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 June 30, 2008
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, a non-accelerated filer, or a smaller reporting company. See definition of large
accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). o Yes þ No
The number
of outstanding shares of the registrants common stock, par value $0.00004 per share, as of August 1, 2008 was 40,871,827.
MICROMET, INC.
FORM 10-Q QUARTERLY REPORT
FOR THE QUARTERLY PERIOD ENDED June 30, 2008
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 |
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3 |
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Condensed Consolidated Balance Sheets as of June 30, 2008 (Unaudited) and
December 31, 2007 |
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3 |
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Condensed Consolidated Statements of Operations for the three-month and six-month
periods ended June 30, 2008 and 2007 (Unaudited) |
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4 |
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Condensed Consolidated Statements of Cash Flows for the six-month periods ended June
30, 2008 and 2007 (Unaudited) |
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5 |
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Notes to Condensed Consolidated Financial Statements |
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
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12 |
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Item 3. Quantitative and Qualitative Disclosures about Market Risk |
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18 |
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Item 4. Controls and Procedures |
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19 |
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PART II OTHER INFORMATION |
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Item 1. Legal Proceedings |
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19 |
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Item 1A. Risk Factors |
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19 |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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36 |
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Item 3. Defaults Upon Senior Securities |
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37 |
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Item 4. Submission of Matters to a Vote of Security Holders |
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37 |
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Item 5. Other Information |
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37 |
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Item 6. Exhibits |
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37 |
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SIGNATURES |
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37 |
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38 |
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2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
Micromet, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except par value)
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June 30, |
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December 31, |
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2008 |
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2007 |
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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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$ |
22,427 |
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$ |
27,066 |
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Accounts receivable |
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2,483 |
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4,689 |
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Prepaid expenses and other current assets |
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2,095 |
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2,579 |
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Total current assets |
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27,005 |
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34,334 |
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Property and equipment, net |
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4,298 |
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4,390 |
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Goodwill |
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6,462 |
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6,462 |
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Patents, net |
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7,061 |
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7,680 |
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Other long-term assets |
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216 |
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196 |
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Restricted cash |
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3,247 |
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3,190 |
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Total assets |
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$ |
48,289 |
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$ |
56,252 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,991 |
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$ |
2,334 |
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Accrued expenses |
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5,195 |
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4,765 |
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Common stock warrants liability |
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6,928 |
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5,219 |
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Other liabilities |
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484 |
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520 |
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Current portion of long-term debt obligations |
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2,586 |
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2,401 |
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Current portion of deferred revenue |
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4,898 |
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3,360 |
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Total current liabilities |
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23,082 |
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18,599 |
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Deferred revenue, net of current portion |
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8,580 |
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8,366 |
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Other non-current liabilities |
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2,203 |
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2,055 |
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Long-term debt obligations, net of current portion |
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2,417 |
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2,254 |
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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, $0.00004 par value; 150,000
shares authorized; 40,829 and 40,778 shares
issued and outstanding at June 30, 2008 and
December 31, 2007, respectively |
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2 |
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2 |
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Additional paid-in capital |
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185,802 |
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184,014 |
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Accumulated other comprehensive income |
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5,629 |
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5,895 |
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Accumulated deficit |
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(179,426 |
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(164,933 |
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Total stockholders equity |
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12,007 |
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24,978 |
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Total liabilities and stockholders equity |
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$ |
48,289 |
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$ |
56,252 |
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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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Six months ended |
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June 30, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues: |
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Collaboration agreements |
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$ |
7,900 |
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$ |
2,548 |
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$ |
13,649 |
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$ |
5,093 |
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License fees and other |
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552 |
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518 |
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727 |
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743 |
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Total revenues |
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8,452 |
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3,066 |
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14,376 |
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5,836 |
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Operating expenses: |
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Research and development |
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10,992 |
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6,714 |
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20,712 |
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13,424 |
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General and administrative |
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3,383 |
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4,370 |
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6,917 |
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7,932 |
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Total operating expenses |
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14,375 |
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11,084 |
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27,629 |
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21,356 |
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Loss from operations |
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(5,923 |
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(8,018 |
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(13,253 |
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(15,520 |
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Other income (expense): |
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Interest expense |
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(32 |
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(178 |
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(144 |
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(434 |
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Interest income |
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199 |
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99 |
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466 |
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225 |
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Change in fair value of warrants |
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(2,962 |
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522 |
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(1,709 |
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522 |
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Other income |
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91 |
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1,106 |
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147 |
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1,148 |
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Net loss |
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$ |
(8,627 |
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$ |
(6,469 |
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$ |
(14,493 |
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$ |
(14,059 |
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Basic and diluted net loss per common share |
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$ |
(0.21 |
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$ |
(0.20 |
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$ |
(0.36 |
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$ |
(0.44 |
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Weighted average shares used to compute basic and
diluted net loss per share |
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40,824 |
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32,315 |
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40,802 |
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31,909 |
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The accompanying notes are an integral part of these financial statements.
4
Micromet, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Six months ended June 30, |
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(14,493 |
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$ |
(14,059 |
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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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1,959 |
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1,606 |
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Non-cash interest on long-term debt obligations |
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58 |
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220 |
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Net gain on debt restructuring |
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(270 |
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Non-cash change in fair value of common stock warrants liability |
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1,709 |
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(522 |
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Stock-based compensation expense |
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1,703 |
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1,916 |
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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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2,312 |
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(1,495 |
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Prepaid expenses and other current assets |
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533 |
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(374 |
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Accounts payable, accrued expenses and other liabilities |
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607 |
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(4,173 |
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Deferred revenue |
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943 |
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9,248 |
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Net cash used in operating activities |
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(4,669 |
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(7,902 |
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Cash flows from investing activities: |
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Proceeds from repayment of loans to employees |
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67 |
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Purchases of property and equipment |
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(267 |
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(193 |
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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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(267 |
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(159 |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock and common stock warrants, net of costs paid |
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23,538 |
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Proceeds from exercise of stock options |
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84 |
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Proceeds from stock subscription receivable |
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27 |
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Principal payments on long-term debt obligations |
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(674 |
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Principal payments on short-term debt obligations |
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(1,157 |
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Principal payments on capital lease obligations |
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(98 |
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(67 |
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Net cash (used in) provided by financing activities |
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(14 |
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21,667 |
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Effect of exchange rate changes on cash and cash equivalents |
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311 |
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67 |
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Net (decrease) increase in cash and cash equivalents |
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(4,639 |
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13,673 |
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Cash and cash equivalents at beginning of period |
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27,066 |
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24,301 |
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Cash and cash equivalents at end of period |
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$ |
22,427 |
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$ |
37,974 |
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Supplemental disclosure of noncash investing and financing activities: |
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Fair value of warrant granted as deferred equity financing cost |
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$ |
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$ |
6,968 |
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Issuance of shares in connection with employee severance payment |
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$ |
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$ |
250 |
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The accompanying notes are an integral part of these financial statements.
5
Note 1. Business Overview
We are a biopharmaceutical company developing novel, proprietary antibodies for the treatment
of cancer, inflammation and autoimmune diseases. Four of our antibodies are currently in clinical
trials, while the remainder of our product pipeline is in preclinical development. To date, we have
incurred significant research and development expenses and have not achieved any product revenues
from sales of our product candidates.
Note 2. Basis of Presentation
The condensed consolidated financial statements as of June 30, 2008, and for the three and six
months ended June 30, 2008 and 2007, 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 consolidated financial statements as of December 31,
2007 and 2006 and each of the two years in the period ended December 31, 2007 included in our
Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on
March 14, 2008.
The accompanying consolidated financial statements include the accounts of our wholly-owned
subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires us to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. On an ongoing basis, we evaluate our
estimates, including those related to revenue recognition, the valuation of goodwill, intangibles
and other long-lived assets, lease exit liabilities, asset retirement obligations 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.
The accompanying financial statements have been prepared assuming we will continue as a going
concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of
our liabilities in the normal course of business. As of June 30, 2008, we had an accumulated
deficit of $179.4 million, and we 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 product 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 2009, without considering any potential
milestone payments that we may receive under current or future collaborations, or any future
capital raising transactions or drawdowns from the committed equity financing facility (CEFF) with
Kingsbridge Capital Limited. To date we have not drawn any funds from the CEFF.
Note 3. Summary of Significant Accounting Policies
Restricted Cash
As of each of June 30, 2008 and December 31, 2007, we had a consolidated total of
$3.2 million in certificates of deposit that are classified as restricted cash in our non-current
assets.
As of June 30, 2008 and December 31, 2007, the U.S. dollar equivalent of restricted cash
related to our building lease in Munich, Germany, is $0.8 million.
As a result of the merger between CancerVax Corporation and our subsidiary Micromet AG in May
2006, we assumed three irrevocable standby letters of credit in connection with building leases.
The letters of credit totaled $2.4 million at the merger date and were secured by certificates of
deposit for similar amounts that are disclosed as restricted cash. During May 2006, we entered into
a lease assignment agreement related to a manufacturing facility lease that resulted in (i) the
issuance of a $1.0 million standby letter of credit, collateralized by a certificate of deposit in
the same amount, to cover restoration costs that we may be obligated for in the future and (ii) the
release of the landlords security interest in $650,000 of certificates of deposit in August 2006.
In addition, during June 2006, we entered into a lease termination agreement for a warehouse
facility that resulted in the release of the landlords security interest in $280,000 of
certificates of deposit in August 2006. As of each of June 30, 2008 and December 31, 2007, a total
of $2.4 million of restricted cash was outstanding related to these leases and has been disclosed
as a non-current asset on our accompanying condensed consolidated balance sheets.
6
Common Stock Warrants Liability
In June 2007, we completed a private placement of 9,216,709 shares of common stock and common
stock warrants to purchase an additional 4,608,356 shares of common stock. Due to certain
provisions in the common stock warrant agreement, these warrants are required to be classified as a
liability. The common stock warrants liability is recorded at fair value, which is adjusted at the
end of each reporting period using the Black-Scholes option-pricing model, with changes in value
included in the condensed consolidated statements of operations.
Foreign Currency Translation
Transactions in foreign currencies are initially recorded at the functional currency rate
ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign
currencies are re-measured into the functional currency at the exchange rate in effect at the
balance sheet date. Transaction gains and losses are recorded in the consolidated statements of
operations in other income (expense) and amounted to $93,000 and $89,000 for the three months ended
June 30, 2008 and 2007, respectively and $103,000 and $146,000 for the six months ended June 30,
2008 and 2007, respectively.
The accompanying condensed consolidated financial statements are presented in U.S. dollars.
The translation of assets and liabilities to U.S. dollars is made at the exchange rate in effect at
the balance sheet date, while equity accounts are translated at historical rates. The translation
of statement of operations data is made at the average rate in effect for the period. The
translation of operating cash flow data is made at the average rate in effect for the period, and
investing and financing cash flow data is translated at the rate in effect at the date of the
underlying transaction. Translation gains and losses are recognized within accumulated other
comprehensive income in the accompanying condensed consolidated balance sheets.
Comprehensive Income (Loss)
Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income
(loss). Other comprehensive income (loss) includes foreign currency translation adjustments. The
following table sets forth the components of comprehensive income (loss) (in thousands):
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2008 |
|
|
2007 |
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|
2008 |
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|
2007 |
|
Net loss |
|
$ |
(8,627 |
) |
|
$ |
(6,469 |
) |
|
$ |
(14,493 |
) |
|
$ |
(14,059 |
) |
Foreign currency translation adjustments |
|
|
(88 |
) |
|
|
47 |
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|
|
(266 |
) |
|
|
(69 |
) |
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|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(8,715 |
) |
|
$ |
(6,422 |
) |
|
$ |
(14,759 |
) |
|
$ |
(13,990 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 the 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. For awards that contain a performance condition, expense is recognized using
the accelerated attribution methodology. Compensation expense related to stock-based awards is
allocated to research and development expense or general and administrative expense based upon the
department to which the associated employee reports. Stock-based awards issued to non-employees are
recorded at their fair value in accordance with SFAS No. 123(R) 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 a measurement date
commensurate with the determination of when service has been completed.
During the six months period ended June 30, 2008, we granted options to purchase 2,230,000
shares of our common stock. Certain of these stock options for employees at or above the vice
president level vest upon the attainment of specific performance targets. The measurement
date of stock options containing performance-based vesting is the date the stock option grant
is authorized and the specific performance goals are communicated. Compensation expense is
recognized based on the probability that the performance criteria will be met. The recognition
of compensation expense associated with performance-based vesting requires judgment in
assessing the probability of meeting the performance goals, as well as defined criteria for
assessing achievement of the performance-related goals. The continued assessment of
probability may result in additional expense recognition or expense reversal depending on the
level of achievement of the performance goals. The weighted-average grant-date fair value of
options granted during the six month periods ended June 30, 2008 was 1.34.
Stock-based compensation related to our stock-based awards is classified in the condensed
consolidated financial statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Research and development expense |
|
$ |
343 |
|
|
$ |
300 |
|
|
$ |
692 |
|
|
$ |
879 |
|
General and administrative expense |
|
|
503 |
|
|
|
390 |
|
|
|
1,011 |
|
|
|
1,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation |
|
$ |
846 |
|
|
$ |
690 |
|
|
$ |
1,703 |
|
|
$ |
1,916 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
As of June 30, 2008, total unrecognized compensation cost related to stock options was
approximately $6.1 million and the weighted average period over which it is expected to be
recognized is 2.3 years.
Net Loss Per Share
We calculate net loss per share in accordance with SFAS No. 128, Earnings Per Share
(SFAS 128). 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 of 7,918,000 and 5,982,000
shares and common stock warrants of 5,527,000 and 919,000 shares, in each case for the three and six
months ended June 30, 2008 and 2007, respectively.
Recent Accounting Standards and Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157), which
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles and expands disclosure about fair value measurements. In February 2008, the
FASB issued FASB Staff Position No. SFAS 157-b, Effective Date of FASB Statement No. 157, which
provides a one-year deferral of the effective date of SFAS 157 for non-financial assets and
non-financial liabilities, except those that are recognized or disclosed in the financial
statements at fair value at least annually. In accordance with this interpretation, we have adopted
the provisions of SFAS 157 with respect to our financial assets and liabilities that are measured
at fair value within our financial statements as of January 1, 2008see Note 4 of our condensed
consolidated financial statements. The provisions of SFAS 157 have not been applied to
non-financial assets and non-financial liabilities. We are currently assessing the impact, if any,
of this deferral on our condensed consolidated financial statements.
Effective January 1, 2008, we adopted SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities (SFAS 159). 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 159 permitted us to choose to measure many financial instruments
and certain other items at fair value and established presentation and disclosure requirements. In
adopting SFAS 159, we did not elect to measure any new assets or liabilities at their respective
fair values.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of ARB No. 51 (SFAS 160). The objective of SFAS 160 is to
improve the relevance, comparability, and transparency of the financial information that a
reporting entity provides in its consolidated financial statements. SFAS 160 is effective for
fiscal years, and interim periods within those fiscal years, beginning on or after December 15,
2008. Earlier adoption is prohibited. We do not believe that the adoption of SFAS 160 will have a
material impact on our condensed consolidated results of operations or financial condition.
In March 2008, the FASB issued SFAS No. 161, Disclosures About Derivative Instruments and
Hedging Activities (SFAS 161). SFAS 161 enhances the disclosure requirements for derivative
instruments and hedging activities. SFAS 161 is effective January 1, 2009. Since SFAS 161 requires
only additional disclosures concerning derivatives and hedging activities, the adoption of SFAS 161
will not affect our condensed consolidated financial condition, results of operations and cash
flows.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS 162), which identifies the sources of accounting principles and provides
entities with a framework for selecting the principles used in the preparation of financial
statements that are presented in conformity with GAAP. The current GAAP hierarchy has been
criticized because it is directed to the auditor rather than the entity, it is complex, and it
ranks FASB Statements of Financial Accounting Concepts, which are subject to the same level of due
process as FASB Statements of Financial Accounting Standards, below industry practices that are
widely recognized as generally accepted but that are not subject to due process. The FASB believes
the GAAP hierarchy should be directed to
8
entities because it is the entity (not its auditors) that is responsible for selecting accounting
principles for financial statements that are presented in conformity with GAAP. The adoption of
SFAS 162 is not expected to have a material impact on our condensed consolidated financial
statements.
Note 4. Fair Value Measurements
We adopted the provisions of SFAS 157 as of January 1, 2008 for financial instruments.
Although the adoption of SFAS 157 did not impact our financial condition, results of operations, or
cash flows, we are now required to provide additional disclosures as part of our financial
statements.
SFAS 157 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in
measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted
prices in active markets; Level 2, defined as inputs other than quoted prices in active markets
that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in
which little or no market data exists, therefore requiring an entity to develop its own
assumptions. The following table presents information about our assets and liabilities that are
measured at fair value on a recurring basis as of June 30, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
Quoted Prices in |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
June 30, |
|
|
Active Markets |
|
|
Observable inputs |
|
|
Inputs |
|
Description |
|
2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
22,427 |
|
|
$ |
22,427 |
|
|
$ |
|
|
|
$ |
|
|
Restricted cash |
|
|
3,247 |
|
|
|
3,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
25,674 |
|
|
$ |
25,674 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
warrant liability |
|
$ |
6,928 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
6,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents information about our common stock warrant liability, which was our
only financial instrument measured at fair value on a recurring basis using significant
unobservable inputs (Level 3) as defined in SFAS 157 at June 30, 2008:
|
|
|
|
|
|
|
Fair Value |
|
Balance at December 31, 2007 |
|
$ |
5,219 |
|
Total unrealized change in fair value of
warrants included in earnings during the three
months ended March 31, 2008 |
|
|
(1,254 |
) |
|
|
|
|
Balance March 31, 2008 |
|
|
3,965 |
|
Total unrealized change in fair value of
warrants included in earnings during the
three months ended June 30, 2008 |
|
|
2,963 |
|
|
|
|
|
Balance June 30, 2008 |
|
$ |
6,928 |
|
|
|
|
|
The carrying value of the common stock warrant liability is calculated using the Black-Scholes
option pricing model, which requires the input of highly subjective assumptions. 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.
Note 5. Deferred Revenue
As of June 30, 2008 and December 31, 2007, deferred revenues were derived mainly from research
and development agreements with Nycomed, TRACON and Merck Serono as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Nycomed |
|
$ |
9,153 |
|
|
$ |
7,205 |
|
TRACON |
|
|
1,371 |
|
|
|
1,421 |
|
Merck Serono |
|
|
2,318 |
|
|
|
2,722 |
|
Other |
|
|
636 |
|
|
|
378 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
13,478 |
|
|
|
11,726 |
|
Current portion |
|
|
(4,898 |
) |
|
|
(3,360 |
) |
|
|
|
|
|
|
|
Long term portion |
|
$ |
8,580 |
|
|
$ |
8,366 |
|
|
|
|
|
|
|
|
9
The deferred revenue for Nycomed and TRACON consists mainly of the upfront license fees that
are being recognized over the period that we are required to participate on joint steering
committees of 20 years and 15 years respectively.
The upfront license fees and research and development service reimbursements in the
collaboration agreement with Merck Serono are considered to be a combined unit of accounting and
accordingly, the related amounts are recognized ratably over the expected period of the research
and development program, which continues through 2011.
Note 6. Other Non-Current Liabilities
Other non-current liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Facility lease exit liability, net of current portion |
|
$ |
1,309 |
|
|
$ |
1,381 |
|
GEK subsidy, net of current portion |
|
|
180 |
|
|
|
198 |
|
Asset retirement obligation |
|
|
487 |
|
|
|
415 |
|
Capital lease obligations, net of current portion (see Note 8) |
|
|
210 |
|
|
|
47 |
|
Other |
|
|
17 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
$ |
2,203 |
|
|
$ |
2,055 |
|
|
|
|
|
|
|
|
Facility Lease Exit Liability and Restructuring Provision
In May 2006, we assumed exit liabilities relating to a facility lease for our former corporate
headquarters in Carlsbad, California and a former manufacturing facility that was no longer in use.
During May 2006, we entered into a lease assignment agreement related to the manufacturing
facility lease. As of April 2007, we have fully subleased the former corporate headquarters. We
review the adequacy of our estimated exit accruals on an ongoing basis.
We also previously recorded a lease exit liability relating to a portion of our Munich
facility that was no longer in use. In June 2007, we signed a sublease agreement with Roche to
lease a portion of this facility, and accordingly, we adjusted our lease exit liability to reflect
the terms of this sublease for the remaining lease period. The adjustment of $394,000 was recorded
as a reduction to research and development expense during the second quarter of 2007. We no longer
have a lease exit liability on this facility, as future sublease income is expected to cover our
lease expense.
The following table summarizes the facility lease activity for these obligations for the six
months ended June 30, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued |
|
|
|
|
|
|
|
|
|
Accrued |
Balance as of |
|
Amounts |
|
|
|
|
|
Balance as of |
December 31, |
|
Paid |
|
Accretion |
|
June 30, |
2007 |
|
in Period |
|
Expense |
|
2008 |
$1,537 |
|
$ |
(180 |
) |
|
$ |
136 |
|
|
$ |
1,493 |
|
Of the $1,493,000 lease exit liability as of June 30, 2008, $184,000 is current and $1,309,000
is non-current.
Asset Retirement Obligation
In February 2001, we entered into a building lease agreement with GEK. Under the terms of the
agreement, GEK agreed to lease laboratory and office space to us for a period of 10 years beginning
on July 1, 2002. Upon termination of the agreement, we may, under certain conditions, be obligated
to remove those leasehold improvements that will not be assumed by GEK. The fair value of the asset retirement obligation
will increase due to
accretion through the term of the lease agreement. In connection with our sublease with Roche in 2007,
certain leasehold improvements were made to our facility which we will be required to remove at the
end of our lease and which increased the liability. The
following table summarizes the activity for the six months ended June 30, 2008 (in thousands):
|
|
|
|
|
Balance January 1, 2008 |
|
$ |
415 |
|
Accretion expense |
|
|
40 |
|
Currency translation adjustment |
|
|
32 |
|
|
|
|
|
Balance June 30, 2008 |
|
$ |
487 |
|
|
|
|
|
10
Note 7. Long-Term Debt
Long-term debt obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
TBG borrowings, repaid on July 1, 2008 |
|
$ |
2,586 |
|
|
$ |
2,401 |
|
MedImmune borrowings due June 6, 2010; unsecured with interest payable monthly at 4.5% |
|
|
2,417 |
|
|
|
2,254 |
|
|
|
|
|
|
|
|
Total long-term debt obligations |
|
|
5,003 |
|
|
|
4,655 |
|
Less: current portion |
|
|
(2,586 |
) |
|
|
(2,401 |
) |
|
|
|
|
|
|
|
Long-term debt obligations, net of current portion |
|
$ |
2,417 |
|
|
$ |
2,254 |
|
|
|
|
|
|
|
|
Scheduled repayment of principal for the debt agreements is as follows as of June 30, 2008
(in thousands):
|
|
|
|
|
2008 |
|
$ |
2,586 |
|
2009 |
|
|
|
|
2010 |
|
|
2,417 |
|
|
|
|
|
Total |
|
$ |
5,003 |
|
|
|
|
|
TBG Silent Partnership Agreements
Silent partnerships are a common form of investment in German business practice. These types
of lenders were created to support the development of technology-oriented companies in the start-up
phase. We entered into a silent partnership agreement with tbg
Technologie-Beteiligungs-Gesellschaft mbH (TBG) and based on the amount loaned, they became a
stiller Gesellschafter (silent partner) in our subsidiary Micromet AG. Silent partners are not
involved in our management, but significant business decisions such as changes in the articles of
incorporation, mergers and acquisitions or significant contractual matters are subject to their
approval.
The TBG silent partner borrowings bore interest at a rate of 7%, payable semi-annually. In
addition to the stated contractual interest rate, the silent partnership agreement provided TBG
(i) with profit sharing equal to 9% of our profit before income taxes in any year obtained
determined in accordance with German generally accepted accounting principles,
(ii) additional amounts of interest in years 6 through 10 of the agreement if the borrowings remain
outstanding, with such additional amounts due at the end of the agreement, and (iii) an amount
representing approximately 35% of the original loan balance due at the end of the silent
partnership agreement. We accreted the amounts included in items (ii) and (iii) over the life of
the silent partnership agreements using the effective interest method. In accordance with the
agreement, we notified TBG of our election to terminate the obligation six months early, and the
remaining amounts due to TBG were repaid in full on July 1, 2008.
Interest expense related to this silent partnership agreement with TBG amounted to $63,000 and
$270,000 for the six months ended June 30, 2008 and 2007, respectively.
Note 8. Commitments and Contingencies
Leases
Future minimum lease payments under non-cancelable operating and capital leases as of June 30,
2008 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected |
|
|
|
|
|
|
Capital |
|
|
Operating |
|
|
Sublease |
|
|
Net Operating |
|
|
|
Leases |
|
|
Leases |
|
|
Income |
|
|
Leases |
|
2008 (July 1, 2008 December 31, 2008) |
|
$ |
118 |
|
|
$ |
2,653 |
|
|
$ |
(1,285 |
) |
|
$ |
1,368 |
|
2009 |
|
|
92 |
|
|
|
5,302 |
|
|
|
(2,590 |
) |
|
|
2,712 |
|
2010 |
|
|
61 |
|
|
|
5,366 |
|
|
|
(2,107 |
) |
|
|
3,259 |
|
2011 |
|
|
61 |
|
|
|
5,427 |
|
|
|
(1,413 |
) |
|
|
4,014 |
|
2012 |
|
|
60 |
|
|
|
2,698 |
|
|
|
(717 |
) |
|
|
1,981 |
|
Thereafter |
|
|
109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
|
501 |
|
|
|
21,446 |
|
|
$ |
(8,112 |
) |
|
$ |
13,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: amount representing imputed interest |
|
|
(152 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease payments |
|
|
349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: current portion |
|
|
(139 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligation, less current portion |
|
$ |
210 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The sublease income is from sublease agreements related to our former headquarters and our
Munich facility (see Note 6).
11
License Agreements
We have entered into various license agreements under which we are granted the right to use
licensed technology in our research and development efforts. In consideration of these licenses, we
are generally required to 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 agreements as of June 30, 2008 are as follows (in
thousands):
|
|
|
|
|
2008 (July 1, 2008 - December 31, 2008) |
|
$ |
40 |
|
2009 |
|
|
140 |
|
2010 |
|
|
113 |
|
2011 |
|
|
113 |
|
2012 |
|
|
115 |
|
Thereafter |
|
|
209 |
|
|
|
|
|
Total minimum payments |
|
$ |
730 |
|
|
|
|
|
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, 2007, 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 14, 2008.
Ongoing Business Activities
We are a biopharmaceutical company developing novel, proprietary antibodies for the treatment
of cancer, inflammation and autoimmune diseases. Four of our antibodies are currently in clinical
trials, while the remainder of our product pipeline is in preclinical development. Blinatumomab
(MT103), the most advanced antibody in our product pipeline developed using our BiTE® antibody
technology platform, is being evaluated in a phase 2 clinical trial for the treatment of patients
with acute lymphoblastic leukemia (ALL) and in a phase 1 clinical trial for the treatment of patients with
non-Hodgkins lymphoma (NHL). BiTE antibodies
represent a new class of antibodies that activate a patients own cytotoxic T cells, considered the
most powerful killer cells of the human immune system, to eliminate cancer cells. We are
developing blinatumomab in collaboration with MedImmune. Our second clinical stage antibody is
adecatumumab, a human monoclonal antibody which targets epithelial cell adhesion molecule (EpCAM) expressing solid tumors. We are
developing adecatumumab in collaboration with Merck Serono in a phase 1b clinical trial evaluating
adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast
cancer. MT110, a BiTE antibody targeting EpCAM-expressing tumors, is in a phase 1 clinical trial
in patients with lung or gastrointestinal cancers in 2008. MT293, our fourth clinical stage
antibody, is licensed to TRACON, and is being developed in a phase 1 clinical trial for the
treatment of patients with cancer. In addition, we have established a collaboration with Nycomed
for the development and commercialization of MT203, our human antibody neutralizing the activity of
GM-CSF, which has potential applications in the treatment of various inflammatory and autoimmune
diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. Further, we have used
and will continue to use our proprietary BiTE antibody technology platform to generate additional
antibodies for our product pipeline. To date, we have incurred significant research and
development 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
12
from the initial identification of a lead compound to the completion of preclinical and
clinical trials, before applying for marketing approval from the United States Food and Drug Administration (FDA)
or European Medicines Agency (EMEA), or equivalent regulatory agencies in other countries and
regions. 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 preclinical studies or clinical trials, we may elect to discontinue
the development of 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 program 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 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, through private placements of common stock and associated warrants. We intend to continue
to seek funding through public or private financings in the future, including as a result of issuing warrants in connection with the financing.
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.
Research and Development
Through June 30, 2008, our research and development expenses consisted of costs associated
with the clinical development of adecatumumab and blinatumomab, as well as development costs
incurred for MT110 and MT203, research activities under our collaboration with MedImmune and
Nycomed, and research conducted with respect to the BiTE antibody platform. The costs incurred
include costs associated with clinical trials and manufacturing processes, 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 charge all research and development expenses to operations as incurred.
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 preclinical efforts for our human antibodies and BiTE antibodies 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 developed in our collaborations.
Under our collaboration agreement with Merck Serono for the development of adecatumumab, we 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 the product candidate. 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, we and Merck Serono agreed that Micromet would continue
to conduct an ongoing phase 1 clinical trial testing the safety of adecatumumab in combination with
docetaxel in patients with metastatic breast cancer. In October 2007, we and Merck Serono further
amended the agreement and reallocated certain of our respective development responsibilities with
respect to adecatumumab. As part of the revised responsibilities, Micromet now has all decision
making authority and operational responsibility for the ongoing phase 1 clinical trial, as well as
an additional clinical trial to be conducted by us. Merck Serono will continue to bear the
development expenses associated with the collaboration in accordance with the agreed-upon budget.
Our collaboration agreement with MedImmune for blinatumomab provides for potential future
milestone payments and royalty payments based on net sales of blinatumomab. A second agreement with
MedImmune for the development of new BiTE antibodies provides for potential future milestone
payments and royalty payments based on future sales of the BiTE antibodies 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.
13
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 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
advance 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.
Results of Operations
Comparison of Three Months Ended June 30, 2008 and 2007
Revenues. The following table summarizes our primary sources of revenue for the periods
presented (in millions):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
Collaborative R&D revenue: |
|
|
|
|
|
|
|
|
Nycomed |
|
$ |
4.8 |
|
|
$ |
0.3 |
|
MedImmune |
|
|
2.0 |
|
|
|
1.2 |
|
Merck Serono |
|
|
0.9 |
|
|
|
1.1 |
|
TRACON |
|
|
0.1 |
|
|
|
|
|
Other |
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
Total collaborative R&D revenue |
|
|
7.9 |
|
|
|
2.6 |
|
License and other revenue |
|
|
0.6 |
|
|
|
0.5 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
8.5 |
|
|
$ |
3.1 |
|
|
|
|
|
|
|
|
Collaborative research and development revenues from Nycomed reflect their full cost
responsibility for the MT203 program. Collaborative research and development revenues from
MedImmune represent their share of the costs of clinical development of blinatumomab and
their full cost responsibility for the development of MT111, a BiTE antibody binding to CEA with
potential applications in the treatment of solid tumors, and another BiTE antibody binding to
EphA2. Collaborative research and development revenues from Merck Serono reflect their full cost
responsibility for the adecatumumab program. Collaborative research and development revenues from
TRACON reflect the amortization of upfront licensing fees and miscellaneous pass-through expenses.
The Nycomed collaboration agreement commenced during the second quarter of 2007 and therefore
generated revenues for only a portion of the second quarter of 2007, compared to a full period for
2008. The Nycomed revenue represents the reimbursement of our clinical development activities,
including reimbursement for full-time equivalents as well as the portion of the up-front payment
from Nycomed that is being recognized over a 20-year period. The increase in MedImmune
collaborative R&D revenue was due to an increase in revenue of $0.3 million under the blinatumomab
program and aggregate increases of $0.5 million in the MedImmune BiTE antibody programs. The Merck Serono
collaborative R&D revenue is for the phase 1 clinical trial of MT201 in combination with docetaxel for the
treatment of metastatic breast cancer and the revenue recognition will continue through 2011. The TRACON collaboration agreement was
also signed during the second quarter of 2007, and no revenue was recorded during that quarter.
The TRACON revenue represents the portion of the up-front payment received from TRACON that is
being recognized over a 15-year period, in addition to miscellaneous pass-through expenses.
Research and Development Expenses. Research and development expense consists of costs
incurred to discover and develop our 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
14
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 $11.0 million and $6.7 million for the three months
ended June 30, 2008 and 2007, respectively. This increase of $4.3 million results primarily from a
$2.1 million increase in manufacturing for our MT203 program, an increase of $0.5 for licensing
fees and an increase of $0.4 million due to higher personnel costs, including increases in the
number of full-time equivalents.
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 $3.4 million and $4.4 million for the three months
ended June 30, 2008 and 2007, respectively. The decrease is primarily the result of a reduction of
expense in the aggregate amount of $0.8 million during the second quarter of 2007 for the facility
lease exit liability incurred in connection with our former corporate headquarters.
Interest Expense. Interest expense for the three months ended June 30, 2008 and 2007 was
$32,000 and $178,000, respectively. The decrease was not material.
Interest Income. Interest income for the three months ended June 30, 2008 and 2007 was
$199,000 and $99,000, respectively. The increase was primarily due to the higher average cash
balances in 2008 resulting from the June 2007 PIPE financing.
Change in Fair Value of Common Stock Warrants Liability. The common stock warrants issued in
connection with the private placement in June 2007 are classified as a liability. The expense of
$3.0 million recorded in the second quarter of 2008 represents the change in fair value of
the warrants as of June 30, 2008 non-cash as compared to the value on March 31, 2008. The increase in our
common stock price during the second quarter of 2008 resulted in the increase in the liability.
Comparison of Six Months Ended June 30, 2008 and 2007
Revenues. The following table summarizes our primary sources of revenue for the periods
presented (in millions):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
Collaborative R&D revenue: |
|
|
|
|
|
|
|
|
Nycomed |
|
$ |
8.0 |
|
|
$ |
0.3 |
|
MedImmune |
|
|
3.8 |
|
|
|
2.7 |
|
Merck Serono |
|
|
1.6 |
|
|
|
2.1 |
|
TRACON |
|
|
0.2 |
|
|
|
|
|
Other |
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
Total collaborative R&D revenue |
|
|
13.7 |
|
|
|
5.1 |
|
License and other revenue |
|
|
0.7 |
|
|
|
0.7 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
14.4 |
|
|
$ |
5.8 |
|
|
|
|
|
|
|
|
As described above, the Nycomed agreement was signed in the second quarter of 2007, so
that revenue was recorded only for a partial period, accounting for the $7.7 million increase in
revenue relating to this agreement. The increase in MedImmune collaborative R&D revenue results
from increases of $0.4 million under the blinatumomab program and an aggregate increase of $0.7
million in the MT111 and EphA2 BiTE antibody programs. The decrease in Merck Serono collaborative
R&D revenue was the result of amendments to our collaboration agreement that had the effect of
lengthening the time over which revenue is recognized for the phase 1 clinical trial of MT201 in combination
with docetaxel for the treatment of metastatic breast cancer. The period was extended from June
2007 to June 2011. The TRACON collaboration also commenced during the second quarter of 2007, and
no revenue was recorded during that quarter.
15
Research and Development Expenses. Research and development expenses were $20.7 million and
$13.4 million for the six months ended June 30, 2008 and 2007, respectively. The $7.3 million
increase was primarily the result of a $3.8 million increase in manufacturing and preclinical
services on our MT203 program, increases of $0.6 million for feasibility studies in our BiTE
antibody administration programs, $1.0 million in higher personnel costs, including increases in the number
of full-time equivalents, and increases of $0.6 million in clinical expenses for our MT103 and
MT110 programs.
General and Administrative Expenses. General and administrative expenses were $6.9 million
and $7.9 million for the six months ended June 30, 2008 and 2007, respectively. As described
above, the decrease is primarily the result of an adjustment in the aggregate amount of
$0.8 million recorded during the second quarter of 2007 for the facility lease exit liability incurred in
connection with our former corporate headquarters.
Interest Expense. Interest expense for the six months ended June 30, 2008 and 2007 was
$0.1 million and $0.4 million, respectively. The decrease was not material.
Interest Income. Interest income for the six months ended June 30, 2008 and 2007 was $0.5
million and $0.2 million, respectively. The increase was primarily due to the higher average cash
balances in 2008 resulting from the June 2007 PIPE financing.
Change in Fair Value of Common Stock Warrants Liability. The expense of $1.7 million
recorded in the six months ended June 30, 2008 represents the non-cash change in fair value of the
warrants as of June 30, 2008 as compared to the value on December 31, 2007 and was the result of an
increase in the price of our common stock during this period.
Liquidity and Capital Resources
We had cash and cash equivalents of $22.4 million and $27.1 million as of June 30, 2008 and
December 31, 2007, respectively. The decrease between these dates resulted primarily from our net
loss of $14.5 million for the six months ended June 30, 2008, partially offset by $5.4 million in non-cash
expenses and $4.4 million in changes in working capital, including a net decrease in accounts
receivable of $2.3 million and an increase of $0.9 in deferred revenue. As discussed in Note 7 to our consolidated financial statements included with this report, we
repaid in full the silent partnership debt of $2.6 million to TBG on July 1, 2008.
Net cash used in operating activities was $4.7 million for the six months ended June 30, 2008,
compared to $7.9 million used in operating activities for the six months ended June 30, 2007. The
decrease results primarily from an increase of $2.5 million in non-cash charges, including a net
$2.2 million increase due to the change in fair value of our common stock warrant liability.
Changes in operating assets and liabilities included a net decrease of $2.3 million of accounts
receivable and $0.9 million increase in deferred revenue during the six months ended June 30, 2008,
as compared to the increase of $9.2 million in deferred revenue offset by payments on accounts
payable and accrued liabilities of $4.2 million and a net increase in accounts receivable of $1.5
million during the six months ended June 30, 2007.
Net cash used in investing activities was $267,000 for the six months ended June 30, 2008,
compared to $159,000 for the six months ended June 30, 2007. The decrease results primarily from
increases in expenditures for property and equipment.
Net cash used in financing activities was $14,000 for the six months June 30, 2008, compared
to $21.7 million provided by financing activities for the six months ended June 30, 2007. We
closed a private placement financing in June 2007 that resulted in net proceeds of $23.5 million,
which was partially offset by silent partnership debt repayments of $1.7 million during the six
months ended June 30, 2007.
To date, we have funded our operations through proceeds from private placements of preferred
stock, debt financing, government grants for research, license fees, milestone payments and
research-contribution revenues from our collaborations with pharmaceutical companies, and, more
recently, through private placements 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 continue to seek funding through public or private
equity or debt financings in the future or to raise additional funds 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, including as a result of issuing warrants in connection with the financing.
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
16
obtain adequate financing may adversely affect our ability to operate as a going concern.
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 2009 at current spending levels,
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 our CEFF with
Kingsbridge Capital Limited. To date we have not drawn down any funds from the CEFF.
Our future capital uses and requirements depend on numerous forward-looking factors and
involves risks and uncertainties. Actual results could vary as a result of a number of factors,
including the factors discussed in Risk Factors herein. In light of the numerous risks and
uncertainties associated with the development and commercialization of our product candidates, we
are unable to estimate the amounts of increased capital outlays and operating expenditures
associated with our current and anticipated clinical trials. Our future funding requirements will
depend on many factors, including:
|
|
the number, scope, rate of progress, results and costs of our preclinical studies, clinical trials and other research and
development activities; |
|
|
|
the terms and timing of any strategic collaborations that we may establish, and the success of these collaborations; |
|
|
|
the cost, timing and outcomes of regulatory approvals; |
|
|
|
the number and characteristics of product candidates that we pursue; |
|
|
|
the cost and timing of establishing manufacturing, marketing and sales, and distribution capabilities; |
|
|
|
the cost of establishing clinical and commercial supplies of our product candidates; |
|
|
|
the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and |
|
|
|
the extent to which we acquire or invest in businesses, products or technologies. |
We are parties to three irrevocable standby letters of credit in connection with former
facilities being subleased and our current building leases in Munich, Germany and Bethesda,
Maryland. As of June 30, 2008, we had $3.2 million of cash and certificates of deposit relating to
these letters of credit that are considered restricted cash, all of which is recorded as a
non-current asset.
Contractual Obligations
We have contractual obligations
related to our facility leases, license agreements and
financing agreements. The following table sets forth our significant contractual obligations as of
June 30, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due by Period |
|
|
|
|
|
|
|
Less Than |
|
|
|
|
|
|
|
|
|
|
More Than |
|
Contractual Obligations |
|
Total |
|
|
1 Year (1) |
|
|
1-3 Years |
|
|
3-5 Years |
|
|
5 Years |
|
Operating leases(2) |
|
$ |
21,446 |
|
|
$ |
2,654 |
|
|
$ |
10,667 |
|
|
$ |
8,125 |
|
|
$ |
|
|
Long-term debt MedImmune |
|
|
2,417 |
|
|
|
|
|
|
|
2,417 |
|
|
|
|
|
|
|
|
|
Silent partnership
obligations (repaid July
1, 2008) |
|
|
2,586 |
|
|
|
2,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual payments
under licensing
agreements (3) |
|
|
730 |
|
|
|
40 |
|
|
|
253 |
|
|
|
228 |
|
|
|
209 |
|
Capital leases |
|
|
501 |
|
|
|
118 |
|
|
|
154 |
|
|
|
121 |
|
|
|
108 |
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,680 |
|
|
$ |
5,398 |
|
|
$ |
13,491 |
|
|
$ |
8,474 |
|
|
$ |
317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes amounts payable from July 1, 2008 through December 31, 2008. |
|
(2) |
|
The amounts shown in operating leases excludes expected sub-lease income (see Note 8 to
our condensed consolidated financial statements included in this report). |
17
|
|
|
(3) |
|
We have license 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 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 license fees and royalties and the costs
associated with the prosecution and maintenance of the patents covering the licensed
technology. |
|
|
|
|
|
In addition, we have entered into agreements with clinical research
organizations responsible for conducting and monitoring our clinical trials, and other
outside contractors who will be responsible for additional services supporting our ongoing
clinical development programs. These contractual obligations are not reflected in the table
above because we may terminate them on short notice without incurring additional material
charges (other than charges for work completed but not paid for through the effective date
of termination and other costs incurred by our contractors in closing out work in progress
as of the effective date of termination). Further, we have entered into agreements with
contract manufacturing organizations under which they conduct periodic production runs to
manufacture our product candidates. The timing of these production runs depends on the
availability of manufacturing slots at the contract manufacturing organization and the
progress of the associated development programs. Given the uncertainties associated with
these manufacturing activities and the resulting payment obligations, these contractual
obligations are also not reflected in the table above. |
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 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, possible, can, estimate, continue,
ongoing, consider, anticipate, intend, seek, plan, project, expect, should, or
would or the negative of these terms, or other comparable terminology, although not all
forward-looking statements contain these words. 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, timing or success of our clinical trials; difficulties or delays in development, testing,
obtaining regulatory approval for producing and marketing our product candidates; regulatory
developments in the United States or in foreign countries; the risks associated with reliance on
collaborations for the development and commercialization of our product candidates; unexpected
adverse side effects or inadequate therapeutic efficacy of our product candidates that could delay
or prevent product development or commercialization, or that could result in recalls or product
liability claims; our ability to attract and retain key scientific, management or commercial
personnel; the loss of key scientific, management or commercial personnel; the size and growth
potential of the potential markets for our product candidates and our ability to serve those
markets; the scope and validity of patent protection for our product candidates; competition from
other pharmaceutical or biotechnology companies; our ability to establish and maintain strategic
collaborations or to otherwise obtain additional financing to support our operations on
commercially reasonable terms; 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 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.
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As a result, our financial results and capital resources may be affected by changes in the
U.S. dollar/Euro exchange rate. As of June 30, 2008, we had U.S. dollar-denominated cash and cash
equivalents of $14.4 million and Euro-denominated liabilities of approximately 15.9 million. The
Euro amount as of June 30, 2008 is equivalent to approximately $25.2 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
As of the end of the period covered by this Quarterly Report, management performed, with the
participation of our Chief Executive Officer and our Acting Chief Financial Officer, an evaluation
of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and
15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to ensure that
information required to be disclosed in the reports we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the SECs rules
and forms, and that such information is accumulated and communicated to our management, including
our Chief Executive Officer and our Acting Chief Financial Officer, to allow timely decisions
regarding required disclosures. As of June 30, 2008, based on our evaluation and the identification
of the material weaknesses in our internal control over financial reporting, as previously disclosed in
our Annual Report on Form 10-K for the year ended December 31, 2007, the Companys disclosure
controls and procedures were not effective. During 2008, we have taken a number of steps to
strengthen our internal control over financial reporting in order to address the weaknesses. The
improvements include additional procedures relating to the expense accrual process for research and
development
and the overall review of our financial statements, including comparisons to budget and prior periods.
In addition, during 2008 we have conducted regular finance staff meetings to
discuss accounting issues and unusual transactions. We expect to complete the full implementation
of our remediation measures during the third quarter of 2008.
Because of the material weaknesses identified in our evaluation of internal control over
financial reporting as of June 30, 2008, we performed additional substantive procedures, similar to
those previously disclosed in Form 10-K for the year ended December 31, 2007, to ensure that our
consolidated condensed financial statements as of and for the six month period ended June 30, 2008
are fairly stated in all material respects in accordance with GAAP.
Our management, including the Chief Executive Officer and Acting Chief Financial Officer, does
not expect that our disclosure controls and procedures or our internal control over financial
reporting will prevent all error and all fraud. A control system, no matter how well designed and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control
system are met. Because of the inherent limitations in all control systems, no evaluation of
controls can provide absolute assurance that all control issues and instances of fraud, if any,
within the Company have been detected.
Changes in Internal Control over Financial Reporting
Except as described above, there have been no changes in our internal control over financial reporting during the most
recently completed fiscal quarter that have materially affected or are reasonably likely to
materially affect our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
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.
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
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we may never achieve or maintain profitability.
We have incurred losses from the inception of Micromet through June 30, 2008, 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: Merck Serono, MedImmune, Nycomed and TRACON. 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.
Even if we do achieve profitability, we may not be able to sustain or increase profitability on a
quarterly or annual basis. Our failure to become and remain profitable may depress the market value
of our common stock and could impair our ability to raise capital, expand our business, diversify
our product offerings or continue our operations and, as a result, you could lose part or all of
your investment.
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 our 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. |
We filed a shelf registration statement, declared effective by the SEC 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, including as a result of the issuance of warrants in connection with the financing, 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.
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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 until September 2009, 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. For example, Kingsbridge may terminate the CEFF after August 30, 2008
if we have not drawn down at least $1.25 million in funds over a consecutive 12-month period. As
of the date of this report, we have not drawn down any funds from the CEFF. We are only eligible
to draw down funds under the CEFF at such times as our stock price is above $2.00 per share. 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. 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 for any given period 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 strategic collaborators and the timely payment
by these 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; |
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variations in the level of research and development expenses related to our clinical or
preclinical product candidates during any given period; |
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the change in fair value of the common stock warrants issued to investors in connection
with our 2007 private placement financing, remeasured at each balance sheet date using a
Black-Scholes option-pricing model, with the change in value recorded as other income or
expense; and |
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general market conditions affecting companies with our risk profile and market
capitalization. |
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.
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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 and related 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.
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 to respond 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 2007 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
(Sarbanes-Oxley) and the related rules and regulations of the SEC, including Section 404 of
Sarbanes-Oxley. We are in the process of upgrading our existing, and implementing additional,
procedures and controls. The process of updating the procedures and controls is requiring
significant time and expense and is more time-consuming and expensive than we previously
anticipated.
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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, 2007, 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 accrual processes and an
insufficient level of management review in our financial statement close and reporting process.
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. 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.
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, strategic collaborations, new technologies,
acquisitions, commercial relationships, joint ventures or capital commitments; |
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the execution of new collaboration agreements or termination of existing collaborations
related to our clinical or preclinical product candidates or our BiTE antibody 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 commercial
products or 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 collaboration arrangements with respect to
our product candidates; |
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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 31%of our outstanding common stock. As a result, if they act together, they 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. |
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.
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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 and license
arrangements. We currently have strategic collaborations or license arrangements with Merck Serono,
MedImmune, Nycomed and TRACON. We expect to enter into additional collaborations and license
arrangements in the future. Our existing and any future collaborations and licensed programs may
not be scientifically or commercially successful. The risks that we face in connection with these
collaborations and licensed programs 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 and licensing
arrangements will depend on, among other things, such collaborators efforts and allocation
of resources. |
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All of our strategic collaboration and license 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 its agreement
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 or programs licensed from 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 product candidates
involved in strategic collaborations 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 or license agreement with us. In the event of such a
termination, we may not be able to identify and enter into a collaboration agreement for our
product candidates 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
these product candidates on our own. As a result, we may incur delays in the development for
these product candidates following any potential termination of the collaboration agreement,
or we may need to reallocate financial resources that may cause delays in other development
programs for our other product candidates. |
We may not be successful in establishing additional strategic collaborations, which could
adversely affect our ability to develop and commercialize product candidates.
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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
antibodies 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. 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 in this or future clinical trials, 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
blinatumomab 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 blinatumomab 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 blinatumomab 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 blinatumomab, which involved a short-term infusion, as
opposed to a continuous infusion dosing regimen of blinatumomab, due to adverse side effects and
the lack of observed tumor responses. Serious adverse events included infections, dyspnoea,
hypersensitivity and various symptoms of the CNS. CNS-related side effects led to termination of
the treatment in a total of six patients in these short-term infusion trials. All of these side
effects fully resolved within a period of a few hours to a few days, with the exception of one
patient, who suffered from seizures and a myocardial ischemia, or loss of blood flow to the heart.
This patient ultimately died 49 days after receiving the last dose, and the cause of death was
determined to be pneumonia. 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 and are
continuing the dose escalation in accordance with the clinical trial protocol. We have also seen
objective tumor responses at the 15 µg/m2 and above per day dose level with the
continuous infusion regimens. While this preliminary data suggest that blinatumomab 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.
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.
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, that are safer, more effective, or have fewer side
27
effects, or are less expensive, or they 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
antibody therapeutics. We are seeking to do so through our internal research programs and
in-licensing activities, which could place a strain on our human and capital resources. 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 the FDA,
EMEA or other regulatory authorities may require us, to conduct preclinical studies or clinical
trials or other development activities in addition to those performed or 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 clinical and preclinical 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. We are responsible for confirming that our preclinical
studies are conducted in accordance with applicable regulations and that each of our clinical
trials is conducted in accordance with its general investigational plan and protocol. Our reliance
on third parties does not relieve us of responsibility for ensuring compliance with appropriate
regulations and standards for conducting, monitoring, recording and reporting of preclinical and
clinical trials. 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, do not meet expected deadlines, fail to comply with the good laboratory
practice guidelines or good clinical practice regulations, do not adhere to our preclinical and
clinical trial protocols, suffer an unforeseen business interruption unrelated to our agreement
with them that delays the clinical trial, or otherwise fail to generate reliable clinical data,
then the completion of these studies or trials may be delayed, the results may not be useable and
the studies or trials may have to be repeated, and we may need to enter into new arrangements with
alternative third parties. Any of these events could cause our clinical trials to be extended,
delayed, or terminated or create the need for them to be repeated, or otherwise 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
antibodies 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.
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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.
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. Competition for skilled personnel is intense and the turnover rate can be high.
Competition for experienced management and clinical, scientific and engineering personnel from
numerous companies and academic and other research institutions may limit our ability to attract
and retain qualified personnel on acceptable terms. As a result, 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, quality assurance, and control 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. Failure to attract and retain personnel would prevent us from developing
and commercializing our product candidates.
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.
We have no manufacturing experience or manufacturing capabilities for the production of our
product candidates for clinical trials or commercial sale. 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.
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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,
limitations in the scope of our approved labeling, withdrawal of the approved products from the
market, voluntary or mandatory recall and associated publicity requirements, fines, suspension or
withdrawal 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.
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, 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
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negatively affect our projected and actual revenues and our prospects for profitability.
We are unable to predict what additional legislation or regulation, if any, relating to the
healthcare industry or third-party coverage and reimbursement may be enacted in the future or what
effect such legislation or regulation would have on our business. Any cost containment measures or
other healthcare system reforms that are adopted could have a material adverse effect on our
ability to commercialize successfully any future products or could limit or eliminate our spending
on development projects and affect our ultimate 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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the timing of market entry relative to competitive treatments; |
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cost effectiveness; |
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effectiveness of our marketing and pricing strategy for any product candidates that we
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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 cause a loss of revenue or otherwise 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, injury to our
reputation, or reduced acceptance of our product candidates in the market. If we are sued for any
injury caused by any future products, our liability could exceed our total assets.
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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 which could impose greater
compliance costs and increased risks and penalties associated with violations. If an accident or
contamination occurred, we would likely incur significant costs associated with civil penalties or
criminal fines, substantial investigation and remediation costs, and costs associated with
complying with environmental laws and regulations. There can be no assurance that violations of
environmental laws or regulations will not occur in the future as a result of the inability to
obtain permits, human error, accident, equipment failure or other causes. We do not have any
insurance for liabilities arising from hazardous materials. Compliance with environmental and
safety 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. Furthermore, claims of employees or former
employees of Micromet related to their inventorship or compensation pursuant to the German Act on
Employees Inventions may lead to legal disputes.
We rely on third-party payment services and external law firms 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.
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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.
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. For example, we
are aware that GlaxoSmithKline holds a European patent covering the administration of adecatumumab
in combination with taxotere, which is the combination that we are currently testing in a phase 1
study. We have filed an opposition proceeding against this patent with the European Patent Office
seeking to have the patent invalidated. We may not be successful in this proceeding, and if it is
not resolved in our favor, we could be required to obtain a license under this patent from
GlaxoSmithKline, which we may not be able to obtain on commercially reasonable terms, if at all.
34
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.
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
35
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.
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 Merck Serono, MedImmune, Nycomed and TRACON, 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, then we could face a number of additional
risks, including:
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we may not be able to attract and build an experienced 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.
36
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
On June 27, 2008, we held an annual meeting of our stockholders. The proxy materials related
to the meeting were distributed on or about May 3, 2008. As of the record date of April 28, 2008,
40,828,759 shares of our common stock were outstanding and entitled to vote at the meeting. Of
these shares, 25,952,690 shares were present at the meeting in person or by proxy, representing
approximately 64% of our outstanding shares of common stock.
The following sets forth the matters presented for a vote by the stockholders and the votes
cast for, withheld, abstained, and broker non-votes:
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Votes |
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Broker |
Matter |
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Votes For |
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Against |
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Votes Withheld |
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Abstentions |
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Non-Votes |
(1) Election of
Christian Itin as a
Class II director
with a term serving
until the 2011
Annual Meeting |
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25,919,105 |
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33,585 |
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(2) Election of Peter
Johann as a Class
II director with a
term serving until
the 2011 Annual
Meeting |
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25,894,420 |
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58,270 |
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(3) Election of Joseph
Slattery as a Class
II director with a
term serving until
the 2011 Annual
Meeting |
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25,933,885 |
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18,805 |
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(4) Ratification of the
appointment of
Ernst & Young LLP
as our independent
auditors for the
current fiscal year |
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25,938,733 |
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13,699 |
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258 |
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Item 5. Other Information
None.
Item 6. Exhibits
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Exhibit |
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|
Number |
|
Description |
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3.1(1)
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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(2)
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Certificate of Designations for Series A Junior Participating Preferred Stock of the Registrant |
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3.4(4)
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Amended and Restated Bylaws effective October 3, 2007 |
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4.1(5)
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Form of Specimen Common Stock Certificate |
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31.1
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Certification of Principal Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under
the Securities Exchange Act of 1934 |
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31.2
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Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under
the Securities Exchange Act of 1934 |
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32(*)
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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 |
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(1) |
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Incorporated by reference to the Registrants Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on
December 11, 2003 |
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(2) |
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Incorporated by reference to the Registrants Current Report on
Form 8-K filed with the Securities and Exchange Commission on
November 8, 2004 |
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(3) |
|
Incorporated by reference to the Registrants Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on May 10,
2006 |
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(4) |
|
Incorporated by reference to the Registrants Current Report on
Form 8-K filed with the Securities and Exchange Commission on
October 9, 2007 |
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(5) |
|
Incorporated by reference to the Registrants Annual Report on
Form 10-K filed with the Securities and Exchange Commission on March
14, 2008 |
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* |
|
These certifications are being furnished solely to accompany this
annual 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 |
37
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.
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Dated: August 8, 2008 |
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Micromet, Inc.
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By:
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/s/ DONALD A. ZELM
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Donald A. Zelm
Executive Director of Finance
Acting Chief Financial Officer
(Principal Financial Officer) |
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38
Exhibit List
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
3.1(1)
|
|
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(2)
|
|
Certificate of Designations for Series A Junior Participating Preferred Stock of the Registrant |
|
|
|
3.4(4)
|
|
Amended and Restated Bylaws effective October 3, 2007 |
|
|
|
4.1(5)
|
|
Form of Specimen Common Stock Certificate |
|
|
|
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 Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on
December 11, 2003 |
|
(2) |
|
Incorporated by reference to the Registrants Current Report on
Form 8-K filed with the Securities and Exchange Commission on
November 8, 2004 |
|
(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
October 9, 2007 |
|
(5) |
|
Incorporated by reference to the Registrants Annual Report on
Form 10-K filed with the Securities and Exchange Commission on March
14, 2008 |
|
* |
|
These certifications are being furnished solely to accompany this
annual 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 |
39