e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-50440
MICROMET, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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52-2243564 |
(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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2110 Rutherford Road, Carlsbad, CA
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92008 |
(Address of principal executive offices)
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(Zip Code) |
(760) 494-4200
(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):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o |
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 outstanding shares of the registrants common stock, par value $0.00004 per share, as
of August 4, 2006 was 31,413,032.
MICROMET, INC.
FORM 10-Q QUARTERLY REPORT
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2006
TABLE OF CONTENTS
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Page No |
PART I FINANCIAL INFORMATION |
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Item 1 Financial Statements (unaudited) |
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Condensed Consolidated Balance Sheets as of June 30, 2006 and December 31, 2005 |
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3 |
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Condensed Consolidated Statements of Operations for the three-month and six-month
periods ended June 30, 2006 and 2005 |
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4 |
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Condensed Consolidated Statements of Cash Flows for the six-month periods ended June
30, 2006 and 2005 |
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5 |
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Notes to Condensed Consolidated Financial Statements |
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6 |
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Item 2 Managements Discussion and Analysis of Financial Condition and Results of Operations |
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19 |
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Item 3 Quantitative and Qualitative Disclosure about Market Risk |
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26 |
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Item 4 Controls and Procedures |
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27 |
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PART II OTHER INFORMATION |
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Item 1 Legal Proceedings |
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28 |
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Item 1A Risk Factors |
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29 |
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Item 2 Unregistered Sales of Equity Securities and Use of Proceeds |
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46 |
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Item 3 Defaults Upon Senior Securities |
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46 |
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Item 4 Submission of Matters to a Vote of Security Holders |
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46 |
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Item 5 Other Information |
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48 |
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Item 6 Exhibits |
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49 |
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SIGNATURES |
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50 |
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EXHIBIT 10.1 |
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EXHIBIT 10.8 |
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EXHIBIT 31.1 |
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EXHIBIT 31.2 |
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EXHIBIT 32 |
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2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
Micromet, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except par value)
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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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$ |
36,077 |
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$ |
11,414 |
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Restricted cash |
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930 |
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Accounts receivable |
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1,375 |
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2,170 |
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Prepaid expenses and other current assets |
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3,040 |
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1,043 |
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Total current assets |
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41,422 |
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14,627 |
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Property and equipment, net |
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3,350 |
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3,513 |
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Loans to related parties |
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213 |
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Loans to employees |
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74 |
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70 |
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Goodwill |
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6,917 |
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Patents, net |
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9,348 |
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9,705 |
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Deposits |
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109 |
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113 |
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Restricted cash |
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3,024 |
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636 |
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Total assets |
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$ |
64,244 |
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$ |
28,877 |
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LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable |
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$ |
2,260 |
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$ |
1,287 |
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Accrued expenses |
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8,934 |
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6,534 |
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Other liabilities |
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487 |
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1,927 |
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Short-term note |
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3,022 |
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2,852 |
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Current portion of long-term debt obligations |
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18,082 |
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3,638 |
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Current portion of convertible notes payable |
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2,761 |
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Current portion of deferred revenue |
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4,366 |
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6,035 |
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Total current liabilities |
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37,151 |
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25,034 |
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Convertible notes payable, net of current portion |
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1,920 |
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11,844 |
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Deferred revenue, net of current portion |
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99 |
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52 |
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Other non-current liabilities |
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2,437 |
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949 |
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Long-term debt obligations, net of current portion |
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4,951 |
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5,531 |
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Commitments |
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Stockholders equity (deficit): |
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Preferred stock, $0.00004 par value; 10,000
shares authorized; no shares issued and
outstanding at June 30, 2006 and December
31, 2005, respectively |
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Common stock, $0.00004 par value; 150,000
shares authorized; 29,191 and 17,915 shares
issued and outstanding at June 30, 2006 and
December 31, 2005, respectively |
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1 |
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1 |
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Additional paid-in capital |
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154,588 |
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67,181 |
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Stock subscription from conversion |
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23,108 |
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Stock subscription receivables |
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(30 |
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(242 |
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Accumulated other comprehensive income |
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5,563 |
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6,234 |
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Accumulated deficit |
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(142,436 |
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(110,815 |
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Total stockholders equity (deficit) |
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17,686 |
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(14,533 |
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Total liabilities and stockholders equity (deficit) |
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$ |
64,244 |
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$ |
28,877 |
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The accompanying notes are an integral part of these financial statements.
3
Micromet, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three months ended June 30, |
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Six months ended 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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Collaboration agreements |
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$ |
4,518 |
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$ |
5,284 |
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$ |
8,387 |
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$ |
10,872 |
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License fees |
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480 |
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406 |
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721 |
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604 |
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Other |
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19 |
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37 |
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32 |
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42 |
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Total revenues |
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5,017 |
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5,727 |
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9,140 |
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11,518 |
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Operating expenses |
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Research and development |
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9,496 |
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6,842 |
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14,032 |
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14,197 |
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In-process research and development |
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20,890 |
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20,890 |
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General and administrative |
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4,000 |
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1,421 |
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5,200 |
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2,978 |
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Total operating expenses |
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34,386 |
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8,263 |
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40,122 |
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17,175 |
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Loss from operations |
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(29,369 |
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(2,536 |
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(30,982 |
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(5,657 |
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Other income (expenses) |
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Interest expense |
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(569 |
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(1,358 |
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(1,023 |
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(2,773 |
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Interest income |
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272 |
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72 |
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309 |
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166 |
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Other income |
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211 |
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202 |
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75 |
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403 |
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Net loss |
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$ |
(29,455 |
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$ |
(3,620 |
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$ |
(31,621 |
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$ |
(7,861 |
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Basic and diluted net loss per common share |
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$ |
(1.18 |
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$ |
(2.40 |
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$ |
(1.47 |
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$ |
(5.22 |
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Weighted average shares used to compute basic and diluted net
loss per share |
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24,922 |
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1,506 |
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21,529 |
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1,506 |
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The accompanying notes are an integral part of these financial statements
4
Micromet, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Six months ended June 30, |
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2006 |
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2005 |
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Operating activities |
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Net loss |
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$ |
(31,621 |
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$ |
(7,861 |
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Adjustments to reconcile net loss to net cash (used in) provided by operating activities: |
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Depreciation and amortization |
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1,496 |
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1,668 |
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In-process research and development |
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20,890 |
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Non-cash interest on convertible notes payable |
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1,544 |
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Non-cash interest on long-term debt obligations |
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293 |
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304 |
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Net gain on debt restructuring |
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(315 |
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Stock-based compensation expense |
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4,014 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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1,355 |
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13,225 |
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Prepaid expenses and other current assets |
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(1,433 |
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277 |
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Accounts payable, accrued expenses and other liabilities |
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(6,705 |
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(3,557 |
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Deferred revenue |
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(1,947 |
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(1,190 |
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Restricted cash |
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(1,000 |
) |
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(118 |
) |
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Net cash (used in) provided by operating activities |
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(14,973 |
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4,292 |
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Investing activities |
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Proceeds from disposals of property and equipment |
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13 |
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Proceeds for loans to related parties |
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226 |
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Purchases of property and equipment |
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(217 |
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(25 |
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Cash acquired in connection with merger, net of costs paid |
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37,401 |
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Net cash provided by (used in) investing activities |
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37,423 |
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(25 |
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Financing activities |
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Proceeds from capital contributions from stockholders |
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4,796 |
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Proceeds from exercise of stock options |
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84 |
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Proceeds from stock subscription receivable |
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211 |
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3 |
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Principal payments on long-term debt obligations |
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(3,526 |
) |
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(729 |
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Principal payments on capital lease obligations |
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(30 |
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(33 |
) |
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Net cash provided by (used in) financing activities |
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1,535 |
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(759 |
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Effect of exchange rate changes on cash and cash equivalents |
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678 |
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(1,738 |
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Net increase in cash and cash equivalents |
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24,663 |
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1,770 |
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Cash and cash equivalents at beginning of period |
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11,414 |
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12,749 |
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Cash and cash equivalents at end of period |
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$ |
36,077 |
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$ |
14,519 |
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Supplemental disclosure of noncash investing and financing activities: |
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Conversion of 2004 convertible notes |
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$ |
2,764 |
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$ |
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The accompanying notes are an integral part of these financial statements.
5
1. Organization
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders an aggregate of 19,761,688
shares of CancerVax common stock and CancerVax assumed all of the stock options, stock warrants and
restricted stock of Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet
AG stockholders, option holders, warrant holders and note holders owned, as of the closing,
approximately 67.5% of the combined company on a fully-diluted basis and former CancerVax
stockholders, option holders and warrant holders owned, as of the closing, approximately 32.5% of
the combined company on a fully-diluted basis. CancerVax was renamed Micromet, Inc. and our
Nasdaq National Market ticker symbol was changed to MITI.
Subsequent
to the completion of the merger, we are a biopharmaceutical company
focusing on the development of novel, proprietary antibody-based
products for cancer, inflammatory and autoimmune diseases. We operate in only one business
segment, which primarily focuses on the discovery and development of antibody-based drug candidates
using proprietary technologies.
2. Basis of Presentation
As former Micromet AG security holders own approximately 67.5% of the voting stock of the
combined company after the merger, Micromet AG is deemed to be the acquiring company for accounting
purposes and the transaction was accounted for as a reverse acquisition under the purchase method
of accounting for business combinations in accordance with accounting principles generally accepted
in the United States. Accordingly, unless otherwise noted, all pre-merger financial information is
that of Micromet AG and all post-merger financial information is that of Micromet, Inc. and its
wholly owned subsidiaries Micromet AG, Micromet Holdings, Inc., Tarcanta, Inc., Tarcanta, Limited
and Cell-Matrix, Inc. Substantially all of the post-merger operating activities are conducted
through Micromet AG, a wholly-owned subsidiary of Micromet Holdings, Inc. and an indirect
wholly-owned subsidiary of Micromet, Inc.
Unless specifically noted otherwise, as used throughout these consolidated financial
statements, Micromet, we, us, our refers to the business of the combined company after the
merger and the business of Micromet AG prior to the merger. Unless specifically noted otherwise, as
used throughout these consolidated financial statements, CancerVax Corporation or CancerVax
refers to the business of CancerVax prior to the merger.
The condensed consolidated financial statements as of June 30, 2006, and for the three and six
months ended June 30, 2006 and 2005 are unaudited. In the opinion of management, these condensed
consolidated financial statements include all adjustments, consisting of normal recurring
adjustments, necessary for a fair presentation of results for the interim periods presented. We
have condensed or omitted certain information and disclosures normally included in financial
statements presented in accordance with accounting principles generally accepted in the United
States. We believe the disclosures made are adequate to make the information presented not
misleading. However, you should read these condensed consolidated financial statements in
conjunction with the Micromet AG audited financial statements as of December 31, 2005 and 2004, and
each of the three years in the period ended December 31, 2005 included at pages F-26 through F-60
of our proxy statement/prospectus dated March 31, 2006, filed by CancerVax with the Securities and
Exchange Commission on April 3, 2006.
The accompanying unaudited condensed consolidated financial statements include the accounts of
our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in
consolidation.
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires us to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. On an on-going basis, we evaluate our
estimates, including those related to revenue recognition, the valuation of goodwill,
intangibles and other long-lived assets and assumptions in the
valuation of stock-based compensation. We base our estimates on historical experience and on
various other assumptions that we believe to be reasonable under the circumstances. Actual results
could differ from those estimates. Interim results are not necessarily indicative of results for a
full year or for any subsequent interim period.
Unless otherwise indicated, the pre-merger financial information of Micromet AG has been
restated to reflect the closing of our merger and the related conversion of all Micromet AG capital
stock into Micromet Holdings common stock, the conversion of each share of Micromet Holdings common
stock into 15.74176 shares of Micromet, Inc. common stock, a 1-for-3 reverse stock split that
became effective upon the closing of the merger and a final par value of $0.00004 per common share.
The accompanying financial statements have been prepared assuming we will continue as a going
concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of
our liabilities in the normal course of business. As of June 30, 2006 and December 31, 2005, we had
an accumulated deficit of $142.4 million and $110.8 million, respectively, and expect to continue
6
to incur substantial, and possibly increasing, operating losses for the next several years.
These conditions create substantial doubt about our ability to continue as a going concern. We are
continuing our efforts in research and development and for the preclinical studies and clinical
trials of our products. These efforts, and obtaining requisite regulatory approval, prior to
commercialization, will require substantial expenditures. Once requisite regulatory approval has
been obtained, substantial additional financing will be required to manufacture, market and
distribute our products in order to achieve a level of revenues adequate to support our cost
structure. As of the date of filing this report, we received in the private placement of our common
stock and warrants, which closed on July 24, 2006, $8.0 million of gross proceeds, before offering
expenses. Management believes we have sufficient resources to fund our required expenditures into
the third quarter of 2007, without considering any potential future milestone payments which we may
receive under current or future collaborations. Our business is subject to significant risks
consistent with other biotechnology companies that are developing products for human therapeutic
use. These risks include, but are not limited to, uncertainties regarding research and development,
failure to demonstrate the safety and efficacy of its product candidates, access to capital,
obtaining and enforcing patents, receiving regulatory approvals, and competition with other
biotechnology and pharmaceutical companies. Our plans are to continue to finance our operations
with a combination of equity and/or debt financing, research and development collaborations, and in
the longer term, revenues from product sales. However, there can be no assurance that we will
successfully develop any product or, if we do, that the product will generate revenue.
Historically, we have relied on a limited number of scientists and other specialists to
perform our research and development activities. The loss of senior employees could materially and
adversely affect our operating outcome.
3. Summary of Significant Accounting Policies
Foreign Currency Translation
Each legal entity in our consolidated group that maintains monetary assets and liabilities in
foreign currencies initially translates such assets and liabilities into their functional currency
at the exchange rate in effect at the date of transaction. Monetary assets and liabilities
denominated in foreign currencies are translated into the functional currency at the exchange rate
in effect at the balance sheet date. Transaction gains and losses are recorded in the statement of
operations.
The accompanying financial statements are presented in U.S. dollars. Translation of assets and
liabilities to U.S. dollars is made at the exchange rate in effect at the balance sheet date while
equity accounts are translated at historical rates. Translation of statement of operations data is
made at the average rate in effect for the period. Translation of operating cash flow data is made
at the average rate in effect for the period and investing and financing cash flow data is
translated at the rate in effect at the date of the underlying transaction. Translation gains and
losses are recognized within accumulated other comprehensive income (loss) in the accompanying
balance sheets.
Cash and Cash Equivalents
Cash and cash equivalents on the balance sheets are comprised of cash at banks, money market
funds and short-term deposits with an original maturity of three months or less.
Restricted Cash
As of June 30, 2006 and December 31, 2005, the U.S. dollar equivalent of restricted cash
related to our building lease in Munich, Germany, is $0.7 million and $0.6 million, respectively,
and is disclosed as a non-current asset.
As a result of our merger with CancerVax we assumed three irrevocable standby letters of
credit in connection with three building leases. The letters of credit totaled $2.3 million at the
merger date and were secured by certificates of deposit for similar amounts that are disclosed as
restricted cash. During May 2006, we entered into a lease assignment agreement related to a
manufacturing facility lease that resulted in (i) the issuance of a $1.0 million standby letter of
credit, collateralized by a certificate of deposit in the same amount, to cover restoration costs
that we may be obligated for in the future and (ii) the release of the landlords security interest
in $650,000 of certificates of deposit in August 2006. In addition, during June 2006, we entered
into a lease termination agreement for a warehouse facility that will result in the release of the
landlords security interest in $280,000 of certificates of deposit in August 2006. As of June 30,
2006, we have $3.3 million of certificates of deposit that are disclosed as restricted cash, of
which $2.4 million is disclosed as a non-current asset.
Accounts Receivable
Receivables are stated at their cost less an allowance for any uncollectible amounts. The
allowance for doubtful accounts is based on managements assessment of the collectibility of
specific customer accounts. If there is a deterioration of a customers credit worthiness or actual
defaults are higher than historical experience, managements estimates of the recoverability of
amounts due to us could be adversely affected. We do not have a policy of requiring collateral.
Based on managements assessment, an allowance of
7
$84,000 and $0 was recorded as of June 30, 2006
and December 31, 2005, respectively.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation and amortization.
Major replacements and improvements that extend the useful life of assets are capitalized while
general repairs and maintenance are charged to expense as incurred. Property and equipment are
depreciated using the straight-line method over the estimated useful lives of the assets, ranging
from three to ten years. Leasehold improvements are amortized over the estimated useful lives of
the assets or the related lease term, whichever is shorter.
Goodwill
We have goodwill with a carrying value of $6.9 million at June 30, 2006, which resulted
from our merger with CancerVax in May 2006. In accordance with Statement of Financial Accounting
Standards (SFAS) No. 142, Goodwill and Other Intangible Assets, we do not amortize goodwill.
Instead, we review goodwill for impairment at least annually and more frequently if events or
changes in circumstances indicate a reduction in the fair value of the reporting unit to which the
goodwill has been assigned. Goodwill is determined to be impaired if the fair value of the
reporting unit to which the goodwill has been assigned is less than its carrying amount, including
the goodwill. We have selected October 1 as our annual goodwill impairment testing date.
Patents
We hold patents for single-chain antigen binding molecule technology, which we acquired from
Curis, Inc. in 2001. Patents are amortized over their estimated useful life of ten years using the
straight-line method. The patents are utilized in revenue producing activities as well as in
research and development activities.
Impairment of Long-Lived and Identifiable Intangible Assets
In accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal
of Long-Lived Assets, we evaluate the carrying value of long-lived assets and identifiable
intangible assets for potential impairment whenever events or changes in circumstances indicate
that the carrying amount of such assets may not be recoverable. Recoverability is determined by
comparing projected undiscounted cash flows associated with such assets to the related carrying
value. An impairment loss would be recognized when the estimated undiscounted future cash flow is
less than the carrying amount of the asset. An impairment loss would be measured as the amount by
which the carrying value of the asset exceeds the fair value of the asset. No impairment charges
have been recognized for the three and six months ended June 30, 2006 and 2005.
Revenue Recognition
Our revenues generally consist of licensing fees, milestone payments, royalties and fees for
research services earned from license agreements or from research and development collaboration
agreements. We recognize revenue upon satisfying the following four criteria: persuasive evidence
of an arrangement exists, delivery has occurred, the price is fixed or determinable, and
collectibility is reasonably assured.
We recognize revenue on development and collaboration agreements, including upfront payments,
over the expected life of the development and collaboration agreement on a straight-line basis.
Milestone payments are derived from the achievement of predetermined goals under the collaboration
agreements. For milestones that are subject to contingencies, the related contingent revenue is not
recognized until the milestone has been reached and customer acceptance has been obtained as
necessary.
Fees for research services performed under the agreements are generally stated at a yearly
fixed fee per research scientist. We recognize revenue as the services are performed. Amounts
received in advance of services performed are recorded as deferred revenue until earned.
We have received initial license fees and annual renewal fees upfront each year under license
agreements. Revenue is recognized when the above noted criteria are satisfied unless we have
further obligations associated with the license granted.
We are entitled to receive royalty payments on the sale of products under license and
collaboration agreements. Royalties are based upon the volume of products sold and are recognized
as revenue upon notification of sales from the customer. Through June 30, 2006, we have not
received or recognized any royalty payments.
For arrangements that include multiple deliverables, we identify separate units of accounting
based on the consensus reached on Emerging Issues Task Force Issue (EITF) No. 00-21, Revenue
Arrangements with Multiple Deliverables. EITF No. 00-21 provides that revenue arrangements with
multiple deliverables should be divided into separate units of accounting if certain criteria are
met. The
8
consideration for the arrangement is allocated to the separated units of accounting based on
their relative fair values. Applicable revenue recognition criteria are considered separately for
each unit of accounting.
Research and Development
Research and development expenditures, including direct and allocated expenses, are charged to
operations as incurred.
Total Comprehensive Income (Loss)
For the three and six months ended June 30, 2006 and 2005, comprehensive loss consists of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss |
|
$ |
(29,455 |
) |
|
$ |
(3,620 |
) |
|
$ |
(31,621 |
) |
|
$ |
(7,861 |
) |
Realized gain on investments |
|
|
38 |
|
|
|
|
|
|
|
38 |
|
|
|
|
|
Foreign currency translation adjustments |
|
|
(483 |
) |
|
|
2,499 |
|
|
|
(710 |
) |
|
|
4,340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(29,900 |
) |
|
$ |
(1,121 |
) |
|
$ |
(32,293 |
) |
|
$ |
(3,521 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Payment
We adopted SFAS No. 123R as of January 1, 2006. As permitted by SFAS No. 123R, we utilized the
Black-Scholes option-pricing model (Black-Scholes model) as our method of valuation for
share-based awards granted. The Black-Scholes model was previously utilized for our expense
recorded under SFAS No. 123. We adopted SFAS No. 123R using the modified prospective method. Based
on the terms of our plans, we did not have a cumulative effect related to our plans. The
determination of the fair value of our share-based payment awards on the date of grant using an
option-pricing model is affected by our stock price as well as assumptions regarding a number of
highly complex and subjective variables. These variables include, but are not limited to, our
expected stock price volatility over the term of the awards, and actual and projected employee
stock option exercise behaviors. Option-pricing models were developed for use in estimating the
value of traded options that have no vesting or hedging restrictions and are fully transferable.
Because our employee stock options have certain characteristics that are significantly different
from traded options, and because changes in the subjective assumptions can materially affect the
estimated value, in managements opinion, the existing valuation models may not provide an accurate
measure of the fair value of our employee stock options. Although the fair value of employee stock
options is determined in accordance with SFAS No. 123R using an option-pricing model, that value
may not be indicative of the fair value observed in a willing buyer/willing seller market
transaction.
The weighted-average estimated fair value of employee stock options granted during the three
month period ended June 30, 2006 was $3.51 per share, using the Black-Scholes option-pricing model
with the following assumptions (annualized percentages):
|
|
|
|
|
|
|
Three months ended |
|
|
June 30, |
|
|
2006 |
Expected volatility 2006 and 2003 Plan |
|
|
80.0 |
% |
Risk-free interest rate 2006 and 2003 Plan |
|
|
5.00 |
% |
Dividend yield 2006 and 2003 Plan |
|
|
0.0 |
% |
Expected term 2006 Plan |
|
5.2 years |
Expected term 2003 Plan |
|
5.8 years |
There were no employee stock options granted during the three months and six months ended June
30, 2005. The only options granted during the six month period ended June 30, 2006, were granted
during the second quarter.
Expected volatility is based on our historical volatility and the historical volatilities of
the common stock of comparable publicly traded companies. The risk-free interest rate is based on
the U.S. Treasury rates in effect at the time of grant for periods within the expected term of the
award. The expected term of at-the-money options granted is derived from the average midpoint
between vesting and the contractual term, as described in U. S. Securities and Exchange Commission
(SEC) Staff Accounting Bulletin (SAB) No. 107, Share-Based Payment. The expected term for other
options granted was determined by comparison to peer companies. As stock-based compensation expense
recognized in the Statement of Operations for the six-months ended June 30, 2006 is based on awards
ultimately expected to vest, it should be reduced for estimated forfeitures. SFAS No. 123R requires
forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates. Pre-vesting forfeitures
9
were estimated to be 0% in the first six months of fiscal 2006. If pre-vesting forfeitures
occur in the future, we will record the benefit related to such forfeitures as the forfeitures
occur.
During the second quarter, stock options were granted which in part replaced the stock options
that were outstanding as of December 31, 2005. Under the guidance of SFAS 123R, a modification of
an option award is treated as an exchange of the previously issued option award for a new option
award. Any incremental fair value in measuring the new award would be amortized along with any
remaining unamortized compensation for the original award over the new vesting period. The
original grant and the modification resulted in compensation expense of $2.7 million recorded in
the three and six months ending June 30, 2006.
In conjunction with the adoption of SFAS No. 123R, we continued our method of attributing the
value of stock-based compensation to expense using the straight-line single option method.
Compensation expense related to stock-based compensation is allocated to research and development
or general and administrative based upon the department to which the associated employee reports.
Reported share-based compensation is classified, in the condensed consolidated interim
financial statements, as follows (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, 2006 |
|
|
June 30, 2006 |
|
Research and development |
|
$ |
2,088 |
|
|
$ |
2,088 |
|
General and administrative |
|
|
927 |
|
|
|
927 |
|
|
|
|
|
|
|
|
Employee stock-based compensation expense |
|
$ |
3,015 |
|
|
$ |
3,015 |
|
|
|
|
|
|
|
|
Employee stock-based compensation expense, per common share, basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.14 |
) |
|
|
|
|
|
|
|
For the three and six months ended June 30, 2005 there was no compensation expense recorded.
Prior to adopting the provisions of SFAS No. 123R, we recorded estimated compensation expense
for employee stock-based compensation under the provisions of SFAS No. 123, Accounting for
Stock-Based Compensation (SFAS 123). Under the guidance of SFAS 123, we estimated the value of
stock options issued to employees using the Black-Scholes options pricing model with a near-zero
volatility assumption (a minimum value model). The value was determined based on the stock price
of our stock on the date of grant and was recognized as expense over the vesting period using the
straight-line method. Prior to January 1, 2006 there was no significant stock-based compensation
expense recorded.
Options or stock awards issued to non-employees were recorded at their fair value in
accordance with SFAS No. 123 and EITF Issue No. 96-18, Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring or in Conjunction with Selling Goods or Services, and
expense is recognized upon measurement date commensurate with the determination of when service has
been completed.
Net Loss Per Share
We calculate net loss per share in accordance with SFAS No. 128, Earnings Per Share. Basic net
loss per share is calculated by dividing the net loss by the weighted average number of common
shares outstanding for the period, without consideration for common stock equivalents. Diluted net
loss per share is computed by dividing the net loss by the weighted average number of common stock
equivalents outstanding for the period determined using the treasury-stock method. For purposes of
this calculation, convertible preferred stock, stock options, and warrants are considered to be
common stock equivalents and are only included in the calculation of diluted net loss per share
when their effect is dilutive. The outstanding anti-dilutive securities excluded from the diluted
net loss computation consisted of common stock options and warrants in the amount of 3,323,000 and
29,000, respectively, as of June 30, 2006 and 3,029,000 common stock options as of June 30, 2005.
Reclassifications
Certain amounts in the previous period financial statements have been reclassified to conform
to the current period presentation.
10
Recent Accounting Pronouncements
In July 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation 48,
Accounting for Uncertain Tax Positions, (FIN 48) to clarify the criteria for recognizing tax
benefits under FASB Statement No. 109, Accounting for Income Taxes and to require additional
financial statement disclosure. FIN 48 requires that we recognize, in our consolidated financial
statements, the impact of a tax position if that position is more likely than not to be sustained
on audit, based on the technical merits of the position. We currently recognize the impact of a tax
position if it is probable of being sustained. The provisions of FIN 48 are effective for us
beginning January 1, 2007, with the cumulative effect of the change in accounting principle
recorded as an adjustment to opening retained earnings. We are currently evaluating the impact of
the adoption of FIN 48 on our financial statements.
4. Merger
On May 5, 2006, we completed our merger with CancerVax, a biotechnology company focused on the
research, development and commercialization of novel biological products for the treatment and
control of cancer. The acquisition of unrestricted cash, a Nasdaq listing, and selected ongoing
product development programs were the primary reasons for the merger. The primary driver in the
recognition of goodwill was the acquisition of selected ongoing product development programs.
Because former Micromet AG security holders owned approximately 67.5% of the voting stock of the
combined company after the merger on a fully diluted basis, Micromet AG is deemed to be the
acquiring company for accounting purposes and the transaction has been accounted for as a reverse
acquisition under the purchase method of accounting for business combinations in accordance with
accounting principles generally accepted in the United States. Accordingly, CancerVaxs assets and
liabilities are recorded as of the merger closing date at their estimated fair values.
The fair value of the 9,380,457 outstanding shares of CancerVax common stock used in
determining the purchase price was $41.0 million or $4.38 per share, based on the average of the
closing prices for a range of trading days (January 5, 2006 through January 11, 2006, inclusive)
around and including the announcement date of the merger transaction. The fair value of the
CancerVax stock options and stock warrants assumed by Micromet was determined using the
Black-Scholes option pricing model with the following assumptions: stock price of $4.38, which is
the value ascribed to the CancerVax common stock in determining the purchase price; volatility of
75%; dividend rate of 0%; risk-free interest rate of 4.0%; and a weighted average expected option
life of 0.88 years.
The purchase price is summarized as follows (in thousands):
|
|
|
|
|
Fair value of CancerVax common stock |
|
$ |
41,030 |
|
Estimated fair value of CancerVax stock options and stock
warrants assumed |
|
|
710 |
|
Estimated transaction costs incurred by Micromet |
|
|
2,257 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
|
|
|
|
Under the purchase method of accounting, the total purchase price is allocated to the acquired
tangible and intangible assets and assumed liabilities of CancerVax based on their estimated fair
values as of the merger closing date. The excess of the purchase price over the fair value of
assets acquired and liabilities assumed is allocated to goodwill.
The preliminary allocation of the total purchase price, as shown above, to the acquired
tangible and intangible assets and assumed liabilities of CancerVax based on their fair values as
of the merger date are as follows (in thousands):
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,645 |
|
Receivables under collaborations |
|
|
447 |
|
Restricted cash |
|
|
2,280 |
|
Other assets |
|
|
569 |
|
Accounts payable |
|
|
(2,639 |
) |
Accrued expenses |
|
|
(5,764 |
) |
Current portion of long-term debt obligations |
|
|
(16,816 |
) |
Long-term liabilities |
|
|
(1,532 |
) |
|
|
|
|
Net book value of acquired assets and liabilities |
|
|
16,190 |
|
In-process research and development |
|
|
20,890 |
|
Goodwill |
|
|
6,917 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
|
|
|
|
The acquired in-process research and development (IPR&D) projects consists of the following:
D93 and other denatured collagen related anti-angiogenesis programs that potentially target various
solid tumors; SAI-EGF and related programs that target the
11
epidermal growth factor receptor, or, EGFR, signaling pathway that potentially target
non-small cell lung cancer and various solid tumors; GD2, a humanized, monoclonal antibody that
appears to target tumor-associated antigens that are expressed in a variety of solid tumor cancers;
and certain other non-denatured collagen related humanized, monoclonal antibodies and peptides that
potentially target various solid tumors.
The fair value of the IPR&D projects was determined utilizing the income approach, assuming
that the rights to the IPR&D projects will be sub-licensed to third parties in exchange for certain
up-front, milestone and royalty payments, and the combined company will have no further involvement
in the ongoing development and commercialization of the projects. Under the income approach, the
expected future net cash flows from sub-licensing for each IPR&D project are estimated,
risk-adjusted to reflect the risks inherent in the development process and discounted to their net
present value. Significant factors considered in the calculation of the discount rate are the
weighted-average cost of capital and return on assets. Management believes that the discount rate
utilized is consistent with the projects stage of development and the uncertainties in the
estimates described above. Because the acquired IPR&D projects are in the early stages of the
development cycle, the amount allocated to IPR&D was recorded as an expense immediately upon
completion of the merger.
We expect to finalize our purchase price allocation by May 2007.
Pro Forma Results of Operations
The results of operations of CancerVax are included in Micromet Inc.s condensed consolidated
financial statements from the closing date of the merger on May 5, 2006. The following table
presents pro forma results of operations and gives effect to the merger transaction as if the
merger was consummated at the beginning of the period presented. The unaudited pro forma results of
operations are not necessarily indicative of what would have occurred had the business combination
been completed at the beginning of the period or of the results that may occur in the future.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Revenues |
|
$ |
5,017 |
|
|
$ |
11,973 |
|
|
$ |
9,592 |
|
|
$ |
24,390 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(32,764 |
) |
|
$ |
(11,794 |
) |
|
$ |
(42,886 |
) |
|
$ |
(23,458 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(1.15 |
) |
|
$ |
(1.08 |
) |
|
$ |
(1.53 |
) |
|
$ |
(2.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The pro forma results for the three months and six months ended June 30, 2006 include $20.9 million
of nonrecurring charges for the write-off of in-process research and development.
5. Convertible Notes Payable
Convertible notes payable consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
MedImmune, Inc. convertible promissory note due June 6, 2010 |
|
$ |
1,920 |
|
|
$ |
11,844 |
|
2004 convertible promissory notes including accrued
interest of $572,000 at December 31, 2005 |
|
|
|
|
|
|
2,761 |
|
|
|
|
|
|
|
|
Total convertible notes payable |
|
|
1,920 |
|
|
|
14,605 |
|
Less current portion |
|
|
|
|
|
|
(2,761 |
) |
|
|
|
|
|
|
|
Convertible notes payable, net of current portion |
|
$ |
1,920 |
|
|
$ |
11,844 |
|
|
|
|
|
|
|
|
MedImmune, Inc.
In May 2006, 8.5 million, or $10.7 million of the convertible note was converted into an
aggregate of 1,660,483 shares of common stock.
2004 Convertible Notes
In January 2006, we issued 98,145 shares of our common stock in satisfaction of both the stock
subscription from conversion and the conversion notices received from the remaining note holders
that had not converted as of December 31, 2005. See Note 9.
12
6. Other Non-Current Liabilities
Included in the June 30, 2006 other non-current liabilities balance of $2,437,000 is a lease exit
liability for the Munich facility as a consequence of the restructuring of operations during 2004.
Activity of the restructuring provision in 2006 is as follows:
|
|
|
|
|
|
|
|
|
Accrued |
|
|
|
|
|
|
|
|
Balance as of |
|
Amounts |
|
|
|
Currency |
|
Accrued |
December 31, |
|
Paid in |
|
Accretion |
|
Translation |
|
Balance as of |
2005 |
|
Period |
|
Expense |
|
Adjustment |
|
June 30, 2006 |
$599,000
|
|
$(205,000)
|
|
$46,000
|
|
$32,000
|
|
$472,000 |
Of the $472,000 lease exit liability as of June 30, 2006, $48,000 is current and $424,000 is
non-current.
7. Long-Term Debt
Long-term debt obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Silicon Valley Bank borrowings due in 48 monthly installments through
December 31, 2009; interest payable monthly at 8.25% |
|
$ |
16,034 |
|
|
$ |
|
|
tbg borrowings due December 31, 2006; interest payable semi-annually at 6.00% |
|
|
|
|
|
|
1,593 |
|
Bayern Kapital borrowings due December 31, 2006; interest payable quarterly
at 6.75% |
|
|
1,942 |
|
|
|
1,761 |
|
tbg borrowings due December 31, 2008; interest payable semi-annually at
rates ranging from 6.00% to 7.00% |
|
|
1,883 |
|
|
|
2,700 |
|
Technologie-Fonds Bayern borrowings due December 31, 2008; interest payable
quarterly at 6.00% |
|
|
3,109 |
|
|
|
2,831 |
|
GEDO, borrowings due December 31, 2006; interest payable monthly at 7.50% |
|
|
65 |
|
|
|
175 |
|
ETV, borrowings due 36 months after drawdown; interest payable monthly at
rates ranging from 11.55% to 12.81% |
|
|
|
|
|
|
109 |
|
|
|
|
|
|
|
|
Total long-term debt obligations |
|
|
23,033 |
|
|
|
9,169 |
|
Less current portion |
|
|
(18,082 |
) |
|
|
(3,638 |
) |
|
|
|
|
|
|
|
Long-term debt obligations, net of current portion |
|
$ |
4,951 |
|
|
$ |
5,531 |
|
|
|
|
|
|
|
|
Scheduled repayment of principal for the debt agreements is as follows as of June 30,
2006 (in thousands):
|
|
|
|
|
2006 (July 1, 2006 December 31, 2006) |
|
$ |
18,082 |
|
2007 |
|
|
|
|
2008 |
|
|
4,951 |
|
|
|
|
|
Total |
|
$ |
23,033 |
|
|
|
|
|
Loan and Security Agreement
As a result of the merger with CancerVax, we assumed an $18 million loan and security
agreement entered into by CancerVax in December 2004 with Silicon Valley Bank. The loan and
security agreement contains certain customary events of default, including, among other things,
non-payment of principal and interest, violation of covenants, the occurrence of a material adverse
change in our ability to satisfy our obligations under the loan agreement or with respect to the
lenders security interest in our assets and in the event we are involved in certain insolvency
proceedings. Upon the occurrence of an event of default, the lender may be entitled to, among other
things, accelerate all of our obligations and sell our assets to satisfy our obligations under the
loan agreement. In addition, in an event of default, our outstanding obligations may be subject to
increased rates of interest. The terms of the loan and security agreement also require that it be
repaid in full upon the occurrence of a change in control event. The financing institution
consented to the merger without requiring that we immediately pay down any portion of the note. As
of June 30, 2006, $16.0 million remained unpaid. There are no prepayment penalties and we
anticipate repaying the loan during the third quarter of 2006. We have classified the outstanding
borrowings as a current liability as of June 30, 2006.
13
Amendment to the Silent Partnership Agreements
In January 2006, certain of the silent partnership agreements were amended to accelerate
repayment of amounts due (principal, accrued interest, and one-time payments) upon the occurrence
of certain events. The amended silent partnership agreements with Bayern Kapital GmbH and
Technologie Beteiligungsfonds Bayern GmbH & Co. KG state that repayment of certain amounts due is
required upon further rounds of financing and after the consummation of the merger with CancerVax.
The amount subject to accelerated repayment is dependent on the amount and date of the further
financing and amounted to $5.1 million and $4.6 million as of June 30, 2006 and December 31, 2005,
respectively.
In January 2006, four of the six silent partnership agreements with tbg
Technologie-Beteiligungs-Gesellschaft mbH were amended to require repayment of all amounts due. In
May 2006, upon consummation of our merger with CancerVax, we paid 2.0 million, or $2.5 million, of
the 2.3 million, or $2.8 million, total debt balance. Upon repayment we satisfied obligations in
the amount of $1.7 million related to the borrowings originally due on December 31, 2006. As of
December 31, 2005, the value of these obligations was recorded at $1.6 million also representing
accrued interest expense. Up until repayment further interest expense of $0.1 million were
accrued. Furthermore, obligations in the amount of $1.1 million related to the borrowings due on
December 31, 2008 were settled upon repayment. As of June 30, 2006, borrowings to tbg due on
December 31, 2008 represent $1.3 million principal amount and $0.6 million accrued interest
expense. As a result, we recorded a gain on debt extinguishment of 251,000, or $315,000.
8. Commitments
Leases
In May 2006, we repaid 496,000, or $623,000 of deferred rental payments to GEK, lessor of our
Munich facility, that became due upon of the consummation of our merger with CancerVax.
Future minimum lease payments under non-cancelable operating and capital leases as of June 30,
2006 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Capital |
|
|
Operating |
|
|
|
Leases |
|
|
Leases |
|
2006 (July 1, 2006 December 31, 2006) |
|
$ |
26 |
|
|
$ |
1,426 |
|
2007 |
|
|
48 |
|
|
|
2,843 |
|
2008 |
|
|
26 |
|
|
|
2,827 |
|
2009 |
|
|
|
|
|
|
2,658 |
|
2010 |
|
|
|
|
|
|
2,658 |
|
Thereafter |
|
|
|
|
|
|
4,264 |
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
|
100 |
|
|
$ |
16,676 |
|
|
|
|
|
|
|
|
|
Less: amount representing imputed interest |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease payments |
|
|
98 |
|
|
|
|
|
Less: current portion |
|
|
49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligation, less current portion |
|
$ |
49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The current and long-term portions of capital leases are included on the balance sheet in
other current liabilities and other non-current liabilities, respectively.
License and Research and Development Agreements
Upon closing of our merger with CancerVax we became party to several license and research and
development agreements as discussed in Note 10.
Annual future minimum payments under our license and research and development agreements,
including those assumed from CancerVax, are as follows at June 30, 2006 (in thousands):
|
|
|
|
|
2006 (July 1, 2006 December 31, 2006) |
|
$ |
1,430 |
|
2007 |
|
|
455 |
|
2008 |
|
|
155 |
|
2009 |
|
|
55 |
|
2010 |
|
|
55 |
|
Thereafter |
|
|
330 |
|
|
|
|
|
|
|
$ |
2,480 |
|
|
|
|
|
14
9. Stockholders Equity (Deficit)
Equity Transactions
At the stockholders meeting in October 2005, the Micromet AG stockholders resolved to further
invest up to 8.0 million. On October 11, 2005, Micromet received proceeds of 4.0 million, or $4.8
million, in return for the issuance of 16,408,660 shares of common stock to existing stockholders
at approximately 0.24, or $0.29, per share as a first payment resulting from the October 2005
stockholder investment resolution. In March and April 2006, we received an aggregate of 4.0
million, or $4.8 million, as additional contributed capital from the Micromet AG stockholders as a
second payment resulting from the October 2005 stockholder investment resolution.
MedImmune, Inc.
On May 4, 2006, convertible notes in the aggregate nominal amount of 8.5 million, or $10.7
million, were converted into an aggregate of 1,660,483 shares of common stock.
Enzon, Inc. Convertible Promissory Note
As of December 31, 2005 the carrying amount of the convertible note was included in stock
subscription from conversion in stockholders equity due to the irrevocable notice received from
Enzon and our irrevocable obligation to issue shares to Enzon in accordance with the terms of the
amended convertible note agreement. On January 3, 2006, we issued 88,343 shares of our common stock
and classified the carrying amount of the note as common stock and additional paid-in in the amount
of 9.3 million, or $11.0 million.
2004 Convertible Notes
As of December 31, 2005, 10.2 million, or $12.1 million, including accrued interest, was
included in stock subscription from conversion in stockholders equity due to the irrevocable
notice received from certain note holders in December 2005 and our irrevocable obligation to issue
shares to these note holders in accordance with the terms of the note agreements. As of December
31, 2005, 2.3 million, or $2.8 million, including accrued interest, remained in current
liabilities related to the 2004 convertible notes as the notice from certain note holders was not
received until subsequent to December 31, 2005. In January 2006, we issued 98,145 shares of our
common stock in satisfaction of both the stock subscription from conversion and the conversion
notices received from the remaining note holders that had not converted as of December 31, 2005. We
classified the aggregate carrying amount of the note and the stock subscription from conversion as
common stock and additional paid-in capital in the amount of 12.5 million, or $14.8 million.
Stock Warrants
As a result of our merger with CancerVax we assumed outstanding, fully exercisable stock
warrants that upon cash exercise will result in the issuance of approximately 29,000 shares of our
common stock. The exercise prices of the warrants range from $32.34 to $35.25 per share and the
warrants will expire between November 2006 and June 2013. The warrant holders have the option to
exercise the warrants with a (i) cash payment; (ii) cancellation of our indebtedness to the holder;
or (iii) net issuance exercise based on the fair market value of our common stock on the date of
exercise.
Equity Incentive Plans
2000 and 2002 Stock Option Plans:
In December 2000, we adopted the 2000 Stock Option Plan (2000 Plan) and in November 2002, we
adopted the 2002 Stock Option Plan (2002 Plan). The 2000 and 2002 Plans provide for the granting
of incentive stock options to selected employees, executives of Micromet AG and its affiliates. The
2000 Plan authorized the grant of options to purchase up to 600,305 shares of our common stock and
the 2002 Plan authorized the grant of options to purchase up to 11, 932 shares of our common stock.
Options granted under the 2000 and 2002 Plans were exercisable after two years and in general
vested ratably over a three-year period commencing with the grant date and expired no later than
eight years from the date of grant. During the second quarter of 2006, all outstanding options
under the 2000 and 2002 Plans were cancelled and were partially replaced with options granted under
the 2006 Equity Incentive Plan described below. The cancellation and partial replacement resulted
in compensation expense of $2.7 million recorded in the three and six months ending June 30, 2006.
As a result of these cancellations as of June 30, 2006, an aggregate of 612,237 options were
available for grant under the 2000 Plan and the 2002 Plan, however, we do not intend to grant any
options under those plans in the future.
15
2000 and 2003 Stock Option Plans Assumed in Merger:
In connection with the merger with CancerVax, we assumed CancerVaxs Third Amended and
Restated 2000 Stock Incentive Plan (2000 Stock Incentive Plan) and CancerVaxs 2003 Amended and
Restated Equity Incentive Award Plan (2003 Plan). The 2000 Stock Incentive Plan was effectively
terminated on June 10, 2004 by the approval of the 2003 Plan. Prior to its termination, the 2000
Stock Incentive Plan allowed for the grant of options and restricted stock to employees, outside
directors and consultants. Options granted under the 2000 Stock Incentive Plan generally expire no
later than ten years from date of grant and vest over a period of four years. Under the 2003 Plan,
stock options, stock appreciation rights, restricted or deferred stock awards and other awards may
be granted to employees, outside directors and consultants. Options issued under the 2003 Plan may
be issued to purchase a fixed number of shares of our common stock at prices not less than 100% of
the fair market value at the date of grant. Options generally become exercisable one-fourth
annually beginning one year after the grant date with monthly vesting thereafter and expire ten
years from the grant date. Some options allow for vesting in full upon the termination of the
recipients employment or service with us. Stock options granted to our non-employee directors
generally vest over a one to three year period. Options granted under the 2003 Plan during 2006
have a three year vesting period. At June 30, 2006, options to purchase approximately 1,561,000
shares of our common stock were outstanding, and there were approximately 2,240,000 additional
shares remaining available for future grants, under these plans.
2006 Stock Option Plan:
In April 2006 we adopted a 2006 Equity Incentive Award Plan, which provides for the granting
of stock options to certain officers, directors, founders employees and consultants to acquire up
to approximately 1,923,000 shares of our common stock. Of this amount, options to purchase an
aggregate of 1,761,880 were issued upon the closing of the merger with CancerVax to incentivize
such individuals and were issued, in part, to replace the options issued under the 2000 and 2002
Plans described above. For a given participant under the 2006 Equity Incentive Award Plan, 50% of
the options granted to such individual vested upon grant, with the remaining 50% vesting ratably
on a monthly basis over the 24 months following the date of grant. The exercise price for such
options was set at approximately 25% of the closing price of a share of CancerVax common stock on
the date immediately preceding the date of grant of the option (as adjusted for the exchange ratio
in the merger). As of June 30, 2006 there were approximately 161,000 shares remaining available
for future option grants under this plan.
16
The following is a summary of stock option activity under the 2003 and 2006 Plans through June
30, 2006 (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of Options |
|
Exercise Price |
Outstanding at January 1, 2006 |
|
|
3,029 |
|
|
$8.49 $67.93 |
Granted |
|
|
2,057 |
|
|
$2.37 |
Exercised |
|
|
(18 |
) |
|
$4.40 |
Assumed in merger |
|
|
1,384 |
|
|
$13.13 |
Cancelled |
|
|
(3,129 |
) |
|
$8.49 $67.93 |
|
|
|
|
|
|
|
Outstanding at June 30, 2006 |
|
|
3,323 |
|
|
$6.42 |
|
|
|
|
|
|
|
Included in the shares granted for the six month period ended June 30, 2006 was 1,762,000
shares granted below fair market value at a weighted average exercise price of $1.66 per share.
The following is a further breakdown of the options outstanding as of June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
Weighted |
|
|
|
|
|
Weighted |
|
|
Number |
|
Contractual |
|
Average |
|
Number |
|
Average |
Range of |
|
Outstanding |
|
Life |
|
Exercise |
|
Exercisable |
|
Exercise |
Exercise Prices |
|
(thousands) |
|
(years) |
|
Price |
|
(thousands) |
|
Price |
$1.66 - $1.66 |
|
|
1,762 |
|
|
|
9.85 |
|
|
$ |
1.66 |
|
|
|
954 |
|
|
$ |
1.66 |
|
$3.23 - $4.44 |
|
|
351 |
|
|
|
7.85 |
|
|
$ |
4.07 |
|
|
|
300 |
|
|
$ |
4.00 |
|
$6.47 - $8.46 |
|
|
487 |
|
|
|
9.47 |
|
|
$ |
7.33 |
|
|
|
200 |
|
|
$ |
8.33 |
|
$8.61 - $9.90 |
|
|
388 |
|
|
|
7.72 |
|
|
$ |
9.43 |
|
|
|
272 |
|
|
$ |
9.75 |
|
$19.71 - $32.85 |
|
|
194 |
|
|
|
8.44 |
|
|
$ |
24.15 |
|
|
|
161 |
|
|
$ |
24.24 |
|
$33.15 - $36.00 |
|
|
83 |
|
|
|
7.70 |
|
|
$ |
35.44 |
|
|
|
67 |
|
|
$ |
35.38 |
|
$36.00 - $38.61 |
|
|
58 |
|
|
|
7.63 |
|
|
$ |
36.96 |
|
|
|
48 |
|
|
$ |
37.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1.66 - $38.61 |
|
|
3,323 |
|
|
|
9.16 |
|
|
$ |
6.42 |
|
|
|
2,002 |
|
|
$ |
7.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30, 2006, share-based compensation expense related to stock
options granted to employees was $3.0 million. As of June 30, 2006, there was $4.8 million of
unamortized compensation cost related to unvested stock option awards, which is expected to be
recognized over a remaining weighted-average vesting period of 1.2 years. The aggregate intrinsic
value of options exercised during the period ended June 30, 2006 and outstanding and exercisable at
June 30, 2006 was approximately $16,000, $4.7 million and $2.6 million, respectively.
Employee Stock Purchase Plan
As of June 30, 2006, there are no participants in the Employee Stock Purchase Plan. At June
30, 2006, approximately 84,000 options were available for future grants under this plan.
10. License Agreements
CIMAB, S.A. and YM BioSciences, Inc.
As a result of our merger with CancerVax we assumed a license agreement with CIMAB, S.A.,
a Cuban corporation, and YM BioSciences, Inc., a Canadian corporation, whereby we obtained the
exclusive rights to develop and commercialize in a specific territory, which includes the U.S.,
Canada, Japan, Australia, New Zealand, Mexico and certain countries in Europe, three specific
active immunotherapeutic product candidates that target the epidermal growth factor receptor, or
EGFR, signaling pathway for the treatment of cancer. Of CancerVaxs original obligation to pay
CIMAB and YM BioSciences technology access and transfer fees totaling $5.7
17
million, we assumed the remaining $1.7 million of such obligation, which is required to be
paid through July 2007. Future milestone payments to CIMAB and YM BioSciences up to a maximum of
$34.7 million would be payable upon meeting certain regulatory, clinical and commercialization
objectives, and royalties on future sales of commercial products, if any. We are actively seeking
sublicensing opportunities for all three of these product candidates.
The agreements terminate upon the later of the expiration of the last of any patent
rights to licensed products that are developed under the agreements or 15 years after the date of
the first commercial sale of the last product licensed or developed under the agreements. CIMAB may
terminate the agreements if we have not used reasonable commercial efforts to submit an
investigational new drug application, or IND, to the United States Food and Drug Administration, or
FDA, for the leading product candidate by July 12, 2006, or if the first regulatory approval for
marketing this product candidate within our territory is not obtained by July 12, 2016, provided
that CIMAB has timely complied with all of its obligations under the agreements, or if CIMAB does
not receive timely payment of the initial technology access and transfer fees. In addition, if
CIMAB does not receive payments under the agreements due to changes in United States law, actions
by the United States government or by order of any United States court for a period of more than
one year, CIMAB may terminate our rights to the licensed product candidates in countries within our
territory other than the United States and Canada. We may terminate the agreement for any reason
following 180 days written notice to CIMAB.
Other Licensing and Research and Development Agreements
As a result of our merger with CancerVax we also assumed licensing and research and
development agreements with various universities, research organizations and other third parties
under which we have received licenses to certain intellectual property, scientific know-how and
technology. In consideration for the licenses received, we are required to pay license and research
support fees, milestone payments upon the achievement of certain success-based objectives and/or
royalties on future sales of commercialized products, if any. We may also be required to pay
minimum annual royalties and the costs associated with the prosecution and maintenance of the
patents covering the licensed technology. If all of our product candidates currently being pursued
under these agreements were successfully developed and commercialized, the aggregate amount of
milestone payments we would be required to pay approximately $63.0 million over the terms of the
related agreements as well as royalties on net sales of each commercialized product.
11. Legal Proceedings
Litigation Concerning Cell Therapeutics Inc.
On January 2, 2004, our collaborator, Novuspharma S.p.A., was acquired by Cell Therapeutics
Inc. (CTI). Subsequently, CTI management announced that it would not make any payments to us for
outstanding invoices and contractual obligations. In December 2005, the parties submitted the
dispute to non-binding mediation, which led to a settlement agreement with CTI in May 2006,
pursuant to which CTI made a payment of $1.9 million to Micromet AG. The settlement payment was
included in collaboration revenue during the quarter ended June 30, 2006 since the amount would
have been recorded as collaboration revenue had CTI met its original contractual obligations.
Litigation Concerning Curis, Inc.
On March 6, 2006, Curis, Inc. filed a lawsuit against Micromet AG in the Local Court of
Munich I. Curis claims that Micromet AG was obligated to pay Curis the outstanding amount of Curis
promissory note of 2.0 million, or $2.5 million, within 30 days after the completion of the
merger. We dispute Curis position, but agree that an amount of 533.000 of the loan will become
payable in October 2006. Our maximum exposure is the amount claimed of 2.0 million, or $2.5
million, which is included in current liabilities as of June 30, 2006 and December 31, 2005, plus
the costs of the proceedings. In addition, if Curis prevails in the proceeding, it would be
entitled to interest on the claimed amount of 2.0 million at the base rate of the European Central
Bank plus 8%, accruing from the time of default.
We filed a writ stating our defenses against the lawsuit on May 16, 2006. A date for
the hearing has been set for September 25, 2006.
18
12. Subsequent Events
Private Placement
On July 24, 2006, we closed a private placement pursuant to which we issued an aggregate
of 2,222,222 shares of common stock and warrants to purchase an additional 555,556 shares of common
stock to funds managed by NGN Capital, LLC in return for aggregate gross proceeds, before expenses,
of $8.0 million. The warrants are exercisable for a period of six years from issuance and have an
exercise price of $5.00 per share.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements, which involve risks and
uncertainties. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including those set forth in Part II
Item 1A, below, under the caption, Risk Factors.
The interim financial statements and this Managements Discussion and Analysis of Financial
Condition and Results of Operations should be read in conjunction with the financial statements of
Micromet AG and the notes thereto for the year ended December 31, 2005, and the related
Managements Discussion and Analysis of Financial Condition and Results of Operations relating to
Micromet AG, both of which are contained in our proxy statement/prospectus dated March 31, 2006,
filed with the Securities and Exchange Commission on April 3, 2006 and in conjunction with
CancerVaxs financial statements and notes thereto for the year ended December 31, 2005, and the
related Managements Discussion and Analysis of Financial Condition and Results of Operations, both
of which are contained in CancerVaxs Annual Report on Form 10-K filed with the Securities and
Exchange Commission (SEC) on March 16, 2006.
For periods prior to May 4, 2006, the results of operations and cash flows presented in the
interim financials contained herein reflect Micromet AG only. For periods from May 5, 2006 (the
date of the closing of the merger) through June 30, 2006, the results of operations and cash flows
presented in the interim financials contained herein reflect the combined operations of CancerVax
and Micromet AG. Accordingly, the results of operations and cash flows presented herein are not
necessarily indicative of the results of operations and cash flows that we would experience if the
operations of the two companies had been combined for the entire periods presented.
Overview
The formation of Micromet, Inc.
through the merger of CancerVax Corporation and Micromet AG
created a biopharmaceutical company focusing on the development of
novel, proprietary antibody-based products for cancer, inflammatory and autoimmune
diseases.
Merger of CancerVax Corporation and Micromet AG
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders shares of CancerVax common
stock and CancerVax assumed all of the stock options, stock warrants and restricted stock of
Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet AG stockholders,
option holders, warrant holders and note holders owned, as of the closing, approximately 67.5% of
the combined company on a fully-diluted basis and former CancerVax stockholders, option holders and
warrant holders owned, as of the closing, approximately 32.5% of the combined company on a
fully-diluted basis. In connection with the merger, CancerVax was renamed Micromet, Inc. and our
Nasdaq National Market ticker symbol was changed to MITI.
Unless specifically noted otherwise, as used throughout this report:
|
|
|
CancerVax Corporation or CancerVax refers to the business, operations and financial
results of CancerVax Corporation prior to the closing of the merger between CancerVax
Corporation and Micromet AG on May 5, 2006, at which time CancerVaxs name was changed to
Micromet, Inc.; |
|
|
|
|
Micromet AG refers to the business, operations and financial results of Micromet AG, a
privately-held German company, prior to the closing of the merger and after the merger, as
the context requires; and |
|
|
|
|
Micromet, we, our, or us refers to the operations and financial results of
Micromet, Inc. and Micromet AG on a consolidated basis after the closing of the merger, and
Micromet AG prior to the closing of the merger, as the context requires. |
Ongoing Business Activities
We are a
biopharmaceutical company focusing on the development
of novel, proprietary antibody-based products for cancer, inflammatory and
autoimmune diseases.
19
Our product pipeline consists of two clinical product candidates, adecatumumab (MT201) and MT103, and six
preclinical product candidates, D93, MT110, MT203, MT204, BiTEÒ-I and BiTEÒ-II. This does not
include a clinical candidate SAI-EGF and preclinical product candidates SAI-TGF, SAI-EGFR, which we
plan to out-license. To date, we have incurred significant expenses and have not achieved any
product revenues from sales of our products.
We began our clinical program for our lead product candidate (adecatumumab) with a Phase 1
clinical trial in patients with hormone-refractory prostate cancer in September 2001 in Germany.
Phase 2 clinical trials were started in February 2004 in patients with prostate cancer and in March
2004 in patients with metastatic breast cancer. Adecatumumab (MT201) is being evaluated as a
monotherapy in these two clinical trials. In addition, adecatumumab (MT201) is being evaluated in a
Phase 1 clinical trial in combination with docetaxel in patients with metastatic breast cancer. An
Investigational New Drug Application, or IND, was approved by the Food and Drug Administration, or
FDA, in November 2004 for a Phase 2 trial in patients with metastatic breast cancer.
A second clinical program, MT103, a BiTEÒ compound, is currently in a Phase 1 dose
escalation clinical trial in patients with indolent non-Hodgkins Lymphoma.
In addition, we have product candidates in pre-clinical development including therapeutic
human antibodies and BiTEÒ molecules that may be used to treat patients with inflammatory
diseases and cancer.
We believe that our novel technologies, product candidates and clinical development experience
in these fields will continue to enable us to identify and develop promising new product candidates
in these important markets.
Each of our programs will require many years and significant costs to advance through
development. Typically it takes many years from the initial identification of a lead compound to
the completion of pre-clinical and clinical trials, before applying for possible marketing approval
from the FDA, the European Agency for the Evaluation of Medical Products (the EMEA) or other
equivalent international regulatory agencies. The risk, that a program has to be terminated, in
part or in full, for safety reasons, or lack of adequate efficacy is very high. In particular, we
can neither predict which if any potential product candidates can be successfully developed
and for which marketing approval may be obtained, nor predict the time and cost to complete
development.
As we obtain results from pre-clinical studies or clinical trials, we may elect to discontinue
clinical trials for certain product candidates for safety and/or efficacy reasons. We may also
elect to discontinue development of one or more product candidates in order to focus our resources
on more promising product candidates. Our business strategy includes entering into collaborative
agreements with third parties for the development and commercialization of our product candidates.
Depending on the structure of such collaborative agreements, a third party may take over the
clinical trial process for one of our product candidates. In such a situation, the third party,
rather than us, may in fact control development and commercialization decisions for the respective
product candidate. Consistent with our business model, we may enter into additional collaboration
agreements in the future. We cannot predict the terms of such agreements or their potential impact
on our capital requirements. Our inability to complete our research and development projects in a
timely manner, or our failure to enter into new collaborative agreements, when appropriate, could
significantly increase our capital requirements and affect our liquidity.
Since our inception, we have financed our operations through private placements of preferred
stock, government grants for research, research-contribution revenues from our collaborations with
pharmaceutical companies, debt financing and, more recently by accessing the capital resources of
CancerVax through the merger and through a private placement of common stock and associated
warrants. We intend to continue to seek funding through public or private financings in the
future. If we are successful in raising additional funds through the issuance of equity securities,
stockholders may experience substantial dilution, or the equity securities may have rights,
preferences or privileges senior to existing stockholders. If we are successful in raising
additional funds through debt financings, these financings may involve significant cash payment
obligations and covenants that restrict our ability to operate our business. There can be no
assurance that we will be successful in raising additional capital on acceptable terms, or at all.
Based on our capital resources as of the date of this report, we believe that we have adequate
resources to fund our operations into the third quarter of 2007.
Currently, we have strategic collaborations with Serono and MedImmune to develop therapeutic
antibodies in cancer. We also have an exclusive marketing agreement with Enzon to market and
license to third parties the companies respective single-chain antibody patent estates.
Research and Development and In-Process Research and Development
Through June 30, 2006, our research and development expenses consisted of costs associated
with the clinical development of MT201-Adecatumumab and MT103, as well as pre-clinical development
costs for a new BiTEÒ molecule MT110 and a new human antibody against GM-CSF called MT203.
The costs incurred include costs associated with clinical trials and manufacturing process, quality
systems and analytical development, including compensation and other personnel expenses, supplies
and materials, costs for consultants and related contract research, facility costs, license fees
and depreciation. We charged all research and development
20
expenses to operations as they were incurred.
In addition, as a result of our merger with CancerVax, we acquired in-process research and
development (IPR&D) projects with an assigned value of $20.9 million. The fair value of the
IPR&D projects was determined utilizing the income approach, assuming that the rights to the IPR&D
projects will be sub-licensed to third parties in exchange for certain up-front, milestone and
royalty payments, and the combined company will have no further involvement in the ongoing
development and commercialization of the projects. Under the income approach, the expected future
net cash flows from sub-licensing for each IPR&D project are estimated, risk-adjusted to reflect
the risks inherent in the development process and discounted to their net present value.
Significant factors considered in the calculation of the discount rate are the weighted-average
cost of capital and return on assets. Management believes that the discount rate utilized is
consistent with the projects stage of development and the uncertainties in the estimates described
above. Because the acquired IPR&D projects are in the early stages of the development cycle, the
amount allocated to IPR&D were recorded as an expense immediately upon completion of the merger.
We expect to incur substantial additional research and development expenses that may increase
from historical levels as we further develop our compounds into more advanced stages of clinical
development and increase our pre-clinical efforts for our human antibodies and BiTEÒ
molecules in cancer, anti-inflammatory and autoimmune diseases.
Our strategic collaborations and license agreements generally provide for our research,
development and commercialization programs to be partly or wholly funded by our collaborators and
provide us with the opportunity to receive additional payments if specified development or
commercialization milestones are achieved, as well as royalty payments upon the successful
commercialization of any products based upon our collaborations.
Under our adecatumumab, or MT201, collaboration agreement with Ares Trading, S.A., a
wholly-owned subsidiary of Serono International, S.A., we received a $10.0 million up-front payment
from Serono and the agreement provides for potential future clinical development milestone payments
of up to an additional $138.0 million. Our collaboration agreement with MedImmune for MT103
provides for potential future milestone payments and royalty payments based on net sales from
MT103. A second agreement with MedImmune for the development of new BiTEÒ product candidates
provides for potential future milestone payments and royalty payments based on future sales of the
BiTEÒ product candidates currently under development. The potential milestone payments are
subject to successful completion of development and obtaining marketing approval for one or more
indications in one or more national markets.
We intend to pursue additional collaborations to provide resources for further development of
our product candidates and expect to continue to grant technology access licenses. However, we
cannot forecast with any degree of certainty whether we will be able to enter into collaborative
agreements, and if we do, on what terms we might do so.
We are unable to estimate with any certainty the costs we will incur in the continued
development of our other product candidates. However, we expect our research and development costs
associated with these product candidates to increase as we continue to develop new indications and
move these product candidates through preclinical and clinical trials.
Clinical development timelines, likelihood of success and total costs vary widely. We
anticipate that we will make determinations as to which research and development projects to pursue
and how much funding to direct to each project on an on-going basis in response to the scientific
and clinical success of each product candidate.
The costs and timing for developing and obtaining regulatory approvals of our product
candidates vary significantly for each product candidate and are difficult to estimate. The
expenditure of substantial resources will be required for the lengthy process of clinical
development and obtaining regulatory approvals as well as to comply with applicable regulations.
Any failure by us to obtain, or any delay in obtaining, regulatory approvals could cause our
research and development expenditures to increase and, in turn, have a material adverse effect on
our results of operations.
Critical Accounting Policies and the Use of Estimates
Our financial statements are prepared in conformity with accounting principles generally
accepted in the United States. Such statements require management to make estimates and assumptions
that affect the amounts reported in our financial statements and accompanying notes. Actual results
could differ materially from those estimates. The significant policies in our financial statements
requiring significant estimates and judgments are as follows:
Revenue Recognition
We currently recognize revenue resulting from the licensing and use of our technology and
from services we perform in connection with the licensed technology. These revenues are typically
derived from our proprietary patent portfolio.
21
We enter into patent licenses and research and development agreements that may contain
multiple elements, such as upfront license fees, reimbursement of research and development
expenses, milestones related to the achievement of particular stages in product development and
royalties. As a result, significant judgment is required to determine the appropriate accounting,
including whether the deliverables specified in a multiple element arrangement should be treated as separate units
of accounting for revenue recognition purposes, and if so, how the aggregate contract value should
be allocated among the deliverable elements and when to recognize revenue for each element. We
recognize revenue for delivered elements only when the fair values of undelivered elements are
known, when the associated earnings process is complete, and when payment is reasonably assured.
Changes in the allocation of the contract value between deliverable elements might impact the
timing of revenue recognition, but would not change the total revenue recognized on the contract.
Goodwill
In accordance with Statement of Financial Accounting Standards (SFAS) No. 142,
Goodwill and Other Intangible Assets, we do not amortize goodwill. Instead, we review goodwill for
impairment at least annually and whenever events or changes in circumstances indicate a reduction
in the fair value of the reporting unit to which the goodwill has been assigned. Conditions that
would necessitate a goodwill impairment assessment include a significant adverse change in legal
factors or in the business climate, an adverse action or assessment by a regulator, unanticipated
competition, a loss of key personnel, or the presence of other indicators that would indicate a
reduction in the fair value of the reporting unit to which the goodwill has been assigned. SFAS No.
142 prescribes a two-step process for impairment testing of goodwill. The first step of the
impairment test is used to identify potential impairment by comparing the fair value of the
reporting unit to which the goodwill has been assigned to its carrying amount, including the
goodwill. Such a valuation requires significant estimates and assumptions including but not limited
to: determining the timing and expected costs to complete in-process projects, projecting
regulatory approvals, estimating future cash inflows from product sales and other sources, and
developing appropriate discount rates and probability rates by project. If the carrying value of
the reporting unit exceeds the fair value, the second step of the impairment test is performed in
order to measure the impairment loss. As a result of our merger with CancerVax, we recorded $6.9
million of goodwill. Through June 30, 2006, there have been no indicators of impairment have been
noted and no impairment analysis has been performed.
Long-Lived and Intangible Assets
The evaluation for impairment of long-lived and intangible assets requires significant
management estimates and judgment. Subsequent to the initial recording of long-lived and intangible
assets, we must test such assets for impairment. When we conduct our impairment tests, factors that
are important in determining whether impairment might exist include assumptions regarding our
underlying business and product candidates and other factors specific to each asset being
evaluated. Any changes in key assumptions about our business and our prospects, or changes in
market conditions or other external factors, could result in impairment. Such impairment charge, if
any, could have a material adverse effect on our results of operations.
Share-Based Compensation
On January 1, 2006, we adopted the provisions of SFAS No. 123R and SEC Staff Accounting
Bulletin No. 107, Share-Based Payment, or SAB 107, requiring the measurement and recognition of all
share-based compensation under the fair value method. Effective January 1, 2006, we began
recognizing share-based compensation, under SFAS No. 123R, for all awards granted during 2006 based
on each awards grant date fair value. Prior to adopting the provisions of SFAS No. 123R, we
recorded estimated compensation expense for employee stock-based compensation under the provisions
of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123) following the minimum value
method. Under the guidance of SFAS 123, we estimated the value of stock options issued to
employees using the Black-Scholes options pricing model with a near-zero volatility assumption (a
minimum value model). The value was determined based on the stock price of our stock on the date
of grant and was recognized to expense over the vesting period using the straight-line method. We
implemented SFAS No. 123R using the prospective transition method. Under this transition method
our financial statements and related information presented pertaining to periods prior to our
adoption of SFAS No. 123R have not been adjusted to reflect fair value of the share based
compensation expense. Prior to January 1, 2006, there was no significant stock compensation
expense recorded.
We estimate the fair value of each share-based award on the grant date using the Black-Scholes
valuation model. To facilitate our adoption of SFAS No. 123R, we applied the provisions of SAB 107
in developing our methodologies to estimate our Black-Scholes model inputs. Option valuation
models, including Black-Scholes, require the input of highly subjective assumptions, and changes in
the assumptions used can materially affect the grant date fair value of an award. These assumptions
include the risk free rate of interest, expected dividend yield, expected volatility, and the
expected life of the award. The risk free rate of interest is based on the U.S. Treasury rates
appropriate for the expected term of the award. Expected dividend yield is projected at 0% as we
have not paid any dividends on our common stock since our inception and we do not anticipate paying
dividends on our common stock in the foreseeable future. Expected volatility is based on our
historical volatility and the historical volatilities of the common stock of comparable publicly
traded companies. The expected term of at-the-money options granted is derived from the average
midpoint between vesting and the contractual term, as described in SAB 107. The expected term for
other options granted was determined by comparison to peer
22
companies. SFAS No. 123R also requires
that forfeitures be estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates. Pre-vesting forfeitures were estimated to be 0%
in the first six months of fiscal 2006. If pre-vesting forfeitures occur in the future, we will
record the benefit related to such forfeitures as the forfeitures occur.
Recent Accounting Pronouncements
In July 2006, the FASB issued FASB Interpretation 48, Accounting for Uncertain Tax Positions,
(FIN 48) to clarify the criteria for recognizing tax benefits under FASB Statement No. 109,
Accounting for Income Taxes and to require additional financial statement disclosure. FIN 48
requires that we recognize in our consolidated financial statements, the impact of a tax position
if that position is more likely than not to be sustained on audit, based on the technical merits of
the position. We currently recognize the impact of a tax position if it is probable of being
sustained. The provisions of FIN 48 are effective for us beginning January 1, 2007, with the
cumulative effect of the change in accounting principle recorded as an adjustment to opening
retained earnings. We are currently evaluating the impact of the adoption of FIN 48 on our
financial statements.
Results of Operations
Subsequent to June 30, 2005, we have engaged in a number of significant transactions,
including a recapitalization in October 2005 and the merger with CancerVax in May 2006. As a
result, our results of operations for the three and six months ended June 30, 2006 are not
comparable to the results of operations for the three and six months ended June 30, 2005.
Comparison of the Three Months and Six Months Ended June 30, 2006 and 2005
Revenues. Total revenues were $5.0 million and $9.1 million, respectively, for the three and
six months ended June 30, 2006, compared to $5.7 million and $11.5 million, respectively, for the
three and six months ended June 30, 2005. Revenues for the three and six months ended June 30, 2006
consisted of collaborative research and development revenues of $1.8 million and $4.9 million,
respectively, from our collaboration agreement with Serono and $0.8 million and $1.6 million,
respectively, from our collaboration agreement with MedImmune. In the three months ended June 30,
2006 we also received a $1.9 million settlement payment related to collaboration revenue from the
Cell Therapeutics, Inc. collaboration agreement terminated in February 2004. Revenues from our
licensing activities for the three and six months ended June 30, 2005 amounted to $0.5 million and
$0.7 million, respectively. Revenues for the three and six months ended June 30, 2005 consisted of
collaborative research and development revenues of $3.4 million and $7.0 million, respectively,
from our collaboration agreement with Serono and $1.6 million and $3.2 million, respectively, from
our collaboration agreement with MedImmune. Revenues from our licensing activities for the three
and six months ended June 30, 2005 amounted to $0.4 million and $0.6 million respectively.
Collaborative research and development revenues from Serono reflect its full cost responsibility
for the MT201-adecatumumab program. Collaborative research and development revenues from MedImmune
represent its share of the costs of clinical development of MT103 and its full cost responsibility
for the development of certain new BiTEÒ candidates.
Research and Development Expenses. Research and development expenses were $9.5 million and
$14.0 million, respectively, for the three and six months ended June 30, 2006, compared to $6.8
million and $14.2 million, respectively, for the three and six months ended June 30, 2005. The $2.7
million increase in research and development expenses for the three months ended June 30, 2006
compared to the prior year was due primarily to $2.1 million in share-based compensation expense
related to the issuance of options. The decrease by $0.2 million for the six months ended June 30,
2006, as compared to the prior year, is primarily the result of reductions in process development
and production expenses partially offset by an increase in share-based compensation of $2.1
million incurred in 2006.
General and Administrative
Expenses. General and administrative expenses were $4.0 million and
$5.2 million, respectively, for the three and six months ended June 30, 2006, compared to $1.4
million and $3.0 million, respectively, for the three and six
months ended June 30, 2005. The $2.6
million and $2.2 million increase in general and administrative expenses, respectively, was
primarily due to the issuance of options and increased costs of preparing for becoming and
operating as a public company. Increased public company costs primarily related to higher personnel
expenses resulting from an increased finance staff, directors and officers insurance, additional
legal fees and the extra costs for investor relation activities. During the three and six months
ended June 30, 2006, general and administrative expenses also increased from the inclusion of
approximately $1.9 million in share-based compensation expense, of which $0.9 million related to
stock options granted to employees and $1.0 million related to stock options granted to
non-employees.
Interest Income, Net
Interest Income. Interest income for the three and six months ended June 30, 2006 was $0.3
million and $0.3 million respectively, compared to $0.1 million and $0.2 million, respectively, for
the three and six months ended June 30, 2005. The increase in interest income was primarily due to
an increase in invested balances in 2006.
23
Interest Expense. Interest expense for the three and six months ended June 30, 2006 was $0.6
million and $1.0 million, respectively, compared to $1.4 million and $2.8 million for the three and
six months ended June 30, 2005. The $0.8 million and $1.8 million decrease was primarily due to the
conversion of all but $1.9 million of the convertible notes that had been outstanding during 2005,
offset by the assumption of the Silicon Valley Bank Loan in connection with the merger.
Liquidity and Capital Resources
As of June 30, 2006, we had $36.1 million in cash and cash equivalents as compared to $11.4
million as of December 31, 2005, an increase of $24.7 million. This increase was primarily the
result of our merger with CancerVax in which cash and cash equivalents of $39.6 million were part
of an acquired net book value of $16.2 million. This inflow of cash was partially offset by payment
of $2.2 million in transaction costs, continued investment to fund ongoing operations and increased
spending as a result of our becoming a public company upon completion of our merger with CancerVax.
Net
cash used in operating activities was $15.0 million for the six months ended June 30,
2006, compared to $4.3 million provided by operating activities for the six months ended June 2005.
The decrease in cash flows from operating activities was primarily due to the receipt of a $10.0
million up-front license fee from Serono in January 2005 and further payments received under our
collaboration agreement.
Net
cash provided by investing activities was $37.4 million for the six months ended June 30,
2006, compared to $25,000 used in investing activities for the six months ended June 30, 2005.
Cash flows from investing activities for the six months ended June 30,
2006 consisted of $37.4 million of cash, net of costs paid, acquired in connection with our merger with
CancerVax.
Net cash provided by financing activities was $1.5 million for the six months ended June 30,
2006, compared to $0.8 million used in financing activities for the six months ended June 30, 2005.
Significant components of cash flows from financing activities for
the six months ended June 30, 2006
included the net payments on long-term debt of $3.5 million, $4.8 million capital contribution from
stockholders and $0.2 million of proceeds from stock subscription receivables. Cash flows used in
financing activities for the six months ended June 30, 2005 primarily consisted of the payment of
long-term debt obligations of $0.7 million.
To date, we have funded our operations through proceeds from private placements of preferred
stock, government grants for research, research-contribution revenues from our collaborations with
pharmaceutical companies, debt financing and, more recently by accessing the capital resources of
CancerVax through the merger and through a private placement of common stock and associated
warrants.
We expect that operating losses and negative cash flows from operations will continue for at
least the next several years and we will need to raise additional funds to meet future working
capital and capital expenditure needs. We may wish to raise substantial funds through the sale of
our common stock or raise additional funds through debt financing or through additional strategic
collaboration agreements. We do not know whether additional financing will be available when
needed, or whether it will be available on favorable terms, or at all. If we were to raise
additional funds through the issuance of common stock, substantial dilution to our existing
stockholders would likely result. If we were to raise additional funds through additional debt
financing, the terms of the debt may involve significant cash payment obligations as well as
covenants and specific financial ratios that may restrict our ability to operate our business.
Having insufficient funds may require us to delay, scale back or eliminate some or all of our
research or development programs or to relinquish greater or all rights to product candidates at an
earlier stage of development or on less favorable terms than we would otherwise choose. Failure to
obtain adequate financing may adversely affect our ability to operate as a going concern.
As a result of our merger with CancerVax we assumed three building leases associated with a
manufacturing facility, a warehouse facility and CancerVaxs former corporate headquarters. During
the second quarter of 2006 CancerVax entered into a lease assignment related to the manufacturing
facility, a lease termination related to the warehouse facility and a sublease agreement pursuant
to which 46,527 rentable square feet of the 61,618 total rentable square feet of the former
CancerVaxs corporate headquarters was subleased. Our estimated lease exit liability related to
these facilities amounted to $2.0 million at June 30, 2006 and is included in accrued expenses.
In connection with the three building leases described above, we also assumed three
irrevocable standby letters of credit. The letters of credit associated with these three leases
totaled $2.3 million at the merger date and were secured by certificates of deposit for similar
amounts that are recorded as restricted cash. As of June 30, 2006, we have $4.0 million of cash and
certificates of deposit that are recorded as restricted cash, of which $3.0 million is recorded as
a non-current asset.
As a result of our merger with CancerVax we assumed licensing and research and development
agreements with various universities, research organizations and other third parties under which we
have received licenses to certain intellectual property, scientific know-how and technology. In
consideration for the licenses received, we are required to pay license and research support fees,
24
milestone payments upon the achievement of certain success-based objectives and/or royalties on
future sales of commercialized products, if any. We may also be required to pay minimum annual
royalties and the costs associated with the prosecution and maintenance of the patents covering the
licensed technology. If all potential product candidates under our licensing and research and
development agreements were successfully developed and commercialized, the aggregate amount of
milestone payments we would be required to pay would be approximately $63.0 million over the terms
of the related agreements in addition to royalties on net sales of each commercialized product.
Contractual obligations
We have contractual obligations, some of which were assumed in our merger with CancerVax,
related to our facility lease, research agreements and financing agreements. The following table
sets forth our significant contractual obligations as of June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due by Period |
|
Contractual obligations (in thousands) |
|
Total |
|
|
2006
(1) |
|
|
2007 - 2008 |
|
|
2008 - 2009 |
|
|
2010 and Beyond |
|
Bank loan
(2) |
|
$ |
16,034 |
|
|
$ |
16,034 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Convertible note obligations |
|
|
1,920 |
|
|
|
|
|
|
|
|
|
|
|
1,920 |
|
|
|
|
|
Silent partnership obligations |
|
|
6,934 |
|
|
|
1,983 |
|
|
|
4,951 |
|
|
|
|
|
|
|
|
|
Curis loan |
|
|
3,022 |
|
|
|
3,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
GEDO loan |
|
|
65 |
|
|
|
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual payments under licensing
and research and development
agreements |
|
|
2,480 |
|
|
|
1,430 |
|
|
|
610 |
|
|
|
110 |
|
|
|
330 |
|
Operating leases |
|
|
16,676 |
|
|
|
1,426 |
|
|
|
5,670 |
|
|
|
5,316 |
|
|
|
4,264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
47,131 |
|
|
$ |
23,960 |
|
|
$ |
11,231 |
|
|
$ |
7,346 |
|
|
$ |
4,594 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes amounts payable from July 1, 2006 through December 31, 2006. |
|
(2) |
|
We anticipate repaying this bank loan in the third quarter of 2006 as described
below. |
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
|
|
|
the progress of our clinical trials |
|
|
|
|
the progress of our research activities |
|
|
|
|
the number and scope of our research programs |
|
|
|
|
the progress of our preclinical development activities |
|
|
|
|
the costs involved in preparing, filing, prosecuting, maintaining, enforcing and
defending patent and other intellectual property claims; |
|
|
|
|
the costs related to development and manufacture of pre-clinical, clinical and
validation lots for regulatory and commercialization of drug supply associated with our
product candidates; |
|
|
|
|
our ability to enter into corporate collaborations and the terms and success of these collaborations; |
|
|
|
|
the costs and timing of regulatory approvals; and |
|
|
|
|
the costs of establishing manufacturing, sales and distribution capabilities. |
As a result of the merger with CancerVax, we assumed an $18.0 million loan and security
agreement entered into by CancerVax in December 2004 with Silicon Valley Bank. As of June 30, 2006,
CancerVax had borrowed the full $18.0 million available under the credit facility, of which $16.0
million remains unpaid as of June 30, 2006. The interest rate on the outstanding borrowing under
this credit facility was 8.25% as of June 30, 2006. Commencing January 2006, CancerVax began, and
we are obligated to continue, making principal payments, which are due in 48 monthly installments.
All borrowings under the credit facility must be paid in full by December 31, 2009, unless
otherwise accelerated under certain conditions, including a merger, as further discussed below.
We have granted the financing institution a first priority security interest in substantially
all of our assets, excluding our intellectual property. In addition to various customary
affirmative and negative covenants, the loan and security agreement requires us to maintain, as of
the last day of each calendar quarter, aggregate cash, cash equivalents and securities
available-for-sale in an amount at least equal to the greater of (i) our quarterly cash burn
multiplied by 2 or (ii) the then outstanding principal amount of the obligations under such
agreement multiplied by 1.5. In the event that we breach this financial covenant, we are obligated
to pledge and deliver to the bank a
25
certificate of deposit in an amount equal to the
then-outstanding borrowings under the credit facility. We were in compliance with our debt
covenants as of June 30, 2006.
The loan and security agreement contains certain customary events of default, including, among
other things, non-payment of principal and interest, violation of covenants, the occurrence of a
material adverse change in our ability to satisfy our obligations under the loan agreement or with
respect to the lenders security interest in our assets and in the event we are involved in certain
insolvency proceedings. Upon the occurrence of an event of default, the lender may be entitled to, among other
things, accelerate all of our obligations and sell our assets to satisfy our obligations under the
loan agreement. In addition, in an event of default, our outstanding obligations may be subject to
increased rates of interest. The terms of our loan and security agreement require that it be repaid
in full upon the occurrence of a change of control event.
We anticipate repaying the loan during the third quarter of 2006. There are no penalties for early
repayment of the loan.
Cautionary Note Regarding Forward-Looking Statements
Any statements in this report about our expectations, beliefs, plans, objectives, assumptions
or future events or performance are not historical facts and are forward-looking statements. Such
forward-looking statements include statements regarding the effects of the merger between CancerVax
and Micromet AG, the ongoing restructuring activities related to our business, the efficacy, safety
and intended utilization of our product candidates, the conduct and results of future clinical
trials, and plans regarding regulatory filings, future research and clinical trials and plans
regarding partnering activities. You can identify these forward-looking statements by the use of
words or phrases such as believe, may, could, will, estimate, continue, anticipate,
intend, seek, plan, expect, should, or would. Among the factors that could cause actual
results to differ materially from those indicated in the forward-looking statements are risks and
uncertainties inherent in our business including, without limitation, statements about the progress
and timing of our clinical trials; difficulties or delays in development, testing, obtaining
regulatory approval, producing and marketing our products; unexpected adverse side effects or
inadequate therapeutic efficacy of our products that could delay or prevent product development or
commercialization, or that could result in recalls or product liability claims; the scope and
validity of patent protection for our product candidates; competition from other pharmaceutical or
biotechnology companies; our ability to obtain additional financing to support our operations; and
other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2005 filed
with the Securities and Exchange Commission on March 16, 2006, our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2006 filed with the Securities and Exchange Commission on May 10,
2006, in the proxy statement/prospectus dated March 31, 2006, filed with the Securities and
Exchange Commission on April 3, 2006, and the discussions set forth below under the caption Risk
Factors.
Although we believe that the expectations reflected in our forward-looking statements are
reasonable, we cannot guarantee future results, events, levels of activity, performance or
achievement. We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, unless required by
law.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rates.
Our financial instruments consisted principally of cash and cash equivalents. These financial
instruments, principally comprised of corporate obligations and U.S. and foreign government
obligations, are subject to interest rate risk and will decline in value if interest rates
increase. Because of the relatively short maturities of our investments, we do not expect interest
rate fluctuations to materially affect the aggregate value of our financial instruments. We have
not used derivative financial instruments in our investment portfolio.
Borrowings under our $18.0 million bank credit facility bear interest at a variable interest
rate equal to the greater of the banks prime rate (8.25% as of June 30, 2006) or 4.75% and
therefore expose us to interest rate risk. Based on the outstanding borrowings under our $18.0
million bank credit facility at June 30, 2006 of $16.0 million, a 1% hypothetical increase in the
prime rate would result in an approximately $0.2 million increase in our annual interest expense.
Exchange Rates.
A significant majority of our cash and cash equivalents are currently denominated in U.S.
dollars, as are a significant amount of the potential milestone payments and royalty payments under
our collaboration agreements. However, a significant portion of our operating expenses, including
our research and development expenses, are performed in Europe pursuant to arrangements that are
generally denominated in Euros.
As a result, our financial results and capital resources may be affected by changes in the
U.S. dollar/Euro exchange rate. As of June 30, 2006, we had U.S. dollar-denominated cash and cash
equivalents of $36.1 million and Euro-denominated commitments of approximately 13.4 million Euros.
The unexpended Euro amount as of June 30, 2006 is equivalent to approximately $16.8 million, using
the exchange rate as of that date. A decrease in the value of the U.S. dollar relative to the Euro
would result in an increase in our
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reported operating expenses due to the translation of the
Euro-denominated expenses into U.S. dollars, and would negatively impact the length of time that
our existing capital resources would be sufficient to finance our operations. We have not engaged
in foreign currency hedging transactions to manage this exchange rate exposure.
Item 4. Controls and Procedures
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer (our principal executive officer) and our Senior Vice President of
Operations (our principal financial officer), as appropriate, to allow for timely decisions
regarding required disclosure. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired control objectives, and management
is required to apply its judgment in evaluating the cost-benefit relationship of possible controls
and procedures. In addition, the design of any system of controls also is based in part upon
certain assumptions about the likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all potential future conditions; over time,
control may become inadequate because of changes in conditions, or the degree of compliance with
policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective
control system, misstatements due to error or fraud may occur and not be detected.
Under the supervision and with the participation of our management, including our principal
executive officer and principal financial officer, we conducted an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures as such term is defined under
Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended
(the Exchange Act), as of June 30, 2006, the end of the period covered by this report. Based on
their evaluation, our principal executive officer and principal financial officer concluded that
our disclosure controls and procedures were not effective as of the evaluation date.
Prior to the merger in May 2006, Micromet AG, as a private German-based company, was not
required to, nor did it, maintain effective disclosure controls and procedures or internal control
over financial reporting that would be appropriate for a U.S. public company filing reports with
the Securities and Exchange Commission. We have undergone significant changes in our corporate and
financial reporting structure in 2006 as a result of the merger with Micromet AG. As a result of
the merger, we are now a trans-Atlantic company with a multi-tier reporting and consolidation
process with related currency translations. These transactions and the operations of our company
involve complex accounting issues. Following the merger, we have expended significant resources on
financial reporting activities and integration of operations, including expansion of our disclosure
controls and procedures and internal control systems to address, among other things, operations at
multiple sites and in multiple countries.
As of June 30, 2006, we noted deficiencies relating to monitoring and oversight of the work
performed by our accounting personnel, which did not provide adequate review of transactions by
accounting personnel with sufficient technical accounting expertise. We also noted a lack of
sufficiently skilled personnel within our accounting and financial reporting functions to ensure
that all transactions are accounted for in accordance with U.S. generally accepted accounting
principles.
Notwithstanding the deficiencies cited above that existed as of June 30, 2006, management
believes that (i) this Quarterly Report on Form 10-Q does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which they were made, not misleading with respect to the periods covered by
this report and (ii) the financial statements, and other financial information included in this
report, fairly present in all material respects our financial condition, results of operations and
cash flows as of, and for, the dates and periods presented in this report.
Changes in Internal Control Over Financial Reporting
Our principal executive officer and principal financial officer also evaluated whether any
change in our internal control over financial reporting, as such term is defined under Rules
13a-15(f) and 15d-15(f) promulgated under the Exchange Act, occurred during our most recent fiscal
quarter covered by this report that has materially affected, or is likely to materially affect, our
internal control over financial reporting. Based on their evaluation, our principal executive
officer and principal financial officer concluded that the merger with Micromet AG has materially
affected our internal control over financial reporting as a result of the following:
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Micromet AG, as a private, German-based company, was not required to, nor did it,
maintain a system of effective internal control over financial reporting prior to the
merger that would be appropriate for a U.S. public company
filing reports with the Securities and Exchange Commission; |
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a lack of sufficiently skilled personnel within our accounting and financial reporting
functions to ensure that all transactions are accounted for in accordance with U.S.
generally accepted accounting principles; and |
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the departure of CancerVaxs chief financial officer shortly after the completion of the
merger. |
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Following the merger, we have taken a number of steps to strengthen our internal control over
our financial reporting. However, material weaknesses in our internal control over financial
reporting process continue to exist, and we need to take additional steps to remediate these
situations. We intend to address the remaining actions required to remediate our existing
weaknesses as part of our ongoing efforts to upgrade our control environment following the merger.
As discussed below, we have been and continue to be engaged in efforts to improve our internal
control over financial reporting. Measures we have taken or are taking to remediate our identified
material weaknesses include:
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Consolidating operating and financial reporting locations and structure; |
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Implementing additional review and approval procedures over accruals; |
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Seeking to hire a chief financial officer with significant public company experience; |
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Formalizing process and documentation related to financial statement closing and
consolidation review, including face-to-face meeting of all members of our financial staff
involved in preparation of financial statements and a review of those financial statements
by the entire staff as a group; |
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Formalizing and enhancing documentation, oversight and review procedures related to
accounting records of Micromet AG to ensure compliance with U.S. generally accepted
accounting principles; |
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Reviewing and making appropriate staffing adjustments at all company locations to enhance accounting expertise; |
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Supplementing our accounting and financial staff to improve the breadth and depth of experience; |
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Hiring of consultants to aid us in the implementation of controls; and |
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Improving training for, and integration and communication among, accounting and financial staff. |
We will also continue to review our internal control procedures in order to determine whether
additional steps are necessary to strengthen our internal control over financial reporting. Except
as noted above, there have been no changes in our internal control over financial reporting that
have materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Litigation with Cell Therapeutics, Inc. (CTI)
As previously disclosed in our proxy statement/prospectus dated March 31, 2006 which was
filed with the Securities and Exchange Commission on April 4, 2006, Micromet AG and CTI were
involved in litigation arising out of their prior collaboration, and the parties had submitted to
non-binding mediation. This mediation led to a settlement agreement with CTI on May 3, 2006,
pursuant to which CTI made a payment of $1.9 million to Micromet AG. The settlement payment was
included in collaboration revenue during the quarter ended June 30, 2006 since the amount would
have been recorded as collaboration revenue had CTI met its original contractual obligations.
Patent Opposition in Europe
Micromet AGs patent EP1071752B1 was opposed under Articles 99 and 100 of the European
Patent Convention, or EPC, by Affimed Therapeutics AG in March 2004. The opponent alleged that the
patent does not fulfill the requirements of the EPC. On January 19, 2006, the Opposition Division
of the European Patent Office (EPO) revoked the opposition in oral proceedings according to Article
116 of the EPC and maintained the patent as granted. The opponent filed a notice of appeal on May
30, 2006. On August 4, 2006, we entered into a settlement agreement with the opponent, pursuant to
which the opponent withdrew its appeal and the opposition.
Curis, Inc.
On March 6, 2006, Curis, Inc. filed a lawsuit against Micromet AG in the Local Court of
Munich I. Curis claims that Micromet AG was obligated to pay Curis the outstanding amount of Curis
promissory note of 2.0 million, or $2.5 million, within 30 days after the completion of the merger
with CancerVax. We dispute Curis position, but agree that an amount of 533,000, or $667,000, of
the loan will become payable in October 2006. Our maximum exposure is the amount claimed 2.0
million, or approximately $2.5 million based on the Euro/U.S. dollar exchange rate as of June 30,
2006, plus the costs of the proceedings. In addition, if Curis prevails in the proceeding, it would
be entitled to interest on the claimed amount of 2.0 million, or $2.5 million at the base rate of
the European Central Bank plus 8%, accruing from the time of default.
We filed a writ stating our defenses against the lawsuit on May 16, 2006. A date for
the hearing has been set for September 25, 2006.
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Item 1A. Risk Factors
The following information sets forth factors that could cause our actual results to differ
materially from those contained in forward-looking statements we have made in this report, the
information incorporated herein by reference and those we may make from time to time.
Certain factors may have a material adverse effect on our business, financial condition and
results of operations and you should carefully consider them. It is difficult to predict or
identify all such factors and many of the risk factors identified below have changed from those
previously disclosed in our 2005 Annual Report on Form 10-K, as supplemented by the risk factors in
our Quarterly Report on Form 10-Q for the quarter ended March 31, 2006. Accordingly, in evaluating
our business, we encourage you to consider the following discussion of risk factors in its entirety, in addition to other information
contained in this report as well as our other public filings with the Securities and Exchange
Commission.
Risks Relating to Our Clinical and Regulatory Matters
Our preliminary review of the final results of our Phase 2 clinical trial of adecatumumab, or
MT201, in patients with prostate cancer suggests that the primary endpoint of the trial was not
reached and, if final assessment of the trial results do not warrant continuation of the
development program in this indication, we may discontinue development of this product candidate in
prostate cancer.
Our preliminary review of the final results from our Phase 2 clinical trial of adecatumumab,
or MT201, in patients with prostate cancer indicates that the primary endpoint (mean change in
prostate specific antigen, compared to placebo control) was not reached in the trial. An expert
review meeting performed earlier this year suggested that additional post-hoc sub-analyses be performed before coming to a final
assessment of this trial. These sub-analyses have been performed and, although a final assessment
has not yet been completed, it appears that some measurable level of biological activity was
observed in patients with high EpCAM expression. If, upon final assessment, we, and our partner
Serono conclude that the results of the trial do not warrant continuation of the development of
adecatumumab for the treatment of prostate cancer (or a suitable alternative indication), this
would have a material adverse impact on our future results of operations.
Based upon our preliminary review of the final results of our Phase 2 clinical trial of
adecatumumab, or MT201, in patients with metastatic breast cancer, it appears that the trial did
not reach its primary endpoint and, if final assessment of the trial results do not warrant
continuation of the development program in this indication, we may discontinue development of this
product candidate in breast cancer.
We previously have reported that our initial review of the preliminary radiography assessments
from our Phase 2 clinical trial of adecatumumab in patients with metastatic breast cancer suggested
that the trial had more likely than not met its primary clinical endpoint (clinical benefit rate at
week 24). We also reported that the radiographs from the patients in this clinical trial would be
subjected to the assessment of an independent review board, as some centralized radiology
assessments differed from the radiology assessments performed at the local clinical trial sites.
Such radiographs have now been reviewed and the database used to perform the analysis has now
been locked and is currently subject to a formal assessment, which will not be completed until
later this year. Based upon our initial assessment of the final data set, it now appears that the
trial more likely than not failed to satisfy its primary clinical endpoint. However, based on the
data that we have reviewed thus far, we believe that the results of the trial are nevertheless
encouraging as they appear to indicate clinical activity for adecatumumab, particularly in patients with high
EpCAM expression. Moreover, based upon our current assessment, it does not appear that there were
significant safety concerns observed during the trial.
A final assessment of the study data will not be possible until a full analysis of the data
has been performed, which is currently anticipated to occur in the second half of 2006. Based upon
our preliminary review of the final results of this trial, we currently expect to continue with the
development of adecatumumab. However, if upon final assessment we and our partner Serono conclude
that the results of the trial do not warrant continuation of the development of adecatumumab for
the treatment of breast cancer (or a suitable alternative indication), this would have a material
adverse impact on our future results of operations.
We previously terminated three Phase 1 trials involving short-term infusion regimens of MT103
due to the adverse event profile and a lack of perceived tumor response, and there can be no
assurance that our current continuous infusion Phase 1 clinical trial of MT103 will produce a
different outcome.
In April 2004, we initiated a Phase 1, dose finding clinical trial designed to evaluate the
safety and tolerability of a continuous intravenous infusion of MT103 over 4-8 weeks at different
dose levels in patients with relapsed Non-Hodgkins Lymphoma. We previously terminated three other
Phase 1 clinical trials for MT103, which involved a short-term, as opposed to a continuous,
infusion
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of MT103, due to adverse events and the lack of observed tumor responses. Although we have
redesigned the dosing regimen for our ongoing Phase 1 clinical trial and, based upon the
preliminary data, we currently are seeing considerably fewer adverse events in response to the new
dosing regimen and also do see objective tumor responses at the
currently highest dose level tested (15
µg/m2/d), there can be no assurance that our ongoing, continuous-infusion clinical trial
will not produce an unacceptable level of adverse events.
Risks Relating to Our Financial Results and Need for Financing
We have a history of losses, we expect to incur substantial losses and negative operating cash
flows for the foreseeable future and we may never achieve profitability.
We have incurred losses from the inception of Micromet through June 30, 2006, and we expect to
incur substantial losses for the foreseeable future. We have no current sources of material ongoing
revenue, other than expense reimbursement and milestones from our current collaborators, Serono and
MedImmune. We have not commercialized any products to date, either alone or with a third party
collaborator. If we are not able to commercialize any products, whether alone or with a
collaborator, we may not achieve profitability. Even if our collaboration agreements provide funding for a portion of our research and
development expenses for some of our programs, we expect to spend significant capital to fund our
internal research and development programs for the foreseeable future. As a result, we will need to
generate significant revenues in order to achieve profitability. We cannot be certain whether or
when this will occur because of the significant uncertainties that affect our business. Our failure
to become and remain profitable may depress the market price of our common stock and could impair
our ability to raise capital, expand our business, diversify our product offerings or continue our
operations.
We will require additional financing, which may be difficult to obtain and may dilute your
ownership interest in us. If we fail to obtain the capital necessary to fund our operations, we
will be unable to develop or commercialize our product candidates and our ability to operate as a
going concern may be adversely affected.
We will require substantial funds to continue our research and development programs and our
future capital requirements may vary from what we expect. There are factors that may affect our
future capital requirements and accelerate our need for additional financing. Many of these factors
are outside our control, including the following:
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continued progress in our research and development programs, as well as the magnitude of these programs; |
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our ability to establish and maintain collaborative arrangements; |
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the timing, receipt and amount of research funding and milestone, license, royalty and
other payments, if any, from collaborators; |
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the timing, receipt and amount of sales revenues and associated royalties to us, if any,
from our product candidates in the market; |
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the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and
other patent-related costs, including litigation costs and technology license fees; |
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our ability to complete our post-merger integration; |
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costs associated with litigation, including our ongoing litigation with Curis, Inc.; and |
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competing technological and market developments. |
We have filed a shelf registration statement, declared effective by the Securities and
Exchange Commission on December 9, 2004, under which we may raise up to $80 million through the
sale of our common stock. This shelf registration statement became
inactive in March 2006, and we may decide to activate it by filing a post-effective amendment
in the future. We expect to seek additional funding through public or private financings and may
seek additional funding for programs that are not currently licensed to collaborators, from new
strategic collaborators. However, the biotechnology market in general, and the market for our
common stock, in particular, is likely to be highly volatile. Due to market conditions and the
status of our product development pipeline, additional funding may not be available to us on
acceptable terms, or at all. Having insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or to relinquish greater or all
rights to product candidates at an earlier stage of development or on less favorable terms than we
would otherwise choose. Failure to obtain adequate financing also may adversely affect our ability
to operate as a going concern.
If we raise additional funds through the issuance of equity securities, our stockholders may
experience substantial dilution, or the equity securities may have rights, preferences or
privileges senior to existing stockholders. If we raise additional funds through debt financings,
these financings may involve significant cash payment obligations and covenants that restrict our
ability to operate our
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business and make distributions to our stockholders. We also could elect to
seek funds through arrangements with collaborators or others that may require us to relinquish
rights to certain technologies, product candidates or products.
We have an outstanding promissory note issued to Curis in the amount of 2.0 million, or $2.5
million. Curis has filed a lawsuit against us claiming that the merger triggered our obligation to
repay the note. We dispute Curis position, but agree that an amount of 533,000, or $667,000, of
the loan will become payable in October 2006. Our maximum exposure is the amount claimed of 2.0
million, or approximately $2.5 million based on the Euro/U.S. dollar exchange rate as of June 30,
2006, plus the costs of the proceedings. In addition, if Curis prevails in the proceeding, it would
be entitled to interest on the claimed amount of 2.0 million, or $2.5 million, at the base rate of
the European Central Bank plus 8%, accruing from the time of default. In the event that we are
required to immediately repay any substantial portion or all of the amounts outstanding under this
note, it would have a material adverse effect on our financial resources in the near term.
Our quarterly operating results and stock price may fluctuate significantly.
We expect our results of operations to be subject to quarterly fluctuations. The level of our
revenues, if any, and results of operations at any given time, will be based primarily on the
following factors:
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the status of development of our product candidates; |
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the time at which we enter into research and license agreements with strategic
collaborators that provide for payments to us, and the timing and accounting treatment of
payments to us, if any, under those agreements; |
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whether or not we achieve specified research or commercialization milestones under any
agreement that we enter into with collaborators and the timely payment by commercial
collaborators of any amounts payable to us; |
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the addition or termination of research programs or funding support; |
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the timing of milestone and other payments that we may be required to make to others; |
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variations in the level of expenses related to our product candidates or potential
product candidates during any given period; and |
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the progress of our integration activities. |
These factors may cause the price of our stock to fluctuate substantially. We believe that
quarterly comparisons of our financial results are not necessarily meaningful and should not be
relied upon as an indication of our future performance.
If the estimates we make and the assumptions on which we rely in preparing our financial statements
prove inaccurate, our actual results may vary significantly.
Our financial statements have been prepared in accordance with generally accepted accounting
principles in the United States. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and
expenses, the amounts of charges taken by us and related disclosure. We base our estimates on
historical experience and on various other assumptions that we believe to be reasonable under the
circumstances. We cannot assure you that our estimates, or the assumptions underlying them, will be
correct. Accordingly, our actual financial results may vary significantly from the estimates
contained in our financial statements.
Changes in, or interpretations of, accounting rules and regulations, such as expensing of stock
options, could result in unfavorable accounting charges or require us to change our compensation
policies.
Accounting methods and policies for biopharmaceutical companies, including policies governing
revenue recognition, expenses, accounting for stock options and in-process research and development
costs are subject to further review, interpretation and guidance from relevant accounting
authorities, including the Securities and Exchange Commission. Changes to, or interpretations of,
accounting methods or policies in the future may require us to reclassify, restate or otherwise
change or revise our financial statements, including those contained in this filing.
Our operating and financial flexibility, including our ability to borrow money, is limited by
certain debt arrangements.
In December 2004, CancerVax entered into a loan and security agreement with a financing
institution, and borrowed the full $18.0 million available under this credit facility. In order to
secure its obligations under this loan and security agreement, CancerVax granted the bank a first
priority security interest in substantially all of its assets, excluding its intellectual property.
CancerVax used the proceeds from the loan agreement primarily to construct and equip an additional
production suite in its manufacturing facility and to
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create additional warehouse and laboratory
space to support its manufacturing operations. The terms of our loan and security agreement require
that it be repaid in full upon the occurrence of a change of control event.
The loan agreement contains various customary affirmative and negative covenants, including,
without limitation:
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financial reporting; |
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limitation on liens; |
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limitations on the occurrence of future indebtedness; |
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maintenance of a minimum amount of cash in deposit accounts of our lenders or in the accounts of affiliates of our lenders; |
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limitations on mergers and other consolidations; |
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limitations on dividends; |
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limitations on investments; and |
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limitations on transactions with affiliates. |
In addition, under this loan agreement, we are generally obligated to maintain, as of the last
day of each quarter, cash, cash equivalents and securities available-for-sale in an amount at least
equal to the greater of (i) our quarterly cash burn multiplied by 2 or (ii) the then outstanding
principal amount of the obligations under such agreement multiplied by 1.5. In the event that we
breach this financial covenant, we are obligated to pledge and deliver to the bank a certificate of
deposit in an amount equal to the aggregate outstanding principal amount of the obligations under
such agreement.
Our loan agreements contain certain customary events of default, which generally include,
among others, non-payment of principal and interest, violation of covenants, cross defaults, the
occurrence of a material adverse change in our ability to satisfy our obligations under our loan
agreements or with respect to one of our lenders security interest in our assets and in the event
we are involved in certain insolvency proceedings. Upon the occurrence of an event of default, our
lenders may be entitled to, among other things, accelerate all of our obligations and sell our
assets to satisfy our obligations under our loan agreements. In addition, in an event of default,
our outstanding obligations may be subject to increased rates of interest.
In addition, we may incur additional indebtedness from time to time to finance acquisitions,
investments or strategic alliances or capital expenditures or for other purposes. Our level of
indebtedness could have negative consequences for us, including the following:
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our ability to obtain additional financing, if necessary, for working capital, capital
expenditures, acquisitions or other purposes may be impaired or such financing may not be
available on favorable terms; |
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payments on our indebtedness will reduce the funds that would otherwise be available for
our operations and future business opportunities; |
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we may be more highly leveraged than our competitors, which may place us at a competitive disadvantage; |
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our debt level reduces our flexibility in responding to changing business and economic conditions; and |
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our business and financial condition would be adversely effected if we are unable to
service our indebtedness or obtain additional financing, as needed. |
Risks Relating to Our Common Stock
Future sales of our common stock may cause our stock price to decline.
Our current stockholders hold a substantial number of shares of our common stock that they
will be able to sell in the public market. A significant portion of these shares are held by a
small number of stockholders. Sales by our current stockholders of a substantial number of our
shares could significantly reduce the market price of our common stock. Moreover, the holders of a
substantial number of shares of our common stock have rights, subject to some conditions, to
require us to file registration statements covering their shares or to include their shares in
registration statements that we may file for ourselves or other stockholders. We intend to file a
registration statement covering (i) the resale by former affiliates of Micromet AG of shares issued
to them in the merger and (ii) the resale of the shares of common stock and shares underlying
warrants that were sold in our private placement, which closed on July 24, 2006. We have also
registered shares of our common stock that we may issue under our stock incentive plans and
employee stock
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purchase plan. These shares generally can be freely sold in the public market upon
issuance. Sales of a large number of these shares in the public market, or the mere availability of
these shares for resale, could reduce the trading price of our common stock.
Our stock price may be volatile, and you may lose all or a substantial part of your investment.
The market price for our common stock is volatile and may fluctuate significantly in response
to a number of factors, most of which we cannot control, including:
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the financial markets acceptance of the merger between Micromet and CancerVax, and our
ability to successfully integrate our operations following the merger; |
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our ability to upgrade and implement our disclosure controls and our internal control over financial reporting; |
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our ability to successfully raise capital to fund our continued operations; |
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our ability to successfully develop our product candidates within acceptable timeframes; |
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changes in the regulatory status of our product candidates; |
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changes in significant contracts, new technologies, acquisitions, commercial
relationships, joint ventures or capital commitments; |
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the execution of new contracts or termination of existing contracts related to our
clinical or preclinical product candidates; |
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announcements of the results of clinical trials by companies with product candidates in
the same therapeutic category as our product candidates; |
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events affecting our collaboration partners; |
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fluctuations in stock market prices and trading volumes of similar companies; |
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announcements of new products or technologies, clinical trial results, commercial
relationships or other events by us or our competitors; |
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our ability to successfully complete sublicensing arrangements with respect to our
product candidates that target the EGFR signaling pathway, denatured collagen, GM-CSF and
interleukin-2; |
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variations in our quarterly operating results; |
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changes in securities analysts estimates of our financial performance; |
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changes in accounting principles; |
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sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders; |
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additions or departures of key personnel; and |
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discussions of Micromet or our stock price by the financial and scientific press and
online investor communities such as chat rooms. |
If our officers and directors choose to act together, they can significantly influence our
management and operations in a manner that may be in their best interests and not in the best
interests of other stockholders.
Our officers and directors, together with their affiliates, may significantly influence all
matters requiring approval by our stockholders, including the election of directors and the
approval of mergers or other business combination transactions. The interests of this group of
stockholders may not always coincide with our interests or the interests of other stockholders, and
they may act in a manner that advances their best interests and not necessarily those of other
stockholders.
Our stockholder rights plan, anti-takeover provisions in our organizational documents and Delaware
law may discourage or prevent a change in control, even if an acquisition would be beneficial to
our stockholders, which could affect our stock price adversely and prevent attempts by our
stockholders to replace or remove our current management.
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Our stockholder rights plan and provisions contained in our amended and restated certificate
of incorporation and amended and restated bylaws contain provisions that may delay or prevent a
change in control, discourage bids at a premium over the market price of our common stock and
adversely affect the market price of our common stock and the voting and other rights of the
holders of our common stock. The provisions in our amended and restated certificate of
incorporation and bylaws include:
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dividing our board of directors into three classes serving staggered three-year terms; |
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prohibiting our stockholders from calling a special meeting of stockholders; |
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permitting the issuance of additional shares of our common stock or preferred stock without stockholder approval; |
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prohibiting our stockholders from making certain changes to our amended and restated
certificate of incorporation or bylaws except with
662/3% stockholder approval; and |
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requiring advance notice for raising matters of business or making nominations at
stockholders meetings. |
We are also subject to provisions of the Delaware corporation law that, in general, prohibit any
business combination with a beneficial owner of 15% or more of our common stock for five years
unless the holders acquisition of our stock was approved in advance by our board of directors.
Risks Relating to Our Collaborations
We are dependent on collaborators for the development and commercialization of many of our product
candidates. If we lose any of these collaborators, of if they fail or delay in developing or
commercializing our product candidates, our anticipated product pipeline and operating results
would suffer.
The success of our strategy for development and commercialization of product candidates
depends upon our ability to form and maintain productive strategic collaborations. We currently
have strategic collaborations with Serono and MedImmune. We expect to enter into additional
collaborations in the future. Our existing and any future collaborations may not be scientifically
or commercially successful.
The risks that we face in connection with these collaborations include the following:
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Each of our collaborators has significant discretion in determining the efforts and
resources that it will apply to the collaboration. The timing and amount of any future
royalty and milestone revenue that we may receive under such collaborative arrangements
will depend on, among other things, such collaborators efforts and allocation of
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All of our strategic collaboration agreements are for fixed terms and are subject to
termination under various circumstances, including in some cases, on short notice without
cause. If any collaborator were to terminate an agreement, we may be required to undertake
product development, manufacturing and commercialization and we may not have the funds or
capability to do this, which could result in a discontinuation or delay of such program. |
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Our collaborators may develop and commercialize, either alone or with others, products
and services that are similar to or competitive with the products and services that are the
subject of the collaboration with us. |
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Our collaborators may change the focus of their development and commercialization
efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their
priorities following mergers and consolidations, which have been common in recent years in
these industries. The ability of certain of our product candidates to reach their potential
could be limited if our collaborators decrease or fail to increase spending related to such
product candidates. |
Changes in the laws or regulations of the United States or Cuba related to the conduct of our
business with CIMAB may adversely affect our ability to develop and commercialize or sublicense our
rights to SAI-EGF and the two other product candidates that we have licensed from that company.
The United States government has maintained an embargo against Cuba for more than 40 years.
The embargo is administered by the Office of Foreign Assets Control, or OFAC, of the U.S.
Department of Treasury. Without a license from OFAC, U.S. individuals and companies may not engage
in any transaction in which Cuba or Cubans have an interest. In order to enter into and carry out
our licensing agreements with CIMAB, we have obtained from OFAC a license authorizing us to carry
out all transactions set forth in the license agreements that we have entered into with CIMAB for
the development, testing, licensing and commercialization of SAI-EGF, and with CIMAB and YM
BioSciences for the two other product candidates that target the EGF receptor signaling pathway. In
the absence of such a license from OFAC, the execution of and our performance under these
agreements could have exposed us to legal and criminal liability. At any time, there may occur for
reasons beyond our control a change in United States or Cuban law, or in the
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regulatory environment in the U.S. or Cuba, or a shift in the political attitudes of either the U.S. or Cuban governments,
that could result in the suspension or revocation of our OFAC license or in our inability to carry
out part or all of the licensing agreements with CIMAB. There can be no assurance that the U.S. or
Cuban governments will not modify existing law or establish new laws or regulations that may
adversely affect our ability to develop, test, license and commercialize these product candidates.
Our OFAC license may be revoked or amended at anytime in the future, or the U.S. or Cuban
governments may restrict our ability to carry out all or part of our respective duties under the
licensing agreements between us, CIMAB and YM BioSciences. Similarly, any such actions may restrict
CIMABs ability to carry out all or part of its licensing agreements with us. In addition, we
cannot be sure that the FDA, EMEA or other regulatory authorities will accept data from the
clinical trials of these products that were conducted in Cuba as the basis for our applications to
conduct additional clinical trials, or as part of our application to seek marketing authorizations
for such products.
In 1996, a significant change to the United States embargo against Cuba resulted from
congressional passage of the Cuban Liberty and Democratic Solidarity Act, also known as the
Helms-Burton Bill. That law authorizes private lawsuits for damages against anyone who traffics in
property confiscated, without compensation, by the government of Cuba from persons who at the time
were, or have since become, nationals of the United States. We do not own any property in Cuba and
do not believe that any of CIMABs properties or any of the scientific centers that are or have
been involved in the development of the technology that we have licensed from CIMAB were
confiscated by the government of Cuba from persons who at the time were, or who have since become,
nationals of the U.S. However, there can be no assurance that our understanding in this regard is
correct. We do not intend to traffic in confiscated property, and have included provisions in our
licensing agreements to preclude the use of such property in association with the performance of
CIMABs obligations under those agreements.
As part of our interactions with CIMAB, we will be subject to the U.S. Commerce Departments
export administration regulations that govern the transfer of technology to foreign nationals.
Specifically, we or our sublicensees, if any, will require a license from the Commerce Departments
Bureau of Industry and Security, or BIS, in order to export or otherwise transfer to CIMAB any
information that constitutes technology under the definitions of the Export Administration Regulations, or
EAR, administered by BIS. The export licensing process may take months to be completed, and the
technology transfer in question may not take place unless and until a license is granted by the
Commerce Department. Due to the unique status of the Republic of Cuba, technology that might
otherwise be transferable to a foreign national without a Commerce Department license requires a
license for export or transfer to a Cuban national. If we or our sublicensees fail to comply with
the export administration regulations, we may be subject to both civil and criminal penalties.
There can be no guarantee that any license application will be approved by BIS or that a license,
once issued, will not be revoked, modified, suspended or otherwise restricted for reasons beyond
our control due to a change in U.S.-Cuba policy or for other reasons.
We may not be successful in establishing additional strategic collaborations, which could adversely
affect our ability to develop and commercialize products.
As an integral part of our ongoing research and development efforts, we periodically review
opportunities to establish new collaborations, joint ventures and strategic collaborations for the
development and commercialization of products in our development pipeline. We face significant
competition in seeking appropriate collaborators and the negotiation process is time-consuming and
complex. We may not be successful in our efforts to establish additional strategic collaborations
or other alternative arrangements. Even if we are successful in our efforts to establish a
collaboration or agreement, the terms that we establish may not be favorable to us. Finally, such
strategic alliances or other arrangements may not result in successful products and associated
revenue.
Risks Relating to the Life Sciences Industry, Our Business, Strategy and Operations
We face substantial competition, which may result in our competitors discovering, developing or
commercializing products before or more successfully than we do.
Our product candidates face competition with existing and new products being developed by
biotechnology, medical device and pharmaceutical companies, as well as universities and other
research institutions. For example, research in the fields of antibody-based therapeutics for the
treatment of cancer and inflammatory disease is highly competitive. A number of entities are
seeking to identify and patent antibodies, potentially active proteins and other potentially active
compounds without specific knowledge of their therapeutic function. Our competitors may discover,
characterize and develop important inducing molecules or genes in advance of us.
Many of our competitors have substantially greater capital resources, research and development
staffs and facilities than we have. Efforts by other biotechnology, medical device and
pharmaceutical companies could render our programs or products uneconomical or result in therapies
superior to those that we develop alone or with a collaborator. For those programs that we have
selected for further internal development, we face competition from companies that are more
experienced in product development and commercialization, obtaining regulatory approvals and
product manufacturing. As a result, they may develop competing products more rapidly and at a lower
cost. For those programs that are subject to a collaboration agreement, competitors may discover,
develop and commercialize products, which render our products non-competitive or obsolete. We
expect competition to intensify in antibody research as technical advances in the field are made
and become more widely known.
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The product candidates in our pipeline are in early stages of development and our efforts to
develop and commercialize these product candidates are subject to a high risk of failure. If we
fail to successfully develop our product candidates, our ability to generate revenues will be
substantially impaired.
The process of successfully developing product candidates for the treatment of human diseases
is very time-consuming, expensive and unpredictable and there is a high rate of attrition for
product candidates in preclinical and clinical trials. All of our product candidates are in early
stages of development, so we will require substantial additional financial resources, as well as
research, development and clinical capabilities, to pursue the development of these product
candidates, and we may never develop an approvable product.
We do not know whether our planned preclinical development or clinical trials for our product
candidates will begin on time or be completed on schedule, if at all. In addition, we do not know
whether these clinical trials will result in marketable products. We cannot assure you that any of
our product candidates will:
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be successfully developed; |
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prove to be safe and effective in clinical trials; |
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be approved for marketing by United States or foreign regulatory authorities; |
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be adequately protected by our intellectual property rights or the rights of our licensors; |
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be capable of being produced in commercial quantities at acceptable costs; |
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achieve market acceptance and be commercially viable; or |
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be eligible for third party reimbursement from governmental or private insurers. |
Since our product candidates may have different efficacy profiles in certain clinical
indications, sub-indications or patient profiles and we have limited resources, our election to
focus on a particular indication, sub-indication and patient profile may result in our failure to
capitalize on other potentially profitable applications of our product candidates.
We have limited financial and managerial resources. These limitations require us to focus on a
select group of product candidates in specific therapeutic areas and to forego the exploration of
other product opportunities. While our technologies may permit us to work in multiple areas,
resource commitments may require trade-offs resulting in delays in the development of certain
programs or research areas, which may place us at a competitive disadvantage. Our decisions as to
resource allocation may not lead to the development of viable commercial products and may divert
resources away from other market opportunities, which ultimately prove to be more profitable.
The development process necessary to obtain regulatory approval is lengthy, complex and expensive.
If we and our collaborative partners do not obtain necessary regulatory approvals, then our
business will be unsuccessful and the market price of our common stock will substantially decline.
To the extent that we, or our collaborative partners, are able to successfully advance a
product candidate through the clinic, we, or such partner, will be required to obtain regulatory
approval prior to marketing and selling such product.
The process of obtaining FDA and EMEA and other required regulatory approvals is expensive.
The time required for FDA and EMEA and other approvals is uncertain and typically takes a number of
years, depending on the complexity and novelty of the product candidate. The process of obtaining
FDA and EMEA and other required regulatory approvals for many of our product candidates under
development is further complicated because some of these product candidates use non-traditional or
novel materials in non-traditional or novel ways, and the regulatory officials have little
precedent to follow. Moreover, an unrelated biotech company recently observed multiple severe
adverse reactions in a Phase 1 trial of an antibody that stimulates T cells. This development could
cause the FDA and EMEA or comparable international regulatory authorities to become less supportive
of the T-cell related drugs in our portfolio. With respect to internal programs to date, we have
limited experience in filing and prosecuting applications to obtain marketing approval.
Any regulatory approval to market a product may be subject to limitations on the indicated
uses for which we, or our collaborative partners, may market the product. These limitations may
restrict the size of the market for the product and affect reimbursement by third-party payers. In
addition, regulatory agencies may not grant approvals on a timely basis or may revoke or
significantly modify previously granted approvals.
We and our collaborative partners also are subject to numerous foreign regulatory requirements
governing the manufacturing and marketing of our potential future products outside of the United
States. The approval procedure varies among countries, additional
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testing may be required in some
jurisdictions, and the time required to obtain foreign approvals often differs from that required
to obtain FDA and EMEA approvals. Moreover, approval by the FDA and EMEA does not ensure approval
by regulatory authorities in other countries, and vice versa.
As a result of these factors, we or our collaborators may not successfully begin or complete
clinical trials in the time periods estimated, if at all. Moreover, if we or our collaborators
incur costs and delays in development programs or fail to successfully develop and commercialize
products based upon our technologies, we may not become profitable and our stock price could
decline.
We and our collaborators are subject to governmental regulations other than those imposed by the
FDA and EMEA. We, and any of our collaborators, may not be able to comply with these regulations,
which could subject us, or such collaborators, to penalties and otherwise result in the limitation
of our or such collaborators operations.
In addition to regulations imposed by the FDA, EMEA and other international regulatory
agencies, we and our collaborators are subject to regulation under the Occupational Safety and
Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Research
Conservation and Recovery Act, as well as regulations administered by the Nuclear Regulatory
Commission, national restrictions on technology transfer, import, export and customs regulations
and certain other local, state or federal regulations, or their foreign counterparts. From time to
time, other federal agencies and congressional committees or international governmental bodies have
indicated an interest in implementing further regulation of biotechnology applications. We are not
able to predict whether any such regulations will be adopted or whether, if adopted, such
regulations will apply to our business, or whether we or our collaborators would be able to comply
with any applicable regulations.
We expect to rely heavily on third parties for the conduct of clinical trials of our product
candidates. If these clinical trials are not successful, or if we or our collaborators are not able
to obtain the necessary regulatory approvals, we will not be able to commercialize our product
candidates.
In order to obtain regulatory approval for the commercial sale of our product candidates, we
and our collaborators will be required to complete extensive preclinical studies as well as
clinical trials in humans to demonstrate to the FDA, EMEA and other foreign regulatory authorities
that our product candidates are safe and effective. We have limited experience in conducting
clinical trials and expect to rely primarily on collaborative partners and contract research organizations for
their performance and management of clinical trials of our product candidates.
Clinical development, including preclinical testing, is a long, expensive and uncertain
process. Accordingly, preclinical testing and clinical trials, if any, of our product candidates
under development may not be successful. We and our collaborators could experience delays in
preclinical or clinical trials of any of our product candidates, obtain unfavorable results in a
development program, or fail to obtain regulatory approval for the commercialization of a product.
Preclinical studies or clinical trials may produce negative, inconsistent or inconclusive results,
and we or our collaborators may decide, or regulators may require us, to conduct additional
preclinical studies or clinical trials. The results from early clinical trials may not be
statistically significant or predictive of results that will be obtained from expanded, advanced
clinical trials.
Furthermore, the timing and completion of clinical trials, if any, of our product candidates
depend on, among other factors, the number of patients we will be required to enroll in the
clinical trials and the rate at which those patients are enrolled. Any increase in the required
number of patients, decrease in recruitment rates or difficulties retaining study participants may
result in increased costs, program delays or both.
Also, our products under development may not be effective in treating any of our targeted
disorders or may prove to have undesirable or unintended side effects, toxicities or other
characteristics that may prevent or limit their commercial use. Institutional review boards or
regulators, including the FDA and the EMEA, may hold, suspend or terminate our clinical research or
the clinical trials of our product candidates for various reasons, including non-compliance with
regulatory requirements or if, in their opinion, the participating subjects are being exposed to
unacceptable health risks. Additionally, the failure of third parties conducting or overseeing the
operation of the clinical trials to perform their contractual or regulatory obligations in a timely
fashion could delay the clinical trials. Failure of clinical trials can occur at any stage of
testing. Any of these events would adversely affect our ability to market a product candidate.
Our growth could be limited if we are unable to attract and retain key personnel and consultants.
Our success depends on the ability to attract, train and retain qualified scientific and
technical personnel to further our research and development efforts. The loss of services of one or
more of our key employees or consultants could have a negative impact on our business and operating
results. Locating candidates with the appropriate qualifications can be difficult. Although we
expect to be able to attract and retain sufficient numbers of highly skilled employees for the
foreseeable future, we may not be able to do so.
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Any growth and expansion into areas and activities that may require additional human resources
or expertise, such as regulatory affairs and compliance, would require us to either hire new key
personnel or obtain such services via an outsourcing arrangement. The pool of personnel with the
skills that we require is limited, and we may not be able to hire or contract such additional
personnel.
If our third-party manufacturers facilities do not follow current good manufacturing practices,
our product development and commercialization efforts may be harmed.
There are a limited number of manufacturers that operate under the FDAs and EMEAs good
manufacturing practices regulations and are capable of manufacturing products. Third-party
manufacturers may encounter difficulties in achieving quality control and quality assurance and may
experience shortages of qualified personnel. A failure of third-party manufacturers to follow
current good manufacturing practices or other regulatory requirements and to document their
adherence to such practices may lead to significant delays in the availability of products for
commercial use or clinical study, the termination of, or hold on a clinical study, or may delay or
prevent filing or approval of marketing applications for our products. In addition we could be
subject to sanctions being imposed on us, including fines, injunctions and civil penalties.
Changing manufacturers may require additional clinical trials and the revalidation of the
manufacturing process and procedures in accordance with FDA and EMEA mandated current good
manufacturing practices and will require FDA and EMEA approval. This revalidation may be costly and
time consuming. If we are unable to arrange for third-party manufacturing of our products, or to do
so on commercially reasonable terms, we may not be able to complete development or marketing of our
products.
If we fail to obtain an adequate level of reimbursement for our products by third-party payors,
there may be no commercially viable markets for our products or the markets may be much smaller
than expected.
If any of our product candidates are approved for marketing, the availability and levels of
reimbursement by governmental and other third-party payors will affect the market for our products.
The efficacy, safety and cost-effectiveness of our products as well as the efficacy, safety and
cost-effectiveness of any competing products will determine the availability and level of
reimbursement. These third-party payors continually attempt to contain or reduce the costs of
healthcare by challenging the prices charged for healthcare products and services. In certain
countries, particularly the countries of the European Union, the pricing of prescription
pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with
governmental authorities can take six to twelve months or longer after the receipt of regulatory
marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we
may be required to conduct clinical trials that compare the cost-effectiveness of our products to
other available therapies. If reimbursement for our products is unavailable or limited in scope or
amount or if pricing is set at unsatisfactory levels, our revenues would be reduced.
Another development that may affect the pricing of drugs is regulatory action regarding drug
reimportation into the United States. The Medicare Prescription Drug, Improvement and Modernization
Act of 2003, which became law in December 2003, requires the Secretary of the U.S. Department of
Health and Human Services to promulgate regulations allowing drug reimportation from Canada into
the United States under certain circumstances. These provisions will become effective only if the
Secretary certifies that such imports will pose no additional risk to the publics health and
safety and result in significant cost savings to consumers. To date, the Secretary has made no such
finding, but he could do so in the future. Proponents of drug reimportation may also attempt to
pass legislation that would remove the requirement for the Secretarys certification or allow
reimportation under circumstances beyond those anticipated under current law. If legislation is
enacted, or regulations issued, allowing the reimportation of drugs, it could decrease the
reimbursement we would receive for any products that we may commercialize, negatively affecting our
anticipated revenues and prospects for profitability.
Even if our products are approved by regulatory authorities, if we fail to comply with ongoing
regulatory requirements, or if we experience unanticipated problems with our products, these
products could be subject to restrictions or withdrawal from the market.
Any product for which we obtain marketing approval, along with the manufacturing processes,
post-approval clinical data and promotional activities for such product, will be subject to
continual review and periodic inspections by the FDA, EMEA and other regulatory bodies. Even if
regulatory approval of a product is granted, the approval may be subject to limitations on the
indicated uses for which the product may be marketed or contain requirements for costly
post-marketing testing and surveillance to monitor the safety or efficacy of the product. Later
discovery of previously unknown problems with our products, including unanticipated adverse events
or adverse events of unanticipated severity or frequency, manufacturer or manufacturing processes,
or failure to comply with regulatory requirements, may result in restrictions on such products or
manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recall,
fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil
or criminal penalties.
Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our
products abroad.
We intend to market our drugs in international markets. In order to market our products in the
European Union and many other foreign jurisdictions, we must obtain separate regulatory approvals.
The approval procedure varies among countries and can involve additional testing, and the time
required to obtain approval may differ from that required to obtain FDA and EMEA approval. The
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foreign regulatory approval process may include all of the risks associated with obtaining FDA and
EMEA approval. We may not obtain foreign regulatory approvals on a timely basis, if at all.
Approval by the FDA and EMEA does not ensure approval by regulatory authorities in other countries,
and approval by one foreign regulatory authority does not ensure approval by regulatory authorities
in other foreign countries or by the FDA and EMEA. We may not be able to file for regulatory
approvals and may not receive necessary approvals to commercialize our products in any market.
We are subject to uncertainty relating to health care reform measures and reimbursement policies
which, if not favorable to our product candidates, could hinder or prevent our product candidates
commercial success.
The continuing efforts of the government, insurance companies, managed care organizations and
other payors of health care costs to contain or reduce costs of health care may adversely affect:
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our ability to generate revenues and achieve profitability; |
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the future revenues and profitability of our potential customers, suppliers and collaborators; and |
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the availability of capital. |
In certain foreign markets, the pricing of prescription pharmaceuticals is subject to
government control. In the United States, given recent federal and state government initiatives
directed at lowering the total cost of health care, the U.S. Congress and state legislatures will
likely continue to focus on health care reform, the cost of prescription pharmaceuticals and on the
reform of the Medicare and Medicaid systems. For example, legislation was enacted on December 8,
2003, which provides a new Medicare prescription drug benefit that began in 2006 and mandates other
reforms. While we cannot predict the full effects of the implementation of this new legislation or
whether any legislative or regulatory proposals affecting our business will be adopted, the
implementation of this legislation or announcement or adoption of these proposals could have a
material and adverse effect on our business, financial condition and results of operations.
Our ability to commercialize our product candidates successfully will depend in part on the
extent to which governmental authorities, private health insurers and other organizations establish
appropriate reimbursement levels for the cost of our products and related treatments. Third-party
payors are increasingly challenging the prices charged for medical products and services. Also, the
trend toward managed health care in the United States, which could significantly influence the
purchase of health care services and products, as well as legislative proposals to reform health
care or reduce government insurance programs, may result in lower prices for our product candidates
or exclusion of our product candidates from reimbursement programs. The cost containment measures
that health care payors and providers are instituting and the effect of any health care reform could
materially and adversely affect our results of operations.
We face the risk of product liability claims and may not be able to obtain insurance.
Our business exposes us to the risk of product liability claims that is inherent in the
testing, manufacturing, and marketing of drugs and related devices. Although we have product
liability and clinical trial liability insurance that we believe is appropriate, this insurance is
subject to deductibles and coverage limitations. We may not be able to obtain or maintain adequate
protection against potential liabilities. In addition, if any of our product candidates are
approved for marketing, we may seek additional insurance coverage. If we are unable to obtain
insurance at acceptable cost or on acceptable terms with adequate coverage or otherwise protect
against potential product liability claims, we will be exposed to significant liabilities, which
may harm our business. These liabilities could prevent or interfere with our product
commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert
management attention and might result in adverse publicity or reduced acceptance of our products in
the market.
Our operations involve hazardous materials and we must comply with environmental laws and
regulations, which can be expensive.
Our research and development activities involve the controlled use of hazardous materials,
including chemicals and radioactive and biological materials. Our operations also produce hazardous
waste products. We are subject in the United States to a variety of federal, state and local
regulations, and in Europe to European, national, state and local regulations, relating to the use,
handling, storage and disposal of these materials. We generally contract with third parties for the
disposal of such substances and store certain low-level radioactive waste at our facility until the
materials are no longer considered radioactive. We cannot eliminate the risk of accidental
contamination or injury from these materials. We may be required to incur substantial costs to
comply with current or future environmental and safety regulations. If an accident or contamination
occurred, we would likely incur significant costs associated with civil penalties or criminal fines
and in complying with environmental laws and regulations. We do not have any insurance for
liabilities arising from hazardous materials. Compliance with environmental laws and regulations is
expensive, and current or future environmental regulation may impair our research, development or
production efforts.
If physicians and patients do not accept the products that we may develop, our ability to generate
product revenue in the future will be adversely affected.
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The product candidates that we may develop may not gain market acceptance among physicians,
healthcare payors, patients and the medical community. Market acceptance of and demand for any
product that we may develop will depend on many factors, including:
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our ability to provide acceptable evidence of safety and efficacy; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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availability of alternative treatments; |
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cost effectiveness; |
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effectiveness of our marketing strategy and the pricing of any product that we may develop; |
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publicity concerning our products or competitive products; and |
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our ability to obtain third-party coverage or reimbursement. |
Legislative or regulatory reform of the healthcare system may affect our ability to sell our
products profitably.
In both the United States and certain foreign jurisdictions, there have been a number of
legislative and regulatory changes to the healthcare system in ways that could impact upon our
ability to sell our products profitably. In the United States in recent years, new legislation has
been enacted at the federal and state levels that would effect major changes in the healthcare
system, either nationally or at the state level. These new laws include a prescription drug benefit
for Medicare beneficiaries and certain changes in Medicare reimbursement. Given the recent
enactment of these laws, it is still too early to determine its impact on the pharmaceutical
industry and our business. Further federal and state proposals are likely. More recently,
administrative proposals are pending and others have become effective that would change the method
for calculating the reimbursement of certain drugs. The adoption of these proposals and potential
adoption of pending proposals may affect our ability to raise capital, obtain additional
collaborators or market our products. Such proposals may reduce our revenues, increase our expenses
or limit the markets for our products. In particular, we expect to experience pricing pressures in
connection with the sale of our products due to the trend toward managed health care, the
increasing influence of health maintenance organizations and additional legislative proposals.
Risks Relating to Our Intellectual Property and Litigation
Our success depends on our ability to maintain and enforce our licensing arrangements with various
third party licensors.
We are party to intellectual property licenses and agreements that are important to our
business and expect to enter into similar licenses and agreements in the future. These licenses and
agreements impose various research, development, commercialization, sublicensing, royalty,
indemnification, insurance and other obligations on us. If we or our collaborators fail to perform
under these agreements or otherwise breach obligations thereunder, we could lose intellectual
property rights that are important to our business.
We may become involved in expensive patent litigation or other intellectual property proceedings,
which could result in liability for damages or require us to stop our development and
commercialization efforts.
There has been significant litigation in the biotechnology industry over patents and other
proprietary rights. Our patents and patents that we have licensed the rights to may be the subject
of other challenges by our competitors in Europe, the United States and elsewhere. Furthermore, our
patents and the patents that we have licensed the rights to may be circumvented, challenged,
narrowed in scope, declared invalid, or unenforceable. Legal standards relating to the scope of
claims and the validity of patents in the biotechnology field are still evolving, and no assurance
can be given as to the degree of protection any patents issued to or licensed to us would provide.
The defense and prosecution of intellectual property suits and related legal and administrative
proceedings can be both costly and time consuming. Litigation and interference proceedings could
result in substantial expense to us and significant diversion of effort by our technical and
management personnel. Further, the outcome of patent litigation is subject to uncertainties that
cannot be adequately quantified in advance, including the demeanor and credibility of witnesses and
the identity of the adverse party. This is especially true in biotechnology related patent cases
that may turn on the testimony of experts as to technical facts upon which experts may reasonably
disagree. An adverse determination in an interference proceeding or litigation to which we may
become a party could subject us to significant liabilities to third parties or require us to seek
licenses from third parties. If required, the necessary licenses may not be available on acceptable
terms or at all. Adverse determinations in a judicial or administrative proceeding or failure to
obtain necessary licenses could prevent us from commercializing our product candidates, which could
have a material and adverse effect on our business, financial condition and results of operations.
40
We cannot be certain we will be able to obtain additional patent protection to protect our product
candidates and technology.
We cannot be certain that patents will be issued on our product candidates as a result of
pending applications filed to date. If a third party has also filed a patent application relating
to an invention claimed by us or our licensors, we may be required to participate in an
interference proceeding in the United States or in one or more foreign jurisdictions to determine
priority of invention, which could result in substantial uncertainties and cost for us, even if the
eventual outcome is favorable to us. The degree of future protection for our proprietary rights is
uncertain. For example:
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we or our licensors might not have been the first to make the inventions covered by each
of our patents and our pending patent applications; |
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we or our licensors might not have been the first to file patent applications for these inventions; |
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others may independently develop similar or alternative technologies or duplicate any of our technologies; |
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it is possible that none of our pending patent applications will result in issued patents; |
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any patents under which we hold rights may not provide us with a basis for
commercially-viable products, may not provide us with any competitive advantages or may be
challenged by third parties as not infringed, invalid, or unenforceable under United States
or foreign laws; |
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any of the issued patents under which we hold rights may not be valid or enforceable; or |
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we may develop additional proprietary technologies that are not patentable and which may
not be adequately protected through trade secrets, for example, if a competitor
independently develops duplicative, similar, or alternative technologies. |
If we are not able to protect and control our unpatented trade secrets, know-how and other
technological innovation, we may suffer competitive harm.
We also rely on proprietary trade secrets and unpatented know-how to protect our research,
development and manufacturing activities, particularly when we do not believe that patent
protection is appropriate or available. However, trade secrets are difficult to protect. We attempt
to protect our trade secrets and unpatented know-how by requiring our employees, consultants and
advisors to execute a confidentiality and non-use agreement. We cannot guarantee that these
agreements will provide meaningful protection, that these agreements will not be breached, that we
will have an adequate remedy for any such breach, or that our trade secrets will not otherwise
become known or independently developed by a third party. Our trade secrets, and those of our
present or future collaborators that we utilize by agreement, may become known or may be independently
discovered by others, which could adversely affect the competitive position of our product
candidates.
If our products violate third party patents or were derived from a patients cell lines without the
patients consent, we could be forced to pay royalties or cease selling our products.
Our commercial success will depend in part on not infringing the patents or violating the
proprietary rights of third parties. We are aware of competing intellectual property relating to
our areas of practice. Competitors or third parties may obtain patents that may cover subject
matter we use in developing the technology required to bring our products to market, that we use in
producing our products, or that we use in treating patients with our products.
In addition, from time to time we receive correspondence inviting us to license patents from
third parties. There has been, and we believe that there will continue to be, significant
litigation in the pharmaceutical industry regarding patent and other intellectual property rights.
While we believe that our pre-commercialization activities fall within the scope of an available
exemption against patent infringement provided by 35 U.S.C. § 271(e), and that our subsequent
manufacture of our commercial products, if any, will also not require the license of any of these
patents, claims may be brought against us in the future based on these or other patents held by
others.
Third parties could bring legal actions against us claiming we infringe their patents or
proprietary rights, and seek monetary damages and seeking to enjoin clinical testing, manufacturing
and marketing of the affected product or products. If we become involved in any litigation, it
could consume a substantial portion of our resources, regardless of the outcome of the litigation.
If any of these actions are successful, in addition to any potential liability for damages, we
could be required to obtain a license to continue to manufacture or market the affected product, in
which case we may be required to pay substantial royalties or grant cross-licenses to our patents.
However, there can be no assurance that any such license will be available on acceptable terms or
at all. Ultimately, we could be prevented from commercializing a product, or forced to cease some
aspect of our business operations, as a result of claims of patent infringement or violation of
other intellectual property rights, which could harm our business.
41
We know that others have filed patent applications in various countries that relate to several
areas in which we are developing products. Some of these patent applications have already resulted
in patents and some are still pending. The pending patent applications may also result in patents
being issued. In addition, patent applications are secret until patents are published in the United
States or foreign countries, and in certain circumstances applications are not published until a
patent issues, so it may not be possible to be fully informed of all relevant third party patents.
Publication of discoveries in the scientific or patent literature often lags behind actual
discoveries. All issued patents are entitled to a presumption of validity under the laws of the
United States and certain other countries. Issued patents held by others may therefore limit our
ability to develop commercial products. If we need licenses to such patents to permit us to develop
or market our product candidates, we may be required to pay significant fees or royalties and we
cannot be certain that we would be able to obtain such licenses at all.
We may incur substantial costs enforcing our patents, defending against third-party patents,
invalidating third-party patents or licensing third-party intellectual property, as a result of
litigation or other proceedings relating to patent and other intellectual property rights.
We may not have rights under some patents or patent applications that may cover technologies
that we use in our research, drug targets that we select, or product candidates that we seek to
develop and commercialize. Third parties may own or control these patents and patent applications
in the United States and abroad. These third parties could bring claims against us, or our
collaborators that would cause us to incur substantial expenses and, if successful against us,
could cause us to pay substantial damages. Further, if a patent infringement suit were brought
against us, or our collaborators, we or they could be forced to stop or delay research,
development, manufacturing or sales of the product or product candidate that is the subject of the
suit. We, or our collaborators therefore may choose to seek, or be required to seek, a license from
the third-party and would most likely be required to pay license fees or royalties or both. These
licenses may not be available on acceptable terms, or at all. Even if we, or our collaborators were
able to obtain a license, the rights may be nonexclusive, which would give our competitors access
to the same intellectual property. Ultimately, we could be prevented from commercializing a
product, or forced to cease some aspect of our business operations, as a result of patent
infringement claims, which could harm our business.
There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries. Although we are
not currently a party to any patent litigation or any other adversarial proceeding, including any
interference proceeding declared before the United States Patent and Trademark Office, regarding
intellectual property rights with respect to our products and technology, we may become so in the
future. We are not currently aware of any actual or potential third party infringement claim
involving our product candidates. The cost to us of any patent litigation or other proceeding, even
if resolved in our favor, could be substantial. The outcome of patent litigation is subject to
uncertainties that cannot be adequately quantified in advance, including the demeanor and
credibility of witnesses and the identity of the adverse party, especially in biotechnology related
patent cases that may turn on the testimony of experts as to technical facts upon which experts may
reasonably disagree. Some of our competitors may be able to sustain the costs of such litigation or
proceedings more effectively than we can because of their substantially greater financial
resources. If a patent or other proceeding is resolved against us, we may be enjoined
from researching, developing, manufacturing or commercializing our products without a license
from the other party and we may be held liable for significant damages. We may not be able to
obtain any required license on commercially acceptable terms or at all.
Uncertainties resulting from the initiation and continuation of patent litigation or other
proceedings could harm our ability to compete in the marketplace. Patent litigation and other
proceedings may also absorb significant management time.
We may not be successful in our efforts to expand our portfolio of drugs and develop additional
delivery technologies.
A key element of our strategy is to discover, develop and commercialize a portfolio of new
drugs and technologies to deliver those drugs safely and efficiently. We are seeking to do so
through our internal research programs and in-licensing. A significant portion of the research that
we are conducting involves new and unproven technologies. Research programs to identify new disease
targets, product candidates and delivery technologies require substantial technical, financial and
human resources whether or not any candidates or technologies are ultimately identified. Our
research programs may initially show promise in identifying potential product candidates or
delivery technologies, yet fail to yield product candidates or delivery technologies for clinical
development for any of the following reasons:
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research methodology used may not be successful in identifying potential product candidates; |
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potential delivery technologies may not safely or efficiently deliver our drugs; and |
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product candidates may on further study be shown to have harmful side effects or other
characteristics that indicate they are unlikely to be safe or effective drugs. |
If we are unable to discover suitable potential product candidates, develop additional
delivery technologies through internal research programs or in-license suitable products or
delivery technologies on acceptable business terms, our business prospects will suffer.
42
If we are unable to protect our intellectual property rights, our competitors may develop and
market products with similar features that may reduce demand for our potential products.
The following factors are important to our success:
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receiving patent protection for our product candidates; |
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preventing others from infringing our intellectual property rights; |
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maintaining our patent rights and trade secrets; and |
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protecting our trademarks. |
We will be able to protect our intellectual property rights in patents and trade secrets from
unauthorized use by third parties only to the extent that such intellectual property rights are
covered by valid and enforceable patents or are effectively maintained as trade secrets.
To date, we have sought to protect our proprietary positions by filing U.S. and foreign patent
applications related to our important proprietary technology, inventions and improvements. Because
the patent position of pharmaceutical companies involves complex legal and factual questions, the
issuance, scope and enforceability of patents cannot be predicted with certainty. Patents, if
issued, may be challenged, invalidated or circumvented. U.S. patents and patent applications may
also be subject to interference proceedings, and U.S. patents may be subject to reexamination
proceedings in the U.S. Patent and Trademark Office and foreign patents may be subject to
opposition or comparable proceedings in corresponding foreign patent offices, which proceedings
could result in either loss of the patent or denial of the patent application or loss or reduction
in the scope of one or more of the claims of the patent or patent application. In addition, such
interference, reexamination and opposition proceedings may be costly. Thus, any patents that we own
or license from others may not provide any protection against competitors. Furthermore, an adverse
decision in an interference proceeding can result in a third-party receiving the patent rights
sought by us, which in turn could affect our ability to market a potential product to which that
patent filing was directed. Our pending patent applications, those that we may file in the future,
or those that we may license from third parties may not result in patents being issued. If issued,
they may not provide us with proprietary protection or competitive advantages against competitors
with similar technology. Furthermore, others may independently develop similar technologies or
duplicate any technology that we have developed. We rely on third-party payment services for the
payment of foreign patent annuities and other fees. Non-payment or delay in payment of such fees,
whether intentional or unintentional, may result in loss of patents or patent rights important to
our business. Many countries, including certain countries in Europe, have compulsory licensing laws
under which a patent owner may be compelled to grant licenses to third parties. For example,
compulsory licenses may be required in cases where the patent owner has failed to work the
invention in that country, or the third-party has patented improvements. In addition, many
countries limit the enforceability of patents against government agencies or government
contractors. In these countries, the patent owner may have limited remedies, which could materially
diminish the value of the patent. Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the aggressive enforcement
of patent and other intellectual property protection, which makes it difficult to stop
infringement.
In addition, our ability to enforce our patent rights depends on our ability to detect
infringement. We are not currently aware of any actual or potential infringement claim involving
our intellectual property rights. It is difficult to detect infringers who do not advertise the
compounds that are used in their products. Any litigation to enforce or defend our patent rights,
even if we prevail, could be costly and time-consuming and would divert the attention of management
and key personnel from business operations.
We have also relied on trade secrets, know-how and technology, which are not protected by
patents, to maintain our competitive positions. We have sought to protect this information by
entering into confidentiality agreements with parties that have access to it, such as strategic
partners, collaborators, employees and consultants. Any of these parties may breach these
agreements and disclose our confidential information or our competitors might learn of the
information in some other way. If any trade secret, know-how or other technology not protected by a
patent were disclosed to, or independently developed by a competitor, our business, financial
condition and results of operations could be materially adversely affected.
If licensees or assignees of our intellectual property rights breach any of the agreements under
which we have licensed or assigned our intellectual property to them, we could be deprived of
important intellectual property rights and future revenue.
We are a party to intellectual property out-licenses, collaborations and agreements that are
important to our business and expect to enter into similar agreements with third parties in the
future. Under these agreements, we license or transfer intellectual property to third parties and
impose various research, development, commercialization, sublicensing, royalty, indemnification,
insurance, and other obligations on them. If a third party fails to comply with these requirements,
we generally retain the right to terminate the agreement, and to bring a legal action in court or
in arbitration. In the event of breach, we may need to enforce our rights under these agreements by
resorting to arbitration or litigation. During the period of arbitration or litigation, we may be
unable to effectively use, assign or
43
license the relevant intellectual property rights and may be
deprived of current or future revenues that are associated with such intellectual property.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or
disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at other biotechnology or pharmaceutical
companies, including our competitors or potential competitors. Although no claims against us are
currently pending, we may be subject to claims that these employees or we have inadvertently or
otherwise used or disclosed trade secrets or other proprietary information of their former
employers. Litigation may be necessary to defend against these claims. Even if we are successful in
defending against these claims, litigation could result in substantial costs and be a distraction
to management. If we fail in defending such claims, in addition to paying money claims, we may lose
valuable intellectual property rights or personnel. A loss of key personnel or their work product
could hamper or prevent our ability to commercialize certain product candidates, which would
adversely affect commercial development efforts.
We may become involved in securities class action litigation that could divert managements
attention and harm our business.
The stock market has from time to time experienced significant price and volume fluctuations
that have affected the market prices for the common stock of pharmaceutical and biotechnology
companies. These broad market fluctuations may cause the market price of our common stock to
decline. In the past, following periods of volatility in the market price of a particular companys
securities, securities class action litigation has often been brought against that company. We may
become involved in this type of litigation in the future. Litigation often is expensive and diverts
managements attention and resources, which could adversely affect our business.
Risks Relating to the Merger
We will need to modify our finance and accounting systems, procedures and controls to integrate the
operations of CancerVax into the operations of Micromet, which modifications may be time consuming
and expensive to implement, and there is no guarantee that we will be able to do so.
As a public reporting company, we are required to comply with the Sarbanes-Oxley Act of 2002
and the related rules and regulations of the Securities and Exchange Commission, including Section
404 of the Sarbanes-Oxley Act of 2002. As a result of the merger between CancerVax and Micromet AG,
we will need to upgrade the existing, and implement additional, procedures and controls to
incorporate the operations of Micromet AG. These updates may require significant time and expense,
and there can be no guarantee that we will be successful in implementing them. Furthermore, certain
of the managerial, financial and accounting personnel who worked for CancerVax prior to its merger
with Micromet AG have terminated their employment with us. The loss of these personnel could limit
our ability to successfully complete these updates. If we are unable to complete the required
modifications to our internal control reporting or if our independent registered public accounting
firm is unable to provide us with an unqualified report as to the effectiveness of our internal
control over financial reporting, investors could lose confidence in the reliability of our
internal control over financial reporting, which could have a material adverse effect on our stock
price.
Integrating our business operations may divert managements attention away from our operations.
The successful integration of CancerVax into Micromets technical and business operations may
place a significant burden on our management and internal resources. The diversion of managements
attention and any difficulties encountered in the transition and integration process could result
in delays in our clinical trials and product development programs and could otherwise harm our
business, financial condition and operating results.
If one or more of our product candidates cannot be shown to be safe and effective in clinical
trials, is not approvable or not commercially successful, then the benefits of the merger may not
be realized.
Following the merger, we have two product candidates in clinical trials, and we plan to
commence clinical trials for at least one additional product candidate in 2007. All of these
product candidates must be rigorously tested in clinical trials, and be shown to be safe and
effective before the FDA, the EMEA or other regulatory authorities. will consider them for
approval. Failure to demonstrate that one or more of our product candidates is safe and effective,
or significant delays in demonstrating such safety and efficacy, could diminish the benefits of the
merger. Failure to obtain marketing approval of one or more of our product candidates from
appropriate regulatory authorities, or significant delays in obtaining such approval, could
diminish the benefits of the merger. If approved for sale, our product candidates must be
successfully commercialized. Failure to successfully commercialize one or more of our product
candidates could diminish the benefits of the merger.
The merger may result in dilution of future earnings per share to the former stockholders of
CancerVax and Micromet.
The merger may result in greater net losses or a weaker financial condition compared to that,
which would have been achieved by either CancerVax or Micromet on a stand-alone basis. The merger
could fail to produce the benefits that the companies anticipated, or
44
could have other adverse effects that the companies did not foresee. In addition, some of the assumptions that either
company made in connection with the decision to complete the merger, such as the achievement of
operating synergies, may not be realized. In this event, the merger could result in greater losses
as compared to the losses that would have been incurred by either CancerVax or Micromet if the
merger had not occurred.
Risks Relating to Our Product Manufacturing and Sales
We will depend on our collaborators and third-party manufacturers to produce most, if not all, of
our products under development, and if these third parties do not successfully manufacture these
products our business will be harmed.
We have no manufacturing experience or manufacturing capabilities for clinical or commercial
material. In order to continue to develop product candidates, apply for regulatory approvals, and
commercialize our products, we or our collaborators must be able to manufacture products in
clinical and commercial quantities, in compliance with regulatory requirements, at acceptable costs
and in a timely manner. The manufacture of our product candidates may be complex, difficult to
accomplish and difficult to scale-up when large-scale production is required. Manufacture may be
subject to delays, inefficiencies and poor or low yields of quality products. The cost of
manufacturing some of our products may make them prohibitively expensive. If supplies of any of our
product candidates or related materials become unavailable on a timely basis or at all or are
contaminated or otherwise lost, clinical trials by us and our collaborators could be seriously
delayed. This is due to the fact that such materials are time-consuming to manufacture and cannot
be readily obtained from third-party sources.
To the extent that we, or our collaborators, seek to enter into manufacturing arrangements
with third parties, we and such collaborators will depend upon these third parties to perform their
obligations in a timely and effective manner and in accordance with government regulations.
Contract manufacturers may breach their manufacturing agreements because of factors beyond our
control or may terminate or fail to renew a manufacturing agreement based on their own business
priorities at a time that is costly or inconvenient for us. Contract manufacturers are subject to
ongoing periodic, unannounced inspection by the FDA and EMEA and corresponding state and foreign
agencies or their designees to ensure strict compliance with current good manufacturing practices
and other governmental regulations and corresponding foreign standards. Failure of contract
manufacturers or our collaborators or us to comply with applicable regulations could result in
sanctions being imposed, including fines, injunctions, civil penalties, failure of regulatory
authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal
of approvals, seizures or recalls of product candidates, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect our business. If we need to
change manufacturers, the FDA, EMEA and corresponding foreign regulatory agencies must approve
these manufacturers in advance. This would involve testing and pre-approval inspections to ensure
compliance with FDA, EMEA and other foreign regulations and standards. If third-party manufacturers
fail to perform their obligations, our competitive position and ability to generate revenue may be
adversely affected in a number of ways, including:
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we and our collaborators may not be able to initiate or continue clinical trials of
products that are under development; |
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we and our collaborators may be delayed in submitting applications for regulatory
approvals for our product candidates; and |
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we and our collaborators may not be able to meet commercial demands for any approved
products. |
We have no sales or marketing experience and, as such, will depend significantly on third parties
who may not successfully sell our products.
We have no sales, marketing or product distribution experience. If we receive required
regulatory approvals, we plan to rely primarily on sales, marketing and distribution arrangements
with third parties, including our collaborative partners. For example, as part of our agreements
with Serono and MedImmune, we have granted our collaborators rights to distribute certain products
resulting from such collaborations, if any are ever successfully developed. We may have to enter
into additional marketing arrangements in the future and we may not be able to enter into these
additional arrangements on terms which are favorable to us, if at all. In addition, we may have
limited or no control over the sales, marketing and distribution activities of these third parties
and sales through these third parties could be less profitable to us than direct sales. These third
parties could sell competing products and may devote insufficient sales efforts to our products.
Our future revenues will be materially dependent upon the success of the efforts of these third
parties.
We may seek to independently market products that are not already subject to marketing
agreements with other parties. If we determine to perform sales, marketing and distribution
functions ourselves, we could face a number of additional risks, including:
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we may not be able to attract and build a significant and skilled marketing staff or
sales force; |
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the cost of establishing a marketing staff or sales force may not be justifiable in
light of the revenues generated by any particular product; and |
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our direct sales and marketing efforts may not be successful. |
45
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
A special meeting of CancerVax stockholders was held on May 3, 2006 for the following
purposes:
1. To consider and vote upon a proposal to approve the issuance of CancerVax common stock
pursuant to the Agreement and Plan of Merger and Reorganization, dated as of January 6, 2006 and
amended as of March 17, 2006, by and among CancerVax, Carlsbad Acquisition Corporation, a
wholly-owned subsidiary of CancerVax, Micromet Holdings, Inc., and Micromet AG, and the resulting
change of control of CancerVax.
2. To approve an amendment to CancerVaxs amended and restated certificate of incorporation to
increase the number of authorized shares of common stock from 75,000,000 shares to 150,000,000
shares, representing an additional 75,000,000 shares.
3. To authorize the board of directors of CancerVax to amend in its discretion
CancerVaxs amended and restated certificate of incorporation to effect a reverse stock split of
the CancerVax common stock, at a ratio within the range of 1:2 to 1:4, and at such ratio to be
determined by the board of directors of CancerVax.
4. To approve an amendment to CancerVaxs amended and restated certificate of incorporation to
change the name of CancerVax Corporation to Micromet, Inc.
5. To elect three directors for a three-year term to expire at the 2009 annual meeting of
stockholders, subject to the restructuring of the board of directors upon completion of the merger.
6. To ratify the selection of Ernst & Young LLP as our independent registered public
accounting firm for the fiscal year ending December 31, 2006.
7. To consider and vote upon an adjournment of the annual meeting, if necessary, if a quorum
was present, to solicit additional proxies if there are not sufficient votes in favor of Proposal
Nos. 1 through 6.
8. To transact such other business as may properly come before the annual meeting or any
adjournment or postponement thereof.
Proxies for the special meeting were solicited pursuant to Section 14(a) of the Securities Exchange
Act of 1934, as amended, and there was no solicitation in opposition of managements solicitations.
Each proposal presented at the meeting was approved. The final vote on the proposals were recorded
on a pre-split basis as follows:
Proposal No. 1:
Issuing shares of CancerVax common stock in the merger combining CancerVax and Micromet, and the
resulting change of control of CancerVax.
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For |
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13,074,065 |
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Against |
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64,669 |
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Abstain |
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3,600 |
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Broker Non-Votes |
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6,318,454 |
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Proposal No. 2:
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Amendment of the certificate of incorporation of CancerVax to increase the number of authorized
shares of common stock from 75,000,000 shares to 150,000,000 shares.
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For |
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19,301,039 |
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Against |
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142,556 |
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Abstain |
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17,192 |
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Broker Non-Votes |
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1 |
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Proposal No. 3:
Amendment of the certificate of incorporation of CancerVax, in the discretion of the board of
directors, to effect a reverse stock split of the CancerVax common stock, at a ratio within the
range of 1:2 to 1:4, and at such ratio to be determined by the board of directors.
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For |
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19,297,177 |
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Against |
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152,453 |
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Abstain |
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11,157 |
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Broker Non-Votes |
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1 |
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Proposal No. 4:
Amendment of the certificate of incorporation to change the name of CancerVax Corporation to
Micromet, Inc.
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For |
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19,372,788 |
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Against |
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61,103 |
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Abstain |
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26,895 |
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Broker Non-Votes |
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2 |
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47
Proposal No. 5:
Election of three directors for a three-year term to expire at the 2009 annual meeting of
stockholders, subject to the restructuring of the board of directors upon completion of the merger.
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David F. Hale |
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Votes For |
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19,392,859 |
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Votes Withheld |
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67,929 |
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Donald L. Morton |
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|
|
Votes For |
|
|
19,382,368 |
|
Votes Withheld |
|
|
78,422 |
|
Michael G. Carter,
M.B., Ch.B, F.R.C.P |
|
|
|
|
Votes For |
|
|
19,393,980 |
|
Votes Withheld |
|
|
66,808 |
|
Proposal No. 6:
Ratification of the selection of Ernst & Young LLP as our independent registered public accounting
firm for the fiscal year ending December 31, 2006.
|
|
|
|
|
For |
|
|
19,388,233 |
|
Against |
|
|
57,438 |
|
Abstain |
|
|
15,117 |
|
Broker Non-Votes |
|
|
0 |
|
Proposal No. 7:
Adjournment of the annual meeting, if necessary, if a quorum is present, to solicit additional
proxies if there are not sufficient votes in favor of Proposal Nos. 1 through 6.
|
|
|
|
|
For |
|
|
19,276,693 |
|
Against |
|
|
149,564 |
|
Abstain |
|
|
34,530 |
|
Broker Non-Votes |
|
|
1 |
|
Item 5. Other Information
None.
48
Item 6. Exhibits
Exhibit
|
|
|
Number |
|
Description |
|
|
|
3.1(1)
|
|
Amended and Restated Certificate of Incorporation |
3.2(2)
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Registrant |
3.3(3)
|
|
Second Amended and Restated Bylaws |
3.4(2)
|
|
First Amendment to Second Amended and Restated Bylaws of the Registrant |
3.5(4)
|
|
Second Amendment to Second Amended and Restated Bylaws of the Registrant |
3.6(5)
|
|
Certificate of Designations for Series A Junior Participating Preferred Stock |
10.1*
|
|
First Amendment to Amended and Restated Collaboration Agreement between Cell-Matrix, Inc. and Applied Molecular Evolution |
10.2(2)
|
|
Fifth Amendment to Lease between CancerVax and Marina Business Centre, LLC and American Bioscience Inc. |
10.3(6)
|
|
Third Amendment to Amended and Restated Employment Agreement Between CancerVax Corporation and David Hale |
10.4(7)
|
|
Sublease between CancerVax Corporation and Genoptix, Inc. |
10.5(7)
|
|
Consulting Agreement with William LaRue |
10.6(7)
|
|
Consulting Agreement with Hazel Aker |
10.7(8)
|
|
Assignment and Assumption of Sublease between CancerVax and American Bioscience |
10.8
|
|
Lease Termination Agreement between Micromet, Inc. and Carson Dominguez Properties |
31.1
|
|
Certification of principal executive officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934 |
31.2
|
|
Certification of principal financial officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934 |
32**
|
|
Certifications of principal executive officer and principal financial officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on December 11, 2003. |
|
(2) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on May 10, 2006. |
|
(3) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(4) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on July 26, 2006. |
|
(5) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
(6) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on May 9, 2006. |
|
(7) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on May 1, 2006. |
|
(8) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on April 20, 2006. |
|
* |
|
Portions of this agreement have been omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment. |
|
** |
|
These certifications are being furnished solely to accompany this quarterly report pursuant to
18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities
Exchange Act of 1934 and are not to be incorporated by reference into any filing of the Registrant,
whether made before or after the date hereof, regardless of any general incorporation language in
such filing. |
49
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
Dated: August 8, 2006 |
Micromet, Inc.
|
|
|
By: |
/s/ Gregor Mirow |
|
|
Gregor Mirow |
|
|
Senior Vice President Operations (Duly authorized Officer and Principal Financial Officer) |
|
50
Exhibit List
|
|
|
Number |
|
Description |
|
|
|
3.1(1)
|
|
Amended and Restated Certificate of Incorporation |
3.2(2)
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Registrant |
3.3(3)
|
|
Second Amended and Restated Bylaws |
3.4(2)
|
|
First Amendment to Second Amended and Restated Bylaws of the Registrant |
3.5(4)
|
|
Second Amendment to Second Amended and Restated Bylaws of the Registrant |
3.6(5)
|
|
Certificate of Designations for Series A Junior Participating Preferred Stock |
10.1*
|
|
First Amendment to Amended and Restated Collaboration Agreement between Cell-Matrix, Inc. and Applied Molecular Evolution |
10.2(2)
|
|
Fifth Amendment to Lease between CancerVax and Marina Business Centre, LLC and American Bioscience Inc. |
10.3(6)
|
|
Third Amendment to Amended and Restated Employment Agreement Between CancerVax Corporation and David Hale |
10.4(7)
|
|
Sublease between CancerVax Corporation and Genoptix, Inc. |
10.5(7)
|
|
Consulting Agreement with William LaRue |
10.6(7)
|
|
Consulting Agreement with Hazel Aker |
10.7(8)
|
|
Assignment and Assumption of Sublease between CancerVax and American Bioscience |
10.8
|
|
Lease Termination Agreement between Micromet, Inc. and Carson Dominguez Properties |
31.1
|
|
Certification of principal executive officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934 |
31.2
|
|
Certification of principal financial officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934 |
32**
|
|
Certifications of principal executive officer and principal financial officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on December 11, 2003. |
|
(2) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on May 10, 2006. |
|
(3) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(4) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on July 26, 2006. |
|
(5) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
(6) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on May 9, 2006. |
|
(7) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on May 1, 2006. |
|
(8) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on April 20, 2006. |
|
* |
|
Portions of this agreement have been omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment. |
|
** |
|
These certifications are being furnished solely to accompany this quarterly report pursuant to
18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities
Exchange Act of 1934 and are not to be incorporated by reference into any filing of the Registrant,
whether made before or after the date hereof, regardless of any general incorporation language in
such filing. |
51