e10vq
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 |
For Quarterly Period Ended March 31, 2009
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 1934 |
Commission File No. 0-26770
NOVAVAX, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of incorporation or organization)
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22-2816046
(I.R.S. Employer
Identification No.) |
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9920 Belward Campus Drive, Rockville, MD
(Address of principal executive offices)
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20850
(Zip code) |
(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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
o 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 definitions of large accelerated
flier, accelerated flier and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
o Large accelerated filer |
þ Accelerated filer |
o Non-accelerated filer (Do not check if a smaller reporting company) |
o Smaller reporting company |
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 May 5, 2009: 86,518,220
NOVAVAX, INC.
Form 10-Q
For the Quarters Ended March 31, 2009 and 2008 (unaudited)
Table of Contents
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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 March 31, 2009 (unaudited) and
December 31, 2008 |
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1 |
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Consolidated Statements of Operations for the three-months ended
March 31, 2009 and 2008 (unaudited) |
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2 |
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Consolidated Statements of Stockholders Equity as of March 31,
2009 (unaudited) |
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3 |
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Consolidated Statements of Cash Flows for the three months ended
March 31, 2009 and 2008 (unaudited) |
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4 |
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Notes to the Consolidated Financial Statements (unaudited) |
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6 |
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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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21 |
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Item 3 |
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Quantitative and Qualitative Disclosures about Market Risk |
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32 |
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Item 4 |
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Controls and Procedures |
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33 |
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PART II. OTHER INFORMATION |
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Item 1 |
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Legal Proceedings |
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34 |
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Item 1A |
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Risk Factors |
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34 |
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Item 6 |
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Exhibits |
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34 |
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SIGNATURES |
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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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March 31, |
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December 31, |
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2009 |
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2008 |
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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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$ |
19,629 |
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$ |
26,938 |
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Short-term investments classified as available for sale |
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5,958 |
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6,962 |
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Accounts and other receivables, net of allowance for
doubtful accounts of $218 as of March 31, 2009 and
December 31, 2008 |
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61 |
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290 |
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Prepaid expenses and other current assets |
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994 |
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774 |
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Current assets of discontinued operations |
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132 |
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Total current assets |
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26,642 |
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35,096 |
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Property and equipment, net |
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8,019 |
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8,228 |
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Goodwill |
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33,141 |
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33,141 |
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Other non-current assets |
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160 |
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160 |
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Total assets |
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$ |
67,962 |
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$ |
76,625 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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1,024 |
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1,750 |
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Accrued expenses and other current liabilities |
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3,208 |
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2,969 |
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Current portion of notes payable |
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385 |
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650 |
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Current liabilities of discontinued operations |
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242 |
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Convertible notes, current |
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21,881 |
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21,778 |
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Deferred rent |
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334 |
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328 |
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Total current liabilities |
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26,832 |
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27,717 |
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Non-current portion of notes payable |
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468 |
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480 |
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Deferred rent |
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2,868 |
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2,939 |
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Total liabilities |
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30,168 |
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31,136 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock, $0.01 par value, 2,000,000 shares
authorized; no shares issued and outstanding |
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Common stock, $0.01 par value, 100,000,000 shares
authorized; 69,310,521 shares issued and 68,855,091
shares outstanding at March 31, 2009 and 69,220,221
shares issued and 68,764,591 shares outstanding at
December 31, 2008 |
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693 |
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692 |
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Additional paid-in capital |
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285,248 |
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284,595 |
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Notes receivable from directors |
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(1,572 |
) |
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(1,572 |
) |
Accumulated deficit |
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(244,125 |
) |
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(235,776 |
) |
Treasury stock, 455,430 shares at March 31, 2009 and
December 31, 2008, cost basis |
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(2,450 |
) |
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(2,450 |
) |
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Total stockholders equity |
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37,794 |
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45,489 |
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Total liabilities and stockholders equity |
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$ |
67,962 |
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$ |
76,625 |
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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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March 31, |
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2009 |
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2008 |
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Revenues |
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$ |
21 |
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$ |
458 |
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Operating costs and expenses: |
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Research and development |
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4,266 |
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4,434 |
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Selling, general and administrative |
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2,892 |
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3,244 |
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Total operating costs and expenses |
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7,158 |
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7,678 |
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Loss from continuing operations before other (expense) income, net |
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(7,137 |
) |
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(7,220 |
) |
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Other (expense) income, net |
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(1,212 |
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117 |
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Loss from continuing operations |
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(8,349 |
) |
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(7,103 |
) |
Loss from discontinued operations |
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(652 |
) |
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Net loss |
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$ |
(8,349 |
) |
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$ |
(7,755 |
) |
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Basic and diluted net loss per share: |
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Loss per share from continuing operations |
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$ |
(0.12 |
) |
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$ |
(0.12 |
) |
Loss per share from discontinued operations |
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(0.01 |
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Net loss per share |
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$ |
(0.12 |
) |
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$ |
(0.13 |
) |
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Basic and diluted weighted average number of common shares
outstanding |
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68,692,455 |
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61,280,155 |
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The accompanying notes are an integral part of these consolidated financial statements.
2
NOVAVAX, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY
For the Three Months Ended March 31, 2009
(in thousands, except share information)
(unaudited)
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Additional |
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Notes |
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Total |
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Common Stock |
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Paid-in |
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Receivable |
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Accumulated |
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Treasury |
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Stockholders |
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Shares |
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Amount |
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Capital |
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From Directors |
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Deficit |
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Stock |
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Equity |
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Balance, December 31, 2008 |
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69,220,021 |
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$ |
692 |
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$ |
284,595 |
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$ |
(1,572 |
) |
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$ |
(235,776 |
) |
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$ |
(2,450 |
) |
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$ |
45,489 |
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Non-cash compensation costs
for stock options |
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350 |
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350 |
|
Exercise of stock options |
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20,000 |
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35 |
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35 |
|
Issuance of stock |
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70,500 |
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1 |
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121 |
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122 |
|
Amortization of restricted
stock for
compensation |
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147 |
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|
147 |
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Net loss |
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|
|
|
|
|
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(8,349 |
) |
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(8,349 |
) |
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Balance, March 31, 2009 |
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69,310,521 |
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|
$ |
693 |
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|
$ |
285,248 |
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|
$ |
(1,572 |
) |
|
$ |
(244,125 |
) |
|
$ |
(2,450 |
) |
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$ |
37,794 |
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The accompanying notes are an integral part of these consolidated financial statements.
3
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Three months ended |
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March 31, |
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2009 |
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2008 |
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Operating Activities: |
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Net loss |
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$ |
(8,349 |
) |
|
$ |
(7,755 |
) |
Plus net income from discontinued operations |
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|
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|
652 |
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|
|
|
|
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|
Net loss from continuing operations |
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(8,349 |
) |
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|
(7,103 |
) |
Reconciliation of net loss to net cash used in operating activities: |
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Depreciation |
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294 |
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|
209 |
|
Amortization of debt discount |
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|
103 |
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|
102 |
|
Loss on disposal of property and equipment |
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29 |
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|
18 |
|
Amortization of net discounts on short-term investments |
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(147 |
) |
Reserve for notes receivable and accrued interest |
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|
194 |
|
Amortization of deferred financing costs |
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|
64 |
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|
65 |
|
Deferred rent |
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(66 |
) |
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|
(1 |
) |
Impairment of short-term investments |
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|
879 |
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Non-cash stock compensation |
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|
497 |
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|
450 |
|
Changes in operating assets and liabilities: |
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Accounts and other receivables |
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|
216 |
|
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|
20 |
|
Inventory |
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(2 |
) |
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|
(18 |
) |
Prepaid expenses and other current assets |
|
|
(150 |
) |
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|
196 |
|
Accounts payable and accrued expenses |
|
|
(242 |
) |
|
|
(1,172 |
) |
Other non-current assets |
|
|
|
|
|
|
(28 |
) |
|
|
|
|
|
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|
Net cash used in operating activities from continuing operations |
|
|
(6,727 |
) |
|
|
(7,215 |
) |
Net cash provided by operating activities from discontinued
operations |
|
|
|
|
|
|
2,013 |
|
|
|
|
|
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|
|
Net cash used in operating activities |
|
|
(6,727 |
) |
|
|
(5,202 |
) |
|
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Investing Activities: |
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Capital expenditures |
|
|
(63 |
) |
|
|
(1,631 |
) |
Proceeds from disposal of property and equipment |
|
|
6 |
|
|
|
|
|
Purchases of short-term investments |
|
|
|
|
|
|
(15,650 |
) |
Proceeds from maturities of short-term investments |
|
|
125 |
|
|
|
31,745 |
|
|
|
|
|
|
|
|
Net cash provided by investing activities from continuing
operations |
|
|
68 |
|
|
|
14,464 |
|
Net cash provided by investing activities from discontinued
operations |
|
|
|
|
|
|
1,134 |
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
68 |
|
|
|
15,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
Principal payments of notes payable |
|
|
(807 |
) |
|
|
(658 |
) |
Net proceeds from sales of common stock |
|
|
122 |
|
|
|
|
|
Proceeds from the exercise of stock options |
|
|
35 |
|
|
|
35 |
|
Bank overdraft |
|
|
|
|
|
|
579 |
|
|
|
|
|
|
|
|
Net cash (used in) financing activities |
|
|
(650 |
) |
|
|
(44 |
) |
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(7,309 |
) |
|
|
10,352 |
|
Cash and cash equivalents at beginning of period |
|
|
26,938 |
|
|
|
4,350 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
19,629 |
|
|
$ |
14,702 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash interest payments |
|
$ |
523 |
|
|
$ |
688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash activities: |
|
|
|
|
|
|
|
|
Equipment purchases included in accounts payable |
|
$ |
47 |
|
|
$ |
1,128 |
|
|
|
|
|
|
|
|
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 biopharmaceutical company focused on creating differentiated, value-added
vaccines that improve upon current preventive options for a range of infectious diseases. These
vaccines leverage the Companys virus-like-particle (VLP) platform technology coupled with a
unique, disposable production technology.
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 and other subtypes of avian influenza with
pandemic potential, human seasonal influenza, Varicella Zoster (VZV), which causes Shingles, and
Respiratory Syncytial Virus (RSV).
Subsequent Events
Cadila Pharmaceuticals Ltd.
On March 31, 2009, the Company and Cadila Pharmaceuticals Ltd., a company incorporated under
the laws of India (Cadila), entered into a Joint Venture Agreement (the JVA) pursuant to which
the Company and Cadila formed CPL Biologicals Limited, a joint venture (the JV), of which 80%
will be owned by Cadila and 20% is owned by the Company. The JV must obtain approval from Indias
Foreign Investment Promotion Board (the FIPB) prior to issuing shares to Novavax. The JV will
develop and commercialize the Companys seasonal influenza virus-like-particle (VLP)-based vaccine
candidate and Cadilas therapeutic vaccine candidates against cancer as well as its adjuvants,
biogeneric products and other diagnostic products for the territory of India. Novavax will also
contribute to the JV technology for the development of several other VLP vaccine candidates against
diseases of public health concern in the territory, such as hepatitis E and chikungunya fever.
Cadila will contribute approximately $8 million over three years to support the JVs operations.
The JV will be responsible for clinical testing and registration of products that will be marketed
and sold in India.
The board of directors of the JV consists of five members, three of whom (including the
Chairman of the board) are nominated by Cadila and two of whom are nominated by Novavax. If the
board is not in unanimous agreement on an issue, the Chief Executive Officers (CEOs) of the
Company and Cadila will work to resolve the issue. If the CEOs cannot resolve the issue in five
business days, a vote by the majority of the board will decide. However, the approval of the
Company and Cadila, as shareholders of the JV, and the board of directors of the JV is required for
(1) the sale of all or most of the assets of the JV, (2) a change in control of the JV, (3) the
liquidation, dissolution, or winding up of the JV, (4) any occurrence of indebtedness that results
in the JV having a debt-to-equity ratio of 3-to-1 or greater, or (5) most amendments of the JVA or
the JVs Articles of Association.
The JV has the right to negotiate a definitive agreement for rights to certain future Novavax
products (other than RSV) and certain future Cadila products in each case for the territory of
India prior to Novavax or Cadila licensing such rights to a third party. Novavax has the right to
negotiate the licensing of vaccines developed by the joint venture using Novavaxs technology for
commercialization in every country except for India and vaccines developed by the joint venture
using Cadilas technology for commercialization in certain countries, including the United States.
In connection with the JVA, on March 31, 2009, the Company also entered into license
agreement, an option to enter into a license agreement, a technical services agreement and a supply
agreement with the JV.
Also on March 31, 2009, Novavax entered into a binding, non-cancellable Stock Purchase
Agreement (the SPA) with Satellite Overseas (Holdings) Limited (SOHL), a subsidiary of Cadila,
pursuant to which SOHL agreed to purchase 12.5 million shares of Company common stock, par value
$0.01 (the Common Stock) at the market price of $0.88 per share.
5
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The stock purchase was consummated on April 1, 2009. The Company raised gross proceeds of $11
million in the offering. The net proceeds to the Company from the sale of the Common Stock, after
deducting estimated offering expenses payable by the Company, was approximately $10.5 million.
The SPA provides that, as long as SOHL owns more than 5% of the Companys then-outstanding
Common Stock, SOHL may purchase a pro-rata portion of any Company Common Stock sale or issuance.
Under the SPA, certain issuances are exempt from SOHLs pre-emptive right, including shares issued
(1) as stock dividends, stock splits, or otherwise payable pro rata to all holders of Common Stock;
(2) to employees, officers, directors or consultants of the Company pursuant to an employee benefit
program; (3) upon the conversion or exercise of any options, warrants or other rights to purchase
Common Stock; and (4) as consideration for a merger, consolidation, purchase of assets, or in
connection with a joint venture or strategic partnership. However, any issuances pursuant to (4)
above, must be approved by a majority of the full board and, if the transaction exceeds 5% of the
Companys then issued and outstanding shares of Common Stock, the per share purchase price cannot
be less than $0.88.
Under the SPA, for so long as SOHL owns 5% of the Companys Common Stock, SOHL may designate
one member of the Companys board of directors.
Finally, on March 31, 2009, Novavax and Cadila entered into a Master Services Agreement (the
Master Services Agreement) pursuant to which Novavax may request services from Cadila in the
areas of biologics research, preclinical development, clinical development, process development,
manufacturing scale up, and general manufacturing related services in India. If, at the third
anniversary of the Master Services Agreement, the amount of services provided by Cadila is less
than $7.5 million, Novavax will pay Cadila a portion of the shortfall. Novavax will have to pay
Cadila the portion of the shortfall amount that is less than or equal to $2.0 million and 50% of
the portion of the shortfall amount that exceeds $2.0 million. When calculating the shortfall, the
amount of services provided by Cadila includes amounts that have been paid under all project plans,
the amounts that will be paid under ongoing executed project plans and amounts for services that
had been offered to Cadila, that Cadila was capable of performing, but exercised its right not to
accept such project. The term of the Master Services Agreement is five years, but may be terminated
by either party if there is a material breach that is not cured within 30 days of notice or, at any
time after three years, provided that 90 days prior notice is given to the other party.
As a result of the contribution of the intellectual property to the joint venture, the company
could recognize a taxable gain. Furthermore, since the Company has not analyzed whether it has had
a change in ownership under Internal Revenue Code section 382, a gain could result in a tax
liability to the Company since the Companys tax net operating losses could be limited by section
382.
At the Market Issuance
On January 12, 2009 the Company entered into an At Market Issuance Sales Agreement (the Sales
Agreement), with Wm Smith & Co. (Wm Smith), under which the Company may sell an aggregate of up
to $25.0 million in gross proceeds of the Companys common stock from time to time through Wm
Smith, as the agent for the offer and sale of the common stock. The board of directors has
authorized the sale of up to 12.5 million shares of common stock under the Sales Agreement. Based
on the trading price of the Companys common stock, the Company may not be able to raise the full
$25.0 million in gross proceeds permitted under the Sales Agreement. Wm Smith may sell the common
stock by any method permitted by law, including sales deemed to be an at the market offering as
defined in Rule 415 of the Securities Act, including without limitation sales made directly on
NASDAQ Global Market, on any other existing trading market for the common stock or to or through a
market maker. Wm Smith may also sell the common stock in privately negotiated transactions, subject
to the Companys prior approval. The Company will pay Wm Smith a commission equal to 3% of the
gross proceeds of the sales price of all common stock sold through it as sales agent under the
Sales Agreement. During the first quarter of 2009, the Company sold 70,500 shares and received net
proceeds in the amount of $121,457, under the Sales Agreement. As of
May 5, 2009, the Company sold approximately an
additional 3.1 million shares for net proceeds approximately of $7.5 million.
6
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Amendments to Convertible Notes
As of March 31, 2009, the Company had $22.0 million of senior convertible notes outstanding
(the Notes). The Notes carried a 4.75% coupon; are convertible into shares of Novavax common
stock at $4.00 per share; and mature on July 15, 2009. On April 29, 2009, the Company entered into
amendment agreements (the 2009 Amendments) with holders of the outstanding 4.75% Note
representing $17.0 million of the $22.0 million outstanding principal amount of the Notes to amend
the terms of the Notes to allow for early payment under specific terms described below.
The 2009 Amendments (i) provide for payment of $17.0 million aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of common stock that equals 30% of this principal amount divided
by $2.50. The Company paid $12.1 million in principal and accrued interest and issued 2,040,000
shares in accordance with the 2009 Amendments on April 29, 2009. After payment of this $17.0
million in principal amount, $5.0 million aggregate principal amount remains outstanding under the
Notes and will mature on July 15, 2009.
Under the terms of the Notes, Novavax, at its option, can pay up to 50% of the remaining $5.0
million outstanding Notes in Novavax common stock on the due date of July 15, 2009, subject to the
satisfaction of certain conditions, including, among other things, a requirement that the shares
issued upon conversion be registered or freely tradable without registration, that Novavaxs shares
of common stock have not been suspended from trading on NASDAQ Global Market during the applicable
measurement period and there is no threatened delisting or suspension, and that the Company is
otherwise in compliance with its agreements with the Note holders. The amount of shares that may
be issued at maturity may be subject to adjustment depending on the Note holders percentage
ownership of the Company on an as-converted basis and if the Companys stock price falls below
$2.00 during the measurement period. As a result, the Company will have to pay at least $2.5
million in cash to satisfy the remaining Notes on the due date unless the notes are converted into
common stock, redeemed or amended prior to July 15, 2009.
Liquidity Matters
The Company has incurred losses since its inception and as of March 31, 2009 has an
accumulated deficit of $244 million.
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 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 does not expect to generate revenue in the near future.
At March 31, 2009 the Company had cash and cash equivalents totaling $19.6 million and auction
rate securities with a face value of $8.1 million and a fair value of $6.0 million. There has been
insufficient demand at auction for each of the Companys five auction rate securities. The Company
recorded impairment charges of $1.2 million in the fourth quarter of 2008 and $0.9 million during
the first quarter of 2009 due primarily to their illiquidity and believes the $6.0 million it has
recorded at March 31, 2009 represents their fair market value and the value the Company could
liquidate the investments for, if necessary. The Company is currently evaluating what purchase
price it could get for these securities currently, along with the risks and benefits of holding
versus selling these securities. Without liquidity of these auction rate securities, the Companys
cash position will be negatively affected.
7
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
During the three months ended March 31, 2009, the Company sold 70,500 shares of common stock
and received net proceeds in the amount of $121,457 pursuant to the Sales Agreement with Wm Smith.
On March 31, 2009, the Company entered into a non-cancellable binding Stock Purchase Agreement for
the sale of 12.5 million shares of common stock to a wholly-owned subsidiary of Cadila
Pharmaceuticals Ltd., at the market price of $0.88 per share for a net purchase price of $10.5
million (See Subsequent Events At the Market Issuance and Cadila Pharmaceuticals, Ltd.). These
proceeds were received on April 1, 2009.
As of May 5, 2009, the Company has sold approximately 3.1 million shares under the Sales
Agreement with Wm Smith for net proceeds of approximately $7.5 million.
As of March 31, 2009, the Company had $22.0 million of senior convertible notes outstanding
(the Notes). (See Subsequent Events Amendments to Convertible Notes).
The 2009 Amendments (i) provide for payment of $17.0 million aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of common stock that equals 30% of this principal amount divided
by $2.50. The Company paid $12.1 million in principal and accrued interest and issued 2,040,000
shares in accordance with the 2009 Amendments on April 29, 2009. After payment of this $17.0
million in principal amount, $5.0 million aggregate principal amount remains outstanding under the
Notes and will mature on July 15, 2009.
Based on the amount of funds on hand and the Companys proceeds from the Cadila transaction
and the sales of shares under the Sales Agreement with Wm Smith, the Company believes that its cash
and cash equivalents, excluding the value of its current illiquid auction rate securities, will be
sufficient to cover its estimated funding needs for at least twelve months. The Company is planning
to raise additional capital in order to continue its current level of operations and to pursue the
business plan beyond 2009. The Company has not, however, secured any additional commitments for
new financing at this time nor can it provide any assurance that new financing will be available on
commercially acceptable terms, if at all. If the Company is unable to immediately secure
additional capital, it will continue to assess its capital resources and the Company may be
required to downsize its operations, reduce general and administrative costs or delay or reduce the
scope of, or eliminate one or more of its product research and development programs, thereby
causing delays in the Companys efforts to introduce its future products to market.
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 not
misleading, certain information and footnote disclosures, including a description of significant
accounting policies 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 the
financial statements and notes thereto included in the companys latest Annual Report on Form 10-K.
The results of operations for the three months ended March 31, 2009 are not necessarily indicative
of the results for any subsequent quarter or the entire fiscal year ending December 31, 2009.
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.
8
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Cash and Cash Equivalents
Cash equivalents consist of highly liquid investments with original maturities of three months
or less from the date of purchase.
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 loss per share only when the effect of the inclusion would be dilutive. Outstanding
stock options with an exercise price above market, are excluded from the Companys diluted
computation as their effect would be anti-dilutive. For the three months ended March 31, 2009,
there were approximately 5.5 million outstanding stock options and 3.3 million outstanding warrants
that were excluded from the calculation of net loss per share. For the three months ended March 31,
2008, there were approximately 4.3 million outstanding stock options that were excluded from the
calculation of net loss per share.
Short-term investments
Short-term investments at March 31, 2009 and December 31, 2008 consist of investments in five
auction rate securities with a par value of $8.1 million and $8.2 million, respectively, and a fair
value of $6.0 million and $7.0 million, respectively. The Company recorded an other than temporary
impairment charge to other expenses related to these securities during the three months ended March
31, 2009 of $0.9 million as a result of the current turmoil in the credit markets and managements
belief these securities cannot presently be sold at par value, but are saleable at a discount from
their par value. The Company did not record any impairment charges during the three months ended
March 31, 2008. The auction rate securities are AAA-rated securities.
The Company has classified these securities as short-term investments and have accounted for
the investments in these securities as available for sale securities under the guidance of
Statement of Financial Accounting Standards, Accounting for Certain Investments in Debt and Equity
Securities (SFAS No. 115). Although the auction rate securities have variable interest rates,
which typically reset every 16 to 32 days through a competitive bidding process known as a Dutch
auction, they have long-term contractual maturities. These investments are classified within
current assets because the Company may need to liquidate these securities within the next year to
fund working capital requirements.
The available for sale securities are carried at fair value and unrealized gains and losses on
these securities, if determined to be temporary, are included in accumulated other comprehensive
income (loss) in stockholders equity. The Company assesses the recoverability of its
available-for-sale securities and, if impairment is indicated, the Company measures the amount of
such impairment by comparing the fair value to the carrying value. Other than temporary impairments
are included in the consolidated statements of operations. The impairment for the three months
ended March 31, 2009 was concluded to be other than temporary, thus the charge was recorded in the
consolidated statement of operations.
The Company had invested in auction rate securities for short periods of time as part of its
cash management program. Uncertainties in the credit markets have prevented the Company from
liquidating certain holdings of auction rate securities subsequent to December 31, 2008 as the
amount of securities submitted for sale during the auction has exceeded the amount of purchase
orders. Although an event of an auction failure does not necessarily mean that a security is
impaired, the Company considered various factors to assess the fair value and the classification of
the securities as short-term assets. Fair value was determined through independent valuation using
two valuation methods a discounted cash flow method and a market comparables method. Certain
factors used in these methods include, but are not limited to, comparable securities traded on
secondary markets, timing of the failed auction, specific security auction history, quality of
underlying collateral, rating of the security and the bond insurer, our ability and intent to
retain the securities for a period of time to allow for anticipated recovery in the market value,
and other factors.
9
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Interest and dividend income is recorded when earned and included in interest income.
Premiums and discounts, if any, on short-term investments are amortized or accreted to maturity and
included in interest income. The specific identification method is used in computing realized
gains and losses on sale of the Companys securities.
Fair Value Measurements
On January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements (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. The Company does
not have any Level 1 assets as of March 31, 2009.
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 Company considers its auction
rate securities to be Level 2 assets.
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 composed of
goodwill.
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 measurement of the instrument.
10
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Financial assets and liabilities measured at fair market value on a recurring basis as of
March 31, 2009 are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at |
|
|
|
March 31, 2009 using |
|
|
|
(in thousands) |
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
For Identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
|
Assets |
|
Assets |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
At Fair Value |
|
Auction rate
securities |
|
$ |
|
|
|
$ |
5,958 |
|
|
$ |
|
|
|
$ |
5,958 |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
33,141 |
|
|
|
33,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
|
|
|
$ |
5,958 |
|
|
$ |
33,141 |
|
|
$ |
39,099 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment
Property and equipment are recorded at cost and are depreciated using 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 |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
(in thousands) |
|
Construction in progress |
|
$ |
1,219 |
|
|
$ |
5,394 |
|
Machinery and equipment |
|
|
4,037 |
|
|
|
3,880 |
|
Leasehold improvements |
|
|
4,523 |
|
|
|
637 |
|
Computer software and hardware |
|
|
338 |
|
|
|
339 |
|
|
|
|
|
|
|
|
|
|
|
10,117 |
|
|
|
10,250 |
|
Less accumulated depreciation and amortization |
|
|
(2,098 |
) |
|
|
(2,022 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,019 |
|
|
$ |
8,228 |
|
|
|
|
|
|
|
|
Construction in progress is related to costs incurred in the construction of the Companys
Good Manufacturing Practice (GMP) pilot manufacturing facility, which started during the third
quarter of 2007. The GMP pilot manufacturing facility was ready for use in January 2009, when the
Company announced that all equipment in the pilot plant was installed and ready for operations
supporting scale-up and validation.
Goodwill and Other Intangible Assets
Goodwill originally results from certain 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 is deemed to have an indefinite life and is
subject to impairment tests annually, or more frequently should indicators of impairment arise. The
Companys judgments regarding the existence of impairment indicators are primarily dependent on the
successful commercialization of its vaccine technologies, probability of success, growth and
profitability. Achievability of prospective results is subject to a great deal of risk and, because
events or circumstances may not occur as expected, differences between actual and expected results
may be material.
11
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Due to continued volatility in the financial and credit markets including the Companys stock
price, the Company determined it should perform an interim test for impairment of the Companys
goodwill as of March 31, 2009.
At March 31, 2009 and December 31, 2008, the Company used both the market approach and the
income approach to determine if the Company had an impairment of its goodwill. The income approach
was used as a confirming look to the market approach. The Company used a market approach to
determine the market value of capitalization of its single reporting unit. Step one of the
impairment test states that if the fair value of a reporting unit exceeds its carrying amount,
goodwill is considered not to be impaired. The Companys forecasts were used to create a risk
adjusted discounted cash flow analysis to indicate the market value capitalization. The fair value
of the Companys reporting unit was compared to the carrying amount of the reporting unit. Under
both approaches, the fair value of the reporting unit was higher than the carrying value, resulting
in no impairment recorded against goodwill at March 31, 2009.
Revenue Recognition
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. The Company
estimates the amount of rebates and returns and records them as a liability and reduction of
revenue upon sale of the products. 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.
Stock-Based Compensation
Stock Options
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 requisite service period (generally the vesting period)
of the options. Compensation cost included in operating expenses was $350,000 and $365,000 for the
three months ended March 31, 2009 and March 31, 2008, respectively.
As of March 31, 2009, there were 6,771,669 stock options outstanding with the aggregate fair
value of the remaining compensation cost of unvested options, as determined using a Black-Scholes
option valuation model, was approximately $345,471 (net of estimated forfeitures). This
unrecognized compensation cost of unvested options is expected to be recognized over a weighted
average period of 1.58 years. During the three months ended March 31, 2009, the Company granted
751,025 stock options, with a fair value of approximately $292,468 (net of estimated forfeitures),
and 65,734 options were forfeited. During the three months ended March 31, 2008, the Company
granted 784,150 options, with a fair value of approximately $1,072,000 (net of estimated
forfeitures), and 156,950 options were forfeited.
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 months ended March 31, 2009 and
2008, using the Black-Scholes options valuation model, were as follows:
12
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2009 |
|
2008 |
Weighted average fair value of options granted |
|
$ |
0.39 |
|
|
$ |
1.72 |
|
Expected life (years) |
|
|
4.0 6.29 |
|
|
|
4.03 5.94 |
|
Expected volatility |
|
|
85.68% 95.08 |
% |
|
|
81.14% 89.34 |
% |
Risk free interest rate |
|
|
1.56% 2.27 |
% |
|
|
2.37% 2.50 |
%% |
Expected dividend |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected forfeiture rate |
|
|
21.96 |
% |
|
|
20.34 |
% |
The expected life of options granted was based on the Companys historical share option
exercise experience using the historical expected term from the vesting date. The expected
volatility of the options granted during the three months ended March 31, 2009 and 2008 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 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
Non-cash compensation expense related to all restricted stock issued to employees and
directors has been recorded as compensation using the straight-line method of amortization. The
Company accounts for stock-based awards issued to non-employees in accordance with Emerging Issues
Task Force (EITF) Issue No. 96-18, Accounting for Equity Instruments That are Issued to Other
than Employees for Acquiring, or in Conjunction with Selling Goods or Services. For the three
months ended March 31, 2009, $147,000 of non-cash stock compensation expense was included in total
operating costs and expenses and additional paid-in capital was increased accordingly. For the
three months ended March 31, 2008, $85,000 of non-cash stock compensation expense was included in
total operating costs and expenses and additional paid in capital was increased accordingly.
Recent Accounting Pronouncements
In April 2009, the Financial Accounting Standards Board (FASB) issued FSP SFAS 141(R)-1,
Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from
Contingencies, to amend the provisions related to the initial recognition and measurement,
subsequent measurement and disclosure of assets and liabilities arising from contingencies in a
business combination under SFAS 141(R). Under the new guidance, assets acquired and liabilities
assumed in a business combination that arise from contingencies should be recognized at fair value
on the acquisition date if fair value can be determined during the measurement period. If fair
value cannot be determined, companies should typically account for the acquired contingencies using
existing guidance. The Company is reviewing this pronouncement as it relates to its recent
agreement Joint Venture (JV) with Cadila Pharmaceuticals Ltd. The adoption of this pronouncement is
not expected to have a material effect on the Companys financial position and results from
operations.
In April 2009, the FASB issued FSP SFAS 157-4, Determining Fair Value When the Volume and
Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying
Transactions That Are Not Orderly which provides additional guidance for estimating fair value in
accordance with FASB Statement No. 157, Fair Value Measurements, when the volume and level of
activity for the asset or liability have significantly decreased. This FSP also includes guidance
on identifying circumstances that indicate a transaction is not orderly. This pronouncement is
effective for periods ending after June 15, 2009. The Company does not expect this pronouncement
to have a material effect on the Companys financial position and results of operations.
In April 2009, the FASB issued FSP SFAS 115-2 and SFAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments, to amend the other-than-temporary impairment guidance in debt
securities to be based on intent to sell instead of ability to hold the security and to improve the
presentation and disclosure of other-than-temporary impairments on debt and equity securities in
the financial statements.
13
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
This pronouncement is effective for periods ending after June 15, 2009. The Company does not
expect this pronouncement to have a material effect on the Companys financial position and results
of operations.
In
April 2009, the FASB issued FSP FAS 107-1 and APB 28-1 Interim
Disclosures about Fair Value of Financial Instruments (FSP FAS
107), which amends SFAS No. 107, Disclosures about
Fair Value of Financial Instruments, to require disclosures
about fair value of financial instruments for interim reporting
periods of publicly traded companies as well as in annual financial
statements. This FSP also amends APB Opinion No. 28, Interim
Financial Reporting, to require those disclosures in summarized
financial information at interim reporting periods and is effective
for interim periods ending after June 15, 2009. The Company does
not believe this pronouncement will have a material impact on the
financial position and results of operations.
Significant Transactions
Graceway 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 August
2008. Graceway will pay a preset transfer price per unit of Estrasorb for the supply of this
product. Once Novavax delivered the required quantity of Estrasorb, Novavax cleaned the
manufacturing equipment and prepared the equipment for transport. Graceway removed the equipment
from the manufacturing facility and Novavax exited the facility in August 2008.
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 licensed grant allows
Novavax to make, use and sell licensed products and services in certain, limited fields. Upon
commencement of the Graceway agreement, 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 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 evaluated
the deliverables related to the Graceway supply and asset purchase agreements under the criteria of
EITF 00-21 to determine whether they met the requirements for separation within a multi-element
arrangement.
14
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The Company concluded that the deliverables would not be treated as separate units of accounting as
there was 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, was deferred and was not recognized until the
Companys obligations were completed in August 2008.
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. As of March 31, 2009 and December 31, 2008, the Company
made payments to UMMS in an aggregate amount that is not material. 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. The Company believes that all payments under
the UMMS agreement will not be material to the Company in the foreseeable future. The UMMS
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 the Companys option or by
UMMS for an uncured breach by Novavax.
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. If each milestone is achieved for any particular product candidate, the Company
would be obligated to pay an aggregate of $14 million to Wyeth Holdings for each product candidate
developed and commercialized under the agreement. Achievement of each milestone is subject to many
risks, including those described in the Companys risk factors described in Item 1A of Part I of
the Companys Annual Report of Form 10-K for the year ended in December 31, 2008. Annual license maintenance fees under the Wyeth
Holdings agreement aggregate $0.3 million per year. The royalty to be paid by the Company under
the agreement, if a product is approved by the FDA for commercialization, will be based on single
digit percentage of net sales. Payments under the agreement to Wyeth as of March 31, 2009
aggregated $4.8 million and could aggregate up to an additional $0.3 million in 2009, 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.
Notes Payable
Notes payable consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
(In thousands) |
|
Note payable; insurance financing; bears
interest at 4.9% per annum; principal and
interest due in monthly installments of
$51,677 through September 2009 |
|
$ |
305 |
|
|
$ |
570 |
|
Notes payable; Opportunity Grant Funds;
non-interest bearing; principal only
payments due in monthly installments of
$6,666 through May 2012 |
|
|
240 |
|
|
|
260 |
|
Other |
|
|
308 |
|
|
|
300 |
|
|
|
|
|
|
|
|
Total |
|
|
853 |
|
|
|
1,130 |
|
Less current portion |
|
|
(385 |
) |
|
|
(650 |
) |
|
|
|
|
|
|
|
Long-term portion |
|
$ |
468 |
|
|
$ |
480 |
|
|
|
|
|
|
|
|
15
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Opportunity Grant Funds
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 the
Companys corporate headquarters and product development activities to Malvern, Pennsylvania.
The Company announced in December 2006, that it had signed a long-term lease for its then new
corporate headquarters and research and development facility in Rockville, Maryland. As a result of
the Companys failure to comply with the conditions of the grant, the Department of Community &
Economic Development (DCED) of the Commonwealth of Pennsylvania requested that the Company repay
the full amount of the Opportunity Grant.
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 months ended March 31, 2009 and 2008, the Company made payments totaling $20,000. The
$240,000 balance of the loan is included in notes payable at March 31, 2009.
Convertible Notes
Convertible notes consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(In thousands) |
|
Note payable; 4.75% senior
convertible, issued July 19, 2004,
due July 15, 2009, currently
convertible by the holders into
4,029,304 shares of Novavax common
stock at $4.00 per share |
|
$ |
22,000 |
|
|
$ |
22,000 |
|
Less: Discount |
|
|
(119 |
) |
|
|
(222 |
) |
|
|
|
|
|
|
|
Note payable, net |
|
$ |
21,881 |
|
|
$ |
21,778 |
|
|
|
|
|
|
|
|
As of March 31, 2009 and December 31, 2008, the Company had an aggregate principal amount of
$22.0 million of senior convertible notes outstanding (the Notes). The Notes carry a 4.75%
coupon; are convertible into shares of Novavax common stock at $4.00 per share; and mature in five
years on July 15, 2009. On June 15, 2007, the Company entered into amendment agreements (the 2007
Amendments) with each of the holders of the outstanding Notes to amend the terms of the Notes.
The 2007 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 than
$7.00 (a decrease from $9.56) in any 15 out of 30 consecutive trading days after July 19, 2007.
The Notes are also redeemable upon the occurrence of specified events of default as well as a
change of control (as that term is defined in the Notes) of Novavax. At March 31, 2009 and
December 31, 2008, the Company had accrued interest of $213,000 and $478,123, respectively,
relating to these Notes.
On April 29, 2009, the Company entered into amendment agreements (the 2009 Amendments) with
holders of the outstanding 4.75% Notes representing $17.0 million of the $22.0 million outstanding
principal amount of the Notes to amend the terms of the Notes to allow for early payment under
specific terms described below.
16
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The 2009 Amendments (i) provide for payment of $17,000,000 aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of Common Stock that equals 30% of this principal amount divided
by $2.50. On April 29, 2009, the Company paid $12.1 million in principal and accrued interest and
issued 2,040,000 shares of common stock in accordance with the terms of the 2009 Amendments. After
payment of this $17.0 million in principal amount, $5.0 million aggregate principal amount remains
outstanding under the Notes and will mature on July 15, 2009.
Under the terms of the Notes, Novavax, at its option, can pay up to 50% of the remaining $5.0
million outstanding Notes in Novavax common stock on the due date of July 15, 2009, subject to the
satisfaction of certain conditions, including, among other things, a requirement that the shares
issued upon conversion be registered or freely tradable without registration, that Novavaxs shares
of common stock have not been suspended from trading on NASDAQ Global Market during the applicable
measurement period and there is no threatened delisting or suspension, and that the Company is
otherwise in compliance with its agreements with the Note holders. The amount of shares that may
be issued at maturity may be subject to adjustment depending on the Note holders percentage
ownership of the Company on an as-converted basis and if the Companys stock price falls below
$2.00 during the measurement period. As a result, the Company will have to pay at least $2.5
million in cash to satisfy the Notes on the due date unless the Notes are converted into common
stock, redeemed or amended.
In connection with the 2007 Amendments, the Company 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 Notes. Interest expense includes $102,000 related to the amortization of the
debt discount for the three months ended March 31, 2009 and 2008.
Operating Leases
Future minimum rental commitments under non-cancelable leases as of March 31, 2009 are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
|
|
|
|
Net Operating |
|
Year |
|
Leases |
|
|
Sub-Leases |
|
|
Leases |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
$ |
1,701 |
|
|
$ |
248 |
|
|
$ |
1,453 |
|
2010 |
|
|
2,088 |
|
|
|
338 |
|
|
|
1,750 |
|
2011 |
|
|
2,087 |
|
|
|
259 |
|
|
|
1,828 |
|
2012 |
|
|
2,132 |
|
|
|
|
|
|
|
2,132 |
|
2013 |
|
|
2,179 |
|
|
|
|
|
|
|
2,179 |
|
Thereafter |
|
|
6,399 |
|
|
|
|
|
|
|
6,399 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
$ |
16,586 |
|
|
$ |
845 |
|
|
$ |
15,741 |
|
|
|
|
|
|
|
|
|
|
|
In April 2009, we negotiated an amendment to our sublease with PuriCore to expand the term of
the sublease until September 30, 2011, to expand the sublease premises to include all of the
approximately 32,900 rentable square feet and to grant PuriCore the option to renew the sublease
for an additional three-year term. We are currently awaiting the landlords approval of this
amendment, which is required before it can become effective.
Sales and Issuance of Common Stock
During the three months ended March 31, 2008, the Company received net proceeds of $35,000
from the exercise of 20,571 shares of common stock options, at a range of $1.34 to $2.67 per share.
During the three months ended March 31, 2009, the Company received net proceeds of $35,000 for
the exercise of 20,000 shares of common stock options at $1.75 per share.
17
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Income Taxes
The American Recovery and Reinvestment Act of 2009 was enacted and signed into law on February
17, 2009. The Act include the extension of a provision passed by the United States Congress in 2008
which allows companies to accelerate the recognition of a portion of research and development
(R&D) credits in lieu of bonus depreciation and convert the R&D credits carry forward into
currently refundable credits. The amount that may be converted is based on the amount invested in
property that would otherwise qualify for bonus depreciation and is capped at the lesser of 6% of
historic R&D credits or $30 million. The Company is evaluating the R&D credit provisions of the Act
but has not yet reached a decision whether it will forego the bonus depreciation to obtain any R&D
credit that may be refundable.
18
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
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 manufacturing facility in Philadelphia,
Pennsylvania had identifiable cash flows that were largely independent of the cash flows of other
groups of assets and liabilities and the Company did 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 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. The Company delivered the required quantity of
Estrrasorb as required under the Graceway agreements, and exited the facility in August 2008.
The following table presents summarized financial information for the Companys discontinued
manufacturing operations presented in the consolidated statements of operations for the three
months ended March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
(Unaudited) |
|
|
|
(In thousands) |
|
Revenues |
|
$ |
|
|
|
$ |
86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
|
|
|
|
738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
|
|
|
$ |
(652 |
) |
|
|
|
|
|
|
|
The following table presents major classes of assets and liabilities that have been presented
as assets and liabilities of discontinued operations in the accompanying consolidated balance
sheets.
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(Unaudited) |
|
|
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
$ |
|
|
|
$ |
132 |
|
|
|
|
|
|
|
|
Current assets of discontinued operations |
|
$ |
|
|
|
$ |
132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
|
|
|
$ |
209 |
|
Accrued expenses and other liabilities |
|
|
|
|
|
|
33 |
|
|
|
|
|
|
|
|
Current liabilities of discontinued operations |
|
$ |
|
|
|
$ |
242 |
|
|
|
|
|
|
|
|
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, 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.
19
4. Related Party Transactions
Effective April 1, 2009, the Board elected Rajiv I. Modi Ph.D., managing director of Cadila,
as a Class I director. Dr. Modi was elected to the board pursuant to the Stock Purchase Agreement
dated March 31, 2009 between Novavax and SOHL, a subsidiary of Cadila, which requires that, for so
long as SOHL owns 5% of the Companys Common Stock, SOHL may designate one member of the Board.
On March 31, 2009, Novavax entered into several material agreements with Cadila, SOHL and CPL
Biologicals Limited, the JV formed by the Company and Cadila, 80% of which will be owned by Cadila
(the JV). Cadila has committed to fund approximately $8 million of working capital to the JV over
three years. Dr. Modi serves as managing director of Cadila and his family has a substantial
ownership interest in Cadila and therefore he has an indirect material interest in these material
agreements further described below. Due to Dr. Modis interest in Cadila and the JV, he is not
independent as that term is defined in the NASDAQ listing standards.
As stated above, on March 31, 2009, Novavax entered into a Stock Purchase Agreement (the
SPA) with SOHL, pursuant to which SOHL agreed to purchase 12.5 million shares of Company Common
Stock at $0.88 per share, which closed on April 1, 2009. The Company raised gross proceeds of $11
million in the offering. The net proceeds to the Company from the sale of the Common Stock, after
deducting estimated offering expenses payable by the Company, is approximately $10.5 million. The
SPA provides that, as long as SOHL owns more than 5% of the Companys then-outstanding Common
Stock, SOHL may purchase a pro-rata portion of most Company Common Stock sales or issuances.
Finally, on March 31, 2009, Novavax and Cadila entered into a Master Services Agreement (the
Master Services Agreement) pursuant to which Novavax may request services from Cadila in the
areas of biologics research, preclinical development, clinical development, process development,
manufacturing scale up, and general manufacturing related services in India. If, at the third
anniversary of the Master Services Agreement, the amount of services provided by Cadila is less
than $7.5 million, Novavax will pay Cadila a portion of the shortfall. Novavax will have to pay
Cadila the portion of the shortfall amount that is equal to $2.0 million and 50% of the portion of
the shortfall amount that exceeds $2.0 million. When calculating the shortfall, the amount of
services provided by Cadila includes amounts that have been paid under all project plans, the
amounts that will be paid under ongoing executed project plans and amounts for services that had
been offered to Cadila, that Cadila was capable of performing, but exercised its right not to
accept such project.
The aggregate dollar value of the these agreements above is approximately $11 million for the
Stock Purchase Agreement, $7.5 million for the Master Services Agreement, and $8 million for the
Joint Venture Agreement.
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. 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. On
March 5, 2009, the Company granted Mr. Lambert 25,000 stock options under the 2005 plan with a fair
value of approximately, 10,000. For the three months ended March 31, 2009 and 2008, the Company
recorded consulting expenses for Mr. Lambert of $55,000 in accordance with the consulting
agreement.
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.
20
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
restates the entire amount outstanding as of December 31, 2007, including accrued interest, or
$578,848, as the new outstanding principal amount. Furthermore, 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 on June 30, 2008. The
Company received a first payment of $50,000 in July 2008 and a second payment of $5,000 in October
2008, with a balance due by December 31, 2008 of $45,000. In January 2009, the Company received an
additional payment of $10,000.
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.
21
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 product sales, future product development and related clinical trials, and future
research and development, including Food and Drug Administration approval. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors which may cause the
actual results, performance or achievements of the Company, or industry results, to be materially
different from those expressed or implied by such forward-looking statements.
Factors that may cause actual results to differ materially from the results discussed in the
forward-looking statements or historical experience include risks and uncertainties, including the
Companys ability to raise capital through public or private equity and/or debt financings; the
maturity of the convertible notes on July 15, 2009, the failure by Novavax to secure and maintain
relationships with collaborators; risks relating to the early stage of Novavaxs product candidates
under development; uncertainties relating to commencing clinical trials and their outcome; risks
relating to the supply and commercialization, if any, of Novavaxs proposed product candidates;
dependence on the efforts of third parties; dependence on intellectual property; competition for
clinical resources and patient enrollment from drug candidates in development by other companies
with greater resources and visibility and other factors referenced herein.
All forward-looking statements contained in this quarterly 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 biopharmaceutical company focused on creating differentiated, value-added
vaccines that improve upon current preventive options for a range of infectious diseases. These
vaccines leverage the Companys virus-like-particle (VLP) platform technology coupled with a
unique, disposable production 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 and other subtypes of avian influenza with pandemic potential, human
seasonal influenza, Varicella Zoster (VZV), which causes shingles, and a Respiratory Syncytial
Virus (RSV).
We made significant progress since 2007 in our vaccine that targets the H5N1 avian influenza
with pandemic potential. In December 2007, we announced favorable interim results for a Phase I
clinical trial which began in July 2007 for our pandemic influenza vaccine, that demonstrated
immunogenicity and safety. In August 2008, we received favorable results from a Phase I/IIa trial
which was conducted to gather additional patient immunogenicity and safety data, as well as to
determine a final dose, which demonstrated strong neutralizing antibody titers across all three
doses tested. Although the safety data are still blinded pending complete safety follow-up, there
were no serious adverse events reported. In February 2009, we announced that the vaccine induced
robust hemagglutination inhibition (HAI) responses, which have been shown to be important for
protection against influenza disease. In April 2009, we reported preclinical study results,
conducted by scientists from both the Centers for Disease Control and Prevention, and the Company
under a Collaborative Research and Development Agreement showing that an investigational H1N1 VLP
vaccine based on the 1918 Spanish influenza strain protected against both the Spanish flu and a
highly pathogenic H5N1 avian influenza strain. We have begun the work
on creating a VLP vaccine candidate against the 2009 H1N1 swine flu
virus and expect to complete production of the first batch of vaccine
within 12 weeks of receiving the protein sequences. This faster
cycle time from strain identification to first vaccine batch would
be another demonstration of our abilities to create strain specific vaccines
to potential pandemic influenza viruses. Over the past few years, we
have gone through the process of creating recombinant VLP vaccines
for multiple strains of influenza, both of seasonal as well as avian
strains. This experience and knowledge has prepared us to execute
this real life challenge.
We only intend to initiate further human clinical trials for our pandemic influenza vaccine,
which would be required for regulatory approval, with a collaborative partner.
22
We also progressed development of our VLP trivalent vaccine that targets seasonal influenza
virus in 2008 and 2007. In December 2008, we announced favorable safety and immunogenicity results
from our Phase IIa seasonal study in healthy adults which we commenced in September 2008 to
evaluate the safety and immunogenicity of different doses of our seasonal influenza vaccine. We
observed a slightly different safety profile (non-serious adverse events) from our Phase IIa trial
of our pandemic VLP vaccine, and are reviewing and analyzing the dose response curve as well as the
safety data from the healthy adult seasonal trial before commencing a seasonal influenza dose
ranging study in the elderly (>65 years of age) in the second half of 2009.
On May 5, 2009, we announced the initiation of enrollment in the second Phase II study of its
trivalent seasonal influenza VLP vaccine candidate. This clinical trial is designed to evaluate the
safety and immunogenicity of a broader range of vaccine doses and to provide data to help select
doses for future studies in older adults and a Phase III efficacy study. The Company plans to
report top-line immunogenicity and safety results from this study by the fourth quarter of this
year. We continue to seek a collaborative partner for our seasonal influenza vaccine upon completion
of additional Phase II clinical studies, which are expected to be completed by the end of 2009.
We have also developed vaccine candidates for both RSV and VZV, both of which are currently
being evaluated in preclinical studies. To date, preliminary data have shown that an RSV vaccine
candidate has shown positive results in two separate studies with mice. In December 2008, Novavax
and the University of Massachusetts jointly announced favorable results from a preclinical study to
evaluate the immunogenicity and efficacy of an RSV vaccine candidate in mice. The RSV VLP vaccine
induced strong antibody responses against RSV. In February 2009, we announced favorable results
from an RSV preclinical study performed in mice against the viral fusion (F) protein, which fuses
with cells in the respiratory tract and causes illness. A VZV vaccine candidate has also induced
antibody and T-cell responses. We plan on moving forward with further preclinical development of
both vaccines in 2009.
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.
Subsequent Events
Cadila
Pharmaceuticals Ltd.
On March 31, 2009, Company and Cadila Pharmaceuticals Ltd., a company incorporated under the
laws of India (Cadila) entered into a Joint Venture Agreement (the JVA) pursuant to which the
Company and Cadila formed CPL Biologicals Limited, a joint venture (the JV), of which 80% will be
owned by Cadila and 20% is owned by the Company. The JV must obtain approval from Indias Foreign
Investment Promotion Board (the FIPB) prior to issuing shares to Novavax. The JV will develop and
commercialize our seasonal influenza virus-like-particle (VLP)-based vaccine candidate and Cadilas
therapeutic vaccine candidates against cancer as well as its adjuvants, biogeneric products and
other diagnostic products for the territory of India. We will also contribute to the JV technology
for the development of several other VLP vaccine candidates against diseases of public health
concern in the territory, such as hepatitis E and chikungunya fever. Cadila will contribute
approximately $8 million over three years to support the JVs operations. The JV will be
responsible for clinical testing and registration of products that will be marketed and sold in
India.
The board of directors of the JV consists of five members, three of whom (including the
Chairman of the board) are nominated by Cadila and two of whom are nominated by Novavax. If the
board is not in unanimous agreement on an issue, the Chief Executive Officers (CEOs) of the
Company and Cadila will work to resolve the issue. If the
CEOs cannot resolve the issue in five business days, a vote by the majority of the board will
decide. However, the approval of the Company and Cadila, as shareholders of the JV, and the board
of directors of the JV is required for (1) the sale of all or most of the assets of the JV, (2) a
change in control of the JV, (3) the liquidation, dissolution, or winding up of the JV, (4) any
occurrence of indebtedness that results in the JV having a debt-to-equity ratio of 3-to-1 or
greater, or (5) most amendments of the JVA or the JVs Articles of Association.
23
The JV has the right to negotiate a definitive agreement for rights to certain future Novavax
products (other than RSV) and certain future Cadila products in India prior to Novavax or Cadila
licensing such rights to a third party. Novavax has the right to negotiate the licensing of
vaccines developed by the joint venture using Novavaxs technology for commercialization in every
country except for India and vaccines developed by the joint venture using Cadilas technology for
commercialization in certain other countries, including the United States.
In connection with the JVA, on March 31, 2009, we also entered into license agreement, an
option to enter into a license agreement, a technical services agreement and a supply agreement
with the JV.
Also on March 31, 2009, we entered into a binding, non-cancellable Stock Purchase Agreement
(the SPA) with Satellite Overseas (Holdings) Limited (SOHL), a subsidiary of Cadila, pursuant
to which SOHL has agreed to purchase 12.5 million shares of our common stock, par value $0.01 (the
Common Stock) at the market price of $0.88 per share. We delivered the shares of Common Stock on
April 1, 2009. We raised gross proceeds of $11 million in the offering. The net proceeds to us from
the sale of the Common Stock, after deducting estimated offering expenses payable by us, is
approximately $10.5 million.
The SPA provides that, as long as SOHL owns more than 5% of the Companys then-outstanding
Common Stock, SOHL may purchase a pro-rata portion of any Company common stock sale issuance. Under
the SPA, certain issuances are exempt from SOHLs pre-emptive right, including shares issued (1) as
stock dividends, stock splits, or otherwise payable pro rata to all holders of Common Stock; (2) to
our employees, officers, directors or consultants pursuant to an employee benefit program; (3) upon
the conversion or exercise of any options, warrants or other rights to purchase Common Stock; and
(4) as consideration for a merger, consolidation, purchase of assets, or in connection with a joint
venture or strategic partnership. However, any issuances pursuant to (4) above, must be approved by
a majority of the full board and, if the transaction exceeds 5% of our then issued and outstanding
shares of Common Stock, the per share purchase price cannot be less than $0.88. Under the SPA, for
so long as SOHL owns 5% of our common stock, SOHL may designate one member of our board of
directors.
Finally, on March 31, 2009, Novavax and Cadila entered into a Master Services Agreement (the
Master Services Agreement) pursuant to which we may request services from Cadila in the areas of
biologics research, preclinical development, clinical development, process development,
manufacturing scale up, and general manufacturing related services in India. If, at the third
anniversary of the Master Services Agreement, the amount of services provided by Cadila is less
than $7.5 million, we will pay Cadila a portion of the shortfall. We will have to pay Cadila the
portion of the shortfall amount that is less than or equal to $2.0 million and 50% of the portion
of the shortfall amount that exceeds $2.0 million. When calculating the shortfall, the amount of
services provided by Cadila includes amounts that have been paid under all project plans, the
amounts that will be paid under ongoing executed project plans and amounts for services that had
been offered to Cadila, that Cadila was capable of performing, but exercised its right not to
accept such project. The term of the Master Services Agreement is five years, but may be terminated
by either party if there is a material breach that is not cured within 30 days of notice or, at any
time after three years, provided that 90 days prior notice is given to the other party.
At the Market Issuance
On January 12, 2009, we entered into an At Market Issuance Sales Agreement (the Sales
Agreement), with Wm Smith & Co. (Wm Smith), under which we may sell an aggregate of up to $25
million in gross proceeds of our common stock from time to time through Wm Smith, as the agent for
the offer and sale of the common stock. The Board of Directors has authorized the sale of up to
12,500,000 shares of common stock under the Sales Agreement. Based on the trading price of our
common stock, we may not be able to sell all 12,500,000 shares or we may not be able to raise the
full $25 million in gross proceeds permitted under the Sales Agreement. Wm Smith may sell the
common stock by any method permitted by law, including sales deemed to be an at the market
offering as defined in Rule 415 of the Securities Act, including without limitation sales made
directly on NASDAQ Global
Market, on any other existing trading market for the common stock or to or through a market maker.
Wm Smith may also sell the common stock in privately negotiated transactions, subject to our prior
approval. We will pay Wm Smith a commission equal to 3% of the gross proceeds of the sales price of
all common stock sold through it as sales agent under the Agreement. In the first quarter of 2009,
we sold 70,500 shares and received net proceeds in the amount of $121,457, under the Sales
Agreement. As of May 5, 2009, we sold approximately an additional 3.1 million shares for net
proceeds of approximately $7.5 million.
24
Amendments to Convertible Notes
On April 29, 2009, we entered into amendment agreements (the 2009 Amendments) with holders
of the outstanding 4.75% senior convertible notes (the Notes) representing $17.0 million of the
$22.0 million outstanding principal amount of the Notes to amend the terms of the Notes to allow
for early payment under specific terms described below.
The 2009 Amendments (i) provide for payment of $17,000,000 aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provide for the remaining portion of this principal amount to
be paid in that number of shares of Common Stock that equals 30% of this principal amount divided
by $2.50. On April 29, 2009, we paid $12.1 million in principal and accrued interest and issued
2,040,000 shares in accordance with the terms of the 2009 Amendments.
After payment of this $17.0 million in principal amount, $5.0 million aggregate principal
amount remains outstanding under the Notes and will mature on July 15, 2009. Under the terms of the
Notes, Novavax, at its option, can pay up to 50% of the remaining $5.0 million outstanding Notes in
Novavax common stock on the due date of July 15, 2009, subject to the satisfaction of certain
conditions, including, among other things, a requirement that the shares issued upon conversion be
registered or freely tradable without registration, that Novavaxs shares of common stock have not
been suspended from trading on NASDAQ Global Market during the applicable measurement period and
there is no threatened delisting or suspension, and that the Company is otherwise in compliance
with its agreements with the Note holders.
Significant Transactions in 2009 and 2008
Facility Exit Costs
In July 2008, we decided to consolidate our research and development and manufacturing
activities into our facility at Belward Campus Drive in Rockville, Maryland by closing our Taft
Court facility in Rockville, Maryland. The Taft Court location was used to support the
manufacturing requirements for early stage clinical trial materials for our VLP vaccine candidates.
Our new GMP pilot manufacturing facility located at our Belward Campus Drive location will be used
to support clinical trials and may also be used for future commercialization quantities of our VLP
vaccines. The move commenced in September 2008 and was completed on October 17, 2008. Our accrued
expenses on the consolidated balance sheet as of March 31, 2009 and December 31, 2008 include
$237,000 and $296,000, respectively, related to the remaining lease payments.
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. 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 had agreed to manufacture additional units of Estrasorb. Final delivery was made in July
2008. Graceway paid a preset transfer price per unit of Estrasorb for the supply of this product.
After we delivered the required quantity of Estrasorb, we were required to clean the manufacturing
equipment and prepare the equipment for transport. Graceway removed the equipment from the
manufacturing facility and we exited the facility in August 2008.
In February 2008, Novavax and Graceway also entered into a license agreement, pursuant to
which Graceway granted us 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 licensed grant allows us to make, use and
sell licensed products and services in certain, limited fields.
25
The net cash proceeds from these transactions were 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.
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
diseases in humans. As of March 31, 2009 and December 31, 2008, we made payments to UMMS in an
aggregate amount that is not material. 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 the technology. We believe that all payments under the UMMS agreement will not be material to
us in the foreseeable future. The UMMS 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 our option or by UMMS for an uncured breach by Novavax.
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. If each milestone is achieved for any particular product candidate, we would be
obligated to pay an aggregate of $14 million to Wyeth Holdings for each product candidate developed
and commercialized under the agreement. Achievement of each milestone is subject to many risks,
including those described in our Item IA of Part I of our annual report on Form 10-K for the year
ended December 31, 2008. Annual license
maintenance fees under the Wyeth Holdings agreement aggregate $0.3 million per year. The royalty
to be paid by us under the agreement, if a product is approved by the FDA for commercialization,
will be based on single digit percentage of net sales. Payments under the agreement to Wyeth as of
March 31, 2009 aggregated $4.8 million and could aggregate up to an additional $0.3 million in
2009, 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 our option or by Wyeth for an uncured breach by
Novavax.
Sublease Agreement with PuriCore, Inc.
In April 2006, we entered into a sublease agreement with Sterilox Technologies, Inc. (now
known 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. This sublease resulted from our corporate move to
Rockville, Maryland. 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 concurrent with the initial lease on September 30, 2009. In April 2009, we
negotiated an amendment to our sublease with PuriCore to expand the term of the sublease until
September 30, 2011, to expand the sublease premises to include all of the approximately 32,900
rentable square feet and to grant PuriCore the option to renew the sublease for an additional
three-year term. We are currently awaiting the landlords approval of this amendment, which is
required before it can become effective.
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.
26
In May 2006, one of these directors resigned from our 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 restates the entire amount outstanding as of December 31, 2007, including
accrued interest, or $578,848, as the new outstanding principal amount. Furthermore, the Amendment
extends the maturity date of the note to June 30, 2009, permits us 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. We
received the first payment of $50,000 in July 2008 for the first half of 2008 and a second payment
of $5,000 in October 2008, with a balance for the next payment due by December 31, 2008 of $45,000.
In January 2009, we received an additional payment of $10,000.
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 payable on
June 30, 2009, or earlier to the extent of the net proceeds from any sale of the pledged shares. In
addition, we have 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.
We continue to actively work with these two individuals to collect the amounts outstanding and
reserve our rights to pursue the remedies available to us. 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
Our discussion and analysis for our financial condition and results of operations are based
upon our consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States.
The preparation of our consolidated financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities and equity 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. These estimates, particularly estimates
relating to revenue recognition, allowance for doubtful accounts and rebates, accounting for stock
based compensation, goodwill, valuation of net deferred tax assets, and valuation of marketable
securities, have a material impact on our financial statements and are discussed in detail
throughout our analysis of the results of operations discussed below.
We base our estimates on historical experience and various other assumptions that we believe
are reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying value of assets, liabilities and equity that are not readily apparent from other
sources. Actual results and outcomes could differ from these estimates and assumptions.
For a more detailed explanation of the judgments made in these areas and a discussion of our
accounting estimates and policies, refer to Critical Accounting Policies and Use of Estimates
included in Item 7 and Summary of Significant Accounting Policies (Note 2) included in Item 15 of
our Annual Report on Form 10-K for the year ended December 31, 2008. Since December 31, 2008,
there have been no significant changes to our critical accounting estimates and policies.
Recent Accounting Standards
In April 2009, the Financial Accounting Standards Board (FASB) issued FSP SFAS 141(R)-1,
Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from
Contingencies, to amend the provisions related to the initial recognition and measurement,
subsequent measurement and disclosure of assets and liabilities arising from contingencies in a
business combination under SFAS 141(R).
27
Under the new guidance, assets acquired and liabilities
assumed in a business combination that arise from contingencies should be recognized at fair value
on the acquisition date if fair value can be determined during the measurement period. If fair
value cannot be determined, companies should typically account for the acquired contingencies using
existing guidance. We are reviewing this pronouncement as it relates
to our recent agreements with
Cadila Pharmaceuticals Ltd. The adoption of these pronouncements is not expected to have a
material effect on the Companys financial position and results from operations.
In April 2009, the FASB issued FSP SFAS 157-4, Determining Fair Value When the Volume and
Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying
Transactions That Are Not Orderly which provides additional guidance for estimating fair value in
accordance with FASB Statement No. 157, Fair Value Measurements, when the volume and level of
activity for the asset or liability have significantly decreased. This FSP also includes guidance
on identifying circumstances that indicate a transaction is not orderly. This pronouncement is
effective for periods ending after June 15, 2009. We do not expect this pronouncement to have a
material effect on our financial position and results of operations.
In April 2009, the FASB issued FSP SFAS 115-2 and SFAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments, to amend the other-than-temporary impairment guidance in debt
securities to be based on intent to sell instead of ability to hold the security and to improve the
presentation and disclosure of other-than-temporary impairments on debt and equity securities in
the financial statements. This pronouncement is effective for periods ending after June 15, 2009.
We do not expect this pronouncement to have a material effect on our financial position and results
of operations.
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
our SEC filings, including but not limited to our Annual Report on Form 10-K for the fiscal year
ended December 31, 2008.
Three months ended March 31, 2009 (Q1 2009) compared to the three months ended March 31, 2008
(Q1 2008): (Amounts in the tables are presented in thousands, except percentage changes and share and per share information)
Revenues:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 |
|
|
Q1 |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
21 |
|
|
$ |
458 |
|
|
$ |
(437 |
) |
|
|
(95 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for the first quarter 2009 were $21,000 as compared to $458,000 in the comparable
period in 2008. The decrease in revenue from the comparable period in 2008 was principally due to
lower contract revenue. Contract research and development revenue is comprised of revenue from
government and commercial contracts and for the three months ended March 31, 2008 is comprised of
revenue from two National Institutes of Health (NIH) grants, one of which was completed in 2008.
Contract research and development revenue for the three months ended March 31, 2009 is comprised of
revenue from one NIH contract, which was completed in 2009.
Operating costs and expenses:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 |
|
|
Q1 |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,266 |
|
|
$ |
4,434 |
|
|
$ |
(168 |
) |
|
|
(4 |
)% |
General and administrative |
|
|
2,892 |
|
|
|
3,244 |
|
|
|
(352 |
) |
|
|
(11 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,158 |
|
|
$ |
7,678 |
|
|
$ |
(520 |
) |
|
|
(7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
28
Research and Development Expenses
Research and development costs decreased from $4.4 million in 2008 to $4.3 million in 2009, a
decrease of $0.1 million or 4%. Our research and development costs are incurred in support of the
development of VLP based vaccines. A portion of the decrease can be attributed to a $0.2 million
decrease in employee costs and a $0.1 million decrease associated with the closing of our Taft
Court facility. In October 2008, we consolidated our manufacturing operations into our facility at
Belward Campus Drive in Rockville, Maryland and accrued the remaining lease payments related to our
Taft Court facility.
These decreases were partially offset by a $0.1 million increase in outside testing costs
associated with the continuing preclinical testing, human clinical trials, process development,
manufacturing and quality-related programs and a $0.1 million increase in facility costs. The
increase in facility costs relate to increased rent and depreciation charges.
General and Administrative Expenses
General and administrative costs were $2.9 million in 2009 compared to $3.2 million in 2008.
The $0.3 million decrease in general and administrative costs can be attributed to a $0.1 million
decrease in employee costs and a $0.1 million decrease in facility costs associated with general
and administrative functions. General and administrative costs for the three months ended March 31,
2008 included $0.2 million related to the allowance established for two notes receivable from
former directors. During 2008, we determined that the notes receivable should be classified as a
reduction of equity. We have not recorded any reserved charges during the three months ended March
31, 2009. These decreases were partially offset by an increase of $0.1 million related to
professional fees associated with the preparation of SEC filings during the three months ended
March 31, 2009.
Other income (expense):
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 |
|
|
Q1 |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
104 |
|
|
$ |
543 |
|
|
$ |
(439 |
) |
|
|
(81 |
)% |
Interest expense |
|
|
(437 |
) |
|
|
(426 |
) |
|
|
(11 |
) |
|
|
(3 |
)% |
Impairment loss on
short-term
investments |
|
|
(879 |
) |
|
|
|
|
|
|
(879 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(1,212 |
) |
|
$ |
117 |
|
|
$ |
(1,329 |
) |
|
|
(1,136 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income was $0.1 million for 2009 compared to interest income of $0.5 million for
2008. The $0.4 million decrease in net interest income in the first quarter of 2009 as compared to
the quarter ended March 31, 2008, was principally due to a decrease in the average balance
outstanding for cash and short-term investments. The average cash and short-term investment
balances outstanding decreased as a result of our continuing investment in our research and
development activities surrounding our vaccine candidates. Interest expense for the three months
ended March 31, 2009 and 2008 primarily represents interest on the outstanding convertible debt of
$22.0 million and the amortization of the debt discount of $102,000. The debt discount resulted
from the amendment of our convertible notes in June 2007, which resulted in the recording of a debt
discount, which is being amortized over the remaining period of the notes. Additionally, we
recorded $0.9 as an impairment loss for the quarter ended March 31, 2009, related to an other than
temporary impairment loss on our auction rate securities.
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 manufacturing facility in Philadelphia, Pennsylvania. The results of operations
for the manufacturing facility are being reported as discontinued operations. In August 2008, we
completed our final obligation to Graceway and exited the facility.
The following table presents summarized financial information for our discontinued operations
for the three months ended March 31, 2009 and 2008:
29
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 |
|
|
Q1 |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
|
|
|
$ |
86 |
|
|
$ |
(86 |
) |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of products sold |
|
|
|
|
|
|
738 |
|
|
|
(738 |
) |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
|
|
|
$ |
652 |
|
|
$ |
(652 |
) |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded a loss from discontinued operations of $0.7 million for the three months ended
March 31, 2008. We recorded revenue from discontinued operations of $86,000 for 2008 from the sale
of Estrasorb.
Costs of products sold, which includes fixed idle capacity costs, were $0.7 million for the
three months ended March 31, 2008. Of the $0.7 million cost of products sold in 2008, $0.6 million
represented idle plant capacity costs at our manufacturing facility. The remaining $0.1 million
represented the cost of Estrasorb sales to Allergan. In accordance with the Supply Agreement with
Allergan, which terminated in February 2008, we were required to sell Estrasorb at a price that is
lower than our manufacturing costs.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 |
|
|
Q1 |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,349 |
) |
|
$ |
(7,755 |
) |
|
$ |
(594 |
) |
|
|
(8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(0.12 |
) |
|
$ |
(0.13 |
) |
|
$ |
0.01 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares
outstanding |
|
|
68,692,455 |
|
|
|
61,280,155 |
|
|
|
6,952,264 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Our net loss for the three months ended March 31, 2009 was $8.3 million, or 0.12 per share, as
compared to $7.8 million, or $0.13 per share, for the three months ended March 31, 2008, an
increase in the net loss of $0.6 million. The increase was principally due to the impairment loss
on short-term investments recorded for the three months ended March 31, 2009, and a decrease in
contract revenue, partially offset by a decrease in operating expenses.
Liquidity and Capital Resources
Our future capital requirements depend on numerous factors including but not limited to the
maturing of the remaining Notes on July 15, 2009, the commitments and progress of our research and
development programs, the progress of preclinical and clinical testing, the costs of filing,
prosecuting, defending and enforcing any patent claims and other intellectual property rights, and
manufacturing cost. 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 increase. We will need to engage in capital
raising transactions in the near term. Future activities, particularly vaccine and product
development, are subject to our ability to raise funds through public or private financings using
equity and/or debt securities, or collaborative licensing and development arrangements with
industry partners and government agencies.
30
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, 2009 |
|
|
|
(unaudited) |
|
Summary of Cash Flows: |
|
(In thousands) |
|
Net cash (used in) provided by: |
|
|
|
|
Operating activities |
|
$ |
(6,727 |
) |
Investing activities |
|
|
68 |
|
Financing activities |
|
|
(650 |
) |
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(7,309 |
) |
Cash and cash equivalents at beginning of period |
|
|
26,938 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
19,629 |
|
|
|
|
|
As of March 31, 2009, we held $19.6 million in cash and investments as compared to $26.9
million at December 31, 2008. The $7.3 million decrease in cash and investments during 2008 was
primarily due to the operating loss of $8.3 million and
principal payments on debt of $0.9 million.
As of March 31, 2009, our working capital deficit was $0.2 million compared to $7.3 million surplus
as of December 31, 2008. This $7.5 million decrease primarily resulted from our net loss.
Additionally, our working capital was used for $0.8 million in principal payments on our
outstanding debt obligations for the three months ended March 31, 2009.
We will seek to raise additional capital through public or private equity and/or debt
financing. We intend to use the proceeds from these financing transactions to pay all or a portion
of the principal and interest due on the Notes and for general corporate purposes, including but
not limited to our internal research and development programs, such as preclinical and clinical
testing and studies for our vaccine and other product candidates, the development of new
technologies, capital improvements and general working capital. We will also seek to fund our
operations through licensing and development arrangements. 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. Any capital raised by an equity offering will likely be
substantially dilutive to the stockholders and any licensing or development arrangement may require
us to give up rights to a product or technology at less than its full potential value.
As of May 5, 2009, we have sold approximately 3.1 million shares of common stock and received
net proceeds of approximately $7.5 million pursuant to the sales agreement with Wm Smith. On March
31, 2009, we entered into a binding, non-cancellable stock purchase agreement to sell 12.5 million
shares to a wholly-owned subsidiary of Cadila for a market price of $0.88 per share. We closed
this transaction on April 1, 2009 and received net proceeds in the amount of $10.5 million.
As of March 31, 2009, we had $22.0 million of senior convertible notes outstanding (the
Notes). The Notes carry a 4.75% coupon; are convertible into shares of Novavax common stock at
$4.00 per share; and mature on July 15, 2009. We may require that the Notes be converted into our
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 April 29, 2009, we entered into
amendment agreements (the 2009 Amendments) with holders of the outstanding Notes representing
$17.0 million of the $22.0 million outstanding principal amount of the Notes to amend the terms of
the Notes to allow for early payment under specific terms described below.
The 2009 Amendments (i) provide for payment of $17.0 million aggregate principal amount of the
Notes on April 29, 2009, (ii) provide for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) for the remaining portion of this principal amount to be paid
in that number of shares of Common Stock that equals 30% of this principal amount divided by $2.50.
Based on the amount of funds on hand, the proceeds from the Cadila transaction and the sale of
stock under the Wm Smith agreement, our intention to pay 50% of the remaining $5.0 million
outstanding Notes in Novavax common stock, and our planned business operations, we believe we will
have adequate capital resources to operate at planned levels for at least the next twelve months.
We are planning to raise additional capital in 2009 in order to continue our current level of
operations and to pursue the business plan beyond 2009. We have not, however, secured any
additional commitments for new financing at this time nor can we provide any assurance that new
financing will be available on commercially acceptable terms, if at all.
31
Any equity financing would cause significant dilution to our shareholders at current market prices.
If we are not able to secure additional capital, we will continue to assess our capital resources
and we may be required to downsize our operations, reduce general and administrative costs or to
delay or reduce the scope of, or eliminate one or more of
our product research and development programs, thereby causing delays in our efforts to introduce
our future products to market. Should we be unable to accomplish these activities, we may not be
able to continue our business.
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 March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
16,586 |
|
|
|
2,253 |
|
|
|
6,296 |
|
|
|
4,288 |
|
|
|
3,749 |
|
Notes payable |
|
|
853 |
|
|
|
385 |
|
|
|
468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total principal payments |
|
|
39,439 |
|
|
|
24,638 |
|
|
|
6,764 |
|
|
|
4,288 |
|
|
|
3,749 |
|
Less: Subleases |
|
|
(845 |
) |
|
|
(328 |
) |
|
|
(517 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
commitments and obligations |
|
|
38,594 |
|
|
|
24,310 |
|
|
|
6,247 |
|
|
|
4,288 |
|
|
|
3,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
This is the gross obligation for the convertible notes at March 31, 2009. |
On March 31, 2009, we entered into a Master Service Agreement with Cadila in which we may
request services from Cadila in areas of biologics research, preclinical development, clinical
development, process development, manufacturing scale up and general related services in India.
This commitment is for $7.5 million in services over the next three years. If, at the third
anniversary of the Master Service Agreement, the amount of services provided by Cadila is less than
$7.5 million, we will pay Cadilia a portion of the shortfall. We will have to pay Cadilia the
portion of the shortfall amount that is less than or equal to the shortfall amount that exceeds
$2.0 million and 50% of the portion of the shortfall that exceeds $2.0 million.
In April 2009, we negotiated an amendment to our sublease with PuriCore to expand the term of
the sublease until September 30, 2011, to expand the sublease premises to include all of the
approximately 32,900 rentable square feet and to grant PuriCore the option to renew the sublease
for an additional three-year term. We are currently awaiting the landlords approval of this
amendment, which is required before it can become effective.
32
In addition to the amounts reflected in the table above in the future, we may owe royalties
and other contingent payments to our collaborators or license holders based on the achievement
product sales, milestones and other specific objectives.
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 March 31, 2009, we had cash and cash
equivalents and short-term investments of $25.6 million as follows:
|
|
|
|
|
Cash and cash equivalents |
|
|
$ |
19.6 million |
|
|
|
|
|
Short-term investments classified as available for sale |
|
|
$ |
6.0 million |
Our exposure to market risk is confined to our investment portfolio. As of March 31, 2009, our
short-term investments are classified as available for sale. 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.
Short-term investments at March 31, 2009 consist of investments in five auction rate
securities with a par value of $8.1 million and a fair value of $6.0 million. We recorded an
additional other than temporary impairment charge to operating related to these securities during
the first quarter of 2009 of $0.9 million because of the current turmoil in the credit markets and
managements belief these securities cannot presently be sold at par value but are saleable at a
discount from their par value.
We have classified these securities as short-term investments and have accounted for our
investments in these securities as available for sale securities under the guidance of Statement of
Financial Accounting Standards, Accounting for Certain Investments in Debt and Equity Securities
(SFAS No. 115). Although the auction rate securities have variable interest rates which typically
reset every 16 to 32 days through a competitive bidding process known as a Dutch auction, they
have long-term contractual maturities. These investments are classified within current assets
because we may need to liquidate these securities within the next year.
The available for sale securities are carried at fair value and unrealized gains and losses on
these securities, if determined to be temporary, are included in accumulated other comprehensive
income (loss) in stockholders equity. We assess the recoverability of our available-for-sale
securities and, if impairment is indicated, we measure the amount of such impairment by comparing
the fair value to the carrying value. Other than temporary impairments are included in the
consolidated statements of operations. Our cumulative other than temporary impairment charges
approximate $2.1 million, which include an impairment charge of 1.2 million recorded in 2008.
We had invested in auction rate securities for short periods of time as part of our cash
management program. Recent uncertainties in the credit markets have prevented us from liquidating
certain holdings of auction rate securities subsequent to December 31, 2008 as the amount of
securities submitted for sale during the auction has exceeded the amount of the purchase orders.
Although an event of an auction failure does not necessarily mean that a security is impaired, we
considered various factors to assess the fair value and the classification of the securities as
short-term assets. Fair value was determined through an independent valuation using two valuation
methods - a discounted cash flow method and a market comparables method. Certain factors used in
these methods include, but are not necessary limited to, comparable securities traded on secondary
markets, timing of the failed auction, specific security auction history, quality of underlying
collateral, rating of the security and the bond insurer, our ability and intent to retain the
securities for a period of time to allow for anticipated recovery in the market value, and other
factors.
33
Interest and dividend income is recorded when earned and included in interest income.
Premiums and discounts, if any, on short-term investments are amortized or accreted to maturity and
included in interest income. The specific identification method is used in computing realized
gains and losses on sale of our securities.
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.
At March 31, 2009, we had a total debt of $22.7 million, most of which bears interest at fixed
interest rates. We do not believe that it is exposed to any material interest rate risk as a result
of our borrowing activities.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Companys chief executive officer and interim principal accounting officer, who performs
functions similar to a principal financial officer, have reviewed and evaluated the effectiveness
of the Companys disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this
quarterly report. Based on that review and evaluation, which included the participation of
management and certain other employees of the Company, the chief executive officer and interim
principal accounting officer have concluded that the Companys current disclosure controls and
procedures, as designed and implemented, are effective.
Changes in Internal Control over Financial Reporting
The Companys management, including our principal executive officer and interim principal
accounting officer, has evaluated any changes in the Companys internal control over financial
reporting that occurred during the three months ended March 31, 2009, and has concluded that there
was no change that occurred during the quarter ended March 31, 2009 that has materially affected,
or is reasonably likely to materially affect, the Companys internal control over financial
reporting.
34
PART II. OTHER INFORMATION
Item 1 Legal Proceedings
The Company does not have any pending legal matters at this time.
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, 2008, as filed with the
SEC, other than as mentioned below.
Item 6 Exhibits
Confidential treatment has been requested for portions of exhibits marked with a double asterisk
(**).
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10.1
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Stock Purchase Agreement between Novavax, Inc. and Satellite Overseas (Holdings)
Limited, dated March 31, 2009 |
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10.2
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Registration Rights Agreement between Novavax, Inc. and Satellite Overseas
(Holdings) Limited, dated March 31, 2009 |
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10.3**
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Joint Venture Agreement between Novavax Inc. and Cadila Pharmaceuticals Limited, dated
March 31, 2009 |
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10.4**
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Master Services Agreement between Novavax, Inc. and Cadila Pharmaceuticals Limited,
dated March 31, 2009 |
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10.5**
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Supply Agreement between Novavax, Inc. and CPL Biologicals Limited, dated March 31,
2009 |
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10.6**
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Technical Services Agreement between Novavax, Inc. and CPL Biologicals Limited, dated
March 31, 2009 |
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10.7**
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Seasonal / Other License Agreement between Novavax, Inc. and CPL Biologicals Limited,
dated March 31, 2009 |
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10.8**
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Option to Obtain License between Novavax, Inc. and CPL Biologicals Limited, dated March
31, 2009 |
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10.9
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At the Market Issuance Sales
Agreement, dated January 12, 2009, by & between Novavax,
Inc. and Wm. Smith & Co. (Incorporated by reference to Exhibit
10.1 to the Companys Current Report on Form 8-K, filed
January 13, 2009) |
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10.10
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Consulting Agreement of Len
Stigliano, effective January 28, 2009 (Incorporated by reference
to the Companys Current Report on Form 8-K, filed
February 20, 2009) |
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31.1
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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. |
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31.2
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Certification of Interim Principal Accounting Officer (performing functions similar to a
principal 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. |
35
|
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32.1
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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. * |
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32.2
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Certification of Interim Principal Accounting Officer (performing functions similar to a
principal 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.* |
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* |
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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. |
36
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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NOVAVAX, INC.
(Registrant)
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Date: May 11, 2009 |
By: |
/s/ Rahul Singhvi
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Rahul Singhvi |
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President and Chief Executive
Officer
(Principal Executive Officer) |
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Date May 11, 2009 |
By: |
/s/ Evdoxia E. Kopsidas
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Evdoxia E. Kopsidas |
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Director of Finance and Interim Principal
Accounting Officer (performing functions
similar to a principal financial officer) |
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37