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 |
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For Quarterly Period Ended June 30, 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 1034 |
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,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
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o Large accelerated filer |
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þ Accelerated filer |
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o Non-accelerated filer
(Do not check if a smaller reporting company) |
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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 July 31, 2009 90,813,798
NOVAVAX, INC.
Form 10-Q
For the Quarter Ended June 30, 2009 and 2008 (unaudited)
Table of Contents
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Page No. |
PART I. FINANCIAL INFORMATION |
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Item 1 |
Financial Statements |
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1 |
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Consolidated Balance Sheets as of June 30, 2009 (unaudited)
and December 31, 2008 |
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1 |
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Consolidated Statements of Operations for the three and
six-months ended June 30, 2009 and 2008 (unaudited) |
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2 |
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Consolidated Statements of Stockholders Equity as of
June 30, 2009 (unaudited) |
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3 |
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Consolidated Statements of Cash Flows for the six months ended
June 30, 2009 and 2008 (unaudited) |
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4 |
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Notes to the Consolidated Financial Statements (unaudited) |
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5 |
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Item 2 |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
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26 |
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Item 3 |
Quantitative and Qualitative Disclosures about Market Risk |
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43 |
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Item 4 |
Controls and Procedures |
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45 |
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PART II. OTHER INFORMATION |
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Item 1 |
Legal Proceedings |
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46 |
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Item 1A |
Risk Factors |
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46 |
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Item 4 |
Submission of Matters to a Vote of Security Holders |
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47 |
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Item 6 |
Exhibits |
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48 |
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SIGNATURES |
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50 |
i
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
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June 30, |
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December 31, |
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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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$ |
25,216 |
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$ |
26,938 |
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Short-term investments classified as available for sale |
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5,978 |
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6,962 |
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Accounts and other receivables, net of allowance for doubtful
accounts of $218
as of June 30, 2009 and December 31, 2008, respectively |
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41 |
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290 |
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Prepaid expenses and other current assets |
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806 |
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774 |
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Current assets of discontinued operations |
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132 |
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Total current assets |
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32,041 |
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35,096 |
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Property and equipment, net |
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7,879 |
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8,228 |
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Goodwill |
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33,141 |
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33,141 |
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Other non-current assets |
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160 |
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160 |
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Total assets |
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$ |
73,221 |
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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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1,460 |
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1,750 |
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Accrued expenses and other current liabilities |
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3,229 |
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2,969 |
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Current portion of notes payable |
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234 |
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650 |
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Convertible notes, current |
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4,996 |
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21,778 |
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Current liabilities of discontinued operations |
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242 |
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Deferred rent |
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273 |
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328 |
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Total current liabilities |
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10,192 |
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27,717 |
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Non-current portion of notes payable |
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450 |
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480 |
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Deferred rent |
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2,858 |
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2,939 |
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Total liabilities |
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13,500 |
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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, $0.01 par value, 200,000,000 shares and
100,000,000 shares authorized at June 30, 2009 and December
31, 2008; 89,229,598 shares issued and 88,774,168 outstanding
at June 30, 2009, and 69,220,221 shares issued and 68,764,591
outstanding at December 31, 2008 |
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892 |
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692 |
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Additional paid-in capital |
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315,037 |
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284,595 |
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Notes receivable from directors |
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(1,572 |
) |
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(1,572 |
) |
Accumulated deficit |
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(252,665 |
) |
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(235,776 |
) |
Treasury stock of 455,430 shares at June 30, 2009 and at
December 31, 2008, cost basis |
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(2,450 |
) |
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(2,450 |
) |
Accumulated other comprehensive income |
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479 |
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Total stockholders equity |
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59,721 |
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45,489 |
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Total liabilities and stockholders equity |
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$ |
73,221 |
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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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Six months ended |
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June 30, |
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June 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Revenues |
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$ |
29 |
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$ |
342 |
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$ |
50 |
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$ |
800 |
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Operating costs and expenses: |
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Research and development |
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5,297 |
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5,380 |
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9,563 |
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9,814 |
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General and administrative |
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2,562 |
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3,166 |
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5,454 |
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6,410 |
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Total operating costs and expenses |
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7,859 |
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8,546 |
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15,017 |
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16,224 |
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Loss from operations before other (expense)
Income |
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(7,830 |
) |
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(8,204 |
) |
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(14,967 |
) |
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(15,424 |
) |
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Other (expense) income, net |
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(710 |
) |
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(110 |
) |
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(1,922 |
) |
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7 |
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Loss from continuing operations |
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(8,540 |
) |
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(8,314 |
) |
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(16,889 |
) |
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(15,417 |
) |
Loss from discontinued operations |
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(1,058 |
) |
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(1,710 |
) |
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Net loss |
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$ |
(8,540 |
) |
|
$ |
(9,372 |
) |
|
$ |
(16,889 |
) |
|
$ |
(17,127 |
) |
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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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$ |
(0.10 |
) |
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$ |
(0.14 |
) |
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$ |
(0.22 |
) |
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$ |
(0.25 |
) |
Loss per share from discontinued operations |
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(0.02 |
) |
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(0.03 |
) |
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Net loss per share |
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$ |
(0.10 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.22 |
) |
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$ |
(0.28 |
) |
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Basic and diluted weighted average number
of common shares outstanding |
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84,832,226 |
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61,329,699 |
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76,806,926 |
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61,286,169 |
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The accompanying notes are an integral part of these consolidated financial statements.
- 2 -
NOVAVAX, INC.
CONSOLIDATED STATEMENTS STOCKHOLDERS EQUITY
For the six months ended June 30, 2009
(in thousands, except share information)
(unaudited)
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Notes |
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Accumulated |
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Additional |
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Receivable |
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Other |
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Total |
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Common Stock |
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Paid-in |
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From |
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Accumulated |
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Treasury |
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Comprehensive |
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Stockholders |
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Shares |
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Amount |
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Capital |
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Directors |
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Deficit |
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Stock |
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Income |
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|
Equity |
|
Balance,
December 31, 2008 |
|
|
69,220,021 |
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|
$ |
692 |
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|
$ |
284,595 |
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|
$ |
(1,572 |
) |
|
$ |
(235,776 |
) |
|
$ |
(2,450 |
) |
|
$ |
|
|
|
$ |
45,489 |
|
|
|
|
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Non-cash
compensation costs
for stock options |
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|
|
|
|
|
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|
658 |
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|
|
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|
658 |
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Issuance of stock
to Cadila, net of
issuance costs of
$0.3 million |
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12,500,000 |
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|
125 |
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|
10,529 |
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|
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|
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|
|
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10,654 |
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Redemption of
convertible debt |
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2,040,000 |
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|
36 |
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|
5,080 |
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|
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|
|
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5,116 |
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|
Sales of stock
under ATM, net of
offering costs of
$0.7 million |
|
|
5,449,577 |
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|
39 |
|
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|
13,944 |
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
13,983 |
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock
options |
|
|
20,000 |
|
|
|
|
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
restricted stock
for compensation |
|
|
|
|
|
|
|
|
|
|
196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on
short-term
investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
479 |
|
|
|
479 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,889 |
) |
|
|
|
|
|
|
|
|
|
|
(16,889 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
June 30, 2009 |
|
|
89,229,598 |
|
|
$ |
892 |
|
|
$ |
315,037 |
|
|
$ |
(1,572 |
) |
|
$ |
(252,665 |
) |
|
$ |
(2,450 |
) |
|
$ |
479 |
|
|
$ |
59,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
The accompanying notes are an integral part of these consolidated financial statements.
- 3 -
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
Operating Activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(16,889 |
) |
|
$ |
(17,127 |
) |
Plus net loss from discontinued operations |
|
|
|
|
|
|
1,710 |
|
|
|
|
|
|
|
|
Net loss from continuing operations |
|
|
(16,889 |
) |
|
|
(15,417 |
) |
Reconciliation of net loss from continuing operations to net cash
used
in operating activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
602 |
|
|
|
420 |
|
Amortization of debt discount |
|
|
218 |
|
|
|
204 |
|
Reserve for notes receivable and accrued interest |
|
|
|
|
|
|
270 |
|
Loss and disposal of property and equipment |
|
|
28 |
|
|
|
73 |
|
Impairment of short-term investments |
|
|
1,338 |
|
|
|
|
|
Impairment of long lived assets |
|
|
21 |
|
|
|
148 |
|
Amortization of net discounts on short-term investments |
|
|
|
|
|
|
(178 |
) |
Amortization of deferred financing costs |
|
|
145 |
|
|
|
129 |
|
Deferred rent |
|
|
(137 |
) |
|
|
2,995 |
|
Non-cash stock compensation |
|
|
854 |
|
|
|
1,146 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
236 |
|
|
|
577 |
|
Inventory |
|
|
|
|
|
|
(22 |
) |
Prepaid expenses and other assets |
|
|
(45 |
) |
|
|
250 |
|
Accounts payable and accrued expenses |
|
|
(398 |
) |
|
|
953 |
|
Other assets |
|
|
|
|
|
|
(12 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities from continuing operations |
|
|
(14,027 |
) |
|
|
(8,464 |
) |
Net cash provided by operating activities from discontinued
operations |
|
|
|
|
|
|
1,292 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(14,027 |
) |
|
|
(7,172 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities: |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(168 |
) |
|
|
(4,273 |
) |
Purchases of short-term investments |
|
|
|
|
|
|
(15,650 |
) |
Proceeds from disposal of property and equipment |
|
|
7 |
|
|
|
|
|
Proceeds from maturities of short-term investments |
|
|
125 |
|
|
|
45,595 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities from continuing
operations |
|
|
(36 |
) |
|
|
25,672 |
|
Net cash provided by investing activities from
discontinued operations |
|
|
|
|
|
|
1,354 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(36 |
) |
|
|
27,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
Principal payments of notes payable |
|
|
(12,346 |
) |
|
|
(828 |
) |
Proceeds from the exercise of stock options |
|
|
35 |
|
|
|
137 |
|
Net proceeds from the sales of common stock, net of offering costs
of
$1.0 million |
|
|
24,652 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided (used in) by financing activities |
|
|
12,341 |
|
|
|
(691 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(1,722 |
) |
|
|
19,163 |
|
Cash and cash equivalents at beginning of period |
|
|
26,938 |
|
|
|
4,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
25,216 |
|
|
$ |
23,513 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash interest payments |
|
$ |
761 |
|
|
$ |
654 |
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash activities: |
|
|
|
|
|
|
|
|
Equipment purchases included in accounts payable |
|
$ |
84 |
|
|
$ |
201 |
|
|
|
|
|
|
|
|
Repayment of notes payable through issuance of common stock |
|
$ |
5,100 |
|
|
$ |
|
|
|
|
|
|
|
|
|
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, H1N1, human seasonal influenza, Varicella Zoster (VZV), which causes
Shingles, and Respiratory Syncytial Virus (RSV).
Subsequent Events
The Company evaluated its June 30, 2009 consolidated financial statements for subsequent
events through August 10, 2009, the date the financial statements were available to be issued. Other
than the events noted below, the Company is not aware of any subsequent events which would require
recognition or disclosure in the financial statements.
At the Market Issuance
Pursuant to the At Market Issuance Sales Agreement (the Sales Agreement), with Wm Smith &
Co. (Wm Smith), 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. During the three and six months ended
June 30, 2009, the Company sold 5,379,077 shares and 5,449,577 shares and received net proceeds of
$13.8 million and $14.0 million, respectively. Subsequent to June 30, 2009, the Company sold
approximately an additional 2.0 million shares for net proceeds of approximately $8.0 million.
Convertible Notes
As of June 30, 2009, the Company had $5.0 million of senior convertible notes outstanding (the
Notes). The Notes carried a 4.75% coupon; were convertible into shares of Novavax common stock
at $4.00 per share plus all accrued interest; and matured on July 15, 2009. On July 15, 2009, the
Company repaid the $5.0 million balance of its convertible notes. Under the terms of the Notes,
Novavax elected to repay the remaining balance of principal and accrued interest for approximately
$2.6 million of cash and issued 1,016,939 shares of common stock representing the remaining $2.6
million of the principal plus accrued and unpaid interest due by dividing that principal amount by
$2.5163.
- 5 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
ROVI Pharmaceuticals
On
June 30, 2009, Novavax announced the signing of a letter of intent to license its proprietary,
recombinant VLP vaccine technology to ROVI Pharmaceuticals of Spain
(ROVI) for influenza vaccines. ROVI will use the
VLP technology to create a comprehensive influenza vaccine solution for the Spanish government
under a new 60 million-euro program sponsored and led by the Spanish Ministry of Health and other
government groups to develop pandemic and seasonal flu vaccines while
also establishing its only in-border
facility.
Under separate agreements that are in
the process of being finalized, ROVI will receive
exclusive licenses to Novavaxs VLP vaccine and
manufacturing technology to commercialize flu vaccines in
Spain and Portugal, and non-exclusive licenses in Europe, Latin America and Africa. On July 6,
2009, under a stock purchase agreement, ROVI made a $3.0 million equity investment in Novavax at
$2.74 per share, a 10% premium to the June 29, 2009 closing bid price on the NASDAQ Global Market.
Under a definitive agreement yet to be finalized, a non-profit foundation, jointly sponsored by ROVI
and the Spanish authorities, will be formed. It is anticipated that
the non-profit foundation will initially be funded with a 25 million euro credit line
from the Spanish government, to support Phase III clinical development and other studies necessary
to achieve marketing authorization of the VLP influenza vaccines in the European Union in 2012.
Additional clinical development funds will be contributed by ROVI if
required, but are not anticipated at this time. In addition, the
State of Andalucía will support ROVI in building a new VLP
vaccine plant in the city of Granada at a cost of approximately 20
million euro with plans to bring it on-line in 2012. The plant, with
certain licensed manufacturing rights from Novavax, is expected to have enough manufacturing
capacity to supply Spain and other parts of Europe, Latin America,
and Africa. As part of the final agreements, it is anticipated ROVI will be
authorized to manufacture and sell an unlimited annual number of doses in Spain, Portugal, Latin
America, and Africa, but will be limited to 5.0 million annual doses in other parts of Europe.
Liquidity Matters
The Company has incurred losses since its inception and has an accumulated
deficit of $253 million, as of June 30, 2009.
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 June 30, 2009, the Company had cash and cash equivalents totaling $25.2 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 originally purchased from Oppenheimer &
Co. Inc. The Company recorded other than temporary impairment charges, which have been
recorded in the Statement of Operations, of $1.2 million in the
fourth quarter of 2008, $0.8 million during the first quarter of
2009, and $0.5 million during the second quarter of 2009,
- 6 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
due primarily to their illiquidity. During the three months ended June 30, 2009
the Company recorded $0.5 million as a recovery of losses previously recorded as impairment losses
related to four of its auction rate securities and recorded this recovery as unrealized gains in
other comprehensive income. The Company believes the fair value of its auction rate securities of
$6.0 million as of June 30, 2009 represents the fair value and the value at which the Company
would liquidate the investments, if necessary, at the present time. The Company is currently evaluating what a buyer might pay
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.
During the three months and six months ended June 30, 2009, the Company has sold
5,379,077 and 5,449,577 shares of common stock and received net proceeds in the amount of $13.8
million and $14.0 million, respectively under the Sales Agreement with Wm Smith.
On June 30, 2009 the Company entered into a stock purchase agreement with ROVI for the
purchase of $3.0 million of Novavax common stock at $2.74 per share. The Company issued
approximately 1.1 million shares and received the proceeds on July 6, 2009. (See Subsequent Events
Rovi.)
As of June 30, 2009, the Company had $5.0 million of its Notes outstanding. The Company repaid
the Notes on July 15, 2009. (See Subsequent Events Convertible Notes).
Based on the amount of funds on hand, the $3.0 million in proceeds from the ROVI transaction,
the sales of stock under the Wm Smith Sales Agreement subsequent to the end of the quarter, and the
Companys planned business operations, the Company believes it will have adequate capital resources
to operate at planned levels for at least the next twelve months. The Company is planning to raise
additional capital in 2009 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.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim consolidated financial statements include the accounts of
the Company and its wholly owned subsidiary (Fielding Pharmaceutical Company). All significant
inter-company accounts and transactions have been eliminated in consolidation. They have been
prepared pursuant to the rules and regulations of the Securities and Exchange Commission. The
financial statements reflect all adjustments that are in the opinion of management, necessary for a
fair statement of such information. All such adjustments are of a normal recurring nature.
Although Novavax believes that the disclosures are adequate to make the information presented
herein not misleading, certain information and footnote disclosures, including a description of
significant accounting policies, which are normally included in financial statements prepared in
accordance with accounting principles generally accepted in the United States of America, have been
condensed or omitted pursuant to such rules and regulations. Certain information and disclosures
required by accounting principles generally
- 7 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
accepted in the United States for complete consolidated financial statements are not included
herein. The interim statements should be read in conjunction with financial statements and notes
thereto included in the companys latest Annual Report on Form 10-K. The results of operations for
the three and six months ended June 30, 2009 are not necessarily indicative of the results for any
subsequent quarter or the entire fiscal year ended 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.
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 earnings 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 and six months ended June 30,
2009, there were approximately 4.2 million and 4.4 million outstanding stock options, respectively,
along with 3.3 million outstanding warrants that were excluded from the calculation of diluted loss
per share. For the three and six months ended June 30, 2008, there were approximately 4.9 million
and 4.8 million outstanding stock options, respectively, that were excluded from the calculation of
diluted loss per share.
Comprehensive Loss
Under SFAS No. 130, Reporting Comprehensive Income, the Company is required to display
comprehensive loss and its components as part of its consolidated financial statements.
Comprehensive loss is comprised of the net loss and other comprehensive income (loss), which
includes certain changes in equity that are excluded from the net loss.
- 8 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The following table summarizes the Companys comprehensive loss (in thousands, unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Net loss |
|
$ |
(8,540 |
) |
|
$ |
(9,372 |
) |
|
$ |
(16,889 |
) |
|
$ |
(17,127 |
) |
Unrealized gains on short-term investments
classified as available for sale |
|
|
479 |
|
|
|
|
|
|
|
479 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(8,061 |
) |
|
$ |
(9,372 |
) |
|
$ |
(16,410 |
) |
|
$ |
(17,127 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Investments
Short-term investments at June 30, 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, and a fair value of $6.0
million and $7.0 million, respectively. The Company recorded other than temporary impairment
charges to other expenses related to these securities during the three and six months ended June
30, 2009 of $0.5 million and $1.4 million, respectively, as a result of the liquidity issues 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. During the three and six months ended June 30,
2009, the Company also recorded a temporary unrealized gain of $0.5 million related to the increase
in fair value for four of the Companys auction rate securities. The Company did not record any
changes in fair value during the three and six months ended June 30, 2008.
The Company has classified these securities as short-term investments and has 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 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 June 30, 2009 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
- 9 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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. Such factors have been consistently
applied in our quarterly valuation of the Companys auction
rate securities.
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 Statement of Financial Accounting Standards No. 157,
Fair Value Measurements (SFAS No. 157), which clarifies the definition of fair value, establishes
a framework for measuring fair value, and expands the disclosures on fair value measurements. SFAS
No. 157 defines fair value as the exchange price that would be received to sell 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. In
determining fair value, SFAS 157 permits the use of various valuation approaches, including market,
income and cost approaches. SFAS No. 157 also establishes a fair value hierarchy, which is outlined
below, that requires an entity to maximize the use of observable inputs and minimize the use of
unobservable inputs when measuring fair value by requiring that the observable inputs be used when
available.
The fair value hierarchy is broken down into three levels based on the reliability of inputs
as follows:
Level 1 Quoted prices in active markets for identical assets or liabilities. Valuations of these
products do not require a significant amount of judgment. The Company does not have any level 1
assets at June 30, 2009.
Level 2 These valuations are based primarily on a market approach using quoted prices in
markets that are not very active, broker or dealer quotations, or alternative pricing sources with
reasonable levels of transparency. The Company considers its auction rate securities to be Level 2
assets.
Level 3 These valuations are based primarily on unobservable inputs that are supported by little
or no market activity and that are financial instruments whose value is determined using pricing
models, discounted cash flow methodologies, or similar techniques, as well as instruments for which
the determination of fair value requires significant judgment or estimation. The Companys Level 3
assets are comprised of goodwill.
If the inputs used to measure the financial assets and liabilities fall within more than one
of the different levels described above, the categorization is based on the lowest level input that
is significant to the fair value measurement of the instrument.
- 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 June
30, 2009, are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at June 30, 2009 |
|
|
|
(Unaudited) |
|
|
|
(in thousands) |
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
for Identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
|
Assets |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
At Fair Value |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
$ |
|
|
|
$ |
5,978 |
|
|
$ |
|
|
|
$ |
5,978 |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
33,141 |
|
|
|
33,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
|
|
|
$ |
5,978 |
|
|
$ |
33,141 |
|
|
$ |
39,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table represents a roll forward of the activity related to the credit
loss component recognized in earnings on auction rate securities held by the Company for which a
portion of other than temporary impairment was recognized in other comprehensive loss.
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, 2009 |
|
Beginning balance, January 1 |
|
$ |
1,237 |
|
|
|
|
|
|
Additions for other than temporary
impairments where credit losses have
been recognized prior to the beginning
of the period |
|
|
1,338 |
|
|
|
|
|
|
Reductions for securities that had a
portion of other than temporary
impairment recorded in other
comprehensive income |
|
|
(478 |
) |
|
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
2,097 |
|
|
|
|
|
Property and Equipment
Property and equipment are recorded at cost. Depreciation of furniture, fixtures and equipment
is provided under the straight-line method over the estimated useful lives of the assets, generally
three to ten years. Amortization of leasehold improvements is provided over the shorter of the
estimated useful lives of the improvements or the term of the respective lease. Repairs and
maintenance costs are expensed as incurred.
Property and equipment are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 30, 2009 |
|
|
December 31, 2008 |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
(in thousands) |
|
Construction in progress |
|
$ |
1,118 |
|
|
$ |
5,394 |
|
Furniture, machinery and equipment |
|
|
4,305 |
|
|
|
3,880 |
|
Leasehold improvements |
|
|
4,525 |
|
|
|
637 |
|
Computer software and hardware |
|
|
334 |
|
|
|
339 |
|
|
|
|
|
|
|
|
|
|
|
10,282 |
|
|
|
10,250 |
|
Less accumulated depreciation and amortization |
|
|
(2,403 |
) |
|
|
(2,022 |
) |
|
|
|
|
|
|
|
|
|
$ |
7,879 |
|
|
$ |
8,228 |
|
|
|
|
|
|
|
|
- 11 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Construction in progress is primarily 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. Amounts included in construction in progress will be
placed in service upon completion of validation, which is expected to occur by December 31, 2009.
Goodwill and Other Intangible Assets
Goodwill originally resulted from business acquisitions. Assets acquired and liabilities
assumed were recorded at their fair values; the excess of the purchase price over the identifiable
net assets acquired was recorded as goodwill. In accordance with SFAS No. 142, Goodwill and Other
Intangible Assets (SFAS No. 142), goodwill and intangible assets deemed to have indefinite lives
are not amortized but are subject to impairment tests annually, or more frequently should
indicators of impairment arise. The Company utilizes a discounted cash flow analysis that includes
profitability information, estimated future operating results, trends and other information in
assessing whether the value of indefinite-lived intangible assets can be recovered. Under SFAS No.
142, goodwill impairment is deemed to exist if the carrying value of a reporting unit exceeds its
estimated fair value.
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. The Company did not perform an interim test for impairment of the
Companys goodwill as of June 30, 2009 due to the Companys increasing stock price.
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 or
December 31, 2008.
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
- 12 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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 $309,000 and
$658,000 for the three and six months ended June 30, 2009, and $612,000 and $977,000 for the three
and six months ended June 30, 2008.
As of June 30, 2009, there were stock options outstanding for the purchase of 6,384,556 shares
of common stock. At June 30, 2009, the aggregate fair value of the remaining compensation cost of
unvested options, as determined using a Black-Scholes option valuation model, was approximately
$3,565,076 (net of estimated forfeitures). This unrecognized compensation cost of unvested options
is expected to be recognized over a weighted average period of 1.88 years.
During the three and six months ended June 30, 2009, the Company granted stock options for the
purchase of 37,500 and 788,525 shares of common stock, respectively, with a fair value of
approximately $71,730 and $364,198 (net of estimated forfeitures). Stock options for the purchase
of 379,038 and 490,347 shares of common stock were forfeited during the three and six months ended
June 30, 2009, respectively. During the three and six months ended June 30, 2008, the Company
granted stock options for the purchase of 66,750 and 850,900 shares of common stock, respectively,
with a fair value of approximately $112,000 and $1,370,000 (net of estimated forfeitures),
respectively. Stock options for the purchase of 231,033 and 344,650 shares of common stock were
forfeited during the three and six months ended June 30, 2008, respectively.
The weighted average fair value of stock options on the date of grant and the assumptions used
to estimate the fair value of stock options issued during the three and six months ended June 30,
2009 and 2008, using the Black-Scholes option valuation model were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
Weighted average fair
value of options
granted |
|
$ |
1.91 |
|
|
$ |
2.62 |
|
|
$ |
0.46 |
|
|
$ |
2.61 |
|
Expected life (years) |
|
|
4.17-7.05 |
|
|
|
4.12 |
|
|
|
4.00-7.05 |
|
|
|
3.62-6.37 |
|
Expected volatility |
|
|
100.36-111.83 |
% |
|
|
84.75-84.89 |
% |
|
|
85.68-111.83 |
% |
|
|
81.14-87.78 |
% |
Risk free interest rate |
|
|
2.09-3.19 |
% |
|
|
3.29 |
% |
|
|
1.56-3.19 |
% |
|
|
1.97-3.29 |
% |
Expected dividend |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected forfeiture rate |
|
|
21.96 |
% |
|
|
21.96 |
% |
|
|
21.96 |
% |
|
|
21.96 |
% |
The expected life of options granted was based on the Companys historical share option
exercise experience using the historical expected term from vesting date. The expected volatility
of the options granted during the three and six months ended June 30, 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.
- 13 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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 and
six months ended June 30, 2009, $49,000 and $196,000 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 and six months ended June 30, 2008, $84,000 and 169,000, respectively,
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 recently
entered Joint Venture (JV) with Cadila Pharmaceuticals Ltd. The pronouncement is effective January
1, 2009, to be applied prospectively for all business combinations for which the acquisition date
is on or after January 1, 2009. This pronouncement will significantly change our accounting and
reporting for business combination transactions completed on or after January 1, 2009. The adoption
of this pronouncement did not have an impact on our consolidated financial statements for the six
months ended June 30, 2009, because we did not complete any business combination transactions
during this period but it will impact our consolidated financial statements if such transactions
occur in future periods.
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. The FSP emphasizes that,
regardless of whether the volume and level of activity for an asset or liability have decreased
significantly and regardless of which valuation technique was used, the objective of a fair value
measurement under FASB Statement 157, Fair Value Measurements, remains the sameto estimate the
price that would be received to sell an asset or transfer a liability in an orderly transaction
between market participants at the measurement date under current market conditions. The Company
adopted FSP FAS 157-4 effective April 1, 2009. The adoption did not have a material impact on the
Companys financial condition and results of operations. The
- 14 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
additional disclosures related to FSP FAS 157-4 are included in Note 2 Short Term Investments
and Fair Value Measurements.
In April 2009, the FASB issued FSP SFAS 115-2 and FAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments, to make the guidance on other-than-temporary impairments of debt
securities more operational and improve the financial statement disclosures related to
other-than-temporary impairments for debt and equity securities. The FSP clarifies the interaction
of the factors that should be considered when determining whether a debt security is
other-than-temporarily impaired. To evaluate whether a debt security is other-than-temporarily
impaired, an entity must first determine whether the fair value of the debt security is less than
its amortized cost basis at the balance sheet date. If the fair value is less than the amortized
cost basis, then the entity must assess whether it intends to sell the security or whether it is
more likely than not that it will be required to sell the debt security before recovery of its
amortized cost basis. If an entity determines that it will sell a debt security or that it more
likely than not will be required to sell a debt security before recovery of its amortized cost
basis, then it must recognize the difference between the fair value and the amortized cost basis of
the debt security in earnings. Otherwise, the other-than-temporary impairment must be separated
into two components: the amount related to the credit loss and the amount related to all other
factors. The amount related to the credit loss must be recognized in earnings, while the other
component must be recognized in other comprehensive income, net of tax. The portion of
other-than-temporary impairment recognized in earnings would decrease the amortized cost basis of
the debt security, and subsequent recoveries in the fair value of the debt security would not
result in a write-up of the amortized cost basis. The Company adopted FSP FAS 115-2 and FAS 124-2
effective April 1, 2009. The adoption did not have a material impact on the Companys financial
condition and results of operations. The additional disclosures related to FSP FAS 115-2 and FAS
124-2 are included in Note 2 Short Term Investments and Fair Value Measurements.
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. This pronouncement has not had a material impact on the
financial position and results of operations.
In May 2009, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 165
Subsequent Events, which establishes general standards of accounting for and disclosures of events
that occur after the balance sheet date but before the financial statements are issued or are
available to be issued. Statement No. 165 introduces new terminology, defines a date through which
management must evaluate subsequent events, and lists the circumstances under which an entity must
recognize and disclose events or transactions occurring after the balance-sheet date. This
requirement is effective for statements issued for interim and annual periods ending after June 15,
2009. The adoption of SFAS No. 165 did not have any impact on the Companys consolidated results
of operations and financial position.
- 15 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards Codification and
the Hierarchy of Generally Accepted Accounting Principles (SFAS No. 168). SFAS No. 168 will
become the source for authoritative U.S. Generally Accepted Accounting Principles recognized by the
FASB to be applied by non-governmental entities. Rules and interpretive releases of the Securities
and Exchange Commission under the authority of the federal securities laws are also sources of
authoritative GAAP for SEC registrants. All guidance contained in the Codification carries an equal
level of authority. The Codification does not change current US GAAP. SFAS No. 168 is effective for
interim and annual periods ending on or after September 15, 2009. The adoption of SFAS No. 168 is
not expected to have any impact on the Companys consolidated results of operations and financial
position.
Significant Transactions
Cadila Pharmaceuticals Ltd.
On March 31, 2009, the Company and Cadila Pharmaceuticals Ltd., a private 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% is owned by Cadila and 20% is owned by the Company. The JV will develop and commercialize the
Companys seasonal influenza 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. The Company also contributed 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 is 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 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 JV using Novavaxs technology for commercialization in every country
except for India and vaccines developed by the JV using Cadilas technology for commercialization
in certain other countries, including the United States.
- 16 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
In connection with the JVA, on March 31, 2009, the Company also entered into license
agreement, and an option to enter into a license agreement, a technical services agreement and a
supply agreement with the JV.
Also on March 31, 2009, the Company 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 our common stock, par value $0.01
at the market price of $0.88 per share. The Company delivered the shares of
common stock on April 1, 2009. 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 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
the Company 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 the Companys common stock, SOHL may designate one
member of the Companys board of directors. SOHL designated Rajiv I. Modi, Ph.D., who was elected
to the board of directors effective April 1, 2009.
Finally, on March 31, 2009, Novavax and Cadila entered into a Master Services Agreement (the
Master Services Agreement) pursuant to which the Company 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, the Company will pay Cadila a portion of the shortfall, as defined in the Master
Services Agreement. The Company 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 of June 30, 2009, the Company has not incurred any
expenses related to the Master Services Agreement.
- 17 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
At the Market Issuance
On January 12, 2009 the Company entered into the Sales Agreement, with 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. Wm Smith may sell the common stock at the market 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 pays 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 three and six months ended June 30, 2009, the Company sold 5,379,077 shares
and 5,449,577 shares and received net proceeds of $13.8 million and $14.0 million, respectively.
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 June 30, 2009 aggregated $5.1 million. The agreement will remain effective (i) as long as there is at least one claim of the licensed patent rights cover the manufacture, sale or use of
any product, (ii) unless Novavax has not terminated the agreement at
its option or, (iii) Wyeth has not terminated the agreement for an uncured breach by
Novavax.
License Agreement with University of Massachusetts Medical School
Effective February 26, 2007, the Company entered into a worldwide agreement to exclusively
license a VLP technology from the University of Massachusetts Medical School (UMMS). Under the
agreement, the Company has the right to use this technology to develop VLP vaccines for the
prevention of any viral diseases in humans.
As of June 30, 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 future payments under the UMMS
- 18 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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.
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 paid 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. 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 the supply agreement. Accordingly, all revenue associated with
the deliverables, under both the
- 19 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
supply and asset purchase agreement, was deferred and was not recognized until the Companys
obligations were completed in August 2008.
Sales and Issuance of Common Stock
On July 15, 2009, the Company issued 1,016,939 shares in connection
with the repayment of the remaining portion of its convertible
notes. (See Subsequent Events Convertible Notes).
On July 6, 2009, the Company received net proceeds of
$3.0 million from the issuance of 1,094,891 shares to ROVI at $2.74 per share
(See Subsequent Events ROVI Pharmaceuticals).
During the three and six months ended June 30, 2009, the Company repaid as portion of the principal outstanding on its
convertible notes by issuing 2,040,000 shares at a conversion price of $2.50.
During the three and six months ended June 30, 2009, the Company received net
proceeds of $34,800 from the exercise of 20,000 shares of common stock options at $1.75 per share.
During the three and six months ended June 30, 2009, the company received net proceeds of
$10.7 million from the sale of 12.5 million shares to Cadila at $0.88 per share. (See Significant
Transactions Cadila Pharmaceuticals).
During the three and six months ended June 30, 2009, the Company received net proceeds of
$13.8 million and $14.0 million, from the sale of stock of 5,379,077 shares and 5,449,577 shares at
a range of $1.75 to $5.03 per share. (See Significant Transactions At the Market Issuance).
During the three and six months ended June 30, 2008, the Company received net proceeds of
$102,000 and $137,000, respectively, from the exercise of 45,467 and 66,038 shares of common stock
options, at a range of $1.34 to $2.77 per share.
Convertible Notes
As of June 30, 2009 and December 31, 2008, the Company had $5.0 million and $22 million,
respectively, of senior convertible notes outstanding (the Notes). The Notes carried a 4.75%
coupon, were convertible into shares of Novavax common stock at $4.00
per share, and matured on
July 15, 2009. 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.
The 2009 Amendments (i) provided for payment of $17.0 million aggregate principal amount of
the Notes on April 29, 2009, (ii) provided for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provided 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.
Under the terms of the Notes, Novavax, at its option, could 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. On July 15, 2009, the Company repaid the $5.0 million
balance of the Notes. (See Note 1 Subsequent Events Convertible Notes).
- 20 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Operating Leases
Future minimum rental commitments under non-cancelable leases as of June 30, 2009 are as
follows:
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating |
|
|
|
|
|
|
Net Operating |
|
Year |
|
Leases |
|
|
Sub-Leases |
|
|
Leases |
|
2009 |
|
$ |
1,134 |
|
|
$ |
166 |
|
|
$ |
968 |
|
2010 |
|
|
2,088 |
|
|
|
339 |
|
|
|
1,749 |
|
2011 |
|
|
2,087 |
|
|
|
259 |
|
|
|
1,828 |
|
2012 |
|
|
2,132 |
|
|
|
|
|
|
|
2,132 |
|
2013 |
|
|
2,179 |
|
|
|
|
|
|
|
2,179 |
|
Thereafter |
|
|
6,400 |
|
|
|
|
|
|
|
6,400 |
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payment |
|
$ |
16,020 |
|
|
$ |
764 |
|
|
$ |
15,256 |
|
|
|
|
|
|
|
|
|
|
|
In April 2009, the Company negotiated an amendment to its 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.
On June 26, 2008, Novavax amended the lease for its corporate headquarters at 9920 Belward
Campus Drive in Rockville, Maryland. The amendment (1) extends the terms of the lease to January
31, 2017, (2) provides that the landlord will reimburse Novavax for up to $3.0 million in leasehold
improvements (the Allowance) and (3) increases the monthly installments of base rent going
forward by an amount equal to the monthly amortization of the Allowance over the remaining term of
the lease at 11% interest, or an additional $45,132 per month. The additional monthly rent is
subject to the annual 2.125% escalation included in the original lease. On June 27, 2008, the
Company received $3.0 million from the landlord as reimbursement for leasehold improvements. The
amount is included in deferred rent on the balance sheet at June 30, 2009 and December 31, 2008 and
is being amortized as a credit to rent expense over the remaining lease term.
Income Taxes
The American Recovery and Reinvestment Act of 2009 was enacted and signed into law on February
17, 2009. The Act includes 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.
- 21 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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
Estrasorb 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 and
six months ended June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
|
(In thousands) |
|
|
(In thousands) |
|
Revenues |
|
$ |
|
|
|
$ |
143 |
|
|
$ |
|
|
|
$ |
229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
|
|
|
|
736 |
|
|
|
|
|
|
|
1,474 |
|
Excess inventory costs
over market |
|
|
|
|
|
|
465 |
|
|
|
|
|
|
|
465 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
1,201 |
|
|
|
|
|
|
|
1,939 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
|
|
|
$ |
(1,058 |
) |
|
$ |
|
|
|
$ |
(1,710 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
- 22 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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.
|
|
|
|
|
|
|
|
|
|
|
June 30, 2009 |
|
|
December 31, 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.
4. Related Parties
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.
As stated above, 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 is
owned by Cadila (the JV). 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.
Additionally, 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.
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.
- 23 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The aggregate dollar value of these agreements 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. Additionally, on March 7,
2007, the Company granted Mr. Lambert 100,000 shares of restricted common stock, under the 2005
Plan totaling $277,000 in value at the date of grant and 250,000 stock options under the 2005 Plan
with a fair value of approximately $420,000. Both the restricted stock and stock options vest upon
the achievement of certain milestones. On March 6, 2008, the Company granted Mr. Lambert 25,000
stock options under the 2005 Plan with a fair value of approximately $41,000. 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 and six months ended June 30, 2009, the Company recorded
consulting expenses for Mr. Lambert of $55,000 and $110,000 respectively, in accordance with the
consulting agreement. For the three and six months ended June 30, 2008, the Company recorded
consulting expenses for Mr. Lambert of $55,000 and $110,000, respectively.
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.
As of June 30, 2009, the outstanding principal and interest for these two footnotes was $1,992,000.
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
restated the entire amount outstanding as of December 31, 2007, including accrued interest, or
$578,848, as the new outstanding principal amount. Furthermore, the Amendment extended the
maturity date of the note to June 30, 2009, permitted the Company to sell the pledged shares if the
market price of the common stock as reported on NASDAQ Global market
- 24 -
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
exceeded certain targets, increased the interest rate to 8.0% and stipulated 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. The note is currently in
default.
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. The note is currently in default.
- 25 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Statements herein relating to future financial or business performance, conditions or
strategies and other financial and business matters, including expectations regarding revenues,
operating expenses, cash burn, and clinical developments and anticipated milestones are
forward-looking statements within the meaning of the Private Securities Litigation Reform Act.
Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks
and uncertainties, which change over time. Factors that may cause actual results to differ
materially from the results discussed in the forward-looking statements or historical experience
include risks and uncertainties, including the Companys ability to progress any product candidates
in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and
clinical trials and other research and development activities; clinical trial results; current
results may not be predictive of future results; even if the data from preclinical studies or
clinical trials is positive, the product may not prove to be safe and efficacious; Novavaxs pilot
plant facility is subject to extensive validation and FDA inspections, which may result in delays
and increased costs; the success of the Companys foreign joint venture and licensing agreements;
the Companys ability to enter into future collaborations with industry partners and the government
and the terms, timing and success of any such collaboration; the cost of filing, prosecuting,
defending and enforcing any patent claims and other intellectual property rights; our ability to
obtain rights to technology; competition for clinical resources and patient enrollment from drug
candidates in development by other companies with greater resources and visibility; our ability to
obtain adequate financing in the future through product licensing, co-promotional arrangements,
public or private equity or debt financing or otherwise; general business conditions; competition;
business abilities and judgment of personnel; and the availability of qualified personnel.
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, H1N1, human
seasonal influenza, Varicella Zoster (VZV), which causes shingles, and a Respiratory Syncytial
Virus (RSV).
We have made significant progress 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
- 26 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
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. A final Clinical Study Report has been completed. The vaccine was well tolerated at
all dosages as compared with placebo. No serious adverse events were reported. More reports of
injection site pain were received from vaccine as compared with placebo recipients; however, the
majority of reactions were categorized as mild or moderate. All dose levels elicited HAI and
neutralizing antibody responses as compared with placebo. The highest seroconversion
(>4-fold rise in titer from baseline to postvaccination) rates for the HAI (64%; 95%
CI:45,80) and neutralizing antibody (97%; 95% CI:84,100) responses were observed with the 90 µg
dose.
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. We entered into a letter of intent with
ROVI Pharmaceuticals which, among other things, will support Phase
III Clinical development, however, a definitive agreement is yet to be finalized.
We are working to develop and test a VLP vaccine against the novel influenza H1N1 virus which
was first detected in April 2009 and is now causing a worldwide
pandemic. We began production of the H1N1 VLPs in our manufacturing
facility on June 5, 2009 and have completed production of the first batch of vaccine within 12
weeks from the receipt of the viral H1N1 RNA. This faster cycle time from strain identification to
first vaccine batch is another demonstration of our ability 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.
Unrelated
to the discovery of the 2009 pandemic H1N1 virus, in April 2009, we
reported preclinical study results from work conducted by scientists
from both the Centers for Disease Control and Prevention, and the
Company under a Collaborative Research and Development showing that
an investigational VLP vaccine against the 1918 H1N1 influenza strain
(that caused the Spanish flu virus and a highly pathogenic 2004 H5N1
avian influenza strain.
We also progressed development of our VLP trivalent vaccine that targets seasonal influenza
virus. 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 thus reviewed and analyzed the dose response curve as well as the safety data from the
healthy adult seasonal trial. A final Clinical Study Report has been completed. No vaccine-related
serious adverse events were reported. Non-serious adverse events were reported more commonly in
vaccine as compared with placebo recipients although the differences in rates between the two
groups were not statistically significant. The majority of adverse events were categorized as mild
or moderate. The seasonal influenza VLP vaccine was also immunogenic. Among subjects who received
either the 15 or 30 µg/HA/strain/dose, the vaccine induced HAI responses ³1:40 against one or more
vaccine strains in more than 80% of the subjects. HAI responses were highest to the H3N2 strain,
followed by the H1N1 and B strains. High HAI titers, similar to those seen with the vaccine
strains, were also observed against drifted H3N2 and H1N1 strains, demonstrating the potential for
the vaccine to be cross-protective.
In May, 2009, we enrolled subjects in the second Phase II study of our 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. We plan to report top-line
immunogenicity and safety results from this study by the fourth quarter of this year. We intend to
- 27 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
commence a seasonal influenza dose ranging study in the elderly (>65 years of age) in the second
half of 2009. We continue to seek a collaborative partner for our seasonal influenza vaccine upon
completion of these additional Phase II clinical studies.
We have also developed vaccine candidates for both RSV and VZV, both of which are currently
being evaluated in preclinical studies.
On July 22, 2009 we announced final selection of an RSV vaccine candidate that will be
advanced into additional preclinical studies to support an Investigational New Drug (IND)
application. We had been evaluating a number of RSV vaccine candidates, all of which had
successfully induced antibody responses in mice. Our scientists have now engineered a new vaccine
candidate which has been shown to protect mice against RSV disease and can be produced at
sufficient yields to allow commercial manufacture. This new candidate is directed against a
protein on the surface of the virus, the F or fusion protein, which is the protein that the
virus uses to infect and fuse with cells in the respiratory tract and cause disease. The new RSV-F
vaccine candidate consists of novel three dimensional particles containing the F protein. The
structure of the F protein in these particles is identical to the configuration in which it exists
on the surface of the native virus. The particle nature of the vaccine holds the promise for
inducing a broad set of immune responses including antibody and cell mediated immune responses to
prevent infection of the respiratory tract and attack respiratory cells that may already be
infected with RSV. The first preclinical study of this new vaccine candidate in mice, the results
of which we announced in February 2009, showed that it induced production of antibodies that
neutralized live RSV. In addition, the vaccine protected mice against replication of RSV in the
lungs. 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
At the Market Issuance
Pursuant to the At Market Issuance Sales Agreement (the Sales Agreement), with Wm Smith &
Co. (Wm Smith), we may sell an aggregate of up to $25.0 million in gross proceeds of our common
stock from time to time through Wm Smith. During the three and six months ended June 30, 2009, we
sold 5,379,077 shares and 5,449,577 shares and received net proceeds of $13.8 million and $14.0
million, respectively. Subsequent to June 30, 2009, we sold approximately an additional 2.0 million
shares for net proceeds of approximately $8.0 million.
- 28 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Convertible Notes
As of June 30, 2009, we had $5.0 million of senior convertible notes outstanding (the
Notes). The Notes carried a 4.75% coupon; were convertible into shares of Novavax common stock
at $4.00 per share; and matured on July 15, 2009. On July 15, 2009, we repaid the remaining $5.0
million balance of its convertible notes. Under the terms of the Notes, we elected to pay the
remaining balance of the principal plus accrued and unpaid interest for approximately $2.6 million
in cash and issued 1,016,939 shares of common stock representing the remaining $2.6 million of the
principal plus accrued and unpaid interest due by dividing that principal amount by $2.5163.
ROVI Pharmaceuticals
On June 30, 2009
we announced the signing of a letter of intent to license its proprietary, VLP vaccine
technology to ROVI Pharmaceuticals of Spain (ROVI) for influenza vaccines. ROVI
will use the VLP technology to create a
comprehensive influenza vaccine solution for the Spanish government under a new 60 million-euro
program sponsored and led by the Spanish Ministry of Health and other government groups to develop
pandemic and seasonal flu vaccines while also establishing its only in-border facility.
Under separate agreements that are in
the process of being finalized, ROVI will receive
exclusive licenses to our VLP vaccine and manufacturing technology to commercialize flu vaccines in Spain
and Portugal, and non-exclusive licenses in Europe, Latin America and Africa. Furthermore, under a
stock purchase agreement, ROVI made a $3.0 million equity investment in Novavax at $2.74 per share,
a 10% premium to the June 29, 2009 closing bid price on the NASDAQ Global Market. Under a
definitive agreement, to be finalized, a non-profit Foundation, jointly sponsored by ROVI and the
Spanish authorities, will be formed. It is anticipated that the non-profit foundation will initially be funded with a 25 million euro credit line from
the Spanish government, to support Phase III clinical development and other studies necessary to
achieve marketing authorization of the VLP influenza vaccines in the European Union in 2012.
Additional clinical development funds will be contributed by ROVI if required, but are not anticipated at this time. In addition, the
State of Andalucía will support ROVI in building a new VLP vaccine plant in the city of Granada
at a cost of approximately 20 million euro with bring it on-line in 2012 at a cost of approximately 20 million euro. The plant, with certain
licensed manufacturing rights from us, is expected to have enough manufacturing capacity to supply
Spain and other parts of Europe, Latin America, and Africa. As part of the final agreements, it is anticipated ROVI will be authorized to manufacture and
sell an unlimited annual number of doses in Spain, Portugal, Latin America, and Africa, but will be
limited to 5.0 million annual doses in other parts of Europe.
Significant Transactions in 2009 and 2008
Cadila Pharmaceuticals Ltd.
On March 31, 2009, Company and Cadila Pharmaceuticals Ltd., a private 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 will develop and commercialize
our seasonal influenza 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
- 29 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
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 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 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 $10.7 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
- 30 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
common stock, SOHL may designate one member of our board of directors. SOHL designated Rajiv I.
Modi, Ph.D., who was elected to the board of directors effective April 1, 2009.
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, as defined in the Master Services
Agreement. 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. As of June 30, 2009, we have not incurred any expenses
related to the Master Services Agreement.
At the Market Issuance
On January 12, 2009 we entered into the Sales Agreement with Wm Smith under which we may sell
an aggregate of up to $25.0 million in gross proceeds of the 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 12.5 million shares of common stock under the Sales Agreement. Wm
Smith may sell the common stock at the market 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 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 three and six months ended June 30,
2009, we sold 5,379,077 shares and 5,449,577 shares and received net proceeds of $13.8 million and
$14.0 million, respectively.
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) provided for payment of $17.0 million aggregate principal amount of the
Notes on April 29, 2009, (ii) provided for 70% of this principal amount plus accrued and unpaid
interest to be paid in cash and (iii) provided 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.
- 31 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
On July 15, 2009, we repaid the remaining $5.0 million balance of the Notes. (See Subsequent
Events Convertible Notes).
Sublease Agreement with PuriCore, Inc.
We have 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 former
corporate headquarters at a premium price per square foot. The sublease, with a commencement date
of July 1, 2006, expires on September 30, 2009. 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. 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.
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. Our new GMP pilot manufacturing facility located at our
Belward Campus Drive location is being 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
June 30, 2009 and December 31, 2008 include $178,000 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. We retained the rights to commercialize Estrasorb outside of the United
States, Canada and Mexico.
In February 2008, Novavax and Graceway also entered into a supply agreement, pursuant to which
Novavax manufactured additional units of Estrasorb. 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 Novavax an exclusive, non-transferable (except for certain allowed
assignments and sublicenses), royalty-free, limited license to the patents and know-how that
- 32 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Novavax sold to Graceway pursuant to the asset purchase agreement. The license allows Novavax to
make, use and sell licensed products and services in certain, limited fields.
The net cash impact from these transactions 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 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 June 30, 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 (i) as long
as there is at least one claim of the licensed patent rights cover the manufacture, sale or use of any
product, (ii) unless Novavax has not terminated the agreement at its
option or, (iii) Wyeth has not terminated the agreement for an uncured breach by Novavax.
License Agreement with University of Massachusetts Medical School
Effective February 26, 2007, we entered into a worldwide agreement to exclusively license a
VLP technology from the University of Massachusetts Medical School (UMMS). Under the agreement,
we have the right to use this technology to develop VLP vaccines for the prevention of any viral
diseases in humans. As of June 30, 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.
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. As of June 30, 2009, the outstanding principal
and interest for these two notes was $1,992,000.
- 33 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
In May 2006, one of these directors resigned from the Companys board of directors. Following
his resignation, we approved an extension of the former directors $448,000 note to be payable on
December 31, 2007, or earlier to the extent of the net proceeds from any sale of the pledged
shares. We entered into negotiations with the former director to extend the loan in January 2008.
On May 7, 2008, the Company and the former director entered into an Amended and Restated Promissory
Note and an Amended and Restated Pledge Agreement (the Amendment).
The Amendment 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 or $45,000.
In January 2009, we received an additional payment of $10,000. This note is currently in default.
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. This note is currently in default.
We continue our efforts 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 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
- 34 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
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.
Results of Operations
The following is a discussion of the historical consolidated financial condition and results
of operations of Novavax, Inc. and its wholly owned subsidiary and should be read in conjunction
with the consolidated financial statements and notes thereto set forth in this Quarterly Report on
Form 10-Q. Additional information concerning factors that could cause actual results to differ
materially from those in the Companys forward-looking statements is contained from time to time in
the Companys SEC filings, including but not limited to the Companys Annual Report on Form 10-K
for the fiscal year ended December 31, 2008.
Three months ended June 30, 2009 (2009) compared to the three months ended June 30, 2008
(2008): (Amounts in the tables are presented in thousands, except percentage changes and share
and per share information)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
29 |
|
|
$ |
342 |
|
|
$ |
(313 |
) |
|
|
(92 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for the three months ended June 30, 2009 were $29,000 as compared to
$342,000 for the three months ended June 30, 2008, a decrease of $313,000, or 92%. The decrease in
revenue from the comparable period in 2008 is due to lower contract research and development
revenue. Contract research and development revenue is comprised of revenue from government and
commercial research and development contracts and for the three months ended June 30, 2008 was
comprised of revenue from two National Institutes of Health (NIH) contracts, of which one of
these ended in the first quarter of 2009.
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
5,297 |
|
|
$ |
5,380 |
|
|
$ |
(83 |
) |
|
|
(2 |
)% |
General and administrative |
|
|
2,562 |
|
|
|
3,166 |
|
|
|
(604 |
) |
|
|
(19 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,859 |
|
|
$ |
8,546 |
|
|
$ |
(687 |
) |
|
|
(8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
- 35 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Research and Development Expenses
Research and development costs decreased from $5.4 million for the three months ended June 30,
2008 to $5.3 million for the three months ended June 30, 2009, a decrease of $0.1 million, or 2%.
Our research and development costs are incurred in support of the development of VLP based
vaccines. The decrease can be attributed to a $0.2 million decrease in employee costs from 2008 to
2009. This decrease is 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.
General and Administrative Expenses
General and administrative costs were $2.6 million for the three months ended June 30, 2009
compared to $3.2 million for the three months ended June 30, 2008. The decrease of $0.6 million,
or 19%, was primarily due to decrease in employee related expenses of $0.2 million, and a decrease
of $0.1 million in our facility costs associated with general and administrative functions.
General and administrative costs for the three months ended June 30, 2008 included $0.1
million related to the allowance established for two notes receivable from former directors. The
general and administrative cost for the first half of 2008 also included a public relations
campaign of $0.1 million for our influenza vaccine program. We did not have this expense in 2009.
During 2008, we determined that the notes receivable should be classified as a reduction of equity.
Accordingly, we have not recorded any reserve charges for the three months ended June 30, 2009. In
2009, we had a slight decrease in our legal and accounting fees.
Other (Expense) Income, net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
75 |
|
|
$ |
323 |
|
|
$ |
(248 |
) |
|
|
(77) |
% |
Interest expense |
|
|
(326 |
) |
|
|
(433 |
) |
|
|
107 |
|
|
|
25 |
% |
Impairment loss on
short-term
investments |
|
|
(459 |
) |
|
|
|
|
|
|
(459 |
) |
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net other expense |
|
$ |
(710 |
) |
|
$ |
(110 |
) |
|
$ |
(600 |
) |
|
|
(545 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Our net other expense was $0.7 million for the three months ended June 30, 2009 compared to
net other expense of $0.1 million for the three months ended June 30, 2008. The increase in net
interest and other expense resulted from an additional other than temporary impairment in the
amount of $0.5 million related to one of the Companys auction rate securities due primarily to its
continued illiquidity and a $0.2 million decrease in interest income due to a decrease in the
average cash and short-term investments balance during the quarter. Interest expense for the three
months ended June 30, 2009 decreased to $0.3 million from $0.4 million for the three months ended
June 30, 2008, a decrease of $0.1 million, or 25%. The decrease in interest expense is due to the
2009 Amendments to the Notes which resulted in early retirement of $17.0 million of the Notes.
- 36 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Discontinued Operations:
In October 2007 we entered into agreements to terminate our supply agreement 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 June 30, 2009 and 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
|
|
|
$ |
143 |
|
|
$ |
(143 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of products sold |
|
|
|
|
|
|
736 |
|
|
|
(736 |
) |
|
|
(100 |
)% |
Excess inventory
costs over market |
|
|
|
|
|
|
465 |
|
|
|
(465 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
1,201 |
|
|
|
(1,201 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
|
|
|
$ |
(1,058 |
) |
|
$ |
(1,058 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded a loss from discontinued operations of $1.1 million for the three months
ended June 30, 2008. We recorded revenue from discontinued operations of $0.1 million which related
to the sale of Estrasorb. In the costs of products sold of $0.7 million in 2008, $0.2 million
represents idle capacity costs at our manufacturing facility. The remaining $0.5 million
represents the cost of Estrasorb sales to Graceway. In accordance with the supply agreement with
Graceway, we sold Estrasorb at a price that was lower than our manufacturing costs. The excess
cost over the product cost totaled $0.5 million for the three months ended June 30, 2008.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,540 |
) |
|
$ |
(9,372 |
) |
|
$ |
832 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(0.10 |
) |
|
$ |
(0.15 |
) |
|
$ |
0.05 |
|
|
|
33 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding |
|
|
84,832,226 |
|
|
|
61,329,699 |
|
|
|
23,502,527 |
|
|
|
38 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the three months ended June 30, 2009 was $8.5 million or $0.10 per share, as
compared to $9.4 million or $0.15 per share for the three months ended June 30, 2008, a decrease of
$0.8 million or $0.05 per share. The decreased net loss was primarily due to the conclusion of our
discontinued operations, which accounted for $1.1 million of the net loss during the first six
months of 2008 and an overall decrease in operating expenses, primarily attributable to employee
related costs. This decrease is partially offset by a $0.6 million increase in net other expense,
primarily related to impairment losses on our auction rate securities and a decrease in revenues.
The weighted shares outstanding increased from 61,329,699 for the six months ended June 30, 2008 to
84,832,226 for the six months ended June 30, 2009 primarily as a result of the 12.5 million shares
issued to Cadila, 5.4 million shares sold under the Sales
- 37 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
agreement with Wm Smith and the
conversion of $5.1 million of the Notes into 2,040,000 shares of our common stock.
Six months ended June 30, 2009 (2009) compared to the six months ended June 30, 2008
(2008): (Amounts in the tables are presented in thousands, except percentage changes and share
and per share information.)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
50 |
|
|
$ |
800 |
|
|
$ |
(750 |
) |
|
|
(94 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues for the six months ended June 30, 2009 were $0.1 million, a decrease in
revenues of $0.7 million from revenues of $0.8 million for the six months ended June 30, 2008. The
decrease in revenues is attributable to a decrease in contract related research and development
revenues principally due to the completion of a National Institutes of Health (NIH) grant in
January 2009. We are currently seeking a no cost extension on this grant to cover the remainder of
2009.
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
$ Change |
|
|
% Change |
|
Research and development |
|
$ |
9,563 |
|
|
$ |
9,814 |
|
|
$ |
(251 |
) |
|
|
(3 |
)% |
General and administrative |
|
|
5,454 |
|
|
|
6,410 |
|
|
|
(956 |
) |
|
|
(15 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
15,017 |
|
|
$ |
16,224 |
|
|
$ |
(1,207 |
) |
|
|
(7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development Expenses
Research and development costs decreased from $9.8 million in 2008 to $9.6 million in 2009, a
decrease of $0.3 million, or 3%. This decrease was primarily due to a $0.5 million employee
related services. This decrease was partially offset by a $0.2 million increase in outside testing
costs.
General and Administrative Expenses
General and administrative costs were $5.5 million in 2009 compared to $6.4 million in 2008.
The decrease of $1.0 million or 15% was partially due to a decrease in employee related expenses of
$0.3 million. We also decreased our facility costs by $0.3 million associated with the general and
administrative function. General and administrative costs for the six months ended June 30, 2008
included $0.3 million related to the allowance established for two notes receivable from former
directors discussed above.
- 38 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Other (Expense) Income, (net):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
180 |
|
|
$ |
866 |
|
|
$ |
(686 |
) |
|
|
(79 |
)% |
Interest expense |
|
|
(764 |
) |
|
|
(859 |
) |
|
|
95 |
|
|
|
(11 |
)% |
Impairment loss on
short-term investments |
|
|
(1,338 |
) |
|
|
|
|
|
|
(1,338 |
) |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net other (expense) income |
|
$ |
(1,922 |
) |
|
$ |
7 |
|
|
$ |
(1,929 |
) |
|
|
(27,557 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income was $0.2 million for 2009 compared to $0.9 million for 2008, a decrease of
$0.7 million. The decrease is primarily due to the decrease in our average cash, cash equivalents
and short-term investment balances from 2008 to 2009 resulting from our continuing investment in
research and development activities surrounding our vaccine candidates. Interest expense decreased
from $0.9 million in 2008 to $0.8 million in 2009, a decrease of $0.1 million or 11%. The decrease
in interest expense is due to the early extinguishment of $17.0 million in convertible notes in
April 2009. Additionally, we recorded $1.3 million as other expense related to other than temporary
impairment losses on our auction rate securities.
Discontinued Operations:
The following table presents summarized financial information for our discontinued operations
for the six months ended June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
|
|
|
$ |
229 |
|
|
$ |
(229 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of products sold |
|
|
|
|
|
|
1,474 |
|
|
|
(1,474 |
) |
|
|
(100 |
)% |
Excess inventory costs over
market |
|
|
|
|
|
|
465 |
|
|
|
(465 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
|
|
|
|
1,939 |
|
|
|
(1,939 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
|
|
|
$ |
(1,710 |
) |
|
$ |
(1,710 |
) |
|
|
(100 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded a loss from discontinued operations of $1.7 million for the six months ended June
30, 2008. We recorded revenue from discontinued operations of $0.2 million related to the sale of
Estrasorb. Costs of products sold, which include fixed idle capacity costs of $0.8 million at our
manufacturing facility were $1.5 million. The remaining $1.1 million represents the cost of
Estrasorb sales to Graceway. In accordance with the supply agreement with Graceway, we sold
Estrasorb at a price that was lower than our manufacturing costs. The excess over market cost were
$0.5 million for the six months ended 2008.
- 39 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(16,889 |
) |
|
$ |
(17,127 |
) |
|
$ |
238 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(0.22 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.06 |
) |
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding |
|
|
76,806,926 |
|
|
|
61,286,169 |
|
|
|
15,520,757 |
|
|
|
25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the six months ended June 30, 2009 was $16.9 million or $0.22 per
share, as compared to $17.1 million or $0.28 per share for the six months ended June 30, 2008, a
decrease of $0.2 million. The decrease in net loss was primarily due to the conclusion of our
discontinued operations which accounted for a net loss of $1.7 million in the first six months of
2008 and a decrease in our operating expenses. These decreases were partially offset by an
impairment loss of $1.3 million we recorded related to our auction rate securities. The weighted
shares outstanding increased from 61,286,169 for the six months ended June 30, 2008 to 76,806,926
for the six months ended June 30, 2009 primarily as a result of the issuance of 12.5 million shares
issued to Cadila, 5.4 million shares sold under the Wm Smith Sales Agreement and the conversion of
a portion of two convertible notes into equity.
Liquidity and Capital Resources
Our future capital requirements depend on numerous factors including, but not limited to, the
commitments and progress of our research and development programs, the progress of preclinical and
clinical testing, the time and costs involved in obtaining regulatory approvals, the costs of
filing, prosecuting, defending and enforcing any patent claims and other intellectual property
rights, competing technological and market developments, and manufacturing costs. 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 debt or equity financing or collaborative licensing, and
development arrangements with industry partners and government agencies.
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, 2009 |
|
|
|
(unaudited) |
|
|
|
(In thousands) |
|
Summary of Cash Flows: |
|
|
|
|
Net cash (used in) provided by
Operating activities |
|
$ |
(14,027 |
) |
Investing activities |
|
|
(36 |
) |
Financing activities |
|
|
12,341 |
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(1,722 |
) |
Cash and cash equivalents at beginning of period |
|
|
26,938 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
25,216 |
|
|
|
|
|
- 40 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
As of June 30, 2009, we held $31.2 million in cash, cash equivalents and short-term
investments as compared to $33.9 million at December 31, 2008. The $2.7 million decrease in cash,
cash equivalents and short-term investments during 2009 was primarily due to the operating loss
from continuing operations of $16.9 million and principal payments on debt of $12.3 million,
partially offset by proceeds received from the Cadila SPA and sales of common stock under the Sales
Agreement with Wm Smith. As of June 30, 2009, our working capital was $21.8 million compared to
$7.4 million as of December 31, 2008. This $14.4 million increase primarily resulted from the
proceeds from the Cadila transaction and sales of common stock discussed above. Additionally, our
working capital was used for $0.2 million in capital expenditures activities and $12.3 million in
principal payments primarily for the repayment of a portion of our Notes during the six months
ended June 30, 2009.
On July 6, 2009 ROVI purchased 1.1 million shares at $2.74 per share and we received net
proceeds of $3.0 million.
Between July 1 and July 31, 2009, we have sold approximately 2.0 million additional shares of
common stock and received net additional proceeds of approximately $8.0 million pursuant to the
sales agreement with Wm Smith. Under the current sales agreement, we may raise an additional
approximately $3.0 million and no arrangements have been made at this time to increase such amount.
As of June 30, 2009, we had $5.0 million of senior convertible notes outstanding (the
Notes). The Notes carried a 4.75% coupon; were convertible into shares of Novavax common stock at
$4.00 per share; and matured on July 15, 2009. On July 15, 2009, we repaid the remaining $5.0
million balance of our convertible notes in cash and common stock.
We will seek to raise additional capital through public or private equity and/or debt
financing. We used an additional $2.6 million of cash to repay the remaining outstanding Notes on
July 15, 2009 and intend to use the remaining proceeds from these financing transactions 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 additional 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.
Based on the amount of funds on hand as of June 30, 2009, the $3.0 million in proceeds from
the ROVI transaction, the additional sales of stock under the Wm Smith Sales Agreement in July
2009, 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.
- 41 -
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Contractual Obligations and Commitments
We utilize different financing instruments, such as debt and operating leases, to finance
various equipment and facility needs. The following table summarizes our current financing
obligations and commitments (in thousands) as of June 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
1 - 3 |
|
|
4 5 |
|
|
More than |
|
Commitments & Obligations |
|
Total |
|
|
1 Year |
|
|
Years |
|
|
Years |
|
|
5 Years |
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Convertible notes |
|
$ |
5,000 |
|
|
$ |
5,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating leases |
|
|
16,020 |
|
|
|
2,197 |
|
|
|
6,330 |
|
|
|
4,251 |
|
|
|
3,242 |
|
Notes payable |
|
|
684 |
|
|
|
234 |
|
|
|
450 |
|
|
|
|
|
|
|
|
|
Purchase obligations (1) |
|
|
9,300 |
|
|
|
1,800 |
|
|
|
7,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total principal payments |
|
|
31,004 |
|
|
|
9,231 |
|
|
|
14,280 |
|
|
|
4,251 |
|
|
|
3,242 |
|
Less: Subleases |
|
|
(764 |
) |
|
|
(335 |
) |
|
|
(429 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total commitments & obligations |
|
$ |
30,240 |
|
|
$ |
8,896 |
|
|
$ |
13,851 |
|
|
$ |
4,251 |
|
|
$ |
3,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Our purchase obligations consist of $7.5 million. We are required to purchase from Cadila for
biologic research, preclinical development, clinical development, process development,
manufacturing scale up, and general manufacturing related services pursuant to the Master Service
Agreement. The $1.8 million consists of contractual agreements with outside providers for our
preclinical and clinical development. |
On June 26, 2008, we amended the lease for its corporate headquarters at 9920 Belward Campus
Drive in Rockville, Maryland. The amendment (1) extends the term of the lease to January 31, 2017,
(2) provides that the landlord will reimburse Novavax for up to $3 million in leasehold
improvements (the Allowance) and (3) increases the monthly installments of base rent going
forward by an amount equal to the monthly amortization of the Allowance over the remaining term at
11% interest, or an additional $45,132 per month. The additional monthly rent is subject to the
annual 2.125% escalation included in the original lease. On June 27, 2008, we received $3 million
from the Landlord as reimbursement for leasehold improvements. The amount is included in deferred
rent on the balance sheet at June 30, 2009, and will be amortized as a credit to rent expense over
the remaining lease term.
In April 2009, we negotiated an amendment to our sublease with PuriCore to extend 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.
- 42 -
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The primary objective of our investment activities is to preserve our capital until it is
required to fund operations while at the same time maximizing the income we receive from our
investments without significantly increasing risk. As of June 30, 2009, we had cash, cash
equivalents and short-term investments of $31.2 million as follows:
|
|
|
|
|
Cash and cash equivalents |
|
$25.2 million |
Short-term investments classified as available for sale |
|
$6.0 million |
- 43 -
Our exposure to market risk is confined to our investment portfolio. As of June 30, 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 June 30, 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 earnings related to these securities during the first six
months of 2009 of $1.3 million (offset by recovery of $0.5 million of unrealized gain through other
comprehensive income) because of the current liquidity issues 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
through June 30, 2009 approximate $2.1 million (net of unrealized gain of $0.5 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 with Oppenheimer & Co. Inc. 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 necessarily 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.
- 44 -
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 have conducted the vast majority of our
business activities. Accordingly, we have not had any material exposure to foreign currency rate
fluctuations. We have entered into agreements with Cadila Pharmaceuticals in India and ROVI
Pharmaceuticals in Spain which may expose us to foreign currency rate fluctuations. We cannot
currently determine whether the exposure will have a material impact on our operations, financial
condition or cash flows.
At June 30, 2009 we had total debt of $5.7 million, most of which bears interest at fixed
interest rates. We do not believe that we are 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 the 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 13(a) 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 the 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 principal accounting
officer, has evaluated any changes in the Companys internal control over financial reporting that
occurred during the six months ended June 30, 2009, and has concluded that there was no change that
occurred during the quarter ended June 30, 2009 that has materially affected, or is reasonably
likely to materially affect, the Companys internal control over financial reporting.
- 45 -
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.
Novavaxs collaborations with Cadila Pharmaceuticals and ROVI Pharmaceuticals expose the Company to
additional risks associated with doing business outside the United States, and any adverse event
could have a material negative impact on operations.
On March 31, 2009, we and Cadila Pharmaceuticals Ltd., a company incorporated under the laws
of India (Cadila) entered into a Joint Venture Agreement (the JVA) pursuant to which we and
Cadila formed CPL Biologicals Limited, a joint venture (the JV), of which 80% will be owned by
Cadila and 20% is owned by us. The JV will develop and commercialize our seasonal influenza 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 also
contributed 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 has committed to 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.
On
June 30, 2009, we announced our initial agreement to license our VLP vaccine technology to
ROVI Pharmaceuticals of Spain (ROVI). ROVI will use the VLP technology to create a comprehensive
influenza vaccine solution for the Spanish government under a new 60 million-euro program sponsored
and led by the Spanish Ministry of Health and other government groups to develop pandemic and
seasonal flu vaccines and establish its only in-border facility.
Risks of conducting business outside the United States include:
|
|
|
Multiple regulatory requirements could affect the ability to develop, manufacture and
sell products in such local markets; |
|
|
|
|
Compliance with anti-bribery laws such as the U.S. Foreign Corrupt Practices Act and
similar anti-bribery laws in other jurisdictions; |
|
|
|
|
Trade protections measures and import and export licensing requirements; |
|
|
|
|
Different labor regulations; |
|
|
|
|
Changes in environmental, health and safety laws; |
|
|
|
|
Potentially negative consequences from changes in or interpretations of tax laws; |
|
|
|
|
Political instability and actual or anticipated military or potential conflicts; |
|
|
|
|
Economic instability, inflation, recession, and interest rate fluctuations; |
|
|
|
|
Minimal or diminished protection of intellectual property in some countries; and |
- 46 -
|
|
|
Possible nationalization and expropriation. |
These risks, individually or in the aggregate, could have a material adverse effect on our
business, financial conditions, results of operations and cash flows.
Item 4 Submission of Matters to a Vote of Security Holders
At the Companys Annual Meeting of stockholders held on May 13, 2009, the following
proposals were adopted by the votes specified below:
|
1. |
|
To elect three directors as Class II directors to serve on the Board of Directors for a
three-year term expiring at the 2012 Annual Meeting of Stockholders. |
|
|
|
|
|
|
|
|
|
|
|
FOR |
|
WITHHELD |
Gary C. Evans |
|
|
70,352,223 |
|
|
|
914,575 |
|
John O. Marsh |
|
|
70,481,742 |
|
|
|
785,056 |
|
James B. Tananbaum, MD |
|
|
69,954,290 |
|
|
|
1,312,508 |
|
In addition to the three Class II directors elected at this years Annual Meeting of
Stockholders, the Board is composed of three Class I Directors and two Class III
Directors. The continuing Class I Directors, whose term will expire at the Companys 2011
Annual Meeting, are John Lambert, Rahul Singhvi, Sc.D, and Rajiv I. Modi, Ph.D. The
continuing Class III directors, whose terms will expire at the Companys 2010 Annual
Meeting, are Michael A. McManus and Thomas P. Monath, MD.
On June 26, 2009, the Company appointed Stanley Erck to the Companys Board of Directors.
Mr. Erck will serve as a Class III director and his term will expire in 2010.
|
2. |
|
To ratify the appointment of Grant Thornton LLP, an independent registered accounting
firm, as the independent auditor for the Company for the year ended December 31, 2009. |
|
|
|
|
|
For |
|
|
70,958,791 |
Against |
|
|
116,678 |
Abstain |
|
|
191,329 |
Broker Non-Votes |
|
|
0 |
|
3. |
|
To approve an amendment to the Companys Amended and Restated Certificate of
Incorporation, as amended, to increase the number of authorized shares of common stock of
the Company by 100,000,000 shares from 100,000,000 shares to 200,000,000 shares. |
|
|
|
|
|
For |
|
|
64,060,965 |
Against |
|
|
6,860,354 |
|
Abstain |
|
|
345,479 |
Broker Non-Votes |
|
|
0 |
- 47 -
Item 6 Exhibits
3.1 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Novavax,
Inc., dated May 13, 2009 |
|
10.1 |
|
Amendment Agreement by and between Novavax, Inc. and Smithfield Fiduciary LLC, dated as of
April 28, 2009 (Incorporated by reference to Exhibit 10.1 to the Companys Current Report on
Form 8-K, filed April 29, 2009) |
|
10.2 |
|
Amendment Agreement by and between Novavax, Inc. and Portside Growth and Opportunity Fund,
dated as of April 28, 2009 (Incorporated by reference to Exhibit 10.2 to the Companys Current
Report on Form 8-K, filed April 29, 2009) |
|
10.3 |
|
Second Amendment to Sublease Agreement between Novavax, Inc. and PuriCore, Inc., dated April
22, 2009 |
|
10.4** |
|
Amended and Restated Joint Venture Agreement between Novavax Inc. and Cadila Pharmaceuticals
Limited, dated as of June 29, 2009 |
|
10.5** |
|
Amended and Restated Master Services Agreement between Novavax, Inc. and Cadila
Pharmaceuticals Limited, dated as of June 29, 2009 |
|
10.6** |
|
Amended and Restated Supply Agreement between Novavax, Inc. and CPL Biologicals Limited,
dated as of June 29, 2009 |
|
10.7** |
|
Amended and Restated Technical Services Agreement between Novavax, Inc. and CPL Biologicals
Limited, dated as of June 29, 2009 |
|
10.8** |
|
Amended and Restated Seasonal / Other License Agreement between Novavax, Inc. and CPL
Biologicals Limited, dated as of June 29, 2009 |
|
10.9** |
|
Amended and Restated Option to Obtain License between Novavax, Inc. and CPL Biologicals
Limited, dated as of June 29, 2009 |
|
10.10 |
|
Stock Purchase Agreement between Novavax, Inc. and Laboratorios Farmaceuticos ROVI S.A.,
dated June 30, 2009 |
|
10.11 |
|
Amended and Restated Employment Agreement of Rahul Singhvi, effective July 20, 2009
(Incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed
July 22, 2009) |
|
10.12 |
|
Second Amendment to Amended and Restated Employment Agreement of Raymond Hage, effective
July 20, 2009 (Incorporated by reference to Exhibit 10.2 to the Companys Current Report on
Form 8-K, filed July 22, 2009) |
- 48 -
10.13 |
|
Employment Agreement of Frederick Driscoll, dated August 6, 2009 (Incorporated by reference
to Exhibit 10.1 to the Companys Current Report on Form 8-K, filed August 7, 2009) |
|
31.1 |
|
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a) or Rule
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
31.2 |
|
Certification of Principal Accounting Officer pursuant to Exchange Act Rule 13a-14(a) or Rule
15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
32.1 |
|
Certification of Chief Executive Officer, pursuant to Exchange Act Rule 13a-14(a) or Rule
15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. * |
|
32.2 |
|
Certification of Principal Accounting Officer, pursuant to Exchange Act Rule 13a-14(a) or
Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. * |
|
|
* |
|
This exhibit is not filed for purposes of Section 18 of the Securities Exchange Act of 1934,
and is not and should not be deemed to be incorporated by reference into any filing under the
Securities Act of 1933 or the Securities Exchange Act of 1934. |
|
** |
|
Confidential treatment has been requested for portions of this exhibit. |
- 49 -
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.
|
|
|
|
|
|
NOVAVAX, INC.
(Registrant)
|
|
Date: August 10, 2009 |
By: |
/s/ Rahul Singhvi
|
|
|
|
Rahul Singhvi |
|
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
Date: August 10, 2009 |
By: |
/s/ Evdoxia E. Kopsidas
|
|
|
|
Director of Finance and Principal |
|
|
|
Accounting Officer (Performing
functions similar to a principal
financial officer) |
- 50 -