e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT UNDER SECTION 13 or 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For Quarterly Period Ended March 31, 2007
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
Commission File No. 0-26770
NOVAVAX, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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22-2816046 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
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9920 Belward Campus Drive, Rockville, MD
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20850 |
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(Address of principal executive offices)
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(Zip code) |
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(240) 268-2000
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(Registrants telephone number, including area code)
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
þ Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
o Large accelerated filer þ Accelerated filer o Non-accelerated filer
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
o Yes þ No
The number of shares outstanding of each of the issuers classes of common stock, as of the latest
practicable date:
Shares of Common Stock Outstanding at May 4, 2007: 61,905,090
NOVAVAX, INC.
Form 10-Q
For the Quarter Ended March 31, 2007 and 2006 (unaudited)
Table of Contents
i
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
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March 31, |
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December 31, |
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2007 |
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2006 |
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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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$ |
7,782 |
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$ |
7,161 |
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Short-term investments |
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59,847 |
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66,434 |
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Accounts and other receivables, net of allowance for doubtful accounts of $185 and
$117 as of March 31, 2007 and December 31, 2006, respectively. |
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906 |
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1,274 |
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Inventory |
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735 |
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600 |
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Prepaid expenses and other current assets |
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1,796 |
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1,873 |
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Total current assets |
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71,066 |
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77,342 |
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Property and equipment, net |
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9,710 |
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9,861 |
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Goodwill |
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33,141 |
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33,141 |
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Other intangible assets, net |
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945 |
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978 |
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Other non-current assets |
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528 |
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555 |
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Total assets |
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$ |
115,390 |
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$ |
121,877 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Bank overdraft |
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$ |
790 |
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$ |
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Current portion of notes payable |
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508 |
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731 |
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Accounts payable |
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1,764 |
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1,530 |
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Accrued expenses |
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2,612 |
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3,078 |
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Total current liabilities |
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5,674 |
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5,339 |
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Convertible notes |
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22,000 |
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22,000 |
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Non-current portion of notes payable |
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396 |
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458 |
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Deferred rent |
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208 |
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79 |
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Total liabilities |
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28,278 |
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27,876 |
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Stockholders equity: |
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Preferred stock, $.01 par value, 2,000,000 shares authorized; no shares issued and
outstanding |
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Common stock, $.01 par value, 100,000,000 shares authorized; 62,253,805 shares
issued and 61,905,043 outstanding at March 31, 2007 and 62,139,851 issued and
61,791,089 outstanding at December 31, 2006 |
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623 |
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622 |
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Additional paid-in capital |
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262,289 |
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261,822 |
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Notes receivable from directors |
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(1,031 |
) |
Accumulated deficit |
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(173,350 |
) |
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(164,962 |
) |
Treasury stock, 348,762 shares at March 31, 2007 and at December 31, 2006, cost basis |
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(2,450 |
) |
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(2,450 |
) |
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Total stockholders equity |
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87,112 |
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94,001 |
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Total liabilities and stockholders equity |
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$ |
115,390 |
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$ |
121,877 |
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The accompanying notes are an integral part of these consolidated financial statements.
1.
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
(unaudited)
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Three months ended |
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March 31, |
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2007 |
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2006 |
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Revenues: |
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Net product sales |
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$ |
357 |
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$ |
719 |
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Contract research and development |
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222 |
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474 |
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Royalties, milestone and licensing fees |
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89 |
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110 |
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Total revenues |
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668 |
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1,303 |
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Operating costs and expenses: |
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Cost of products sold |
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1,317 |
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1,233 |
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Excess inventory costs over market |
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87 |
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315 |
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Research and development |
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3,659 |
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2,032 |
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Selling, general and administrative |
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4,597 |
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2,758 |
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Total operating costs and expenses |
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9,660 |
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6,338 |
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Loss from operations |
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(8,992 |
) |
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(5,035 |
) |
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Interest expense, net |
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604 |
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(460 |
) |
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Net loss |
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$ |
(8,388 |
) |
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$ |
(5,495 |
) |
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Basic and diluted loss per share |
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$ |
(0.14 |
) |
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$ |
(0.11 |
) |
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Basic and diluted weighted average number of common shares outstanding |
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61,221,075 |
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52,267,386 |
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The accompanying notes are an integral part of these consolidated financial statements.
2.
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
As of March 31, 2007
(in thousands, except share information)
(unaudited)
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Notes |
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Common Stock |
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Additional |
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Receivable |
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Total |
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Paid |
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From |
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Accumulated |
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Treasury |
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Stockholders |
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Shares |
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Amount |
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Capital |
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Directors |
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Deficit |
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Stock |
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Equity |
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Balance, December 31, 2006 |
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62,139,851 |
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$ |
622 |
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$ |
261,822 |
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|
$ |
(1,031 |
) |
|
$ |
(164,962 |
) |
|
$ |
(2,450 |
) |
|
$ |
94,001 |
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Non-cash compensation costs
for stock options |
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237 |
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|
237 |
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Exercise of stock options |
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54,002 |
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85 |
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|
85 |
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Restricted stock issued as
compensation |
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60,000 |
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|
1 |
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(1 |
) |
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|
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Non-cash compensation cost
for amortization of
restricted stock |
|
|
|
|
|
|
|
|
|
|
146 |
|
|
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|
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|
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|
146 |
|
Reclassification due to
change in status of a
director |
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|
1,031 |
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|
|
|
|
|
|
|
|
|
|
1,031 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
(8,388 |
) |
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(8,388 |
) |
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|
|
|
|
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|
|
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Balance, March 31, 2007 |
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|
62,253,805 |
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|
$ |
623 |
|
|
$ |
262,289 |
|
|
$ |
|
|
|
$ |
(173,350 |
) |
|
$ |
(2,450 |
) |
|
$ |
87,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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The accompanying notes are an integral part of these consolidated financial statements.
3.
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
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|
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Three months ended |
|
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|
March 31, |
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|
2007 |
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|
2006 |
|
Operating Activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,388 |
) |
|
$ |
(5,495 |
) |
Reconciliation of net loss to net cash used in operating activities: |
|
|
|
|
|
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|
Amortization |
|
|
33 |
|
|
|
33 |
|
Depreciation |
|
|
707 |
|
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|
713 |
|
Provision for bad debts |
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|
68 |
|
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|
(141 |
) |
Amortization of net discounts on short-term investments |
|
|
(698 |
) |
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|
Reserve for notes receivable and accrued interest |
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|
1,011 |
|
|
|
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|
Amortization of deferred financing costs |
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|
65 |
|
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|
270 |
|
Deferred rent |
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|
129 |
|
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|
(16 |
) |
Non-cash expense for services |
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|
27 |
|
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|
25 |
|
Non-cash stock compensation |
|
|
356 |
|
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|
1,034 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
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|
Trade accounts receivable |
|
|
300 |
|
|
|
111 |
|
Inventory |
|
|
(135 |
) |
|
|
20 |
|
Prepaid expenses and other assets |
|
|
59 |
|
|
|
219 |
|
Accounts payable and accrued expenses |
|
|
(231 |
) |
|
|
(1,059 |
) |
Facility exit costs |
|
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|
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|
(42 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net cash used in operating activities |
|
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(6,697 |
) |
|
|
(4,328 |
) |
|
|
|
|
|
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|
|
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|
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|
Investing Activities: |
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|
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Capital expenditures |
|
|
(556 |
) |
|
|
(227 |
) |
Purchases of short-term investments |
|
|
(24,848 |
) |
|
|
|
|
Proceeds from maturities of short-term investment |
|
|
32,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
Net cash provided by (used in) investing activities |
|
|
6,729 |
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|
|
(227 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Financing Activities: |
|
|
|
|
|
|
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|
Principal payments of notes payable |
|
|
(285 |
) |
|
|
(217 |
) |
Net proceeds from sales of common stock |
|
|
|
|
|
|
56,022 |
|
Proceeds from the exercise of stock options |
|
|
84 |
|
|
|
798 |
|
Bank overdraft |
|
|
790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
589 |
|
|
|
56,603 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
621 |
|
|
|
52,048 |
|
Cash and cash equivalents at beginning of period |
|
|
7,161 |
|
|
|
31,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
7,782 |
|
|
$ |
83,941 |
|
|
|
|
|
|
|
|
Non-cash transactions: |
|
|
|
|
|
|
|
|
Conversion of convertible debt and accrued interest to common stock |
|
$ |
|
|
|
$ |
7,068 |
|
|
|
|
|
|
|
|
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 biopharmaceutical company focused on creating differentiated, value-added vaccines that
leverage the Companys proprietary virus-like particle (VLP) technology as well as its
proprietary Novasomes ® adjuvants. VLPs imitate the three-dimensional structures of
viruses but are composed of recombinant proteins and therefore, are believed incapable of causing
infection and disease. Our proprietary production technology uses insect cells rather than chicken
eggs or mammalian eggs. The Companys product targets include vaccines against the H5N1, H9N2 and
other subtypes of avian influenza with pandemic potential and against human seasonal influenza as
well as other infectious diseases. The Company also has a drug delivery platform based on its
micellar nanoparticle (MNP) technology, proprietary oil and water nano emulsions used for the
topical delivery of drugs. The MNP technology was the basis for the development of the Companys
first Food and Drug Administration approved estrogen replacement product,
ESTRASORB®.
In April 2006, the Company entered into a License and Development Agreement and a
Supply Agreement with Esprit to co-develop, supply and commercialize the Companys MNP testosterone
product candidate for the treatment of female hypoactive sexual desire disorder. Esprit was granted
exclusive rights to market the product in North America.
The Company has a unique blend of capabilities consisting of formulation technologies, vaccine
technologies and drug development infrastructure, including clinical and commercial production
facilities. The Company is leveraging its capabilities to develop differentiated, value-added
vaccine products and licensing them at various stages of development to realize their value.
The products currently under development or in clinical trials by the Company will require
significant additional research and development efforts, including extensive pre-clinical and
clinical testing and regulatory approval, prior to commercial use. There can be no assurance that
the Companys research and development efforts will be successful or that any potential products
will prove to be safe and effective in clinical trials. Even if developed, these 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 product is subject to certain risks
including, but not limited to, manufacturing scale-up and market acceptance. No assurance can be
given that the Company can generate sufficient product revenue to become profitable or generate
positive cash flow from operations at all or on a sustained basis.
The consolidated financial statements of Novavax for the three months ended March
31, 2007 and 2006 are unaudited. These financial statements reflect all adjustments which, in the
opinion of management, are necessary for a fair presentation of the results of operations for the
interim periods presented. All such adjustments are of a normal, recurring nature. These interim
results are not necessarily indicative of the results to be expected for the fiscal year ending
December 31, 2007.
Certain information in footnote disclosures normally included in financial statements prepared
in accordance with generally accepted accounting principles has been condensed or omitted pursuant
to the rules and regulations of the Securities and Exchange Commission, although the Company
believes the disclosures are adequate to make the information presented not misleading. These
consolidated financial statements should be read in conjunction with the audited consolidated
financial statements and the notes thereto in the Companys Annual Report on Form 10-K for the year
ended December 31, 2006.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying 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.
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.
5.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Revenue Recognition
The Company recognizes revenue in accordance with the provisions of Staff Accounting Bulletin
No. 104, Revenue Recognition (SAB No. 104). For product sales, revenue is recognized when all of
the following criteria are met: persuasive evidence of an arrangement exists, delivery has
occurred, the sellers price to the buyer is fixed or determinable and collectibility is reasonably
assured. The Company recognizes these sales, net of allowances for returns, rebates and
chargebacks. A large part of the Companys product sales is to Esprit or to distributors who resell
the products to their respective customers. The Company provides rebates to members of certain
buying groups who purchase from the Companys distributors, to distributors that sell to their
customers at prices determined under a contract between the Company and the customer, and to state
agencies that administer various programs such as the federal Medicaid and Medicare. Rebate amounts
are usually based upon the volume of purchases or by reference to a specific price for a product.
The Company estimates the amount of the rebate that will be paid, and records the liability as a
reduction of revenue when the Company records its sale of the products. Settlement of the rebate
generally occurs from three to 12 months after the sale. The Company regularly analyzes the
historical rebate trends and makes adjustments to recorded reserves for changes in trends and terms
of rebate programs. In a similar manner, the Company estimates amounts for returns based on
historical trends, distributor inventory levels, product prescription data and generic competition
and makes adjustments to the recorded reserves based on such information. The sales return
allowance as of March 31, 2007 was $201,000, a decrease from the balance as of December 31, 2006 of
$238,000.
A roll-forward of the sales return allowances is a follows:
|
|
|
|
|
|
|
(in thousands) |
|
|
|
(unaudited) |
|
Balance, December 31, 2006 |
|
$ |
238 |
|
Provision for 2007 sales |
|
|
|
|
Returns received from 2006 sales |
|
|
(38 |
) |
|
|
|
|
|
|
|
|
|
Balance, March 31, 2007 |
|
$ |
200 |
|
|
|
|
|
6.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Revenue Recognition (continued):
The shipping and handling costs the Company incurs are included in cost of products sold in
its statements of operations.
For upfront payments and licensing fees related to contract research or technology, the
Company follows the provisions of SAB No. 104 in determining if these payments and fees represent
the culmination of a separate earnings process or if they should be deferred and recognized as
revenue earned over the life of the related agreement. Milestone payments are recognized as revenue
upon achievement of contract-specified events and when there are no remaining performance
obligations.
Revenue earned under research contracts is recognized in accordance with the terms and
conditions of such contracts for reimbursement of costs incurred and defined milestones. Revenue
earned under a drug development contract is recognized in proportion to the work performed.
Inventory
Inventory consists of raw materials, work-in-process and finished goods, and are priced at the
lower of cost or market, using the first-in-first-out method, and were as follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2007 |
|
|
December 31, 2006 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
(amounts in thousands) |
|
Raw materials |
|
$ |
422 |
|
|
$ |
263 |
|
Work-in-process |
|
|
42 |
|
|
|
86 |
|
Finished goods |
|
|
271 |
|
|
|
251 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
735 |
|
|
$ |
600 |
|
|
|
|
|
|
|
|
The Company utilizes Statement of Financial Accounting Standard No. 151, Inventory Costs
an amendment of ARB No. 43, Chapter 4 (SFAS No. 151). Under SFAS No. 151, the Company
allocates fixed production overhead costs to inventories based on the anticipated normal capacity
of its manufacturing facility at the time. Included in cost of products sold for the three months
ended March 31, 2007 is $791,000, or $(.01) per share, of idle capacity costs, which amounts
represent the excess of fixed production overhead costs over that allocated to inventories as
compared to $400,000, or $(.01) per share for the period ended March 31, 2006.
During the three months ended March 31, 2007, $87,000 of inventory costs in excess of market
value were included in the accompanying consolidated statement of operations related to the Supply
Agreement with Esprit, as compared to $315,000 for the same period in 2006. Under the terms of this
Supply Agreement, the Company has sold ESTRASORB at a price which was below its manufacturing
costs.
It is likely that the Company will continue to manufacture ESTRASORB at a loss until
production volumes increase or it enters into additional contract manufacturing agreements with
third parties to more fully utilize its manufacturing facilitys capacity. The facility is able to
accommodate much greater production than its current schedule, which, if more fully utilized, would
offset the fixed costs related to the manufacturing process and facility. In addition, the Company
is negotiating revisions to its agreements for packaging costs of ESTRASORB as well as its fixed
lease costs for the manufacturing facility. If these negotiations result in higher packaging or
lease costs to the Company, it may have a material adverse impact on future financial results.
7.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Earnings per Share
The Company calculates earnings per share in accordance with SFAS No. 128, Earnings per Share.
Basic earnings per share is computed based on the weighted average number of common shares
outstanding during the period. The dilutive effect of common stock equivalents is included in the
calculation of diluted earnings per share only when the effect of the inclusion would be dilutive.
For the three months ended March 31, 2007 and 2006, there were no common stock equivalents included
in the calculations of earnings per share as they were all anti-dilutive.
Short-term investments
As of March 31, 2007, the Company had short-term investments, with original maturity dates
ranging from 105 days to six months. These short-term investments have been classified as held
until maturity, as the Company has the positive intent and ability to hold them until maturity.
Initial investments are recorded at face value less any premiums or discounts. These premiums or
discounts are then amortized over the remaining maturity periods of the investments. Included in
net interest income on the consolidated statement of operations for the three months ended March
31, 2007 is $698,000 of amortization of premiums/discounts related to these short-term investments.
As of March 31, 2007 short-term investments were comprised of $53,836,000 of commercial paper
and $6,011,000 of corporate obligations. The Company did not have any short-term investments as of
March 31, 2006.
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 |
|
|
|
March 31, 2007 |
|
|
December 31, 2006 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
(amounts in thousands) |
|
Machinery and equipment |
|
$ |
12,599 |
|
|
$ |
12,193 |
|
Leasehold improvements |
|
|
6,363 |
|
|
|
6,248 |
|
Computer software and hardware |
|
|
432 |
|
|
|
396 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,394 |
|
|
|
18,837 |
|
|
|
|
|
|
|
|
|
|
Less accumulated depreciation and amortization |
|
|
(9,684 |
) |
|
|
(8,976 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
9,710 |
|
|
$ |
9,861 |
|
|
|
|
|
|
|
|
8.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Accounting for Facility Exit Costs
Consistent with the strategic focus to further develop vaccines, the Company moved its
Corporate headquarters to Rockville, Maryland, in January 2007. This move allowed the company to
add additional space for its vaccine operations which had been based in Rockville previously. As a
result, the Company entered into an amendment to the sublease agreement with Sterilox Technologies,
Inc. (now known as Puricore, Inc.) to sublease an additional 7,500 square feet of the Malvern
former corporate headquarters at a premium price per square foot. This amendment had a commencement
date of October 25, 2006, and expires on September 30, 2009. As a result of the premium price
received on these sublease agreements, there were no facility exit costs associated with this
transaction. In April 2006, the Company entered into a sublease agreement with Puricore, Inc. to
sublease 20,469 square feet of the Malvern corporate headquarters at a premium price per square
foot the new sublease, with a commencement date of July 1, 2006 and expires on September 30, 2009.
The aforementioned subleased space was from the original lease agreement for a 32,900 square foot
facility in Malvern, Pennsylvania signed in July 2004 for the consolidation and expansion of its
corporate headquarters and product development activities. The lease, with a commencement date of
September 15, 2004, has an initial term of ten years with two five year renewal options and an
early option to terminate after the first five years of the lease.
Goodwill and Other Intangible Assets
Goodwill originally resulted from business acquisitions. Assets acquired and liabilities
assumed were recorded at their fair values; the excess of the purchase price over the identifiable
net assets acquired was recorded as goodwill. Other intangible assets are a result of product
acquisitions, non-compete arrangements and patents. In accordance with SFAS No. 142, Goodwill and
Other Intangible Assets (SFAS No. 142), goodwill and intangible assets deemed to have indefinite
lives are not amortized but are subject to impairment tests annually, or more frequently should
indicators of impairment arise. The Company utilizes a discounted cash flow analysis that includes
profitability information, estimated future operating results, trends and other information in
assessing whether the value of indefinite-lived intangible assets can be recovered. Under SFAS No.
142, goodwill impairment is deemed to exist if the carrying value of a reporting unit exceeds its
estimated fair value.
Other intangible assets are amortized on a straight-line basis over their estimated useful
lives, ranging from five to 17 years. Amortization expense was $33,000 for each of the three months
ended March 31, 2007 and 2006.
Goodwill and Other Intangible Assets (continued):
As of March 31, 2007 and December 31, 2006, the Companys intangible assets and related
accumulated amortization consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2007 |
|
|
As of December 31, 2006 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
Goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill- Company acquisition |
|
$ |
33,141 |
|
|
$ |
|
|
|
$ |
33,141 |
|
|
$ |
33,141 |
|
|
$ |
|
|
|
$ |
33,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other intangible assets, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents |
|
$ |
2,525 |
|
|
$ |
1,580 |
|
|
$ |
945 |
|
|
$ |
2,525 |
|
|
$ |
(1,547 |
) |
|
$ |
978 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation
Stock Options
The Company has various stock incentive and option plans, which are described in Note 9 of the
Notes to the Consolidated Financial Statements to the Companys 2006 Annual Report on Form 10-K,
that provide for the grant of options and restricted stock to eligible employees, officers,
directors and consultants of the Company.
Effective January 1, 2006, the Company adopted the fair value recognition provisions of
Statement of Financial Accounting Standard No. 123 (revised), Accounting for Stock-Based
Compensation (SFAS No. 123R) using the modified prospective method. This standard requires the
Company to measure the cost of employee services received in exchange for equity share options
granted based on the grant-date fair value of the options. The cost is recognized as compensation
expense over the vesting period of the options. Under the modified prospective method, compensation
cost included in operating expenses was $237,000 and $261,000 for the three months ended March 31,
2007 and March 31, 2006, respectively.
As of March 31, 2007, there were 6,295,081 stock options outstanding. At March 31, 2007, the
aggregate fair value of the remaining compensation cost of unvested options, as determined using a
Black-Scholes option valuation model, was approximately $3,105,000 (net of estimated forfeitures).
This unrecognized compensation cost of unvested options is expected to be recognized over a
weighted average period of 1.63 years. During the three months ended March 31, 2007, the Company
granted 941,900 options, with a fair value of approximately $1,869,000 (net of estimated
forfeitures), and 304,725 options were forfeited. During the three months ended March 31, 2006,
the Company granted 751,500 stock options, with a fair value of approximately $2,578,000 (net of
estimated forfeitures), and 1,000 options were forfeited.
The weighted average fair value of stock options on the date of grant and the assumptions used
to estimate the fair value of stock options issued during the three months ended March 31, 2007 and
2006, using the Black-Scholes options valuation model were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Weighted average fair value of options granted |
|
$ |
1.98 |
|
|
$ |
2.73 |
|
Expected life (years) |
|
|
4.94 |
|
|
|
4.4 |
|
Expected volatility |
|
|
91 |
% |
|
|
85 |
% |
Risk free interest rate |
|
|
4.45 |
% |
|
|
4.73--4.99 |
% |
Expected dividend |
|
|
0 |
% |
|
|
0 |
% |
Expected forfeiture rate |
|
|
20.34 |
% |
|
|
20.37 |
% |
The expected life of options granted was based on the Companys historical share option
exercise experience using the historical expected term from the vesting date. The expected
volatility of the options granted during the three months ended March 31, 2007 and 2006 was
determined using historical volatilities based on stock prices since the inception of the plans.
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.
10.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Restricted Stock
During the three months ended March 31, 2007 and 2006, the Company granted 60,000 and 155,000
shares of restricted common stock, respectively, under the 2005 Plan totaling $166,000 and
$870,000, respectively, in value at the date of grant to current and former employees, a director
and a consultant of the Company, which vest upon the achievement of certain milestones or over a
period of up to three years.
Non-cash compensation expense related to all restricted stock issued has been recorded as
compensation cost in accordance with SFAS No. 123R using the straight-line method of amortization.
For the three months ended March 31, 2007, $146,000 of non-cash stock compensation expense was
included in total operating costs and expenses and additional paid-in capital was increased
accordingly. For the three months ended March 31, 2006, $208,000 of non-cash stock compensation
expense was included in total operating costs and expenses and additional paid in capital was
increased accordingly.
For restricted stock issued prior to January 1, 2006, non-cash compensation cost was recorded
using the straight-line method of amortization and unearned compensation was increased accordingly.
The initial issuance of restricted stock increased common stock and additional paid-in capital and
was offset by unearned compensation, which was included in the stockholders equity section of the
consolidated balance sheet. The balance as of December 31, 2005 or the unearned compensation
account was $425,000 and in accordance with SFAS No. 123R was netted against additional paid-in
capital as of March 31, 2006.
Recent Accounting Pronouncements
SFAS No. 157
In September 2006, the Financial Accounting Standards Board issued Statement of Financial
Accounting Standards No. 157, Fair Value Measurements (SFAS No. 157). SFAS No. 157 defines fair
value, establishes a framework for measuring fair value in generally accepted accounting principles
and expands disclosures about fair value measurements. SFAS No. 157 applies under other accounting
pronouncements that require or permit fair value measurements, but does not require any new fair
value measurements. SFAS No. 157 will become effective for financial statements issued for fiscal
years beginning after November 15, 2007, and interim periods within those fiscal years. The Company
is currently evaluating what impact, if any, SFAS No. 157 will have on its financial condition,
results of operations or liquidity.
SFAS No. 159
In February 2007, the FASB issued Statement of Financing Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities (FAS 159). This Statement
establishes a fair value option which permits entities to choose to measure many financial
instruments and certain other items at fair value at specified election dates. Any unrealized
gains and losses on items for which the fair value option has been elected will be reported in
earnings. FAS 159 is effective for our fiscal year beginning January 1, 2008. We do not currently
have any financial instruments for which we intend to elect the fair value option.
FIN 48
In July 2006, the FASB issued Interpretation No. 48 (FIN 48), Accounting for Uncertainty in
Income Taxes, to address the noncomparability in reporting tax assets and liabilities resulting
from a lack of specific guidance in SFAS No. 109, Accounting for Income Taxes, on the uncertainty
in income taxes recognized in an enterprises financial statements. Specifically, FIN 48
prescribes (a) a consistent recognition threshold and (b) a measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax
return, and provides related guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure, and transition. FIN 48 applies to fiscal years
beginning after December 15, 2006.
The Company adopted the provisions of FIN 48 on January 1, 2007. As a result of the adoption
of FIN 48, the Company recorded $3.8 million in uncertain tax positions. The $3.8 million of
unrecognized tax benefits was accounted for as a $3.8 million reduction to the January 1, 2007
balance of deferred tax assets and a corresponding $3.8 million dollar reduction of the valuation
allowances. Therefore, the Company did not record any adjustment to the beginning balance of
retained earnings in our condensed consolidated balance sheet. To the extent these unrecognized
tax benefits are ultimately recognized it would affect the annual effective income tax rate. The
Company and its subsidiary file income tax returns in the U.S. federal jurisdiction and in various
states. The Company has tax net operating loss and credit carryforwards that are subject to
examination for a number of years beyond the year in which they are utilized for tax purposes.
Since a portion of these carryforwards will be utilized in the future, many of these attribute
carryforwards may remain subject to examination.
11.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
FIN 48(continued)
The Companys policy is to recognize interest and penalties related to income tax matters in
income tax expense. As of January 1 and March 31, 2007, the Company had no accruals for interest
or penalties related to income tax matters.
Sales and Issuance of Common and Treasury Stock
During the three months ended March 31, 2007, the Company received net proceeds of $85,000
from the exercise of 54,002 shares of common stock options, at a range of $1.34 to $2.21 per share.
In February 2006, the Company completed an offering of 4,597,700 shares of common stock at
$4.35 per share. The stock was offered and sold pursuant to an existing shelf registration
statement. Net proceeds, after deducting legal fees, were approximately $19,925,000.
In March 2006, the Company completed an offering of 5,205,480 shares of common stock at $7.30
per share. The stock was offered and sold pursuant to an existing shelf registration statement. Net
proceeds, after deducting underwriter fees of approximately $1,900,000 as well as legal and other
miscellaneous fees, were $36,059,000.
During the three months ended March 31, 2006, the Company received net proceeds of $798,000
for the exercise of 158,750 shares of common stock options at a range of $3.56 to $5.81 per share.
In March 2006, the Company issued 5,981 shares of treasury stock in lieu of payment of
services rendered by a consultant for the value of $25,000. The treasury stock has a weighted
average cost of $9.51 per share and additional paid in capital was reduced by $32,000.
Convertible Notes Conversion
In March 2006, the holders of $7,000,000 principal amount of the Companys senior convertible
notes exercised their optional right to convert their notes plus accrued interest of $68,000 into
1,294,564 shares of Novavax common stock, at the per share conversion price then in effect of
$5.46. This reduced the aggregate principal amount of such notes outstanding from $29,000,000 to
$22,000,000.
Related Party Transactions
On March 21, 2002, pursuant to the Novavax, Inc. 1995 Stock Option Plan, the Company
approved the payment of the exercise price of options by two of its directors, through the
delivery of full-recourse, interest-bearing promissory notes in the aggregate amount of
$1,480,000. The borrowings accrued interest at 5.07% per annum and were secured by an
aggregate of 261,667 shares of common stock owned by the directors. The notes were payable
upon the earlier to occur of the following: (i) the date on which the director ceases for
any reason to be a director of the Company, (ii) in whole, or in part, to the extent of net
proceeds, upon the date on which the director sells all or any portion of the pledged shares
or (iii) payable in full on March 21, 2007.
12.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Related Party Transactions (continued)
In May 2006, one of these directors resigned from the Companys Board of Directors.
Following his resignation from the Company approved an extension of the former directors
$448,000 note. Accordingly, the note has been reclassified out of stockholders equity. As
of March 31, 2007, the note and the corresponding accrued interest receivable totaling
$561,766 is classified in other current assets in the accompanying consolidated balance
sheet. The note continues to accrue interest at 5.07% per annum and is secured by 95,000
shares of common stock owned by the former director and is payable on December 31, 2007, or
earlier to the extent of the net proceeds from any sale of the pledged shares. In connection
with this extension, the former director executed a general release of all claims against
the Company. The Company reserved $167,000 against this note receivable and the
corresponding accrued interest receivable, which represents the difference between the book
value of the receivables less the market value of the 95,000 pledged shares as of December
31, 2006. For the period ended March 31, 2007, the reserve was increased by a further
$149,123 representing the difference in stock price between December 31, 2006 and March 31,
2007 (the share price decreased from $4.10 to $2.59 during the first quarter of 2007). This
reserve is included as an offset to other current assets in the accompanying consolidated
balance sheet as of March 31, 2007 and correspondingly, in general and administrative
expenses in the accompanying consolidated statement of operations for the year ended March
31, 2007.
In March 2007, the second director resigned from the Board of Directors. As of
March 31, 2007, the director owed $1,294,808 on his note payable. 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 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 March 31, 2007, the note and the corresponding
accrued interest receivable totaling $1,294,808 is classified in other current assets in the
accompanying consolidated balance sheet. The note continues to accrue interest at 5.07% per
annum and continues to be secured by 166,666 shares of common stock owned by the former
director. A reserve of $863,143 has been established as of March 31, 2007, representing
the amount of the loan balance due, less the value of the pledged common stock valued at
March 31, 2007. This reserve is included as an offset to other current assets in the
accompanying consolidated balance sheet as of March 31, 2007 and correspondingly, in general
and administrative expenses in the accompanying consolidated statement of operations for the
quarter ended March 31, 2007 .
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
1/3rd of his time to the Companys activities. As a consultant, Mr. Lambert will
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. He will be paid $220,000 per year in consideration for his
consulting services.
License and Development Agreement and Supply Agreement with Esprit Pharma, Inc.
In April 2006, the Company entered into a License and Development Agreement and a Supply
Agreement with Esprit to co-develop, supply and commercialize the Companys MNP testosterone
product candidate for the treatment of female hypoactive sexual desire disorder. Under the terms of
the License and Development Agreement, Esprit was granted exclusive rights to market the product in
North America. The Company will receive a royalty on all net sales of the product as well as
milestone payments on specific pre-determined clinical and regulatory milestones. Esprit will be
responsible for all development costs and will lead the clinical programs. Under the terms of the
Supply Agreement, the Company will be responsible for manufacturing the product.
13.
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Opportunity Grant Funds
In July 2005, the Company received a $400,000 Opportunity Grant from the Commonwealth of
Pennsylvania for the reimbursement of certain costs incurred in connection with the move of our
corporate headquarters and product development activities to Malvern, Pennsylvania.
In line with our business strategy, the Company announced in December 2006 that it had signed
a long-term lease for its new corporate headquarters and research facility in Rockville, Maryland,
where its vaccine operations were currently located. As a result of the Companys failure to
comply with the conditions of the grant by moving out of Pennsylvania, the Department of Community
& Economic Development (DCED) of the Commonwealth of Pennsylvania requested that the Company
repay the full amount of the Opportunity Grant. The Company recorded a current liability of
$400,000 in the Consolidated Balance Sheet as of December 31, 2006 and a corresponding expense in
general and administrative expenses in the Consolidated Statement of Operations for the year ended
December 31, 2006.
In April, 2007, the Company entered into a Settlement and Release Agreement with the
Commonwealth of Pennsylvania, whereby the Company agreed to repay the sum of the original grant in
60 monthly installments starting on May 1, 2007. The terms of the agreement stipulate the amount
of the monthly repayment to be $6,667 for 60 months. Interest will not accrue on the outstanding
balance. The Company made its first payment on May 1, 2007.
Segment Information
The Company currently operates in one business segment, which is the creation of
differentiated value-added vaccines, the development of novel vaccine adjuvants and the development
of a drug delivery platform using MNP technology. The Company is managed and operated as one
business. A single management team that reports to the Chief Executive Officer comprehensively
manages the entire business. The Company does not operate separate lines of business with respect
to its products or product candidates. Accordingly, the Company does not have separately reportable
segments as defined by SFAS No. 131, Disclosure about Segments of an Enterprise and Related
Information.
14.
Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Certain statements contained herein or as may otherwise be incorporated by reference herein
constitute forward-looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include, but are not limited to, statements
regarding product sales, future product development and related clinical trials, and future
research and development, including Food and Drug Administration approval. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors which may cause the
actual results, performance or achievements of the Company, or industry results, to be materially
different from those expressed or implied by such forward-looking statements.
Such factors include, among other things, the following: general economic and business
conditions; competition; ability to enter into future collaborations with industry partners or
governmental agencies; unexpected changes in technologies and technological advances by us or
others; ability to obtain rights to technology; ability to obtain and enforce patents; ability to
commercialize and manufacture products; ability to maintain commercial-scale manufacturing
capabilities; results of clinical studies; progress of research and development activities;
business abilities and judgment of personnel; availability of qualified personnel; changes in, or
failure to comply with, governmental regulations; ability to obtain adequate financing in the
future through product licensing, co-promotional arrangements, public or private equity financing
or otherwise; and other factors referenced herein.
All forward-looking statements contained in this quarterly report are based on information
available to the Company on the date hereof, and the Company assumes no obligation to update any
such forward-looking statements, except as specifically required by law. Accordingly, past results
and trends should not be used to anticipate future results or trends.
Overview
During 2005, Novavax successfully transitioned from a specialty pharmaceutical company, which
included the sale and marketing of products serving the womens health space, to an innovative,
biopharmaceutical company committed to becoming a leader in the fight against infectious disease by
developing novel, highly potent vaccines that are safer and more effective than current preventive
options. The Companys platforms include the virus-like particle (VLP) technology for vaccines,
which utilizes the baculovirus expression system in insect cells, as well as novel vaccine
adjuvants based on Novasomes ® .
Currently, our main focus is to leverage our proprietary VLP technology to
develop vaccines against influenza viruses that have the potential to cause a pandemic outbreak.
VLPs are genetically engineered particles that mimic three-dimensional structures of viruses but
are composed of recombinant proteins lacking viral genetic material and therefore are believed to
be incapable of causing infection and disease. Our proprietary production technology employs insect
cells rather than eggs. We believe we can more rapidly produce a safe, effective, low-cost vaccine
as compared with the labor-intensive egg-based process. Key advantages of the technology are the
ability to rapidly respond to emerging threats of new strains and a reduced risk of allergic
reactions associated with the egg-based process. A proof-of-concept study, conducted in
collaboration with the National Institutes of Health and Center for Disease Control, demonstrated
that a recombinant VLP vaccine against the H9N2 strain of avian influenza reduced disease morbidity
in mice against a live H9N2 virus challenge when compared with unvaccinated animals. This study is
the basis for the development of VLP vaccines against H5N1 strains of avian and human seasonal
influenza. In addition, Novavaxs vaccine was tested in three animal models, including the
ferret, which is the most predictive model for influenza vaccine effectiveness in humans. Ferrets
experience flu symptoms very similar to people who are infected with the virus. Protection, as
measured by a reduction in viral load, was assessed in vaccinated ferrets challenged with live H9N2
avian influenza. Like the H5N1 strain, the H9N2 strain initially spread among domestic poultry in
Asia. Since then, it has been isolated from humans and is identified as having pandemic potential.
Lastly, the Company is studying the applicability of its proprietary adjuvants in conjunction with
VLP vaccines to further enhance the immunogenicity of vaccines. Other projects in development using
our proprietary VLP technology include vaccines for seasonal influenza and HIV.
15.
We also are committed to creating value by leveraging our micellar
nanoparticle (MNP) drug delivery technology. ESTRASORB, our first internally developed product
using MNP technology, is the first topical emulsion for estrogen therapy approved by the FDA for
the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
ESTRASORB was licensed in October 2005 to Esprit Pharma, Inc. (Esprit) for marketing in North
America. In April 2006, we entered into agreements with Esprit to co-develop, supply and
commercialize our MNP testosterone product candidate for the treatment of female hypoactive sexual
desire disorder. We remain in discussions with several pharmaceutical companies to co-develop and
co-market or license additional products.
The products currently under development or in clinical trials by the Company 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 products may not receive
regulatory approval or be successfully introduced and marketed at prices that would permit us to
operate profitably. We also recognize that the commercial launch of any product is subject to
certain risks including, but not limited to, manufacturing scale-up, market acceptance and
competition. 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.
Significant Transactions in 2007 and 2006
License and Development Agreements and Supply Agreement with Esprit Pharma, Inc.
In April 2006, we entered into a License and Development Agreement and a Supply Agreement with
Esprit to co-develop, supply and commercialize our MNP testosterone product candidate for the
treatment of female hypoactive sexual desire disorder. Under the terms of the License and
Development Agreement, Esprit was granted exclusive rights to market the product in North America.
We will receive a royalty on all net sales of the product as well as milestone payments on specific
pre-determined clinical and regulatory milestones. Esprit will be responsible for all development
costs and will lead clinical programs. Under the terms of the Supply Agreement, we will be
responsible for manufacturing the product.
In October 2005, we entered into a License and Supply Agreement for ESTRASORB with Esprit.
Under the License Agreement, Esprit obtained exclusive rights to market ESTRASORB in North America
and we will continue to manufacture ESTRASORB. In consideration for the rights granted, Esprit
agreed to pay us a minimum cash consideration of $12.5 million: $2.0 million was paid at closing,
$8.0 million was paid in December 2005, and the remaining $2.5 million was paid on the first
anniversary date of the License Agreement in October 2006. We also received a royalty on all net
sales of ESTRASORB as well as milestone payments based on specific pre-determined net sales levels
of ESTRASORB. As of the year ended December 31, 2005, we wrote off $2.2 million, the remaining net
balance of our intangible asset for ESTRASORB rights at the date of the transaction. As part of
this transaction, Esprit also paid us $0.3 million for inventory and sales and promotional
materials for which we had a book value of $0.4 million. We incurred $20,000 of fees related to
this transaction and recorded a gain of $10.1 million.
New building lease and sublease Agreement with Puricore, Inc.
Consistent with our strategic focus, we have increased our presence in Rockville, Maryland by
entering into a new lease effective January 2007 for 51,000 square feet. The new office will house
our new Corporate office as well as additional laboratories for our vaccine business.
Accordingly, in October 2006, the Company entered into an amendment to the sublease agreement
with Puricore, Inc. (formerly known as Sterilox Technologies, Inc.) to sublease an additional 7,500
square feet of the Malvern, Pennsylvania corporate headquarters at a premium price per square foot.
This amendment has a commencement date of October 25, 2006 and expires on September 30, 2009. In
April 2006, we entered into a sublease agreement with Puricore, Inc. to sublease 20,469 square
feet of the Malvern, Pennsylvania corporate headquarters at a premium price per square foot. The
new sublease, with a commencement date of July 1, 2006, expires on September 30, 2009.
16.
Asset Purchase Agreement with Pharmelle, LLC
In September 2005, we entered into an Asset Purchase Agreement with Pharmelle, LLC for the
sale of assets related to AVC Cream and Suppositories, NovaNatal and NovaStart products, as well as
assets relating to formerly marketed products. The assets sold included, but were not limited to,
intellectual property, the New Drug Application for AVC products, inventory and sales and
promotional materials. In connection with the sale, Pharmelle agreed to assume (i) those
liabilities and obligations arising after the closing date of the transaction in connection with
the performance by Pharmelle of certain assumed contracts, (ii) those liabilities and obligations
arising after the closing date in connection with products sold by Pharmelle after the closing date
or the operation of the business relating to such products or the assets after such date (including
any product liability claims associated with such products), and (iii) all liability and
responsibility for returns of the products incurred after the closing date, regardless of when such
products were produced, manufactured or sold.
In consideration for the sale of these assets, Pharmelle paid us $2.5 million in cash and
assumed the liabilities noted above. In addition, we are entitled to royalties on AVC for a
five-year period if net sales exceed certain levels. During 2005, we wrote off $1.1 million, the
net balance of the intangible assets related to the AVC product acquisition and $0.3 million of
inventory, recorded a $0.3 million liability for future obligations and recorded a gain on the
transaction of $0.8 million.
In July 2006, we entered into an amendment to Asset Purchase Agreement with Pharmelle, LLC, to
revise the royalty formula. We are now entitled to royalties on AVC products for a five year period
based on a percentage of gross margins if net sales exceed certain levels.
Equity Financing Transactions
In March 2006, we completed an agent-led offering of 5,205,480 shares of common stock at $7.30
per share, for gross proceeds of $38.0 million. The stock was offered and sold pursuant to an
existing shelf registration statement. Net proceeds were approximately $36.1 million.
In February 2006, we completed an offering of 4,597,700 shares of common stock at $4.35 per
share for gross proceeds of $20.0 million. The stock was offered and sold pursuant to an existing
shelf registration statement. Net proceeds were approximately $19.9 million.
Convertible Notes Conversion
In March 2006, the holders of $7.0 million principal amount of our 4.75% senior convertible
notes due July 15, 2009 exercised their optional right to convert their notes plus accrued interest
of $68,000 into 1,294,564 shares of Novavax common stock, at the per share conversion price of
$5.46. This reduces the aggregate principal amount of such notes outstanding from $29.0 million to
$22.0 million.
Critical Accounting Policies and Changes to Accounting Policies
The preparation of 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.
Other than the adoption of Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48), there have been no material changes in our critical accounting policies or critical
accounting estimates since December 31, 2006, nor have we adopted any accounting policy that has or
will have a material impact on our consolidated financial statements. For further discussion of our
accounting policies see Note 2 Summary of Significant Accounting Policies, in the Notes to the
Consolidated Financial Statements included in this Quarterly Report on Form 10-Q and Note 2 in the
Notes to the Consolidated Financial Statements for our Annual Report on Form 10-K for the fiscal
year ended December 31, 2006.
17.
FIN 48
In July 2006, the FASB issued Interpretation No. 48, (FIN 48), Accounting for Uncertainty in
Income Taxes, to address the noncomparability in reporting tax assets and liabilities resulting
from a lack of specific guidance in SFAS No. 109, Accounting for Income Taxes, on the uncertainty
in income taxes recognized in an enterprises financial statements. Specifically, FIN 48
prescribes (a) a consistent recognition threshold and (b) a measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax
return, and provides related guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure, and transition. FIN 48 applies to fiscal years
beginning after December 15, 2006.
We adopted the provisions of FIN 48 on January 1, 2007. As a result of the adoption of FIN
48, we recorded $3.8 million in uncertain tax positions. The $3.8 million of unrecognized tax
benefits was accounted for as a $3.8 million reduction to the January 1, 2007 balance of deferred
tax assets and a corresponding $3.8 million dollar reduction of the valuation allowances.
Therefore, we did not record any adjustment to the beginning balance of retained earnings in our
condensed consolidated balance sheet. To the extent these unrecognized tax benefits are ultimately
recognized it would affect the annual effective income tax rate. We and its subsidiary file income
tax returns in the U.S. federal jurisdiction and in various states. We had tax net operating loss
and credit carryforwards that are subject to examination for a number of years beyond the year in
which they are utilized for tax purposes. Since a portion of these carryforwards will be utilized
in the future, many of these attribute carryforwards may remain subject to examination.
Our policy is to recognize interest and penalties related to income tax matters in income tax
expense. As of January 1 and March 31, 2007, we had no accruals for interest or penalties related
to income tax matters.
SFAS No. 157
In September 2006, the Financial Accounting Standards Board issued Statement of Financial
Accounting Standards No. 157, Fair Value Measurements (SFAS No. 157). SFAS No. 157 defines fair
value, establishes a framework for measuring fair value in generally accepted accounting principles
and expands disclosures about fair value measurements. SFAS No. 157 applies under other accounting
pronouncements that require or permit fair value measurements, but does not require any new fair
value measurements. SFAS No. 157 will become effective for financial statements issued for fiscal
years beginning after November 15, 2007, and interim periods within those fiscal years. We are
currently evaluating what impact, if any, SFAS No. 157 will have on our financial condition,
results or operations or liquidity.
SFAS No. 159
In February 2007, the FASB issued Statement of Financing Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities (FAS 159). This Statement
establishes a fair value option which permits entities to choose to measure many financial
instruments and certain other items at fair value at specified election dates. Any unrealized
gains and losses on items for which the fair value option has been elected will be reported in
earnings. FAS 159 is effective for our fiscal year beginning January 1, 2008. We do not currently
have any financial instruments for which we intend to elect the fair value option.
18.
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, 2006.
Three months ended March 31, 2007 (2007) compared to the three months ended March 31, 2006
(2006): (In thousands)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product lines sold in 2005 |
|
$ |
|
|
|
$ |
31 |
|
|
$ |
(31 |
) |
|
|
|
% |
Gynodiol and other products |
|
|
204 |
|
|
|
31 |
|
|
|
173 |
|
|
|
558 |
% |
ESTRASORB |
|
|
153 |
|
|
|
657 |
|
|
|
(504 |
) |
|
|
(77 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
357 |
|
|
|
719 |
|
|
|
(362 |
) |
|
|
(50 |
)% |
Contract research and development |
|
|
222 |
|
|
|
474 |
|
|
|
(252 |
) |
|
|
(53 |
)% |
Royalties, milestone and licensing fees |
|
|
89 |
|
|
|
110 |
|
|
|
(21 |
) |
|
|
(19 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
668 |
|
|
$ |
1,303 |
|
|
$ |
(635 |
) |
|
|
(49 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for the first quarter 2007 were $668,000 as compared to $1,303,000 in the
comparable period in 2006. The decrease in revenue from the comparable period in 2006 of $635,000
was principally, due to lower sales of Estrasorb of $504,000, lower contract revenue of $252,000,
partially offset by an increase of sales from Gynodiol. Contract research and development revenue
is comprised of revenue from government and commercial contracts. The Company recorded revenue
from a National Institutes of Health grant to develop a second generation AIDS vaccine of $222,000
for the three months ended March 31, 2007 compared to $340,000 for the three months ended March 31,
2006, a decrease of $118,000.
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Cost of products sold, (which includes idle capacity) |
|
$ |
1,317 |
|
|
$ |
1,233 |
|
|
$ |
84 |
|
|
|
7 |
% |
Excess inventory costs over market |
|
|
87 |
|
|
|
315 |
|
|
|
(228 |
) |
|
|
(72 |
)% |
Research and development |
|
|
3,659 |
|
|
|
2,032 |
|
|
|
1,627 |
|
|
|
82 |
% |
Selling, general and administrative |
|
|
4,597 |
|
|
|
2,758 |
|
|
|
1,839 |
|
|
|
67 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
9,660 |
|
|
$ |
6,338 |
|
|
$ |
3,322 |
|
|
|
52 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
19.
Cost of Products Sold and Idle Capacity
Cost of products sold, which includes fixed idle capacity costs at our manufacturing facility,
increased to $1.3 million for the three months ended March 31, 2007, compared to $1.2 million for
the three months ended March 31, 2006. Of the $1.3 million cost of products sold during the three
months ended March 31, 2007, $0.8 million was due to idle plant capacity costs at our manufacturing
facility, compared to $0.4 million for the three months ended March 31, 2006. Plant capacity costs
were negatively impacted by an increase in rent for the three months ended March 31, 2007 as well
as lower production of Estrasorb. The remaining cost of products sold in both 2007 and 2006
primarily represents the cost of ESTRASORB sales to Esprit and Gynodiol cost of products sold.
Excess Inventory Costs over Market
As part of the October 2005 License and Supply Agreement for ESTRASORB, we agreed to
manufacture and sell ESTRASORB to Esprit Pharma, Inc. at a price that is lower than our current
production costs for the inventory manufactured and sold. These excess costs over the fixed price
totaled $0.1 million for the three months ended March 31, 2007, as compared to $.3 million in the
first quarter of 2006.
It is likely we will continue to manufacture ESTRASORB at a loss until production volumes
increase or we enter into additional contract manufacturing agreements with third parties to more
fully utilize our manufacturing facilitys capacity. The facility is able to accommodate much
greater production than its current schedule, which, if more fully utilized, would offset the fixed
costs related to the manufacturing process and facility. In addition, we are negotiating revisions
to our agreements for packaging costs of ESTRASORB as well as our fixed lease costs for the
manufacturing facility. If these negotiations result in higher packaging or lease costs for us, it
may have a material adverse impact on future financial results.
Research and Development Expenses
Research and development costs increased from $2.0 million in 2006 to $3.6 million in 2007, an
increase of $1.6 million or 82%. This increase was due primarily to higher research and
development spending to support our strategic focus on creating differentiated, value-added
vaccines that leverage the Companys proprietary virus-like particle (VLP) technology. Research
and development expenses were significantly higher in 2007 due to increases in personnel, facility
and outside-testing costs (including sponsored research and consulting agreements) associated with
expanded preclinical testing and process development, manufacturing and quality-related programs
necessary to move the Companys influenza vaccine candidates into clinical testing.
Selling, General and Administrative Expenses
Selling, general and administrative costs were $4.6 million in 2007 compared to $2.8 million
in 2006. The increase of $1.8 million was principally due to an increase of the reserves for two
former board of directors notes receivable of $1.0 million in the first quarter of 2007. This
reserve represents the difference between the book value of the notes receivables less the market
value of the pledged shares of common stock of the Company as of March 31, 2007. In addition,
expenses increased in the first quarter of 2007 as a result of increased facility costs of
approximately $0.4 million for the Companys new facility in Rockville, Maryland which was leased
in the fourth quarter of 2006.
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
904 |
|
|
$ |
250 |
|
|
$ |
654 |
|
|
|
262 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(300 |
) |
|
|
(710 |
) |
|
|
410 |
|
|
|
(58 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
604 |
|
|
$ |
(460 |
) |
|
$ |
1,064 |
|
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income was $0.6 million for 2007 compared to net interest expense of
$0.5 million for 2006. The change in net interest income in the first quarter of 2007 as compared
to the comparable period ended March 31, 2006, was principally due to significantly higher
investment balances resulting from the equity financing which generated proceeds of $56.0 million
received late in the first quarter of 2006. Interest expense for the periods ended March 31, 2007
and 2006 primarily represents interest on outstanding convertible debt of $22.0 million.
20.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,388 |
) |
|
$ |
(5,495 |
) |
|
$ |
(2,893 |
) |
|
|
53 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(0.14 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.03 |
) |
|
|
(27 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding |
|
|
61,221,075 |
|
|
|
52,267,386 |
|
|
|
8,953,689 |
|
|
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the three months ended March 31, 2007 was $8.4 million or $(0.14) per
share, as compared to $5.5 million or $(0.11) per share for the three months ended 2006, an
increase in net losses of $2.9 million or $0.03 per share. The increase in net losses for the
period as compared to the quarter ended March 31, 2006, was principally due to increased research
spending related to vaccine development of $1.7 million and the expenses related to the reserve
recorded in the first quarter of 2007 for former board of directors receivables of $1.0 million.
Liquidity and Capital Resources
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 cost involved in obtaining regulatory approvals, the costs of filing,
prosecuting, defending and enforcing any patent claims and other intellectual property rights,
competing technological and market developments, and manufacturing costs related to ESTRASORB. The
Company plans to have multiple vaccines and products in various stages of development and we
believe our research and development as well as general administrative expenses and capital
requirements will continue to exceed our revenues. Future activities, particularly vaccine and
product developments, are subject to our ability to raise funds through debt or equity financing,
or collaborative arrangements with industry partners and government agencies.
Cash, cash equivalents and short term investments were $67.6 million at March 31, 2007, a
decrease of $6.0 million from the December 31, 2006 balance of $73.6 million. The decrease in cash
and cash equivalents for the first quarter of 2007 was primarily due to operating activities
incurred during the quarter. Working capital as of March 31, 2007 was $65.5 million as compared to
$72.0 of December 31, 2006. The decrease in working capital of $6.5 million was principally a
result of the operating loss incurred during the first quarter of 2007.
We intend to use our cash and cash equivalents on hand 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 product candidates, the development of new technologies,
capital improvement and general working capital. We will continue to pursue obtaining capital
through product licensing, co-development arrangements on new products, or the public or private
sale of securities of the Company. 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 the Company. Based on our assessment of the availability of capital and our
business operations as currently contemplated, in the absence of new financings, licensing
arrangements or partnership agreements, we believe we will have adequate capital resources to
sustain operations into 2008.
As of March 31, 2007, the Company had $22 million of senior convertible notes outstanding (the
Notes). The Notes carry a 4.75% coupon; are currently convertible into shares of Novavax common
stock at $5.46 per share; and mature on July 19, 2009. The Note holders have the right to redeem
all or a portion of the Notes if the weighted average price of the Companys common stock is less
than the ten applicable conversion price (currently $5.46 per share) of the Companys common stock
on each of 30 trading days out of the 40 consecutive trading days immediately prior to either the
third anniversary (July 19, 2007 or the further anniversary (July 19, 2008) of the issue date of
the Notes. If the Note holders exercise their optional redemption right, the Company may elect to
pay up to 50% of the outstanding Notes being redeemed in shares of Common Stock. The
redemption of the Companys senior convertible notes would have an adverse effect on the Companys
current cash position and its ability to fund its operations. Based on our assessment of the
availability of capital and our business operations as currently contemplated, in the absence of
new financings, any potential redemption of Notes, licensing arrangements or partnership
agreements, we believe we will have adequate capital resources into the second half of 2008.
If we are unable to obtain additional capital, we will continue to assess our capital
resources and we may be required to delay, reduce the scope of, or eliminate one or more of our
product research and development programs, downsize our organization, or reduce general and
administrative infrastructure.
21.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The primary objective of our investment activities is to preserve our capital until it is
required to fund operations while at the same time maximizing the income we receive from our
investments without significantly increasing risk. As of March 31, 2007, we had cash and cash
equivalents and short-term investments of $67.6 million as follows:
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Cash and cash equivalents
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$ |
7.8 |
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million |
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Short-term investments
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$ |
59.8 |
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million |
Our exposure to market risk is confined to our investment portfolio. We maintain an
investment portfolio of investment grade government agency notes and corporate bonds. The
securities in our investment portfolio are classified as held until maturity. While we do not
believe that an increase in market rates of interest would have any significant negative impact on
the realizable value of our investment portfolio, changes in interest rates affect the investment
income we earn on our investments and, therefore, impact our cash flow and results of operations.
We are headquartered in the U.S. where we conduct the vast majority of our business activities.
Accordingly, we have not had any material exposure to foreign currency rate fluctuations.
At March 31, 2007, the Company has a total debt of $22.9 million, most of which bears interest
at fixed interest rates. The Company therefore does not believe that it is exposed to any material
interest rate risk as a result of its borrowing activities.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
For the quarterly period ended March 31, 2007, we carried out an evaluation, under the
supervision and with the participation of the Companys management, including the Companys chief
executive officer and chief financial officer, of the effectiveness of the Companys disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the
Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period
covered by this quarterly report. Based on that review and evaluation, which included inquiries
made to certain other employees of the Company, the chief executive officer and chief financial
officer have concluded that as of March 31, 2007 the Companys current disclosure controls and
procedures, as designed and implemented, are effective.
Changes in Internal Control over Financial Reporting
There were no changes in the Companys internal control over financial reporting during the
quarter ended March 31, 2007 that have materially affected, or are reasonably likely to materially
affect the Companys internal control over financial reporting.
22.
PART II. OTHER INFORMATION
Item 1 Legal Proceedings
The Company is a defendant in a lawsuit filed in December 2003 by a former director alleging
that the Company wrongfully terminated the former directors stock options. In April 2006, a
directed verdict in favor of the Company was issued and the case was dismissed. The plaintiff has
filed an appeal with the court. Management believes the lawsuit is without merit and the likelihood
of an unfavorable outcome of such appeal is minimal. Accordingly, no liability related to this
contingency has been accrued in the consolidated financial statements as of March 31, 2007.
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, 2006, as filed with the
SEC, other than as mentioned below.
It is likely the Company will continue to manufacture ESTRASORB at a loss until production
volumes increase or it enters into additional contract manufacturing agreements with third parties
to more fully utilize its manufacturing facilitys capacity. The facility is able to accommodate
much greater production than its current schedule, which, if more fully utilized, would offset the
fixed costs related to the manufacturing process and facility. In addition, the Company is
negotiating revisions to its agreements for packaging costs of ESTRASORB as well as its fixed lease
costs for the manufacturing facility. If these negotiations result in higher packaging or lease
costs for us, it may have a material adverse impact on future financial results.
Item 6 Exhibits
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10.1 |
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Consulting Agreement dated April 27, 2007 and effective as of March
7, 2007 between the Company and John Lambert. |
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31.1 |
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Certification of Chief Executive Officer pursuant to Exchange Act
Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification of Interim Chief Financial Officer pursuant to Exchange
Act Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certification of Chief Executive Officer, pursuant to Exchange Act
Rule 13a-14(a) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the
United States Code, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002. * |
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32.2 |
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Certification of Interim Chief Financial Officer, pursuant to
Exchange Act Rule 13a-14(a) or Rule 15d-14(b) and Section 1350 of Chapter 63 of
Title 18 of the United States Code as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. * |
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* |
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This exhibit is not filed for purposes of Section 18 of the
Securities Exchange Act of 1934, and is not and should not be deemed to be
incorporated by reference into any filing under the Securities Act of 1933 or the
Securities Exchange Act of 1934. |
23.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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NOVAVAX, INC. |
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(Registrant) |
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Date: May 10, 2007
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By:
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/s/ Rahul Singhvi |
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Rahul Singhvi |
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President and Chief Executive Officer
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(Principal Executive Officer) |
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Date May 10, 2007
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By:
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/s/ Len Stigliano |
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Len Stigliano |
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Interim Chief Financial Officer |
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(Principal Financial Officer) |
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24.