipment under the terms of supply
agreement. Accordingly, all revenue associated with the deliverables, under both the supply and
asset purchase agreement, is being deferred and will be recognized upon the completion of all
obligations. Current liabilities of discontinued operations in the Companys consolidated balance
sheet as of June 30, 2008 includes deferred revenue of $2.8 million related to the Graceway
agreements which relates to the upfront payment received from Graceway and the payments received
for delivery of additional lots of Estrasorb.
License and Supply Agreements with Allergan
In October 2007, Allergan purchased Esprit and subsequently entered into an agreement with
Novavax, which among other things terminated the license and supply agreement for testosterone and
the supply agreement for Estrasorb. In February 2008, in connection with the sale of Estrasorb
assets to Graceway, Novavax terminated the Estrasorb license agreement with Allergan.
21
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
License Agreement with Wyeth Holdings Corporation
On July 5, 2007, the Company entered into a License Agreement with Wyeth Holdings Corporation,
a subsidiary of Wyeth (Wyeth). The license is a non-exclusive, worldwide license to a family of
patent applications covering VLP technology for use in human vaccines in certain fields of use.
The agreement provides for an upfront payment, annual license fees, milestone payments and
royalties on any product sales. Payments under the agreement to Wyeth could aggregate up to $3.3
million in 2008, depending on the achievement of clinical development milestones. The agreement
will remain effective as long as at least one claim of the licensed patent rights cover the
manufacture, sale, or use of any product unless terminated sooner at Novavaxs option or by Wyeth
for an uncured breach by Novavax.
License Agreement with University of Massachusetts Medical School
Effective February 26, 2007, the Company entered into a worldwide agreement to exclusively
license a VLP technology from the University of Massachusetts Medical School (UMMS). Under the
agreement, the Company has the right to use this technology to develop VLP vaccines for the
prevention of any viral diseases in humans. The Company made an upfront cash payment to UMMS
during the six months ended June 30, 2007. In addition, the Company will make certain payments based on development
milestones as well as future royalties on any sales of products that may be developed using the
technology.
Sales and Issuance of Common Stock
During the three and six months ended June 30, 2008, the Company received net proceeds of
$102,000 and $137,000, respectively, from the exercise of 45,467 and 66,038 shares of common stock
options, at a range of $1.34 to $2.77 per share.
During the three and six months ended June 30, 2007, the Company received net proceeds of
$85,000 and $89,000, respectively, from the exercise of 3,125 and 57,126 shares of common stock
options, at a range of $1.34 to $2.21 per share.
Convertible Notes
On June 15, 2007, the Company entered into amendment agreements (the Amendments) with each
of the holders of the outstanding Notes to amend the terms of
the Notes. As of June 30, 2007 and December 31, 2006, $22.0 million aggregate principal amount
remained outstanding under the Notes. The Amendments (i) lowered the conversion price from $5.46
to $4.00 per share, (ii) eliminated the holders right to require the Company to redeem the Notes
if the weighted average price of the Companys common stock is less than the conversion price on 30
of the 40 consecutive trading days preceding July 19, 2007 or July 19, 2008 and (iii) mandated that
the Notes be converted into Company common stock if the weighted average price
22
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Convertible Notes (continued)
of the Companys common stock is greater than $7.00 (a decrease from $9.56) in any 15 out of 30
consecutive trading days after July 19, 2007.
The Company determined the change in the value of the conversion option and reduced the
convertible debt amount by $852,000 and re-classified this amount to additional paid-in capital.
The difference in the option value of $852,000 is being accreted over the remaining term (through
July 19, 2009) of the convertible notes as interest expense.
Related Party Transactions
On March 21, 2002, pursuant to the Novavax, Inc. 1995 Stock Option Plan, the Company approved
the payment of the exercise price of options by two of its directors, through the delivery of
full-recourse, interest-bearing promissory notes in the aggregate amount of $1,480,000. The
borrowings accrued interest at 5.07% per annum and were secured by an aggregate of 261,667 shares
of common stock owned by the directors. The notes were payable upon the earlier to occur of the
following: (i) the date on which the director ceases for any reason to be a director of the
Company, (ii) in whole, or in part, to the extent of net proceeds, upon the date on which the
director sells all or any portion of the pledged shares or (iii) payable in full on March 21, 2007.
In May 2006, one of these directors resigned from the Companys Board of Directors. Following
his resignation, the Company approved an extension of the former directors $448,000 note to
December 31, 2007 or earlier to the extent of the net proceeds of the pledged shares. In
connection with this extension, the former director executed a general release of all claims
against the Company. Accordingly, the note was reclassified out of stockholders equity. As of
December 31, 2007, the note and the corresponding accrued interest receivable totaling $579,000
were included in other current assets in the accompanying consolidated balance sheet. As of
December 31, 2007, the Company had recorded a reserve of $262,555 against this note receivable and
the corresponding accrued interest receivable, which represented the difference between the book
value of the receivables less the market value of the 95,000 pledged shares. During the six months
ended June 30, 2008, the Company adjusted the reserve to $365,326 representing
the difference between the book value of the receivable and the market value of the pledged
securities. This reserve is included as an offset to other current assets in the accompanying
consolidated balance sheet as of June 30, 2008 and December 31, 2007. General and administrative
expenses in the accompanying consolidated statement of operations include $102,771 related to the
increase in the reserve for the six months ended June 30, 2008. On May 7, 2008, the Company and
the former director entered into an Amended and Restated Promissory Note and an Amended and
Restated Pledge Agreement (the Amendment). The Amendment extends the maturity date of the note
to June 30, 2009, permits the Company to sell the pledged shares if the market price of the common
stock as reported on NASDAQ Global Market exceeds
23
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Related Party Transactions (continued)
certain targets, increases the interest rate to 8.0% and stipulates quarterly payments beginning on
June 30, 2008. The Company received the payment due of $50,000 on July 3, 2008. As of June 30, 2008,
the note and corresponding accrued interest totaling $601,876 are included in other current assets
in the accompanying consolidated balance sheet.
In March 2007, the second director resigned from the Board of Directors. In an agreement
dated May 7, 2007, the Board agreed to extend the note that was due March 21, 2007 to June 30, 2009
and secured additional collateral in the form of a lien on certain outstanding stock options. Also
under the May 7, 2007 agreement, the Company has the right to exercise the stock options, sell the
acquired shares and the other shares held as collateral and use the proceeds to pay the debt, if
the share price exceeds $7.00 at any time during the period between May 7, 2007 and June 30, 2009.
As of December 31, 2007, the note and the corresponding accrued interest receivable totaling
$1,334,117 was included in non-current other assets in the accompanying consolidated balance sheet.
The note continues to accrue interest at 5.07% per annum and continues to be secured by 166,666
shares of common stock owned by the former director. A reserve of $778,450 was included in the
balance sheet as of December 31, 2007, representing the amount of the loan balance due, less the
value of the pledged common stock valued at December 31, 2007. During the six months ended June
30, 2008, the Company adjusted the reserve to $945,316. As of June 30, 2008, the note and
corresponding accrued interest totaling $1,360,317 are included in other current assets the
accompanying consolidated balance sheet. This reserve is included as an offset to other current
assets in the accompanying consolidated balance sheet as of June 30, 2008 and as an offset to non-current assets as of December 31, 2007.
General and administrative expenses in the accompanying consolidated statement of operations
include $166,866 related to the increase in the reserve for the six months ended June 30, 2008.
On April 27, 2007 and effective as of March 31, 2007, the Company entered into a consulting
agreement with Mr. John Lambert, the Chairman of the Companys Board of Directors. The agreement
terminates on March 8, 2010, unless terminated sooner by
either party upon 30 days written notice. Under the agreement, Mr. Lambert is expected to devote
one-third of his time to the Companys activities. As a consultant, Mr. Lambert is required to
work closely with the senior management of the Company on matters related to clinical development
of its vaccine products, including manufacturing issues, FDA approval strategy and
commercialization strategy. His annual compensation is $220,000 in consideration for his
consulting services. Additionally, on March 7, 2007, the Company granted Mr. Lambert 100,000
shares of restricted common stock, under the 2005 Plan totaling $277,000 in value at the date of
grant and 250,000 stock options under the 2005 Plan with a fair value of approximately $420,000.
Both the restricted stock and stock options vest upon the achievement of certain milestones. On
March 6, 2008, the Company granted Mr. Lambert 25,000 stock options under the 2005 Plan with a fair
value of approximately $41,000. For the three and six months ended June 30, 2008, the Company
recorded consulting expenses for Mr. Lambert of $55,000 and $110,000 respectively,
24
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Related Party Transactions (continued)
in accordance with the consulting agreement. For the three and six months ended June 30, 2007, the
Company recorded consulting expenses for Mr. Lambert of $41,000.
Notes payable consist of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
(in thousands)
|
|
Note payable; bears interest at
3.00% per annum; principal and
interest due in monthly
installments of $6,600, repaid
February 2008
|
|
$
|
|
|
|
$
|
135
|
|
Note payable; bears interest at
2.85% per annum; principal and
interest due in monthly
installments of $6,573, repaid
February 2008
|
|
|
|
|
|
|
153
|
|
Note payable; bears interest at
2.38% per annum; principal and
interest due in monthly
installments of $6,468, repaid
February 2008
|
|
|
|
|
|
|
152
|
|
Note payable; insurance
financing; bears interest of
6.00% per annum; principal and
interest due in monthly
installments of $51,385 through
November 2008
|
|
|
253
|
|
|
|
600
|
|
Notes payable; non-interest
bearing; principal only
payments due in monthly
installments of $6,667 through
May 2012
|
|
|
300
|
|
|
|
340
|
|
|
|
|
|
|
|
|
Total
|
|
|
553
|
|
|
|
1,380
|
|
Less current portion
|
|
|
(333
|
)
|
|
|
(1,120
|
)
|
|
|
|
|
|
|
|
Long-term portion
|
|
$
|
220
|
|
|
$
|
260
|
|
|
|
|
|
|
|
|
The notes payable (except for the notes payable for financing insurance premiums and the
non-interest bearing note payable) were secured by $2.4 million of the Companys machinery and
equipment located at its leased manufacturing facility in Philadelphia, Pennsylvania. In February
2008, in connection with the execution of the asset purchase agreement with Graceway, the Company
repaid the outstanding balance on the 3.00%, 2.85% and 2.38% notes payable and received a release
of the lien on the equipment. In July 2005, the Company received a $400,000 Opportunity Grant from
the Commonwealth of Pennsylvania for the reimbursement of certain costs incurred in connection with the
move of its corporate headquarters and product development activities to Malvern, Pennsylvania.
In line with its business strategy, the Company announced in December 2006 that it had signed
a long-term lease for its new corporate headquarters and research facility in Rockville, Maryland,
where its vaccine operations were located, but at another physical location. As a result of the Companys failure to comply with the
conditions of the grant by moving out of Pennsylvania, the Department of Community & Economic
Development (DCED) of the Commonwealth of Pennsylvania requested that the Company repay the full
amount of the Opportunity Grant. The Company recorded a current liability of $400,000 in the
consolidated balance sheet as of December 31, 2006, and a corresponding expense in general and
administrative expense in the consolidated statement of operations for the year ended December 31,
2006.
25
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Opportunity Grant Funds
In April 2007, the Company entered into a Settlement and Release Agreement with the
Commonwealth of Pennsylvania, acting by and through DCED, whereby the Company agreed to repay the
sum of the original grant in 60 monthly installments starting on May 1, 2007. The loan was
reclassified to notes payable. The terms of the agreement stipulate the amount of the monthly
repayment to be $6,667 for 60 months. Interest does not accrue on the outstanding balance. During
the three and six months ended June 30, 2008, the Company made repayments totaling $20,000 and
$40,000, respectively. During the three and six months ended June 30, 2007, the Company made
repayments totaling $20,000.
3. Discontinued Operations
In October 2007, the Company entered into agreements to terminate its supply agreements with
Allergan. In connection with the termination, the Company decided to wind down operations at its
leased manufacturing facility in Philadelphia, Pennsylvania. The results of operations for the
manufacturing facility are being reported as discontinued operations and the consolidated
statements of operations for prior periods have been adjusted to reflect this presentation.
The assets and liabilities related to the Companys leased manufacturing facility in
Philadelphia, Pennsylvania have identifiable cash flows that are largely independent of the cash
flows of other groups of assets and liabilities, and the Company will not have a significant
continuing involvement beyond one year after the closing of the Graceway transaction.
Therefore, in accordance with Statement of Financial Accounting Standards No. 144
, Accounting
for the Impairment or Disposal of Long-Lived Assets
(SFAS No. 144), the accompanying consolidated
balance sheets report the assets and liabilities related to the Companys leased Philadelphia
manufacturing facility as discontinued operations in all periods presented, and the results of
operations have been classified as discontinued operations in the accompanying consolidated
statements of operations for all periods presented.
26
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Discontinued Operations (continued)
The following table presents summarized financial information for the Companys discontinued
manufacturing operations presented in the consolidated statements of operations for the three and
six months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
|
(In thousands)
|
|
Revenues
|
|
$
|
143
|
|
|
$
|
374
|
|
|
$
|
229
|
|
|
$
|
581
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
736
|
|
|
|
754
|
|
|
|
1,474
|
|
|
|
2,021
|
|
Excess inventory costs over market
|
|
|
465
|
|
|
|
473
|
|
|
|
465
|
|
|
|
560
|
|
Research and development
|
|
|
|
|
|
|
201
|
|
|
|
|
|
|
|
207
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
1,201
|
|
|
|
1,428
|
|
|
|
1,939
|
|
|
|
2,788
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,058
|
)
|
|
$
|
(1,054
|
)
|
|
$
|
(1,710
|
)
|
|
$
|
(2,207
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents major classes of assets and liabilities that have been presented as
assets and liabilities of discounted operations in the accompanying consolidated balance sheets.
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008
|
|
|
December 31, 2007
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
(In thousands)
|
|
Accounts and other receivables, net
|
|
$
|
244
|
|
|
$
|
105
|
|
Inventory
|
|
|
403
|
|
|
|
289
|
|
Prepaid expenses and other current assets
|
|
|
64
|
|
|
|
137
|
|
|
|
|
|
|
|
|
Current assets of discontinued operations
|
|
$
|
711
|
|
|
$
|
531
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets held for sale
|
|
$
|
280
|
|
|
$
|
1,634
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
581
|
|
|
|
175
|
|
Accrued expenses and other liabilities
|
|
|
241
|
|
|
|
441
|
|
Deferred revenue
|
|
|
2,803
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities of discontinued operations
|
|
$
|
3,625
|
|
|
$
|
616
|
|
|
|
|
|
|
|
|
In February 2008, the Company completed the sale of certain assets used in the production of
Estrasorb to Graceway (See Note 2). As discussed above, the Company received an upfront payment
from Graceway in connection with the execution of the agreements. As part of the asset purchase
agreement, the Company transferred to Graceway, the title to manufacturing equipment valued at $1.1
million related to the production of Estrasorb on the closing date, which had been included as
assets held for sale in the Companys consolidated balance sheet as of December 31, 2007.
27
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Discontinued Operations (continued)
In June 2008, the Company received $220,000 from the sale of a portion of the assets
classified as assets held for sale. Assets held for sale related to discontinued operations
recorded at their estimated net realizable value of $280,000 and $1,634,000 and included in
non-current assets of discontinued operations in the Companys consolidated balance sheet at June
30, 2008 and December 31, 2007, respectively. These assets include equipment, furniture, and
fixtures and the remaining assets are being actively marketed as of June 30, 2008.
The Company accrued $137,000 of estimated severance costs in its December 31, 2007 financial
statements, in accordance with No. 146,
Accounting for Costs Associated with Exit or Disposal
Activities
(SFAS No. 146). SFAS No. 146 requires that a liability for a cost associated with an
exit or disposal activity be recognized when the liability is incurred. The liability has been
adjusted to $147,000. The corresponding liability is included in accrued expenses and other
liabilities of discontinued operations and totals $147,000 and $137,000 as of June 30, 2008 and
December 31, 2007, respectively. The severance payments cover seven employees associated with the
production of Estrasorb, who must continue to be employed until their employment is involuntarily
terminated by the Company in order to receive the severance.
4. Operating Leases
Novavax leases manufacturing, laboratory and office space and machinery and equipment under
non-cancelable operating lease agreements expiring at various dates through January 2007 and is
subleasing one facility through September 2009. Several of these leases contain renewal options at
the Companys option and standard annual escalation rental rates. Future minimum rental
commitments under non-cancelable leases as of June 30, 2008 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
|
|
|
|
|
|
|
Net Operating
|
|
Year
|
|
Leases
|
|
|
Sub-Leases
|
|
|
Leases
|
|
2008
|
|
$
|
1,286
|
|
|
$
|
(254
|
)
|
|
$
|
1,032
|
|
2009
|
|
|
2,443
|
|
|
|
(363
|
)
|
|
|
2,080
|
|
2010
|
|
|
2,268
|
|
|
|
|
|
|
|
2,268
|
|
2011
|
|
|
2,268
|
|
|
|
|
|
|
|
2,268
|
|
2012
|
|
|
2,313
|
|
|
|
|
|
|
|
2,313
|
|
Thereafter
|
|
|
8,872
|
|
|
|
|
|
|
|
8,872
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments
|
|
$
|
19,450
|
|
|
$
|
(617
|
)
|
|
$
|
18,833
|
|
|
|
|
|
|
|
|
|
|
|
28
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Operating Leases (continued)
On June 26, 2008, the Company amended the lease for its corporate headquarters
at 9920 Belward Campus Drive in Rockville, Maryland. The amendment (1) extends the terms of the
lease to January 31, 2017, (2) provides that the landlord will reimburse Novavax for up to $3.0
million in leasehold improvements (the Allowance) and (3) increases the monthly installments of
base rent going forward by an amount equal to the monthly amortization of the Allowance over the
remaining term of the lease at 11% interest, or an additional $45,132 per month. The additional
monthly rent is subject to the annual 2.125% escalation included in the original lease. On June
27, 2008, the Company received $3.0 million from the landlord as reimbursement for leasehold
improvements. The amount is included in deferred rent on the consolidated balance sheet at June 30, 2008 and
will be amortized as a credit to rent expense over the remaining lease term.
5. Subsequent Events
On July 31, 2008, the Company completed a registered direct offering of 6,686,650 units (the
Units), with each unit consisting of one share of common stock and a warrant to purchase 0.5
shares of common stock at a price of $2.68 per unit (or $2.8425 per unit for units sold to
affiliates of the Company). The warrants represent the right to acquire an aggregate of 3,343,325
shares of common stock at an exercise price of $3.62 per share and have a five year term. The net
proceeds were approximately $17.6 million. The purchasers in the offering were comprised of
current and new institutional shareholders and affiliates of the Company. The securities described
above were offered by the Company pursuant to a registration statement previously filed and
declared effective by the Securities and Exchange Commission.
29
|
|
|
Item 2.
|
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
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 future product development and related clinical trials, and future research and
development, including Food and Drug Administration approval.
Such factors include, among other things, the following: results of clinical studies;
progress of research and development activities; ability to obtain adequate financing in the future
through product licensing, co-development or co-promotional arrangements, public or private equity
or debt financing or otherwise; competition; ability to enter into future collaborations with
industry partners or governmental agencies; unexpected changes in technologies and technological
advances by us or others; ability to obtain rights to technology; ability to obtain and enforce
patents; ability to commercialize and manufacture products; ability to develop commercial-scale
high yield manufacturing capabilities; business abilities and judgment of personnel; availability
of qualified personnel; changes in, or failure to comply with, governmental regulations; general
economic and business conditions and other factors referenced herein.
All forward-looking statements contained in this report 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, except as specifically required by law. Accordingly, past results and
trends should not be used to anticipate future results or trends.
Overview
Novavax, Inc., a Delaware corporation (Novavax or the Company), was incorporated in 1987,
and is a clinical-stage biotechnology company creating novel vaccines to address a broad range of
infectious diseases worldwide using advanced, proprietary virus-like-particle (VLP) technology.
The Company produces these VLP based, potent, recombinant vaccines utilizing new and efficient
manufacturing approaches. VLPs are genetically engineered three-dimensional nanostructures, which
incorporate immunologically important, lipids and recombinant proteins. Our VLPs resemble the
virus but lack the genetic material to replicate the virus. Our proprietary production technology
uses insect cells rather then chicken eggs or mammalian cells. The Companys current product
targets include vaccines against the H5N1, H9N2 and other subtypes of avian influenza with pandemic
potential, human seasonal influenza, Varicella Zoster, which causes shingles, and a fourth
undisclosed disease target.
On July 31, 2007, the Company began Phase I clinical trials for its H5N1 pandemic influenza
vaccine. In December 2007, the Company announced favorable interim results for its pandemic
influenza vaccine that demonstrated immunogenicity and safety. The Company began subject
enrollment for the Phase I/IIa trial in March 2008 to gather additional patient immunogenicity and
safety data, as well as determining a final dose through completion of this clinical trial. It is
anticipated that initial immunogenicity and safety data will be available in the third quarter of
2008 with study completion by the end of 2008 to include ongoing safety data collection.
30
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Overview (continued)
Our vaccine products currently under development or in clinical trials will require
significant additional research and development efforts, including extensive pre-clinical and
clinical testing and regulatory approval, prior to commercial use. There can be no assurance that
our research and development efforts will be successful or that any potential products will prove
to be safe and effective in clinical trials. Even if developed, these vaccine products may not
receive regulatory approval or be successfully introduced and marketed at prices that would permit
us to operate profitably. The commercial launch of any vaccine product is subject to certain risks
including but not limited to, manufacturing scale-up and market acceptance. No assurance can be
given that we can generate sufficient product revenue to become profitable or generate positive
cash flow from operations at all or on a sustained basis. Our efforts to divest the MNP technology
may not be successful because we may not be able to identify a potential licensee or buyer and,
even if we do identify a licensee or buyer, the price and terms may not be acceptable to us.
We also have a drug delivery platform based on its micellar nanoparticle (MNP)
technology, proprietary oil and water nano emulsions used for the topical delivery of drug. The
MNP technology was the basis for the development of the Companys first Food and Drug
Administration (FDA) approval estrogen replacement product known as Estrasorb. In October 2007,
Allergan, Inc. (Allergan) purchased Esprit Pharma, Inc. (Esprit) and subsequently entered into
an agreement with Novavax, which among other things, terminated the license and supply agreements
for Estrasorb. In February 2008, we sold our assets related to Estrasorb in the United States,
Canada and Mexico to Graceway Pharmaceuticals, LLC (Graceway). In connection with the sale of
Estrasorb assets to Graceway, Novavax terminated the Estrasorb license agreement with Allergan.
The Company is seeking to divest its remaining non-vaccine MNP technology through sales and licenses.
Significant Transactions in 2008 and 2007
Registered Direct Offering
On July 31, 2008, we completed a registered direct offering of 6,686,650 units (the Units),
with each unit consisting of one share of common stock and a warrant to purchase 0.5 shares of
common stock at a price of $2.68 per unit (or $2.8425 per unit for units sold to affiliates of the
Company). The warrants represent the right to acquire 3,343,325 shares of common stock at an
exercise price of $3.62 per share and have a five year term. The net proceeds were approximately
$17.6 million. The purchasers in the offering were comprised of current and new institutional
shareholders and affiliates of the Company. The securities described above were offered by the
Company pursuant to a registration statement previously filed and declared effective by the
Securities and Exchange Commission (the SEC).
31
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Significant Transactions (continued)
Belward Lease Amendment
On June 26, 2008, we amended the lease for our corporate headquarters at 9920 Belward Campus
Drive in Rockville, Maryland. The amendment (1) extends the terms of the lease to January 31,
2017, (2) provides that the landlord will reimburse Novavax for up to $3.0 million in leasehold
improvements (the Allowance) and (3) increases the monthly installments of base rent going
forward by an amount equal to the monthly amortization of the Allowance over the remaining term of
the lease at 11% interest, or an additional $45,132 per month. The additional monthly rent is
subject to the annual 2.125% escalation included in the original lease. On June 27, 2008, we
received $3.0 million from the landlord as reimbursement for leasehold improvements. The amount is
included in deferred rent on the balance sheet at June 30, 2008 and will be amortized as a credit
to rent expense over the remaining lease term.
Graceway Agreements
In February 2008, we entered into an asset purchase agreement with Graceway Pharmaceuticals,
LLC (Graceway), pursuant to which Novavax sold Graceway its assets related to Estrasorb in the
United States, Canada and Mexico. The assets sold include certain patents related to the MNP
technology, trademarks, know-how, manufacturing equipment, customer and supplier relations,
goodwill and other assets. We retained the rights to commercialize Estrasorb outside of the United
States, Canada and Mexico.
In February 2008, Novavax and Graceway also entered into a supply agreement, pursuant to which
Novavax manufactured additional units of Estrasorb with final delivery completed in July 2008.
Graceway is paying a preset transfer price per unit of Estrasorb for the supply of this product.
Because Novavax has delivered the required quantity of Estrasorb, Novavax must clean the
manufacturing equipment and prepare the equipment for transport. Graceway will remove the
equipment from the manufacturing facility and Novavax will then exit the facility by mid- August
2008. During the three and six months ended June 30, 2008, we received payment for the manufacture
and delivery of additional units of Estrasorb delivered during the quarter.
In February 2008, Novavax and Graceway also entered into a license agreement, pursuant to
which Graceway granted Novavax an exclusive, non-transferable (except for certain allowed
assignments and sublicenses), royalty-free, limited license to the patents and know-how that
Novavax sold to Graceway pursuant to the asset purchase agreement. The license allows Novavax to
make, use and sell licensed products and services in certain, limited fields.
The net cash impact from these transactions are expected to be in excess of $2.5 million. The
license and supply agreements with Allergan, Inc., successor-in-interest to Esprit Pharma, Inc.,
were terminated in February 2008 and October 2007, respectively.
32
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
License and Supply Agreements with Allergan
In October 2007, Allergan purchased Esprit and subsequently entered into an agreement with
Novavax, which among other things, terminated the license and supply agreement for testosterone and
the supply agreement for Estrasorb. In February 2008, in connection with the sale of Estrasorb
assets to Graceway, Novavax terminated the Estrasorb license agreement with Allergan.
License Agreement with Wyeth Holdings Corporation
On July 5, 2007, we entered into a License Agreement with Wyeth Holdings Corporation, a
subsidiary of Wyeth (Wyeth). The license is a non-exclusive, worldwide license to a family of
patent applications covering VLP technology for use in human vaccines in certain fields of use.
The agreement provides for an upfront payment, annual license fees, milestone payments and
royalties on any product sales. Payments under the agreement to Wyeth could aggregate up to $3.3
million in 2008, depending on the achievement of clinical development milestones. The agreement
will remain effective as long as at least one claim of the licensed patent rights cover the
manufacture, sale or use of any product unless terminated sooner at Novavaxs option or by Wyeth
for an uncured breach by Novavax.
License Agreement with University of Massachusetts Medical School
Effective February 26, 2007, we entered into a worldwide agreement to exclusively license a
VLP technology from the University of Massachusetts Medical School (UMMS). Under the agreement,
we have the right to use this technology to develop VLP vaccines for the prevention of any viral
disease in humans. We made an upfront cash payment to UMMS during the six months ended June 30, 2007. In addition, we will make certain
payments based on development milestones as well as future royalties on any sales of products that
may be developed using this technology.
Sublease Agreement with PuriCore, Inc.
In April 2006, we entered into a sublease agreement with Sterilox Technologies, Inc. (now know
as PuriCore, Inc.) to sublease 20,469 square feet of the Companys Malvern, Pennsylvania corporate
headquarters at a premium price per square foot. The sublease, with a commencement date of July 1,
2006, expires on September 30, 2009. The sublease is consistent with our strategic focus to
increase our presence in Rockville, Maryland, where our vaccine operations are currently located.
In line with that strategy, in October 2006, we entered into a lease for an additional 51,000
square feet in Rockville, Maryland. Accordingly, in October 2006, we entered into an amendment to
the Sublease Agreement with PuriCore, Inc. to sublease an additional 7,500 square feet of the
Malvern corporate headquarters at a premium price per square foot. This amendment has a
commencement date of October 25, 2006 and expires on September
30, 2009.
33
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Convertible Notes
On June 15, 2007, we entered into amendment agreements (the Amendments) with each of the
holders of the outstanding 4.75% senior convertible notes (the Notes) to amend the terms
of the Notes. As of June 30, 2008, $22.0 million aggregate principal amount remained outstanding
under the Notes. The Amendments (i) lowered the conversion price from $5.46 to $4.00 per share,
(ii) eliminated the holders right to require the Company to redeem the Notes if the weighted
average price of the Companys common stock is less than the conversion price on 30 of the 40
consecutive trading days preceding July 19, 2007 or July 19, 2008 and (iii) mandated that the Notes
be converted into Company common stock if the weighted average price of the Companys common stock
is greater then $7.00 (a decrease from $9.56) in any 15 out of 30 consecutive trading days after
July 19, 2007.
We determined the change in the value of the conversion option and have reduced the
convertible debt amount by $852,000 and re-classified this amount to additional paid-in capital on
June 30, 2007. The difference in the option value of $852,000 is being accreted over the remaining
term (through July 19, 2009) of the convertible notes as interest expense.
Notes with Former Directors
In March 2002, pursuant to the Novavax, Inc. 1995 Stock Option Plan, we approved the payment
of the exercise price of options by two of directors through the delivery of full-recourse,
interest-bearing promissory notes in the aggregate amount of $1,480,000. The notes were secured by
an aggregate of 261,667 shares of our common stock.
In May 2006, one of these directors resigned from the Companys board of directors. Following
his resignation, we approved an extension of the former
directors $448,000 note to be payable on December 31, 2007, or earlier to the extent of the net proceeds from any sale of the
pledged shares. We entered into negotiations with the former director to extend the loan in
January 2008. On May 7, 2008 the Company and the former director entered into an Amended and
Restated Promissory Note and an Amended and Restated Pledge Agreement (the Amendment).
The Amendment extends the maturity date of the note to June 30, 2009, permits the Company to
sell the pledged shares if the market price of the common stock as reported on NASDAQ Global Market
exceeds certain targets, increases the interest rate to 8.0% and stipulates quarterly payments
beginning June 30, 2008. The Company received the payment due of $50,000 on July 3, 2008.
As of June 30, 2008, the note and corresponding accrued interest totaling
$601,876 are included in other current assets in the accompanying consolidated balance sheet.
In March 2007, the other director resigned. Following his resignation, we approved an
extension of the former directors $1,031,668 note. The note continues to accrue interest at 5.07%
per annum and is secured by shares of common stock owned by the former director and is
34
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Notes with Former Directors (continued)
payable on June 30, 2009, or earlier to the extent of the net proceeds from any sale of the pledged
shares. In addition, the Company has the option to sell the pledged shares on behalf of the former
director at any time that the market price of our common stock, as reported on NASDAQ Global
Market, exceeds $7.00 per share. As of June 30, 2008, the note and corresponding accrued interest
totaling $1,360,317 are included in other current assets in the accompanying consolidated balance
sheet.
As of June 30, 2008, we have reserved an amount of $1,310,642 for the outstanding notes
receivable. This amount has been netted against the pledged common stock. Due to heightened
sensitivity in the current environment surrounding related-party transactions and the extensions of
the maturity dates, these transactions could be viewed negatively in the market and our stock price
could be negatively affected.
Critical Accounting Policies and Changes to Accounting Policies
We prepare our consolidated financial statements in conformity with accounting principles
generally accepted in the United States. Such accounting principles require that our management
make estimates and assumptions that affect the reported amount of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. We base our estimates on
historical and anticipated results and trends and on various other assumptions that we believe are
reasonable under the circumstances, including assumptions as to future events. These estimates form
the basis for making judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. By their nature, estimates are subject to an inherent degree
of uncertainty. Actual results could differ materially from these estimates.
The accounting policies that we use affect our consolidated financial statements. Certain of
our accounting policies are critical to an understanding of our results of operations and financial
condition, and in some cases, the application of these policies can be significantly affected by
the estimates, judgments and assumptions made by management during the preparation of our
consolidated financial statements. See Note 2 to our consolidated financial statements for further
discussion of our accounting policies. The items in our consolidated financial statements that
have required us to make significant estimates and judgments are as follows:
Revenue Recognition
We recognize revenue in accordance with the provisions of Staff Accounting Bulletin No. 104,
Revenue Recognition
(SAB No. 104). For product sales, revenue is recognized when all of the
following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred,
the price is fixed and determinable and collectability is reasonably assured. We establish
allowances for estimated uncollectible amounts, product returns, rebates and charge backs based on
historical trends and specifically identified problem accounts.
35
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Revenue Recognition (continued)
For upfront payments and licensing fees related to contract research or technology, we follow
the provisions of SAB No. 104 in determining if these payments and fees represent the culmination
of a separate earnings process or if they should be deferred and recognized as revenue as earned
over the life of the related agreement. Revenue earned under research contracts is recognized in
accordance with the terms and conditions of such contracts for reimbursement of costs incurred and
defined milestones.
We have determined that the Graceway agreements should be accounted for as a single
arrangement with multiple elements as defined in EITF 00-21,
Revenue Arrangements with Multiple
Deliverables
(EITF 00-21). Under EITF 00-21, in an arrangement with multiple deliverables, the
delivered item(s) should be considered a separate unit of accounting if it has
stand-alone value and the fair value of the undelivered performance obligations can be determined.
We have evaluated the deliverables related to the Graceway agreements under the criteria of EITF
00-21 and have concluded that the deliverables should not be treated as separate units of
accounting as there is no objective and reliable evidence of the fair value of the undelivered
items. Accordingly, all revenue associated with the deliverables, under both the supply and asset
purchase agreement, is being deferred and will be recognized upon the completion of all
obligations. The revenue recognition rules for multi-elements arrangements are complex and require
us to exercise judgment and make assumptions. If we were to change any of these assumptions or
judgments, it could result in a change in the amount of revenue we report in a particular period.
SFAS No. 123R
We account for our stock options in accordance with Statement of Financial Accounting Standard
No. 123 (revised),
Accounting for Stock-Based Compensation
(SFAS No. 123R). This standard
requires us to measure the cost of employee services received in exchange for equity share options
granted based on the grant-date fair value of the options. The cost is recognized as compensation
expense over the vesting period of the options. The Black-Scholes option pricing model requires
the input of the fair value of the Companys stock at the date of grant of the stock options as
well as the input of several subjective assumptions including: the expected life of the option,
the risk-free interest rate, the expected volatility at the time of the options are granted, and
the expected forfeiture rate at the time the options were granted. Changes in the inputs and
assumptions can materially affect the measure of the estimated fair value of employee stock
options. Also, the accounting estimate of stock-based compensation expense is reasonably likely to
change from period to period as further stock options are granted and adjustments are made for
stock option forfeitures and cancellations.
36
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Income Taxes
Our income taxes are accounted for using the liability method. Under the liability method,
deferred income taxes are recognized for the future tax consequences attributable to differences
between the consolidated financial statement carrying amounts of existing assets and liabilities
and their respective tax basis and operating loss carry forward. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable income in the year in
which those temporary differences are expected to be recovered or settled.
The effect of changes in tax rates on deferred tax assets and liabilities is recognized in
operations in the period that includes the enactment date. A valuation allowance is established
when necessary to reduce net deferred tax assets to the amount expected to be realized.
We make assumptions, judgments and estimates to determine our income tax expense (benefit),
deferred tax assets and liabilities and any valuation allowance to be recorded against a deferred
tax asset. Our assumptions, judgments and estimates take into account current tax laws, our
interpretation of current tax laws and possible outcomes of current and future audits conducted by
foreign and domestic tax authorities. Changes in tax law or our interpretation of tax law and the
resolution for current and future tax audits could significantly impact the amounts provided for
income taxes in our consolidated financial statements. Our assumptions, judgments and estimates
also take into account estimates of the amount of future taxable income, and actual operating
results in future years could render our current assumptions, judgments and estimates inaccurate.
Any of the assumptions, judgments and estimates mentioned above could cause our actual income tax
expense (benefit) to differ from our estimates.
Goodwill
Goodwill originally results from business acquisitions. Assets acquired and liabilities
assumed are recorded at their fair values; the excess of the purchase price over the identifiable
net assets acquired is recorded as goodwill. In accordance with SFAS No. 142,
Goodwill and Other
Intangible Assets
(SFAS No. 142) goodwill and intangible assets deemed to have indefinite lives
are not amortized but are subject to impairment tests annually, or more frequently should
indicators of impairment arise. We utilize a discounted cash flow analysis that includes
profitability information, estimated future operating results, trends and other information in
assessing whether the value of the indefinite-lived intangible assets can be recovered. Under SFAS
No. 142, goodwill impairment is deemed to exist if the carrying value of a reporting unit exceeds
its estimated fair value. The assumptions and forecasts used to estimate cash flows and extremely
subjective and require a high degree of judgment. While the Company uses available information to
prepare the estimates utilized in the discounted cash flow analysis, actual results in the future
could differ significantly. Impairment tests in future periods may result in impairment changes
which could materially impact our future results of operations.
37
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Disposal of Long-Lived Assets/Discontinued Operations
We account for the impairment of long-lived assets and long-lived assets to be disposed of in
accordance with Statement of Financial Accounting Standard No. 144,
Accounting for the Impairment
or Disposal
(SFAS No. 144). SFAS No. 144 requires a periodic evaluation of the recoverability of
the carrying value of long-lived assets and identifiable intangibles and whenever events or changes
in circumstances indicate that the carrying value of the asset may not be recoverable. Examples of
events or changes in circumstances that indicate that the recoverability of the carrying value of
an asset should be assessed include, but are not limited to, the following: a significant decrease
in the market value of an asset, a significant change in the extent or manner in which an asset is
used, a significant physical change in an asset, a significant adverse change in legal factors or
in the business climate that could affect the value of an asset, an accumulation of costs
significantly in excess of the amount originally expected to acquire or construct an asset, a
current period operating or cash flow loss combined with a history of operating or cash flow
losses, and/or a projection or forecast that demonstrates continuing losses associated with an
asset used for the purpose of producing revenue. We consider historical performance and
anticipated future results in its evaluation of potential impairment. Accordingly, when indicators
of impairment are present, we evaluate the carrying value of these assets in relation to the
operating performance of the business and future undiscounted cash flows expected to result from
the use of these assets. Impairment losses are recognized when the sum of expected future cash
flows is less than the assets carrying value.
Recent Accounting Pronouncements
Other than the adoption of
Statement of Financial Accounting Standards No. 157, Fair Value
Measurements,
there have been no material changes in our critical accounting policies or critical
accounting estimates since December 31, 2007, nor have we adopted any accounting policy that has or
will have a material impact on our consolidated financial statements. For further discussion of
our accounting policies see Note 2
Summary of Significant Accounting Policies
, in the Notes to be
Consolidated Financial Statements included in this Quarterly Report on Form 10-Q and Note 2 in the
Notes to the Consolidated Financial Statements for our Annual Report on Form 10-K for the fiscal
year ended December 31, 2007.
SFAS No. 157
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. 157,
Fair Value Measurements
(SFAS No. 157). SFAS No. 157
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles and expands disclosures about fair value measurements. SFAS No. 157 applies
under other accounting pronouncements that require or permit fair value measurements, but does not
require any new fair value measurements. In February 2008, the FASB issued Staff Position 157-2,
Effective Date of FASB Statement No. 157
(FSP 157-2) that defers the effective date of SFAS No.
157 for one year for nonfinancial assets and liabilities
38
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
SFAS No. 157 (continued)
recorded at fair value on a non-recurring basis. SFAS No. 157 is effective for financial statement
issued for fiscal years beginning after November 15, 2007, and interim periods within those fiscal
years. The adoption of SFAS No. 157 for financial assets and liabilities did not have a material
impact on our financial condition, results or operations or liquidity.
On January 1, 2008, we adopted SFAS No. 157, which clarifies the definition of fair value,
establishes a framework for measuring fair value, and expends the disclosures on fair value
measurements. In February 2008, the FASB issued FSP 157-2 that deferred the effective date of SFAS
No. 157 for one year for nonfinancial assets and liabilities recorded at fair value on a non-recurring basis. SFAS No. 157 defines fair value as the exchange price that would be received for
an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the
measurement date. SFAS No. 157 also establishes a fair value hierarchy which, as outlined below,
requires an entity to maximize the use of observable inputs and minimize the use of unobservable
inputs when measuring fair value.
Level 1
Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets
include corporate bonds.
Level 2
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or
liabilities, or other inputs that are observable or can be corroborated by observable market data
for substantially the full term of the assets or liabilities. Our level 2 assets and liabilities
primarily include assets held for sale.
Level 3
Unobservable inputs that are supported by little or no market activity and that are
financial instruments whose value is determined using pricing models, discounted cash flow
methodologies, or similar techniques, as well as instruments for which the determination of fair
value requires significant judgment or estimation. Our Level 3 assets are comprised of goodwill
and auction rate securities.
If the inputs used to measure the financial assets and liabilities fall within the different
levels described above, the categorization is based on the lowest level input that is significant
to the fair value measurements of the instrument.
39
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Financial assets and liabilities measured at fair market value on a recurring basis as of June
30, 2008 are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at
|
|
|
|
June 30, 2008 using
|
|
|
|
(in thousands)
|
|
|
|
Quoted Prices in
|
|
|
Significant other
|
|
|
Significant
|
|
|
|
|
|
|
Active Markets for
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
|
|
|
Identical Assets
|
|
|
Inputs
|
|
|
Inputs
|
|
|
Assets
|
|
Assets
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
At Fair Value
|
|
Auction rate securities
|
|
$
|
|
|
|
$
|
|
|
|
$
|
8,875
|
|
|
$
|
8,875
|
|
Corporate Bonds
|
|
|
3,497
|
|
|
|
|
|
|
|
|
|
|
|
3,497
|
|
Asset held for sale
|
|
|
|
|
|
|
899
|
|
|
|
|
|
|
|
899
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
33,141
|
|
|
|
33,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
3,497
|
|
|
$
|
899
|
|
|
$
|
42,016
|
|
|
$
|
46,412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Results of Operations
The following is a discussion of the historical consolidated financial condition and results
of operations of Novavax, Inc. and its wholly owned subsidiary and should be read in conjunction
with the consolidated financial statements and notes thereto set forth in this Quarterly Report on
Form 10-Q. Additional information concerning factors that could cause actual results to differ
materially from those in the Companys forward-looking statements is contained from time to time in
the Companys SEC filings, including but not limited to the Companys Annual Report on Form 10-K
for the fiscal year ended December 31, 2007.
Three months ended June 30, 2008 (2008) compared to the three months ended June 30, 2007
(2007): (In thousands, except share amounts)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
$
|
|
|
|
$
|
(327
|
)
|
|
$
|
327
|
|
|
|
100
|
%
|
Contract research and development
|
|
|
325
|
|
|
|
68
|
|
|
|
257
|
|
|
|
378
|
%
|
Royalties, milestone and
licensing fees
|
|
|
17
|
|
|
|
43
|
|
|
|
(26
|
)
|
|
|
60
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
342
|
|
|
$
|
(216
|
)
|
|
$
|
558
|
|
|
|
258
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for the three months ended June 30, 2008 were $342,000 as compared to a credit of
$216,000 for the three months ended June 30, 2007, a positive change of $558,000. The change in
revenues during the second quarter of 2008 as compared to the second quarter of 2007 was
principally due to lower product sales resulting from the discontinuation of sales from Gynodiol
and an increase in contract research and development revenues. We announced our decision to
discontinue the sale of Gynodiol in June 2007. Accordingly, during the three months ended June
40
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Revenues (continued)
30, 2007 we recorded additional allowances for sales returns of $200,000 related to the
discontinuation. Contract research and development revenue is compromised of revenue from
government and commercial contracts and, for the three months ended June 30, 2008, is comprised of
revenue from two National Institutes of Health (NIH) grants. Contract research revenues were
$325,000 for the second quarter of 2008 as compared to $68,000 in the comparable 2007 period. The
increase in contract research revenues for the comparable quarters was primarily due to the
completion of two milestones for one government contract.
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
$
|
|
|
|
$
|
101
|
|
|
$
|
(101
|
)
|
|
|
(100
|
)%
|
Research and development
|
|
|
5,380
|
|
|
|
3,992
|
|
|
|
1,388
|
|
|
|
35
|
%
|
Selling, general and administrative
|
|
|
3,166
|
|
|
|
3,362
|
|
|
|
(196
|
)
|
|
|
(6
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
8,546
|
|
|
$
|
7,455
|
|
|
$
|
1,091
|
|
|
|
15
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Products Sold
Cost of products sold, was $101,000 for the three months ended June 30, 2007 which represents
the cost of products sold for Gynodiol. In June 2007, we decided to discontinue the sale of
Gynodiol. In connection with our decision, we recorded an inventory reserve totaling $52,000
during the three months ended June 30, 2007.
Research and Development Expenses
Research and development costs increased from $4.0 million for the three months ended June 30,
2007 to $5.4 million for the three months ended June 30, 2008, an increase of $1.4 million, or 35%.
This increase was due primarily to higher research and development spending to support our
strategic focus on creating differentiated, value-added vaccines that leverage our proprietary VLP
technology. Research and development expenses were significantly higher in 2008 due to increases
in personnel, facility and outside-testing costs (including sponsored research and consulting
agreements) associated with expanded preclinical testing and process development, manufacturing and
quality-related programs necessary to move our influenza vaccine candidates into clinical
testing.
General and Administrative Expenses
General and administrative costs were $3.2 million for the three months ended June 30, 2008
compared to $3.4 million for the three months ended June 30, 2007. The decrease of $0.2
million was primarily due to decreased accounting costs of $0.2 million primarily related to the
adoption of FIN 48 during the three months ended June 30, 2008 and a $0.2 million decrease in
41
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
General and Administrative Expenses (Continued)
facility costs allocated to general and administrative expenses as we have continued to consolidate
research and development into our Rockville, Maryland facility. These decreases were partially
offset by a $0.1 million increase in the reserve for two former board of directors notes
receivable and a $0.1 million increase in employee related costs.
Interest Income (expense), net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
$
|
323
|
|
|
$
|
870
|
|
|
$
|
(547
|
)
|
|
|
(63
|
)%
|
Interest expense
|
|
|
(433
|
)
|
|
|
(339
|
)
|
|
|
(94
|
)
|
|
|
(28
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense)
|
|
$
|
(110
|
)
|
|
$
|
531
|
|
|
$
|
(641
|
)
|
|
|
(121
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded net interest expense of $0.1 million for the three months ended June 30, 2008
compared to net interest income of $0.5 million for the three months ended June 30, 2007. The
interest income decrease from $0.9 million in 2007 to $0.3 million in 2008 was entirely due to the
decrease in our cash, cash equivalents, and short-term investment balances from June 30, 2007 to
June 30, 2008, primarily due to increased spending levels related to our vaccine drug development
programs. Interest expense for the three months ended June 30, 2008 increased to $0.4 million from
$0.3 million for the three months ended June 30, 2007, an increase of $0.1 million or 28%. The
increase in interest expense is due to the amortization of debt discount of $0.1 million, which is
included in interest expense for the three months ended June 30, 2008 related to the amendments of
the convertible notes in June 2007. In connection with these amendments, in June 2007 we recorded
a debt discount of $852,000 and increased additional paid-in capital accordingly. The debt
discount is being amortized over the remaining term of the convertible notes. We did not record
any amortization of the debt discount for the three months ended June 30, 2007.
Discontinued Operations
:
In October 2007, we entered into agreements to terminate our supply agreements with Allergan,
successor-in-interest to Esprit. In connection with the termination, we decided to wind down
operations at our leased manufacturing facility in Philadelphia, Pennsylvania. The results of
operations for the manufacturing facility are being reported as discontinued operations. As
discussed above, in February 2008, we entered into a series of agreements with Graceway, pursuant
to which we sold assets related to Estrasorb, agreed to manufacture additional units of Estrasorb
with a preset transfer price per unit, and entered into a license agreement which granted Novavax
an exclusive, non-transferable, royalty-free, limited license to the patents and know-how that
Novavax sold to Graceway pursuant to the asset purchase agreement. We have
completed the manufacture of the additional quantities of Estrasorb and expect to complete the
production and close the manufacturing facility by mid-August 2008.
42
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Discontinued Operations (continued)
The following table presents summarized financial information for our discontinued operations
for the three months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q2
|
|
|
Q2
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
143
|
|
|
$
|
374
|
|
|
$
|
(231
|
)
|
|
|
(62
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of products sold
|
|
|
736
|
|
|
|
754
|
|
|
|
(18
|
)
|
|
|
(2
|
)%
|
Excess inventory costs over market
|
|
|
465
|
|
|
|
473
|
|
|
|
(8
|
)
|
|
|
(2
|
)%
|
Research and development
|
|
|
|
|
|
|
201
|
|
|
|
(201
|
)
|
|
|
(100
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
1,201
|
|
|
|
1,428
|
|
|
|
(227
|
)
|
|
|
(16
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,058
|
)
|
|
$
|
(1,054
|
)
|
|
$
|
(4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded a loss from discontinued operations of $1.1 million for the three months ended
June 30, 2008 and June 30, 2007. The loss remained relatively constant as revenues and operating
expenses both decreased by approximately the same amount. Revenue from discontinued operations
decreased to $0.1 million for 2008 from $0.4 million for 2007, a decrease of $0.3 million or 62%
due to lower Estrasorb shipments.
Costs of products sold for the three months ended June 30, 2008, which included fixed idle
capacity costs, decreased from $0.8 million in 2007 to $0.7 million in 2008, a decrease of $0.1
million, or 2%. Of the $0.7 million cost of products sold in 2008, $0.2 million represented idle
plant capacity costs at our manufacturing facility. The remaining $0.5 million represented the
cost of Estrasorb sales to Graceway. Of the $0.8 million cost of products sold in 2007, $0.6
million represents idle plant capacity costs and the balance of $0.2 million represents the costs
of Estrasorb sales to Allergan. In accordance with the Supply Agreement with Allergan, which
terminated in February 2008, and with the supply agreement with Graceway, during the three months
ended June 30, 2008 and 2007, we were required to sell Estrasorb at a price that is lower than our
manufacturing costs. These excess costs over the product cost totaled $0.5 million for the three
months ended June 30, 2008 and 2007.
Research and development costs from discontinued operations were $0.2 million for the three
months ended June 2007. There were no research and development costs from discontinued operations
for the three months ended June 30, 2008.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
%Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(9,372
|
)
|
|
$
|
(8,194
|
)
|
|
$
|
(1,178
|
)
|
|
|
(14
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.15
|
)
|
|
$
|
(0.13
|
)
|
|
$
|
(0.02
|
)
|
|
|
(15
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding
|
|
|
61,329,699
|
|
|
|
61,311,954
|
|
|
|
17,745
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Net loss (continued)
Net loss for the three months ended June 30, 2008 was $9.4 million or $0.15 per share, as
compared to $8.2 million or $0.13 per share for the three months ended June 30, 2007, an increase
of $1.2 million or $0.02 per share. The increased loss was primarily due to an increase in
operating expenses of $1.1 million, and a $0.6 million decrease in net interest income, partially
offset by an increase in revenues of $0.6 million, all previously discussed. The weighted shares
outstanding increased from 61,311,954 in 2007 to 61,329,699 in 2008 due to the exercise of stock
options and the vesting of restricted stock.
Six months ended June 30, 2008 (2008) compared to the six months ended June 30, 2007
(2007): (In thousands, except share amounts)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
$
|
|
|
|
$
|
(123
|
)
|
|
$
|
123
|
|
|
|
100
|
%
|
Contract research and development
|
|
|
783
|
|
|
|
309
|
|
|
|
474
|
|
|
|
153
|
%
|
Royalties, milestone and licensing fees
|
|
|
17
|
|
|
|
59
|
|
|
|
(42
|
)
|
|
|
(71
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
800
|
|
|
$
|
245
|
|
|
$
|
555
|
|
|
$
|
227
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues for the six months ended June 30, 2008 were $0.8 million, an increase in
revenues of $0.6 million from revenues of $0.2 million for the six months ended June 30, 2007. The
increase in revenues for the period in 2008 as compared to 2007 was principally due to lower
product sales resulting from the discontinuation of sales from Gynodiol. The increase in contract
research revenues of $0.5 million was principally due to a delay on the renewal of contracts in
2007. We announced our decision to discontinue the sale of Gynodiol in June. Accordingly, we
recorded additional allowances for sales returns of $0.2 million. Contract research and development
revenue is comprised of revenue from government and commercial contracts and, for the six months
ended June 30, 2008, is comprised of revenue from two National Institutes of Health (NIH) grants.
Contract research revenues were $783,000 for the six months ended June 30, 2008 as compared to
$309,000 in the comparable 2007 period. The increase in contract research revenues for the
comparable quarters was primarily due to the completion of two milestones for one government
contract.
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(
unaudited
)
|
|
|
(
unaudited
)
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
$
|
|
|
|
$
|
151
|
|
|
$
|
(151
|
)
|
|
|
(100
|
%)
|
Research and development
|
|
|
9,814
|
|
|
|
7,645
|
|
|
|
2,169
|
|
|
|
28
|
%
|
General and administrative
|
|
|
6,410
|
|
|
|
7,959
|
|
|
|
(1,549
|
)
|
|
|
(19
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
16,224
|
|
|
$
|
15,755
|
|
|
$
|
469
|
|
|
|
3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
44
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Cost of Products Sold
Cost of products sold was $151,000 for the six months ended June 30, 2007. In June 2007, we
decided to discontinue the sale of Gynodiol. In connection with our decision, we recorded an
inventory reserve totaling $52,000.
Research and Development Expenses
Research and development costs increased from $7.6 million in 2007 to $9.8 million in 2008, an
increase of $2.2 million, or 28%. This increase was primarily due to higher research and
development spending to support our strategic focus on creating differentiated, value-added
vaccines that leverage the Companys proprietary VLP technology. Research and development expenses
were significantly higher in 2008 due to increases in personnel, facility and outside-testing costs
(including sponsored research and consulting agreements) associated with expanded preclinical
testing and process development, manufacturing and quality-related programs necessary to move the
Companys influenza vaccine candidates into clinical testing.
General and Administrative Expenses
General and administrative costs were $6.4 million in 2008 compared to $8.0 million in 2007.
The decrease of $1.6 million or 19% was partially due, to a decrease in the reserves for two former
board of directors notes receivable of $0.7 million in 2008. This reserve represents the
difference between the book value of the notes receivables less the market value of the pledged
shares of common stock of the Company as of June 30, 2008. In addition, expenses decreased in 2008
as a result of decreased facility costs of approximately $0.4 million for the new facility in
Rockville, Maryland as we have continued our plan to consolidate all operations into our Belward
facility. Expenses for 2007 also included non-recurring costs for the adoption of FIN 48 of $0.2
million, and consulting fees related to studies of the vaccine market of $0.2 million.
Interest Income, (net):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
$
|
866
|
|
|
$
|
1,810
|
|
|
$
|
(944
|
)
|
|
|
(52
|
%)
|
Interest expense
|
|
|
(859
|
)
|
|
|
(675
|
)
|
|
|
(184
|
)
|
|
|
(27
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income
|
|
$
|
7
|
|
|
$
|
1,135
|
|
|
$
|
(1,128
|
)
|
|
|
(99
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income was $7,000 for 2008 compared to interest income of $1.1 million for 2007,
a decrease of $1.1 million or 99%. Interest income decreased from $1.8 million in 2007 to $0.9
million in 2008, primarily due to the decrease in our average cash, cash equivalents and
short-term investment balances from 2007 to 2008. Interest expense increased from $0.7 million in
2007 to $0.9 million in 2008, an increase of $0.2 million or 27%. The increase in interest expense
is due to the amortization of debt discount of $205,000 which is included in interest
45
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
expense for the six months ended June 30, 2008, related to the amendment of the convertible notes,
which occurred in June 2007. In connection with the amendment, in June 2007 we recorded a debt
discount of $852,000 and increased additional paid-in capital accordingly. The debt discount is
being amortized over the remaining term of the convertible notes.
Discontinued Operations
:
In October 2007, we entered into agreements to terminate our supply agreements with Allergan,
successor-in-interest to Esprit. In connection with the termination, we decided to wind down
operations at our leased manufacturing facility in Philadelphia, Pennsylvania. The results of
operations for the manufacturing facility are being reported as discontinued operations. As
discussed above, in February 2008, we entered into a series of agreements with Graceway, pursuant
to which we sold assets related to Estrasorb, agreed to manufacture additional units of Estrasorb
with a preset transfer price per unit, and entered into a license agreement which granted Novavax
an exclusive, non-transferable, royalty-free, limited license to the patents and know-how that
Novavax sold to Graceway pursuant to the asset purchase agreement. We have completed the
manufacture of the additional quantities of Estrasorb and expect to complete the production and
close the manufacturing facility by mid-August 2008.
The following table presents summarized financial information for our discontinued operations
for the six months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
% Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
229
|
|
|
$
|
581
|
|
|
$
|
(352
|
)
|
|
|
(61
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of products sold
|
|
|
1,474
|
|
|
|
2,021
|
|
|
|
(547
|
)
|
|
|
(27
|
%)
|
Excess inventory costs over market
|
|
|
465
|
|
|
|
560
|
|
|
|
(95
|
)
|
|
|
(17
|
)%
|
Research and development
|
|
|
|
|
|
|
207
|
|
|
|
(207
|
)
|
|
|
(100
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
1,939
|
|
|
|
2,788
|
|
|
|
(849
|
)
|
|
|
(30
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,710
|
)
|
|
$
|
(2,207
|
)
|
|
$
|
497
|
|
|
|
23
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded a loss from discontinued operations of $1.7 million for the six months ended June
30, 2008 compared to $2.2 million for the six months ended June 30, 2007, a decrease of $0.5
million or 23%. The decrease resulted from a decrease in revenues more than offset by a decrease
in operating expenses. Revenues from discontinued operations decreased to $0.2 million for 2008
from $0.6 million for 2007, a decrease of $0.4 million or 61%, due to lower Estrasorb shipments.
Revenues for the six months ended June 30, 2008 included a $0.1 million adjustment to the sales
return accrual related to Estrasorb.
Costs of products sold for the six months ended June 30, 2007, which included fixed idle
capacity costs, decreased from $2.0 million in 2007 to $1.5 million in 2008, a decrease of $0.5
million, or 27%. Of the $1.5 million cost of products sold in 2008, $0.8 million represented idle
plant capacity costs at our manufacturing facility. The remaining $0.7 million represented the
46
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Discontinued Operations
(continued)
cost of Estrasorb sales to Allergan. Of the $2.0 million cost of products sold in 2007, $1.4
million represents idle plant capacity costs and the balance of $0.6 million represent the costs of
Estrasorb sales to Allergan. In accordance with the supply agreement with Allergan, which
terminated in February 2008, and the supply agreement with Graceway, during the six months ended
June 30, 2008 and 2007, we were required to sell Estrasorb at a price that is lower than our
manufacturing costs. These excess costs over the product cost decreased from $0.6 million for the
six months ended June 30, 2007 to $0.5 million for the six months ended June 30, 2008, a decrease
of $0.1 million or 17%.
Research and development costs from discontinued operations were $0.2 million for the six
months ended June 30, 2007. There were no research and development costs from discontinued
operations for the six months ended June 30, 2008.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
$ Change
|
|
|
%Change
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(17,127
|
)
|
|
$
|
(16,582
|
)
|
|
$
|
(545
|
)
|
|
|
(3
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.28
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.01
|
)
|
|
|
(4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding
|
|
|
61,286,169
|
|
|
|
61,266,765
|
|
|
|
19,404
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the six months ended June 30, 2008 was $17.1 million or $0.27 per share, as
compared to $16.6 million or $0.27 per share for the six months ended June 30, 2007, an increase of
$0.5 million. The increased net loss was primarily due to an increase in operating expense of $0.5
million, and a decrease in net interest income of $1.1 million, partially offset by an increase in
revenues of $0.6 million and a decrease generated in the loss from discontinued operations of $0.5
million. The weighted shares outstanding increased from 61,266,765 in 2007 to 61,286,169 in 2008
due to the exercise of stock options and the vesting of restricted stock.
Liquidity and Capital Resources
Our future capital requirements depend on numerous factors including, but not limited to, the
commitments and progress of our 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 manufacturing costs related to the
additional lots of Estrasorb. We plan to continue to have multiple vaccines and products in
various stages of development and we believe our research and development as well as general and
administrative expenses and capital requirements will continue to exceed our revenues. Future
activities, particularly vaccine and product development, are subject to our ability to raise funds
through product licensing, co-development or co-promotional arrangements with industry partners and
government agencies or public or private debt or equity financing,
47
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Liquidity and Capital Resources (continued)
The Company continues to spend a significant amount of money on, and will need to raise
additional money to continue, its product development initiatives and clinical trials. Raising
capital is particularly difficult in this market and will be more difficult if product development
initiatives and clinical trials do not progress as anticipated.
For more discussion of the risks and uncertainties and our liquidity, see Item 1A Risk
Factors and see Liquidity and Capital Resources.
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30, 2008
|
|
|
|
(unaudited)
|
|
|
|
(In thousands)
|
|
Summary of Cash Flows:
|
|
|
|
|
Net cash (used in) provided by
|
|
|
|
|
Operating activities
|
|
$
|
(7,172
|
)
|
Investing activities
|
|
|
27,026
|
|
Financing activities
|
|
|
(691
|
)
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
19,163
|
|
Cash and cash equivalents at beginning of period
|
|
|
4,350
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
23,513
|
|
|
|
|
|
During the six months ended June 30, 2008, we have funded our operations from existing cash,
proceeds received from Graceway as part of the Estrasorb transaction consummated in February 2008
and the Allowance received from our landlord at our corporate headquarters in June 2008. In July
2008, we raised additional funds through a registered direct offering by issuing 6,686,650 units
(the Units), with each unit consisting of one share of common stock and a warrant to purchase 0.5
shares of common stock, for aggregate net proceeds of approximately $17.6 million.
As part of the Graceway transaction, we sold our rights related to Estrasorb in the United
States, Canada and Mexico to Graceway as well as certain manufacturing equipment for the production
of Estrasorb. The assets sold also included certain patents related to MNP technology, trademarks,
customer and supplier relations and goodwill. Novavax and Graceway also entered into a supply
agreement, pursuant to which Novavax has agreed to manufacture additional quantities of Estrasorb
with final delivery completed in July 2008. Graceway is paying a preset transfer price per unit of
Estrasorb for the supply of this product. The net cash impact from this transaction are estimated
to be in excess of $2.5 million. The license and supply agreements with Allergan,
Inc., successor-in-interest to Esprit Pharma, Inc., were terminated in February 2008 and October
2007, respectively.
As of June 30, 2008, we held $35.9 million in cash, cash equivalents and short-term
investments as compared to $46.5 million at December 31, 2007. The $10.6 million decrease in
48
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Liquidity and Capital Resources (continued)
cash, cash equivalents and short-term investments during 2008 was primarily due to the operating
loss from continuing operations of $15.4 million, principal payments on debt of $0.8 million,
capital expenditures for our Belward Good Manufacturing Practices (GMP) facility project,
partially offset by an upfront payment from Graceway as part of the sale of Estrasorb assets and
the Allowance received from our landlord related to the extension of our period at our corporate
headquarters. As of June 30, 2008, our working capital was $30.0 million compared to $42.8 million
as of December 31, 2007. This $12.8 million decrease primarily resulted from our net loss,
partially offset by an upfront payment received from Graceway as part of the Estrasorb
transaction in February 2008 and a $3.0 million leasehold improvement reimbursement received from our
landlord in June 2008. Additionally, our working capital was used for $4.3 million in capital
expenditures activities and $0.8 million in principal payments on our outstanding debt obligations
for the six months ended June 30, 2008.
We intend to use the proceeds from our equity financing transactions for pre-clinical and
clinical studies for our VLP-based vaccines, internal research and development programs, working
capital, capital expenditures and other general corporate purposes. In the first quarter of 2007,
we entered into sponsored research and licensing agreements with two academic institutions to
conduct early stage research in the vaccine area. These and similar arrangements that we may enter
into may aggregate to a material amount of research and development spending that will accelerate
the use of such proceeds. We will continue to fund our operations through product licensing,
co-development arrangements on new products, or the public or private sale of securities of the
Company or the issuance of additional debt. There can be no assurance that we will be able to
obtain additional capital or, if such capital is available, that the terms of any financing will be
satisfactory to us. We believe that with our July 31, 2008 financing and our cash, cash
equivalents and short-term investment balance at June 30, 2008 we have sufficient cash and
investments to conduct operating activities through September 2009. We have based this estimate on
assumptions that may prove to be wrong, and we could spend our available financial resources faster
than we currently expect.
As of June 30, 2008, we had an aggregate principal amount of $22.0 million of senior
convertible notes outstanding (the Notes). The Notes carry a 4.75% coupon; are currently
convertible into shares of Novavax common stock at $4.00 per share; and mature on July 19, 2009.
We may require that the Notes be converted into Company common stock if the weighted average price
of the our common stock is greater than $7.00 in any 15 out of 30 consecutive trading days after
July 19, 2007.
On June 15, 2007, we entered into amendments (the Amendments) with each of the holders of
the outstanding 4.75% senior convertible notes (Notes) to amend the terms of the Notes. As of
June 30, 2007, $22.0 million aggregate principal amount remained outstanding under the Notes. The
Amendments (i) lower the conversion price from $5.46 to $4.00 per share, (ii) eliminate the
holders right to require the Company to redeem the Notes if the weighted average
49
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Liquidity and Capital Resources (continued)
price of the Companys common stock is less than the conversion price on 30 of the 40 consecutive
trading days preceding July 19, 2007 or July 19, 2008 and (iii) mandate that the Notes be converted
into Company common stock if the weighted average price of the Companys common stock is greater
than $7.00 (a decrease from $9.56) in any 15 out of 30 consecutive trading days after July 19,
2007. We determined the change in the value of the conversion option and have reduced the
convertible debt amount by $852,000 and re-classified this amount to additional paid-in capital.
The difference in the option value of $852,000 is being accreted over the remaining term (through
July 19, 2009) of the convertible notes as interest expense.
Contractual Obligations and Commitments
We utilize different financing instruments, such as debt and operating leases, to finance
various equipment and facility needs. The following table summarizes our current financing
obligations and commitments (in thousands) as of June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than
|
|
|
1 3
|
|
|
4 5
|
|
|
More than
|
|
Commitments and Obligations
|
|
Total
|
|
|
1 Year
|
|
|
Years
|
|
|
Years
|
|
|
5 Years
|
|
|
|
(unaudited)
|
|
Convertible notes
|
|
$
|
22,000
|
|
|
$
|
|
|
|
$
|
22,000
|
|
|
$
|
|
|
|
$
|
|
|
Operating leases
|
|
|
19,450
|
|
|
|
1,286
|
|
|
|
4,711
|
|
|
|
4,581
|
|
|
|
8,872
|
|
Notes payable
|
|
|
553
|
|
|
|
333
|
|
|
|
160
|
|
|
|
60
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total principal payments
|
|
|
42,003
|
|
|
|
1,619
|
|
|
|
26,871
|
|
|
|
4,641
|
|
|
|
8,872
|
|
Less: Subleases
|
|
|
(617
|
)
|
|
|
(254
|
)
|
|
|
(363
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net principal payments
|
|
|
41,386
|
|
|
|
1,365
|
|
|
|
26,508
|
|
|
|
4,641
|
|
|
|
8,872
|
|
Interest
|
|
|
1,572
|
|
|
|
527
|
|
|
|
1,045
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total commitments and obligations
|
|
$
|
42,958
|
|
|
$
|
1,892
|
|
|
$
|
27,553
|
|
|
$
|
4,641
|
|
|
$
|
8,872
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On June 26, 2008, we amended the lease for our corporate headquarters at 9920 Belward Campus
Drive in Rockville, Maryland. The amendment (1) extends the term of the lease to January 31, 2017,
(2) provides that the landlord will reimburse Novavax for up to $3.0 million in leasehold
improvements (the Allowance) and (3) increases the monthly installments of base rent going
forward by an amount equal to the monthly amortization of the Allowance over the remaining term at
11% interest, or an additional $45,132 per month. The additional monthly rent is subject to the
annual 2.125% escalation included in the original lease. On June 27, 2008, we received $3.0
million from the landlord as reimbursement for leasehold improvements. The amount is included in
deferred rent on the consolidated balance sheet at June 30, 2008, and will be amortized as a credit to rent
expense over the remaining lease term.
50
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The primary objective of our investment activities is to preserve our capital until it is
required to fund operations while at the same time maximizing the income we receive from our
investments without significantly increasing risk. As of June 30, 2008, we had cash and cash
equivalents and short-term investments of $35.9 million as follows:
|
|
|
|
|
Cash and cash equivalents
|
|
$23.5 million
|
Short-term investments classified as held to maturity
|
|
$ 3.5 million
|
Short-term investments classified as available for sale
|
|
$ 8.9 million
|
Our exposure to market risk is confined to our investment portfolio. Our short-term
investments are classified as either held to maturity or available for sale. Short-term
investments held to maturity are comprised of corporate bonds. These investments are held at
amortized cost. We do not believe that a change in the market rates of interest would have any
significant impact on the realizable value of our investment portfolio. Changes in interest rates
may affect the investment income we earn on our investments and, therefore, could impact our cash
flows and results of operations.
Our investment in auction rate securities is classified as short-term investments available
for sale on our consolidated balance sheet and is comprised of taxable municipal bonds and
preferred shares. Auction rate securities are variable rate bonds tied to short-term interest
rates with maturities on the face of the securities between 2010 and 2042. These auction rate securities have interest rate resets through a modified Dutch auction, at
predetermined short-term intervals. Interest paid during a given period is based upon the interest
rate determined during the prior auction.
Failures in auction rate securities have raised concerns about the liquidity of such
investments. When auctions are not successful, the interest rate increases as does the risk of
illiquidity. The principal amount of our auction rate securities will not be accessible until a
successful auction occurs, the issuer calls or restructures the underlying security, or the
underlying security matures and is paid by a buyer outside the auction process. We have determined
that we have both the ability and intent to hold these auction rate securities until the market
recovers. We do not anticipate having to sell these securities in order to operate our business
and, based upon available information, anticipate being able to recover the original cost
basis of all the auction rate securities remaining on our balance sheet. Impairment assessments
are made at the individual security level. When the fair value of an investment is less than its
cost at the balance sheet date, a determination is made as to whether the impairment is other than
temporary and, if it is other than temporary, an impairment loss is recognized. We have determined
that there were no declines in the fair values of our short-term investments as of June 30, 2008.
51
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (continued)
We continue to monitor the market for auction rate securities and consider its effect (if any)
on the fair market value of our investments. If market conditions do not recover, we may be
required to record impairment charges in 2008, which may affect our financial condition, cash flows
and earnings. We believe that the failed auctions experienced to date are not a result of the
deterioration of the underlying credit quality of these securities, although valuation of them is
subject to uncertainties that are difficult to predict, such as changes to credit ratings of the
securities and/or the underlying assets supporting them, default rates applicable to the underlying
assets, underlying collateral value, discount rates, counterparty risk and ongoing strength and
quality of market credit and liquidity. We do not believe the carrying values of these auction
rate securities are permanently impaired and therefore expect the positions will eventually be
liquidated without significant loss.
We are headquartered in the United States where we conduct the vast majority of our business
activities. Accordingly, we have not had any material exposure to foreign currency rate
fluctuations.
52
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
For the quarterly period ended June 30, 2008, we carried out an evaluation, under the
supervision and with the participation of the Companys management, including the Companys chief
executive officer and chief financial officer, of the effectiveness of the Companys disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the
Securities Exchange Act of 1934, as amended (the Exchange Act) as of the end of the period
covered by this quarterly report. Based on this review and evaluation, which included inquiries
made to certain other employees of the Company, the chief executive officer and chief financial
officer have concluded that, as of June 30, 2008, the Companys current disclosure controls and
procedures, as designed and implemented, are effective.
Changes in Internal Control over Financial Reporting
There were no changes in the Companys internal control over financial reporting during the
quarter ended June 30, 2008 that have materially affected, or are reasonably likely to materially
affect the Companys internal control over financial reporting.
53
PART II. OTHER INFORMATION
Item 1 Legal Proceedings
The Company was a defendant in a lawsuit filed in December 2003 by a former director alleging
that the Company wrongfully terminated the former directors stock options. In April 2006, a
directed verdict in favor of the Company was issued and the case was dismissed. The plaintiff has
filed an appeal with the court. In March 2008, the Company was advised that the case was dismissed
by the New Jersey Supreme Court with no bias towards the Company. The ruling ends all potential
liability to the Company.
Item 1A. Risk Factors
There are no material changes to the Companys risk factors as described in Item 1A of the
Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2007, as filed with the
SEC, other than as mentioned below.
From time to time, the Company may apply for grants from academic institutions, government
agencies and non-profit entities. There is often significant competition for these grants. While
each grantor had different requirements, many require clinical data in humans. While the Company
has collected some human clinical data, the available data may not be sufficient to receive a grant
or, if a grant is awarded, may reduce the size of the grant.
We have a history of losses and our future profitability is uncertain
.
Our expenses have exceeded our revenues since our formation in 1987, and our accumulated
deficit at June 30, 2008 was $217 million. Our net revenues for the last three fiscal years from
continuing operations were $1.5 million in 2007, $1.7 million in 2006 and $5.3 million in 2005. We
have received a limited amount of related revenue from research contacts, licenses and agreements
to provide vaccine candidates, services and technologies. We cannot be certain that we will be
successful in entering into strategic alliances or collaborative arrangements with other companies
that will result in significant revenues to offset our expenses. Our net losses for the last three
fiscal years were $34.8 million in 2007, $23.1 million in 2006 and $11.2 million in 2005.
Our historical losses have resulted from research and development expenses for our vaccine and
drug delivery product candidates, sales and marketing expenses, and manufacturing expenses for
Estrasorb, protection of our intellectual property and other general operating expenses. Our
losses increased due to the launch of Estrasorb since 2004 as we expanded our manufacturing
capacity and sales and marketing capabilities. More recently, our losses have increased, and will
continue to increase, as a result of higher research and development efforts to support the
development of our vaccines, particularly our pandemic and seasonal influenza vaccines.
54
Item 1A. Risk Factors (continued)
We expect to continue to incur significant operating expenses and anticipate that our expenses
and losses will increase in the foreseeable future as we seek to:
|
|
|
complete our human Phase I/IIa clinical trial for our pandemic flu vaccines;
|
|
|
|
|
initiate Phase I/II clinical trials for our seasonal flu vaccine;
|
|
|
|
|
initiate additional preclinical studies for Varicella Zoster and our undisclosed
product candidate using our VLP vaccine technology platform;
|
|
|
|
|
obtain validation from the Food and Drug Administration, or FDA as a product
manufacturing facility and comply with the FDAs manufacturing facility requirements;
|
|
|
|
|
complete the manufacture of Estrasorb and Graceway and transition the assets to
Graceway;
|
|
|
|
|
maintain, expand and protect our intellectual property portfolio;
|
|
|
|
|
hire additional clinical, quality control, scientific and management personnel;
|
|
|
|
|
add operations, financial, accounting, facilities engineering and information systems
personnel, consistent with expanding our operations; or
|
|
|
|
|
capitalize on the value of our MNP technology.
|
As a result, we expect our cumulative operating loss to increase until such time, if ever,
that product sales, licensing fees, royalties, milestones, contract research and other sources
generate sufficient revenue to fund our continuing operations. We cannot predict when, if ever, we
might achieve profitability and cannot be certain that we will be able to sustain profitability, if
achieved.
We may have product liability exposure.
The administration of drugs to humans, whether in clinical trials or after marketing
clearances are obtained, can result in product liability claims. We maintain product liability
insurance coverage in the total amount of $10 million for claims arising from the use of our
currently marketed products and products in clinical trials prior to FDA approval. Coverage is
relatively expensive, and the market pricing can significantly fluctuate, therefore, we may not be
able to maintain insurance at a reasonable cost. There can be no assurance that we will be able to
maintain our existing insurance coverage or obtain coverage for the use of our other products in
the future. This insurance coverage and our resources may not be sufficient to satisfy liabilities
resulting from product liability claims. A successful claim may prevent us from obtaining adequate
product liability insurance in the future on commercially desirable items, if at all. Even
55
Item 1A. Risk Factors (continued)
if a claim is not successful, defending such a claim would be time-consuming and expensive, may
damage our reputation in the marketplace, and would likely divert managements attention.
Regardless of merit or eventual outcome, liability claims may result in:
|
|
|
decreased demand for our products;
|
|
|
|
|
impairment of our business reputation;
|
|
|
|
|
withdrawal of clinical trial participants;
|
|
|
|
|
costs of related litigation;
|
|
|
|
|
substantial monetary awards to patients or other claimants;
|
|
|
|
|
loss of revenues; and
|
|
|
|
|
the inability to commercialize our product candidates.
|
We have made loans to certain of our former directors, which if not repaid, would result in a loss
.
We have two outstanding notes to former directors which are secured by shares of our common
stock. The notes were initially due upon the earlier of (a) the date the individual ceased to be a
director of Novavax, (b) in whole or in part, to extent of net proceeds on the date on which the
director sold all or a portion of the pledged shares, or (c) March 21, 2007.
In May 2006, one of these directors resigned from the Companys Board of Directors. Following
his resignation, the Company approved an extension of the former directors $448,000 note to
December 31, 2007 or earlier to the extent of the net proceeds of the pledged shares. In
connection with this extension, the former director executed a general release of all claims
against the Company. On May 7, 2008, the Company and the former director entered into an Amended
and Restated Promissory Note and an Amended and Restated Pledge Agreement (the Amendment). The
Amendment further extends the maturity date of the note to June 30, 2009, permits the Company to
sell the pledged shares if the market price of the common stock exceeds certain targets, increase
the interest rate to 8.0% and stipulates quarterly payments beginning on June 30, 2008.
In March 2007, the second director resigned from the Board of Directors before the maturity
date. In an agreement dated May 7, 2007, the Board agreed to extend the note that was due March 21,
2007 to June 30, 2009 and secured additional collateral in the form of a lien on certain
outstanding stock options. Also under the May 7, 2007 agreement, the Company has the right to
exercise the stock options, sell the acquired shares and the other shares held as collateral and
use the proceeds to pay the debt, if the share price exceeds a certain target at any time during
the
56
Item 1A. Risk Factors (continued)
period between May 7, 2007 and June 30, 2009. The note continues to accrue interest at 5.07% per
annum and continues to be secured by 166,666 shares of common stock owned by the former director.
We do not know if the price of our common stock will reach the target prices allowing us to
realize on the pledged collateral. By issuing additional shares in an equity fundraising
transaction, the dilution could further lower the trading price of our stock reducing the
likelihood of selling the collateral to satisfy the debts. Even if we are able to sell some or all
of the pledged shares, we may not recover the full amount outstanding under either note. There are
no assurances that the former directors will be able to repay the notes when due under the terms of
the current agreements.
We are expecting to announce clinical trial data from its pandemic influenza vaccine in the near
future which could negatively effect the Company and the price of its common stock.
We began the second portion of the Phase I/IIa clinical trial of our pandemic vaccine in March
2008 to gather additional immunogenicity and safety data and determine a final dose. We have
disclosed in our filings with the Securities and Exchange Commission that data from this trial is
anticipated in the third quarter of 2008. Once the raw clinical data is received, we will take
some period of time to analyze and confirm the data in order to fully understand the data and its
impact on the Company, before publicly disclosing it. In the event that the results are negative,
or are viewed by the marketplace as negative, it will have a material adverse impact on the Company
and the price of its common stock.
Because we depend on third parties to conduct some of our laboratory testing and human studies, we
may encounter delays in or lose some control over our efforts to develop products.
We are dependent on third-party research organizations to conduct some of our laboratory
testing and human studies. If we are unable to obtain any necessary testing services on acceptable
terms, we may not complete our product development efforts in a timely manner. If we rely on third
parties for laboratory testing and human studies, we may lose some control over these activities
and become too dependent upon these parties. These third parties may not complete testing
activities on schedule or when we request. We may not be able to secure and maintain suitable
research organizations to conduct our laboratory testing and human studies. We are responsible for
confirming that each of our clinical trials is conducted in accordance with its general
investigational plan and protocol. Moreover, the FDA and foreign regulatory agencies require us to
comply with regulations and standards, commonly referred to as good clinical practices, for
conducting, recording and reporting the results of clinical trials to assure that data and reported
results are credible and accurate and that the trial participants are adequately protected. Our
reliance on third parties does not relieve us of these responsibilities and requirements. If these
third parties do not successfully carry out their contractual duties or regulatory obligations or
meet expected deadlines, if the third parties need to replace or if the quality or accuracy of the
data they obtain is compromised due to the failure to adhere to our clinical protocols or
regulatory requirements or for other reasons, our pre-clinical development
57
Item 1A. Risk Factors (continued)
activities of clinical trials may be extended, delayed, suspended or terminated, and we may not be
able to obtain regulatory approval for our product candidates.
Even if regulatory approval is received for our product candidates, the later discovery of
previously unknown problems with a product, manufacturer or facility may result in restrictions,
including withdrawal of the product from the market.
Approval of a product candidate may be conditioned upon certain limitations and restrictions
as to the drugs use, or upon the conduct of further studies, and may be subject to continuous
review. After approval of a product, if any, there will be significant ongoing regulatory
compliance obligations, and if we or our collaborators fail to comply with these requirements, we
and/or our collaborators could be subject to penalties, including:
|
|
|
Warning letters;
|
|
|
|
|
Fines;
|
|
|
|
|
Product recalls;
|
|
|
|
|
Withdrawal of regulatory approval;
|
|
|
|
|
Operation restrictions:
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|
|
|
|
Disgorgement of profits;
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|
|
|
|
Injunctions; and
|
|
|
|
|
Criminal prosecution.
|
Regulatory agencies may require us or our collaborators to delay, restrict or discontinue
clinical trials on various grounds, including a finding that the subjects or patients are being
exposed to an unacceptable health risk. In addition, we or our collaborators may be unable to
submit applications to regulatory agencies within the time frame we currently expect. Once
submitted, applications must be approved by various regulatory agencies before we or our
collaborators can commercialize the product described in the application. All statutes and
regulations governing the conduct of clinical trials are subject to change in the future, which
could affect the cost of such clinical trials. Any unanticipated costs or delays in our clinical
studies could delay our ability to generate revenues and harm our financial condition and results
of operations.
58
Item 1A. Risk Factors (continued)
Our product candidates may never achieve market acceptance even if we obtain regulatory approvals.
Even if we receive regulatory approvals for the commercial sale of our product candidates, the
commercial success of these product candidates will depend on, among other thing, their acceptance
by physician, patients, third party payors such as health insurance companies and other members of
the medical community as a therapeutic and cost-effective alternative to competing products and
treatments. If our product candidates fail to gain market acceptance, we may be unable to earn
sufficient revenue to continue our business. Market acceptance of, and demand for, any product that we may develop and commercialize will depend on many factors,
including:
|
|
|
Our ability to provide acceptable evidence of safety and efficacy;
|
|
|
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|
The prevalence and severity of adverse side effects
|
|
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|
Availability, relative cost and relative efficacy of alternative and competing
treatments;
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|
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The effectiveness of our marketing and distribution strategy;
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|
Publicity concerning our products or competing products and treatments; and
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Our ability to obtain sufficient third party insurance coverage or reimbursement.
|
If our product candidates do not become widely accepted by physicians, patients, third party
payors and other members of the medical community, our business, financial condition and results of
operations would be materially and adversely affected.
Our costs related to manufacturing Estrasorb may exceed our estimates and reduce expected cash flow
from the sale of the Estrasorb related assets.
In February 2008, Novavax entered into and consummated asset sale and supply agreements for
Estrasorb related assets with Graceway Pharmaceuticals, LLC. The manufacturing of Estrasorb under
this agreement was completed in July 2008 and we will exit the Philadelphia manufacturing location
in August 2008. The net cash impact from these transactions are expected to be in excess of $2.5
million. If the cost of manufacturing the additional lots of Estrasorb, transitioning the assets
to Graceway or closing the manufacturing facility exceed expectations for any reason, the
anticipated cash impact would be lower.
59
Item 1A. Risk Factors (continued)
Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our
products internationally.
We intend to have our product candidates marketed outside the United States. In order to
market our products in the European Union and many other non-U.S. jurisdictions, we must obtain
separate regulatory approvals and comply with numerous and varying regulatory requirements. To
date, we have not filed for marketing approval for any of our products candidates and may not
receive the approvals necessary to commercialize our product candidates in any market. The
approval procedure varies among countries and can involve additional testing and data review. The
time required to obtain foreign regulatory approval may differ from that required to obtain FDA
approval. The foreign regulatory approval process may include all of the risks associated with
obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely basis, if at
all. Approval by the FDA does not ensure approval by regulatory agencies in other foreign
countries or by the FDA. However, a failure or delay in obtaining regulatory approval in one
jurisdiction may have a negative effect on the regulatory approval process in other jurisdictions,
including approval by the FDA. The failure to obtain regulatory approval in foreign jurisdictions
could harm our business.
Item 4 Submission of Matters to a Vote of Security Holders
At the Companys Annual Meeting of stockholders held on June 18, 2008, the following proposals
were adopted by the votes specified below:
|
1.
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|
To elect two directors as Class I directors to serve on the Board of Directors for a
three-year term expiring at the 2011 Annual Meeting of Stockholders.
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FOR
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|
WITHHELD
|
John Lambert
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50,316,102
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855,639
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|
Rahul Singhvi
|
|
|
50,210,173
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|
|
|
961,568
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|
In addition to the two Class I directors elected at this years Annual Meeting of
Stockholders, the Board is composed of three Class II Directors and two Class III Directors.
The continuing Class II Directors, whose term will expire at the Companys 2009 Annual
Meeting, are Gary C. Evans, John Marsh and James Tanabaum. The continuing Class III
directors, whose terms will expire at the Companys 2010 Annual Meeting, are Michael A.
McMannus and Thomas P. Monath, MD.
|
2.
|
|
To ratify the appointment of Grant Thornton LLP, an independent registered accounting
firm, as the independent auditor for the company for the year ending December 31, 2008.
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|
For
|
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|
50,789,919
|
|
Against
|
|
|
298,781
|
|
Abstain
|
|
|
83,041
|
|
Broker Non-Votes
|
|
|
|
|
60
Item 6 Exhibits
4.1
|
|
Form of Common Stock Purchase Warrant (incorporated by
reference to Exhibit 4.1 to the Current Report on Form 8-K filed on July 30,
2008.
|
|
10.1
|
|
Form of Subscription Agreement dated July 28, 2008
(incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K
filed on July 30, 2008.
|
|
10.2
|
|
Form of Investor Rights Agreement dated July 29, 2008
(incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K
file on July 30, 2008.
|
|
10.3
|
|
Termination of Sublease dated as of May 7, 2007 between
Human Genome Sciences, Inc and Novavax, Inc.
|
|
10.4
|
|
Lease Agreement between GP Rock One, LLC and Novavax, Inc.,
dated as of May 7, 2007.
|
|
10.5
|
|
First Amendment to Lease Agreement between GP Rock One, LLC
and Novavax, Inc., dated as of May 30, 2008.
|
|
10.6
|
|
Second Amendment to Lease Agreement between BMR-9920 Belward
Campus Q, LLC (formerly GP Rock One, LLC) and Novavax, Inc., dated as of June
26, 2008.
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Exchange
Act Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Exchange
Act Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
|
Certification of Chief Executive Officer, pursuant to Exchange
Act Rule 13a-14(a) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18
of the United States Code, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. *
|
|
32.2
|
|
Certification of Chief Financial Officer, pursuant to Exchange
Act Rule 13a-14(a) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18
of the United States Code as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. *
|
|
|
|
*
|
|
This exhibit is not filed for purposes of Section 18 of the Securities Exchange Act of
1934, and is not and should not be deemed to be incorporated by reference into any filing
under the Securities Act of 1933 or the Securities Exchange Act of 1934.
|
61
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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|
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|
|
NOVAVAX, INC.
(Registrant)
|
|
Date: August 11, 2008
|
By:
|
/s/ Len Stigliano
|
|
|
|
Len Stigliano
|
|
|
|
Vice President, Chief Financial
Officer and Treasurer
(Duly authorized officer and
Principal Financial Officer)
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|
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62
Exhibit 10.4
LEASE AGREEMENT
THIS LEASE AGREEMENT (this
Lease
) is made as of the 7
th
day of May, 2007, by and
between GP ROCK ONE, L.L.C., a Rhode Island limited
liability company (
Landlord
) and NOVAVAX,
INC., a Delaware corporation (
Tenant
).
WITNESSETH:
WHEREAS, Landlord owns that certain improved real property known as Lot 4, Block A in The
Johns Hopkins Belward Research Campus Subdivision, Montgomery County, Maryland (the
Land
), on
which is constructed a building (the
Building
) containing approximately 51,181 rentable square
feet located at 9920 Belward Drive, Rockville, Maryland 20850 (the Land and the Building being
collectively referred to herein as the
Premises
); and
WHEREAS, prior to the date hereof, Landlord leased all of the Premises to HUMAN GENOME
SCIENCES, INC., a Delaware corporation (
HGS
) pursuant to the terms of a certain Lease Agreement
dated December 19, 2000, as amended by a certain First Amendment to Lease dated March 23, 2001
(collectively, the
HGS Lease
), and, in turn, HGS subleased all of the Premises to Tenant
pursuant to the terms of a certain Sublease dated October 6, 2006 (
Sublease
) by and between HGS,
as sublandlord, and Tenant, as subtenant; and
WHEREAS, on or about the date of this Lease (i) Landlord and HGS have terminated the HGS
Lease, (ii) HGS and Tenant have terminated the Sublease, and (iii) Landlord and Tenant have agreed
to enter into a direct lease upon the terms and conditions set forth below, including, without
limitation, the terms set forth in the Lease Addendum of even date herewith, attached hereto as
Exhibit A
, and incorporated by reference herein.
NOW, THEREFORE, in consideration of the rents, covenants and agreements herein contained,
Landlord does hereby lease and demise the Premises unto Tenant and Tenant hereby takes and leases
the Premises from Landlord on the terms and conditions herein contained.
1.
Lease Term and Lease Year
.
A.
Lease Term
. The term of this Lease (the
Lease Term
) shall commence on the Initial
Delivery Date (as defined below) (the
Lease Commencement Date
) and, unless otherwise set forth
herein, shall expire on the last day of the month which is six (6) years following the Full
Delivery Date (as defined below), except that if the Full Delivery Date is not the first day of a
calendar month, then the Lease Term shall expire on the last day of the sixth (6
th
) year
following the first day of the first full month following the Full Delivery Date (the
Lease
Expiration Date
). The
Initial Delivery Date
shall mean the later of the third (3
rd
)
business day following satisfaction of the contingencies described in
paragraph 31
below or
the date upon which the Initial Delivery Areas are
Delivered
(as defined below) in accordance
with
subparagraph 4A
. The
Full Delivery Date
shall be the third (3
rd
) business
day following
Delivery
(as defined below) of the balance of the Premises
other than
the
Select Areas
(as defined below). Tenant shall have the option to extend the Lease Term in
accordance with the provisions of
paragraph 26
below.
Delivery
,
Deliver
and
Delivered
shall mean the date on which all obligations of Landlord pursuant to this Lease have been met under
paragraph 4
with respect to the Initial Delivery Areas, the Lab Areas and the Select Areas,
as applicable.
B.
Lease Year
. The term
Lease Year
shall mean each twelve (12) month period
commencing on the first day of the first full month following the Full Delivery Date. The first
Lease Year shall also include the number of days between the Full Delivery Date and the last day
of the month in which the Full Delivery Date occurs.
-2-
C.
Certificate of Commencement
. Within ten (10) days following the date the Initial
Delivery Areas (as defined below) of the Premises have been Delivered to Tenant, the parties shall
execute a certificate in the form attached hereto as
Exhibit B
certifying as to the Lease
Commencement Date and the Initial Delivery Date, which are one and the same. Within ten (10) days
following the date the remainder of the Premises (other than the Select Areas) has been Delivered
to Tenant, the parties shall execute a certificate in the form attached hereto as
Exhibit C
certifying as to the Full Delivery Date and the Lease Expiration Date. Additionally, within ten
(10) days following the Delivery of each portion of the Lab Areas and the Select Areas, as the case
may be, to the Tenant, the parties shall execute a certificate in the form attached hereto as
Exhibit D
certifying as to the date of the respective Deliveries. All such certificates
shall be attached hereto and incorporated by reference herein.
[As of the date of this Lease
(
i
)
the Initial Delivery Date and the Lease Commencement Date are January 1, 2007, as set forth in the
attached
Exhibit B
,
(
ii
)
the Full Delivery Date is January 18, 2007 and Lease Expiration
Date is January 31, 2013, as set forth in the attached
Exhibit C
, and
(
iii
)
the dates of
Deliveries of the remainder of the Premises, also known as the Select Areas are March 1, 2007, as
set forth in the attached
Exhibit D
.]
2.
Rent
.
A.
Preliminary Term Rent
. From the Initial Delivery Date through the day immediately
preceding the Full Delivery Date (the
Preliminary Term
), Tenant
shall pay to Landlord
Tenants
Proportionate Share
(as defined below) of the Additional Rent (as defined in
subparagraph
2D
below). Tenants Proportionate Share of the Additional Rent shall be the percentage arrived
at by dividing the number of square feet of rentable area of the Premises as has been Delivered to
Tenant by 51,181 square feet (the
Tenants Proportionate Share
). Tenants
-3-
Proportionate Share shall be adjusted on a monthly basis (as of the first day of each calendar
month) as areas of the Premises are delivered to Tenant. All amounts due by Tenant to Landlord
during the Preliminary Term shall be paid within ten (10) days following Tenants receipt of a
bill therefor from Landlord.
[As of the date of this Lease, Tenants Proportionate Share is one
hundred percent
(
100%
)
.]
B.
Base Rent
. Subject to the rent abatement provisions of the last sentence of this
subparagraph and
subparagraph 4C
of this Lease, commencing on the Full Delivery Date,
Tenant shall pay to Landlord Base Rent for the first Lease Year of One Million One Hundred
Seventy-Seven Thousand One Hundred Sixty-Three and No/100 Dollars ($1,177,163.00), payable in equal
monthly installments of Ninety Eight Thousand Ninety-Six and 92/100 Dollars ($98,096.92), the first
such installment being due on the Full Delivery Date (provided that if the Full Delivery Date is a
day other than the first day of a month, Base Rent for the month in which the Full Delivery Date
occurs shall be adjusted on the basis of a 30-day month) and the remaining installments being
payable, in advance, without notice, demand, deduction or set-off, on the first day of each and
every calendar month thereafter during the Lease Term. Notwithstanding the foregoing provisions of
this subparagraph, (i) Base Rent (but not Additional Rent) for the first six (6) months following
the Full Delivery Date (
Abatement Period
) shall be abated by an amount equal to fifty percent
(50%) thereof and shall be payable in monthly installments of Forty-Nine Thousand Forty-Eight and
46/100 Dollars ($49,048.46), and (ii) after the Abatement Period, Tenant shall be responsible for
the full Base Rent; provided, however, no Base Rent shall be due and payable for the Select Areas
until the date(s) each Select Area is Delivered to Tenant, with the Base Rent to be adjusted to
reflect Delivery of Select Areas on the first day of each calendar month to reflect a prior months
Delivery of part or
-4-
all of the Select Areas.
[As of the date of this Lease all Select Areas have been Delivered to
Tenant and Tenants Abatement Period ends on July 18, 2007.]
C.
Increases in Base Rent
. Commencing on February l, 2008, and continuing on the
first day of February in each succeeding year thereafter during the Lease Term, the Base Rent
payable by Tenant shall be increased by an amount equal to 2.125% multiplied by the Base Rent (as
adjusted pursuant to this subparagraph) payable during the last month of the immediately preceding
Lease Year.
D.
Additional Rent
. On and after the Full Delivery Date, Tenant shall pay to
Landlord, as additional rent, an amount equal to (i) all amounts payable by Landlord with respect
to (a) that certain Declaration of Covenants, Easements and Restrictions (Protective Covenants)
dated September 24, 1997, and recorded among the Land Records of Montgomery County, Maryland in
Liber 15181 at folio 74 (the
Protective Covenants
) a copy of which is attached hereto and made a
part hereof as
Exhibit E
, (b) that certain Declaration of Covenants, Conditions, Easement
and Restrictions for The Johns Hopkins University Belward Research Campus dated September 24,
1997, and recorded among the Land Records of Montgomery County, Maryland in Liber 15181 at folio
84 (the
Declaration
) a copy of which is attached hereto and made a part hereof as
Exhibit
F
, and (c) that certain Easement Agreement dated February 28, 2001, and recorded among the
Land Records of Montgomery County, Maryland in Liber 18918 at folio 448 (the
Easement
Agreement
), a copy of which is attached hereto and made a part hereof as
Exhibit G
, and
(ii) all other amounts payable by Tenant as set forth in this Lease, including, without
limitation, the Lease Addendum (such amounts are sometimes individually and collectively referred
to as
Additional Rent
). If any such amounts are payable by Landlord on a monthly basis, Tenant
shall likewise pay to Landlord such Additional Rent (upon presentation of an invoice for same or
delivery of notice of
-5-
such recurring charges), on a monthly basis, in addition to and on the same dates as the monthly
installments of Base Rent. Any Additional Rent not paid monthly shall be payable by Tenant to
Landlord within ten (10) days after receipt of a bill therefor from Landlord. Landlord shall
furnish Tenant with copies of statements setting forth the amount due from Tenant.
E.
Payment of Rent
. Base Rent and Additional Rent (hereinafter collectively
Rent
)
shall be payable to Landlord, c/o Human Genome Sciences, Inc., 14200 Shady Grove Road, Rockville,
MD 20850, Attention; Chief Financial Officer, or to such other address as Landlord may from time to
time specify.
F.
Late Charges
. Tenant shall pay to Landlord an amount equal to five percent (5%) of
any Rent not received by Landlord within five (5) days after such payment is due as compensation
to Landlord for its costs and inconvenience incurred as a consequence of Tenants delinquency.
Additionally, except as provided in
subparagraph 8A
of this Lease, all payments required
hereunder from Tenant which are not paid within five (5) days of the due date shall bear interest
from the date due until paid at an annual rate equal to the greater of (i) two percent (2%) per
annum in excess of the prime rate of interest published from time to time in the
Wall Street
Journal Eastern Edition
or (ii) twelve percent (12%) per annum. In no event, however, shall
the charges permitted hereunder or elsewhere in this Lease, to the extent they are considered to
be interest under applicable law, exceed the maximum lawful rate of interest.
3.
Security Deposit
.
A. Concurrent with the Initial Delivery Date, Tenant has paid to Landlord a security deposit
of Ninety-Eight Thousand Ninety-Six Dollars and Ninety-Two Cents ($98,096.92) (payable in cash or,
as and to the extent set forth in
subparagraph B
below, in the form of a letter of credit
reasonably acceptable to Landlord) (the
Security Deposit
).
-6-
B. In lieu of depositing cash as the Security Deposit, Tenant shall have the right to deliver
to Landlord an unconditional, irrevocable, standby letter of credit in the amount of the cash
Security Deposit otherwise required hereunder, which letter of credit shall (i) be in a form
reasonably acceptable to Landlord, (ii) be issued by a financial institution selected by Tenant and
reasonably acceptable to Landlord, (iii) be for the benefit of Landlord, (iv) be payable by draft
sight in a location reasonably acceptable to Landlord upon presentation of a certification signed
by an officer of Landlord which states that an event of default has occurred under this Lease, and
(v) be payable in the event such letter of credit is not renewed on or before the date which is
thirty (30) days prior to its expiration. Any amounts of cash drawn on a letter of credit Security
Deposit will thereafter be treated as a cash Security Deposit hereunder.
C. Tenant shall have the right at any time during the Lease Term upon thirty (30) days prior
written notice to Landlord (i) to replace a cash Security Deposit with a letter of credit which
complies with all the above terms of, or (ii) to replace a letter of credit Security Deposit with
a corresponding amount of cash or another letter of credit which complies with all the terms set
forth above.
D. If Tenant fails to pay Rent when required or fails to perform any other covenant contained
herein following any notice and cure period provided herein, Landlord may use or retain all or any
part of the Security Deposit for the payment of any sum not so paid, or for the payment of any
amount which Landlord may spend or become obligated to spend by reason of Tenants default. If any
portion of the Security Deposit is so applied or used, then Tenant shall, within five (5) business
days after the effective date of written notice thereof, deposit an additional amount with
Landlord sufficient to restore said Security Deposit to the amount set forth above, or
-7-
replenish the letter of credit to the amount required hereunder, and Tenants failure to do so
shall constitute a default under this Lease.
E. If Tenant has performed all of its monetary and other obligations hereunder (including, but
not limited to (i) radiological decommissioning of all laboratory and/or manufacturing suites
within the Premises in accordance with all applicable governmental requirements to the satisfaction
of all applicable governmental authorities (hereinafter referred to as
Decommissioning
), to the
satisfaction of Landlord; and (ii) decontamination of all
Hazardous Substances
(as defined in the
Lease Addendum), Biologics (as hereinafter defined) and all other potentially hazardous biological
materials in, on or about the Premises, other than with respect to Hazardous Substances referred to
in
subparagraph 20D
below, in accordance with the requirements of all applicable
governmental authorities and to the reasonable satisfaction of Landlord as demonstrated by an
environmental audit, satisfactory to Landlord in its reasonable discretion, performed at Tenants
cost (
Decontamination
) at the termination of this Lease, Landlord shall return said Security
Deposit or letter of credit to Tenant within sixty (60) days after termination of this Lease, less
any amounts required to restore the Premises to good condition and repair, reasonable wear and tear
and damage caused by casualty and condemnation excepted, including repairing any damage resulting
from the removal by Tenant of its Alterations (as defined below), trade fixtures or equipment.
4.
Delivery and Acceptance of Lease Premises
.
A. Upon satisfaction of the contingencies described in
paragraph 31
below, the
office, laboratory and administrative portions of the Premises shown on
Exhibit H
attached
hereto and made a part hereof (collectively, the
Initial Delivery Areas
) shall be Delivered to
Tenant in the following condition: professionally cleaned and with all base building systems
servicing the
-8-
Premises in good repair and working order, and in a condition that will enable Tenant to obtain
maintenance contracts from contractors reasonably acceptable to Tenant and Landlord for
commercially reasonable prices covering such systems. In all other respects, the Initial Delivery
Areas are to be Delivered and subleased on an
AS IS, WHERE IS BASIS.
Tenant understands and
agrees that the laboratory suites which are part of the Initial Delivery Areas are subject to a
license issued by the State of Maryland for the handling and use of radioactive materials
(
License
); Landlord represents that it has requested that the License be amended to release such
laboratory areas thereby eliminating the requirement that the Landlord pursue and complete
Decommissioning with respect thereto, and such License amendment or Decommissioning, as the case
may be, shall be a condition precedent to Delivery of the initial Delivery Areas.
B. Except for the Select Areas and the Initial Delivery Areas, the balance of the Premises,
as depicted and listed on
Exhibit I
and as depicted and listed on
Schedule 1-A and 1-B
(individually and collectively, the
Lab Areas
) shall be Delivered by Landlord in the same
condition as required of the Initial Delivery Areas and in accordance with the schedule attached
hereto and made a part hereof as
Exhibit I
.
In all other respects, the Lab Areas are to be
Delivered and subleased on an
AS IS, WHERE IS BASIS.
Each date on which a portion of the Lab
Areas has been Delivered shall be a
Lab Premises Delivery Date
. A Lab Premises Delivery Date may
be extended for a Force Majeure event (as defined in the Lease Addendum) or for completion of any
required environmental clean-up. Tenant understands and agrees that the laboratory suites which
are part of the Lab Areas are subject to the License; Landlord covenants that on or before
December 22, 2006, it will request that the License be amended to release such laboratory areas
thereby eliminating the requirement that the Landlord pursue and complete Decommissioning with
respect thereto, and such License amendment or Decommissioning, as the case may be, shall be a
condition precedent to
-9-
Delivery to each portion of the Lab Areas.
[As of the date of this Lease all Lab Areas have been
Delivered to Tenant and the aforesaid condition precedent
(
Landlords amendment of license or
Decommissioning
)
has been satisfied.]
C. Those portions of the Premises labeled as areas B129L, B140L, B263L, B280L, B281 and B282
on
Exhibit J
(the
Select Areas
) shall be Delivered to Tenant within three (3) business
days following Landlords completion of all environmental remediation and Decommissioning
activities (which Landlord agrees to pursue in a timely manner and with all commercially reasonable
due diligence) and delivery to Tenant of copies of written evidence of acceptance of the completion
of said environmental remediation and Decommissioning (with respect to the Select Areas and, if
applicable, the other laboratory suites in the Premises which have not otherwise been removed from
the License) by the appropriate governmental authorities. The Select Areas shall be Delivered in
the same condition as required of the Lab Areas and shall be Delivered in stages as Landlords work
is completed within each of the Select Areas. If any portion of the Selected Areas is not Delivered
by the applicable date set forth in
Exhibit J
,
Tenant shall provide written notice to
Landlord of such failure to Deliver and notwithstanding anything to the contrary contained herein,
Landlord shall have ninety (90) days after such notice to cure (
Cure Period
) such failure to
Deliver; and in the event any portion of the Select Areas is not Delivered by the expiration of the
Cure Period, then, in addition to the Base Rent for such non-Delivered Select Areas not commencing
pursuant to
subparagraph 2B
hereof Base Rent for the remainder of the Premises shall be
reduced by an amount equal to one hundred fifty percent (150%) of the daily rent applicable to such
non-Delivered Select Areas for each day following the Cure Period that such portion of the Select
Areas has not been Delivered, such daily rent to be calculated on the basis of a 30-day month at
the then applicable Base Rent for the entire Premises multiplied by a fraction, the numerator of
-10-
which shall be the square footage of the non-Delivered Select Areas and the denominator of which
shall be 51,181.
[All Select Areas as of the date of this Lease have been timely Delivered.]
D. Except as specifically set forth in this
subparagraph 4D
herein and except for the
work to be performed by Landlord pursuant to
subparagraphs 4A, B and C
above, Tenant
acknowledges that no warranties or representations concerning the condition, quality, or adequacy
of the Premises have been made to Tenant about the Premises. Landlord represents and warrants to
Tenant that (i) to the best of its knowledge, the Premises were constructed in compliance with all
requirements of the Americans with Disabilities Act (
ADA
), (ii) as of the Lease Commencement
Date, the Premises were in material compliance with all requirements of the ADA, (iii) to the best
of Landlords knowledge, as of the Lease Commencement Date, the Premises were in material
compliance with all governmental requirements, and (iv) Tenant is permitted to use the Premises for
its intended use for biological and pharmaceutical laboratories, research, development and
manufacturing and associated administrative uses under all applicable laws and regulations,
including, but not limited to applicable zoning laws and regulations.
E. Other than as provided in
subparagraph 4C
, from and after the Full Delivery Date,
Tenant shall be solely responsible for the operation, maintenance and repair of the Premises in
accordance with the terms of this Lease.
F. Intentionally Omitted.
5.
Lease Addendum
. The Lease Addendum attached hereto as
Exhibit A
and made a
part hereof contains certain material and substantive terms and conditions of this Lease. Any
reference to this Lease or the Lease shall include the terms and conditions of the Lease
Addendum as if the same were fully set forth herein.
-11-
6.
Assignment and Subletting
.
A. Except as provided in
subparagraphs 6B and 6C
below, Tenant shall have no right to
sublet all or any part of the Premises nor shall Tenant have any right to assign or encumber this
Lease, without the prior written consent of Landlord, which consent shall not be unreasonably
withheld or delayed, but shall be subject to the conditions set forth in
subparagraphs 6D and
6E
below. No such assignment or subletting shall release or relieve Tenant from any
obligations under this Lease.
B. Subject to satisfaction of the conditions set forth in
subparagraphs 6D and 6E
below, but notwithstanding anything else to the contrary contained in
subparagraph 6A
,
Tenant may assign the Lease or sublet the Premises for any of the then remaining portion of the
unexpired Lease Term without Landlords consent except as hereafter expressly provided in (d)
below, but with prior written notice to Landlord: (i) to any parent, Affiliate (as hereinafter
defined) or subsidiary of Tenant, (ii) to a surviving person or entity in connection with the
merger, consolidation or acquisition between Tenant and any of its subsidiaries so long as the
Tenants parent as of the date of this Lease retains management control of the Tenant, or (iii) to
the purchaser of all or substantially all of Tenants assets or all of Tenants outstanding stock;
provided, however, that in the event of any such assignment or sublease: (a) Tenant to which the
Premises were initially leased shall continue to remain liable on the Lease for the performance of
all terms; (b) Tenant shall not be in default of any of the terms or provisions of the Lease beyond
any applicable notice and cure period(s); (c) any such sublessee or assignee shall assume in
writing, in a form acceptable to Landlord, all of Tenants obligations arising under this Lease;
and (d) Tenant and the proposed sublessee or assignee shall demonstrate to Landlords reasonable
satisfaction sublessees or assignees creditworthiness and financial capacity to meet all
subsequent financial obligations
-12-
arising under the Lease. Any of the permitted transfers hereinabove provided shall be permitted by
transfer of stock or any other ownership interests by Tenant or any parent of Tenant.
Affiliate
shall mean any entity which is under common control with, controls or is controlled by the Tenant.
C. Notwithstanding anything to the contrary contained herein, including, but not limited to,
subparagraph 6D
below, no public offering of Tenants (or its parents) stock or other
ownership interests or the transfer of the stock or other ownership interests of Tenant or its
parent on a national securities exchange shall be deemed an assignment in violation of the Lease.
D. Notwithstanding the foregoing, if at the time of the proposed assignment or subletting,
Landlord is a real estate investment trust (
REIT
) or is owned by an entity that is a REIT
(
Landlords REIT Entity
), then:
(i) in the event the income generated by the proposed assignee or subtenant would jeopardize
Landlords REIT status or Landlords REIT Entitys status, as a real estate investment trust
within the meaning of Sections 856 through 860 of the Internal Revenue Code of 1986 (
REIT
Status
) or cause Landlord or Landlords REIT Entity to be in receipt of income that does not
constitute rent from real property within the meaning of Section 856(d) of the Code, Tenant
shall be required to obtain Landlords prior written consent, which consent may be given or denied
in Landlords sole and absolute discretion; provided, however, in the event Tenant is unable to
determine whether the proposed assignment or sublease could jeopardize the Landlords REIT
Entitys REIT Status, Tenant shall have the right to deliver a notice to Landlord, complying with
each of the requirements of
subparagraph 6D(ii)
hereof, requesting that Landlord make such
determination. Landlord shall notify tenant within five (5) business days after Landlord receives
such notice and such other information as Landlord may reasonably require whether such assignment
or sublease could jeopardize the Landlords REIT Entitys REIT Status or cause Landlord or
-13-
Landlords REIT Entity to be in receipt of income that does not constitute rent from real
property within the meaning of Section 856(d) of the Code.
(ii) In the event Landlords consent is required pursuant to this
subparagraph 6D(i)
hereof, Tenant shall first notify Landlord of its desire to assign its interest in this Lease or
sublet the Premises and shall submit in writing to Landlord (the
Transfer Notice
); (a) the size
and location of the space Tenant proposes to assign or sublet; (b) the name of the proposed
assignee or subtenant; (c) the date on which the Tenant proposes that the transfer be effective,
which shall not be earlier than the date which is ninety (90) days after the Transfer Notice (d)
the nature of the proposed assignees or subtenants business to be carried on in the Premises; (e)
the terms and provisions of the proposed sublease or assignment; (f) such reasonable financial
information as Landlord may request concerning the proposed assignee or subtenant, and (g) such
other information as Landlord may reasonably require.
E. Any proposed sublease or assignment shall meet the following requirements in
addition to any other requirements set forth above:
(i) Landlord shall be provided with at least ninety (90) days written notice prior to the
effective date of any proposed assignment, subletting or other transfer;
(ii) Any proposed assignee, sublessee or other transferee shall assume, in a written
instrument reasonably acceptable to Landlord, all of the obligations of Tenant hereunder;
(iii) Any proposed assignee, sublessee or other transferee shall use the Premises for the
purposes set forth in
Article 2
of the Lease Addendum;
(iv) Tenant shall in no way be released from any of its obligations under this Lease; and
-14-
(v) Tenant shall reimburse Landlord for legal fees and expenses reasonably incurred by
Landlord in connection with such approval, and the drafting and preparation of appropriate
documentation effectuating the assignment, subletting or other transfer.
7.
Default by Tenant; Remedies
.
A. If (i) default be made in the payment of Rent or any additional charge payable hereunder
by Tenant, and such default shall continue for five (5) days after written notice of default, or
(ii) default be made in any of the other covenants or conditions herein contained on the part of
Tenant and such default shall continue for twenty (20) days after written notice thereof shall
have been given to Tenant, (except that such 20-day period shall be automatically extended for an
additional period of time reasonably necessary to cure such default, if such default cannot be
cured within such first 20-day period and provided Tenant commences the process of curing such
default within said first 20-day period and continuously and diligently pursues such cure to
completion), or (iii) Tenant shall become insolvent or bankrupt or makes an assignment for the
benefit of creditors, or (iv) a receiver or trustee of Tenants property shall be appointed and
such receiver or trustee, as the case may be, shall not be discharged within sixty (60) days after
such appointment, then in any such case, Landlord may, without further notice to Tenant, notice
being hereby waived, terminate Tenants tenancy and recover possession of and reenter the Premises
without accepting a surrender of the Premises or affecting Tenants liability for past Rent and
other charges due or future rent and other charges to accrue hereunder. In the event of any such
default, Landlord shall be entitled to recover from Tenant, in addition to Rent and other charges
equivalent to rent, all other damages sustained by Landlord on account of the breach of this
Lease, including, but not limited to, the costs, expenses and attorney fees incurred by Landlord
in enforcing the terms and provisions hereof and in reentering and recovering possession of the
Premises and for the cost of repairs, alterations and
-15-
brokerage and attorney fees connected with the re-letting of the Premises, but excluding
consequential or incidental damages other than out-of-pocket expenses incurred by Landlord and
delineated herein. As an alternative, at the election of Landlord, Landlord shall have the right to
accept a surrender of the Premises (without the need for any affirmative act or acquiescence by
Tenant), without any further rights or obligations on the part of Landlord or Tenant (other than
Tenants obligation for Rent and other charges due and owing through the date of acceptance of
surrender), so that Landlord may re-let the Premises without any right on the part of Tenant to any
credit or payment resulting from any re-letting of the Premises. Alternatively, at the option of
the Landlord, if Tenants tenancy is so terminated, Landlord may recover forthwith against Tenant
as damages for loss of the bargain and not as a penalty an aggregate sum, which at the time of such
termination of Tenants tenancy, represents the amount of the excess, if any, of the value of the
whole balance of Rent, charges and all other sums payable hereunder for the entire balance of the
term of this Lease herein reserved or agreed to be paid by Tenant, over the then current fair
market rental value of the Premises (including triple net charges), such difference to be
discounted to net present value at the rate of eight percent (8%) per annum. In case of a default
under this Lease, Landlord may, in addition to terminating Tenants tenancy and/or accepting a
surrender, or in lieu thereof, pursue such other remedy or combination of remedies and recover such
other damages for breach of tenancy and/or contract as available at law or otherwise.
B. In addition to the other remedies provided to each party under this Lease, each party is
entitled to all other remedies provided at law or in equity, including without limitation, to the
extent permitted by applicable law, injunctive relief in case of the violation, or attempted or
threatened violation, of any of the terms of this Lease, or to a decree compelling specific
performance of the terms of this Lease. No right or remedy of either party under this Lease is
-16-
intended to be exclusive of any other right or remedy. Each right and remedy of each party is
cumulative and may be exercised in addition to all other rights or remedies under this Lease, or
now or hereafter existing at law, in equity or by statute. The terms of this
paragraph 7
shall survive termination or expiration of the Lease.
8.
Hold Harmless and Indemnities
.
A.
From Tenant
. To the fullest extent permitted by law, Tenant agrees to exonerate,
save harmless, protect and indemnify Landlord and its shareholders, officers, employees and agents
from and against any and all losses, damages, claims, suit, actions, judgments and costs (including
reasonable attorneys fees incurred in defending against any of the foregoing) to the extent caused
by the negligence or acts or omissions of, or use of the Premises by Tenant, its agents, officers,
invitees, employees or contractors. Tenant does hereby indemnify and hold harmless Landlord from
and against any loss, claim damages or expenses, (including reasonable attorneys fees) which
Landlord may suffer, incur or expend arising out of any failure on the part of Tenant to fully
perform its obligations hereunder. Tenant shall reimburse and compensate Landlord for, as
Additional Rent, all expenditures made by, or damages, fines or costs (including reasonable
attorneys fees) sustained or incurred by Landlord due to non-performance of, non-compliance with,
or breach of, or failure by Tenant to observe, any term, covenant or condition of this Lease on
Tenants part to be kept, observed, performed or complied with together with interest from the date
any such amounts are paid by Landlord, with interest at the lesser of twelve percent (12%) per
annum or the maximum lawful rate.
B.
From Landlord.
To the fullest extent permitted by law, Landlord agrees to
exonerate, save harmless, protect and indemnify Tenant and its shareholders, officers, employees
and agents from and against any and all losses, damages, claims, suit, actions, judgments and
costs
-17-
(including reasonable attorneys fees incurred in defending against any of the foregoing) to the
extent caused by the negligence of Landlord with respect to acts or omissions occurring before the
Delivery of the entirety of the Premises, including all Select Areas (
Completed Delivery Date
)
or the gross negligence of the Landlord from and after the Completed Delivery Date or willful
misconduct of the Landlord, its agents, officers, invitees, employees or contractors, provided,
however, that Landlord shall in no event be liable to Tenant for any consequential damages, lost
profits, loss of business or loss of product. [
The Completed Delivery Date is March 1, 2007.
]
C.
Waiver of Subrogation.
Anything in this Lease to the contrary notwithstanding,
Landlord and Tenant each hereby waives to the extent each is actually insured against the same any
and all rights of recovery, claim, action or cause-of action against the other for any loss or
damage that may occur to the Premises, or any improvements thereto, or any property of such party
therein, by reason of fire, the elements, or any other cause which could be insured against under
the terms of standard fire and extended coverage insurance policies, regardless of cause or origin,
including negligence of the other party hereto, its agents, officers or employees, and covenants
that no insurer shall hold any right of subrogation against such other party.
9.
Landlords Access to the Premises
. Tenant agrees that it will allow the Landlord,
its agents or employees to enter the Premises at all reasonable times and upon reasonable prior
written notice (except in an emergency when no notice shall be required) to examine, inspect or
protect the same or to prevent damage or injury to the same or to make such alterations and
repairs to the Premises as the Landlord may deem necessary to comply with this Lease.
Notwithstanding the foregoing, except in the event of an emergency, Tenant may require that
Landlord be accompanied by a representative of Tenant during entry into certain portions of the
Premises.
-18-
10.
Survival
. The provisions of
paragraphs 3E, 5 (which shall include the
applicable provisions of the Lease Addendum), 7, 8, 11, 10, 12, 13, 16, 17, 20C, 20D, 20E, 23, 27
and 30
of this Lease and Tenants liability for all amounts due under this Lease shall survive
the termination of this Lease.
11.
Landlords Exclusions of Liability
. Neither the Landlord, nor any of its
shareholders, officers, employees or agents, shall be liable for (i) loss or damage to any
property of Tenant, or of any entity within Tenants control, from any cause whatsoever other than
such loss or damage arising from Landlords negligence prior to the Completed Delivery Date or
gross negligence on or after the Completed Delivery Date or willful misconduct, (ii) any damage
referred to in clause (i) caused by other occupants or tenants of The Johns Hopkins University
Belward Research Campus or by construction, reconstruction or repair by Landlord or anyone acting
on Landlords behalf or with Landlords authority, or (iii) any latent defect in the Premises or
The Johns Hopkins University Belward Research Campus; and Tenant shall not be entitled to any
compensation for any of the above, or abatement of Rent or to any release from any of Tenants
obligations under this Lease, provided, however, that nothing herein provided shall preclude
Tenant from seeking the recovery of any actual damages (but not consequential damages, lost
profits, loss of business or loss of product) arising from Landlords negligence or gross
negligence, as the case may be, as hereinabove provided, willful misconduct or breach of any
express representation or warranty set forth in this Lease.
12.
Notices
. Any notices or demands required or permitted to be given hereunder shall
be given to Landlord or Tenant, respectively, by (i) prepaid certified mail, return receipt
requested, or (ii) nationally recognized overnight delivery service. Notice shall be given to the
parties at the addresses set forth below, or at such other address as either party shall designate
by written notice to
-19-
the other, and shall be effective the next business day if sent by overnight delivery service, or
four
(4) business days after mailing by certified mail.
|
To Landlord:
|
|
Human Genome Sciences, Inc.
14200 Shady Grove Road
Rockville, Maryland 20850
Attention: Timothy C. Barabe
Senior Vice President and
Chief Financial Officer
E-mail:
Tim_Barabe@hgsi.com
|
|
|
With a copy to:
|
|
James H. Davis, Esquire
Executive Vice President, General Counsel
Human Genome Sciences, Inc.
14200 Shady Grove Road
Rockville, Maryland 20850
E-mail:
Jim_Davis@hgsi.com
|
|
|
To Tenant:
|
|
Novavax, Inc.
9920 Belward Drive
Rockville, Maryland 20850
Attention: Chief Financial Officer
|
|
|
With a copy to:
|
|
Novavax, Inc.
9920 Belward Drive
Rockville, Maryland 20850
Attention: General Counsel
|
13.
Broker
. Landlord and Tenant represent to the other that no broker or agent other
than Stream Realty Partners, L.P, and Scheer Partners, Inc. (
Brokers
) are entitled to a
commission or brokerage fee in connection with the Sublease and this Lease. Landlord shall be
responsible to pay all commissions or brokerage fees due to the Brokers pursuant to separate
agreement(s) between Landlord and Brokers. Each party agrees to indemnify and hold the other
harmless from and against any claim for any commissions, fees or other form of compensation by any
other broker claiming through the indemnifying party, including, without limitation, any and all
claims, causes of action,
-20-
damages, costs and expenses (including attorneys fees), associated therewith. The provisions of
this paragraph shall survive the termination of this Lease.
14.
Condemnation
.
A. If more than twenty-five percent (25%) of the Premises is taken or condemned for a
temporary or permanent public or quasi-public use (
Condemnation
), this Lease shall terminate at
the option of Landlord by notice delivered to Tenant within thirty (30) days of the Condemnation
and Tenant shall have no claim against Landlord for the value of any unexpired portion of the Lease
Term and shall not be entitled to any part of any award which may be made or to any damages
therefor, except that the Rent shall be adjusted as of the date of such termination. Tenant may
make a separate claim against the condemning authority for damages allowed by law provided that any
such award shall not reduce the amount otherwise payable to Landlord. Landlord has no obligation to
restore the Premises as a result of any condemnation or exercise of eminent domain. In the event of
a Condemnation which does not result in the termination of this Lease, Landlord and Tenant shall
agree to an equitable abatement of the Rent in proportion to the value of the Premises condemned.
B. If less than twenty-five percent (25%) of the Premises is subject to a Condemnation and/or
no election has been made by Landlord to terminate this Lease, and subject to Landlords lender
making available to the Landlord award proceeds relating to such Condemnation for the purpose of
restoration of the Premises, then Landlord shall promptly commence and diligently pursue
restoration of the remainder of the Premises.
C. In the event of a condemnation which renders the Premises substantially unfit for Tenants
then current use of same for offices, laboratory and/or manufacturing purposes, as the case may be
(
Functional Utility
), and either the Landlord shall have determined that Functional
-21-
Utility cannot be restored within one hundred eighty days (180) of such condemnation (
Condemnation
Restoration Period
), or if in fact Functional Utility is not restored within the Condemnation
Restoration Period, Tenant shall have the right to elect to terminate the Lease upon delivery of
written notice to Landlord. In the event Tenant exercises its right to terminate the Lease in
accordance with this
subparagraph 14B
, Rent (subject to such equitable abatement as shall
have previously been agreed to by the parties pursuant to
subparagraph 14A
, above) shall be
adjusted as of the date of such termination.
15.
Damage by Fire or Other Casualty
.
A. If more than twenty-five percent (25%) of the Premises shall be damaged by fire or other
casualty, Landlord may, at its option, terminate this Lease, in which case all obligations of the
parties shall be adjusted as of the date of such termination. Except as provided in the
immediately preceding sentence or in
subparagraph 15B
hereof, no damage or destruction of
the Premises shall be grounds for termination of this Lease or relieve Tenant from its obligations
arising hereunder, including, without limitation the Tenants obligations to pay Rent. If Landlord
has not terminated this Lease, Tenant shall, at Tenants sole cost and expense be responsible for
repairing and restoring all of the licensed FF&E (as defined below), all of Tenants improvements,
and for replacing any equipment and trade fixtures of Tenant located in the Premises.
B. If less than twenty-five percent (25%) of the Premises shall be damaged by fire or other
casualty and/or there is no election to terminate this Lease in accordance with the terms hereof,
and subject to Landlord (i) obtaining approval of its mortgagee and (ii) thereafter advancing such
insurance proceeds to the Landlord, the Landlord will promptly commence and diligently pursue
restoration and repair of the Premises.
-22-
C. Other than with respect to a casualty caused by Tenant, its agents, employees or invitees,
in the event of a casualty which renders the Premises substantially unfit for Tenants then current
use of same for offices, laboratory and/or manufacturing purposes, as the case may be, and either
the Landlord shall have determined that Functional Utility cannot be restored within one hundred
eighty (180) days of such casualty (
Casualty Restoration Period
), or if in fact Functional
Utility is not restored within the Casualty Restoration Period, Tenant shall have the right to
elect to terminate the Lease upon delivery of written notice to Landlord. In the event Tenant shall
have the right to terminate the Lease in accordance with this
subparagraph 15B
, Rent shall
be adjusted as of the date of such Tenant termination.
16.
Entire Agreement
. This Lease contains the entire agreement between the parties
relating to the Premises and cannot be modified or terminated except by written instrument signed
by the parties hereto. No representations, understandings or agreements have been made or relied
upon in the making of this Lease other than those specifically set forth herein.
17.
Waiver of Jury Trial
. Landlord and Tenant waive trial by jury in any proceeding
or any matter in any way connected to this Lease.
18. Intentionally Omitted.
19.
Rules and Regulations
. Tenant will comply with all rules and regulations
contained in the Lease and/or which may be hereafter promulgated by Landlord, and shall comply
with all of the terms and provisions contained in the Protective Covenants, the Declaration and
the Easement Agreement. Landlord has no obligation to assure that other tenants and invitees of
The Johns Hopkins University Belward Research Campus comply with any of the foregoing.
-23-
20.
Hazardous Substances
.
A. Except for the work required to be performed by Landlord pursuant to
subparagraph
4C
above and except as specifically set forth in this Lease, Landlord makes no warranties or
representations of any type regarding (i) the environmental condition of the Premises or The Johns
Hopkins University Belward Research Campus, or (ii) the presence or absence therein or thereon of
any Hazardous Substances. Landlord represents to Tenant that neither Landlord, nor its agents,
employees or contractors has used, handled or manufactured within the Premises any penicillins or
cephalosporins.
B. Landlord acknowledges that Tenant will be using, storing or generating the Hazardous
Substances listed on
Exhibit K-1
and the potentially hazardous biological materials
identified in
Exhibit K-2
(
Biologics
). Tenant agrees that all such Hazardous Substances,
Biologics and all other potentially hazardous biological materials brought onto the Premises by or
for the Tenant will be stored, used, generated and disposed of in strict compliance with all
applicable laws, rules, regulations and ordinances of any governmental or quasi-governmental
authority having jurisdiction over the Premises. Tenant shall obtain, at Tenants sole cost, all
permits required by governmental authorities for the storage, use and generation of Hazardous
Substances, Biologics and all other potentially hazardous biological materials used in, on or
about the Premises, Tenant shall update
Exhibits K-1 and K-2
on August 1 and February 1 of
each year during the Lease Term, as the same may be extended.
C. Tenant agrees to indemnify, defend and hold harmless Landlord and its employees, agents,
successors and assigns, from and against any and all damage, claim, liability, or loss, including
reasonable attorneys and other fees, arising out of or in any way connected to Tenants
generation, treatment, storage or disposal of Hazardous Substances, Biologics and all other
-24-
potentially hazardous biological material. Such duty of indemnification shall include, but not be
limited to damage, liability or loss pursuant to all federal, state and local environmental laws,
rules and ordinances, strict liability and common law.
D. Landlord agrees to indemnify, defend and hold harmless Tenant, its employees, agents,
successors and assigns, from and against any and all damage, claim, liability, or loss, including
reasonable attorneys and other fees, arising out of or in any way connected to the generation,
treatment, storage or disposal of Hazardous Substances by Landlord, its employees, agents,
contractors or invitees in, on or near the Premises prior to the Full Delivery Date, except for any
Hazardous Substances introduced by Tenant after the Initial Delivery Date. Such duty of
indemnification shall include, but not be limited to damage, liability or loss pursuant to all
federal, state and local environmental laws, rules and ordinances, strict liability and common law.
E. Each party agrees to promptly notify the other of any disposal of Hazardous Substances in,
on or near the Premises, or any discovery of Hazardous Substances on or near the Premises, or of
any notice by a governmental authority or private party alleging or suggesting that a disposal of
Hazardous Substances on or near the Premises may have occurred.
F. Tenant agrees to promptly notify the Landlord of any notice by a governmental authority or
private party alleging or suggesting that an impermissible disposal of Biologies or any other
potentially hazardous biological materials on or near the Premises may have occurred.
21.
Insurance
. Tenant, at its sole cost and expense, shall maintain insurance as
required under
Article 6
of the Lease Addendum, and, in addition, prior to the
commencement of any manufacturing activities on, in or about the Premises Tenant shall obtain and
thereafter maintain an environmental insurance policy in an amount and insuring such risks as
shall be commercially
-25-
reasonable with respect to Tenants use and occupancy of the Premises. Tenant shall insure the FF&E
(as hereinafter defined) for its full replacement value. Tenant shall include Landlord as an
additional insured and loss payee on all such insurance required to be maintained by Tenant.
Evidence of such insurance shall be furnished to Landlord prior to the Initial Delivery Date, with
respect to the Initial Delivery Areas, the Full Delivery Date with respect to the Lab Areas and
within three (3) business days after Delivery of each of the Select Areas, and shall be
satisfactory to the Landlord in its reasonable discretion. Not less frequently than annually during
each Lease Year, Tenant shall provide Landlord with evidence, reasonably satisfactory to Landlord,
that all insurance required of Tenant hereunder remains in full force and effect.
22.
Subordination
. Subject to delivery of a non-disturbance agreement in a form
reasonably acceptable to Tenant, this Lease is subject and subordinate to all ground or underlying
leases and to all mortgages and/or deeds of trust which may now or hereafter affect this Lease or
the Premises, and to all renewals, modifications, consolidations, replacements and extensions
thereof. This clause shall be self-operative and no further instrument of subordination shall be
required by any mortgagee, trustee or ground lessor. In confirmation of such subordination, Tenant
shall, at the request of Landlord or any party secured by any such mortgage, deed of trust or
ground lease, promptly execute, acknowledge and deliver an instrument that has for its purpose and
effect the subordination of this Lease, provided the same contains non-disturbance language
materially the same
as set forth in Schedule 3 to this Lease
. Tenant hereby constitutes
and appoints Landlord the Tenants attorney-in-fact to execute any such certificate or
certificates referenced in this
paragraph 22
for and on behalf of the Tenant, provided the
same contains non-disturbance language materially the same as the SNDA referred to in
subparagraph 31B
of this Lease, in the event the Tenant fails or refuses within five (5)
business days following a written request to execute a Lease subordination
-26-
agreement in said form. Landlord represents and warrants that to the best of its actual knowledge,
that there are no ground or underlying leases or mortgages or deeds of trust affecting the
Premises as of the date hereof, and Landlord further represents and warrants that there are no
mortgages, security interests or subleases affecting the Landlords interests in the FF&E or this
Lease as of the date hereof.
23.
Holding Over
. If Tenant shall hold over after the expiration of the term of this
Lease, Tenant shall become a tenant by the month, and, during Tenants period of unauthorized
occupancy, Tenant shall be liable for, and shall pay to Landlord, 250% of the monthly installment
of Base Rent then in effect for the month immediately prior to the expiration of the Lease Term,
and the amount of any Additional Rent payable by Tenant pursuant to the terms of this Lease. In
addition, Tenant shall be liable for, and shall promptly reimburse Landlord for all costs incurred
by Landlord in connection with Tenants holding over to the extent not otherwise recoverable under
the preceding sentence. If Landlord shall desire to regain possession of the Premises promptly at
the expiration of the Lease Term, as the same may have been extended, then at any time prior to
Landlords acceptance of Rent from Tenant as a monthly tenant hereunder, Landlord, at its option
may, forthwith re-enter and take possession of the Premises without process, or by any applicable
legal process. For purposes of this
paragraph 23
, the Tenant shall be deemed to have held
over beyond the expiration of the Term of this Lease if the Tenant has not completed all requisite
Decommissioning in conjunction with any governmental licenses issued to Tenant in connection with
its use and occupancy of the Premises and all Decontamination as provided in
subparagraph
3E
hereof.
24.
Americans With Disabilities Act
. From and after the Initial Delivery Date, Tenant
shall be responsible for compliance with the Americans with Disabilities Act of 1990, as the same
may be amended, relating to Tenants use or occupancy of the Premises.
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25.
Representations.
Landlord and Tenant each acknowledge that their respective
officers executing this Lease have been duly authorized to do so and to bind their respective
company.
26.
Renewal Options.
Provided Tenant is not in default under this Lease beyond any
applicable notice and cure period, Tenant has the option to renew the Lease Term for two (2)
additional periods of three (3) years each and a third option to renew the Lease Term until March
30, 2021, each option exercisable upon not less than nine (9) months prior written notice to
Landlord given prior to the expiration of the initial Lease Term or the then applicable extension
period, whichever is applicable. If this Lease is so renewed, the Base Rent for each extension
period shall continue to increase by 2.125% as set forth in
subparagraph 2C
above. All
other terms and provisions of this Lease shall govern each extension period, except that upon each
such extension Tenant shall have one (1) less option to extend the Lease Term. Notwithstanding the
foregoing, if Tenant is then in default under the provisions of this Lease beyond any applicable
notice and cure period at what would have been the commencement date of the then applicable
extension period, or if Tenant fails to timely give its notice to extend the Lease Term, Tenants
option to renew shall be null and void and of no further force or effect.
27.
Signage
. Tenant may install, affix or use any signs or other advertising or
identifying media to the exterior of the Building or within the Premises; provided that: (i) such
signage does not materially adversely affect the structural integrity of the Premises; (ii) any
and all signs and other advertising or identifying media installed, affixed or used by Tenant upon
the Premises shall comply with any and all governmental laws, regulations, ordinances and rules
and all recorded restrictions and covenants; and (iii) Tenant shall prior to the scheduled
termination of this Lease or within thirty (30) days after the earlier termination of this Lease
cause all such signage to be removed and shall
-28-
restore the Premises to its condition prior to installation of such signage and repair any damage
to the Premises caused by such removal.
28.
Counterparts; Telefacsimile Execution
. This Lease may be executed in any number of
counterparts, and by each of the parties on separate counterparts, each of which, when so executed,
shall be deemed an original, but all of which shall constitute but one and the same instrument.
Delivery of an executed counterpart of this Lease by telefacsimile shall be equally as effective as
delivery of a manually executed counterpart of this Lease. Any party delivering an executed
counterpart of this Lease by telefacsimile shall also deliver a manually executed counterpart of
this Lease, but the failure to deliver a manually executed counterpart shall not affect the
validity, enforceability or binding effect of this Lease.
29.
Parking
. The parking area of the Premises consists of 134 parking spaces, and
Tenant shall have use of all of such spaces.
30.
License to Use Furniture, Fixtures and Equipment
. During the Lease Term and in
the absence of a default under the Lease beyond any applicable notice and cure period, Tenant
shall have a license to use the furniture, fixtures and equipment
(FF&E)
owned by Landlord and
located within the Premises, which FF&E is listed on
Exhibit L
attached hereto and made a
part hereof. Tenant shall, at Tenants sole cost and expense, keep the FF&E in the same order and
condition as on the Lease Commencement Date, and shall repair and maintain the FF&E. Unless the
license to use all or part of the FF&E is revoked by Landlord prior to the Lease Expiration Date,
as a result of a Tenant default under this Lease beyond any applicable notice and cure period,
Tenant shall return all FF&E to Landlord at the expiration or earlier termination of this Lease in
the same order and condition it was in at the Lease Commencement Date, reasonable wear and tear
and loss or damage
-29-
by casualty or condemnation (provided Landlord has received insurance or condemnation proceeds
relating to same) excepted.
31.
Intentionally Omitted
.
32.
Capitalized Terms
. Except as defined herein, capitalized terms used herein shall
bear the same meaning ascribed to them in the Lease Addendum.
33.
Time of the Essence.
Time is of the essence of each provision of this Lease.
34.
No Construction Against Drafting Party
. The rule of construction that ambiguities
are resolved against the drafting party shall not apply to this Lease.
35.
Governing Law
. The terms of this Lease shall be governed in accordance with the
laws of the State of Maryland.
36.
Interpretation
. If any provision of this Lease or application thereof to any
person or circumstance shall, for any reason and to any extent, be invalid or unenforceable, the
remainder of this Lease and the application of that provision to other persons or circumstances
shall not be affected but rather shall be enforced to the extent permitted by law. The captions,
headings and titles, if any, in this Lease are solely for convenience of reference and shall be
construed without regard to any presumption or other rule requiring construction against the party
causing this Lease to be drafted. Any words or phrases in this Lease shall be construed as if the
words or phrases so stricken out or otherwise eliminated were never included in this Lease and no
implication or inference shall be drawn from the fact that said words or phrases were so stricken
out or otherwise eliminated. Each covenant, agreement, obligation or other provision of this Lease
shall be deemed and construed as a separate and independent covenant of the party bound by,
undertaking or making same, not dependent on any other provision of this Lease, unless otherwise
expressly provided. All terms and words used in this Lease, regardless of the number or gender, in
which they are used, shall
-30-
be deemed to include any other number and other gender as the context may require. The word
person
as used in this Lease shall mean a natural person or persons, a partnership, a corporation
or any other form of business or legal association or entity. References to paragraphs and
subparagraphs shall mean the paragraphs and subparagraphs of this Lease unless the context clearly
requires otherwise.
37.
Recitals, Exhibits and Schedules
. The recitals set forth above, and the Exhibits
and Schedules attached hereto, are material and substantive parts of this Lease and are
incorporated herein by this reference.
38.
Binding Effect
. The covenants, agreements and obligations set forth in the Lease
and the Lease Addendum, except as herein otherwise specifically provided, shall extend to, bind
and inure to the benefit of the parties here to and their respective personal representatives,
heirs, successors and assigns (but in the case of assigns only to the extent that assignment is
permitted hereunder). No third party, other than such successors and assigns, shall be entitled to
enforce any or all of the terms of this Lease or Lease Addendum or shall have rights hereunder or
thereunder whatsoever.
[Signature Page Follows]
-31-
IN WITNESS WHEREOF, the parties hereto have executed this Lease as of the
date first above written.
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Landlord:
GP ROCK ONE, L.L.C.
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By:
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HUMAN GENOME SCIENCES, INC.,
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its sole Member
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/s/ Illegible
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By:
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/s/ Barry Labinger
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(SEAL)
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Witness/Attest
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Name:
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Barry Labinger
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Title:
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Executive VP & CCO
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Tenant:
NOVAVAX, INC.
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/s/ Illegible
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By:
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/s/ Rahul Singhvi
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(SEAL)
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Witness/Attest
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Name:
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Rahul Singhvi
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Title:
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President & CEO
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EXHIBITS AND SCHEDULES
Exhibits
A
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Lease Addendum
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B
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Certificate re: Commencement Date
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C
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Certificate re: Full Delivery Date and Expiration Date
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D
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Certificate re: Lab Area and Select Area Delivery
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E
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Declaration of Covenants, Easements and Restrictions (Protective Covenants)
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F
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Declaration of Covenants, Conditions, Easement and Restrictions
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G
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Easement Agreement
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H
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Initial Delivery Areas Description
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I
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Lab Areas Description
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J
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Select Areas Description
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K-l
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Hazardous Substances
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K-2
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Biologics
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L
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FF&E
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M
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Intentionally Omitted
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Schedules
1-A
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Select Areas
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1-B
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Initial Delivery Areas
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2
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Intentionally Omitted
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3
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Non-Disturbance
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EXHIBIT A
LEASE ADDENDUM
THIS LEASE ADDENDUM is dated as of even date with, and is attached to and made part of, that
certain Lease Agreement dated of even date by and between GP ROCK ONE, L.L.C., a Rhode Island
limited liability company, as Landlord, and NOVAVAX, INC., a Delaware corporation, as Tenant,
regarding those certain Premises located at 9920 Belward Drive, Rockville, Maryland 20850, as more
fully described in the said Lease Agreement. References in the Lease or in this Lease Addendum to
this Lease or the Lease shall be deemed to include the terms and conditions of this Lease
Addendum.
Article 1.
Taxes
. Throughout the term of this Lease and any extension, Tenant shall pay,
as Additional Rent, all taxes, charges and assessments, general and special, ordinary and
extraordinary, of every nature and kind whatsoever, and all water rates and sewage or sewer use
charges levied, assessed or imposed upon the Premises or any portion thereof, whether such tax,
rate, charge or assessment shall be for village, town, county, state, federal or any other purpose
whatsoever, Tenant hereby covenanting to pay taxes and assessments upon the real estate as well as
upon the improvements thereon and the personal property used in connection with the operation of
the Premises (collectively, the
Taxes
and separately, a
Tax
), but only to the extent the Taxes
arise during and relate to the term of this Lease. Such Taxes shall include, without limitation,
all general real property taxes and general, special and area-wide assessments, charges, fees,
assessments for transit, police, fire or other governmental services or purported benefits to the
Premises, service payments in lieu of or in addition to real estate taxes, and any tax, fee or
excise on the act of entering into this Lease or on the use or occupancy of the Premises or any
part thereof or on the rent payable under this Lease or in connection with the business of renting
the Premises (other than Landlords income and/or franchise taxes), that may be now or may
hereafter be levied or assessed against the Premises or Landlord by the United States of America,
the State of Maryland, Montgomery County, or any political subdivision, public corporation,
district or other political or public entity. Should any governmental agency or political
subdivision impose any taxes and/or assessments, whether or not now customary or within the
contemplation of the parties hereto, either by way of substitution for taxes and assessments
presently levied and assessed against the real estate as well as the improvements thereon, or in
addition thereto, including, without limitation, any taxes based upon the rentals received by
Landlord hereunder (other than an income or franchise tax), such taxes and/or assessments shall be
deemed to constitute a Tax for the purpose of this
Article 1
and shall be paid by Tenant.
Taxes payable by Tenant hereunder shall also include reasonable costs, disbursements and legal
fees of Landlord incurred in connection with proceedings to contest, determine or reduce any such
taxes, charges or assessments; provided that, so long as Tenant is not in default under this
Lease, Landlord shall not commence any such contest or proceeding without the consent of Tenant,
which consent shall not be unreasonably withheld. Tenant shall furnish to Landlord a receipted tax
bill and other satisfactory evidence of the payment of such taxes, assessments and charges within
ten (10) days after the same are due and payable. Tenants obligations under this
Article
1
shall survive the expiration or earlier termination of the Lease. Landlord shall promptly
upon its receipt furnish Tenant with copies of all proposed assessments and final bills for all
Taxes.
Exhibit A; page -1-
Lease Addendum
1.1.
Escrow for Taxes
. If required by Landlords mortgagee at any time after a
default by Tenant in the payment of Base Rent, taxes or any other monetary obligation under this
Lease, Tenant thereafter shall pay all Taxes accruing during the term hereof to Landlord in
monthly installments on or before the first day of each calendar month, in advance, in an amount
estimated by Landlords mortgagee. Upon receipt of all statements for Taxes due for a calendar
year, Landlord shall submit to Tenant a written statement of the actual amount of the Taxes for
such year and the amount, if any, then paid by Tenant. If the total amount paid by Tenant under
this
Article 1.1
for any year shall be more or less than the actual amount due from Tenant
for such year, as shown in such statement, either Tenant shall pay to Landlord the shortfall
within ten days after receipt of the statement or such excess shall be credited against the next
installment of Taxes due from Tenant to Landlord hereunder, as the case may be. All amounts due
hereunder shall be payable to Landlord at the place where the rental is payable and shall be held
in an interest bearing account for the benefit of Tenant with a financial institution designated
by Landlords mortgagee. A copy of a Tax bill submitted by Landlord to Tenant shall at all times
be sufficient evidence of the amount of Taxes levied, assessed or imposed against the Premises to
which such bill relates. Landlords and Tenants obligations under this Section shall survive the
expiration of the Lease Term. In the event of any default by Tenant hereunder, any such deposits
may be used by Landlord to cure the default, but Landlord shall be under no obligation to do so
and Tenant shall have no authority to direct Landlord to apply such deposits against any
obligation of Tenant hereunder.
1.2.
Right to Contest
. Tenant may contest in good faith by appropriate proceedings at
its own expense any Taxes provided that Tenant shall first have paid such Taxes or, if the payment
of such Taxes is to be postponed during the contest, shall have furnished Landlord with a bond of a
surety company reasonably satisfactory to Landlord in an amount equal to, or shall have deposited
with any bank or trust company of Landlords selection in the State wherein the Premises are
located to hold such deposit and apply the same as hereinafter provided, the amount of the Taxes so
contested, together with such additional sums as may reasonably be required to pay interest or
penalties accrued or to accrue on any such Taxes. Nothing contained herein, however, shall release
Tenant of the obligation to pay and discharge contested Taxes as finally adjudicated, with interest
and penalties, and all other charges directed to be paid in or by any such adjudication. Any such
contest or legal proceeding shall be begun by Tenant as soon as reasonably possible after the
imposition of any contested Taxes and shall be prosecuted to final adjudication with all reasonable
promptness and dispatch; provided, however, that Tenant may in its discretion consolidate any
proceeding to obtain a reduction in the assessed valuation of the Premises for tax purposes
relating to any tax year with any similar proceeding or proceedings relating to one or more other
tax years. Notwithstanding anything contained herein to the contrary, Tenant shall pay all such
contested items before the time when the Premises or any part thereof might be forfeited as a
result of nonpayment.
1.3.
Landlords Cooperation
. Landlord shall join in any proceedings referred to in
Article 1.2
and hereby agrees that the same may be brought in its name, if the provisions
of any law, rule or regulation at the time in effect shall so require. Tenant shall indemnify and
save Landlord harmless from any liabilities, losses, or expenses (including reasonable attorneys
fees) in connection with any such proceedings in which Landlord shall join or permit to be brought
in its name. So long as Tenant is not in default under any term or condition of this Lease, (i)
Tenant shall be entitled to any refund of any Taxes, and all penalties or interest thereon
received by Landlord which shall have
Exhibit A; page -2-
Lease Addendum
been paid by Tenant, or which shall have been paid by Landlord but previously reimbursed in full by
Tenant and (ii) Landlord shall not, without Tenants prior written approval (which shall not be
unreasonably withheld), agree to any settlement, compromise or other disposition of any such
proceedings or discontinue or withdraw from any such proceedings or accept any refund of any Taxes
as a result of any such proceedings.
Article 2.
Use of Premises
. Tenant shall not use or allow the Premises to be used for any
improper or unlawful purpose or for any purpose which could violate any recorded covenant or
restriction affecting the Premises. Tenant shall not cause or maintain or permit any nuisance or
commit or suffer the commission of any waste in, on or about the Premises. Tenant may install on
the Premises such trade fixtures and equipment as Tenant deems necessary for its business
activities; provided that the installation and use of all such trade fixtures and equipment shall
be in compliance with any and all applicable governmental laws, rules, regulations and ordinances
and no such trade fixture or equipment shall be affixed to the exterior of the Building or in any
manner which affects the roof or structural components of the Building without the prior written
consent of Landlord which consent shall not be unreasonably withheld, conditioned or delayed. Title
thereto shall remain in Tenant, even though such equipment may be affixed to the Premises. On
termination of this Lease, the removal of such property is governed by
Article 9
of this
Lease Addendum. Except for as represented by Landlord in the Lease, Tenant acknowledges and agrees
that it has made its own independent investigation to confirm that the Tenants use of the Premises
for office and laboratory operations will comply with all applicable covenants and restrictions and
all applicable governmental codes, rules and regulations in effect as of the execution of this
Lease. Notwithstanding the foregoing, Tenant may plan, design, construct, supervise and maintain
upon the roof and/or the exterior of the Building any antennas, satellite dishes and similar
communications facilities, provided that the same (i) do not impair the structural integrity of the
Building, (ii) does not void or impair any roof warranty for the Building that has been provided in
writing to Tenant, and (iii) complies with all applicable governmental codes, ordinances, rules,
regulations and laws. Any such facility which shall be so installed or erected shall, unless and
until Tenant shall remove the same, be maintained by Tenant at Tenants own cost and expense and
any damage to the Premises caused by the removal thereof shall be repaired, at Tenants expense,
upon the expiration or earlier termination of the term of this Lease.
Article 3.
Repairs/Operating Expenses
. Throughout the Lease Term, Tenant shall keep the
Premises in good condition and repair and be responsible for all costs of operating the Premises
and all maintenance, repairs and replacements to the Premises, structural and nonstructural,
ordinary or extraordinary, foreseen or unforeseen, including, but not limited to, all structural
repairs and replacements to the foundation, exterior and/or load bearing walls, roof, and
mechanical systems of the Premises and all landscaping, sidewalks and parking areas contained in
or about the Premises, and all common area and easement expenses and assessments, including, but
not limited to, all assessments imposed on the Premises under the covenants and restrictions for
the Johns Hopkins Belward Campus Biotechnology Park and/or any easement agreement appurtenant to
the Premises. Tenant shall pay any and all such assessments and charges as and when due and shall
make all such repairs and replacements as may be necessary to maintain the Premises in a condition
consistent with other first class office/laboratory (and if altered in accordance with
Article
5
of this Addendum, biomedical manufacturing) buildings located in the State of Maryland,
provided that Tenant shall not
Exhibit A; page -3-
Lease Addendum
be required to provide or install upgraded building improvements of a scope or quality greater than
the scope and quality of the original Building. Tenant shall keep the Premises in a clean, safe,
sanitary and tenantable condition in a manner compatible with its intended use, shall not permit
any garbage, waste, refuse or dirt of any kind to accumulate in or about the Premises, shall keep
all drives, parking areas, entrances and pedestrian walkways reasonably free from snow and ice and
shall make any repairs, replacements or improvements which may be required by any laws, rules,
regulations, ordinances or orders of any federal, state, local or other governmental authority
having jurisdiction over the Premises. Tenant shall further use all reasonable precaution to
prevent waste, damage or injury to the Premises. Notwithstanding the foregoing, Tenant shall not be
required to replace any component of the Improvements during the last twelve (12) months of the
Lease term (including any extension options which have been exercised by the Tenant); provided that
Tenant shall maintain the Improvements and surrender the Improvements and all building systems at
the end of the term of this Lease in good operating condition.
Article 4
.
Utilities
. Throughout the term hereof, Tenant shall be responsible for and
shall promptly pay as and when due all charges for heat, water, gas, electricity and sanitary
sewer charges, as well as any charges for any other utility used or consumed in, on or upon the
Premises. Tenant shall at all times keep the Premises sufficiently heated so as to prevent
freezing and deterioration thereof and/or of the equipment and facilities contained therein.
Article 5.
Alterations
. Except as otherwise expressly provided in this
Article 5
,
Tenant shall not make or suffer to be made, any alterations, additions or improvements to the
Premises (each an
Alteration
and collectively, the
Alterations
), in excess of One Hundred
Thousand Dollars ($100,000.00) for any single Alteration, or in excess of Two Hundred Fifty
Thousand Dollars ($250,000.00) in the aggregate for all Alterations within a twelve (12) month
period or which affect the structural or mechanical components of the Premises in, on or to the
Premises or any part thereof without the prior written consent of Landlord, which consent shall not
be unreasonably withheld, conditioned or delayed; Landlords consent to any Alterations for which
Landlords consent is required hereunder shall be contingent upon Tenant agreeing to the following
minimum conditions:
5.1.
Cost.
Tenant shall pay or cause to be paid the entire cost of the
Alterations;
5.2.
Plans
. Plans and specifications for all Alterations shall be submitted to
Landlord for prior written approval, which approval shall not be unreasonably withheld;
5.3.
Liens
.
Tenant shall take all necessary steps to prevent the imposition of liens
against the Premises as a result of the Alterations;
5.4.
Indemnity
. Tenant shall agree to hold Landlord harmless from all claims, losses,
liabilities, damages, and expenses (including reasonable attorneys, fees) resulting from any
Alterations; and
5.5.
Permits
. Tenant shall obtain and pay for all necessary permits and shall comply
with all applicable governmental requirements and insurance rating bureau recommendations.
Exhibit A; page -4-
Lease Addendum
Notwithstanding the foregoing, in the event that Novavax desires to convert a portion of the
Premises for use as biomedical manufacturing facilities, any alterations in connection therewith
shall be subject only to the requirements of subsections 5.1 through 5.5.
Provided that Landlord incurs no additional responsibility, cost or liability for the removal
and/or restoration of any Alterations made by Tenant, during the Lease Term, Tenant shall have the
right to remove, modify and/or relocate any and all existing Alterations made by Tenant and
fixtures and equipment owned by Tenant provided that (i) Tenant repairs any damage caused by such
removal and (ii) the Premises shall be delivered to Landlord in good repair and working order,
normal wear and tear excepted. At the termination of the Lease Term, removal of Alterations made by
Tenant and fixtures and equipment owned by Tenant shall be governed by
Article 9
of this
Lease Addendum.
Article 6.
Insurance
.
6.1.
Liability Insurance
. Tenant shall, during the entire term hereof, keep in full
force and effect a policy of comprehensive general public liability insurance with respect to the
Premises, and the business operated by Tenant in the Premises, in which the primary coverage per
accident or occurrence is not less than $1,000,000 combined single limit and the umbrella coverage
per accident or occurrence is not less than $10,000,000, or in such greater amounts as Landlord
may reasonably determine in accordance with prudent business practices.
6.2.
Property Insurance
. Tenant agrees to carry, at its expense, property insurance
insuring against fire, vandalism, malicious mischief, and such other hazards as are from time to
time included in a standard extended coverage endorsement, insuring the Premises in an amount
equal to the full replacement value of the Premises (with an agreed amount endorsement, excluding
land value, landscaping, foundation and excavation costs, and costs of underground flues, pipes
and drains), together with rental interruption insurance in an amount equal to twelve (12) months
fixed base rental and real estate tax payments, and insuring the betterments and improvements made
by it to the Premises, and all trade fixtures, furnishings and equipment owned by Tenant and
located on or within the Premises, in an amount equal to the full replacement value thereof.
6.3.
Requirements
. The policies required under this
Article 6.3
shall name
Tenant and Landlord and any other parties in interest designated by Landlord as insureds as their
respective interests may appear, and shall contain a clause that the insurer will not cancel or
change the insurance without first giving the Landlord thirty (30) days prior written notice. Such
insurance may be furnished by Tenant under any blanket policy carried by it or under a separate
policy therefor. The insurance shall be with carriers with a Best financial quality rating of A or
better and a financial size rating of XII or better. A copy of the paid-up policies or
certificates of the insurers evidencing the maintenance of such insurance policies shall be
delivered to Landlord prior to commencement of the term of this Lease or Tenants occupancy,
whichever is sooner, and, upon renewals, prior to the expiration of a coverage period. All such
policies shall be written as primary policies, not contributing with and not in excess of the
coverage that Landlord may carry. Tenant agrees that if
Exhibit A; page -5-
Lease Addendum
Tenant does not take out and maintain insurance, Landlord may (but shall not be required to)
procure said insurance on Tenants behalf and at its cost to be paid by Tenant as additional rent.
Article 7.
Intentionally Omitted
.
Article 8.
Right to Cure; No Waiver, Accord or Satisfaction
. In addition
to the parties respective rights and remedies under
paragraph 7
of the Lease, the following
provisions shall apply:
8.1.
Landlords Right to Cure
. All covenants and agreements to be performed by the
Tenant under any of the terms of this Lease shall be performed by Tenant at Tenants sole cost and
expense and without any abatement of Rent. If the Tenant shall fail to pay any sum of money
required to be paid by it hereunder, other than Rent, or shall fail to perform any other act on its
part to be performed hereunder, and such failure shall continue past any period of notice or cure
provided under
paragraph 7
of the Lease, the Landlord may, but shall not be obligated to,
cure such default, without waiving or releasing the Tenant from any other default by Tenant under
this Lease. All sums so paid by the Landlord and all necessary incidental costs (including
reasonable attorneys fees) incurred by Landlord in enforcing any of the terms, covenants or
conditions of this Lease, or curing any default or in suing for or obtaining relief by reason of a
breach thereof, together with interest on all of the foregoing at the rate set forth in
subparagraph 2F
of the Lease from the date of payment by the Landlord, shall be payable as
Additional Rent to the Landlord on demand. Landlord shall have, in addition to any other right or
remedy of the Landlord, the same rights and remedies in the event of the nonpayment thereof by the
Tenant as in the case of default by the Tenant in the payment of Rent.
8.2.
Tenants Right To Cure
. If Landlord fails to perform or observe any of the
obligations on Landlords part to be performed or observed pursuant to this Lease, and such
failure continues for thirty (30) days after written notice thereof is sent by Tenant to Landlord
informing Landlord of such failure, then Landlord shall be deemed to be in default under this
Lease; provided, however, that if the failure set forth in Tenants notice is such that it
requires more than thirty (30) days to correct, Landlord shall not be deemed to be in default
hereunder if Landlord: (i) promptly and diligently commences curing the failure within thirty (30)
days after written notice is sent by Tenant to Landlord informing Landlord of such failure; and
(ii) diligently prosecutes the cure to completion following the expiration of the original thirty
(30) day period set forth herein. Upon such default by Landlord, Tenant may, in addition to any
remedies available to it at law or in equity, perform the same for and on behalf of Landlord, the
cost of which performance, upon the proper payment thereof, together with all interest and
penalties necessarily paid in connection therewith and any and all other damages incurred by
Tenant as a result of any such default, shall be paid to Tenant by Landlord upon demand, with
interest thereon at the rate set forth in
paragraph 7
of the Lease, from the date of each
expenditure.
8.3.
Waivers
. A waiver by Landlord of a breach or default by Tenant under the terms
and conditions of this Lease shall not be construed to be a waiver of any subsequent breach or
default nor of any other term or condition of this Lease, and the failure of Landlord to assert
any breach or to declare a default by Tenant shall not be construed to constitute a waiver thereof
so long as such breach or default continues unremedied.
Exhibit A; page -6-
Lease Addendum
8.4.
No Accord or Satisfaction
. No receipt of money by Landlord from Tenant after the
expiration or termination of this Lease or after the service of any notice or after the
commencement of any suit, or after final judgment for possession of the Premises shall reinstate,
continue or extend the term of this Lease or affect any such notice, demand or suit.
Article 9.
Termination
. Upon the termination of this Lease, by expiration or otherwise,
Tenant shall surrender the Premises to Landlord in as good condition and repair as when delivered
by Landlord, excepting ordinary wear and tear, condemnation, damage from any cause not required to
be repaired or replaced by Tenant and permitted Alterations. All Alterations and decorations made
to the Premises by and paid for by Tenant, in addition to all moveable furnishings, trade fixtures
and other equipment and personal property owned by Tenant, shall be removed from the Premises by
Tenant at Tenants sole cost and expense no later than the date of termination and Tenant shall
repair any and all damage caused by such removal. If the Premises are not surrendered upon the
scheduled termination of this Lease as set forth herein or within fifteen (15) days after earlier
termination as set forth herein, Tenant shall indemnify Landlord against all loss, liability and
expense (including reasonable attorneys fees) resulting from delay by Tenant in so surrendering
the Premises, including, without limitation, any claim made by any succeeding tenant founded on
such delay (but excluding Landlords lost profits so long as Tenant pays the holdover Rent called
for under
paragraph 23
of the Lease). Tenant shall also surrender all keys to the Premises
and shall inform Landlord of combinations in any locks, safes and vaults, if any, in the Premises.
Notwithstanding the foregoing or anything to the contrary contained herein, if Tenant makes
alterations to any portion of the Premises in accordance with the provisions of
Article 5
of this Addendum in order to convert such portion to biomedical manufacturing facilities, such
alterations regardless of the cost or scope shall not be required to be removed by Tenant at the
end of the Term, nor shall Tenant be required to reimburse Landlord for any costs of such removal.
Article 10.
Quiet Enjoyment
. Landlord covenants, warrants and represents to Tenant that it
has full right and power to execute and perform this Lease and to grant the estate demised herein,
and Landlord further covenants that Tenant shall peaceably and quietly have, hold and enjoy the
Premises and all rights, easements, appurtenances and privileges belonging or in any way
appertaining thereto, during the full Term, subject to all matters of record.
Article 11.
Intentionally Omitted
.
Article 12.
Estoppel Certificates
. Landlord and Tenant agree that at any time and from
time to time upon not less than ten (10) days prior request of the other, they shall execute,
acknowledge and deliver to the requesting party a statement in writing certifying (a) that this
Lease is unmodified and in full force and effect (or if there have been modifications, specifying
the same), (b) the dates to which the rent and other charges have been paid, (c) that, so far as
the party giving the estoppel knows, the other party is not in default under any provisions of
this Lease (or if the party giving the estoppel knows of any such default, specifying the same)
and (d) such other matters as the requesting party or its lender shall reasonably request. It is
intended that any such statement may be relied upon by any person proposing to acquire Landlords
or Tenants interest in this Lease or any prospective mortgagee of, or assignee of any mortgage
upon, such interest.
Exhibit A; page -7-
Lease Addendum
Article 13.
Non-Liability of Landlord
. Landlord shall not be liable to Tenant, and Tenant
hereby waives all claims against Landlord, for any injury or damage to any person or property in or
about the Premises resulting from the Premises, or any part thereof or any equipment thereof,
becoming out of repair; flooding of basements or other areas; damages caused by sprinkling devices,
air conditioning apparatus, snow, frost, water leakage, steam, excessive heat or cold, falling
plaster, broken glass, sewage, gas, odors or noise or the bursting or leaking of pipes or plumbing
fixtures; any act or neglect of other tenants or occupants or employees in the Premises; or any
other thing or circumstance whatsoever concerning the Premises, whether of a like nature or of a
wholly different nature unless caused by the willful misconduct or gross negligence of Landlord.
All property in or about the Premises belonging to Tenant, its agents, employees or invitees shall
be there at the risk of Tenant or other person only, and Landlord shall not be liable for damage
thereto or theft, misappropriation or loss thereof. If Landlord shall fail to perform any covenant
or condition of this Lease upon Landlords part to be performed and, as a consequence of such
default, Tenant shall recover a money judgment against Landlord, then such judgment shall be
satisfied only out of the proceeds of sale received upon execution of such judgment and levy
thereon against the right, title and interest of Landlord in the Premises and out of rents or other
income from such property receivable by Landlord and any insurance or condemnation proceeds that
are available for use by Landlord and Landlord shall not be personally liable for any deficiency.
Article 14.
Transfer by Landlord
. In the event of a sale or conveyance by Landlord of the
Premises, the same shall operate to release Landlord from any future liability upon any of the
covenants or conditions herein contained which accrue after the date of transfer, and in such
event Tenant agrees to look solely to the successor in interest of Landlord in and to this Lease,
provided, further, that the transferee expressly agrees in writing to assume the Landlords
obligations. This Lease shall not be affected by any such sale or conveyance, and Tenant agrees to
attorn to the purchaser or grantee, which shall be obligated on this Lease only so long as it is
the owner of Landlords interest in and to this Lease. Landlord shall give Tenant written notice
of any such transfer.
Article 15.
No Liens
. Without in each instance the prior written consent of Landlord,
Tenant shall not directly or indirectly create or permit to be created or to remain, and will
immediately discharge, any lien, encumbrance, or charge on, or pledge of, the Premises, or any
part thereof, the interest of Tenant hereunder or therein, or the rent or other payments
hereunder, other than: (a) this Lease; (b) any assignment, pledge, lien, encumbrance, charge,
conditional sale, or title retention agreement affecting the Premises, resulting solely from (i)
any action by Landlord or (ii) any liability or obligation of Landlord which Tenant is not
obligated by this Lease to assume; (c) liens for Taxes not yet payable; (d) liens of mechanics,
materialmen, suppliers, or vendors, or rights thereto, incurred in the ordinary course of business
for sums which under the terms of the related contracts are not yet due, provided that such
reserve or other appropriate provision, if any, as may be required by generally accepted
accounting principles shall have been made therefor; or (e) liens created to finance Tenants
removable trade fixtures, equipment and all other personal property. In amplification and not in
limitation of the foregoing, Tenant shall not knowingly permit any portion of the Premises to be
used by any person or persons or by the public, as such, at any time or times during the term of
this Lease, in such manner as might tend to impair the title or interest of Landlord in the
Premises, or any portion thereof, or in such manner as might make possible a claim or claims
Exhibit A; page -8-
Lease Addendum
of adverse use, adverse possession, prescription, dedication, or other similar claims of, in, to,
or with respect to the Premises, or any part thereof.
Article 16.
Net Lease
. This Lease is intended to be and shall be an absolute net, net,
net lease, and the Rent and all other sums payable hereunder by Tenant (all of which shall be
deemed to be Additional Rent) shall be paid without notice or demand and without set-off,
counterclaim, abatement, suspension, deduction, or defense except as otherwise provided in this
Lease. As more particularly set forth herein, Tenant shall pay all Taxes, insurance premiums,
maintenance, repair and replacement costs and expenses, utility charges and expenses, and all other
costs and expenses, of whatever nature, relating in any way to the Premises and/or the operation
thereof during the term of this Lease except as otherwise provided in this Lease. In addition, this
Lease shall continue in full force and effect and the obligations of Tenant hereunder shall not be
released, discharged, diminished, or otherwise affected by reason of any damage to or destruction
of the Premises, or any part or parts thereof any partial taking; any restriction on or prevention
of or interference with any use of the Premises, or any part or parts thereof, except as otherwise
provided in this Lease. It is expressly understood and agreed that, except as specifically stated
herein to the contrary, Landlord shall have no responsibility or obligation, whatsoever, with
respect to the Premises or the condition or use thereof during the term of this Lease and shall be
absolutely, without limitation, exculpated from any and all such responsibilities and/or
obligations, all such responsibilities and obligations being those of Tenant.
Article 17.
Environmental Covenants
. Tenant shall not use the Premises for the production,
sale or storage of any toxic or hazardous chemicals, wastes, materials or substances, or any
pollutants or contaminants, as those terms are defined in any applicable federal, state, local or
other governmental law, statute, ordinance, code, rule or regulation (
Hazardous Substances
),
shall not use any Hazardous Substance in the Premises, and shall not permit any Hazardous
Substance to be disposed of from, in or on the Premises, unless said Hazardous Substances are of
the type normally used in the ordinary course of operating and maintaining Tenants office and
laboratory facilities, and are stored, used and disposed of in strict accordance with all such
laws, statutes, ordinances, codes, rules and regulations which are applicable to the Premises
(
Environmental Regulations
). Tenant shall not permit any Hazardous Substance to be emitted,
discharged, released, spilled or deposited from, in or on the Premises other than in the ordinary
course of operating and maintaining Tenants office and laboratory facilities as may be permitted
by law or applicable permit held by Tenant. Tenant shall obtain and maintain all licenses and
permits, and shall maintain all material safety data sheets, with respect to such Hazardous
Substances, which are required by any Environmental Regulation. Landlord shall have the right to
enter the Premises to inspect the same for compliance with the provisions of this
Article
17
; provided that: (i) entrance to the Premises shall not be denied to Tenant; (ii) the
business of Tenant shall not be interfered with unreasonably; and (iii) Landlord shall comply with
Tenants safety and other reasonable rules governing activities within the Premises. Tenant agrees
to indemnify Landlord against, and to hold Landlord harmless from, any and all claims, demands,
judgments, fines, penalties, costs, damages and expenses resulting from any violation by Tenant of
this
Article 17
or of any Environmental Regulation, including court costs and attorneys,
fees in any suit, action administrative proceeding or negotiations resulting therefrom, and
including costs of remediation, clean-up and detoxification of the Premises and the environment
unless caused by the willful misconduct or gross negligence of Landlord. Tenants obligations and
Exhibit A; page -9-
Lease Addendum
liabilities under this
Article 17
shall survive the termination of this Lease.
Article 18.
Modifications
. Tenant agrees to execute any reasonable modification of this
Lease which may be required by a lender as a condition to making a first mortgage loan on the
Premises; provided that no such modification shall alter the rent or term provided herein or reduce
the full economic value hereof or involve cost to Tenant.
Article 19.
Intentionally Omitted
.
Article 20.
Force Majeure
. In the event that Landlord or Tenant shall be delayed or
hindered in or prevented from the performance of any act required hereunder by reason of a Force
Majeure event, then performance of such act shall be excused for the period of the delay and the
period for the performance of any such act shall be extended for a period equivalent to the period
of such delay; provided that nothing contained in this Section 35 shall excuse, delay or otherwise
apply to the Tenants obligation to pay rent or any other monetary obligation hereunder. For
purposes hereof, a
Force Majeure
event shall mean delays or hindrances caused by (i) acts of
God; (ii) strikes, labor disputes, labor shortages (materially worse than the current labor supply
conditions in effect in October 2006) or material shortages outside of the partys control; (iii)
blackouts; (iv) acts of public enemy; (v) orders of any kind of the government of the United
States or of the State of Maryland or any department, agency, political subdivision or official of
either of them, or any civil or military authority; (vi) riots; (vii) epidemics disabling the
labor force; (viii) landslides; (ix) earthquakes affecting the Premises; (x) fires; (xi)
hurricanes and/or tornadoes; (xii) adverse weather conditions (i.e., the number of days in excess
of the normal weather [rain or snow days] as defined for a thirty (30) day period by the National
Weather Bureau for the Rockville, Maryland metropolitan area); (xiii) floods; (xiv) partial or
entire failure of public utilities affecting the Premises; or (xiv) any other similar cause or
event not reasonably within the control of party and not resulting from that partys acts or
omissions. Landlord and Tenant shall give notice to each other of the occurrence of any event of
Force Majeure that may give rise to a claim for an extension of time to perform hereunder as soon
as reasonably possible after the discovery by such party of such Force Majeure event. The party
claiming the benefit of any such Force Majeure event shall thereafter use all reasonable diligence
in attempting to overcome or lessen the impact of such Force Majeure event and shall keep the
other reasonably informed of their progress in mitigating the effects of any such Force Majeure
event.
Article 21.
Miscellaneous
.
21.1.
Costs and Attorney Fees
. Upon any dispute between Landlord and Tenant under
this Lease, the prevailing party shall be entitled to recover from the non-prevailing party
reasonable attorneys fees, taxable costs and expenses incurred in contesting such dispute.
21.2.
Independent Covenants
. The covenant to pay rent or any additional charge is
hereby declared to be an independent covenant on the part of Tenant to be kept and performed, and
no such Rent or charge shall be subject to any offset or deduction whatsoever.
21.3.
Emergencies
. In case of emergency, if Tenant shall not be present to permit
entry, Landlord or its representatives may enter the same forcibly without rendering Landlord or
its
Exhibit A; page -10-
Lease Addendum
representatives liable therefor or affecting Tenants obligation under this Lease.
21.4.
No Agency
. Nothing contained in this Lease shall be taken or construed to create any
agency between Landlord and Tenant or to authorize the Tenant to do any act or thing or to make
any contract so as to encumber in any manner the title of the Landlord to the Premises or to
create any claim or lien upon the interest of the Landlord in the Premises.
21.5.
No Recording of Lease
. Landlord and Tenant shall not record this Lease or any
memorandum thereof, and Tenant shall indemnify Landlord against and hold Landlord harmless from
any and all fees and/or taxes imposed by any governmental entity for or on account of the
recording of this Lease or any memorandum thereof.
21.6.
Financial Statements
. Tenant shall, within ninety (90) days after the end of
each fiscal year of Tenant, and within thirty (30) days after receipt of written request from
Landlord, provide to Landlord, for the benefit of Landlord, Landlords mortgagee and any
prospective mortgagee or purchaser of the Premises audited financial statements of Tenant,
including: (i) a balance sheet and profit and loss statement of Tenant for Tenants most recent
fiscal year, and (ii) a detailed operating statement of the Premises for the most recent calendar
year. Notwithstanding the foregoing, so long as the Tenant is a publicly traded corporation, Tenant
shall only be required to provide Landlord with (a) a detailed operating statement of the Premises
for the most recent calendar year, and (b) such financial information on Tenant as is made
available to the public or is required to be made available to the public in compliance with all
applicable securities laws governing the Tenant.
Exhibit A; page -11-
Lease Addendum
EXHIBIT B
EXECUTED
SUBLEASE LEASE COMMENCEMENT CERTIFICATE
SEE ATTACHED
Exhibit B; page -1-
SUBLEASE LEASE COMMENCEMENT CERTIFICATE
As required under subparagraph 1C of
that certain Sublease dated October 6, 2006, between Human Genome Sciences, Inc. a Delaware Corporation (Sublandlord) and Novavax, Inc., a Delaware
corporation (Subtenant), the under signed parties acknowledge and confirm that the Sublease Commencement Date and the Initial
Delivery Date, as those terms and defined under the Sublease, is January 1, 2007.
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HUMAN GENOME SCIENCES, INC.
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/s/ Beverly A. Merella
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By:
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/s/ Joe Morin
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Witness/Attest
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Name:
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Joe Morin
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Title:
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V.P. Engineering
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Date:
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14 Dec 06
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NOVAVAX, INC.
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By:
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Witness/Attest
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Name:
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Title:
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Date:
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SUBLEASE LEASE COMMENCEMENT CERTIFICATE
As required under subparagraph 1C of
that certain Sublease dated October 6, 2006, between Human Genome Sciences, Inc., a Delaware corporation (Sublandlord) and Novavax, Inc., a Delaware
corporation (Subtenant), the undersigned parties acknowledge and confirm that the Sublease Commencement Date and the Initial Delivery
Date, as those terms and defined under the Sublease, is January 1, 2007.
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HUMAN GENOME SCIENCES, INC.
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By:
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Witness/Attest
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Name:
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Title:
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Date:
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NOVAVAX, INC.
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/s/ Suzanne Rice
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By:
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/s/ R. Hage
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Witness/Attest
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Name:
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R. Hage
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Title:
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SVP
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Date:
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1-4-07
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