e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 or 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For Quarterly Period Ended
March 31, 2006
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Commission File No.
0-26770 |
NOVAVAX, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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22-2816046 |
(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
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508 Lapp Road, Malvern, PA |
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19355 |
(Address of principal executive offices)
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(Zip code) |
(484) 913-1200
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
þ
Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
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
o Accelerated filer þ 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 12, 2006: 61,423,121
NOVAVAX, INC.
Form 10-Q
For the Quarter Ended March 31, 2006
Table of Contents
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Page No. |
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Part I. Financial Information |
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Item 1 |
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Financial Statements |
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Consolidated Balance Sheets as of March 31, 2006 (unaudited) and December 31, 2005 |
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1 |
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Consolidated Statements of Operations for the three months ended March 31, 2006 and 2005
(unaudited) |
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2 |
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Consolidated Statements of Cash Flows for the three months ended
March 31, 2006 and 2005 (unaudited) |
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3 |
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Notes to the
Consolidated Financial Statements (unaudited) |
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4 |
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Item 2 |
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Managements Discussion and Analysis of Financial
Condition and Results of Operations |
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17 |
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Item 3 |
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Quantitative and Qualitative Disclosures About Market Risk |
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27 |
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Item 4 |
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Controls and Procedures |
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27 |
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Part II. Other Information |
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Item 1 |
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Legal Proceedings |
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28 |
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Item 1A |
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Risk Factors |
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28 |
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Item 2 |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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28 |
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Item 3 |
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Defaults Upon Senior Securities |
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28 |
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Item 4 |
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Submission of Matters to a Vote of Security Holders |
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28 |
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Item 5 |
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Other Information |
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28 |
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Item 6 |
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Exhibits |
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28 |
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Signature |
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29 |
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Certifications |
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30 |
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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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2006 |
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2005 |
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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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$ |
83,941 |
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$ |
31,893 |
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Accounts and other receivables, net of allowance for
doubtful accounts of $288 and $429 as of March 31, 2006 and
December 31, 2005, respectively |
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3,601 |
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3,571 |
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Inventory |
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780 |
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800 |
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Prepaid expenses and other current assets |
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1,128 |
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1,347 |
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Total current assets |
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89,450 |
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37,611 |
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Property and equipment, net |
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11,103 |
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11,589 |
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Goodwill |
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33,141 |
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33,141 |
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Other intangible assets, net |
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1,077 |
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1,110 |
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Other non current assets |
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661 |
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931 |
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Total assets |
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$ |
135,432 |
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$ |
84,382 |
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LIABILITIES and STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
811 |
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$ |
1,426 |
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Accrued expenses |
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2,084 |
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2,597 |
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Current portion of notes payable |
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552 |
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715 |
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Facility exit costs |
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96 |
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138 |
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Total current liabilities |
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3,543 |
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4,876 |
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Convertible notes |
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22,000 |
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29,000 |
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Deferred rent |
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160 |
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176 |
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Non-current portion of notes payable |
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624 |
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678 |
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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, $.01 par value, 100,000,000 shares authorized;
61,670,988 shares issued and 61,423,121 outstanding at
March 31, 2006, and 50,259,494 issued and 50,005,646
outstanding at December 31, 2005 |
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617 |
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503 |
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Additional paid-in capital |
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259,713 |
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195,361 |
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Unearned compensation |
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(425 |
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Notes receivable from directors |
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(1,480 |
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(1,480 |
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Accumulated deficit |
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(147,389 |
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(141,894 |
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Treasury stock, 247,867 shares at March 31, 2006 and
253,848 shares at December 31, 2005, cost basis |
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(2,356 |
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(2,413 |
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Total stockholders equity |
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109,105 |
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49,652 |
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Total liabilities and stockholders equity |
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$ |
135,432 |
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$ |
84,382 |
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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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2006 |
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2005 |
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Revenues: |
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Net product sales |
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$ |
719 |
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$ |
719 |
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Contract research and development |
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474 |
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243 |
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Royalties, milestone and licensing fees |
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110 |
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Total revenues |
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1,303 |
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962 |
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Operating costs and expenses: |
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Cost of products sold |
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1,233 |
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1,979 |
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Excess inventory costs over market |
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315 |
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Research and development |
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2,032 |
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1,222 |
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Selling and marketing |
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38 |
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4,057 |
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General and administrative |
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2,720 |
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2,121 |
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Total operating costs and expenses |
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6,338 |
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9,379 |
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Loss from operations |
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(5,035 |
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(8,417 |
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Interest expense, net |
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(460 |
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(469 |
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Net loss |
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$ |
(5,495 |
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$ |
(8,886 |
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Basic and diluted loss per share |
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$ |
(0.11 |
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$ |
(0.22 |
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Basic and diluted weighted average number
of common shares outstanding |
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52,267,386 |
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39,553,876 |
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The accompanying notes are an integral part of these consolidated financial statements.
2
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Three months ended |
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March 31, |
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2006 |
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2005 |
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Operating Activities: |
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Net loss |
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$ |
(5,495 |
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$ |
(8,886 |
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Reconciliation of net loss to net cash used in
operating activities: |
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Amortization |
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33 |
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216 |
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Depreciation |
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713 |
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708 |
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Provision for bad debts |
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(141 |
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21 |
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Amortization of deferred financing costs |
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270 |
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103 |
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Deferred rent |
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(16 |
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Non-cash expense |
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25 |
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Non-cash stock compensation |
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1,034 |
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Changes in operating assets and liabilities: |
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Trade accounts receivable |
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111 |
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180 |
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Inventory |
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20 |
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1,092 |
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Prepaid expenses and other assets |
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219 |
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397 |
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Accounts payable and accrued expenses |
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(1,059 |
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(2,184 |
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Facility exit costs |
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(42 |
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(38 |
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Other non current assets |
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32 |
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Net cash used in operating activities |
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(4,328 |
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(8,359 |
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Investing Activities: |
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Capital expenditures |
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(227 |
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(8 |
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Net cash used in investing activities |
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(227 |
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(8 |
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Financing Activities: |
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Principal payments of notes payable |
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(217 |
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(307 |
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Net proceeds from sales of common stock |
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56,022 |
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Proceeds from the exercise of stock options |
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798 |
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Net cash provided/(used) in financing activities |
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56,603 |
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(307 |
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Net change in cash and cash equivalents |
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52,048 |
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(8,674 |
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Cash and cash equivalents at beginning of period |
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31,893 |
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17,876 |
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Cash and cash equivalents at end of period |
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$ |
83,941 |
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$ |
9,202 |
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Non-cash transactions: |
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Conversion of convertible debt and accrued
interest to common stock |
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$ |
7,068 |
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$ |
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The accompanying notes are an integral part of these consolidated financial statements.
3
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 pharmaceutical
and vaccine products and technologies. The companys platforms include the virus-like particle
(VLP) manufacturing technology for vaccines utilizing the baculovirus expression system in insect
cells, as well as novel vaccine adjuvants based on Novasomes® and dendrimers. The
Company is developing vaccines against the H5N1, H9N2 and other subtypes of avian influenza with
pandemic potential and human seasonal influenza viruses using its VLP and Novasomes. The Companys
drug delivery platforms include the micellar nanoparticle (MNP) technology which is the basis for
the development of its first Food and Drug Administration-approved product, ESTRASORB®.
In addition to MNP, the Companys drug delivery technologies include Novasomes (paucilamellar
non-phospholipid vesicles) and Sterisomes® (subcutaneous depot injection). The Company
has several products utilizing the MNP technology in various stages of development.
In October 2005, the Company entered into License and Supply Agreements for ESTRASORB. Under
the agreements, the Company will continue to manufacture ESTRASORB and the licensee, Esprit Pharma,
Inc., (Esprit), which was granted an exclusive license, will sell ESTRASORB in North America.
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 Company also recognizes that 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, 2006 and
2005 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,
2006.
4
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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. We suggest
that these consolidated financial statements 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, 2005.
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. 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.
Inventories
Inventories consist 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:
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March 31, 2006 |
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December 31, 2005 |
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(unaudited) |
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(amounts in thousands) |
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Raw materials |
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$ |
331 |
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$ |
358 |
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Work-in-process |
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189 |
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38 |
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Finished goods |
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260 |
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404 |
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$ |
780 |
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$ |
800 |
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5
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Inventories (continued):
During the year ended December 31, 2005, the Company implemented 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 allocated fixed production overheads to inventories based
on the anticipated normal capacity of the manufacturing facility at that time. Included in cost
of products sold for the three months ended March 31, 2006 is $400,000, or $(.01) per share, of
idle capacity costs which represents the excess of fixed production overhead over that allocated to
inventories.
During the three months ended March 31, 2006, $315,000 of inventory costs in excess of market
value was included in the accompanying consolidated statement of operations related to the Supply
Agreement with Esprit. Under the terms of this agreement the Company sells ESTRASORB at a price
which was below its manufacturing costs during the first quarter of 2006.
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 are to Esprit or to
distributors who resell the products to their 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 programs.
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 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 for changes in trends and competition.
6
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Revenue Recognition (continued):
Under the terms of an Asset Purchase Agreement with Pharmelle, LLC the Company no longer has
responsibility for rebates or returns related to AVC Cream and Suppositories, NovaNatal
and NovaStart. Under the License and Supply Agreements with Esprit, as of January 20, 2006, the
Company no longer has responsibility for rebates related to ESTRASORB and no longer has
responsibility for returns related to ESTRASORB sales made subsequent to October 19, 2005.
A roll-forward of the sales return allowances is as follows:
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(in |
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thousands) |
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(unaudited) |
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Balance, December 31, 2005 |
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$ |
282 |
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Provision for 2006 sales |
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7 |
|
Additional provision for 2004 sales |
|
|
34 |
|
Returns received from 2004 sales |
|
|
( 113 |
) |
|
|
|
|
Balance, March 31, 2006 |
|
$ |
210 |
|
|
|
|
|
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 current biological technologies research contracts was recognized per the
terms and conditions of such contracts for invoicing of costs incurred and defined milestones.
Revenue earned under a drug development contract was recognized on the percentage-of-completion
method, whereby revenue was recognized in proportion to the estimated cost-to-complete the
contract.
7
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Net Loss per Share
Basic loss per share is computed by dividing the net loss (the numerator) by the weighted
average number of common shares outstanding (the denominator) during the period. Shares issued
during the period and shares reacquired during the period are weighted for the portion of the
period that they were outstanding. The computation of diluted loss per share is similar to the
computation of basic loss per share except that the denominator is increased to include the number
of additional common shares that would have been outstanding if the dilutive potential common
shares had been issued (e.g. upon exercise of stock options). Potentially dilutive common shares
are not included in the computation of diluted earnings per share if they are anti-dilutive. Net
loss per share as reported was not adjusted for potential common shares, as they are anti-dilutive.
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 10 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 is comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, 2006 |
|
|
December 31, 2005 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
(amounts in thousands) |
|
Machinery and equipment |
|
$ |
11,449 |
|
|
$ |
11,275 |
|
Leasehold improvements |
|
|
6,248 |
|
|
|
6,201 |
|
Computer software and hardware |
|
|
326 |
|
|
|
320 |
|
|
|
|
|
|
|
|
|
|
|
18,023 |
|
|
|
17,796 |
|
Less accumulated depreciation |
|
|
(6,920 |
) |
|
|
(6,207 |
) |
|
|
|
|
|
|
|
|
|
$ |
11,103 |
|
|
$ |
11,589 |
|
|
|
|
|
|
|
|
8
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Accounting for Facility Exit Costs
In July 2004, the Company entered into a long-term agreement to lease a 32,900 square foot
facility in Malvern, Pennsylvania for the consolidation and expansion of 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. Standard annual escalation rental rates are in effect during
the initial lease term. With advance notice, the Company also has an option to lease adjoining
space of 17,000 square feet.
The Company applied the principles of SFAS No. 146, Accounting for Costs Associated with Exit
or Disposal Activities, in accounting for contract termination costs and associated costs that will
continue to be incurred under the operating lease expiring on October 31, 2006 related to the
Companys former corporate offices located in Columbia, Maryland.
A roll-forward of this liability is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non- |
|
|
Current |
|
Current |
|
|
(in thousands) |
Original amount expensed and recorded as a liability |
|
$ |
151 |
|
|
$ |
101 |
|
Lease payments applied to the liability |
|
|
(58 |
) |
|
|
(161 |
) |
Adjustment to original estimate |
|
|
45 |
|
|
|
60 |
|
|
|
|
Balance as of December 31, 2005 |
|
|
138 |
|
|
|
|
|
|
|
|
Lease payments applied to the liability |
|
|
(44 |
) |
|
|
|
|
Adjustment to original estimate |
|
|
2 |
|
|
|
|
|
|
|
|
Balance as of March 31, 2006 (unaudited) |
|
$ |
96 |
|
|
$ |
|
|
|
|
|
Goodwill and Other Intangible Assets
Goodwill originally results from business acquisitions. Assets acquired and
liabilities assumed are recorded at their fair values; the excess of the purchase price over the
identifiable net assets acquired is recorded as goodwill. Other intangible assets are a result of
product acquisitions, non-compete arrangements, and internally-discovered patents. In accordance
with SFAS No. 142, Goodwill and Other Intangible Assets (SFAS No. 142), goodwill and intangible
assets deemed to have indefinite lives are not amortized but are subject to impairment tests
annually, or more frequently should indicators of impairment arise. The Company utilizes a
discounted cash flow analysis that includes profitability information, estimated future operating
results, trends and other information in assessing whether the value of indefinite-lived intangible
assets can be recovered. Under SFAS No. 142, goodwill impairment is deemed to exist if the carrying
value of a reporting unit exceeds its estimated fair value.
9
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Goodwill and Other Intangible Assets (continued):
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 and $216,000 for the three
months ending March 31, 2006 and 2005, respectively.
As of March 31, 2006 and December 31, 2005, the Companys intangible assets and related
accumulated amortization consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2006 |
|
|
As of December 31, 2005 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
Goodwill, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill- Company
acquisition |
|
$ |
33,141 |
|
|
$ |
|
|
|
$ |
33,141 |
|
|
$ |
33,141 |
|
|
$ |
|
|
|
$ |
33,141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other intangible
assets, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents |
|
$ |
2,525 |
|
|
$ |
(1,448 |
) |
|
$ |
1,077 |
|
|
$ |
2,525 |
|
|
$ |
(1,415 |
) |
|
$ |
1,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-Based Compensation
The Company has various stock incentive and option plans which are described in Note 9 of the
Companys 2005 Annual Report on Form 10-K that provide for the grant of stock options 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 $826,000 for the three months ended March 31,
2006 and includes both compensation cost of stock options granted prior to but not yet vested as of
January 1, 2006 and compensation cost for all options granted subsequent to December 31, 2005. No
tax benefit was recorded as of March 31, 2006 in connection with this compensation cost due to the
uncertainty regarding ultimate realization of certain net operating loss carryforwards.
10
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued):
As of March 31, 2006, there were 5,956,561 stock options outstanding. At March 31, 2006, the
aggregate fair value of the remaining compensation cost of unvested options, as determined using a
Black-Scholes option valuation model was approximately $2,228,000 (net of estimated forfeitures).
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 forteitures), and 1,000 options were
forfeited.
Prior to adopting SFAS 123R on January 1, 2006, the Companys equity based employee
compensation cost under the various stock incentive and option plans was accounted for under the
recognition and measurement principles of APB Opinion No. 25, Accounting for Stock Issued to
Employees, and related interpretations, as permitted to by Standard of Financial Accounting
Standards No. 123 Accounting for Stock-Based Compensation
(SFAS No. 123). Under the modified
prospective method, results for prior periods have not been restated to reflect the effects of
implementing SFAS No. 123R. Therefore, for the three month period ended March 31, 2005, no option
based employee compensation cost is reflected in the net loss, because all options granted under
those plans had an exercise price equal to the underlying common stock price on the date of grant.
The following table which is presented for comparative purposes, provides the pro forma information
as required by SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, and
amendment of FASB Statement No. 123, and illustrates the effect on net loss and loss per common
share for the three month period ended March 31, 2005 presented as if the Company had applied the
fair value recognition provisions of SFAS No. 123, to stock based employee compensation prior to
January 1, 2006.
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2005 |
|
|
(unaudited) |
|
|
(Amounts in |
|
|
thousands, except |
|
|
per share data) |
Net loss, as reported |
|
$ |
(8,886 |
) |
Deduct: Total stock-based employee compensation expense
determined under fair value based method for all awards
(revised) |
|
|
(423 |
) |
Pro forma net loss (revised) |
|
$ |
(9,309 |
) |
|
|
|
|
|
Net loss per share: |
|
|
|
|
Basic and
diluted as reported |
|
$ |
(0.22 |
) |
Basic and
diluted pro forma (revised) |
|
$ |
(0.24 |
) |
11
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued):
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, 2006 and
2005 using the Black-Scholes options valuation model are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2006 |
|
2005 |
|
|
(unaudited) |
|
(unaudited) |
Weighted average fair value
of options granted |
|
$ |
3.43 |
|
|
$ |
1.18 |
|
Expected life (years): |
|
|
4.2 |
|
|
|
4.7 |
|
Expected volatility |
|
|
85 |
% |
|
|
64 |
% |
Risk-free interest rate |
|
|
4.28 4.55 |
% |
|
|
3.75 |
% |
Expected dividend |
|
|
0 |
% |
|
|
0 |
% |
Expected forfeiture rate |
|
|
20.37 |
% |
|
|
0 |
% |
The expected life of options granted was based on the Companys historical share option
exercise experience using the historical expected term from vest date. The expected volatility of
the options granted during the three month period ended March 31, 2006 is determined using
historical volatilities based on stock prices since the inception of the plans. The expected
volatility of the options granted during the three months ended March 31, 2005 is determined using
historical volatilities based on stock prices for the preceding twelve month period ended March 31,
2005. The risk-free interest rate is 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 Company has
never paid a dividend, and as such the dividend yield is zero.
Compensation cost for grants issued prior to January 1, 2006 was accounted for using a graded
method. Compensation cost for grants issued on or after January 1, 2006 was accounted for using a
straight line method.
12
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued):
Activity under the 2005 Plan, the 1995 Plan and the Director Plan was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1995 Director Stock |
|
|
|
2005 Stock Option Plan |
|
|
1995 Stock Option Plan |
|
|
Option Plan |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
|
|
Stock |
|
|
Exercise |
|
|
Stock |
|
|
Exercise |
|
|
Stock |
|
|
Exercise |
|
|
|
Options |
|
|
Price |
|
|
Options |
|
|
Price |
|
|
Options |
|
|
Price |
|
Balance, December 31, 2005 |
|
|
2,103,925 |
|
|
$ |
1.21 |
|
|
|
3,120,161 |
|
|
$ |
5.30 |
|
|
|
170,000 |
|
|
$ |
3.95 |
|
Granted |
|
|
751,500 |
|
|
|
4.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(100,000 |
) |
|
|
5.81 |
|
|
|
(58,750 |
) |
|
|
3.70 |
|
|
|
|
|
|
|
|
|
Expired or canceled |
|
|
(1,000 |
) |
|
|
4.60 |
|
|
|
(29,275 |
) |
|
|
5.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2006 |
|
|
2,754,425 |
|
|
$ |
2.00 |
|
|
|
3,032,136 |
|
|
$ |
5.33 |
|
|
|
170,000 |
|
|
$ |
3.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares exercisable at March 31, 2006 |
|
|
890,000 |
|
|
$ |
1.61 |
|
|
|
2,373,107 |
|
|
$ |
5.65 |
|
|
|
170,000 |
|
|
$ |
3.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available for grant at March 31, 2006 |
|
|
1,195,218 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table provides certain information with respect to stock options
outstanding and exercisable at March 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
Weighted |
|
|
Number of |
|
|
Average |
|
|
|
Options |
|
|
Remaining |
|
|
Average |
|
|
Options |
|
|
Exercise |
|
|
|
Outstanding |
|
|
Contractual Life |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Price |
|
Options issued at market value: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.00 - $1.17 |
|
|
710,000 |
|
|
|
9.3 |
|
|
$ |
0.87 |
|
|
|
185,000 |
|
|
$ |
1.03 |
|
$1.17 - $2.33 |
|
|
1,706,363 |
|
|
|
9.1 |
|
|
|
1.51 |
|
|
|
739,650 |
|
|
|
1.48 |
|
$2.33 - $3.50 |
|
|
276,450 |
|
|
|
4.2 |
|
|
|
3.30 |
|
|
|
276,450 |
|
|
|
3.30 |
|
$3.50 - $4.66 |
|
|
1,663,270 |
|
|
|
7.5 |
|
|
|
4.23 |
|
|
|
880,062 |
|
|
|
4.08 |
|
$4.66 - $5.83 |
|
|
254,000 |
|
|
|
3.9 |
|
|
|
5.45 |
|
|
|
227,500 |
|
|
|
5.47 |
|
$5.83 - $6.99 |
|
|
682,233 |
|
|
|
7.7 |
|
|
|
6.03 |
|
|
|
460,200 |
|
|
|
6.03 |
|
$6.99 - $8.16 |
|
|
233,334 |
|
|
|
1.8 |
|
|
|
7.43 |
|
|
|
233,334 |
|
|
|
7.43 |
|
$8.16 - $9.32 |
|
|
265,925 |
|
|
|
5.0 |
|
|
|
8.84 |
|
|
|
265,925 |
|
|
|
8.84 |
|
$9.32 - $10.49 |
|
|
129,986 |
|
|
|
5.3 |
|
|
|
9.53 |
|
|
|
129,986 |
|
|
|
9.53 |
|
$10.49- $11.65 |
|
|
35,000 |
|
|
|
4.6 |
|
|
|
10.98 |
|
|
|
35,000 |
|
|
|
10.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,956,561 |
|
|
|
7.5 |
|
|
$ |
3.75 |
|
|
|
3,433,107 |
|
|
$ |
4.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2005, the Company granted 552,434 shares of restricted Common Stock under the 2005
Stock Incentive Plan totaling $576,000 in value at the date of the grant to various employees,
officers and a board member of the Company, which vest over periods of up to three years.
13
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued):
During the three months ended March 31, 2006, the Company granted 155,000 shares of restricted
Common Stock under the 2005 Stock Incentive Plan totaling $871,000 in value at the date of grant to
officers, a director and a consultant of the Company, which vest upon the achievement of certain
milestones or over a period of up to three years.
Non-cash compensation expense related to all restricted stock issued has been recorded as
compensation cost in accordance with SFAS No. 123R using the straight-line method of amortization.
For the three 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. There was no corresponding expense for the three months ended March 31, 2005.
For restricted stock issued prior to January 1, 2006, non-cash compensation cost was recorded
using the straight-line method of amortization and an unearned compensation was increased
accordingly. The initial issuance of restricted stock increases common stock and additional
paid-in capital and is offset by unearned compensation, which is included the stockholders equity
section of the consolidated balance sheet. The balance as of December 31, 2005 for the unearned
compensation account was $425,000 and in accordance with SFAS No. 123R was netted against
additional paid-in capital as of January 1, 2006.
Sales and Issuance of Common and Treasury Stock
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 $19,963,000.
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 deduction 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 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 had a weighted
average cost of $9.51 per share and additional paid in capital was reduced by $32,000.
During the three months ended March 31, 2005, there were no sales or issuance of common stock.
14
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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.
Cash
interest payments for the three month periods ended March 31, 2006
and 2005 were 769,000 and $848,000, respectively.
Segment Information
The Company currently operates in one business segment, which is focused on new product
development by creating differentiated value-added pharmaceutical and vaccine products and
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.
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 accrue interest at 5.07% per annum and are secured by an aggregate of 261,667 shares of
common stock owned by the directors. The notes are payable upon the earlier to occur of the
following: (i) payable in full upon the date on which the director ceases for any reason to be a
director of the Company, (ii) payable in part to the extent of net proceeds, upon the date on which
the director sells all or any portion of the pledged shares or (iii) payable in full on March 21,
2007. As of March 31, 2006 and December 31, 2005, accrued interest receivable related to the
borrowings was $302,000 and $284,000, respectively.
In April 2004, the Company paid $54,000 to a current officer of the Company at the time of his
initial employment, at which time he was not an officer, as reimbursement of his education costs
that a previous employer had paid on his behalf. This cost is to be forgiven over a three year
period conditional on this officer remaining in employment with the Company and is included in
compensation cost over the three year period. As of March 31, 2006 and December 31, 2005, the
remaining cost that has not being expensed was $17,000 and $22,000, respectively, and is included
in other current assets on the consolidated balance sheets.
15
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Restructuring of the Sales Force
From March through August 2005, the Company implemented measures to reduce costs associated
with its commercial operations by downsizing and then eliminating its sales force to correspond
with the Companys strategy of transitioning from a commercial business model to that of one
focused on the Companys core competency of new product development. The March restructuring
reduced the Companys sales force from 100 to 47 employees, or 53% and the August restructuring
eliminated the remaining sales force personnel. Included in sales and marketing expenses in the
accompanying consolidated statement of operations for the three months ended March 31, 2005 is
$210,000 related to the first of these two restructurings. Included in this amount are (i)
one-time termination benefits of $158,000, (ii) auto lease contract termination costs of
approximately $40,000, and (iii) $12,000 of other associated costs, all of which were paid as of
December 31, 2005.
16
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;
unexpected changes in technologies and technological advances; ability to obtain rights to
technology; ability to obtain and enforce patents; ability to commercialize and manufacture
products; 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 sales and marketing of products serving the womens health space, to an innovative,
biopharmaceutical company leveraging our proprietary technologies in vaccines, adjuvants and drug
delivery. We are now focused on creating differentiated, value-added pharmaceutical and vaccine
products and technologies. The Companys platforms include the virus-like particle (VLP)
manufacturing technology for vaccines utilizing the baculovirus expression system in insect cells,
as well as novel vaccine adjuvants based on Novasomes® and dendrimers. The Company is
developing vaccines against the H5N1, H9N2 and other subtypes of avian influenza with human
pandemic potential and human seasonal influenza viruses using its VLP and Novasomes. The Companys
drug delivery platforms include the micellar nanoparticle (MNP) technology which is the basis for
the development of its first Food and Drug Administration-approved product, ESTRASORB®.
In addition to MNP, Novavax drug delivery technologies include Novasomes (paucilamellar
non-phospholipid vesicles) and Sterisomes® (subcutaneous depot injection). The Company
has several products utilizing the MNP technology in various stages of development.
17
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Currently, our main focus is to develop vaccines against influenza viruses with the potential
to cause a pandemic outbreak, using our VLP vaccine technology. 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 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
egg-based processes. A proof-of-concept study, conducted in collaboration with the NIH and CDC,
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, 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
HIV, SARS and seasonal influenza. We are also developing E-Selectin tolerogen for the prevention
of secondary strokes.
We will also continue to leverage our drug delivery technologies by developing and licensing
new products based on our MNP 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., for marketing in North America (see
Significant Transactions in 2005 and 2006 below). Following the successful development of
ESTRASORB, we have developed a pipeline of over ten product candidates using the MNP technology and
we remain active with several pharmaceutical companies to co-develop and co-market or license these
products.
Significant Transactions in 2005 and 2006
License and Supply Agreements with Esprit Pharma, Inc
In October 2005, we entered into License and Supply Agreements for ESTRASORB with Esprit
Pharma, Inc. 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 will pay us a minimum cash consideration
of $12.5 million: $2.0 million which was paid at closing, $8.0 million which was paid in December
2005, and the remaining $2.5 million will be paid on the first anniversary date of the License
Agreement, in October 2006. We will receive a royalty on all net sales of ESTRASORB as well as milestone payments
based on specific pre-determined net sales levels of ESTRASORB. We also 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 $.02
million of fees related to this transaction and recorded a gain of $10.1 million.
18
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 the AVC Cream and Suppositories, NovaNatal and NovaStart products, as
well as assets relating to certain formerly-marketed products Vitelle, Nestabs, Gerimed, Irospan
and Nessentials. 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 made 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. 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.
Equity Financing Transactions
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 $20.0 million.
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.
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.
19
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Restructuring of the Sales Force
From March through August 2005, we implemented measures to reduce costs associated with our
commercial operations by downsizing and then eliminating our sales force to correspond with our
strategy of transitioning from a commercial business model to that of one focused on our core
competency of new product development. The March 2005 restructuring reduced our sales force from
100 to 47 employees and the August restructuring eliminated the remaining sales force personnel.
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 Statement of Financial Accounting Standards No. 123 (revised)
Accounting for Stock-Based Compensation (SFAS No. 123R), there have been no material changes in
our critical accounting policies or critical accounting estimates since December 31, 2005, 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, 2005.
SFAS 123R
As of January 1, 2006 (effective date) we are applying the principles of SFAS No. 123R in
accounting for stock options issued to our employees, directors and consultants using the modified
prospective method. The modified prospective method requires that compensation costs be
recognized for all share-based payments granted after the effective date and for all awards granted
prior to the effective date that are unvested using the requirements of SFAS No. 123R. Prior to
the adoption of SFAS No. 123R, we accounted our stock-based compensation using the principles of
Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB No. 25)
as permitted to by Statement of Financial Accounting Standards No. 123 Accounting for Stock-Based
Compensation (SFAS No. 123). APB No. 25 generally did not require that options granted to
employees be expensed. Since we elected to use the modified prospective method, there are no
one-time effects from the adoption of SFAS No. 123R, such as a cumulative effect adjustment.
20
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
There were no modifications to outstanding stock options as of December 31, 2005. There have
been no changes in the quantity or type of instruments used in share-based payment programs. There
have been no material modifications to the valuation methodologies or assumptions from those used
in estimating the fair value of options under SFAS No. 123 other than the adjustments for expected
volatility. Prior to the adoption of SFAS No. 123R we utilized the preceding twelve month period
historical stock prices in determining the expected volatility. With the adoption of SFAS No, 123R
we used the historical volatilities based on stock prices since the inception of the stock plans in
determining the expected volatility. There have been no changes in the normal terms of share-based
payments agreements. For grants awarded prior to January 1, 2006, we accounted for compensation
cost using a grated method. For grants awarded on or after January 1, 2006, we accounted for
compensation cost using a straight-line method.
The effects of adopting SFAS No. 123R are recorded as compensation costs in the operating costs and
expenses as follows:
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, 2006 |
|
|
|
(unaudited and in thousands) |
|
|
|
|
|
Cost of products sold which includes idle
capacity |
|
$ |
16 |
|
Research and development |
|
|
238 |
|
General and administrative |
|
|
572 |
|
|
|
|
|
Total effect of adopting SFAS No. 123R |
|
$ |
826 |
|
|
|
|
|
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, 2005.
21
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Three months ended March 31, 2006 (2006) compared to the three months ended March 31, 2005
(2005): (In thousands)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product lines sold in 2005 |
|
$ |
31 |
|
|
$ |
317 |
|
|
$ |
(286 |
) |
|
|
-90 |
% |
Gynodiol and other products |
|
|
31 |
|
|
|
58 |
|
|
|
(27 |
) |
|
|
-47 |
% |
ESTRASORB |
|
|
657 |
|
|
|
344 |
|
|
|
313 |
|
|
|
91 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
719 |
|
|
|
719 |
|
|
|
|
|
|
|
|
% |
Contract research and
development |
|
|
474 |
|
|
|
243 |
|
|
|
231 |
|
|
|
95 |
% |
Royalties, milestone and
licensing fees |
|
|
110 |
|
|
|
|
|
|
|
110 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,303 |
|
|
$ |
962 |
|
|
$ |
341 |
|
|
|
35 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for 2006 consisted of product sales of $0.7 million, compared to $0.7 million in
2005; contract revenues of $0.5 million in 2006, compared to $0.2 million in 2005; and royalties,
milestone and licensing fees of $0.1 million in 2006, compared to zero in 2005. Total net revenues
for the three months ended March 31, 2006 were $1.3 million, as compared to $1.0 million for 2005,
an increase of $0.3 million or 35%. We divested our direct sales of prenatal vitamins and AVC
Cream in 2005. Product sales for 2006 consist primarily of ESTRASORB sales to Esprit at an agreed
upon price. The other product that we currently sell is Gynodiol, which was on back order for most
of the first quarter of 2006.
Contract research and development revenue for 2006 consists of $0.3 million from an National
Institutes of Health grant to develop a second generation AIDS vaccine compared to $0.2 million
received in 2005 from the same NIH grant. In addition, $0.1 million of revenue was also recognized
in 2006 for a commercial manufacturing contract.
Royalties, milestone and licensing fees for 2006 consist of $0.1 million for royalties from
the Licensing Agreement with Esprit for ESTRASORB.
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Cost of products sold
which includes idle
capacity |
|
$ |
1,233 |
|
|
$ |
1,979 |
|
|
$ |
(746 |
) |
|
|
-38 |
% |
Excess inventory costs
over market |
|
|
315 |
|
|
|
|
|
|
|
315 |
|
|
|
100 |
% |
Research and development |
|
|
2,032 |
|
|
|
1,222 |
|
|
|
810 |
|
|
|
66 |
% |
Selling and marketing |
|
|
38 |
|
|
|
4,057 |
|
|
|
(4,019 |
) |
|
|
-99 |
% |
General and administrative |
|
|
2,720 |
|
|
|
2,121 |
|
|
|
599 |
|
|
|
28 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,338 |
|
|
$ |
9,379 |
|
|
$ |
(3,041 |
) |
|
|
-32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
22
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Cost of Products Sold and Idle Capacity
Cost of products sold, which includes fixed idle capacity costs at our manufacturing facility,
decreased to $1.2 million in 2006, compared to $2.0 million in 2005. Of the $1.2 million cost of
products sold for 2006, $0.4 million was due to idle plant capacity costs at our manufacturing
facility. The remaining $0.8 million primarily represent the cost of ESTRASORB sales to Esprit. Of
the $2.0 million cost of products sold for 2005, $1.5 million was due to idle plant capacity costs
at our manufacturing facility. Idle capacity costs for 2005 were $1.1 million higher than in 2006,
partially due to the accounting of excess inventory costs over market in 2006, which is further
discuss below.
Excess Inventory Costs over Market
As part of the Esprit Transaction (see Significant Transactions) we agreed to sell ESTRASORB
at a price that was lower than our current manufacturing costs for the inventory manufactured and
sold. These costs totaled $0.3 million for the first quarter of 2006. We anticipated these excess
costs will decrease in the future as our manufacturing facility becomes more fully
utilized in the manufacturing of
ESTRASORB as well as fulfilling other anticipated contracts.
Research and Development Expenses
Research and development costs increased from $1.2 million in 2005 to $2.0 million in 2006, or
66%. The increase of $0.8 million was primarily due to an increase in research and development
spending to support the development of flu vaccines.
Selling and Marketing Expenses
Selling and marketing costs were $38 thousand in 2006 compared to $4.1 million in 2005. The
decrease of $4.0 million, or 99%, was due to our strategy of transitioning from a commercial
business model to that of one focused on our core competency of new product development. With the
sale of our vitamin and AVC lines to Pharmelle and the licensing of ESTRASORB in North America to
Esprit, our ongoing selling expenses consist primarily of costs related to the selling of Gynodiol.
General and Administrative Expenses
General and administrative costs were $2.7 million in 2006 compared to $2.1 million in 2005.
The increase of $0.6 million is primarily due to non-cash compensation costs resulting from the
implementation of SFAS 123R in 2006, using the modified prospective method, while no costs were
recorded in 2005 utilizing the accounting recognition methods under APB No. 25.
23
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Interest expense, net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
250 |
|
|
$ |
62 |
|
|
$ |
188 |
|
|
|
303 |
% |
Interest expense |
|
|
(710 |
) |
|
|
(531 |
) |
|
|
(179 |
) |
|
|
-34 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(460 |
) |
|
$ |
(469 |
) |
|
$ |
9 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest expense was $0.5 million for 2006 compared to $0.5 million for 2005.
Interest income increased from $0.1 million in 2005 to $0.3 million in 2006, primarily due to the
increase in cash balance from 2005 to 2006. The Equity Financing Transactions during the fourth
quarter of 2005 and the first quarter of 2006 accounted for the increase in cash. Partially
offsetting the increase in interest income is the increase in interest expense from $0.5 million in
2005 to $0.7 million in 2006, or $0.2 million. This increase is due to the write off $0.3 million
of deferred financing costs in March 2006 relating to the conversion of $7.0 million of our 4.75%
senior convertible notes.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,495 |
) |
|
$ |
(8,886 |
) |
|
$ |
(3,391 |
) |
|
|
-38 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(.11 |
) |
|
$ |
(.22 |
) |
|
$ |
(.11 |
) |
|
|
-50 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding |
|
|
52,267,386 |
|
|
|
39,553,876 |
|
|
|
12,713,510 |
|
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for 2006 was $5.5 million or $(.11) per share, as compared to $8.9 million or
$(.22) per share for 2005, a decrease of $3.4 million, or $.11 per share. The decrease is
primarily due to the increase in revenues of $0.3 million and the decrease in other operating
expenses of $3.0 million, all previously discussed. The weighted shares outstanding increased from
39,553,876 in 2005 to 52,267,386 in 2006 due to the Equity Financing Transactions in the second
half to 2005 and the first quarter of 2006 and the conversion of $13.0 million of notes to equity.
In addition stock options were exercised during the fourth quarter of 2005 and the first quarter of
2006.
24
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Liquidity and Capital Resources
Our capital requirements depend on numerous factors, including but not limited to the
commitments and progress of our research and development programs, the progress of preclinical and
clinical testing, the time and costs involved in obtaining regulatory approvals, the costs of
filing, prosecuting, defending and enforcing any patent claims and other intellectual property
rights, competing technological and market developments, and manufacturing costs related to
ESTRASORB. We plan to have multiple products and vaccines in various stages of product 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 product
development, are subject to our ability to raise funds through debt or equity financing, or
collaborative arrangements with industry partners.
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|
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Three months |
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|
ending |
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|
March 31, 2006 |
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(in thousands) |
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|
(unaudited) |
|
Summary of Cash Flows: |
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|
Net cash provided/(used) in: |
|
|
|
|
Operating activities |
|
$ |
(4,328 |
) |
Investing activities |
|
|
(227 |
) |
Financing activities |
|
|
56,603 |
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
52,048 |
|
Beginning cash and cash equivalents |
|
|
31,893 |
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|
|
|
|
Ending cash and cash equivalents |
|
$ |
83,941 |
|
|
|
|
|
25
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Cash and cash equivalents were $83.9 million at March 31, 2006, an increase of $52.0 million
from the December 31, 2005 balance of $31.9 million. Of the $52.0 million of cash provided in the
first three months of 2006, $4.3 million was used for operating activities and $0.2 million for
investing activities and $56.6 million was obtained from financing activities. Operating
activities consisted of the net loss of $5.5 million, as previously discussed, non-cash activities
of $1.7 million, offset by $(0.8) million of net changes in balance sheet accounts. Working capital
was $85.9 million at March 31, 2006 compared to $32.7 million at December 31, 2005. The increase
in working capital of $53.2 million was primarily due to the $56.0 million obtained from the net
proceeds from the two Equity Financing Transactions as well as the exercising of stock options,
offset by $4.3 million in operating activities.
We intend to use the proceeds from the Equity Financing Transactions for general corporate
purposes, including but not limited to our internal research and development programs, such as
preclinical and clinical testing and studies for our product candidates and 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. We have demonstrated our ability to obtain
capital, as required; however, 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 into 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.
26
Item 3. Quantitative and Qualitative Disclosures about Market Risk
There have been no material changes during the period from the end of our last fiscal year
through March 31, 2006 to the information concerning the Companys quantitative and qualitative
disclosures about market risk set forth in Item 7A of our Annual Report on Form 10-K for the fiscal
year ended December 31, 2005 as filed with the SEC.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Companys chief executive officer and chief financial officer have reviewed and evaluated
the effectiveness of the Companys disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) 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 the Companys current disclosure
controls and procedures, as designed and implemented, are reasonably adequate to ensure that such
officers are provided in a timely manner with material information relating to the Company required
to be disclosed in the reports the Company files or submits under the Exchange Act.
Managements Report on Internal Control over Financial Reporting
The Companys management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and
15d-15(f). Under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, the Company conducted an evaluation of the
effectiveness of our internal control over financial reporting as of March 31, 2006 based on the
framework in Internal Control Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). Based on that evaluation, our management
concluded that our internal control over financial reporting was effective as of March 31, 2006.
Changes in Internal Control over Financial Reporting
During the three month period ended March 31, 2006, the Company took the necessary actions to
comply with all criteria established in Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). There were no
changes in our internal control over financial reporting that materially affected, or is
reasonably likely to materially affect, our internal control over financial reporting.
27
Part II. Other Information
Item 1 Legal Proceedings
The Company was a defendant in a lawsuit filed by a former director alleging that the Company
wrongfully terminated the former directors stock options. In April 2006, the judge issued a
directed verdict in favor of Novavax and the case was dismissed. Management believes the
likelihood of an unfavorable outcome in the future is minimal. Accordingly, no liability related
to this contingency is accrued in the consolidated balance sheet as of March 31, 2006.
Item 1A. Risk Factors
There are no material changes to the Companys risk factors as described in Item 1A of the
Companys Form 10-K for the fiscal year ending December 31, 2005.
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
Item 3 Defaults Upon Senior Securities
Not applicable.
Item 4 Submission of Matters to a Vote of Security Holders
Not applicable
Item 5 Other Information
Not applicable.
Item 6 Exhibits
|
31.1 |
|
Certification of principal executive officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
31.2 |
|
Certification of principal financial officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
32.1 |
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 by Rahul Singhvi,
President and Chief Executive Officer of the Company. |
|
|
32.2 |
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 by Dennis W. Genge,
Vice President and Chief Financial Officer of the Company. |
28
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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NOVAVAX, INC.
(Registrant) |
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Date: May 15, 2006 |
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By:
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/s/ Dennis W. Genge |
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Dennis W. Genge |
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Vice President and Chief Financial Officer |
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(Principal Financial and Accounting Officer)
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29