e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT UNDER SECTION 13 or 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
For Quarterly Period Ended June 30, 2006
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
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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508 Lapp Road, Malvern, PA
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19355 |
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(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 August 9, 2006: 61,528,693
NOVAVAX, INC.
Form 10-Q
For the Quarter Ended June 30, 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 June 30, 2006 (unaudited) and December 31, 2005 |
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1 |
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Consolidated Statements of Operations for the three-month and six-month periods ended June 30, 2006 and 2005 (unaudited) |
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2 |
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Consolidated Statements of Stockholders Equity for the three month periods ended March 31, 2006 and June 30, 2006 (unaudited) |
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3 |
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Consolidated Statements of Cash
Flows for the six months ended June 30, 2006 and 2005 (unaudited) |
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4 |
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Notes to the Consolidated Financial Statements (unaudited) |
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5 |
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Item 2 |
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Managements Discussion and
Analysis of Financial Condition and Results of Operations |
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19 |
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Item 3 |
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Quantitative and Qualitative Disclosures About Market Risk |
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34 |
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Item 4 |
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Controls and Procedures |
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34 |
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Part II. Other Information |
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Item 1 |
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Legal Proceedings |
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35 |
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Item 1A |
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Risk Factors |
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35 |
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Item 2 |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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35 |
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Item 3 |
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Defaults Upon Senior Securities |
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35 |
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Item 4 |
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Submission of Matters to a Vote of Security Holders |
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35 |
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Item 5 |
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Other Information |
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36 |
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Item 6 |
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Exhibits |
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36 |
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Signatures |
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37 |
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i
Part I. Financial Information
Item 1. Financial Statements
NOVAVAX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
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June 30, |
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December 31, |
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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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$ |
78,601 |
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$ |
31,893 |
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Accounts and other receivables, net of allowance for
doubtful accounts of $325 and $429 as of June 30, 2006 and
December 31, 2005, respectively |
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3,825 |
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3,571 |
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Inventory |
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757 |
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800 |
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Prepaid expenses and other current assets |
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1,306 |
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1,347 |
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Total current assets |
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84,489 |
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37,611 |
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Property and equipment, net |
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10,761 |
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11,589 |
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Goodwill |
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33,141 |
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33,141 |
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Other intangible assets, net |
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1,044 |
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1,110 |
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Other non-current assets |
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1,141 |
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931 |
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Total assets |
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$ |
130,576 |
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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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$ |
780 |
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$ |
1,426 |
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Accrued expenses |
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2,813 |
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2,597 |
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Current portion of notes payable |
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386 |
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715 |
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Facility exit costs |
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54 |
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138 |
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Total current liabilities |
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4,033 |
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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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144 |
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176 |
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Non-current portion of notes payable |
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569 |
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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, $.01 par value, 100,000,000 shares authorized;
61,784,738 shares issued and 61,536,871 outstanding at
June 30, 2006, and 50,259,494 issued and 50,005,646
outstanding at December 31, 2005 |
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618 |
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503 |
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Additional paid-in capital |
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260,400 |
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195,361 |
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Unearned compensation |
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(425 |
) |
Notes receivable from directors |
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(1,032 |
) |
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(1,480 |
) |
Accumulated deficit |
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(153,800 |
) |
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(141,894 |
) |
Treasury stock, 247,867 shares at June 30, 2006 and 253,848
shares at December 31, 2005, cost basis |
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(2,356 |
) |
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(2,413 |
) |
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Total stockholders equity |
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103,830 |
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49,652 |
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Total liabilities and stockholders equity |
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$ |
130,576 |
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$ |
84,382 |
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The accompanying notes are an integral part of these consolidated financial statements.
i
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
(unaudited)
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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2006 |
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2005 |
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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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$ |
378 |
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$ |
1,889 |
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$ |
1,097 |
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$ |
2,608 |
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Contract research and development |
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403 |
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426 |
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877 |
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669 |
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Royalties, milestone and licensing fees |
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58 |
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168 |
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Total revenues |
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839 |
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2,315 |
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2,142 |
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3,277 |
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Operating costs and expenses: |
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Cost of products sold |
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1,161 |
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2,027 |
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2,394 |
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4,006 |
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Excess inventory costs over market |
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677 |
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992 |
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Research and development |
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3,401 |
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1,377 |
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5,433 |
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2,599 |
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Selling and marketing |
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28 |
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1,844 |
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66 |
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5,901 |
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General and administrative |
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2,610 |
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2,292 |
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5,330 |
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4,413 |
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Total operating costs and expenses |
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7,877 |
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7,540 |
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14,215 |
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16,919 |
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Loss from operations |
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(7,038 |
) |
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(5,225 |
) |
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(12,073 |
) |
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(13,642 |
) |
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Interest income / (expense), net |
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627 |
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(491 |
) |
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167 |
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(960 |
) |
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Net loss |
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$ |
(6,411 |
) |
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$ |
(5,716 |
) |
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$ |
(11,906 |
) |
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$ |
(14,602 |
) |
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Basic and diluted loss per share |
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$ |
(.10 |
) |
|
$ |
(.14 |
) |
|
$ |
(.21 |
) |
|
$ |
(.37 |
) |
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Basic and diluted weighted average
number of common shares outstanding |
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61,465,003 |
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39,553,876 |
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56,891,602 |
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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 STOCKHOLDERS EQUITY
For the Three Months Ended March 31, 2006 and June 30, 2006
(in thousands, except share information)
(unaudited)
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Additional |
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Notes |
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Total |
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Common Stock |
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Paid-in |
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Unearned |
|
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Receivable |
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Accumulated |
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Treasury |
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Stockholders |
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Shares |
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Amount |
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Capital |
|
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Compensation |
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From Directors |
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Deficit |
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Stock |
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Equity |
|
Balance, December 31, 2005 |
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|
50,259,494 |
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|
$ |
503 |
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|
$ |
195,361 |
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|
$ |
(425 |
) |
|
$ |
(1,480 |
) |
|
$ |
(141,894 |
) |
|
$ |
(2,413 |
) |
|
$ |
49,652 |
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Netted unearned compensation against additional paid
in capital in accordance with SFAS No. 123R |
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|
(425 |
) |
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|
425 |
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|
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Non-cash compensation costs for stock options |
|
|
|
|
|
|
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|
825 |
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
825 |
|
Exercise of stock options |
|
|
158,750 |
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|
1 |
|
|
|
797 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
798 |
|
Conversion of convertible debt |
|
|
1,294,564 |
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|
13 |
|
|
|
7,055 |
|
|
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
7,068 |
|
Restricted stock issued as compensation |
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|
155,000 |
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2 |
|
|
|
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|
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|
2 |
|
Non-cash compensation cost for amortization of
restricted stock |
|
|
|
|
|
|
|
|
|
|
208 |
|
|
|
|
|
|
|
|
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|
|
|
|
|
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|
208 |
|
Treasury stock issued in lieu of payment of services
rendered |
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|
|
|
|
|
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|
(32 |
) |
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|
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|
|
|
|
|
|
|
|
|
|
57 |
|
|
|
25 |
|
Sales of common stock |
|
|
9,803,180 |
|
|
|
98 |
|
|
|
57,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,000 |
|
Financing
costs incurred to raise additional capital |
|
|
|
|
|
|
|
|
|
|
(1,978 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,978 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,495 |
) |
|
|
|
|
|
|
(5,495 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2006 |
|
|
61,670,988 |
|
|
$ |
617 |
|
|
$ |
259,713 |
|
|
|
|
|
|
$ |
(1,480 |
) |
|
$ |
(147,389 |
) |
|
$ |
(2,356 |
) |
|
$ |
109,105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash compensation costs for stock options |
|
|
|
|
|
|
|
|
|
|
420 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
420 |
|
Non-cash compensation cost for amortization of
restricted stock |
|
|
|
|
|
|
|
|
|
|
129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
129 |
|
Restricted stock issued as compensation |
|
|
60,000 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
Exercise of stock options |
|
|
53,750 |
|
|
|
|
|
|
|
179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
179 |
|
Financing
costs incurred to raise additional capital |
|
|
|
|
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(41 |
) |
Reclassification
due to change in status of a director |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
448 |
|
|
|
|
|
|
|
|
|
|
|
448 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,411 |
) |
|
|
|
|
|
|
(6,411 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2006 |
|
|
61,784,738 |
|
|
$ |
618 |
|
|
$ |
260,400 |
|
|
$ |
|
|
|
$ |
(1,032 |
) |
|
$ |
(153,800 |
) |
|
$ |
(2,356 |
) |
|
$ |
103,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
3
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six months ended |
|
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
Operating Activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(11,906 |
) |
|
$ |
(14,602 |
) |
Reconciliation of net loss to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
Amortization |
|
|
66 |
|
|
|
431 |
|
Depreciation |
|
|
1,437 |
|
|
|
1,426 |
|
Provision for bad debts |
|
|
(104 |
) |
|
|
12 |
|
Retirement of capital assets |
|
|
46 |
|
|
|
42 |
|
Amortization of deferred financing costs |
|
|
417 |
|
|
|
206 |
|
Deferred rent |
|
|
(32 |
) |
|
|
(1 |
) |
Non-cash
expense for services |
|
|
25 |
|
|
|
|
|
Non-cash stock compensation |
|
|
1,585 |
|
|
|
15 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Trade accounts receivable |
|
|
(150 |
) |
|
|
(318 |
) |
Inventory |
|
|
43 |
|
|
|
2,063 |
|
Prepaid expenses and other assets |
|
|
(41 |
) |
|
|
440 |
|
Accounts payable and accrued expenses |
|
|
(362 |
) |
|
|
(2405 |
) |
Facility exit costs |
|
|
(84 |
) |
|
|
(85 |
) |
Other non-current assets |
|
|
(97 |
) |
|
|
38 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(9,157 |
) |
|
|
(12,738 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities: |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(655 |
) |
|
|
(80 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(655 |
) |
|
|
(80 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
Principal payments of notes payable |
|
|
(438 |
) |
|
|
(616 |
) |
Net proceeds from sales of common stock |
|
|
55,981 |
|
|
|
|
|
Proceeds from the exercise of stock options |
|
|
977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by/(used in) financing activities |
|
|
56,520 |
|
|
|
(616 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
46,708 |
|
|
|
(13,434 |
) |
Cash and cash equivalents at beginning of period |
|
|
31,893 |
|
|
|
17,876 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
78,601 |
|
|
$ |
4,442 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash transactions: |
|
|
|
|
|
|
|
|
Conversion of convertible debt and accrued interest to
common stock |
|
$ |
7,068 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Interest Payments: |
|
|
|
|
|
|
|
|
Cash interest payments |
|
$ |
778 |
|
|
$ |
862 |
|
|
|
|
|
|
|
|
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 utilizing the baculovirus
expression system in insect cells, as well as developing novel vaccine adjuvants based on
Novasomes®. The Company is developing vaccines against the H5N1, H9N2 and other
subtypes of avian influenza with pandemic potential and against human seasonal influenza as well as
other viral diseases. The Company also has developed a drug delivery platform using micellar
nanoparticle (MNP) technology, which was the basis for the development of its first Food and Drug
Administration-approved product, ESTRASORB®. 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 to sell ESTRASORB in North America.
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
medicine for the treatment of female hypoactive sexual desire disorder. Esprit was granted
exclusive rights to market the product 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.
5
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The consolidated financial statements of Novavax for the three months and six months ended
June 30, 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.
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.
6
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 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.
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 had responsibility for rebates related to ESTRASORB or for returns related to
ESTRASORB sales made subsequent to October 19, 2005.
A roll-forward of the sales return allowances is as follows:
|
|
|
|
|
|
|
(in thousands) |
|
|
|
(unaudited) |
|
Balance, December 31, 2005 |
|
$ |
282 |
|
Provision for 2006 sales |
|
|
7 |
|
Additional provision for 2004 sales |
|
|
34 |
|
Returns received from 2004 sales |
|
|
(113 |
) |
|
|
|
|
Balance, March 31, 2006 |
|
$ |
210 |
|
Provision for 2006 sales |
|
|
6 |
|
Additional provision for 2004 sales |
|
|
105 |
|
Additional provision for 2005 sales |
|
|
93 |
|
Returns received from 2004 sales |
|
|
(77 |
) |
|
|
|
|
Balance, June 30, 2006 |
|
$ |
337 |
|
|
|
|
|
7
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 per 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.
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:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 |
|
|
December 31, 2005 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
(amounts in thousands) |
|
Raw materials |
|
$ |
232 |
|
|
$ |
358 |
|
Work-in-process |
|
|
|
|
|
|
38 |
|
Finished goods |
|
|
525 |
|
|
|
404 |
|
|
|
|
|
|
|
|
|
|
$ |
757 |
|
|
$ |
800 |
|
|
|
|
|
|
|
|
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 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 and six months ended June 30, 2006 is $728,000, or
$(.01) per share, and $1,128,000, or $(.02) per share, respectively, of idle capacity costs, which
amounts represent the excess of fixed production overhead costs over that allocated to inventories.
During the three months and six months ended June 30, 2006, $677,000 and $992,000,
respectively, of inventory costs in excess of market value were included in the accompanying
consolidated statement of operations related to the Supply Agreement with Esprit. Under the terms
of this agreement, the Company sold ESTRASORB at a price
which was below its manufacturing costs for the product during the first half of 2006.
8
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Inventories (continued):
It is most 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 to the Company, it may have a material adverse impact on future financial results.
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 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.
9
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Property and Equipment (continued):
Property and equipment is comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 30, 2006 |
|
|
December 31,2005 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
(amounts in thousands) |
|
Machinery and equipment |
|
$ |
11,765 |
|
|
$ |
11,275 |
|
Leasehold improvements |
|
|
6,248 |
|
|
|
6,201 |
|
Computer software and hardware |
|
|
344 |
|
|
|
320 |
|
|
|
|
|
|
|
|
|
|
|
18,357 |
|
|
|
17,796 |
|
Less accumulated depreciation |
|
|
(7,596 |
) |
|
|
(6,207 |
) |
|
|
|
|
|
|
|
|
|
$ |
10,761 |
|
|
$ |
11,589 |
|
|
|
|
|
|
|
|
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. In April 2006, the Company entered into a sublease agreement with Sterilox
Technologies, 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, expires
on September 30, 2009.
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.
10
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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 |
|
|
(86 |
) |
|
|
|
|
Adjustment to original estimate |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2006 (unaudited) |
|
$ |
54 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Goodwill and Other Intangible Assets
Goodwill originally resulted from business acquisitions. Assets acquired and
liabilities assumed were recorded at their fair values; the excess of the purchase price over the
identifiable net assets acquired was recorded as goodwill. Other intangible assets are a result of
product acquisitions, non-compete arrangements, and internally-discovered patents. In accordance
with SFAS No. 142, Goodwill and Other Intangible Assets (SFAS No. 142), goodwill and intangible
assets deemed to have indefinite lives are not amortized but are subject to impairment tests
annually, or more frequently should indicators of impairment arise. The Company utilizes a
discounted cash flow analysis that includes profitability information, estimated future operating
results, trends and other information in assessing whether the value of indefinite-lived intangible
assets can be recovered. Under SFAS No. 142, goodwill impairment is deemed to exist if the carrying
value of a reporting unit exceeds its estimated fair value.
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 $215,000 for the three
months ending June 30, 2006 and 2005, respectively, and $66,000 and $431,000 for the six months
ending June 30, 2006 and 2005, respectively.
11
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Goodwill and Other Intangible Assets (continued):
As of June 30, 2006 and December 31, 2005, the Companys intangible assets and related
accumulated amortization consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 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 |
|
|
$ |
(1,481 |
) |
|
$ |
1,044 |
|
|
$ |
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
Notes to the Consolidated Financial Statements to the Companys 2005 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 $420,000 and $1,245,000 for the three months
and six months ended June 30, 2006, respectively, and included both the 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 June 30, 2006
in connection with these compensation costs due to the uncertainty regarding ultimate realization
of certain net operating loss carryforwards.
12
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued):
As of June 30, 2006, there were 5,826,386 stock options outstanding. At June 30, 2006, the
aggregate fair value of the remaining compensation cost of unvested options, as determined using a
Black-Scholes option valuation model, was approximately $2,104,000 (net of estimated forfeitures).
During the three and six months ended June 30, 2006, the Company granted 112,500 and 864,000 stock
options, respectively, with a fair value of approximately $394,000 and $2,482,000 (net of estimated
forfeitures), respectively, and 28,625 and 31,375 options were forfeited, respectively.
Prior to adopting SFAS No. 123R on January 1, 2006, the Companys equity-based employee
compensation cost under its 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 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 and six month periods ended June 30, 2005, no option based
employee compensation cost is reflected in the Companys net loss, because all options granted 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 only, provides the pro forma information as
required by SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, an
amendment of FASB Statement No. 123, and illustrates the effect on net loss and loss per common
share for the three month and six month periods ended June 30, 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 |
|
|
Six Months Ended |
|
|
|
June 30, 2005 |
|
|
June 30, 2005 |
|
|
|
(unaudited) |
|
|
|
{(Amounts in thousands, except per share data) |
|
Net loss, as reported |
|
$ |
(5,716 |
) |
|
$ |
(14,602 |
) |
Deduct: Total stock-based employee
compensation expense determined under
fair value based method for all awards
(revised) |
|
|
(363 |
) |
|
|
(786 |
) |
|
|
|
|
|
|
|
Pro forma net loss (revised) |
|
$ |
(6,079 |
) |
|
$ |
(15,388 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
Basic and
diluted as reported |
|
$ |
(.14 |
) |
|
$ |
(.37 |
) |
Basic and
diluted pro forma (revised) |
|
$ |
(.15 |
) |
|
$ |
(.39 |
) |
13
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 and six months ended June 30,
2006 and 2005, using the Black-Scholes options valuation model were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Weighted average fair
value of options
granted |
|
$ |
3.50 |
|
|
$ |
.90 |
|
|
$ |
2.87 |
|
|
$ |
1.05 |
|
Expected life (years) |
|
|
4.9 |
|
|
|
4.7 |
|
|
|
4.2-4.9 |
|
|
|
4.7 |
|
Expected volatility |
|
|
85 |
% |
|
|
73 |
% |
|
|
85 |
% |
|
|
6473 |
% |
Risk free interest rate |
|
|
4.94-5.02 |
% |
|
|
3.75 |
% |
|
|
4.28-5.02 |
% |
|
|
3.75 |
% |
Expected dividend |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected forfeiture rate |
|
|
20.37 |
% |
|
|
0 |
% |
|
|
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 vesting date. The expected volatility
of the options granted during the three and six month periods ended June 30, 2006 was determined
using historical volatilities based on stock prices since the inception of the plans. The expected
volatility of the options granted during the three and six months ended June 30, 2005 was
determined using historical volatilities based on stock prices for the preceding 12 month periods.
The risk-free interest rate was determined using the yield available for zero-coupon U.S.
government issues with a remaining term equal to the expected life of the options. The forfeiture
rate for the three and six month periods ended June 30, 2006 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.
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.
14
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 Stock Option Plan |
|
|
1995 Stock Option Plan |
|
|
1995 Director Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
112,500 |
|
|
|
5.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(15,000 |
) |
|
|
1.48 |
|
|
|
(38,750 |
) |
|
|
4.05 |
|
|
|
|
|
|
|
|
|
Expired or canceled |
|
|
(39,375 |
) |
|
|
2.98 |
|
|
|
(149,550 |
) |
|
|
6.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2006 |
|
|
2,812,550 |
|
|
$ |
2.11 |
|
|
|
2,843,836 |
|
|
$ |
5.30 |
|
|
|
170,000 |
|
|
$ |
3.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
exercisable at June 30, 2006 |
|
|
929,941 |
|
|
$ |
1.60 |
|
|
|
2,306,390 |
|
|
$ |
5.58 |
|
|
|
170,000 |
|
|
$ |
3.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available for grant at June 30, 2006 |
|
|
1,211,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table provides certain information with respect to stock options
outstanding and exercisable at June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
Average |
|
|
Number of |
|
|
Average |
|
|
|
Options |
|
|
Remaining |
|
|
Exercise |
|
|
Options |
|
|
Exercise |
|
|
|
Outstanding |
|
|
Contractual Life |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
|
|
|
Options issued at market value: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0.00 -$ 1.17 |
|
|
710,000 |
|
|
|
9.1 |
|
|
$ |
0.87 |
|
|
|
185,000 |
|
|
$ |
1.03 |
|
$ 1.17 -$ 2.33 |
|
|
1,670,988 |
|
|
|
8.7 |
|
|
|
1.51 |
|
|
|
779,591 |
|
|
|
1.48 |
|
$ 2.33 -$ 3.50 |
|
|
276,450 |
|
|
|
3.9 |
|
|
|
3.30 |
|
|
|
276,450 |
|
|
|
3.30 |
|
$ 3.50 -$ 4.66 |
|
|
1,600,520 |
|
|
|
7.3 |
|
|
|
4.22 |
|
|
|
887,312 |
|
|
|
4.06 |
|
$ 4.66 -$ 5.83 |
|
|
286,500 |
|
|
|
4.3 |
|
|
|
5.44 |
|
|
|
228,000 |
|
|
|
5.46 |
|
$ 5.83 -$ 6.99 |
|
|
719,983 |
|
|
|
7.2 |
|
|
|
6.02 |
|
|
|
488,033 |
|
|
|
6.04 |
|
$ 6.99 -$ 8.16 |
|
|
133,334 |
|
|
|
1.3 |
|
|
|
7.76 |
|
|
|
133,334 |
|
|
|
7.76 |
|
$ 8.16 -$ 9.32 |
|
|
264,225 |
|
|
|
4.0 |
|
|
|
8.84 |
|
|
|
264,225 |
|
|
|
8.84 |
|
$ 9.32 -$10.49 |
|
|
129,386 |
|
|
|
5.0 |
|
|
|
9.53 |
|
|
|
129,386 |
|
|
|
9.53 |
|
$10.49- $11.65 |
|
|
35,000 |
|
|
|
4.4 |
|
|
|
10.98 |
|
|
|
35,000 |
|
|
|
10.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,826,386 |
|
|
|
7.2 |
|
|
$ |
3.72 |
|
|
|
3,406,331 |
|
|
$ |
4.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Stock-Based Compensation (continued):
During the three and six months ended June 30, 2006, the Company granted 60,000 and 215,000
shares of restricted common stock, respectively, under the 2005 Plan totaling $303,000 and
$1,174,000, respectively, in value at the date of grant to officers, a director and a consultant of
the Company, which vest upon the achievement of certain milestones or over a period of up to three
years.
Non-cash compensation expense related to all restricted stock issued has been recorded as
compensation cost in accordance with SFAS No. 123R using the straight-line method of amortization.
For the three and six months ended June 30, 2006, $129,000 and $337,000, respectively, of non-cash
stock compensation expense was included in total operating costs and expenses and additional
paid-in capital was increased accordingly. For the three and six months ended June 30, 2005,
$15,000 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 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
During the three and six months ended June 30, 2006, the Company received net proceeds of
$179,000 and $977,000, respectively, from the exercise of 53,750 and 212,500 common stock options,
respectively, at a range of $1.48 to $5.81 per share.
During the three and six months ended June 30, 2005, there were no sales or issuances of
common stock.
16
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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.
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 principal 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) 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. In May 2006, one of these directors resigned from the Companys board of directors.
Following his resignation the Company approved an extension of the former directors $448,000 note.
Accordingly, the note has been reclassified out of stockholders equity and into other non-current
assets on the consolidated balance sheet as of June 30, 2006. The corresponding accrued interest
receivable has been reclassified from current assets to non-current assets on the consolidated
balance sheet as of June 30, 2006. 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 terms and interest rate remain unchanged for the active director. As of
June 30, 2006, accrued interest receivable related to the borrowing for the active director was
$224,000. As of December 31, 2005, accrued interest receivable related to the borrowings for both
directors was $284,000.
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
June 30, 2006 and December 31, 2005, the remaining cost that had not been expensed was $13,000 and
$22,000, respectively, and is included in accounts and other receivables on the consolidated
balance sheets.
17
NOVAVAX, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
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
medicine 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.
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 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 all
of the remaining sales force personnel. Included in sales and marketing expenses in the
accompanying consolidated statement of operations for the three months and six months ended June
30, 2005 are $32,000 and $238,000, respectively, related to the first of these two restructurings.
Included in this amount as of the six months ended June 30, 2005 are (i) one-time termination
benefits of $129,000, (ii) auto lease contract termination costs of approximately $95,000, and
(iii) $14,000 of other associated costs, all of which were paid as of December 31, 2005.
18
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 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®.
19
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 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 seasonal influenza and HIV.
We also are committed to creating value by leveraging our 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 medicine 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 and market acceptance. No
assurance can be given that we can generate sufficient product revenue to become profitable or
generate positive cash flow from operations at all or on a sustained basis.
20
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Significant Transactions in 2006 and 2005
License and Development Agreement 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 medicine 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.
Sublease Agreement with Sterilox Technologies, Inc.
In April 2006, we entered into a sublease agreement with Sterilox Tehnologies, 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, expires on September 30, 2009.
License and Supply Agreements with Esprit Pharma, Inc (Esprit Transaction)
In October 2005, we entered into License and Supply Agreements 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 which was paid at closing, $8.0 million which was paid
in December 2005, and the remaining $2.5 million that is scheduled to be paid on the first
anniversary date of the License Agreement in October 2006. We also 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. 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.
21
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 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. As of the year ended December 31, 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.
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.
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 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 all of the remaining sales force personnel.
22
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 No. 123R
As of the effective date of January 1, 2006 (effective date), we began 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 for 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 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.
23
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 12 month period
historical stock prices in determining the expected volatility. With the adoption of SFAS No.
123R, we use the historical volatilities based on stock prices since the inception of the stock
plans in determining the expected volatility. Forfeiture rates are estimated based on historical
activities since the inception of the stock plans. 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 graded 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 |
|
|
Six Months |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2006 |
|
|
2006 |
|
|
|
(unaudited and in thousands) |
|
Cost of products sold (which includes idle
capacity) |
|
$ |
13 |
|
|
$ |
29 |
|
Research and development |
|
|
146 |
|
|
|
383 |
|
General and administrative |
|
|
261 |
|
|
|
833 |
|
|
|
|
|
|
|
|
Total effect of adopting SFAS No. 123R |
|
$ |
420 |
|
|
$ |
1,245 |
|
|
|
|
|
|
|
|
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 and the Companys Quarterly Report on Form 10-Q for the
quarter ended March 31, 2006.
24
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Three months ended June 30, 2006 (2006) compared to the three months ended June 30, 2005
(2005): (In thousands)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product lines sold in 2005 |
|
$ |
|
|
|
$ |
906 |
|
|
$ |
(906 |
) |
|
|
-100 |
% |
Gynodiol and other products |
|
|
260 |
|
|
|
292 |
|
|
|
(32 |
) |
|
|
-11 |
% |
ESTRASORB |
|
|
118 |
|
|
|
691 |
|
|
|
(573 |
) |
|
|
-83 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
378 |
|
|
|
1,889 |
|
|
|
(1,511 |
) |
|
|
-80 |
% |
Contract research and
development |
|
|
403 |
|
|
|
426 |
|
|
|
(22 |
) |
|
|
-5 |
% |
Royalties, milestone and
licensing fees |
|
|
58 |
|
|
|
|
|
|
|
57 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
839 |
|
|
$ |
2,315 |
|
|
$ |
(1,476 |
) |
|
|
-64 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for 2006 consisted of product sales of $0.4 million, compared to $1.9 million in
2005; contract revenues of $0.4 million in 2006, compared to $0.4 million in 2005; and royalties,
milestone and licensing fees of $58,000 in 2006, compared to zero in 2005. Total net revenues for
2006 were $0.8 million, as compared to $2.3 million for 2005, a decrease of $1.5 million or 64%.
The primary cause for the decrease was our divesture of our direct sales of prenatal vitamins and
AVC Cream in 2005. Product sales for 2006 consisted primarily of ESTRASORB sales to Esprit, as
well as commercial Gynodiol sales. Included in ESTRASORB net sales for 2006 was a $(0.2) million
adjustment to the ESTRASORB sales return allowance for product sold commercially prior to the
licensing of ESTRASORB to Esprit. ESTRASORB sales to Esprit were lower in the second quarter of
2006 compared to the first quarter of 2006 due to lower production levels at our manufacturing
facility.
Contract research and development revenue for 2006 consisted of $0.3 million from a National
Institutes of Health grant to develop a second generation AIDS vaccine compared to $0.4 million
received in 2005 under 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 consisted of $58,000 relating primarily to
royalties pursuant to the Licensing Agreement with Esprit for ESTRASORB.
25
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Cost of products sold,
(which includes idle
capacity) |
|
$ |
1,161 |
|
|
$ |
2,027 |
|
|
$ |
(866 |
) |
|
|
-43 |
% |
Excess inventory costs
over market |
|
|
677 |
|
|
|
|
|
|
|
677 |
|
|
|
100 |
% |
Research and development |
|
|
3,401 |
|
|
|
1,377 |
|
|
|
2,024 |
|
|
|
147 |
% |
Selling and marketing |
|
|
28 |
|
|
|
1,844 |
|
|
|
(1,816 |
) |
|
|
-98 |
% |
General and administrative |
|
|
2,610 |
|
|
|
2,292 |
|
|
|
318 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,877 |
|
|
$ |
7,540 |
|
|
$ |
337 |
|
|
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
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, $0.7 million was due to idle plant capacity costs at our manufacturing
facility. The remaining $0.5 million primarily represents the cost of ESTRASORB sales to Esprit and
Gynodiol cost of products sold. Of the $2.0 million cost of products sold for 2005, $1.0 million
was due to idle plant capacity costs at our manufacturing facility. The additional $0.3 million of
idle capacity costs for 2005 compared to 2006 was partially due to the accounting of excess
inventory costs over market in 2006, which is further discussed below.
Excess Inventory Costs over Market
As part of the Esprit Transaction (see Significant Transactions in 2006 and 2005) we agreed
to sell ESTRASORB at a price that is lower than our current manufacturing costs for the inventory
manufactured and sold. These excess costs over the fixed price totaled $0.7 million for the three
months ended June 30, 2006.
It is most 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 $1.4 million in 2005 to $3.4 million in 2006, or
147%. The increase of $2.0 million was primarily due to an increase in research and development
spending to support our development of flu vaccines.
26
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Selling and Marketing Expenses
Selling and marketing costs were $28,000 in 2006 compared to $1.8 million in 2005. The
decrease of $1.8 million, or 98%, was due to our strategy of transitioning from a commercial
business model to one focused on our core competency of vaccine and new product development. With
the sale of our vitamin and AVC lines to Pharmelle in 2005 and the licensing of ESTRASORB in North
America to Esprit, our ongoing selling expenses consist primarily of costs related to the sale of
Gynodiol.
General and Administrative Expenses
General and administrative costs were $2.6 million in 2006 compared to $2.3 million in 2005.
The increase of $0.3 million was primarily due to non-cash compensation costs resulting from the
implementation of SFAS No. 123R in 2006, using the modified prospective method, while no costs were
recorded in 2005 utilizing the accounting recognition methods under APB No. 25.
Interest income / (expense), net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
967 |
|
|
$ |
42 |
|
|
$ |
925 |
|
|
|
2202 |
% |
Interest expense |
|
|
(340 |
) |
|
|
(533 |
) |
|
|
193 |
|
|
|
36 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
627 |
|
|
$ |
(491 |
) |
|
$ |
1,118 |
|
|
|
228 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income was $0.6 million for 2006 compared to interest expense of $0.5
million for 2005. Interest income increased from zero in 2005 to $1.0 million in 2006, primarily
due to the increase in our cash balance from 2005 to 2006. The equity financing transactions that
occurred during the fourth quarter of 2005 and the first quarter of 2006 accounted for such
increase in cash. Interest expense decreased from $0.5 million in 2005 to $0.3 million in 2006, or
$0.2 million. This decrease is due to the conversion of $6.0 million of our 4.75% senior
convertible notes in October 2005 and $7.0 million in March 2006.
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,411 |
) |
|
$ |
(5,716 |
) |
|
$ |
695 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(.10 |
) |
|
$ |
(.14 |
) |
|
$ |
(.04 |
) |
|
|
-28 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding |
|
|
61,465,003 |
|
|
|
39,533,876 |
|
|
|
21,931,127 |
|
|
|
55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
27
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Net loss for 2006 was $6.4 million or $(.10) per share, as compared to $5.7 million or $(.14)
per share for 2005, an increase of $0.7 million and a decrease of $(.04) per share. The increase
was primarily due to the decrease in revenues of $1.5 million and the increase in other operating
expenses of $0.3 million, partially offset by the $1.1 million increase in net interest income, all
previously discussed. The weighted shares outstanding increased from 39,533,876 in 2005 to
61,465,003 in 2006 due to the equity financing transactions in the second half to 2005 and the
first quarter of 2006 and the conversion of an aggregate $13.0 million of notes to equity during
the same period. In addition, stock options were exercised throughout the second half of 2005 as
well as during 2006.
Six months ended June 30, 2006 (2006) compared to the six months ended June 30, 2005
(2005): (In thousands)
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product lines sold in 2005 |
|
$ |
31 |
|
|
$ |
1,238 |
|
|
$ |
(1,207 |
) |
|
|
-98 |
% |
Gynodiol and other products |
|
|
291 |
|
|
|
335 |
|
|
|
(44 |
) |
|
|
-13 |
% |
ESTRASORB |
|
|
775 |
|
|
|
1,035 |
|
|
|
(260 |
) |
|
|
-25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
1,097 |
|
|
|
2,608 |
|
|
|
(1,511 |
) |
|
|
-58 |
% |
Contract research and
development |
|
|
877 |
|
|
|
669 |
|
|
|
208 |
|
|
|
31 |
% |
Royalties, milestone and
licensing fees |
|
|
168 |
|
|
|
|
|
|
|
168 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,142 |
|
|
$ |
3,277 |
|
|
$ |
(1,135 |
) |
|
|
-35 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues for 2006 consisted of product sales of $1.1 million, compared to $2.6 million in
2005; contract revenues of $0.9 million in 2006, compared to $0.7 million in 2005; and royalties,
milestone and licensing fees of $0.2 million in 2006, compared to zero in 2005. Total net revenues
for 2006 were $2.1 million, as compared to $3.3 million for 2005, a decrease of $1.2 million or
35%. The primary cause for the decrease was the divesture of our direct sales of prenatal vitamins
and AVC Cream in 2005. Product sales for 2006 consist primarily of ESTRASORB sales to Esprit, as
well as commercial Gynodiol sales. Included in ESTRASORB net sales for 2006 was a $(0.2) million
adjustment to the ESTRASORB sales return allowance for product sold commercially prior to the
licensing of ESTRASORB to Esprit. ESTRASORB sales to Esprit were lower than expected for 2006 due
to lower production levels at our manufacturing facility.
Contract research and development revenue for 2006 is primarily due to $0.6 million from a NIH
grant to develop a second generation AIDS vaccine compared to $0.4 million received in 2005 under
the same NIH grant. In addition, $0.3 million of revenue was also recognized in 2006 from two
manufacturing contracts. Contract research and development revenue for 2005 also includes $0.3
million from other grants that were completed in 2005.
Royalties, milestone and licensing fees for 2006 consist of $0.2 million relating primarily to
royalties pursuant to the Licensing Agreement with Esprit for ESTRASORB.
28
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Cost of products sold
(which includes idle
capacity) |
|
$ |
2,394 |
|
|
$ |
4,006 |
|
|
$ |
(1,612 |
) |
|
|
-40 |
% |
Excess inventory costs
over market |
|
|
992 |
|
|
|
|
|
|
|
992 |
|
|
|
100 |
% |
Research and development |
|
|
5,433 |
|
|
|
2,599 |
|
|
|
2,834 |
|
|
|
109 |
% |
Selling and marketing |
|
|
66 |
|
|
|
5,901 |
|
|
|
(5,835 |
) |
|
|
-99 |
% |
General and administrative |
|
|
5,330 |
|
|
|
4,413 |
|
|
|
917 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
14,215 |
|
|
$ |
16,919 |
|
|
$ |
(2,704 |
) |
|
|
-16 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Products Sold and Idle Capacity
Cost of products sold, which includes fixed idle capacity costs at our manufacturing facility,
decreased to $2.4 million in 2006, compared to $4.0 million in 2005. Of the $2.4 million cost of
products sold for 2006, $1.1 million was due to idle plant capacity costs at our manufacturing
facility. The remaining $1.3 million primarily represents the cost of ESTRASORB sales to Esprit
and Gynodiol cost of products sold. Of the $4.0 million cost of products sold for 2005, $2.5
million was due to idle plant capacity costs at our manufacturing facility. Idle capacity costs
for 2005 were $1.4 million higher than in 2006, partially due to the accounting of excess inventory
costs over market in 2006, which is further discussed below. The remaining positive variance is a
result of streamlining of costs and lower production volumes.
Excess Inventory Costs over Market
As part of the Esprit Transaction (see Significant Transactions in 2006 and 2005), we agreed
to sell ESTRASORB at a price that is lower than our current manufacturing costs for the inventory
manufactured and sold. These excess costs over the fixed price totaled $1.0 million for the six
months ended June 30, 2006.
It is most 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.
29
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Research and Development Expenses
Research and development costs increased from $2.6 million in 2005 to $5.4 million in 2006, or
109%. The increase of $2.8 million was primarily due to an increase in research and development
spending to support our development of flu vaccines.
Selling and Marketing Expenses
Selling and marketing costs were $66,000 in 2006 compared to $5.9 million in 2005. The
decrease of $5.8 million, or 99%, was due to our strategy of transitioning from a commercial
business model to one focused on our core competency of vaccine and 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 sale of Gynodiol.
General and Administrative Expenses
General and administrative costs were $5.3 million in 2006 compared to $4.4 million in 2005.
The increase of $0.9 million was primarily due to non-cash compensation costs resulting from the
implementation of SFAS No. 123R in 2006, using the modified prospective method, while no costs were
recorded in 2005 utilizing the accounting recognition methods under APB No. 25.
Interest income/ (expense), net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
1,218 |
|
|
$ |
103 |
|
|
$ |
1,115 |
|
|
|
1082 |
% |
Interest expense |
|
|
(1,051 |
) |
|
|
(1,063 |
) |
|
|
12 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
167 |
|
|
$ |
(960 |
) |
|
$ |
1,127 |
|
|
|
117 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income was $0.2 million for 2006 compared to interest expense of $1.0
million for 2005. Interest income increased from $0.1 million in 2005 to $1.2 million in 2006,
primarily due to the increase in our cash balance from 2005 to 2006. The equity financing
transactions that occurred during the fourth quarter of 2005 and the first quarter of 2006
accounted for such increase in cash. Interest expense was comparable from 2005 to 2006. The
conversion of $6.0 million of our 4.75% senior convertible notes in October 2005 and $7.0 million
in March 2006 resulted in lower interest expense for 2006 but was offset by the write off of $0.3
million of deferred financing costs relating to the conversion of the notes in March 2006.
30
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
%Change |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(11,906 |
) |
|
$ |
(14,602 |
) |
|
$ |
(2,696 |
) |
|
|
-18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(.21 |
) |
|
$ |
(.37 |
) |
|
$ |
(.16 |
) |
|
|
-43 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted shares outstanding |
|
|
56,891,602 |
|
|
|
39,533,876 |
|
|
|
17,357,726 |
|
|
|
44 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for 2006 was $11.9 million or $(.21) per share, as compared to $14.6 million or
$(.37) per share for 2005, a decrease of $2.7 million or $(.16) per share. The decrease was
primarily due to the decrease in revenues of $1.2 million offset by the decrease in other operating
expenses of $2.7 million, and the increase of net interest income of $1.1 million, all previously
discussed. The weighted shares outstanding increased from 39,533,876 in 2005 to 56,891,602 in 2006
due to the equity financing transactions in the second half to 2005 and the first quarter of 2006
and the conversion of an aggregate $13.0 million of notes to equity during the same period. In
addition, stock options were exercised throughout the second half of 2005 as well as during 2006.
31
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 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. We plan 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.
Summary
of Cash Flows:
|
|
|
|
|
|
|
Six months |
|
|
|
ended |
|
|
|
June 30, 2006 |
|
|
|
(in thousands) |
|
|
|
(unaudited) |
|
Net cash provided by/(used in): |
|
|
|
|
Operating activities |
|
$ |
(9,157 |
) |
Investing activities |
|
|
(655 |
) |
Financing activities |
|
|
56,520 |
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
46,708 |
|
Beginning cash and cash equivalents |
|
|
31,893 |
|
|
|
|
|
Ending cash and cash equivalents |
|
$ |
78,601 |
|
|
|
|
|
Cash and cash equivalents were $78.6 million at June 30, 2006, an increase of $46.7 million
from the December 31, 2005 balance of $31.9 million. Of the $46.7 million of cash provided in the
first six months of 2006, $9.2 million was used for operating activities and $0.7 million for
investing activities and $56.6 million was obtained from financing activities. Operating
activities consisted of the net loss of $11.9 million, as previously discussed, non-cash activities
of $3.4 million, offset by $0.7 million of net changes in balance sheet accounts. Working capital
was $80.5 million at June 30, 2006 compared to $32.7 million at December 31, 2005. The increase in
working capital of $47.8 million was primarily due to the $55.9 million net proceeds of the two
equity financing transactions that occurred during the first quarter ended March 31, 2006, $1.0
million from the exercise of stock options, offset by $9.2 million in operating activities.
32
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We intend to use the proceeds from our recent 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, 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 to sustain operations 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.
33
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 June 30, 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 accounting 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 accounting officer have concluded that the Companys current disclosure
controls and procedures, as designed and implemented, are effective 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 accounting officer, the Company conducted an evaluation of the
effectiveness of our internal control over financial reporting as of June 30, 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 June 30, 2006.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that materially
affected, or are reasonably likely to materially affect, our internal control over financial
reporting during the quarter to which this report relates.
34
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, a directed verdict in
favor of Novavax was issued and the case was dismissed. The plaintiff has filed an appeal with the
court. Management believes the likelihood of an unfavorable outcome of such appeal is minimal.
Accordingly, no liability related to this contingency has been accrued in the consolidated balance
sheet as of June 30, 2006.
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, 2005, as filed with the
SEC, other than mentioned below
It is most 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 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
At the Companys Annual Meeting of Stockholders held on April 26, 2006, the following proposal
was adopted by the votes specified below:
|
1. |
|
To elect three directors as Class II directors to serve on the Board of Directors for a
three-year term expiring at the 2009 Annual Meeting of Stockholders. |
|
|
|
|
|
|
|
|
|
|
|
FOR |
|
|
WITHHELD |
|
Gary C. Evans |
|
|
46,412,988 |
|
|
|
479,488 |
|
John O. Marsh, Jr. |
|
|
46,430,545 |
|
|
|
461,961 |
|
James B. Tananbaum, M.D. |
|
|
46,542,721 |
|
|
|
349,755 |
|
35
In addition to the three Class II directors elected at this years Annual Meeting of
Stockholders, the Board is composed of one Class III Director and two Class I Directors. The
continuing Class III Director, whose term will expire at the Companys 2007 Annual Meeting, is
Michael A. McManus, Jr. The continuing Class I Directors, whose terms will expire at the Companys
2008 Annual Meeting, are Denis M. ODonnell, M.D. and Rahul Singhvi. J. Michael Lazarus, M.D.
retired as a director as of the Annual Meeting of Stockholders held on April 26, 2006 and Mitchell
J. Kelly resigned as director subsequent to the Annual Meeting.
Item 5
Other Information
Not applicable.
Item 6
Exhibits
|
10.1 |
|
License and Development Agreement, dated April 26, 2006, by and
between the Company and Esprit Pharma, Inc. Confidential information has been
omitted from this exhibit and filed separately with the Securities and Exchange
Commission due to a confidential treatment request. |
|
|
10.2 |
|
Supply Agreement, dated April 26, 2006, by and between the
Company and Esprit Pharma, Inc. Confidential information has been omitted from
this exhibit and filed separately with the Securities and Exchange Commission
due to a confidential treatment request. |
|
|
10.3 |
|
Sublease Agreement, dated April 28, 2006, by and between the
Company and Sterilox Technologies, Inc. |
|
|
31.1 |
|
Certification of principal executive officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
31.2 |
|
Certification of principal accounting 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 Patricia A. Hall,
Chief Accounting Officer of the Company. |
36
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.
|
|
|
|
|
|
NOVAVAX, INC.
(Registrant)
|
|
Date: August 14, 2006 |
By: |
/s/ Patricia A. Hall
|
|
|
|
Patricia A. Hall |
|
|
|
Chief Accounting Officer
(Principal Accounting Officer) |
|
|
37