e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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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 March 31, 2007
OR
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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 |
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(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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6707 Democracy Boulevard, Suite 505, Bethesda, MD
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20817 |
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(Address of principal executive offices)
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(Zip Code) |
(240) 752-1420
(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):
Large accelerated filer o Accelerated filer þ 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 May 1, 2007 was 31,504,065.
MICROMET, INC.
FORM 10-Q QUARTERLY REPORT
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2007
TABLE OF CONTENTS
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Page No. |
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PART I FINANCIAL INFORMATION |
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Item 1. Financial Statements (unaudited) |
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Condensed Consolidated Balance Sheets as of March 31, 2007 and December 31, 2006 |
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3 |
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Condensed Consolidated Statements of Operations for the three-month periods ended
March 31, 2007 and 2006 |
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4 |
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Condensed Consolidated Statements of Cash Flows for the three-month periods ended
March 31, 2007 and 2006 |
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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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15 |
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Item 3. Quantitative and Qualitative Disclosures about Market Risk |
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23 |
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Item 4. Controls and Procedures |
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23 |
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PART II OTHER INFORMATION |
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Item 1. Legal Proceedings |
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26 |
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Item 1A. Risk Factors |
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26 |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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41 |
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Item 3. Defaults Upon Senior Securities |
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41 |
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Item 4. Submission of Matters to a Vote of Security Holders |
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41 |
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Item 5. Other Information |
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41 |
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Item 6. Exhibits |
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42 |
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SIGNATURES |
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43 |
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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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March 31, |
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December 31, |
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2007 |
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2006 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
15,787 |
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$ |
24,301 |
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Accounts receivable |
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2,414 |
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2,319 |
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Prepaid expenses and other current assets |
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2,550 |
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2,048 |
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Total current assets |
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20,751 |
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28,668 |
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Property and equipment, net |
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3,333 |
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3,357 |
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Loans to employees |
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78 |
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Goodwill |
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6,917 |
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6,917 |
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Patents, net |
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8,442 |
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8,850 |
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Deposits and other assets |
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285 |
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243 |
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Restricted cash |
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3,099 |
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3,059 |
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Total assets |
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$ |
42,827 |
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$ |
51,172 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,775 |
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$ |
1,680 |
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Accrued expenses |
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6,777 |
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10,153 |
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Other liabilities |
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943 |
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366 |
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Short-term note |
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1,334 |
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1,320 |
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Current portion of long-term debt obligations |
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44 |
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599 |
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Current portion of deferred revenue |
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2,482 |
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2,972 |
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Total current liabilities |
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13,355 |
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17,090 |
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Deferred revenue, net of current portion |
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1,589 |
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195 |
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Other non-current liabilities |
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1,832 |
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1,961 |
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Long-term debt obligations, net of current portion |
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7,592 |
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7,408 |
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Commitments |
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Stockholders equity: |
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Preferred stock, $0.00004 par value; 10,000 shares authorized; no shares issued and
outstanding |
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Common stock, $0.00004 par value; 150,000 shares authorized; 31,504 and 31,419 shares
issued and outstanding at March 31, 2007 and December 31, 2006, respectively |
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1 |
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1 |
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Additional paid-in capital |
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164,964 |
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163,482 |
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Stock subscription receivables |
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(27 |
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Accumulated other comprehensive income |
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5,891 |
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5,869 |
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Accumulated deficit |
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(152,397 |
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(144,807 |
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Total stockholders equity |
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18,459 |
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24,518 |
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Total liabilities and stockholders equity |
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$ |
42,827 |
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$ |
51,172 |
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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 |
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March 31, |
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2007 |
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2006 |
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Revenues: |
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Collaboration agreements |
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$ |
2,545 |
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$ |
3,869 |
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License fees |
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199 |
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241 |
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Other |
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26 |
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13 |
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Total revenues |
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2,770 |
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4,123 |
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Operating expenses: |
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Research and development |
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6,710 |
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4,536 |
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General and administrative |
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3,562 |
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1,200 |
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Total operating expenses |
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10,272 |
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5,736 |
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Loss from operations |
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(7,502 |
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(1,613 |
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Other income (expense): |
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Interest expense |
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(256 |
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(454 |
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Interest income |
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126 |
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37 |
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Other income (expense) |
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42 |
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(136 |
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Net loss |
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$ |
(7,590 |
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$ |
(2,166 |
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Basic and diluted net loss per common share |
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$ |
(0.24 |
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$ |
(0.12 |
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Weighted average shares used to compute basic and
diluted net loss per share |
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31,499 |
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18,099 |
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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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Three months ended March 31, |
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2007 |
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2006 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(7,590 |
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$ |
(2,166 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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774 |
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729 |
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Non-cash interest on long-term debt obligations |
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229 |
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172 |
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Stock-based compensation expense |
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1,227 |
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Net loss on disposal of property and equipment |
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1 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(80 |
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1,276 |
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Prepaid expenses and other current assets |
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(503 |
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(1,430 |
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Accounts payable, accrued expenses and other liabilities |
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(2,796 |
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(2,317 |
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Deferred revenue |
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889 |
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(2,007 |
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Net cash used in operating activities |
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(7,849 |
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(5,743 |
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Cash flows from investing activities: |
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Proceeds from repayments of loans to employees |
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67 |
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Purchases of property and equipment |
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(36 |
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(36 |
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Restricted cash used as collateral |
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(33 |
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Net cash used in investing activities |
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(2 |
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(36 |
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Cash flows from financing activities: |
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Proceeds from issuance of preferred shares |
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4,375 |
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Proceeds from stock subscription receivable |
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27 |
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Principal payments on long-term debt obligations |
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(674 |
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(129 |
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Principal payments on capital lease obligations |
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(26 |
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(14 |
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Net cash (used in) provided by financing activities |
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(673 |
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4,232 |
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Effect of exchange rate changes on cash and cash equivalents |
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10 |
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218 |
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Net decrease in cash and cash equivalents |
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(8,514 |
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(1,329 |
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Cash and cash equivalents at beginning of period |
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24,301 |
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11,414 |
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Cash and cash equivalents at end of period |
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$ |
15,787 |
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$ |
10,085 |
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Supplemental disclosure of noncash investing and financing activities: |
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Acquisitions of equipment purchased through capital leases |
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$ |
152 |
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$ |
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Issuance of shares in connection with employee severance payment |
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$ |
250 |
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$ |
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Issuance of shares in connection with compensation for board of director services |
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$ |
5 |
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$ |
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The accompanying notes are an integral part of these financial statements.
5
Micromet, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 1. Business Overview
Micromet, Inc. (Micromet) is a biopharmaceutical company focusing on the development of
novel, proprietary antibody-based products for cancer, inflammatory and autoimmune diseases. Two
product candidates are currently in clinical trials. MT103 (also known as MEDI-538), which is the
first product candidate based on Micromets novel BiTE® product development platform, is being
evaluated in a phase 1 clinical trial for the treatment of patients with non-Hodgkins lymphoma.
The BiTE product development platform is based on a unique, antibody-based format that leverages
the cytotoxic potential of T cells, widely recognized as the most powerful killer cells of the
human immune system. Adecatumumab (also known as MT201), a recombinant human monoclonal antibody
which targets EpCAM expressing tumors, has completed two phase 2a clinical trials, one in patients
with metastatic breast cancer and the other in patients with prostate cancer. In addition, a phase
1b trial evaluating the safety and tolerability of adecatumumab in combination with docetaxel is
currently ongoing in patients with metastatic breast cancer. Micromet has established
collaborations with MedImmune, Inc. for MT103, Merck Serono for adecatumumab and TRACON
Pharmaceuticals for D93. We operate in only one business segment, which primarily focuses on the
discovery and development of antibody-based drug candidates using proprietary technologies. To
date, we have incurred significant expenses and have not achieved any product revenues from sales
of our product candidates.
Note 2. Basis of Presentation
On May 5, 2006, CancerVax Corporation (CancerVax) 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. (Micromet Holdings), 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 and other security holders 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 Global Market ticker
symbol was changed to MITI.
As former Micromet AG security holders owned approximately 67.5% of the voting stock of the
combined company immediately 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. 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, and 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 refers to the
business of CancerVax Corporation prior to the merger.
The condensed consolidated financial statements as of March 31, 2007, and for the three months
ended March 31, 2007 and 2006, 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, Inc. audited financial statements as of December 31, 2006 and 2005
and each of the three years in the period ended December 31, 2006 included in our Annual Report on
Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 16, 2007.
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.
6
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 ongoing 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.
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 of our
outstanding common stock that became effective upon the closing of the merger and a final par value
of $0.00004 per common share.
The accompanying unaudited condensed consolidated 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 March
31, 2007, we had an accumulated deficit of $152.4 million, and expect to continue 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, preclinical studies and clinical trials of our drug
candidates. 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. Management believes
we have sufficient resources to fund our required expenditures into the second quarter of 2008,
without considering any potential future milestone payments which we may receive under current or
future collaborations, any future capital raising transactions or draw-downs from the committed
equity financing facility with Kingsbridge Capital Limited.
Note 3. Summary of Significant Accounting Policies
Foreign Currency Translation
The accompanying condensed consolidated financial statements are presented in U.S. dollars.
The functional currency for all of our subsidiaries is the U.S. dollar, with the exception of
Micromet AG, whose functional currency is the European Euro. The assets and liabilities of
Micromet AG are translated into U.S. dollars at the exchange rate in effect at the balance sheet
date. The equity accounts of Micromet AG are translated into U.S. dollars at historical exchange
rates. Micromet AGs statement of operations data are translated into U.S. dollars at the average
exchange rate in effect for the period. Micromet AGs operating cash flow data are translated into
U.S. dollars at the average exchange rate in effect for the period, and investing and financing
cash flow data are translated into U.S. dollars at the exchange rate in effect at the date of the
underlying transaction. The gains and losses from currency translation of Euros to U.S. dollars on
the financial statements of Micromet AG are recorded directly as a separate component of
stockholders equity under the caption Accumulated Other Comprehensive Income (Loss). Transaction
gains and losses are recorded in the statement of operations in other income (expense) and amounted
to $57,000 and $(225,000) for the three months ended March 31, 2007 and 2006, respectively.
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 March 31, 2007, we have a total of $3.1 million of standby letters of credit
collateralized by certificates of deposit that are included as restricted cash in our non-current
assets, comprised of the following:
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$0.7 million relates to our building lease in Munich, Germany; |
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$2.4 million relates to two building leases in California assumed in the merger with CancerVax; and |
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$33,000 relates to a new lease agreement for approximately 4,000 square feet of space
that will be used for our new corporate headquarters in Bethesda, Maryland (see Note
13). |
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 collectability 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. Based on managements assessment,
no allowances were necessary as of March 31, 2007 and December 31, 2006.
7
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.
Purchase Price Allocation for Business Combinations
The allocation of purchase price for business combinations requires extensive use of
accounting estimates and judgments to allocate the purchase price to the identifiable tangible and
intangible assets acquired, including in-process research and development, and liabilities assumed
based on their respective values. In fiscal 2006, we completed our merger with CancerVax. See
Note 5 for a detailed discussion, including the purchase price allocation.
Goodwill
We have goodwill with a carrying value of $6.9 million at March 31, 2007, which resulted from
our merger with CancerVax in May 2006. In accordance with 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. On October 1, 2006, we conducted an assessment of the goodwill carrying
value and found no indication of impairment. In March 2007, after entering into a license agreement
with TRACON Pharmaceuticals (see Note 11), we again conducted an assessment of the goodwill
carrying value and found no indication of impairment.
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 to
our long-lived or intangible assets have been recognized through March 31, 2007.
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
collectability is reasonably assured.
We recognize revenue on up-front 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 and
development 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.
8
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 March 31, 2007, 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 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. We recognize revenue on development and collaboration agreements,
including upfront payments, where they are considered combined units of accounting, over the
expected life of the development and collaboration agreement on a straight-line basis.
Research and Development
Research and development expenditures, including direct and allocated expenses, are charged to
operations as incurred.
Contingencies
Contingent gains are not recorded in our financial statements because this accounting
treatment could result in the recognition of gains that might never be realized. Contingent losses
are only recorded in our financial statements if it is probable that a loss will result from a
contingency and the amount can be reasonably estimated.
Total Comprehensive Loss
For the three months ended March 31, 2007 and 2006 comprehensive loss consists of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(7,590 |
) |
|
$ |
(2,166 |
) |
Foreign currency translation adjustments |
|
|
22 |
|
|
|
(227 |
) |
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(7,568 |
) |
|
$ |
(2,393 |
) |
|
|
|
|
|
|
|
Stock-Based Compensation
We account for stock-based awards under SFAS No. 123(R), which requires measurement of
compensation cost for all stock-based awards at fair value on date of grant and recognition of
compensation over the service period for awards expected to vest. The fair value of stock options
is determined using the Black-Scholes valuation model. Such value is recognized as stock-based
compensation expense over the service period, net of estimated forfeitures, using the straight-line
attribution method. Compensation expense related to stock-based awards are allocated to research
and development or general and administrative based upon the department to which the associated
employee reports. Stock-based 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.
For the three months ended March 31, 2007, we recognized $1.2 million of total stock-based
compensation expense related to our stock-based awards. There was no stock-based compensation
expense recorded for the three months ended March 31, 2006
because this period reflects solely the results of operations of
Micromet AG. As of March 31, 2007, total
unrecognized compensation cost related to stock options was approximately $5.1 million and the
weighted average period over which it is expected to be recognized is 2.6 years.
On
February 1, 2007, we granted employees stock options to purchase
an aggregate of 1,099,000 shares of our
common stock. The exercise price was equal to the closing price of our common stock on the trading
date immediately preceding the date of grant. For those options granted to employees who were
hired prior to May 5, 2006, 22% of the shares underlying the option grant vested on the date of
grant, February 1, 2007, with the remaining 78% vesting in equal monthly installments until May 31,
2009. Of the 1,099,000 options granted, 861,500 had this vesting feature. For those options
granted to employees who were hired after May 5, 2006, 25% of the shares underlying the option
grant vest on the first anniversary of the date of grant, with the remainder vesting in thirty-six
equal monthly
installments thereafter. There were no stock options granted during the first quarter of
2006.
9
Income Taxes
We account for income taxes under SFAS No. 109, Accounting for Income Taxes (SFAS 109)
using the liability method. Deferred income taxes are recognized at the enacted tax rates for
temporary differences between the financial statement and income tax bases of assets and
liabilities. Deferred tax assets are reduced by a valuation allowance if, based upon the weight of
available evidence, it is more likely than not that some portion or all of the related tax asset
will not be recovered.
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 attributable to common stockholders by the
weighted average number of common shares outstanding for the period, without consideration for
common stock equivalents. Diluted net loss per share attributable to common stockholders 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 in the amount of 4,643,000 and 3,029,000 shares and
common stock warrants in the amount of 918,726 and 55,316 shares as of March 31, 2007 and 2006,
respectively.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to
make estimates and assumptions that affect the amounts reported in the consolidated financial
statements. These estimates include assessing the collectibility of accounts receivable, the
valuation of stock-based compensation, and the valuation of long-lived assets. Actual results could
differ from those estimates.
Reclassification
Certain amounts in the previous period financial statements have been reclassified to conform
to the current period presentation.
Recent Accounting Pronouncements
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159,
The Fair Value Option for Financial Assets and Financial Liabilities. Under SFAS No. 159,
companies may elect to measure specified financial instruments and warranty and insurance contracts
at fair value on a contract-by-contract basis. Any changes in fair value are to be recognized in
earnings each reporting period. The election must be applied to individual instruments, is
irrevocable for every instrument chosen to be measured at fair value, and must be applied to an
entire instrument and not to portions of instruments. SFAS No. 159 is effective for fiscal years
beginning after November 15, 2007. We are currently evaluating the impact SFAS No. 159 will have
on our results of operations and financial condition.
Note 4. Income Taxes
In July 2006, FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN No. 48). FIN No. 48 clarifies the accounting for uncertainty in income taxes recognized in
an entitys financial statements in accordance with SFAS No. 109, Accounting for Income Taxes.
FIN No. 48 prescribes a recognition threshold and measurement attributes for the financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax
return. Under FIN No. 48, the impact of an uncertain income tax position on the income tax return
must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by
the relevant taxing authority. An uncertain income tax position will not be recognized if it has
less than a 50% likelihood of being sustained. Additionally, FIN No. 48 provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure
and transition. FIN No. 48 is effective for fiscal years beginning after December 15, 2006.
We adopted the provisions of FIN No. 48 on January 1, 2007. There were no unrecognized tax
benefits as of the date of adoption. We did not recognize an increase in the liability for
unrecognized tax benefits as a result of the implementation of FIN No. 48. There are no
unrecognized tax benefits included in the balance sheet that would, if recognized, affect the
effective tax rate.
10
Our practice is to recognize interest and/or penalties related to income tax matters in income
tax expense. We did not have an accrual for interest and penalties on our balance sheets at
December 31, 2006 and at March 31, 2007, and we have not recognized any interest and/or penalties
in the statement of operations for the first quarter of 2007.
We are subject to taxation in the United States, Germany and various state jurisdictions. Our
tax years for 1999 and forward are subject to examination by the United States and California tax
authorities due to the carryforward of unutilized net operating losses and research and development
tax credits. Our German tax returns for tax years 2004 and forward are subject to examination by
the German tax authorities.
The adoption of FIN No. 48 did not impact our financial condition, results of operations or
cash flows. At January 1, 2007, we had net deferred tax assets of $89.4 million. The deferred tax
assets are primarily composed of foreign, federal and state tax net operating loss carryfowards.
Due to uncertainties surrounding our ability to generate future taxable income to realize these
assets, a full valuation allowance has been established to offset our net deferred tax asset.
Note 5. Merger with CancerVax
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 factor 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 on a fully-diluted basis immediately after the merger, 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. Accordingly, CancerVaxs assets and
liabilities were 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 zero; 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 |
|
|
|
|
|
11
The acquired in-process research and development (IPR&D) projects consist 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 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.
Pro Forma Results of Operations
The results of operations of CancerVax are included in Micromet, Inc.s 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 had been consummated at January 1, 2006. The unaudited pro forma results of operations are
not necessarily indicative of what would have occurred had the business combination been completed
at January 1, 2006 or of the results that may occur in the future.
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2007 |
|
|
2006 |
|
Revenues |
|
$ |
2,770 |
|
|
$ |
4,575 |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,590 |
) |
|
$ |
(10,122 |
) |
|
|
|
|
|
|
|
Basic and diluted
net loss per common
share |
|
$ |
(0.24 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
Note 6. Other Non-Current Liabilities
Included in the March 31, 2007 other non-current liabilities balance of $1.8 million is
a lease exit liability for the Munich, Germany facility as a
consequence of a
restructuring of Micromet AG operations during 2004. The following table summarizes the activity in this
obligation for the three months ended March 31, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued |
|
Balance as of |
|
|
|
|
|
|
|
|
|
|
Currency |
|
|
Balance as of |
|
December 31, |
|
|
Amounts Paid |
|
|
Accretion |
|
|
Translation |
|
|
March 31, |
|
2006 |
|
|
in Period |
|
|
Expense |
|
|
Adjustment |
|
|
2007 |
|
$ |
472 |
|
|
$ |
(33 |
) |
|
$ |
21 |
|
|
$ |
4 |
|
|
$ |
464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Of
the $464,000 lease exit liability as of March 31, 2007, $57,000
is current and $407,000 is non-current.
Note 7. Long-Term Debt
Long-term debt obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
TBG borrowings due December 31, 2008; interest payable
semi-annually at rates ranging from 6% to 7% |
|
$ |
2,104 |
|
|
$ |
2,015 |
|
Bayern Kapital borrowings due December 31, 2006; interest payable
quarterly at 6.75% |
|
|
|
|
|
|
586 |
|
TBFB borrowings due December 31, 2008; interest payable quarterly at 6% |
|
|
3,492 |
|
|
|
3,386 |
|
MedImmune borrowings due June 6, 2010; interest payable monthly at 4.5% |
|
|
2,040 |
|
|
|
2,020 |
|
|
|
|
|
|
|
|
Total long-term debt obligations |
|
|
7,636 |
|
|
|
8,007 |
|
Less: current portion |
|
|
(44 |
) |
|
|
(599 |
) |
|
|
|
|
|
|
|
Long-term debt obligations, net of current portion |
|
$ |
7,592 |
|
|
$ |
7,408 |
|
|
|
|
|
|
|
|
12
Scheduled repayment of principal for the debt agreements is as follows as of March 31, 2007
(in thousands):
|
|
|
|
|
2007 |
|
$ |
44 |
|
2008 |
|
|
5,552 |
|
2009 |
|
|
|
|
2010 |
|
|
2,040 |
|
|
|
|
|
Total |
|
$ |
7,636 |
|
|
|
|
|
Note 8. Commitments and Contingencies
Leases
Future minimum lease payments under non-cancelable operating and capital leases as of
March 31, 2007 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Capital |
|
|
Operating |
|
|
|
Leases |
|
|
Leases |
|
2007 (April 1, 2007 December 31, 2007) |
|
$ |
138 |
|
|
$ |
3,511 |
|
2008 |
|
|
162 |
|
|
|
4,674 |
|
2009 |
|
|
24 |
|
|
|
4,686 |
|
2010 |
|
|
|
|
|
|
4,759 |
|
2011 |
|
|
|
|
|
|
4,836 |
|
Thereafter |
|
|
|
|
|
|
2,412 |
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
|
324 |
|
|
$ |
24,878 |
|
|
|
|
|
|
|
|
|
Less: amount representing imputed interest |
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease payments |
|
|
304 |
|
|
|
|
|
Less: current portion |
|
|
169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligation, less current portion |
|
$ |
135 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The minimum lease payments shown above exclude any sublease income that we expect to
receive under the terms of a sublease agreement related to CancerVaxs former headquarters which
amounts to $0.7 million, $1.0 million, $1.0 million, $1.1 million, $1.1 million, and $0.6 million
for the remainder of 2007 and for each of the years ended December 31, 2008 through 2012,
respectively.
License and Research and Development Agreements
We license certain of our technology from third parties. In exchange for the right to
use licensed technology in our research and development efforts, we have entered into various
license agreements. These agreements generally require that we pay license fees and royalties on
future product sales. In addition, many of the agreements obligate us to make contractually defined
payments upon the achievement of certain development and commercial milestones.
Our fixed commitments under license and research and development agreements are as
follows (in thousands):
|
|
|
|
|
2007 (April 1, 2007- December 31, 2007) |
|
$ |
1,250 |
|
2008 |
|
|
155 |
|
2009 |
|
|
55 |
|
2010 |
|
|
55 |
|
2011 |
|
|
55 |
|
Thereafter |
|
|
275 |
|
|
|
|
|
Total minimum payments |
|
$ |
1,845 |
|
|
|
|
|
13
Other Taxes
We had accruals for contingent liabilities related to non-income tax matters as of
December 31, 2006 in the amount of $1.7 million, which included:
|
|
|
$1.3 million related to withholding tax duty on past royalty payments made to
collaborative partners who reside outside of Germany. We paid this amount to the
German tax authorities during the first quarter of 2007 in order to settle this
liability. We are currently pursuing reimbursement of these taxes paid, because the
recipients of these royalty payments are exempt from withholding taxes, by coordinating
additional tax authority filings with these collaborative partners; and |
|
|
|
|
$0.4 million related to a disallowed reimbursement of German Value Added Tax
incurred on expenses as a result of a 2001 increase of stated capital. The German tax
authorities had originally denied the deduction, and we filed an appeal against the
related assessment and accrued amounts potentially owed. The appeal was pending for
several years and depended on the authorities review of a model case then pending with
the German supreme fiscal court in a similar matter. This matter was resolved in our
favor in the first quarter of 2007 at which time the accrual was reversed and the $0.4
million benefit was included in general and administrative expenses. |
Note 9. Employee Loans
We granted unsecured loans to employees with interest rates ranging up to 6%. As of December
31, 2006, the total outstanding loans to employees amounted to $78,000. In the first quarter of
2007, these loans were either repaid in full or partially forgiven, resulting in compensation
expense of $10,000.
Note 10. Stock Subscription Receivable
During 1998, treasury stock was issued to employees in exchange for non-interest bearing stock
subscription receivables. The balance of such receivables as of December 31, 2006 was $27,000. In
the first quarter of 2007, these receivables were either repaid in full or partially forgiven,
resulting in compensation expense of $8,000.
Note 11. License Agreements and Collaborations
On March 14, 2007, we entered into an agreement with TRACON Pharmaceuticals, Inc. (Tracon),
under which we granted Tracon an exclusive, worldwide license to develop and commercialize D93, our
antibody targeting denatured collagen. Under the agreement, Tracon also has an option to expand the
license to an additional antibody, and upon the exercise of the option, the financial and other
terms applicable to D93 would become applicable to such other antibody. Under the terms of the
agreement, Tracon will be responsible for the development and commercialization of D93 on a
worldwide basis, as well as the costs and expenses associated with such activities. We will
transfer to Tracon certain materials, including our inventory of D93 clinical trial materials,
stored at our contract manufacturer. Tracon is obligated to pay us an upfront license fee, make
development and sales milestone payments, and pay a royalty on worldwide net sales of D93. External
costs that we incur related to intellectual property for D93 will be reimbursed by Tracon. In
addition, Tracon will make certain payments for the delivery of the materials and has an obligation
to pay us a portion of sublicensing revenues, which portion decreases based on the point in
development when Tracon enters into the sublicense agreement. If D93 is successfully developed and
commercialized in three indications in three major markets, we would be entitled to receive total
payments, exclusive of royalties on net sales, of more than $100 million. Tracon may terminate the
agreement at any time upon a specified prior notice period, and either party may terminate the
agreement for material breach by the other party. In the event of termination, all product rights
would revert back to us under the agreement.
Note 12. Segment Reporting
We operate in only one segment, which primarily focuses on the discovery and development of
antibody-based drug candidates using our proprietary technologies.
Note 13. Subsequent Events
In April 2007, we received the required consent of our landlord to enter into an amendment to
our existing sublease agreement with Genoptix, Inc. pursuant to which Genoptix will sublease the
remaining 15,091 square feet of office space at our former headquarters in Carlsbad,
California. This space is now fully subleased. As in the existing sublease, the term of the
sublease will expire on June 30, 2012. Genoptix will be responsible for all expenses incurred in
the operation or maintenance of the facility over the term of the sublease.
In May 2007, we entered into a lease agreement (the Lease) with Second Rock Spring Rock
Limited Partnership under which we have agreed to lease approximately 4,000 square feet of office
space for our corporate headquarters in Bethesda, Maryland (the Premises). The commencement date
of the Lease was April 1, 2007, and the Lease has a term through April 30, 2012. Our obligation to
pay rent under the Lease began as of May 1, 2007. Our initial base rent for the Premises is
$10,955.21 per month, increasing by 3% each year under the Lease. Beginning on May 1, 2008, we
will also be responsible for our pro rata share of increases in real estate taxes and operating
expenses associated with the Premises.
14
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 the
Financial Condition and Results of Operations should be read in conjunction with the financial
statements and notes thereto for the year ended December 31, 2006, and the related Managements
Discussion and Analysis of Financial Condition and Results of Operations, both of which are
contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on
March 16, 2007.
For periods prior to May 4, 2006, the results of operations and cash flows presented in the
interim financial statements contained herein reflect Micromet AG only. For periods from May 5,
2006 (the date of the closing of the merger) through March 31, 2007, the results of operations and
cash flows presented in the interim financial statements contained herein reflect the combined
operations of CancerVax and Micromet AG. Accordingly, the results of operations and cash flows for
the three months ended March 31, 2006 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 three months ended March 31, 2006.
Overview
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 and certain other security
holders 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 Global 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.; |
|
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|
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 |
|
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|
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. Two of our product
candidates are currently in clinical trials, while the remainder of our pipeline is in preclinical
development. MT103, also known as MEDI-538, which is the first product candidate based on our
proprietary BiTE® product development platform, is being evaluated in a phase 1
clinical trial for the treatment of patients with non-Hodgkins lymphoma. The BiTE product
development platform is based on a unique, antibody-based class of drug candidates that leverages
the cytotoxic potential of T cells, widely recognized as the most powerful killer cells of the
human immune system. Adecatumumab, also known as MT201, a recombinant human monoclonal antibody
which targets EpCAM-expressing tumors, has completed two phase 2a clinical trials, one in patients
with breast cancer and the other in patients with prostate cancer. In addition, a phase 1b trial
evaluating the safety and tolerability of adecatumumab in combination with docetaxel is currently
ongoing in patients with metastatic breast cancer. We have established collaborations with
MedImmune, Inc. for MT103, Merck Serono for adecatumumab and TRACON
Pharmaceuticals for D93. We believe the BiTE product development platform gives us a strong
proprietary technology platform for the development of additional antibody-based product
candidates.
15
Our goal is to develop products for the treatment of cancer and inflammatory and
autoimmune diseases that address significant unmet medical needs. We believe that our novel
technologies, product candidates and product development expertise in these fields will continue to
enable us to identify and develop promising new product opportunities for these critical markets.
To date, we have incurred significant expenses and have not achieved any product revenues from
sales of our product candidates.
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 marketing approval from the
United States Food and Drug Administration, or FDA, the European Medicines Agency, or 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, efficacy or commercial
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
be granted control 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, licensing revenues and milestone
achievements and, more recently, by accessing the capital resources of CancerVax through the merger
and a subsequent 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 second quarter
of 2008, without considering any potential future milestone payments, that we may receive under
current or future collaborations, any future capital raising transactions or any drawdowns from the
committed equity financing facility, or CEFF, with Kingsbridge Capital Limited.
Research and Development and In-Process Research and Development
Through March 31, 2007, our research and development expenses consisted of costs associated
with the clinical development of adecatumumab and MT103, as well as pre-clinical development costs
for a new BiTE molecule called MT110 and a new human antibody against granulocyte/macrophage colony
stimulating factor, or GM-CSF, called MT203, and research activities under our collaboration with
MedImmune and the BiTE platform. The costs incurred include costs associated with clinical trials
and manufacturing development, 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
expenses to operations as 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.
16
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 BiTE
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
collaboration agreement with Merck Serono for adecatumumab, we have received $22.0
million in up-front and milestone payments from Merck Serono to date, not including reimbursements
for costs and expenses incurred in connection with the development of adecatumumab. The agreement
provides for potential future clinical development milestone payments of up to an additional $126.0
million. In a November 2006 amendment to the original agreement the parties agreed that we would
continue to conduct an ongoing clinical trial testing the safety of adecatumumab with docetaxel in
patients suffering from metastatic breast cancer and a second clinical trial to be initiated in
other solid tumors in 2007. All of our cost for development related to adecatumumab will be fully
reimbursed by Merck Serono.
Under our collaboration agreement with MedImmune for MT103, the agreement provides for
potential future milestone payments and royalty payments based on net sales of MT103. A second
agreement with MedImmune for the development of new BiTE product candidates provides for potential
future milestone payments and royalty payments based on future sales of the BiTE product candidates
currently under development pursuant to that agreement. The potential milestone payments are
subject to the successful completion of development and obtaining marketing approval for one or
more indications in one or more national markets.
Under our collaboration agreement with TRACON Pharmaceuticals, Inc. for D93, Tracon will
be responsible for the development and commercialization of D93 on a worldwide basis, as well as
the costs and expenses associated with such activities. We will transfer to Tracon certain
materials, including our inventory of D93 clinical trial materials, stored at our contract
manufacturer. Tracon is obligated to pay us an upfront license fee, make development and sales
milestone payments, and pay a royalty on worldwide net sales of D93. External costs that we incur
related to intellectual property for D93 will be reimbursed by Tracon. In addition, Tracon will
make certain payments for the delivery of the materials and has an obligation to pay us a portion
of sublicensing revenues.
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, the 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 ongoing basis in response to the scientific
and clinical success of each product candidate as well as relevant commercial factors.
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, could 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 critical accounting policies used in the
preparation of our financial statements which require significant estimates and judgments are as
follows:
17
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
collectability is reasonably assured.
We recognize revenue on up-front 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 and
development 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 March 31, 2007, 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 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. We recognize revenue on development and collaboration
agreements, including upfront payments, where they are considered combined units of accounting,
over the expected life of the development and collaboration agreement on a straight-line basis.
Purchase Price Allocation in Business Combinations
The allocation of purchase price for business combinations requires extensive use of
accounting estimates and judgments to allocate the purchase price to the identifiable tangible and
intangible assets acquired, including in-process research and development, and liabilities assumed
based on their respective values. In fiscal 2006, we completed our merger with CancerVax. See Note
5 in the footnotes to our unaudited condensed consolidated financial statements included in this
report for a detailed discussion, including the purchase price allocation.
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 success 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. We performed our annual
goodwill impairment test as of October 1, 2006 and determined
that there was no impairment. In the first quarter of 2007, after entering into a licensing
agreement with Tracon, we performed an updated goodwill impairment assessment in accordance with SFAS No.
142 and determined that the carrying amount of goodwill continued to
be fully recoverable. We cannot assure you
that our future reviews of goodwill impairment will not result in a material charge.
18
Long-Lived and Intangible Assets
The evaluation for impairment of long-lived and intangible assets requires significant
estimates and judgment by management. 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.
Stock-Based Compensation
On January 1, 2006, we adopted the provisions of SFAS No. 123(R) and SEC Staff Accounting
Bulletin (SAB) 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. 123(R), for all awards granted after January
1, 2006 based on each awards grant date fair value. Prior to adopting the provisions of SFAS No.
123(R), 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. 123(R) using the modified prospective transition
method.
We estimate the fair value of each share-based award on the grant date using the Black-Scholes
option-pricing model. We apply 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 companies. SFAS No. 123(R) 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. The pre-vesting forfeiture rate for the three-month period
ended March 31, 2007 was based on historical forfeiture experience for similar levels of employees
to whom the options were granted. As of March 31, 2007, total unrecognized compensation cost
related to stock options was approximately $5.1 million and the weighted average period over which
it is expected to be recognized is 2.6 years.
Recent Accounting Pronouncements
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159,
The Fair Value Option for Financial Assets and Financial Liabilities. Under SFAS No. 159,
companies may elect to measure specified financial instruments and warranty and insurance contracts
at fair value on a contract-by-contract basis. Any changes in fair value are to be recognized in
earnings each reporting period. The election must be applied to individual instruments, is
irrevocable for every instrument chosen to be measured at fair value, and must be applied to an
entire instrument and not to portions of instruments. SFAS No. 159 is effective for fiscal years
beginning after November 15, 2007. We are currently evaluating the impact SFAS No. 159 will have
on our results of operations and financial condition.
Results of Operations
Revenues. The following table summarizes our primary sources of revenue for the periods
presented (in millions):
|
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|
|
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|
|
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Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Merck Serono revenue: |
|
|
|
|
|
|
|
|
Collaborative R&D revenue |
|
$ |
1.0 |
|
|
$ |
3.1 |
|
MedImmune revenue: |
|
|
|
|
|
|
|
|
Collaborative R&D revenue |
|
|
1.2 |
|
|
|
0.8 |
|
Milestone payment |
|
|
0.3 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue from MedImmune |
|
|
1.5 |
|
|
|
0.8 |
|
License revenue |
|
|
0.2 |
|
|
|
0.2 |
|
Other revenue |
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
2.8 |
|
|
$ |
4.1 |
|
|
|
|
|
|
|
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19
Collaborative research and development revenues from Merck Serono reflect their full
cost responsibility for the adecatumumab program. Collaborative research and development revenues
from MedImmune represent their share of the costs of clinical development of MT103 and their full
cost responsibility for the development of two new BiTE candidates. The decrease in total revenues
for the three months ended March 31, 2007 compared to the same period in 2006 results from lower
revenues under the Merck Serono agreement, offset by an increase in revenues from the MedImmune
programs. The decrease in Merck Serono revenue was a result of the completion of the phase 2a
clinical studies during 2006 and that no such activity was ongoing during the first quarter of 2007. The increase in
MedImmune revenue reflects the increase in activity under the MT103
and EphA2 and CEA BiTE molecule
programs.
Research and Development Expenses. Research and development expense consists of costs
incurred to discover, research and develop product candidates. These expenses consist primarily of
salaries and related expenses for personnel, outside service costs including production of clinical
material, fees for services in the context of clinical trials, medicinal chemistry, consulting and
sponsored research collaborations, and occupancy and depreciation charges. Process development
expenses were mainly incurred for production of good manufacturing practice, or GMP, grade clinical
trial material, as well as fermentation, purification and formulation development. Preclinical
development expenses cover pharmacological in vitro and in vivo experiments as well as development
of analytical testing procedures. We expense research and development costs as incurred.
Research and development expenses were $6.7 million and $4.5 million for the three
months ended March 31, 2007 and 2006, respectively. Included in the 2007 amounts was a share-based
compensation expense of $0.6 million, which was not reflected in 2006. The remaining increase in
research and development expenses primarily results from a $0.5 million license fee paid to Applied
Molecular Evolution as a result of the fees earned under the terms of the Tracon license agreement
signed in March 2007, $0.3 million for GMP manufacturing materials related to the MT110 program,
$0.3 million for legal fees related to our BiTE platform and from licensing activities, and an
increase in Munich facility charges of $0.2 million.
General and Administrative Expenses. General and administrative expense consists primarily of
salaries and other related costs for personnel in executive, finance, accounting, legal,
information technology, corporate communications and human resource functions. Other costs include
facility costs not otherwise included in research and development expense, insurance, and
professional fees for legal and audit services.
General and administrative expenses were $3.6 million and $1.2 million for the three
months ended March 31, 2007 and 2006, respectively. Included in the 2007 amounts was a share-based
compensation expense of $0.6 million, which was not reflected in 2006. Also included in the 2007
amounts was compensation expense of $0.2 million for the payment of severance to a former executive
officer who had resigned and whose separation became effective in
March 2007. The remainder of the increase in general and administrative
expense results from integration costs relating to the merger, including an increased number of
U.S.-based administrative personnel, and from the incremental costs associated with being a public company
post-merger, including investor relations costs, legal, auditing and tax fees and increased
directors and officers insurance premiums.
Interest Expense. Interest expense for the three months ended March 31, 2007 and 2006
was $0.3 million and $0.5 million, respectively. The decrease was primarily due to the conversion
of convertible notes during 2006, which were no longer outstanding during the first quarter of
2007.
Interest Income. Interest income for the three months ended March 31, 2007 was $126,000
compared to $37,000 for the three months ended March 31, 2006. The increase in interest income was
primarily due to an increase in average cash balances, as a result of cash acquired in connection
with the merger with CancerVax and from the net proceeds of $7.3 million received in the July 2006
private placement.
Other Income (Expense). Other income (expense) includes foreign currency transaction gains
(losses) and miscellaneous other items. Other income for the three months ended March 31, 2007 was
$42,000 compared to an expense of $136,000 for the three months ended March 31, 2006. The increase
results primarily from the difference in exchange rate fluctuations.
Liquidity and Capital Resources
We had cash and cash equivalents of $15.8 million and $24.3 million as of March 31, 2007 and
December 31, 2006, respectively. The decrease in 2007 results primarily from repayments of
long-term debt and an increase in general operating expenses, as described above.
20
Net cash used in operating activities was $7.8 million for the three months ended March
31, 2007, compared to $5.7 million used in operating activities for the three months ended March
31, 2006. The decrease in cash flows from operating activities from 2006 to 2007 was primarily due
to the larger net loss resulting from decreased revenues and increased expenses explained above,
partially offset by the
upfront licensing and clinical trial material supply fees received in March 2007 related to
the Tracon license.
Net cash used in investing activities was $2,000 for the three months ended March 31, 2007,
compared to $36,000 used in investing activities for the three months ended March 31, 2006. The
increase was due to the repayment of employee loans partially offset by the increase in restricted
cash required by the lease of our new corporate headquarters.
Net cash used in financing activities was $0.7 million for the three months March 31, 2007,
compared to $4.2 million provided by financing activities for the three months ended March 31,
2006. Investor capital contributions of $4.4 million during the three months ended March 31, 2006
but not present in 2007 account for the majority of the difference, partially offset by an increase
of $0.5 million in repayments of outstanding long-term debt obligations.
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, licensing and milestone payments related to our product candidate
partnering activities, debt financing and, more recently, by accessing the capital resources of
CancerVax through the merger and through a subsequent 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.
Prior to our merger with CancerVax, CancerVax was a party to three building leases
associated with a manufacturing facility, a warehouse facility and CancerVaxs 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
CancerVaxs former corporate headquarters was subleased. We paid termination-related fees of
approximately $0.6 million in connection with the termination of the warehouse facility. Our
remaining estimated lease exit liability related to the two outstanding leases amounted to $1.3
million at March 31, 2007, of which $0.5 million is included in accrued expenses and $0.8 million
is included in other non-current liabilities. In April 2007, we entered into a sublease agreement
for the remaining 15,091 square feet of CancerVaxs former corporate headquarters.
During
May 2007, we entered into a lease agreement for approximately 4,000 square feet of
office space to be used for our new corporate headquarters in Bethesda, Maryland. The building
lease had an effective date of April 1, 2007 and will expire in
2012. The initial base rent is approximately $131,000 per year,
payable monthly.
As of March 31, 2007, we have a total of $3.1 million of standby letters of credit
collateralized by certificates of deposits that are included as restricted cash in our non-current
assets, comprised of the following:
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$0.7 million relates to our building lease in Munich, Germany; |
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$2.4 million relates to two building leases in California assumed in the merger with CancerVax described above; and |
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$33,000 relates to a new lease agreement for approximately 4,000 square feet of space
that will be used for our new corporate headquarters in Bethesda, Maryland. |
21
On October 2, 2006, a court-proposed settlement agreement with Curis, Inc. became effective
that resolves a lawsuit initiated by Curis against Micromet AG in a German court regarding the
repayment of a then outstanding promissory note in the principal amount of 2.0 million, or $2.6
million. Curis had requested immediate repayment of the remaining 2.0 million at the time of the
closing of the merger between CancerVax and Micromet AG in May 2006. We had disagreed with Curiss
interpretation of the repayment terms of the promissory note. In accordance with the settlement, we
paid Curis 1.0 million, or $1.3 million, in October 2006, and have paid 0.8 million, or $1.1
million, in April 2007. These payments did not include any interest charges and the note is now
paid in full.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
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the progress of our clinical trials; |
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the progress of our research activities; |
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the number and scope of our research programs; |
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the progress of our preclinical development activities; |
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the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent
and other intellectual property claims; |
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the costs related to development and manufacture of pre-clinical, clinical and validation lots for
regulatory purposes and commercialization of drug supply associated with our product candidates; |
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our ability to enter into corporate collaborations and the terms and success of these collaborations; |
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the costs and timing of regulatory approvals; and |
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the costs of establishing manufacturing, sales and distribution capabilities. |
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, as well as a new
operating lease executed in May 2007 related to our new corporate headquarters. The following
table sets forth our significant contractual obligations as of March 31, 2007 (in thousands):
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Payment Due by Period |
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Less Than |
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More Than |
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Contractual Obligations |
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Total |
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1 Year (1) |
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1-3 Years |
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3-5 Years |
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5 Years |
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Operating leases |
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$ |
24,878 |
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$ |
3,511 |
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$ |
9,359 |
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$ |
9,595 |
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$ |
2,413 |
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Long-term debt MedImmune |
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2,040 |
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2,040 |
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Silent partnership obligations |
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5,596 |
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44 |
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5,552 |
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Contractual payments under
licensing and research and
development agreements |
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1,845 |
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1,250 |
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210 |
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110 |
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275 |
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Capital leases |
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324 |
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138 |
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186 |
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Short-term note payable Curis |
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1,334 |
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1,334 |
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$ |
36,017 |
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$ |
6,277 |
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$ |
15,307 |
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$ |
11,745 |
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$ |
2,688 |
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(1) |
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Includes amounts payable from April 1, 2007 through December 31, 2007. |
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,
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.
22
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 efficacy, safety and intended utilization of our product candidates, the
conduct and results of future clinical trials, plans regarding regulatory filings, future research
and clinical trials and plans regarding partnering activities, and our goal of monitoring our
internal controls for financial reporting and making modifications as necessary. 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 for 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;
successful administration of our business and financial reporting capabilities, including the
successful remediation of material weaknesses in our internal control our financial reporting and
other risks detailed in this report, including those below in Part II, Item 1A, 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 consist primarily 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.
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 incurred 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 March 31, 2007, we had U.S. dollar-denominated cash and
cash equivalents of $9.5 million and Euro-denominated liabilities of approximately 13.1 million.
The Euro amount as of March 31, 2007 is equivalent to approximately $17.5 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 reported operating expenses due to the translation of the
Euro-denominated expenses into U.S. dollars, and such changes 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
Evaluation 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 Chief Financial Officer (our
principal financial officer), as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures, we recognize that
any controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives, and we are required to apply our 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, controls 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.
23
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 March 31, 2007, the end of the period covered by this report.
Based upon our evaluation prior to the filing of our annual report on Form 10-K, our
management concluded that our disclosure controls and procedures were
ineffective as of December
31, 2006 because of material weaknesses in internal control over financial reporting, as described
below.
Further, based upon our evaluation prior to the filing of this quarterly report, our principal
executive officer and principal financial officer have concluded that our disclosure controls and
procedures were still ineffective as of March 31, 2007 to provide reasonable assurance that
financial information we are required to disclose in our reports under the Securities Exchange Act
of 1934 was recorded, processed, summarized and reported accurately
and that such information is accumulated and communicated to our
management, including our Chief Executive Officer (our principal
executive officer) and our Chief Financial Officer (our principal
financial officer), as appropriate, to allow for timely decisions
regarding required disclosure.
Notwithstanding the deficiencies cited above that existed as of March 31, 2007, there
have been no changes to reported financial results as a result of these identified material
weaknesses, and our 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.
As
reported in our annual report on Form 10-K for the year ended December 31, 2006, filed with the Securities
and Exchange Commission on March 16, 2007, in connection with our management assessment of the
effectiveness of the Companys internal control over financial reporting for the year ended
December 31, 2006, we identified the following material weaknesses:
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Inadequate Procedures Around Estimation and Accruals. As a
result of errors identified in estimates around accrued
liability accounts, we have concluded that controls over
our estimation and analyses processes were not effective
and are indicative of a material weakness. We over-accrued
certain research and development costs and we under-accrued
travel, legal and certain research and development costs.
The effect of these accrual errors required an audit
adjustment to accruals that was material to the
consolidated financial statements. |
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Invoicing Error in Licensee Milestone. A milestone invoice
to one of our single-chain antibody licensees was prepared
by our accounting staff in the wrong currency, approved and
mailed to the licensee. As a result, we have concluded that
the controls over the analysis and recording of revenue
transactions with unusual terms were not effective, and are
indicative of a material weakness in revenue accounting
controls. |
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Inadequate Management Review. As a result of errors
identified by our independent registered public accounting
firm in our financial close process and disclosures and
amounts in our annual report on Form 10-K subsequent to our
financial statement review process but prior to filing of
our Form 10-K, we have concluded that controls over our
financial statement close and reporting process are not
effective, and are indicative of a material weakness. |
There were no changes to any reported financial results that have been released by us as a
result of these identified weaknesses.
Managements Remediation Plan
Based on our findings that our disclosure controls and procedures were not effective and that
we had several material weaknesses in internal controls over financial reporting, we have been and
continue to be engaged in efforts to improve our internal controls and procedures and we expect
that these efforts in 2007 will address the weaknesses in the remainder of 2007.
Following
the merger between Micromet AG and CancerVax in May 2006, 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. We intend to take the remaining actions required to
remediate our existing weaknesses as part of our ongoing efforts to upgrade our control environment
following the merger and integration of operations. 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:
24
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hiring a chief financial officer with significant U.S. public company experience in October 2006; |
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implementing additional preparation, review and approval procedures over estimations and accruals; |
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improving our procedures for verifying and documenting contract terms and implementing of a
company-wide contract management system to facilitate the flow of information amongst various
functional departments; |
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formalizing process and documentation related to financial statement closing and consolidation
review, including more frequent interaction across 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 and additional oversight; |
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supplementing our accounting staff to improve the breadth and depth of experience; |
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engaging qualified accounting and tax consultants to aid us in the implementation of procedures
and policies; and |
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improving training for, and integration and communication among, accounting staff. |
While management believes that the foregoing actions have had a positive effect on our
internal control over financial reporting, all the changes necessary to remediate the material
weakness in our internal control over financial reporting were not in place by March 31, 2007. We
have communicated to the Audit Committee the material weaknesses identified in our internal control
over financial reporting. Management, with the oversight of the Audit Committee, is committed to
effective remediation of known material weakness and other control deficiencies as quickly as
possible.
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. Except for the ongoing progress related to the
remediation measures discussed above, there were no changes in our internal control over financial
reporting during the quarter ended March 31, 2007 that materially affected, or were reasonably
likely to materially affect, our internal control over financial reporting.
25
PART II OTHER INFORMATION
Item 1. Legal Proceedings
None.
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 and the
information incorporated herein by reference and those we may make from time to time. Certain
factors individually or in combination with others may have a material adverse effect on our
business, financial condition and results of operations and you should carefully consider them.
The risk factors which follow are substantially the same as presented in our most recent
annual report on Form 10-K, and we believe that the only material
changes from such previously disclosed risk factors relate to the additional risk disclosures regarding the pending acquisition
of MedImmune by AstraZeneca plc under the caption Risks Relating to Our Collaborations and
Clinical Programs below.
Risks Relating to Our Financial Results, Financial Reporting 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 March 31, 2007, and we
expect to incur substantial losses for the foreseeable future. We have no current sources of
material ongoing revenue, other than the reimbursement of development expenses and potential future
milestone payments from our current collaborators, MedImmune, Merck Serono and TRACON
Pharmaceuticals. 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, many of which are
outside our control, that may affect our future capital requirements and accelerate our need for
additional financing. Among the factors that may affect our future capital requirements and
accelerate our need for additional financing are:
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continued progress in our research and development programs, as well as the scope of these programs; |
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our ability to establish and maintain collaborative arrangements for the discovery, research or
development of product candidates; |
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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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our ability to sell shares of our common stock under our committed equity financing facility, or
CEFF, with Kingsbridge Capital Limited, or Kingsbridge; |
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the costs of preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and
other patent-related costs, including litigation costs and technology license fees; |
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costs associated with litigation; and |
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competing technological and market developments. |
26
We 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, although our ability to do so will
depend on our eligibility to use a shelf registration statement at such time, under applicable SEC
rules. We expect to seek additional funding through public or private financings or from new
collaborators with whom we enter into research or development collaborations with respect to
programs that are not currently licensed. However, the market for stock of companies in the
biotechnology sector in general, and the market for our common stock in particular, is 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 those of 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 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.
Our committed equity financing facility with Kingsbridge may not be available to us if we
elect to make a draw down, may require us to make additional blackout or other payments to
Kingsbridge and may result in dilution to our stockholders.
In August 2006, we entered into a CEFF with Kingsbridge. The CEFF entitles us to sell
and obligates Kingsbridge to purchase, from time to time over a period of three years, shares of
our common stock for cash consideration up to an aggregate of $25 million, subject to certain
conditions and restrictions. Kingsbridge will not be obligated to purchase shares under the CEFF
unless certain conditions are met, which include:
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a minimum price for our common stock that is not less than 85% of
the closing price of the day immediately preceding the applicable
eight-day pricing period, but in no event less than $2.00 per
share; |
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the accuracy of representations and warranties made to Kingsbridge; |
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our compliance with all applicable laws which, if we failed to so
comply, would have a Material Adverse Effect (as that term is
defined in the purchase agreement with Kingsbridge); and |
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the effectiveness of a registration statement registering for
resale the shares of common stock to be issued in connection with
the CEFF. |
Kingsbridge is permitted to terminate the CEFF by providing written notice to us upon the
occurrence of certain events. If we are unable to access funds through the CEFF, or if Kingsbridge
terminates the CEFF, we may be unable to access capital from other sources on favorable terms, or
at all.
We are entitled, in certain circumstances, to deliver a blackout notice to Kingsbridge to
suspend the use of the resale registration statement and prohibit Kingsbridge from selling shares
under the resale registration statement for a certain period of time. If we deliver a blackout
notice during the fifteen trading days following our delivery of shares to Kingsbridge in
connection with any draw down, then we may be required to make a payment to Kingsbridge, or issue
to Kingsbridge additional shares in lieu of this payment, calculated on the basis of the number of
shares purchased by Kingsbridge in the most recent draw down and held by Kingsbridge immediately
prior to the blackout period and the decline in the market price, if any, of our common stock
during the blackout period. If the trading price of our common stock declines during a blackout
period, this blackout payment could be significant.
In addition, if we fail to maintain the effectiveness of the resale registration
statement or related prospectus in circumstances not permitted by our agreement with Kingsbridge,
we may be required to make a payment to Kingsbridge, calculated on the basis of the number of
shares held by Kingsbridge during the period that the registration statement or prospectus is not
effective, multiplied by the decline in market price, if any, of our common stock during the
ineffective period. If the trading price of our common stock declines during a period in which the
resale registration statement or related prospectus is not effective, this payment could be
significant.
Should we sell shares to Kingsbridge under the CEFF or issue shares in lieu of a blackout
payment, it will have a dilutive effect on the holdings of our current stockholders and may result
in downward pressure on the price of our common stock. If we draw down under the CEFF, we will
issue shares to Kingsbridge at a discount of 6% to 14% from the volume weighted average price of
our common stock.
27
If we draw down amounts under the CEFF when our share price is decreasing, we will need to
issue more shares to raise the same amount than if our stock price was higher. Issuances in the
face of a declining share price will have an even greater dilutive effect than if our share price
were stable or increasing and may further decrease our share price. Moreover, the number of shares
that we will be able to issue to Kingsbridge in a particular draw down may be materially reduced if
our stock price declines significantly during the applicable eight-day pricing period.
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, development 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 payments under license agreements,
repayments of outstanding amounts under loan agreements, and other
payments that we may be required to make to others; and |
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variations in the level of research and development expenses
related to our product candidates or potential product candidates
during any given period. |
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 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, research and development expenses, accounting for stock options, and in-process research and
development costs are subject periodically to further review, interpretation and guidance from
relevant accounting authorities, including the SEC. 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.
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.
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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; and |
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our debt level may reduce our flexibility in responding to changing business and economic conditions. |
We have determined and further received an opinion from our independent registered public
accounting firm in connection with our year-end audit for 2006 that our system of internal control
over financial reporting does not meet the requirements of Section 404 of the Sarbanes-Oxley Act of
2002. As a result, 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.
As a publicly traded company, we are required to comply with the Sarbanes-Oxley Act of
2002 and the related rules and regulations of the SEC, including Section 404 of the Sarbanes-Oxley
Act of 2002. As a result of the merger between CancerVax Corporation and Micromet AG, we are in the
process of upgrading the existing, and implementing additional, procedures and controls to
incorporate the operations of Micromet AG, which had been a private German company prior to the
merger. The process of updating the procedures and controls is requiring significant time and
expense. The integration of the two companies finance and accounting systems, procedures and
controls, and the implementation of procedures and controls at Micromet AG are more time-consuming
and expensive than we previously anticipated.
Our internal control system is designed to provide reasonable assurance to our
management and board of directors regarding the preparation and fair presentation of published
financial statements. In connection with the audit of our consolidated financial statements for the
year ended December 31, 2006, our independent registered public accounting firm provided us with an
unqualified opinion on our consolidated financial statements, but it identified material weaknesses
in our internal control over financial reporting based on criteria established in Internal Control
Integrated Framework, issued by the Committee of Sponsoring Organizations (COSO) of the Treadway
Commission. These material weaknesses relate to certain of our estimation and accrual processes,
procedures relating to analysis and recording of revenue transactions with unusual terms, and an
insufficient level of management review due to lack of resources. These weaknesses resulted, in
part, from our inability to sufficiently upgrade our existing procedures and controls and to
implement new procedures and controls to integrate the operations of Micromet AG prior to December
31, 2006. Because of these material weaknesses in our internal control over financial reporting,
there is heightened risk that a material misstatement of our annual or quarterly financial
statements will not be prevented or detected.
We are in the process of expanding our internal resources and implementing additional
procedures in order to remediate these material weaknesses in our internal control over financial
reporting; however, we cannot guarantee that these efforts will be successful. If we do not
adequately remedy these material weaknesses, and if we fail to maintain proper and effective
internal control over financial reporting in future periods, our ability to provide timely and
reliable financial results could suffer, and investors could lose confidence in our reported
financial information, which may have a material adverse effect on our stock price.
Risks Relating to Our Common Stock
Substantial sales of shares may adversely impact the market price of our common stock and our
ability to issue and sell shares in the future.
Substantially all of the outstanding shares of our common stock are eligible for resale in the
public market and certain holders of our shares have the right to require us to file a registration
statement for purposes of registering their shares for resale. A significant portion of these
shares is held by a small number of stockholders. We have also registered shares of our common
stock that we may issue under our equity incentive compensation plans and our employee stock
purchase plan. These shares generally can be freely sold in the public market upon issuance. If our
stockholders sell substantial amounts of our common stock, the market price of our common stock may
decline, which might make it more difficult for us to sell equity or equity-related securities in
the future at a time and price that we deem appropriate. We are unable to predict the effect that
sales of our common stock may have on the prevailing market price of our common stock.
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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, a number of which we cannot control. Among the factors that could
cause material fluctuations in the market price for our common stock are:
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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 or our BiTE technology platform; |
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announcements of the invalidity of, or litigation relating to, our key intellectual property; |
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announcements of the achievement of milestones in our agreements with collaborators or the receipt of
payments under those agreements; |
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announcements of the results of clinical trials by us or by companies with product candidates in the
same therapeutic category as our product candidates; |
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events affecting our collaborators; |
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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, our collaborators or our competitors;
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our ability to successfully complete strategic collaborations with respect to our three product
candidates (MT110, MT203 and MT204) for which we currently have
retained all product rights; |
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variations in our quarterly operating results; |
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changes in securities analysts estimates of our financial performance or product development timelines; |
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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, collectively own an aggregate of
approximately 33% of our outstanding common stock, and, as a result, 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
this group 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.
Our stockholder rights plan and provisions contained in our amended and restated
certificate of incorporation and amended and restated bylaws 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 amended
and restated 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 amended and restated bylaws except with 66 2/3% stockholder approval; and |
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requiring advance notice for raising matters of business or making nominations at stockholders meetings. |
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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.
We may become involved in securities class action litigation that could divert managements
attention and harm our business and our insurance coverage may not be sufficient to cover all costs
and damages.
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 Our Collaborations and Clinical Programs
We are dependent on collaborators for the development and commercialization of many of our
product candidates. If we lose any of these collaborators, or if they fail or incur delays in the
development or commercialization of our current and future product candidates, our operating
results would suffer.
The success of our strategy for development and commercialization of our product
candidates depends upon our ability to form and maintain productive strategic collaborations. We
currently have strategic collaborations with MedImmune, Merck Serono and TRACON Pharmaceuticals. 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
resources.
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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 of our collaborative partners were to
terminate their agreements with us, we may attempt to identify
and enter into an agreement with a new collaborator with
respect to the product candidate covered by the terminated
agreement. If we are not able to do so, we may not have the
funds or capability to undertake the development,
manufacturing and commercialization of that product
candidate, which could result in a discontinuation or delay
of the development of that product candidate. |
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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 product candidates and
services that are the subject of their collaborations with
us. |
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Our collaborators may discontinue the development of our
product candidates in specific indications, for example as
a result of their assessment of the results obtained in
clinical trials, or fail to initiate the development in
indications that have a significant commercial potential. |
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Pharmaceutical and biotechnology companies from time to
time re-evaluate their research and development priorities,
including in connection with mergers and consolidations,
which have been common in recent years in these industries.
The ability of our partnered product candidates to reach
their potential could be limited if, as a result of such
changes, our collaborators decrease or fail to increase
spending related to such product candidates, or decide to
discontinue the development of our product candidates and
terminate their collaboration agreement with us. On April
23, 2007, our collaborator MedImmune announced that it has
agreed to be acquired by AstraZeneca plc. If MedImmune or
AstraZeneca were to perform a review of their development
programs and re-evaluate their priorities in the
development of their product candidates, this could result
in a delay in the development of and the commercialization
of our product candidate MT103, the CEA BiTE molecule, or
the EphA2 BiTE molecule that in each case we are developing
in collaboration with MedImmune, or termination of one or
both of the collaboration agreements we have with MedImmune
under which these product candidates are being developed.
In the event of such a termination, we may not be able to
identify and enter into a collaboration agreement for MT103
with another pharmaceutical company on terms favorable to
us or at all, and we may not have sufficient financial
resources to continue the development program for MT103 on
our own. As a result, we may incur delays in the
development of MT103 following any potential termination of
the collaboration agreement with MedImmune, or we may need
to reallocate financial resources that may cause delays in
other development programs for our other product
candidates. |
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We may not be successful in establishing additional strategic collaborations, which could adversely
affect our ability to develop and commercialize product candidates.
As an integral part of our ongoing research and development efforts, we periodically
review opportunities to establish new collaborations for development and commercialization of new
BiTE molecules or existing product candidates 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 collaborations or other
alternative arrangements. Even if we are successful in our efforts to establish a collaboration,
the terms of the agreement may not be favorable to us. Finally, such collaborations or other
arrangements may not result in successful products and associated revenue from milestone payments,
royalties or profit share payments.
If the combination of adecatumumab (MT201) with cytotoxics, such as docetaxel, is not
tolerable or safe, if higher serum levels of adecatumumab cannot be administered safely, or if
sufficient anti-tumor activity cannot be shown, we and our collaborator Merck Serono may decide to
abandon all or part of the development program, and we could experience a material adverse impact
on our results of operations.
We previously have reported that the phase 2 clinical trials of adecatumumab did not reach
their respective primary endpoint in patients with metastatic breast cancer (clinical benefit rate
at week 24) and in patients with prostate cancer (mean change in prostate specific antigen,
compared to placebo control). We have also reported that we are continuing the development of
adecatumumab in a clinical trial in combination with docetaxel with escalating doses of
adecatumumab to investigate the tolerability and the safety of this combination. We have also
reported that we, in collaboration with Merck Serono, are planning to start a new phase 1
monotherapy study for the treatment of patients with solid tumors estimated to begin in 2007. If
the combination of adecatumumab with docetaxel proves not to be tolerable or safe or if no higher
serum levels of adecatumumab compared to previous clinical trials can be administered safely or if
sufficient anti-tumor activity cannot be shown, we and our collaborator Merck Serono may decide to
abandon all or part of the development program of adecatumumab and as a result we may experience a
material adverse impact on our results of operations.
We previously terminated three phase 1 trials involving short-term infusion regimens of MT103 due
to adverse side effects 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 infusion, as opposed to a continuous
infusion dosing regimen of MT103, due to adverse side effects and the lack of observed tumor
responses. We have redesigned the dosing regimen for our ongoing phase 1 clinical trial and, based
upon the preliminary clinical data, we currently are seeing a considerably more favorable safety
profile in response to the new continuous infusion dosing regimen. We have also seen objective
tumor responses at the highest dose level tested (15 µg/m2/d) with the continuous infusion
regimens. While this preliminary data suggest that MT103 has anti-tumor activity, there can be no
assurance that we will not encounter unacceptable adverse events during the continued dose
escalation of our ongoing, continuous-infusion phase 1 clinical trial or that the preliminary
suggestion of anti-tumor activity will be confirmed during the ongoing or any future study.
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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 sublicense or otherwise transfer our rights
to SAI-EGF and our 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 S.A., a Cuban company, 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 our
product candidate SAI-EGF, and with CIMAB and its affiliate YM BioSciences, Inc., a Canadian
company, for our 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 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 product candidates 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 product candidates.
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 we 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, although we cannot ensure that CIMAB or other third
parties will comply with these provisions.
As part of our interactions with CIMAB, we are 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.
Risks Relating to Our Operations, Business Strategy, and the Life Sciences Industry
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 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 autoimmune and inflammatory diseases, 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 functions. Our competitors may
discover, characterize and develop important inducing molecules or genes in advance of us.
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Many of our competitors have substantially greater capital resources, research and development
staffs and facilities than we have. Efforts by other biotechnology and pharmaceutical companies
could render our programs or product candidates uneconomical or result
in therapies that are superior to those that we are developing alone or with a collaborator.
We and our collaborators face competition from companies that may be 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, or may discover,
develop and commercialize products, which render our product candidates 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.
We may not be successful in our efforts to expand our portfolio of product candidates.
A key element of our strategy is to discover, develop and commercialize a portfolio of
new drugs. We are seeking to do so through our internal research programs and in-licensing
activities. A significant portion of the research that we are conducting involves new and unproven
technologies. Research programs to identify new disease targets and product candidates require
substantial technical, financial and human resources regardless of whether or not any suitable
candidates are ultimately identified. Our research programs may initially show promise in
identifying potential product candidates, yet fail to yield product candidates suitable for
clinical development. If we are unable to discover suitable potential product candidates, develop
additional delivery technologies through internal research programs or in-license suitable product
candidates or delivery technologies on acceptable business terms, our business prospects will
suffer.
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 delay and 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 failure
for product candidates in preclinical development and in clinical trials. The preclinical studies
and clinical trials may produce negative, inconsistent or inconclusive results, and the results
from early clinical trials may not be statistically significant or predictive of results that will
be obtained from expanded, advanced clinical trials. Further, we or our collaborators may decide,
or regulators may require us, to conduct preclinical studies or clinical trials in addition to
those planned by us or our collaborators, which may be expensive or could delay the time to market
for our product candidates. In addition, we do not know whether the clinical trials will result in
marketable products.
All of our product candidates are in early stages of development, so we will require
substantial additional financial resources, as well as research, product development and clinical
development capabilities, to pursue the development of these product candidates, and we may never
develop an approvable or commercially viable 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. The timing and
completion of clinical trials of our product candidates depend on, among other factors, the number
of patients that will be required to enroll in the clinical trials, the inclusion and exclusion
criteria used for selecting patients for a particular clinical trial, and the rate at which those
patients are enrolled. Any increase in the required number of patients, tightening of selection
criteria, or decrease in recruitment rates or difficulties retaining study participants may result
in increased costs, delays in the development of the product candidate, or both.
Since our product candidates may have different efficacy profiles in certain clinical
indications, sub-indications or patient profiles, an election by us or our collaborators to focus
on a particular indication, sub-indication or patient profile may result in a failure to capitalize
on other potentially profitable applications of our product candidates.
Our product candidates may not be effective in treating any of our targeted diseases 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,
or if additional information may be required for the regulatory authority to assess the proposed
development activities. Further, regulators may not approve study protocols at all or in a
timeframe anticipated by us if they believe that the study design or the mechanism of action of our
product candidates poses an unacceptable health risk to study participants.
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 would otherwise have
ultimately proved to be more profitable.
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We rely heavily on third parties for the conduct of preclinical and clinical studies of our product
candidates, and we may not be able to control the proper performance of the studies or trials.
In order to obtain regulatory approval for the commercial sale of our product
candidates, we and our collaborators are required to complete extensive preclinical studies as well
as clinical trials in humans to demonstrate to the FDA, EMEA and other regulatory authorities that
our product candidates are safe and effective. We have limited experience and internal resources
for conducting certain preclinical studies and clinical trials and rely primarily on collaborators
and contract research organizations for the performance and management of certain preclinical
studies and clinical trials of our product candidates. If our collaborators or contractors fail to
properly perform their contractual or regulatory obligations with respect to conducting or
overseeing the performance of our preclinical studies or clinical trials, the completion of these
studies or trials may be delayed, or the results may not be useable and the studies or trials may
have to be repeated. Any of these events could delay or create additional costs in the development
of our product candidates and could adversely affect our and our collaborators ability to market a
product after marketing approvals have been obtained.
Even if we complete the lengthy, complex and expensive development process, there is no
assurance that we or our collaborators will obtain the regulatory approvals necessary for the
launch and commercialization of our product candidates.
To the extent that we or our collaborators are able to successfully complete the
clinical development of a product candidate, we or our collaborators will be required to obtain
approval by the FDA, EMEA or other regulatory authorities prior to marketing and selling such
product candidate in the United States, the European Union or other countries.
The process of preparing and filing applications for regulatory approvals with the FDA,
EMEA and other regulatory authorities, and of obtaining the required regulatory approvals from
these regulatory authorities is lengthy and expensive, and may require two years or more. This
process is further complicated because some of our 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 other regulatory authorities to require additional preclinical data or certain precautions
in the designs of clinical protocols that could cause a delay in the development of our BiTE
product candidates or make the development process more expensive.
Any marketing approval by the FDA, EMEA or other regulatory authorities may be subject
to limitations on the indicated uses for which we or our collaborators may market the product
candidate. These limitations could restrict the size of the market for the product and affect
reimbursement levels by third-party payers.
As a result of these factors, we or our collaborators may not successfully begin or
complete clinical trials and launch and commercialize any product candidates 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, and we or our collaborators may not be able to comply with these regulations. Any
non-compliance could subject us or our collaborators to penalties and otherwise result in the
limitation of our or our collaborators operations.
In addition to regulations imposed by the FDA, EMEA and other health regulatory authorities,
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 counterparts in Europe and other countries. From time
to time, other governmental agencies and legislative 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 or our collaborators business, or whether we or our collaborators
would be able to comply, without incurring unreasonable expense, or at all, with any applicable
regulations.
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Our growth could be limited if we are unable to attract and retain key personnel and consultants.
We have limited experience in filing and prosecuting regulatory applications to obtain
marketing approval from the FDA, EMEA or other regulatory authorities. Our success depends on the
ability to attract, train and retain qualified scientific and technical personnel, including
consultants, 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, and we may not be able to attract
and retain sufficient numbers of highly skilled employees.
Any growth and expansion into areas and activities that may require additional personnel or
expertise, such as in regulatory affairs and compliance, would require us to either hire new key
personnel or obtain such services from a third party. 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 do not follow current good manufacturing practices or do not
maintain their facilities in accordance with these practices, our product development and
commercialization efforts may be harmed.
Product candidates used in clinical trials or sold after marketing approval has been
obtained must be manufactured in accordance with current good manufacturing practices regulations.
There are a limited number of manufacturers that operate under these regulations, including the
FDAs and EMEAs good manufacturing practices regulations, and that are capable of manufacturing
our product candidates. Third-party manufacturers may encounter difficulties in achieving quality
control and quality assurance and may experience shortages of qualified personnel. Also,
manufacturing facilities are subject to ongoing periodic, unannounced inspection by the FDA, the
EMEA, and other regulatory agencies or authorities, to ensure strict compliance with current good
manufacturing practices and other governmental regulations and standards. 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
product candidates for use in a clinical trial or for commercial sale, the termination of, or hold
on a clinical trial, or may delay or prevent filing or approval of marketing applications for our
product candidates. In addition, as a result of such a failure, we could be subject to sanctions,
including fines, injunctions and civil penalties, refusal or delays by regulatory authorities to
grant marketing approval of our product candidates, suspension or withdrawal of marketing
approvals, seizures or recalls of product candidates, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect our business. If we were
required to change manufacturers, it may require additional clinical trials and the revalidation of
the manufacturing process and procedures in accordance with applicable current good manufacturing
practices and may require FDA or EMEA approval. This revalidation may be costly and time-consuming.
If we are unable to arrange for third-party manufacturing of our product candidates, or to do so on
commercially reasonable terms, we may not be able to complete development or marketing of our
product candidates.
Even if regulatory authorities approve our product candidates, we may fail to comply with
ongoing regulatory requirements or experience unanticipated problems with our product candidates,
and these product candidates could be subject to restrictions or withdrawal from the market
following approval.
Any product candidates for which we obtain marketing approval, along with the
manufacturing processes, post-approval clinical trials and promotional activities for such product
candidates, will be subject to continual review and periodic inspections by the FDA, EMEA and other
regulatory authorities. Even if regulatory approval of a product candidate 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. Post-approval discovery of previously unknown problems with any approved
products, including unanticipated adverse events or adverse events of unanticipated severity or
frequency, difficulties with a manufacturer or manufacturing processes, or failure to comply with
regulatory requirements, may result in restrictions on such approved products or manufacturing
processes, withdrawal of the approved products from the market, voluntary or mandatory recall,
fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil
or criminal penalties.
The procedures and requirements for granting marketing approvals vary among countries, which
may cause us to incur additional costs or delays or may prevent us from obtaining marketing
approvals in different countries and regulatory jurisdictions.
We intend to market our product candidates in many countries and regulatory
jurisdictions. In order to market our product candidates in the United States, the European Union
and many other jurisdictions, we must obtain separate regulatory approvals in each of these
countries and territories. The procedures and requirements for obtaining marketing approval vary
among countries and regulatory jurisdictions, and can involve additional clinical trials or other
tests. Also, the time required to obtain approval may differ from that required to obtain FDA and
EMEA approval. The various regulatory approval processes may include all of the risks associated
with obtaining FDA and EMEA approval. We may not obtain all of the desirable or necessary
regulatory approvals on a timely basis, if at all. Approval by a regulatory authority in a
particular country or regulatory jurisdiction, such as the FDA in the United States and the EMEA in
the European Union, generally does not ensure approval by a regulatory authority in another
country. We may not be able to file for regulatory approvals and may not receive necessary
approvals to commercialize our product candidates in any or all of the countries or regulatory
jurisdictions in which we desire to market our product candidates.
36
If we fail to obtain an adequate level of reimbursement for any approved products by
third-party payers, there may be no commercially viable markets for these products or the markets
may be much smaller than expected. The continuing efforts of the
government, insurance companies, managed care organizations and other payers of health care costs
to contain or reduce costs of healthcare may adversely affect our ability to generate revenues and
achieve profitability, the future revenues and profitability of our potential customers, suppliers
and collaborators, and the availability of capital.
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 price charged for our product candidates and
related treatments. The efficacy, safety and cost-effectiveness of our product candidates as well
as the efficacy, safety and cost-effectiveness of any competing products will determine in part 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. Given recent federal and state government initiatives directed at lowering the total cost
of healthcare in the United States, the U.S. Congress and state legislatures will likely continue
to focus on healthcare reform, the cost of prescription pharmaceuticals and on the reform of the
Medicare and Medicaid systems. 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 product candidates to other available therapies. If reimbursement for our
product candidates were unavailable or limited in scope or amount or if reimbursement levels or
prices are set at unsatisfactory levels, our projected and actual revenues and our prospects for
profitability would be negatively affected.
Another development that may affect the pricing of drugs in the United States 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.
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 product
candidates that we may commercialize, or require us to lower the price of our product candidates
then on the market that face competition from lower-priced supplies of that product from other
countries. These factors would negatively affect our projected and actual revenues and our
prospects for profitability.
If physicians and patients do not accept the product candidates that we may develop, our
ability to generate product revenue in the future will be adversely affected.
Our product candidates, if successfully developed and approved by the regulatory authorities,
may not gain market acceptance among physicians, healthcare payers, patients and the medical
community. Market acceptance of and demand for any product candidate 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 and pricing strategy for any product candidates that we may develop; |
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publicity concerning our product candidates or competitive products; and |
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our ability to obtain third-party coverage or reimbursement. |
If any product candidates for which we may receive marketing approval fail to gain market
acceptance, our ability to generate product revenue in the future will be adversely affected.
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. 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 ourselves 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
product candidates in the market.
37
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.
Risks Relating to Our Intellectual Property and Litigation
We may not be able to obtain or maintain adequate patents and other intellectual property
rights to protect our business and product candidates against competitors.
Our value will be significantly enhanced if we are able to obtain adequate patents and
other intellectual property rights to protect our business and product candidates against
competitors. For that reason, we allocate significant financial and personnel resources to the
filing, prosecution, maintenance and defense of patent applications, patents and trademarks
claiming or covering our product candidates and key technology relating to these product
candidates.
To date, we have sought to protect our proprietary positions related to our important
proprietary technology, inventions and improvements by filing of patent applications in the U.S.,
Europe and other jurisdictions. Because the patent position of pharmaceutical and biopharmaceutical
companies involves complex legal and factual questions, the issuance, scope and enforceability of
patents cannot be predicted with certainty, and we cannot be certain that patents will be issued on
pending or future patent applications that cover our product candidates and technologies. Claims
could be restricted in prosecution that might lead to a scope of protection which is of minor value
for a particular product candidate. Patents, if issued, may be challenged and sought to be
invalidated by third parties in litigation. In addition, 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. European patents may be subject to opposition
proceedings in the European Patent Office. Patents might be invalidated in national jurisdictions.
Similar proceedings may be available in countries outside of Europe or the U.S. These proceedings
could result in either a loss of the patent or a 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. 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 could result in a third party
receiving the patent rights sought by us, which in turn could affect our ability to market a
potential product or product candidate 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, which fall outside the scope of our patents. Products or technology could also be copied
by competitors after expiration of the patent life.
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.
We may incur substantial costs enforcing our patents against third parties. 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.
We own or control a substantial portfolio of issued patents. From time to time, we may
become aware of third parties that undertake activities that infringe on our patents. We may decide
to grant those third parties a license under our patents, or to enforce the patents against those
third parties by pursuing an infringement claim in litigation. If we initiate patent infringement
litigation, it could consume significant financial and management resources, regardless of the
merit of the claims or the outcome of the litigation. 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. Uncertainties resulting from the initiation and continuation of patent
litigation or other proceedings could harm our ability to compete in the marketplace.
38
Our ability to enforce our patents may be restricted under applicable law. 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 rights, which makes it difficult
to stop infringement. In addition, our ability to enforce our patent rights depends on our ability
to detect infringement. It is difficult to detect infringers who do not advertise the compounds
that are used in their products or the methods they use in the research and development of their
products. If we are unable to enforce our patents against infringers, it could have a material
adverse effect on our competitive position, results of operations and financial condition.
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 rely on proprietary trade secrets and unpatented know-how to protect our research,
development and manufacturing activities and maintain our competitive position, 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 confidentiality and non-use agreements. 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 or proprietary know-how 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 any trade secret, know-how or other
technology not protected by a patent or intellectual property right were disclosed to, or
independently developed by a competitor, our business, financial condition and results of
operations could be materially adversely affected.
If third parties claim that our product candidates or technologies infringe their intellectual
property rights, we may become involved in expensive patent litigation, which could result in
liability for damages or require us to stop our development and commercialization of our product
candidates after they have been approved and launched in the market, or we could be forced to
obtain a license and pay royalties under unfavorable terms.
Our commercial success will depend in part on not infringing the patents or violating the
proprietary rights of third parties. Competitors or third parties may obtain patents that may claim
the composition, manufacture or use of our product candidates, or the technology required to
perform research and development activities relating to our product candidates.
From time to time we receive correspondence inviting us to license patents from third
parties. While we believe that our pre-commercialization activities fall within the scope of an
available exemption against patent infringement provided in the United States by 35 U.S.C. § 271(e)
and by similar research exemptions in Europe, claims may be brought against us in the future based
on patents held by others. Also, we are aware of patents and other intellectual property rights of
third parties relating to our areas of practice, and we know that others have filed patent
applications in various countries that relate to several areas in which we are developing product
candidates. 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, the
publication of patent applications occurs with a certain delay after the date of filing, so we may
not be aware of all relevant patent applications of third parties at a given point in time.
Further, publication of discoveries in the scientific or patent literature often lags behind actual
discoveries, so we may not be able to determine whether inventions claimed in patent applications
of third parties have been made before or after the date on which inventions claimed in our patent
applications and patents have been made. All issued patents are entitled to a presumption of
validity in many countries, including the United States and many European countries. Issued patents
held by others may therefore limit our freedom to operate unless and until these patents expire or
are declared invalid or unenforceable in a court of applicable jurisdiction.
39
We and our collaborators may not have rights under some patents that may cover the
composition of matter, manufacture or use of product candidates that we seek to develop and
commercialize, drug targets to which our product candidates bind, or technologies that we use in
our research and development activities. As a result, our ability to develop and commercialize our
product candidates may
depend on our ability to obtain licenses or other rights under these patents. The third
parties who own or control such patents may be unwilling to grant those licenses or other rights to
us or our collaborators under terms that are commercially viable or at all. Third parties who own
or control these patents could bring claims based on patent infringement against us or our
collaborators and seek monetary damages and to enjoin further clinical testing, manufacturing and
marketing of the affected product candidates or products. 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. If a third party sues us for patent infringement, it could
consume significant financial and management resources, regardless of the merit of the claims or
the outcome of the litigation.
If a third party brings a patent infringement suit against us and we do not settle the
patent infringement suit and are not successful in defending against the patent infringement
claims, we could be required to pay substantial damages or we or our collaborators could be forced
to stop or delay research, development, manufacturing or sales of the product or product candidate
that is claimed by the third partys patent. We or our collaborators 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. However, there can be no assurance that any such license will 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 candidate,
or forced to cease some aspect of our business operations as a result of patent infringement
claims, which could harm our business.
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 we expect to enter into similar licenses and agreements in the future. These licenses
and agreements impose various research, development, commercialization, sublicensing, milestone and
royalty payment, indemnification, insurance and other obligations on us. If we or our collaborators
fail to perform under these agreements or otherwise breach obligations thereunder, our licensors
may terminate these agreements and we could lose licenses to intellectual property rights that are
important to our business. Any such termination could materially harm our ability to develop and
commercialize the product candidate that is the subject of the agreement, which could have a
material adverse impact on our results of operations.
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 we 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 license the relevant intellectual property rights and may be
deprived of current or future revenues that are associated with such intellectual property, which
could have a material adverse effect on our results of operations and financial condition.
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.
Risks Relating to Manufacturing and Sales of Products
We depend on our collaborators and third-party manufacturers to produce most, if not all, of our
product candidates and if these third parties do not successfully manufacture these product
candidates our business will be harmed.
We have no manufacturing experience or manufacturing capabilities for the production of our product
candidates for clinical trials or commercial sale. In order to continue to develop product
candidates, apply for regulatory approvals, and commercialize our product candidates following
approval, we or our collaborators must be able to manufacture or contract with third parties to
manufacture our
product candidates 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 our product candidates 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.
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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. 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 product
candidates 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, marketing or distribution experience and will depend significantly on third
parties who may not successfully sell our product candidates following approval.
We have no sales, marketing or product distribution experience. If we receive required
regulatory approvals to market any of our product candidates, we plan to rely primarily on sales,
marketing and distribution arrangements with third parties, including our collaborators. For
example, as part of our agreements with MedImmune, Merck Serono and TRACON Pharmaceuticals, we have
granted these companies the right to market and distribute 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 that 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 product candidates
following approval. As a result, our future revenues from sales of our product candidates, if any,
will be materially dependent upon the success of the efforts of these third parties.
We may seek to co-promote products with our collaborators, or 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. |
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
None.
Item 5. Other Information
As of May 4, 2007, we entered into a lease agreement (the Lease) with Second Rock Spring
Rock Limited Partnership under which we have agreed to lease approximately 4,000 square feet of
office space for our corporate headquarters in Bethesda, Maryland (the Premises). The
commencement date of the Lease was April 1, 2007, and the Lease has a term through April 30, 2012.
Our obligation to pay rent under the Lease began as of May 1, 2007. Our initial base rent for the
Premises is $10,955.21 per month, increasing by 3% each year under the Lease. Beginning on May 1,
2008, we will also be responsible for our pro rata share of increases in real estate taxes and
operating expenses associated with the Premises. The foregoing is a summary description of certain
terms of the Lease and is qualified in its entirety by the text of
the Lease which will be filed as an exhibit to our Quarterly Report
on Form 10-Q for the quarterly period ending June 30, 2007.
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Item 6. Exhibits
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Exhibit |
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Number |
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Description |
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3.1 (2)
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Amended and Restated Certificate of Incorporation of the Registrant |
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3.2 (3)
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Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Registrant |
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3.3 (4)
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Certificate of Designations for Series A Junior Participating Preferred Stock of the Registrant |
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3.4 (5)
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Second Amended and Restated Bylaws of the Registrant |
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3.5 (3)
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First Amendment to Second Amended and Restated Bylaws of the Registrant |
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3.6 (6)
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Second Amendment to Second Amended and Restated Bylaws of the Registrant |
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4.1 (9)
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Form of Specimen Common Stock Certificate |
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4.2 (1)
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Warrant to Purchase Vendor Preferred Stock, Series 2, issued to Venture Lending & Leasing III, LLC, dated
September 6, 2002 |
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4.3 (4)
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Rights Agreement, by and between the Registrant and Mellon Investor Services LLC, which includes the form
of Certificate of Designations of the Series A Junior Participating Preferred Stock of the Registrant as
Exhibit A, the form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred
Shares as Exhibit C, dated as of November 3, 2004 |
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4.4 (5)
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First Amendment to Rights Agreement, by and between the Registrant and Mellon Investor Services LLC,
dated as of March 17, 2006 |
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4.5 (7)
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Second Amended and Restated Note, in favor of MedImmune Ventures, Inc., dated as of December 27, 2006 |
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4.6 (8)
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Registration Rights Agreement, by and between the Registrant and Kingsbridge Capital Limited, dated as of
August 30, 2006 |
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4.7 (8)
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Warrant to purchase 285,000 shares of Common Stock, issued to Kingsbridge Capital Limited, dated August
30, 2006 |
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4.8 (9)
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Form of Warrant to Purchase Common Stock, dated May 5, 2006 |
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4.9 (6)
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Form of Warrants to purchase an aggregate of 555,556 shares of Common Stock, in favor of funds affiliated
with NGN Capital, LLC, dated July 24, 2006 |
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4.10 (9) &
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Silent Partnership Participation Agreement (Beteiligungsvertrag) with tbg Technologie
Beteiligungsgesellschaft mbH, dated March 2, 1999 |
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4.11 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag) with tbg Technologie
Beteiligungsgesellschaft mbH, dated March 2, 1999 |
|
|
|
4.12 (9) &
|
|
Amendment to Silent Partnership Participation Agreements with tbg Technologie Beteiligungsgesellschaft
mbH, dated February 6, 2006 |
|
|
|
4.13 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag) with Technologie Beteiligungsfond Bayern
GmbH, dated January 17, 2000 |
|
|
|
4.14 (9) &
|
|
Amendment to Silent Partnership Participation Agreement with Technologie Beteiligungsfond Bayern GmbH,
dated February 6, 2006 |
|
|
|
10.1 *
|
|
License Agreement dated March 14, 2007 by and between Cell-Matrix, Inc. and Tracon Pharmaceuticals, Inc. |
|
|
|
10.2
|
|
Amendment No. 1 to Sublease Agreement dated April 2, 2007 by and between Micromet, Inc. and Genoptix, Inc. |
|
|
|
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 the Registrants Registration Statement on Form S-1
filed with the Securities and Exchange Commission on October 24, 2003. |
|
(2) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on December 11, 2003. |
|
(3) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on May 10, 2006. |
|
(4) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
(5) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(6) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on July 26, 2006. |
|
(7) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on January 4, 2007. |
|
(8) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on August 31, 2006. |
|
(9) |
|
Incorporated by reference to the Registrants Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 16, 2007. |
|
& |
|
Indicates that the exhibit is an English translation of a foreign language document. |
|
* |
|
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a
request for confidential treatment and have been separately filed with the
Securities and Exchange Commission. |
|
** |
|
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. |
42
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: May 10, 2007 |
|
Micromet, Inc. |
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ Christopher P. Schnittker |
|
|
|
|
|
|
|
|
|
|
|
|
|
Christopher P. Schnittker |
|
|
|
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
|
|
|
|
(Duly authorized officer and Principal Financial Officer) |
|
|
43
Exhibit List
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
3.1 (2)
|
|
Amended and Restated Certificate of Incorporation of the Registrant |
|
|
|
3.2 (3)
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Registrant |
|
|
|
3.3 (4)
|
|
Certificate of Designations for Series A Junior Participating Preferred Stock of the Registrant |
|
|
|
3.4 (5)
|
|
Second Amended and Restated Bylaws of the Registrant |
|
|
|
3.5 (3)
|
|
First Amendment to Second Amended and Restated Bylaws of the Registrant |
|
|
|
3.6 (6)
|
|
Second Amendment to Second Amended and Restated Bylaws of the Registrant |
|
|
|
4.1 (9)
|
|
Form of Specimen Common Stock Certificate |
|
|
|
4.2 (1)
|
|
Warrant to Purchase Vendor Preferred Stock, Series 2, issued to Venture Lending & Leasing III, LLC, dated
September 6, 2002 |
|
|
|
4.3 (4)
|
|
Rights Agreement, by and between the Registrant and Mellon Investor Services LLC, which includes the form
of Certificate of Designations of the Series A Junior Participating Preferred Stock of the Registrant as
Exhibit A, the form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred
Shares as Exhibit C, dated as of November 3, 2004 |
|
|
|
4.4 (5)
|
|
First Amendment to Rights Agreement, by and between the Registrant and Mellon Investor Services LLC,
dated as of March 17, 2006 |
|
|
|
4.5 (7)
|
|
Second Amended and Restated Note, in favor of MedImmune Ventures, Inc., dated as of December 27, 2006 |
|
|
|
4.6 (8)
|
|
Registration Rights Agreement, by and between the Registrant and Kingsbridge Capital Limited, dated as of
August 30, 2006 |
|
|
|
4.7 (8)
|
|
Warrant to purchase 285,000 shares of Common Stock, issued to Kingsbridge Capital Limited, dated August
30, 2006 |
|
|
|
4.8 (9)
|
|
Form of Warrant to Purchase Common Stock, dated May 5, 2006 |
|
|
|
4.9 (6)
|
|
Form of Warrants to purchase an aggregate of 555,556 shares of Common Stock, in favor of funds affiliated
with NGN Capital, LLC, dated July 24, 2006 |
|
|
|
4.10 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag) with tbg Technologie
Beteiligungsgesellschaft mbH, dated March 2, 1999 |
|
|
|
4.11 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag) with tbg Technologie
Beteiligungsgesellschaft mbH, dated March 2, 1999 |
|
|
|
4.12 (9) &
|
|
Amendment to Silent Partnership Participation Agreements with tbg Technologie Beteiligungsgesellschaft
mbH, dated February 6, 2006 |
|
|
|
4.13 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag) with Technologie Beteiligungsfond Bayern
GmbH, dated January 17, 2000 |
|
|
|
4.14 (9) &
|
|
Amendment to Silent Partnership Participation Agreement with Technologie Beteiligungsfond Bayern GmbH,
dated February 6, 2006 |
|
|
|
10.1 *
|
|
License Agreement dated March 14, 2007 by and between Cell-Matrix, Inc. and Tracon Pharmaceuticals, Inc. |
|
|
|
10.2
|
|
Amendment No. 1 to Sublease Agreement dated April 2, 2007 by and between Micromet, Inc. and Genoptix, Inc. |
|
|
|
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 the Registrants Registration Statement on Form S-1
filed with the Securities and Exchange Commission on October 24, 2003. |
|
(2) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on December 11, 2003. |
|
(3) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on May 10, 2006. |
|
(4) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
(5) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(6) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on July 26, 2006. |
|
(7) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on January 4, 2007. |
|
(8) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on August 31, 2006. |
|
(9) |
|
Incorporated by reference to the Registrants Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 16, 2007. |
|
& |
|
Indicates that the exhibit is an English translation of a foreign language document. |
|
* |
|
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a
request for confidential treatment and have been separately filed with the
Securities and Exchange Commission. |
|
** |
|
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. |