e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2007
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-50440
MICROMET, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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52-2243564 |
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(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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6707 Democracy Boulevard, Suite 505, Bethesda, MD
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20817 |
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(Address of principal executive offices)
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(Zip Code) |
(240) 752-1420
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. þ Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). o Yes þ No
The number
of outstanding shares of the registrants common stock, par value $0.00004 per share, as
of November 5, 2007 was 40,754,730.
MICROMET, INC.
FORM 10-Q QUARTERLY REPORT
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2007
TABLE OF CONTENTS
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Page No. |
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PART I FINANCIAL INFORMATION |
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Item 1. Financial Statements (unaudited) |
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Condensed Consolidated Balance Sheets as of September 30, 2007 and December 31, 2006 |
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3 |
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Condensed Consolidated Statements of Operations for the three-month and nine-month
periods ended September 30, 2007 and 2006 |
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4 |
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Condensed Consolidated Statements of Cash Flows for the nine-month periods ended
September 30, 2007 and 2006 |
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5 |
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Notes to Condensed Consolidated Financial Statements |
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6 |
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
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18 |
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Item 3. Quantitative and Qualitative Disclosures about Market Risk |
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28 |
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Item 4. Controls and Procedures |
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28 |
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PART II OTHER INFORMATION |
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Item 1. Legal Proceedings |
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31 |
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Item 1A. Risk Factors |
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31 |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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47 |
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Item 3. Defaults Upon Senior Securities |
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47 |
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Item 4. Submission of Matters to a Vote of Security Holders |
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47 |
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Item 5. Other Information |
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47 |
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Item 6. Exhibits |
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47 |
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SIGNATURES |
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50 |
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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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September 30, |
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December 31, |
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2007 |
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2006 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
30,976 |
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$ |
24,301 |
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Accounts receivable |
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3,495 |
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2,319 |
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Prepaid expenses and other current assets |
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2,210 |
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2,048 |
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Total current assets |
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36,681 |
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28,668 |
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Property and equipment, net |
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4,407 |
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3,357 |
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Loans to employees |
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78 |
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Goodwill |
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6,917 |
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6,917 |
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Patents, net |
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7,972 |
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8,850 |
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Other long-term assets |
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437 |
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243 |
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Restricted cash |
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3,149 |
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3,059 |
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Total assets |
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$ |
59,563 |
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$ |
51,172 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,706 |
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$ |
1,680 |
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Accrued expenses |
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5,990 |
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10,153 |
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Common stock warrants liability |
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5,260 |
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Other liabilities |
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507 |
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366 |
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Short-term note |
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78 |
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1,320 |
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Current portion of long-term debt obligations |
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34 |
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599 |
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Current portion of deferred revenue |
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3,515 |
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2,972 |
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Total current liabilities |
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17,090 |
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17,090 |
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Deferred revenue, net of current portion |
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7,762 |
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195 |
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Other non-current liabilities |
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2,333 |
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1,961 |
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Long-term debt obligations, net of current portion |
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4,464 |
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7,408 |
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Commitments |
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Stockholders equity: |
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Preferred stock, $0.00004 par value; 10,000
shares authorized; no shares issued and
outstanding |
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Common stock, $0.00004 par value; 150,000
shares authorized; 40,739 and 31,419 shares
issued and outstanding at September 30, 2007
and December 31, 2006, respectively |
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2 |
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1 |
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Additional paid-in capital |
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183,077 |
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163,482 |
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Stock subscription receivables |
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(27 |
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Accumulated other comprehensive income |
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5,969 |
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5,869 |
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Accumulated deficit |
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(161,134 |
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(144,807 |
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Total stockholders equity |
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27,914 |
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24,518 |
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Total liabilities and stockholders equity |
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$ |
59,563 |
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$ |
51,172 |
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The accompanying notes are an integral part of these financial statements.
3
Micromet, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenues: |
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Collaboration agreements |
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$ |
5,522 |
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$ |
4,466 |
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$ |
10,615 |
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$ |
12,853 |
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License fees and other |
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41 |
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170 |
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784 |
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923 |
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Total revenues |
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5,563 |
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4,636 |
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11,399 |
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13,776 |
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Operating expenses: |
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Research and development |
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6,296 |
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6,835 |
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19,720 |
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20,866 |
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In-process research and development |
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20,890 |
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General and administrative |
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2,908 |
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3,317 |
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10,840 |
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8,517 |
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Total operating expenses |
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9,204 |
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10,152 |
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30,560 |
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50,273 |
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Loss from operations |
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(3,641 |
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(5,516 |
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(19,161 |
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(36,497 |
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Other income (expense): |
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Interest expense |
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(146 |
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(508 |
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(580 |
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(1,532 |
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Interest income |
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365 |
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272 |
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590 |
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581 |
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Change in fair value of common stock
warrants liability |
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1,187 |
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1,709 |
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Other income (expense) |
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(33 |
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(14 |
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1,115 |
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61 |
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Net loss |
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$ |
(2,268 |
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$ |
(5,766 |
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$ |
(16,327 |
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$ |
(37,387 |
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Basic and diluted net loss per common share |
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$ |
(0.06 |
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$ |
(0.19 |
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$ |
(0.47 |
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$ |
(1.52 |
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Weighted average shares used to compute basic and diluted net
loss per share |
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40,727 |
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30,833 |
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34,880 |
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24,665 |
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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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Nine months ended September 30, |
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2007 |
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2006 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(16,327 |
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$ |
(37,387 |
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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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2,360 |
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2,276 |
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In-process research and development |
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20,890 |
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Non-cash interest on long-term debt obligations |
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282 |
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428 |
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Net gain on debt restructuring |
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(270 |
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(315 |
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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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Stock-based compensation expense |
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2,801 |
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5,050 |
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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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(1,276 |
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133 |
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Prepaid expenses and other current assets |
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256 |
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(1,005 |
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Accounts payable, accrued expenses and other liabilities |
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(4,695 |
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(7,955 |
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Deferred revenue |
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7,524 |
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(3,149 |
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Restricted cash |
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(70 |
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Net cash used in operating activities |
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(11,053 |
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(21,104 |
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Cash flows from investing activities: |
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Proceeds from disposals of property and equipment |
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129 |
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Proceeds for loans to related parties |
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67 |
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226 |
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Purchases of property and equipment |
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(598 |
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(517 |
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Restricted cash used as collateral |
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(33 |
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Cash acquired in connection with merger, net of costs paid |
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37,401 |
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Net cash (used in) provided by investing activities |
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(564 |
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37,239 |
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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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23,474 |
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7,397 |
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Proceeds from capital contributions from stockholders |
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4,796 |
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Proceeds from exercise of stock options |
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25 |
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84 |
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Proceeds from stock subscription receivable |
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27 |
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346 |
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Principal payments on long-term debt obligations |
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(4,276 |
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(19,599 |
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Principal payments on short-term notes payable |
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(1,235 |
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Principal payments on capital lease obligations |
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(109 |
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(50 |
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Net cash provided by (used in) financing activities |
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17,906 |
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(7,026 |
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Effect of exchange rate changes on cash and cash equivalents |
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386 |
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768 |
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Net increase in cash and cash equivalents |
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6,675 |
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9,877 |
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Cash and cash equivalents at beginning of period |
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24,301 |
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11,414 |
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Cash and cash equivalents at end of period |
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$ |
30,976 |
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$ |
21,291 |
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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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$ |
6,968 |
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$ |
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Issuance of warrant in connection with committed equity financing facility |
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$ |
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$ |
472 |
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Issuance of warrant in connection with common stock issuance |
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$ |
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$ |
1,446 |
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Issuance of shares in connection with employee severance payment |
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$ |
250 |
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$ |
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Issuance of shares in connection with compensation for board of director services |
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$ |
14 |
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$ |
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Funding of insurance premiums through note payable |
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$ |
234 |
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$ |
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Acquisitions of equipment purchased through capital leases |
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$ |
197 |
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$ |
66 |
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Conversion of 2004 convertible notes |
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$ |
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$ |
2,764 |
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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 cancer,
inflammation and autoimmune diseases. Three of our antibodies are currently in clinical trials,
while the remainder of our product pipeline is in preclinical development. MT103, also known as
MEDI-538, the first 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 and in a phase 1 clinical trial for the treatment of
patients with non-Hodgkins lymphoma. BiTE antibodies represent a new class of antibodies that
activate a patients own cytotoxic T cells to eliminate cancer cells. We are developing MT103 in
collaboration with MedImmune, Inc., a subsidiary of AstraZeneca plc. Our second clinical stage
antibody is adecatumumab, also known as MT201, a human monoclonal antibody which targets
EpCAM-expressing 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. The third clinical stage
antibody is MT293 (formerly D93), also known as TRC093, a
first-in-class humanized monoclonal antibody that inhibits
angiogenesis and tumor cell growth by binding cleaved collagen. MT293, which is currently being tested in a phase 1
clinical trial, is licensed to TRACON Pharmaceuticals, Inc. and is being developed for the
treatment of patients with cancer and age-related macular degeneration. In addition, Micromet has
established a collaboration with Nycomed for the development and commercialization of MT203,
Micromets human antibody neutralizing the activity of granulocyte/macrophage colony stimulating
factor (GM-CSF), which has potential applications in the treatment of various inflammatory and
autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. For purposes
of this report, we have included in the term collaborator our licensees, such as TRACON, in
addition to the counterparties to our collaboration agreements. Further, with our BiTE antibody
technology platform, we believe that we have a strong proprietary technology platform that we have
used and will continue to use to generate additional antibody product candidates for our own
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.
Note 2. Basis of Presentation
On May 5, 2006, CancerVax Corporation (CancerVax) completed a merger with Micromet AG, a
privately-held German company, pursuant to which CancerVaxs wholly-owned subsidiary, Carlsbad
Acquisition Corporation, merged with and into Micromet Holdings, Inc. (Micromet Holdings), a
newly created parent corporation of Micromet AG. Micromet Holdings became a wholly-owned subsidiary
of CancerVax and was the surviving corporation in the merger. CancerVax issued to Micromet AG
stockholders and other security holders an aggregate of 19,761,688 shares of CancerVax common
stock, and CancerVax assumed all of the stock options, stock warrants and restricted stock of
Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet AG stockholders,
option holders, warrant holders and note holders owned, as of the closing, approximately 67.5% of
the combined company on a fully-diluted basis and former CancerVax stockholders, option holders and
warrant holders owned, as of the closing, approximately 32.5% of the combined company on a
fully-diluted basis. CancerVax was renamed Micromet, Inc. and our NASDAQ Global Market ticker
symbol was changed to MITI.
As former Micromet AG security holders owned approximately 67.5% of the voting stock of the
combined company immediately after the merger, Micromet AG is deemed to be the acquiring company
for accounting purposes and the transaction was accounted for as a reverse acquisition under the
purchase method of accounting for business combinations. Accordingly, unless otherwise noted, all
pre-merger financial information is that of Micromet AG, and all post-merger financial information
is that of Micromet, Inc. and its wholly owned subsidiaries: Micromet AG; Micromet Holdings, Inc.;
Tarcanta, Inc.; Tarcanta Limited; and Cell-Matrix, Inc. Substantially all of the post-merger
operating activities are conducted through Micromet AG, a wholly-owned subsidiary of Micromet
Holdings, Inc. and an indirect wholly-owned subsidiary of Micromet, Inc.
Unless specifically noted otherwise, as used throughout these consolidated financial
statements, Micromet, we, us, and our refers to the business of the combined company after
the merger and the business of Micromet AG prior to the merger. Unless specifically noted
otherwise, as used throughout these consolidated financial statements, CancerVax refers to the
business of CancerVax Corporation prior to the merger.
The condensed consolidated financial statements as of September 30, 2007, and for the three
and nine months ended September 30, 2007 and 2006, are unaudited. In the opinion of management,
these condensed consolidated financial statements include all adjustments, consisting of normal
recurring adjustments, necessary for a fair presentation of results for the interim periods
presented. We have condensed or omitted certain information and disclosures normally included in
financial statements presented in accordance with accounting principles generally accepted in the
United States. We believe the disclosures made are adequate to make the information presented not
misleading. However, you should read these condensed consolidated financial statements in
conjunction with the Micromet, Inc. audited financial statements as of December 31, 2006 and 2005
and each of the three years in the period ended December 31, 2006 included in our Annual Report on
Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 16, 2007.
6
The accompanying unaudited condensed consolidated financial statements include the accounts of
our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in
consolidation.
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires us to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. On an ongoing basis, we evaluate our
estimates, including those related to revenue recognition, the collectibility of accounts
receivable, the valuation of goodwill, intangibles and other long-lived assets, the valuation of
common stock warrants, and assumptions in the valuation of stock-based compensation. We base our
estimates on historical experience and on various other assumptions that we believe to be
reasonable under the circumstances. Actual results could differ from those estimates.
Unless otherwise indicated, the pre-merger financial information of Micromet AG has been
restated to reflect the closing of our merger and the related conversion of all Micromet AG capital
stock into Micromet Holdings common stock, the conversion of each share of Micromet Holdings common
stock into 15.74176 shares of Micromet, Inc. common stock, a 1-for-3 reverse stock split of our
outstanding common stock that became effective upon the closing of the merger and a final par value
of $0.00004 per common share.
The accompanying unaudited condensed consolidated financial statements have been prepared
assuming we will continue as a going concern. This basis of accounting contemplates the recovery of
our assets and the satisfaction of our liabilities in the normal course of business. As of
September 30, 2007, we had an accumulated deficit of $161.1 million, and we expect to continue to
incur substantial, and possibly increasing, operating losses for the next several years. We are
continuing our efforts in research and development, preclinical studies and clinical trials of our
drug candidates. These efforts, and obtaining requisite regulatory approval prior to
commercialization, will require substantial expenditures. Once requisite regulatory approval has
been obtained, substantial additional financing will be required to manufacture, market and
distribute our products in order to achieve a level of revenues adequate to support our cost
structure. Management believes we have sufficient resources to fund our required expenditures into
the second quarter of 2009, without considering any potential future milestone payments which we
may receive under current or future collaborations, any future capital raising transactions or
draw-downs from the committed equity financing facility with Kingsbridge Capital Limited.
Note 3. Summary of Significant Accounting Policies
Foreign Currency Translation
The accompanying condensed consolidated financial statements are presented in U.S. dollars.
The functional currency for all of our subsidiaries is the U.S. dollar, with the exception of
Micromet AG, whose functional currency is the European Euro. The assets and liabilities of
Micromet AG are translated into U.S. dollars at the exchange rate in effect at the balance sheet
date. The equity accounts of Micromet AG are translated into U.S. dollars at historical exchange
rates. Micromet AGs statement of operations data are translated into U.S. dollars at the average
exchange rate in effect for the period. Micromet AGs operating cash flow data are translated into
U.S. dollars at the average exchange rate in effect for the period, and investing and financing
cash flow data are translated into U.S. dollars at the exchange rate in effect at the date of the
underlying transaction. The gains and losses from currency translation of Euros to U.S. dollars on
the financial statements of Micromet AG are recorded directly as a separate component of
stockholders equity under the caption Accumulated Other Comprehensive Income. Transaction gains
and losses are recorded in the statement of operations in other income (expense) and amounted to
$(75,000) and $(39,000) for the three months ended September 30, 2007and 2006, respectively, and
$71,000 and $(106,000) for the nine months ended September 30, 2007 and 2006, respectively.
Cash and Cash Equivalents
Cash and cash equivalents on the balance sheets are comprised of cash at banks, money market
funds and short-term deposits with an original maturity of three months or less.
Restricted Cash
As of September 30, 2007, we have a total of $3.1 million of standby letters of credit
collateralized by certificates of deposit that are included as restricted cash in our non-current
assets, comprised of the following:
|
|
|
$0.7 million relates to our building lease in Munich, Germany; and |
|
|
|
|
$2.4 million relates to two building leases in California assumed in the merger with
CancerVax. |
7
The Allowance for Doubtful Accounts
The allowance for doubtful accounts is based on managements assessment of the collectability
of specific customer accounts. If there is a deterioration of a customers credit worthiness or
actual defaults are higher than historical experience, managements estimates of the recoverability
of amounts due to us could be adversely affected. Based on managements assessment, no allowances
were necessary as of September 30, 2007 and December 31, 2006.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation and amortization.
Major replacements and improvements that extend the useful life of assets are capitalized, while
general repairs and maintenance are charged to expense as incurred. Property and equipment are
depreciated using the straight-line method over the estimated useful lives of the assets, ranging
from three to ten years. Leasehold improvements are amortized over the estimated useful lives of
the assets or the related lease term, whichever is shorter.
Purchase Price Allocation for Business Combinations
The allocation of purchase price for business combinations requires extensive use of
accounting estimates and judgments to allocate the purchase price to the identifiable tangible and
intangible assets acquired, including in-process research and development, and liabilities assumed
based on their respective values. In fiscal quarter ended June 30, 2006, we completed our merger
with CancerVax. See Note 5 for a detailed discussion, including the purchase price allocation.
Goodwill
We have goodwill with a carrying value of $6.9 million at September 30, 2007, which resulted
from our merger with CancerVax in May 2006. In accordance with Statement of Financial Accounting
Standards (SFAS) No. 142, Goodwill and Other Intangible Assets, we do not amortize goodwill.
Instead, we review goodwill for impairment at least annually and more frequently if events or
changes in circumstances indicate a reduction in the fair value of the reporting unit to which the
goodwill has been assigned. Goodwill is determined to be impaired if the fair value of the
reporting unit to which the goodwill has been assigned is less than its carrying amount, including
the goodwill. We have selected October 1 as our annual goodwill impairment testing date. On
October 1, 2006, we conducted an assessment of the goodwill carrying value and found no indication
of impairment. In March 2007, after entering into a license agreement for MT293 with TRACON, we
again conducted an assessment of the goodwill carrying value and found no indication of impairment.
Patents
We hold patents for single-chain antigen binding molecule technology, which we acquired from
Curis, Inc. in 2001. Patents are amortized over their estimated useful life of ten years using the
straight-line method. The patents are utilized in revenue-producing activities as well as in
research and development activities.
Impairment of Long-Lived and Identifiable Intangible Assets
In accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal
of Long-Lived Assets, we evaluate the carrying value of long-lived assets and identifiable
intangible assets for potential impairment whenever events or changes in circumstances indicate
that the carrying amount of such assets may not be recoverable. Recoverability is determined by
comparing projected undiscounted cash flows associated with such assets to the related carrying
value. An impairment loss would be recognized when the estimated undiscounted future cash flow is
less than the carrying amount of the asset. An impairment loss would be measured as the amount by
which the carrying value of the asset exceeds the fair value of the asset. No impairment charges to
our long-lived or intangible assets have been recognized through September 30, 2007.
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. As discussed further in
Note 9, 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 each quarter using a Black-Scholes option-pricing model.
Revenue Recognition
Our revenues generally consist of licensing fees, milestone payments, and fees for research
services earned from license agreements or from research and development collaboration agreements.
We recognize revenue upon satisfying the following four criteria: persuasive evidence of an
arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability
is reasonably assured.
8
Revenues under collaborative research agreements are recognized as incurred over the period
specified in the related agreement or as the services are performed. Milestone payments are
derived from the achievement of predetermined goals under the collaboration agreements. For
milestones that are subject to contingencies, the related contingent revenue is not recognized
until the milestone has been reached and customer acceptance has been obtained as necessary. Fees
for research and development services performed under the agreements are generally stated at a
yearly fixed fee per research scientist. We recognize revenue as the services are performed.
Amounts received in advance of services performed are recorded as deferred revenue until earned.
We have received initial license fees and annual renewal fees upfront each year under license
agreements. Revenue is recognized when the above noted criteria are satisfied unless we have
further obligations associated with the license granted.
We are entitled to receive royalty payments on the sale of products under license and
collaboration agreements. Royalties are based upon the volume of products sold and are recognized
as revenue upon notification of sales from the collaborator or licensee that is commercializing the
product. Through September 30, 2007, we have not received or recognized any royalty payments.
For arrangements that include multiple deliverables, we identify separate units of accounting
based on the consensus reached on Emerging Issues Task Force Issue (EITF) No. 00-21, Revenue
Arrangements with Multiple Deliverables. EITF No. 00-21 provides that revenue arrangements with
multiple deliverables should be divided into separate units of accounting if certain criteria are
met. The consideration for the arrangement is allocated to the separated units of accounting based
on their relative fair values. Applicable revenue recognition criteria are considered separately
for each unit of accounting. We recognize revenue on development and collaboration agreements,
including upfront payments, where they are considered combined units of accounting, over the period
specified in the related agreement or as the services are performed.
Research and Development
Research and development expenditures, including direct and allocated expenses, are charged to
operations as incurred.
Total Comprehensive Loss
For the three and nine months ended September 30, 2007 and 2006 comprehensive loss consists of
the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(2,268 |
) |
|
$ |
(5,766 |
) |
|
$ |
(16,327 |
) |
|
$ |
(37,387 |
) |
Realized gain on investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38 |
|
Foreign currency translation adjustments |
|
|
32 |
|
|
|
(124 |
) |
|
|
101 |
|
|
|
(585 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(2,236 |
) |
|
$ |
(5,642 |
) |
|
$ |
(16,226 |
) |
|
$ |
(37,934 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-Based Compensation
We account for stock-based awards under SFAS No. 123(R), which requires measurement of
compensation cost for all stock-based awards at fair value on date of grant and recognition of
compensation over the service period for awards expected to vest. The fair value of stock options
is determined using the Black-Scholes valuation model. Such value is recognized as stock-based
compensation expense over the service period, net of estimated forfeitures, using the straight-line
attribution method. Compensation expense related to stock-based awards are allocated to research
and development or general and administrative based upon the department to which the associated
employee reports. Stock-based awards issued to non-employees were recorded at their fair value in
accordance with SFAS No. 123 and EITF Issue No. 96-18, Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring or in Conjunction with Selling Goods or Services, and
expense is recognized upon measurement date commensurate with the determination of when service has
been completed.
9
Stock-based compensation related to our stock-based awards is classified in the condensed
consolidated interim financial statements, as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Research and development expense |
|
$ |
347 |
|
|
$ |
235 |
|
|
$ |
1,225 |
|
|
$ |
2,323 |
|
General and administrative expense |
|
|
539 |
|
|
|
801 |
|
|
|
1,576 |
|
|
|
1,728 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation |
|
$ |
886 |
|
|
$ |
1,036 |
|
|
$ |
2,801 |
|
|
$ |
4,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2007, total unrecognized compensation cost related to stock options was
approximately $6.0 million and the weighted average period over which it is expected to be
recognized is 2.4 years.
Income Taxes
We account for income taxes under SFAS No. 109, Accounting for Income Taxes (SFAS 109) using
the liability method. Deferred income taxes are recognized at the enacted tax rates for temporary
differences between the financial statement and income tax bases of assets and liabilities.
Deferred tax assets are reduced by a valuation allowance if, based upon the weight of available
evidence, it is more likely than not that some portion or all of the related tax asset will not be
recovered.
Net Loss Per Share
We calculate net loss per share in accordance with SFAS No. 128, Earnings Per Share. Basic net
loss per share is calculated by dividing the net loss attributable to common stockholders by the
weighted average number of common shares outstanding for the period, without consideration for
common stock equivalents. Diluted net loss per share attributable to common stockholders is
computed by dividing the net loss by the weighted average number of common stock equivalents
outstanding for the period determined using the treasury-stock method. For purposes of this
calculation, convertible preferred stock, stock options, and warrants are considered to be common
stock equivalents and are only included in the calculation of diluted net loss per share when their
effect is dilutive. All such common stock equivalents have been excluded from our calculations of
diluted net loss due to our losses for the three and nine months ended September 30, 2007 and 2006.
The outstanding anti-dilutive securities excluded from the diluted net loss computation consisted
of common stock options in the amount of 5,886,000 and 3,337,000 shares and common stock warrants
in the amount of 5,527,000 and 84,000 shares as of September 30, 2007 and 2006, respectively.
Reclassification
Certain amounts in the previous period financial statements have been reclassified to conform
to the current period presentation.
10
Recent Accounting Pronouncements
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities. Under SFAS No. 159, companies
may elect to measure specified financial instruments and warranty and insurance contracts at fair
value on a contract-by-contract basis. Any changes in fair value are to be recognized in earnings
each reporting period. The election must be applied to individual instruments, is irrevocable for
every instrument chosen to be measured at fair value, and must be applied to an entire instrument
and not to portions of instruments. SFAS No. 159 is effective for fiscal years beginning after
November 15, 2007. We are currently evaluating the impact SFAS No. 159 will have on our results of
operations and financial condition.
Note 4. Income Taxes
In July 2006, FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an
entitys financial statements in accordance with SFAS No. 109, Accounting for Income Taxes. FIN
48 prescribes a recognition threshold and measurement attributes for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return. Under
FIN 48, the impact of an uncertain income tax position on the income tax return must be recognized
at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant
taxing authority. An uncertain income tax position will not be recognized if it has less than a
50% likelihood of being sustained. Additionally, FIN 48 provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, disclosure and transition.
FIN 48 is effective for fiscal years beginning after December 15, 2006.
We adopted the provisions of FIN 48 on January 1, 2007. There were no unrecognized tax
benefits as of the date of adoption. We did not recognize an increase in the liability for
unrecognized tax benefits as a result of the implementation of FIN 48. There are no unrecognized
tax benefits included in the balance sheet that would, if recognized, affect the effective tax
rate.
Our practice is to recognize interest and penalties related to income tax matters in income
tax expense. We did not have an accrual for interest and penalties on our balance sheets at
December 31, 2006 and at September 30, 2007, and we have not recognized any interest and penalties
in the statement of operations for the nine months ended September 30, 2007.
We are subject to taxation in the United States, Germany and various state jurisdictions. Our
tax years for 1999 and forward are subject to examination by the United States and various state
tax authorities due to the carryforward of unutilized net operating losses and research and
development tax credits. Our German tax returns for tax years 2004 and forward are subject to
examination by the German tax authorities.
The adoption of FIN 48 did not impact our financial condition, results of operations or cash
flows. At January 1, 2007, we had net deferred tax assets of $89.4 million. The deferred tax
assets are primarily composed of foreign, federal and state tax net operating loss carryfowards.
Due to uncertainties surrounding our ability to generate future taxable income to realize these
assets, a full valuation allowance has been established to offset our net deferred tax asset.
Note 5. Merger with CancerVax
On May 5, 2006, we completed our merger with CancerVax, a biotechnology company focused on the
research, development and commercialization of novel biological products for the treatment and
control of cancer. The acquisition of unrestricted cash, a NASDAQ listing, and selected ongoing
product development programs were the primary reasons for the merger. The primary factor in the
recognition of goodwill was the acquisition of selected ongoing product development programs.
Because former Micromet AG security holders owned approximately 67.5% of the voting stock of the
combined company on a fully-diluted basis immediately after the merger, Micromet AG is deemed to be
the acquiring company for accounting purposes, and the transaction has been accounted for as a
reverse acquisition under the purchase method of accounting. Accordingly, CancerVaxs assets and
liabilities were recorded as of the merger closing date at their estimated fair values.
The fair value of the 9,380,457 outstanding shares of CancerVax common stock used in
determining the purchase price was $41.0 million, or $4.38 per share, based on the average of the
closing prices for a range of trading days (January 5, 2006 through January 11, 2006, inclusive)
around and including the announcement date of the merger transaction. The fair value of the
CancerVax stock options and stock warrants assumed by Micromet was determined using the
Black-Scholes option-pricing model with the following assumptions: stock price of $4.38, which is
the value ascribed to the CancerVax common stock in determining the purchase price; volatility of
75%; dividend rate of zero; risk-free interest rate of 4.0%; and a weighted average expected option
life of 0.88 years.
11
The purchase price is summarized as follows (in thousands):
|
|
|
|
|
Fair value of CancerVax common stock |
|
$ |
41,030 |
|
Estimated fair value of CancerVax stock options and stock warrants assumed |
|
|
710 |
|
Transaction costs incurred by Micromet |
|
|
2,257 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
|
|
|
|
Under the purchase method of accounting, the total purchase price is allocated to the acquired
tangible and intangible assets and assumed liabilities of CancerVax based on their estimated fair
values as of the merger closing date. The excess of the purchase price over the fair value of
assets acquired and liabilities assumed is allocated to goodwill.
The final allocation of the total purchase price, as shown above, to the acquired tangible and
intangible assets and assumed liabilities of CancerVax based on their fair values as of the merger
date are as follows (in thousands):
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,645 |
|
Receivables under collaborations |
|
|
447 |
|
Restricted cash |
|
|
2,280 |
|
Other assets |
|
|
569 |
|
Accounts payable |
|
|
(2,639 |
) |
Accrued expenses |
|
|
(5,764 |
) |
Current portion of long-term debt obligations |
|
|
(16,816 |
) |
Long-term liabilities |
|
|
(1,532 |
) |
|
|
|
|
Net book value of acquired assets and liabilities |
|
|
16,190 |
|
In-process research and development |
|
|
20,890 |
|
Goodwill |
|
|
6,917 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
|
|
|
|
The acquired in-process research and development (IPR&D) projects consist of the following:
MT293 (TRC093) and other denatured collagen related anti-angiogenesis programs that potentially
target various solid tumors; SAI-EGF and related programs that target the epidermal growth factor
receptor, or EGFR, signaling pathway that potentially target non-small cell lung cancer and various
solid tumors; MT228 (MORAb-028) an antibody that appears to target tumor-associated antigens that are
expressed in a variety of solid tumor cancers, which had been licensed to Eisai Co.s wholly owned
subsidiary Morphotek; and certain other non-denatured collagen related humanized, monoclonal
antibodies and peptides that potentially target various solid tumors.
The fair value of the IPR&D projects was determined utilizing the income approach, assuming
that the rights to the IPR&D projects will be sub-licensed to third parties in exchange for certain
up-front, milestone and royalty payments, and the combined company will have no further involvement
in the ongoing development and commercialization of the projects. Under the income approach, the
expected future net cash flows from sub-licensing for each IPR&D project are estimated,
risk-adjusted to reflect the risks inherent in the development process and discounted to their net
present value. Significant factors considered in the calculation of the discount rate are the
weighted-average cost of capital and return on assets. Management believes that the discount rate
utilized is consistent with the projects stage of development and the uncertainties in the
estimates described above. Because the acquired IPR&D projects are in the early stages of the
development cycle, the amount allocated to IPR&D was recorded as an expense immediately upon
completion of the merger.
Pro Forma Results of Operations
The results of operations of CancerVax are included in Micromet, Inc.s consolidated financial
statements from the closing date of the merger on May 5, 2006. The following table presents pro
forma results of operations and gives effect to the merger transaction as if the merger had been
consummated at January 1, 2006. The unaudited pro forma results of operations are not necessarily
indicative of what would have occurred had the business combination been completed at January 1,
2006 or of the results that may occur in the future.
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Revenues |
|
$ |
5,563 |
|
|
$ |
4,636 |
|
|
$ |
11,399 |
|
|
$ |
14,228 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,268 |
) |
|
$ |
(5,766 |
) |
|
$ |
(16,327 |
) |
|
$ |
(48,794 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.06 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.68 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The pro forma results for the nine months ended September 30, 2006 includes $20.9 million of
nonrecurring charges for the write-off of in-process research and development.
Note 6. Other Non-Current Liabilities
Included in the September 30, 2007 other non-current liabilities balance of $2.3 million are
facility lease exit liabilities related to two building leases that were assumed as a result of our
merger with CancerVax.
Under the restructuring plan approved by CancerVaxs board of directors in October 2005, a
former manufacturing facility was closed. In January and April 2006, additional restructuring
measures were approved by CancerVaxs Board of Directors, including the plan to vacate the
corporate headquarters. In accordance with SFAS No. 146, Accounting for Costs Associated with
Exit or Disposal Activities, a facility lease exit liability was recorded by CancerVax at the time
of the cease-use date. The facility lease exit liability was assumed at the date of the merger
with CancerVax and was included as part of our allocation of total purchase price (see Note 5).
In April 2007, we entered into an amendment to an existing sublease agreement to sublease the
remaining square footage of CancerVaxs former corporate headquarters. This space is now fully
subleased. The term of the sublease will continue to expire on June 30, 2012. We recorded an
increase in our facility lease exit liability of $759,000 during the second quarter of 2007 to
reflect the cumulative effect of the change in estimated cash flows resulting from a longer period
of time required to sublease the former corporate headquarters facility than originally anticipated
as well as a lower monthly sublease income. The $759,000 adjustment to our facility lease exit
liability was recorded in general and administrative expense during the second quarter of 2007.
As a consequence of the restructuring of our subsidiary Micromet AGs operations during 2004,
we recorded a lease exit liability for certain space at our Munich facility that we no longer
utilized. In June 2007, we signed a sublease agreement 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. As of September 30, 2007, future sublease
income is expected to cover our lease expense for this facility, eliminating the lease exit
liability on this facility.
13
The following table summarizes the activity for these obligations for the nine months ended
September 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as |
|
|
|
Accrued |
|
|
Amounts |
|
|
|
|
|
|
Adjustment |
|
|
Currency |
|
|
of |
|
|
|
Balance as of |
|
|
Paid |
|
|
Accretion |
|
|
to the |
|
|
Translation |
|
|
September |
|
|
|
December 31, 2006 |
|
|
in Period |
|
|
Expense |
|
|
Liability |
|
|
Adjustment |
|
|
30, 2007 |
|
Former CancerVax
facilities |
|
$ |
1,470 |
|
|
$ |
(601 |
) |
|
$ |
179 |
|
|
$ |
759 |
|
|
|
|
|
|
$ |
1,807 |
|
Munich, Germany facility |
|
|
472 |
|
|
|
(130 |
) |
|
|
41 |
|
|
|
(394 |
) |
|
|
11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,942 |
|
|
$ |
(731 |
) |
|
$ |
220 |
|
|
$ |
365 |
|
|
$ |
11 |
|
|
$ |
1,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Of the $1,807,000 lease exit liability as of September 30, 2007, $143,000 is current and $1,664,000
is non-current.
Note 7. Long-Term Debt
Long-term debt obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
TBG borrowings due December 31, 2008; interest payable semi-annually at rates
ranging from 6% to 7% |
|
$ |
2,315 |
|
|
$ |
2,015 |
|
Bayern Kapital borrowings due December 31, 2006; interest payable quarterly at 6.75% |
|
|
|
|
|
|
586 |
|
TBFB borrowings due December 31, 2008; interest payable quarterly at 6% |
|
|
|
|
|
|
3,386 |
|
MedImmune borrowings due June 6, 2010; interest payable monthly at 4.5% |
|
|
2,183 |
|
|
|
2,020 |
|
|
|
|
|
|
|
|
Total long-term debt obligations |
|
|
4,498 |
|
|
|
8,007 |
|
Less: current portion |
|
|
(34 |
) |
|
|
(599 |
) |
|
|
|
|
|
|
|
Long-term debt obligations, net of current portion |
|
$ |
4,464 |
|
|
$ |
7,408 |
|
|
|
|
|
|
|
|
Scheduled repayment of principal for the debt agreements is as follows as of September 30,
2007 (in thousands):
|
|
|
|
|
2007 |
|
$ |
34 |
|
2008 |
|
|
2,281 |
|
2009 |
|
|
|
|
2010 |
|
|
2,183 |
|
|
|
|
|
Total |
|
$ |
4,498 |
|
|
|
|
|
The silent partnership agreement with TBFB requires that 20% of the net proceeds of any
financing be used for the repayment of certain components of our silent partnership debt. The
private placement financing in June 2007 (see Note 9) required us to repay the remaining TBFB
silent partnership debt of $3.6 million in the third quarter of 2007.
14
Note 8. Commitments and Contingencies
Leases
Future minimum lease payments under non-cancelable operating and capital leases as of
September 30, 2007 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital |
|
|
Operating |
|
|
Sublease |
|
|
Net Operating |
|
|
|
Leases |
|
|
Leases |
|
|
Income |
|
|
Leases |
|
2007 (October 1, 2007 - December 31, 2007) |
|
$ |
49 |
|
|
$ |
1,102 |
|
|
$ |
(772 |
) |
|
$ |
330 |
|
2008 |
|
|
171 |
|
|
|
4,420 |
|
|
|
(2,383 |
) |
|
|
2,037 |
|
2009 |
|
|
28 |
|
|
|
4,376 |
|
|
|
(2,422 |
) |
|
|
1,954 |
|
2010 |
|
|
|
|
|
|
4,410 |
|
|
|
(2,008 |
) |
|
|
2,402 |
|
2011 |
|
|
|
|
|
|
4,452 |
|
|
|
(1,413 |
) |
|
|
3,039 |
|
Thereafter |
|
|
|
|
|
|
2,229 |
|
|
|
(717 |
) |
|
|
1,512 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
|
248 |
|
|
$ |
20,989 |
|
|
$ |
(9,715 |
) |
|
$ |
11,274 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: amount representing imputed interest |
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease payments |
|
|
236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: current portion |
|
|
172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligation, less current portion |
|
$ |
64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The sublease income is from sublease agreements related to the former CancerVax headquarters
and our Munich facility (see Note 6).
License and Research and Development 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 and research and development agreements are as follows (in
thousands):
|
|
|
|
|
2007 (October 1, 2007- December 31, 2007) |
|
$ |
1,200 |
|
2008 |
|
|
130 |
|
2009 |
|
|
30 |
|
2010 |
|
|
30 |
|
2011 |
|
|
30 |
|
Thereafter |
|
|
120 |
|
|
|
|
|
Total minimum payments |
|
$ |
1,540 |
|
|
|
|
|
Other Taxes
We had accruals for contingent liabilities related to non-income tax matters as of
December 31, 2006 in the amount of $1.7 million. Included in this accrual was $1.3 million related
to withholding tax duty on past royalty payments made to collaborators who are domiciled outside of
Germany. We paid this amount to the German tax authorities during the first quarter of 2007 in
order to settle this liability. During the second quarter of 2007, we received notification of a
refund of $0.8 million because the recipients of these royalty payments were exempt from
withholding taxes. The $0.8 million benefit was included in other income. We continue to pursue a
refund on the remaining $0.5 million.
The December 31, 2006 accrual also consisted of $0.4 million related to a disallowed
reimbursement of German Value Added Tax incurred on expenses as a result of a 2001 increase of
stated capital. The German tax authorities had originally denied the deduction, and we filed an
appeal against the related assessment and accrued amounts potentially owed. The appeal was pending
for several years and depended on the authorities review of a model case then pending with the
German supreme fiscal court in a similar matter. This matter
15
was resolved in our favor in the first quarter of 2007 at which time the accrual was reversed
and the $0.4 million benefit was included in general and administrative expenses.
Note 9. Private Placement of Common Stock and Warrants
On June 22, 2007, we completed a private placement with various institutional and individual
accredited investors to which we issued an aggregate of 9,216,709 shares of common stock and
warrants to purchase an additional 4,608,356 shares of common stock in return for aggregate gross
proceeds, before expenses, of $25.4 million (excluding any proceeds that might be received upon
exercise of the warrants). We incurred investment banking fees, legal fees, and other financing
costs of approximately $1.9 million resulting in net proceeds of approximately $23.5 million. The
purchase price of each share of common stock sold in the financing was $2.69, the closing price of
our common stock on the Nasdaq Global Market on June 19, 2007, the date we entered into the
securities purchase agreement with the investors, and the purchase price for the warrants was
$0.125 for each share of common stock underlying the warrants. The warrants are exercisable
beginning 180 days after issuance through December 19, 2012 and have an exercise price of $3.09 per
share.
Under the terms of the warrants, if a Fundamental Transaction (as defined in the warrant)
occurs, we (or the successor entity) shall purchase any unexercised warrants from the holder
thereof for cash in an amount equal to its value computed using the Black-Scholes option-pricing
model with prescribed guidelines.
Since the Fundamental Transaction terms provide the warrant holders with a benefit in the form
of a cash payment equal to the fair value of the unexercised warrants calculated using the
Black-Scholes option-pricing model formula in certain qualifying events described above, the
warrants have been classified as a liability until the earlier of the date the warrants are
exercised in full or expire. In accordance with EITF 00-19, Accounting for Derivative Financial
Instruments Indexed To, and Potentially Settled In, a Companys Own Stock, the warrants were
valued on the date of grant using the Black-Scholes option-pricing model and using the following
assumptions: a risk-free rate of 4.78%, a volatility factor of 75.2%, a life of 5.5 years, and a
dividend rate of zero. The estimated fair value of the warrants on the date of grant was
approximately $6.9 million. EITF 00-19 also requires that the warrants be revalued as derivative
instruments at each reporting period end. We will adjust the instruments to their current fair
value using the Black-Scholes model formula at each reporting period end, with the change in value
recorded as a non-cash other income/expense. Fluctuations in the market price of our common stock
between measurement periods will have an impact on the revaluations, the results of which are
highly unpredictable and may have a significant impact on our results of operations.
At each quarter end, the common stock warrants liability was remeasured to the then fair
value, with the corresponding decreases in fair value since June 22, 2007 of $0.5 million
recognized in other income for the quarter ended June 30, 2007 and an additional decrease in fair
value of $1.2 million recognized in other income for the quarter ended September 30, 2007. As of
September 30, 2007, the fair value of the common stock warrants liability recorded on our condensed
consolidated balance sheet was $5.3 million.
In connection with the private placement, we also agreed to file a registration statement
under the Securities Act of 1933, as amended, registering for resale the shares of common stock
sold in the private placement, including the shares of common stock underlying the warrants, by
July 19, 2007. We filed the registration statement with the SEC on July 14, 2007, and it was
declared effective by the SEC on August 2, 2007. We also agreed to other customary obligations
regarding registration, including matters relating to indemnification, maintenance of the
registration statement and payment of expenses. We may be liable for liquidated damages to holders
of the common shares if we do not maintain the effectiveness of the registration statement. The
amount of the liquidated damages is, in aggregate, 1.5% of the purchase price of the common stock
per month, subject to an aggregate maximum of 12% of the aggregate purchase price of the shares.
We are not liable for liquidated damages with respect to the warrants or the common shares issuable
upon exercise of the warrants.
We account for the registration payment arrangement under the provisions of FASB Staff
Position No. EITF 00-19-2, Accounting for Registration Payment Arrangements. As of September 30,
2007, management determined that it is not probable that we will be obligated to pay any liquidated
damages in connection with the June 2007 private placement. Accordingly, no accrual for contingent
obligation is required or recorded as of September 30, 2007.
Note 10. License Agreements and Collaborations
On May 24, 2007, through our wholly-owned subsidiary Micromet AG, we entered into a
Collaboration and License Agreement with Nycomed A/Ss wholly-owned subsidiary Nycomed GmbH under
which the two companies will collaborate exclusively with each other on the development of
antibodies that neutralize granulocyte macrophage colony-stimulating factor (GM-CSF) that may be
useful for the treatment of inflammation and autoimmune diseases. The lead product candidate in
the collaboration is our human antibody MT203. Under the terms of the agreement, we have received
an upfront license fee of 5.0 million or $7.1 million at the exchange rate as of September 30,
2007, and we are eligible to receive research and development reimbursements and payments upon the
achievement
16
of development milestones of more than 120.0 million or $171.0 million at the exchange
rate of September 30, 2007 in the aggregate. We are obligated under the terms of the license
agreement with Nycomed to serve on a Joint Steering Committee for a period of 20 years;
accordingly, we will recognize the up-front payment of $7.1 million as revenue over this 20-year
period on a straight-line basis. We are also eligible to receive royalties on worldwide sales of
MT203 and other products that may be developed under the agreement. We are responsible for
performing preclinical development, process development and manufacturing of MT203 for early
clinical trials, and Nycomed is responsible for clinical development and commercialization of the
product candidate on a worldwide basis. Nycomed will bear the cost of development activities and
reimburses us for our expenses incurred in connection with the development program. The agreement
expires upon the satisfaction of all payment obligations of each party under the agreement.
Note 11. Segment Reporting
We operate in only one segment, which primarily focuses on the discovery and development of
antibody-based drug candidates using our proprietary technologies.
17
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements, which involve risks and
uncertainties. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including those set forth in
Part II Item 1A below under the caption Risk Factors.
The interim financial statements and this Managements Discussion and Analysis of the
Financial Condition and Results of Operations should be read in conjunction with the financial
statements and notes thereto for the year ended December 31, 2006, and the related Managements
Discussion and Analysis of Financial Condition and Results of Operations, both of which are
contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on
March 16, 2007.
For periods up to May 4, 2006, the results of operations and cash flows presented in the
interim financial statements contained herein reflect Micromet AG only. For periods from May 5,
2006 (the date of the closing of the merger) through September 30, 2007, the results of operations
and cash flows presented in the interim financial statements contained herein reflect the combined
operations of CancerVax and Micromet AG. Accordingly, the results of operations and cash flows for
the nine months ended September 30, 2006 presented herein are not necessarily indicative of the
results of operations and cash flows that we would experience if the operations of the two
companies had been combined for the nine months ended September 30, 2006.
Overview
Merger of CancerVax Corporation and Micromet AG
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly-owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly-owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders and certain other security
holders shares of CancerVax common stock, and CancerVax assumed all of the stock options, stock
warrants and restricted stock of Micromet Holdings outstanding as of May 5, 2006, such that the
former Micromet AG stockholders, option holders, warrant holders and note holders owned, as of the
closing, approximately 67.5% of the combined company on a fully-diluted basis and former CancerVax
stockholders, option holders and warrant holders owned, as of the closing, approximately 32.5% of
the combined company on a fully-diluted basis. In connection with the merger, CancerVax was renamed
Micromet, Inc. and our NASDAQ Global Market ticker symbol was changed to MITI.
Unless specifically noted otherwise, as used throughout this report:
|
|
|
CancerVax Corporation or CancerVax refers to the business,
operations and financial results of CancerVax Corporation prior to the
closing of the merger between CancerVax Corporation and Micromet AG on
May 5, 2006, at which time CancerVaxs name was changed to Micromet,
Inc.; |
|
|
|
|
Micromet AG refers to the business, operations and financial results
of Micromet AG, a privately-held German company, prior to the closing
of the merger and after the merger, as the context requires; and |
|
|
|
|
Micromet, we, our, or us refers to the operations and
financial results of Micromet, Inc. and Micromet AG on a consolidated
basis after the closing of the merger, and Micromet AG prior to the
closing of the merger, as the context requires. |
Ongoing Business Activities
Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for
cancer, inflammation and autoimmune diseases. Three of our antibodies are currently in clinical
trials, while the remainder of our product pipeline is in preclinical development. MT103, also
known as MEDI-538, the first 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 and in a phase 1 clinical trial for the
treatment of patients with non-Hodgkins lymphoma. BiTE antibodies represent a new class of
antibodies that activate a patients own cytotoxic T cells to eliminate cancer cells. We are
developing MT103 in collaboration with MedImmune, Inc., a subsidiary of AstraZeneca plc. Our
second clinical stage antibody is adecatumumab, also known as MT201, a human monoclonal antibody
which targets EpCAM-expressing 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. The third clinical stage
antibody is MT293 (formerly D93), also known as TRC093, a
first-in-class humanized monoclonal antibody that inhibits
angiogenesis and tumor cell growth by binding cleaved collagen. MT293, which is currently being tested in a
phase 1 clinical trial, is licensed to TRACON Pharmaceuticals, Inc. and is being developed for the
treatment of patients with cancer and age-related macular degeneration. In addition, Micromet has
established a
18
collaboration with Nycomed for the development and commercialization of MT203, Micromets
human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor
(GM-CSF), which has potential applications in the treatment of various inflammatory and autoimmune
diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. For purposes of this
report, we have included in the term collaborator our licensees, such as TRACON, in addition to
the counterparties to our collaboration agreements. Further, with our BiTE antibody technology
platform, we believe that we have a strong proprietary technology platform that we have used and
will continue to use to generate additional antibody product candidates for our own 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.
Our goal is to develop products for the treatment of cancer and inflammation and autoimmune
diseases that address significant unmet medical needs. We believe that our novel antibody
technologies, antibody product candidates and antibody product development expertise in these
fields will continue to enable us to identify and develop promising new product opportunities for
these critical markets. To date, we have incurred significant expenses and have not achieved any
product revenues from sales of our product candidates.
Each of our programs will require many years and significant costs to advance through
development. Typically it takes many years from the initial identification of a lead compound to
the completion of pre-clinical and clinical trials, before applying for marketing approval from the
United States Food and Drug Administration, or FDA, the European Medicines Agency, or EMEA, or
other equivalent international and national regulatory agencies. The risk is very high that a
program may be terminated, in part or in full, for safety reasons, or lack of adequate efficacy.
In particular, we cannot predict which, if any, of our potential product candidates will be
successfully developed or approved for marketing, nor can we predict the time and cost to complete
development.
As we obtain results from pre-clinical studies or clinical trials, we may elect not to
initiate or to discontinue clinical trials for certain product candidates for safety, efficacy or
commercial reasons. We may also elect to discontinue development of one or more product candidates
in order to focus our resources on more promising product candidates. Our business strategy
includes entering into collaborative agreements with third parties for the development and
commercialization of our product candidates. Depending on the structure of such collaborative
agreements, a third party may be granted control over the clinical trial process for one of our
product candidates. In such a situation, the third party, rather than us, may control development
and commercialization decisions for the respective product candidate. Consistent with our business
model, we may enter into additional collaboration agreements in the future. We cannot predict the
terms of such agreements or their potential impact on our capital requirements. Our inability to
complete our research and development projects in a timely manner, or our failure to enter into new
collaborative agreements, when appropriate, could significantly increase our capital requirements
and affect our liquidity.
Since our inception, we have financed our operations through private placements of preferred
stock, debt financing, government grants for research, license fees, milestone payments and
research-contribution revenues from our collaborations with pharmaceutical companies, and, more
recently, by accessing the capital resources of CancerVax through our 2006 merger with them and
subsequent private placements of common stock and associated warrants. We intend to continue to
seek funding through public or private financings in the future. If we are successful in raising
additional funds through the issuance of equity securities, stockholders may experience substantial
dilution, or the equity securities may have rights, preferences or privileges senior to existing
stockholders. If we are successful in raising additional funds through debt financings, these
financings may involve significant cash payment obligations and covenants that restrict our ability
to operate our business. There can be no assurance that we will be successful in raising
additional capital on acceptable terms, or at all. Based on our capital resources as of the date
of this report, we believe that we have adequate resources to fund our operations into the second
quarter of 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 committed equity financing facility, or CEFF, with
Kingsbridge Capital Limited.
Research and Development and In-Process Research and Development
Through September 30, 2007, our research and development expenses consisted of costs
associated with the clinical development of adecatumumab and MT103, pre-clinical development costs
for a new BiTE antibody called MT110 and a new human antibody against granulocyte/macrophage colony
stimulating factor, or GM-CSF, called MT203, and research activities under our collaboration with
MedImmune and relating to our BiTE antibody development platform. The costs incurred include costs
associated with clinical trials and manufacturing development, quality systems and analytical
development, including compensation and other personnel expenses, supplies and materials, costs for
consultants and related contract research, facility costs, license fees and depreciation. We
charge all research and development expenses to operations as incurred.
In addition, as a result of our merger with CancerVax, we acquired in-process research and
development (IPR&D) projects with an assigned value of $20.9 million. The fair value of the IPR&D
projects was determined utilizing the income approach, assuming that the rights to the IPR&D
projects will be sub-licensed to third parties in exchange for certain up-front, milestone and
royalty payments, and
19
the combined company will have no further involvement in the ongoing development and
commercialization of the projects. Under the income approach, the expected future net cash flows
from sub-licensing for each IPR&D project are estimated, risk-adjusted to reflect the risks
inherent in the development process and discounted to their net present value. Significant factors
considered in the calculation of the discount rate are the weighted-average cost of capital and
return on assets. We believe that the discount rate utilized is consistent with the projects stage
of development and the uncertainties in the estimates described above. Because the acquired IPR&D
projects are in the early stages of the development cycle, the amount allocated to IPR&D were
recorded as an expense immediately upon completion of the merger.
We expect to incur substantial additional research and development expenses that may increase
from historical levels as we further develop our compounds into more advanced stages of clinical
development and increase our pre-clinical efforts for our human
antibodies and 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 sales of any
products commercialized pursuant to our collaborations.
Under our collaboration agreement with Merck Serono for adecatumumab, we have received
$22.0 million in up-front and milestone payments from Merck Serono to date, not including
reimbursements for costs and expenses incurred in connection with the development of adecatumumab.
The agreement provides for potential future clinical development milestone payments of up to an
additional $126.0 million. All of our development costs related to adecatumumab are fully
reimbursed by Merck Serono.
Under our collaboration agreement with MedImmune for MT103, the agreement provides for
potential future milestone payments and royalty payments based on net sales of MT103. A second
agreement with MedImmune for the development of new BiTE product candidates provides for potential
future milestone payments and royalty payments based on future sales of the BiTE product candidates
currently under development pursuant to that agreement. The potential milestone payments are
subject to the successful completion of development and obtaining marketing approval for one or
more indications in one or more national markets. We have received $2.2 million in up-front and
milestone payments to date.
Under our collaboration agreement with TRACON for MT293, TRACON is responsible for the
development and commercialization of MT293 on a worldwide basis, as well as the costs and expenses
associated with such activities. TRACON is obligated to make development and sales milestone
payments, and pay a royalty on worldwide net sales of MT293. External costs that we incur related
to intellectual property for MT293 are reimbursed by TRACON. In addition, TRACON will make certain
payments for the delivery of the materials and has an obligation to pay us a portion of
sublicensing revenues. We have received $1.5 million in up-front and material delivery fees to
date.
Under our collaboration agreement with Nycomed for MT203, our proprietary human antibody
neutralizing the activity of GM-CSF, which has potential applications in the treatment of
inflammatory and autoimmune diseases, we are responsible for performing preclinical development,
process development and manufacturing of MT203 for early clinical trials, and Nycomed is
responsible for the development and commercialization costs of MT203 on a worldwide basis. Under
the terms of the agreement, we received an upfront license fee of 5.0 million or $7.1 million
at the exchange rate of September 30, 2007, and we will be eligible to receive research and
development reimbursements and payments upon the achievement of development milestones of more than
120.0 million or $171.0 million at the exchange rate of September 30, 2007 in the aggregate.
We intend to pursue additional collaborations to provide resources for further development of
our product candidates and expect to continue to grant technology access licenses. However, we
cannot forecast with any degree of certainty whether we will be able to enter into collaborative
agreements, and if we do, on what terms we might do so.
We are unable to estimate with any certainty the costs we will incur in the continued
development of our other product candidates. However, we expect our research and development
costs associated with these product candidates to increase as we continue to develop new
indications and move these product candidates through preclinical and clinical trials.
Clinical development timelines, the likelihood of success and total costs vary widely. We
anticipate that we will make determinations as to which research and development projects to pursue
and how much funding to direct to each project on an ongoing basis in response to the scientific
and clinical success of each product candidate as well as relevant commercial factors.
The costs and timing for developing and obtaining regulatory approvals of our product
candidates vary significantly for each product candidate and are difficult to estimate. The
expenditure of substantial resources will be required for the lengthy process of
20
clinical development and obtaining regulatory approvals as well as to comply with applicable
regulations. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could
cause our research and development expenditures to increase and, in turn, could have a material
adverse effect on our results of operations.
Critical Accounting Policies and the Use of Estimates
Our financial statements are prepared in conformity with accounting principles generally
accepted in the United States. Such statements require management to make estimates and assumptions
that affect the amounts reported in our financial statements and accompanying notes. Actual
results could differ materially from those estimates. The critical accounting policies used in the
preparation of our financial statements which require significant estimates and judgments are as
follows:
Revenue Recognition
Our revenues generally consist of licensing fees, milestone payments and fees for research
services earned from license agreements or from research and development collaboration agreements.
We recognize revenue upon satisfying the following four criteria: persuasive evidence of an
arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability
is reasonably assured.
Revenues under collaborative research agreements are recognized as incurred over the period
specified in the related agreement or as the services are performed. Milestone payments are
derived from the achievement of predetermined goals under the collaboration agreements. For
milestones that are subject to contingencies, the related contingent revenue is not recognized
until the milestone has been reached and customer acceptance has been obtained as necessary. Fees
for research and development services performed under the agreements are generally stated at a
yearly fixed fee per research scientist. We recognize revenue as the services are performed.
Amounts received in advance of services performed are recorded as deferred revenue until earned.
We have received initial license fees and annual renewal fees upfront each year under license
agreements. Revenue is recognized when the above noted criteria are satisfied unless we have
further obligations associated with the license granted.
We are entitled to receive royalty payments on the sale of products under license and
collaboration agreements. Royalties are based upon the volume of products sold and are recognized
as revenue upon notification of sales from the collaborator or licensee that is commercializing the
product. Through September 30, 2007, we have not received or recognized any royalty payments.
For arrangements that include multiple deliverables, we identify separate units of accounting
based on the consensus reached on Emerging Issues Task Force Issue (EITF) No. 00-21, Revenue
Arrangements with Multiple Deliverables. EITF No. 00-21 provides that revenue arrangements with
multiple deliverables should be divided into separate units of accounting if certain criteria are
met. The consideration for the arrangement is allocated to the separated units of accounting based
on their relative fair values. Applicable revenue recognition criteria are considered separately
for each unit of accounting. We recognize revenue on development and collaboration agreements,
including upfront payments, where they are considered combined units of accounting, over the period
specified in the related agreement or as the services are performed.
Purchase Price Allocation in Business Combinations
The allocation of purchase price for business combinations requires extensive use of
accounting estimates and judgments to allocate the purchase price to the identifiable tangible and
intangible assets acquired, including in-process research and development, and liabilities assumed
based on their respective values. In the fiscal quarter ended June 30, 2006, we completed our
merger with CancerVax. See Note 5 in the footnotes to our unaudited condensed consolidated
financial statements included in this report for a detailed discussion, including the purchase
price allocation.
Goodwill
In accordance with Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and
Other Intangible Assets, we do not amortize goodwill. Instead, we review goodwill for impairment at
least annually and whenever events or changes in circumstances indicate a reduction in the fair
value of the reporting unit to which the goodwill has been assigned. Conditions that would
necessitate a goodwill impairment assessment include a significant adverse change in legal factors
or in the business climate, an adverse action or assessment by a regulator, unanticipated
competition, a loss of key personnel, or the presence of other indicators that would indicate a
reduction in the fair value of the reporting unit to which the goodwill has been assigned.
SFAS No. 142 prescribes a two-step process for impairment testing of goodwill. The first step of
the impairment test is used to identify potential impairment by comparing the fair value of the
reporting unit to which the goodwill has been assigned to its carrying amount, including the
goodwill. Such a valuation requires
21
significant estimates and assumptions including but not limited to: determining the timing and
expected costs to complete in-process projects, projecting regulatory approvals, estimating future
cash inflows from product sales and other sources, and developing appropriate discount rates and
success probability rates by project. If the carrying value of the reporting unit exceeds the fair
value, the second step of the impairment test is performed in order to measure the impairment loss.
As a result of our merger with CancerVax, we recorded $6.9 million of goodwill. We performed our
annual goodwill impairment test as of October 1, 2006 and determined that there was no impairment.
In the first quarter of 2007, after entering into a licensing agreement with TRACON, we performed
an updated goodwill impairment assessment in accordance with SFAS No. 142 and determined that the
carrying amount of goodwill continued to be fully recoverable. We cannot assure you that our future
reviews of goodwill impairment will not result in a material charge.
Long-Lived and Intangible Assets
The evaluation for impairment of long-lived and intangible assets requires significant
estimates and judgment by management. Subsequent to the initial recording of long-lived and
intangible assets, we must test such assets for impairment. When we conduct our impairment tests,
factors that are important in determining whether impairment might exist include assumptions
regarding our underlying business and product candidates and other factors specific to each asset
being evaluated. Any changes in key assumptions about our business and our prospects, or changes
in market conditions or other external factors, could result in impairment. Such impairment
charge, if any, could have a material adverse effect on our results of operations.
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. As discussed further in
Note 9 to our consolidated financial statements included in this report, 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 each quarter
using a Black-Scholes option-pricing model.
Stock-Based Compensation
On January 1, 2006, we adopted the provisions of SFAS No. 123(R) and SEC Staff Accounting
Bulletin (SAB) No. 107, Share-Based Payment, or SAB 107, requiring the measurement and recognition
of all share-based compensation under the fair value method. Effective January 1, 2006, we began
recognizing share-based compensation, under SFAS No. 123(R), for all awards granted after
January 1, 2006 based on each awards grant date fair value. Prior to adopting the provisions of
SFAS No. 123(R), we recorded estimated compensation expense for employee stock-based compensation
under the provisions of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123), following
the minimum value method. We implemented SFAS No. 123(R) using the modified prospective transition
method.
We estimate the fair value of each share-based award on the grant date using the Black-Scholes
option-pricing model. We apply the provisions of SAB 107 in developing our methodologies to
estimate our Black-Scholes model inputs. Option valuation models, including Black-Scholes, require
the input of highly subjective assumptions, and changes in the assumptions used can materially
affect the grant date fair value of an award. These assumptions include the risk free rate of
interest, expected dividend yield, expected volatility, and the expected life of the award. The
risk free rate of interest is based on the U.S. Treasury rates appropriate for the expected term of
the award. Expected dividend yield is projected at 0% as we have not paid any dividends on our
common stock since our inception and we do not anticipate paying dividends on our common stock in
the foreseeable future. Expected volatility is based on our historical volatility and the
historical volatilities of the common stock of comparable publicly traded companies. The expected
term of at-the-money options granted is derived from the average midpoint between vesting and the
contractual term, as described in SAB 107. The expected term for other options granted was
determined by comparison to peer companies. SFAS No. 123(R) also requires that forfeitures be
estimated at the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. The pre-vesting forfeiture rate for the three-month and
nine-month periods ended September 30, 2007 was based on historical forfeiture experience for
similar levels of employees to whom the options were granted. As of September 30, 2007, total
unrecognized compensation cost related to stock options was approximately $6.0 million and the
weighted average period over which it is expected to be recognized is 2.4 years.
Recent Accounting Pronouncements
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities. Under SFAS No. 159, companies
may elect to measure specified financial instruments and warranty and insurance contracts at fair
value on a contract-by-contract basis. Any changes in fair value are to be recognized in earnings
each reporting period. The election must be applied to individual instruments, is irrevocable for
every instrument chosen to be measured at fair value, and must be applied to an entire instrument
and not to portions of instruments. SFAS No. 159 is effective for fiscal years
22
beginning after November 15, 2007. We are currently evaluating the impact SFAS No. 159 will
have on our results of operations and financial condition.
Results of Operations
Comparison of Three Months Ended September 30, 2007 and 2006
Revenues. The following table summarizes our primary sources of revenue for the periods
presented (in millions):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Collaborative R&D revenue: |
|
|
|
|
|
|
|
|
Merck Serono |
|
$ |
1.1 |
|
|
$ |
1.9 |
|
MedImmune |
|
|
1.5 |
|
|
|
2.5 |
|
Nycomed |
|
|
0.8 |
|
|
|
|
|
TRACON |
|
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
Total collaborative R&D revenue |
|
|
5.5 |
|
|
|
4.4 |
|
License and other revenue |
|
|
0.1 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
5.6 |
|
|
$ |
4.6 |
|
|
|
|
|
|
|
|
Collaborative research and development revenues from Merck Serono reflect their full cost
responsibility for the adecatumumab program. Collaborative research and development revenues from
MedImmune represent their share of the costs of clinical development of MT103 and their full cost
responsibility for the development of 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 Nycomed reflect their full cost responsibility
for the MT203 program. Collaborative research and development revenues from TRACON reflect their
full cost responsibility for the MT293 program.
The decrease in Merck Serono collaborative R&D revenue was the result of an amendment to our
collaboration agreement that had the effect of lengthening the time over which revenue is
recognized for the phase 1 study of MT201 in combination with docetaxel for the treatment of
metastatic breast cancer. The period was extended from June 2007 to June 2009. The decrease in
MedImmune revenue was due primarily to a milestone payment from MedImmune of $1.7 million recorded
during the third quarter of 2006 while there was no such milestone payment during the current year.
Partially offsetting this decrease was an increase in revenue of $0.6 million under the MT103
program with MedImmune. The Nycomed collaboration commenced during 2007 and there was no
corresponding revenue-generating activity during the prior year. 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 TRACON revenue during 2007 represents the sale of clinical material,
cell banks, and toxicology materials transferred under the terms of our agreement with TRACON,
miscellaneous pass through expenses and the portion of the up-front payment received from TRACON
that is being recognized over a 15-year period. This collaboration also commenced during 2007, and
there was no corresponding revenue-generating activity during 2006.
Research and Development Expenses. Research and development expense consists of costs
incurred to discover, research and develop product candidates. These expenses consist primarily of
salaries and related expenses for personnel, outside service costs including production of clinical
material, fees for services in the context of clinical trials, medicinal chemistry, consulting and
sponsored research collaborations, and occupancy and depreciation charges. Process development
expenses were mainly incurred for production of good manufacturing practice, or GMP, grade clinical
trial material, as well as fermentation, purification and formulation development. Preclinical
development expenses cover pharmacological in vitro and in vivo experiments as well as development
of analytical testing procedures. We expense research and development costs as incurred.
Research and development expenses were $6.3 million and $6.8 million for the three months
ended September 30, 2007 and 2006, respectively. The reduction reflects a decrease in our
manufacturing and pre-clinical toxicology studies for our MT110 program that were ongoing during
the third quarter of 2006. Clinical expenses for our MT103 programs also increased by $0.1 million
but were offset by corresponding decreases in our MT201 program.
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.
23
General and administrative expenses were $2.9 million and $3.3 million for the three months
ended September 30, 2007 and 2006, respectively. The decrease was a result of lower stock-based
compensation costs of $0.3 million due to a stock option grant to an officer during the third
quarter of 2006 and increased legal expenses of $0.4 million during 2006 in connection with our
post-merger activities. These decreases were partially offset by higher personnel and travel costs
of $0.3 million due to an increased number of U.S.-based personnel, sublease income received for
our Munich facility, and the incremental costs of approximately $0.1 million associated with being
a public company post-merger, including investor relations costs, auditing and tax fees and
increased directors and officers insurance premiums.
Interest Expense. Interest expense for the three months ended September 30, 2007 and 2006 was
$0.1 million and $0.5 million, respectively. The decrease was primarily due to the repayment of a
$16.0 million bank loan in the third quarter of 2006, from the conversion of convertible notes
during 2006, and the repayment of certain silent partnership debt during 2006 and 2007.
Change in Fair Value of Common Stock Warrants Liability. The warrants issued in connection
with the private placement in June 2007 are classified as a liability. The income of $1,187,000
recorded in the third quarter of 2007 represents the non-cash change in fair value of the warrants
as of September 30, 2007 as compared to the value on June 30, 2007.
Comparison of Nine Months Ended September 30, 2007 and 2006
Revenues. The following table summarizes our primary sources of revenue for the periods
presented (in millions):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Collaborative R&D revenue: |
|
|
|
|
|
|
|
|
Merck Serono |
|
$ |
3.3 |
|
|
$ |
6.9 |
|
MedImmune |
|
|
4.1 |
|
|
|
4.1 |
|
Nycomed |
|
|
1.1 |
|
|
|
|
|
TRACON |
|
|
2.1 |
|
|
|
|
|
Cell Therapeutics |
|
|
|
|
|
|
1.9 |
|
|
|
|
|
|
|
|
Total collaborative R&D revenue |
|
|
10.6 |
|
|
|
12.9 |
|
License and other revenue |
|
|
0.8 |
|
|
|
0.9 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
11.4 |
|
|
$ |
13.8 |
|
|
|
|
|
|
|
|
The decrease in Merck Serono collaborative R&D revenue was the result of completing the phase
2a clinical trials during 2006 with no such activity ongoing during the nine months ended
September 30, 2007. There was also a reduction in the phase 1 clinical trial of MT201 in
combination with docetaxel for the metastatic breast cancer indication resulting from the contract
amendment as described above. MedImmune revenue remained constant between 2006 and 2007, but the
2007 revenues reflect an increase of $1.7 million from activity in the development programs for
MT103, MT111 and the EphA2 BiTE antibody, which increase was offset by a reduction in milestone
revenues of $1.7 million. As described above, the Nycomed and TRACON collaborations commenced
during the year of 2007 and had no revenue-generating activity in 2006. Also contributing to the
overall decrease in collaborative R&D revenue was a one-time $1.9 million settlement payment from
Cell Therapeutics, Inc. that we received in May 2006 relating to a previously terminated
collaboration. The Cell Therapeutics settlement was recorded as collaboration revenue because the
amount would have been recorded as collaboration revenue had the original contract been fulfilled.
Research and Development Expenses. Research and development expenses were $19.7 million and
$20.9 million for the nine months ended September 30, 2007 and 2006, respectively. There was a
decrease in stock-based compensation expense of $1.1 million related to accelerated vesting
recognized in 2006 in connection with the CancerVax merger. Clinical study expenses also decreased
by $0.5 million as decreases in the adecatumumab phase 2 programs of $1.2 million were partially
offset by increases to the MedImmune antibody programs. There was an increase in license fees of
$0.5 million that was paid to Applied Molecular Evolution as a result of the fees earned under the
terms of the license agreement with TRACON signed in March 2007.
General and Administrative Expenses. General and administrative expenses were $10.8 million
and $8.5 million for the nine months ended September 30, 2007 and 2006, respectively. The $2.3
million increase in general and administrative expense results from an increased number of
U.S.-based personnel for salary and travel of $1.5 million, increased facility expenses of $1.0
million due to lease exit costs of the former CancerVax headquarters, and incremental costs
associated with being a public company of $1.0 million for
24
activites such as investor relations, directors and officers insurance premiums, and legal and
audit expenses. Offsetting these increases was a reduction in stock-based compensation expense of
$1.1 million related to accelerated vesting recognized in 2006 in connection with the CancerVax
merger, and from sublease income on our Munich facility.
Interest Expense. Interest expense for the nine months ended September 30, 2007 and 2006 was
$0.6 million and $1.5 million, respectively. The $0.9 million decrease was primarily due to the
repayment of a $16.0 million bank loan in the third quarter of 2006, the conversion of convertible
notes during the second quarter of 2006, and the repayment of certain silent partnership debt
during 2006 and 2007.
Change in Fair Value of Common Stock Warrants Liability. The warrants issued in connection
with the private placement in June 2007 are classified as a liability. The income of $1,709,000
recorded in the nine months ended September 30, 2007 represents the non-cash change in fair value
of the warrants as of September 30, 2007 as compared to the value on June 22, 2007, the date of
issuance.
Other Income (Expense). Other income for the nine months ended September 30, 2007 was $1.1
million compared to $0.1 million for the nine months ended September 30, 2006. The increase results
primarily from the approval received from the German tax authorities for the refund of withholding
tax payments of $0.8 million and a gain on debt restructuring of $0.3 million, each of which
occurred during 2007.
Liquidity and Capital Resources
We had cash and cash equivalents of $31.0 million and $24.3 million as of September 30, 2007
and December 31, 2006, respectively. The increase in 2007 results from the private placement
financing in June 2007, which yielded net proceeds to us of $23.5 million, as well as the upfront
license fee of approximately $7.1 million received from Nycomed, the upfront license fee and
material transfer of $1.5 million received from TRACON, less repayments of long-term debt of $1.1
million and an increase in general operating expenses, as described above.
Net cash used in operating activities was $11.1 million for the nine months ended
September 30, 2007, compared to $21.1 million used in operating activities for the nine months
ended September 30, 2006. The increase in cash flows from operating activities from 2006 to 2007
was primarily due to the upfront licensing fees and materials transfer payments received from
Nycomed and TRACON as described above, which aggregated approximately $9.0 million.
Net cash used in investing activities was $564,000 for the nine months ended September 30,
2007, compared to $37.2 million provided by investing activities for the nine months ended
September 30, 2006. We had acquired $37.4 million in cash from our merger with CancerVax in 2006.
Net cash provided by financing activities was $17.9 million for the nine months September 30,
2007, compared to $7.0 million used in financing activities for the nine months ended September 30,
2006. The increase is a result of the $23.5 million in net proceeds from the June 2007 private
placement financing as compared to $7.4 million net proceeds received during 2006 from the issuance
of common stock and $4.8 million received from capital contributions from shareholders. Also
contributing to the increase was $5.5 million of debt repayment during 2007 as compared to $19.6
million during 2006.
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, by accessing the capital resources of CancerVax through our 2006 merger with them and
through subsequent 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
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. If we were to raise additional funds through additional debt financing, the terms of the
debt may involve significant cash payment obligations as well as covenants and specific financial
ratios that may restrict our ability to operate our business. Having insufficient funds may
require us to delay, scale back or eliminate some or all of our research or development programs or
to relinquish greater or all rights to product candidates at an earlier stage of development or on
less favorable terms than we would otherwise choose. Failure to obtain adequate financing may
adversely affect our ability to operate as a going concern. 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
25
capital raising transactions or any drawdowns from our CEFF with Kingsbridge Capital Limited.
Prior to our merger with CancerVax, CancerVax was a party to three building leases for a
manufacturing facility, a warehouse facility and CancerVaxs corporate headquarters. During the
second quarter of 2006, CancerVax entered into a lease assignment related to the manufacturing
facility, a lease termination related to the warehouse facility and a sublease agreement pursuant
to which 46,527 rentable square feet of the 61,618 total rentable square feet of CancerVaxs former
corporate headquarters was subleased. We paid termination-related fees of approximately
$0.6 million in connection with the termination of the warehouse facility. Our remaining estimated
lease exit liability related to the two outstanding leases amounted to $1.8 million at September
30, 2007, of which $0.1 million is included in accrued expenses and $1.7 million is included in
other non-current liabilities. In April 2007, we entered into a sublease agreement for the
remaining 15,091 square feet of CancerVaxs former corporate headquarters.
As of September 30, 2007, we have a total of $3.1 million of standby letters of credit
collateralized by certificates of deposit that are included as restricted cash in our non-current
assets, comprised of the following:
|
|
|
$0.7 million relates to our building lease in Munich, Germany; and |
|
|
|
|
$2.4 million relates to two building leases in California assumed in the merger with
CancerVax described above. |
On October 2, 2006, a court-proposed settlement agreement with Curis, Inc. became effective
that resolved a lawsuit initiated by Curis against Micromet AG in a German court regarding the
repayment of a promissory note. Curis had requested immediate repayment of the remaining balance
under the note at the time of the closing of the merger between CancerVax and Micromet AG in May
2006. We had disagreed with Curiss interpretation of the repayment terms of the promissory note.
In accordance with the settlement, we paid Curis 1.0 million, or $1.3 million, in October
2006, and 0.8 million, or $1.1 million, in April 2007, in full settlement of our obligations.
These payments did not include any interest charges. We recorded a gain on extinguishment of this
debt of $0.3 million in the second quarter of 2007.
26
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
|
|
|
the progress of our clinical trials; |
|
|
|
|
the progress of our research activities; |
|
|
|
|
the number and scope of our research programs; |
|
|
|
|
the progress of our preclinical development activities; |
|
|
|
|
the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent
and other intellectual property claims; |
|
|
|
|
the costs related to development and manufacture of pre-clinical, clinical and validation lots for
regulatory purposes and commercialization of drug supply associated with our product candidates; |
|
|
|
|
our ability to enter into corporate collaborations and the terms and success of these collaborations; |
|
|
|
|
the costs and timing of regulatory approvals; and |
|
|
|
|
the costs of establishing manufacturing, sales and distribution capabilities. |
Contractual Obligations
We have contractual obligations, some of which were assumed in our merger with CancerVax,
related to our facility lease, research agreements and financing agreements, as well as a new
operating lease entered into in the second quarter of 2007 related to our corporate headquarters in
Bethesda, Maryland. The following table sets forth our significant contractual obligations as of
September 30, 2007 (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) |
|
$ |
20,989 |
|
|
$ |
1,102 |
|
|
$ |
8,796 |
|
|
$ |
8,862 |
|
|
$ |
2,229 |
|
Short term note to Premier
Assignment Corporation |
|
|
78 |
|
|
|
78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt MedImmune |
|
|
2,183 |
|
|
|
|
|
|
|
|
|
|
|
2,183 |
|
|
|
|
|
Silent partnership obligations |
|
|
2,315 |
|
|
|
34 |
|
|
|
2,281 |
|
|
|
|
|
|
|
|
|
Contractual payments under
licensing and research and
development agreements |
|
|
1,540 |
|
|
|
1,200 |
|
|
|
160 |
|
|
|
60 |
|
|
|
120 |
|
Capital leases |
|
|
248 |
|
|
|
49 |
|
|
|
199 |
|
|
|
|
|
|
|
|
|
Other |
|
|
108 |
|
|
|
25 |
|
|
|
50 |
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,461 |
|
|
$ |
2,488 |
|
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$ |
11,486 |
|
|
$ |
11,138 |
|
|
$ |
2,349 |
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|
|
|
|
|
|
|
|
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(1) |
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Includes amounts payable from October 1, 2007 through December 31, 2007. |
|
(2) |
|
The amounts shown in operating leases excludes sub-lease income (see Note 8 to our condensed
consolidated financial statements included in this report). |
As a result of our merger with CancerVax, we assumed licensing and research and development
agreements with various universities, research organizations and other third parties under which we
have received licenses to certain intellectual property, scientific know-how and technology. In
consideration for the licenses received, we are required to pay license and research support fees,
milestone payments upon the achievement of certain success-based objectives and/or royalties on
future sales of commercialized products, if any. We may also be required to pay minimum annual
royalties and the costs associated with the prosecution and maintenance of the patents covering the
licensed technology.
Cautionary Note Regarding Forward-Looking Statements
Any statements in this report about our expectations, beliefs, plans, objectives, assumptions
or future events or performance are not historical facts and are forward-looking statements. Such
forward-looking statements include statements regarding the effects of the merger between CancerVax
and Micromet AG, the efficacy, safety and intended utilization of our product candidates, the
conduct and results of future clinical trials, plans regarding regulatory filings, future research
and clinical trials and plans regarding partnering activities, and our goal of monitoring our
internal controls for financial reporting and making modifications as necessary. You can
27
identify these forward-looking statements by the use of words or phrases such as believe,
may, could, will, estimate, continue, anticipate, intend, seek, plan, expect,
should, or would. Among the factors that could cause actual results to differ materially from
those indicated in the forward-looking statements are risks and uncertainties inherent in our
business including, without limitation, statements about the progress and timing of our clinical
trials; difficulties or delays in development, testing, obtaining regulatory approval for producing
and marketing our products; 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 products that could delay or prevent product development or
commercialization, or that could result in recalls or product liability claims; the scope and
validity of patent protection for our product candidates; competition from other pharmaceutical or
biotechnology companies; our ability to obtain additional financing to support our operations;
successful administration of our business and financial reporting capabilities, including the
successful remediation of material weaknesses in our internal control our financial reporting and
other risks detailed in this report, including those below in Part II, Item 1A, Risk Factors.
Although we believe that the expectations reflected in our forward-looking statements are
reasonable, we cannot guarantee future results, events, levels of activity, performance or
achievement. We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, unless required by
law.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rates
Our financial instruments consist primarily of cash and cash equivalents. These financial
instruments, principally comprised of corporate obligations and U.S. and foreign government
obligations, are subject to interest rate risk and will decline in value if interest rates
increase. Because of the relatively short maturities of our investments, we do not expect interest
rate fluctuations to materially affect the aggregate value of our financial instruments. We have
not used derivative financial instruments in our investment portfolio.
Exchange Rates
A significant majority of our cash and cash equivalents are currently denominated in
U.S. dollars, as are a significant amount of the potential milestone payments and royalty payments
under our collaboration agreements. However, a significant portion of our operating expenses,
including our research and development expenses, are incurred in Europe pursuant to arrangements
that are generally denominated in Euros.
As a result, our financial results and capital resources may be affected by changes in the
U.S. dollar/Euro exchange rate. As of September 30, 2007, we had U.S. dollar-denominated cash and
cash equivalents of $28.6 million and Euro-denominated liabilities of approximately
14.4 million. The Euro amount as of September 30, 2007 is equivalent to approximately
$20.5 million, using the exchange rate as of that date. A decrease in the value of the U.S. dollar
relative to the Euro would result in an increase in our reported operating expenses due to the
translation of the Euro-denominated expenses into U.S. dollars, and such changes would negatively
impact the length of time that our existing capital resources would be sufficient to finance our
operations. We have not engaged in foreign currency hedging transactions to manage this exchange
rate exposure.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our
principal financial officer), as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures, we recognize that
any controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives, and we are required to apply our judgment in
evaluating the cost-benefit relationship of possible controls and procedures. In addition, the
design of any system of controls also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design will succeed in
achieving its stated goals under all potential future conditions; over time, controls may become
inadequate because of changes in conditions, or the degree of compliance with policies or
procedures may deteriorate. Because of the inherent limitations in a cost-effective control
system, misstatements due to error or fraud may occur and not be detected.
Under the supervision and with the participation of our management, including our principal
executive officer and principal
28
financial officer, we conducted an evaluation of the effectiveness of the design and operation
of our disclosure controls and procedures as such term is defined under Rules 13a-15(e) and
15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the Exchange Act), as
of September 30, 2007, the end of the period covered by this report.
Based upon our evaluation prior to the filing of our Annual Report on Form 10-K for the year
ended December 31, 2006, our management concluded that our disclosure controls and procedures were
ineffective as of December 31, 2006 because of material weaknesses in internal control over
financial reporting, as described below.
Further, based upon our evaluation prior to the filing of this quarterly report, our principal
executive officer and principal financial officer have concluded that our disclosure controls and
procedures were still ineffective as of September 30, 2007 to provide reasonable assurance that
financial information we are required to disclose in our reports under the Exchange Act was
recorded, processed, summarized and reported accurately and that such information is accumulated
and communicated to our management, including our Chief Executive Officer (our principal executive
officer) and Chief Financial Officer (our principal financial officer), as appropriate, to allow
for timely decisions regarding required disclosure.
Notwithstanding the deficiencies cited above that existed as of September 30, 2007, there have
been no changes to reported financial results as a result of these identified material weaknesses,
and our management believes that (i) this Quarterly Report on Form 10-Q does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which they were made, not misleading with respect to the
periods covered by this report and (ii) the financial statements, and other financial information
included in this report, fairly present in all material respects our financial condition, results
of operations and cash flows as of, and for, the dates and periods presented in this report.
As reported in our Annual Report on Form 10-K for the year ended December 31, 2006, filed with
the Securities and Exchange Commission on March 16, 2007, as amended by a Form 10-K/A filed on May
11, 2007, in connection with our management assessment of the effectiveness of the Companys
internal control over financial reporting for the year ended December 31, 2006, we identified the
following material weaknesses:
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Inadequate Procedures Around Estimation and Accruals. As a result of
errors identified in estimates around accrued liability accounts, we
have concluded that controls over our estimation and analyses
processes were not effective and are indicative of a material
weakness. We over-accrued certain research and development costs and
we under-accrued travel, legal and certain research and development
costs. The effect of these accrual errors required an audit adjustment
to accruals that was material to the consolidated financial
statements. |
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Invoicing Error in Licensee Milestone. A milestone invoice to one of
our single-chain antibody licensees was prepared by our accounting
staff in the wrong currency, approved and mailed to the licensee. As a
result, we have concluded that the controls over the analysis and
recording of revenue transactions with unusual terms were not
effective, and are indicative of a material weakness in revenue
accounting controls. |
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Inadequate Management Review. As a result of errors identified by our
independent registered public accounting firm in our financial close
process and disclosures and amounts in our Annual Report on Form 10-K
subsequent to our financial statement review process but prior to
filing of our Form 10-K, we have concluded that controls over our
financial statement close and reporting process are not effective, and
are indicative of a material weakness. |
There were no changes to any reported financial results that have been released by us as a
result of these identified weaknesses.
Managements Remediation Plan
Based on our findings that our disclosure controls and procedures were not effective and that
we had several material weaknesses in internal controls over financial reporting, we have been and
continue to be engaged in efforts to improve our internal controls and procedures and we expect
that these efforts in 2007 will address and resolve the weaknesses.
Following the merger between Micromet AG and CancerVax in May 2006, we have taken a number of
steps to strengthen our internal control over our financial reporting. However, material weaknesses
in our internal control over financial reporting process continue to exist. We intend to take the
remaining actions required to remediate our existing weaknesses as part of our ongoing efforts to
upgrade our control environment following the merger and integration of operations. As discussed
below, we have been and continue to be engaged in efforts to improve our internal control over
financial reporting. Measures we have taken or are taking to remediate our identified material
weaknesses include:
29
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hiring a chief financial officer with significant U.S. public company experience in October 2006; |
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implementing additional preparation, review and approval procedures over estimations and accruals; |
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improving our procedures for verifying and documenting contract terms and implementing a
company-wide contract management system to facilitate the flow of information amongst various
functional departments; |
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formalizing process and documentation related to financial statement closing and consolidation
review, including more frequent interaction across all members of our financial staff involved in
preparation of financial statements and a review of those financial statements by the entire
staff as a group; |
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formalizing and enhancing documentation, oversight and review procedures related to accounting
records of Micromet AG to ensure compliance with U.S. generally accepted accounting principles; |
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reviewing and making appropriate staffing adjustments at all company locations to enhance
accounting expertise and additional oversight; |
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supplementing our accounting staff to improve the breadth and depth of experience; |
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engaging qualified accounting and tax consultants to aid us in the implementation of procedures
and policies; and |
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improving training for, and integration and communication among, accounting staff. |
While management believes that the foregoing actions have had a positive effect on our
internal control over financial reporting, all the changes necessary to remediate the material
weakness in our internal control over financial reporting were not in place by September 30, 2007.
We have communicated to the Audit Committee the material weaknesses identified in our internal
control over financial reporting. Management, with the oversight of the Audit Committee, is
committed to effective remediation of known material weakness and other control deficiencies as
quickly as possible.
Changes in Internal Control over Financial Reporting
Our principal executive officer and principal financial officer also evaluated whether any
change in our internal control over financial reporting, as such term is defined under Rules
13a-15(f) and 15d-15(f) promulgated under the Exchange Act, occurred during our most recent fiscal
quarter covered by this report that has materially affected, or is likely to materially affect, our
internal control over financial reporting. Except for the ongoing progress related to the
remediation measures discussed above, there were no changes in our internal control over financial
reporting during the quarter ended September 30, 2007 that materially affected, or were reasonably
likely to materially affect, our internal control over financial reporting.
30
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 we may never achieve profitability.
We have incurred losses from the inception of Micromet through September 30, 2007, and we
expect to incur substantial losses for the foreseeable future. We have no current sources of
material ongoing revenue, other than the reimbursement of development expenses and potential future
milestone payments from our current collaborators: MedImmune (a subsidiary of AstraZeneca), Merck
Serono, TRACON and Nycomed. We have not commercialized any products to date, either alone or with
a third party collaborator. If we are not able to commercialize any products, whether alone or
with a collaborator, we may not achieve profitability. Even if our collaboration agreements
provide funding for a portion of our research and development expenses for some of our programs, we
expect to spend significant capital to fund our internal research and development programs for the
foreseeable future. As a result, we will need to generate significant revenues in order to achieve
profitability. We cannot be certain whether or when this will occur because of the significant
uncertainties that affect our business. Our failure to become and remain profitable may depress
the market price of our common stock and could impair our ability to raise capital, expand our
business, diversify our product offerings or continue our operations.
We will require additional financing, which may be difficult to obtain and may dilute your
ownership interest in us. If we fail to obtain the capital necessary to fund our operations, we
will be unable to develop or commercialize our product candidates and our ability to operate as a
going concern may be adversely affected.
We will require substantial funds to continue our research and development programs and our
future capital requirements may vary from what we expect. There are factors, many of which are
outside our control, that may affect our future capital requirements and accelerate our need for
additional financing. Among the factors that may affect our future capital requirements and
accelerate our need for additional financing are:
continued progress in our research and development programs, as well as the scope of
these programs;
our ability to establish and maintain collaborative arrangements for the discovery,
research or development of our product candidates;
the timing, receipt and amount of research funding and milestone, license, royalty and
other payments, if any, from collaborators;
the timing, receipt and amount of sales revenues and associated royalties to us, if any,
from our product candidates in the market;
our ability to sell shares of our common stock under our committed equity financing
facility, or CEFF, with Kingsbridge Capital Limited, or Kingsbridge;
the costs of preparing, filing, prosecuting, maintaining, defending and enforcing patent
claims and other patent-related costs, including litigation costs and technology license fees;
costs associated with litigation; and
competing technological and market developments.
31
We filed a shelf registration statement, declared effective by the Securities and Exchange
Commission on December 9, 2004, under which we may raise up to $80 million through the sale of our
common stock. This shelf registration statement became inactive in March 2006, and we may decide
to activate it by filing a post-effective amendment in the future, although our ability to do so
will depend on our eligibility to use a shelf registration statement at such time, under applicable
SEC rules. We expect to seek additional funding through public or private financings or from new
collaborators with whom we enter into research or development collaborations with respect to
programs that are not currently licensed. However, the market for stock of companies in the
biotechnology sector in general, and the market for our common stock in particular, is highly
volatile. Due to market conditions and the status of our product development pipeline, additional
funding may not be available to us on acceptable terms, or at all. Having insufficient funds may
require us to delay, scale back or eliminate some or all of our research or development programs or
to relinquish greater or all rights to product candidates at an earlier stage of development or on
less favorable terms than we would otherwise choose. Failure to obtain adequate financing also may
adversely affect our ability to operate as a going concern.
If we raise additional funds through the issuance of equity securities, our stockholders may
experience substantial dilution, or the equity securities may have rights, preferences or
privileges senior to those of existing stockholders. If we raise additional funds through debt
financings, these financings may involve significant cash payment obligations and covenants that
restrict our ability to operate our business and make distributions to our stockholders. We also
could elect to seek funds through arrangements with collaborators or others that may require us to
relinquish rights to certain technologies, product candidates or products.
Our committed equity financing facility with Kingsbridge may not be available to us if we elect to
make a draw down, may require us to make additional blackout or other payments to Kingsbridge and
may result in dilution to our stockholders.
In August 2006, we entered into a CEFF with Kingsbridge. The CEFF entitles us to sell and
obligates Kingsbridge to purchase, from time to time 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:
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;
the accuracy of representations and warranties made to Kingsbridge;
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
the effectiveness of a registration statement registering for resale the shares of common
stock to be issued in connection with the CEFF.
Kingsbridge is permitted to terminate the CEFF by providing written notice to us upon the
occurrence of certain events. If we are unable to access funds through the CEFF, or if Kingsbridge
terminates the CEFF, we may be unable to access capital from other sources on favorable terms, or
at all.
We are entitled, in certain circumstances, to deliver a blackout notice to Kingsbridge to
suspend the use of the resale registration statement and prohibit Kingsbridge from selling shares
under the resale registration statement for a certain period of time. If we deliver a blackout
notice during the fifteen trading days following our delivery of shares to Kingsbridge in
connection with any draw down, then we may be required to make a payment to Kingsbridge, or issue
to Kingsbridge additional shares in lieu of this payment, calculated on the basis of the number of
shares purchased by Kingsbridge in the most recent draw down and held by Kingsbridge immediately
prior to the blackout period and the decline in the market price, if any, of our common stock
during the blackout period. If the trading price of our common stock declines during a blackout
period, this blackout payment could be significant.
In addition, if we fail to maintain the effectiveness of the resale registration statement or
related prospectus in circumstances not permitted by our agreement with Kingsbridge, we may be
required to make a payment to Kingsbridge, calculated on the basis of the number of shares held by
Kingsbridge during the period that the registration statement or prospectus is not effective,
multiplied by the decline in market price, if any, of our common stock during the ineffective
period. If the trading price of our common stock declines during a period in which the resale
registration statement or related prospectus is not effective, this payment could be significant.
Should we sell shares to Kingsbridge under the CEFF or issue shares in lieu of a blackout
payment, it will have a dilutive effect on the holdings of our current stockholders and may result
in downward pressure on the price of our common stock. If we draw down under the CEFF, we will
issue shares to Kingsbridge at a discount of 6% to 14% from the volume weighted average price of
our common stock. 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
32
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:
the status of development of our product candidates;
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;
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;
the addition or termination of research programs or funding support;
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;
variations in the level of research and development expenses related to our clinical or
preclinical product candidates during any given period; and
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 on a
Black-Scholes option-pricing model, with the change in value recorded as non-cash other income or
expense.
These factors may cause the price of our stock to fluctuate substantially. We believe that
quarterly comparisons of our financial results are not necessarily meaningful and should not be
relied upon as an indication of our future performance.
If the estimates we make and the assumptions on which we rely in preparing our financial statements
prove inaccurate, our actual results may vary significantly.
Our financial statements have been prepared in accordance with generally accepted accounting
principles in the United States. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and
expenses, the amounts of charges taken by us and related disclosure. We base our estimates on
historical experience and on various other assumptions that we believe to be reasonable under the
circumstances. We cannot assure you that our estimates, or the assumptions underlying them, will
be correct. Accordingly, our actual financial results may vary significantly from the estimates
contained in our financial statements.
Changes in, or interpretations of, accounting rules and regulations could result in unfavorable
accounting charges or require us to change our compensation policies.
Accounting methods and policies for biopharmaceutical companies, including policies governing
revenue recognition, research and development 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
33
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:
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;
payments on our indebtedness will reduce the funds that would otherwise be available for
our operations and future business opportunities;
we may be more highly leveraged than our competitors, which may place us at a competitive
disadvantage; and
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 2006 that our system of internal control
over financial reporting does not meet the requirements of Section 404 of the Sarbanes-Oxley Act of
2002. As a result, investors could lose confidence in the reliability of our internal control over
financial reporting, which could have a material adverse effect on our stock price.
As a publicly traded company, we are required to comply with the Sarbanes-Oxley Act of 2002
and the related rules and regulations of the SEC, including Section 404 of the Sarbanes-Oxley Act
of 2002. As a result of the merger between CancerVax Corporation and Micromet AG, and the
establishment of our new corporate headaquarters in Bethesda, Maryland, we are in the process of
upgrading the existing, and implementing additional, procedures and controls to incorporate the
operations of Micromet AG, which had been a private German company prior to the merger. The
process of updating the procedures and controls is requiring significant time and expense. The
integration of the two companies finance and accounting systems, procedures and controls, and the
implementation of procedures and controls at Micromet AG are more time-consuming and expensive than
we previously anticipated.
Our internal control system is designed to provide reasonable assurance to our management and
board of directors regarding the preparation and fair presentation of published financial
statements. In connection with the audit of our consolidated financial statements for the year
ended December 31, 2006, our independent registered public accounting firm provided us with an
unqualified opinion on our consolidated financial statements, but it identified material weaknesses
in our internal control over financial reporting based on criteria established in Internal
Control Integrated Framework, issued by the Committee of Sponsoring Organizations (COSO) of the
Treadway Commission. These material weaknesses relate to certain of our estimation and accrual
processes, procedures relating to analysis and recording of revenue transactions with unusual
terms, and an insufficient level of management review due to lack of resources. These weaknesses
resulted, in part, from our inability to sufficiently upgrade our existing procedures and controls
and to implement new procedures and controls to integrate the operations of Micromet AG prior to
December 31, 2006. Because of these material weaknesses in our internal control over financial
reporting, there is heightened risk that a material misstatement of our annual or quarterly
financial statements will not be prevented or detected.
We are in the process of expanding our internal resources and implementing additional
procedures in order to remediate these material weaknesses in our internal control over financial
reporting; however, we cannot guarantee that these efforts will be successful. If we do not
adequately remedy these material weaknesses, and if we fail to maintain proper and effective
internal control over financial reporting in future periods, our ability to provide timely and
reliable financial results could suffer, and investors could lose confidence in our reported
financial information, which may have a material adverse effect on our stock price.
Risks Relating to Our Common Stock
Substantial
sales of shares may adversely impact the market price of our common stock and our ability to issue and sell shares in the future.
Substantially all of the outstanding shares of our common stock are eligible for resale in the
public market. 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
34
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:
our ability to upgrade and implement our disclosure controls and our internal control
over financial reporting;
our ability to successfully raise capital to fund our continued operations;
our ability to successfully develop our product candidates within acceptable timeframes;
changes in the regulatory status of our product candidates;
changes in significant contracts, strategic collaborations, new technologies,
acquisitions, commercial relationships, joint ventures or capital commitments;
the execution of new collaboration agreements or termination of existing collaborations
related to our clinical or preclinical product candidates or our BiTE technology platform;
announcements of the invalidity of, or litigation relating to, our key intellectual
property;
announcements of the achievement of milestones in our agreements with collaborators or
the receipt of payments under those agreements;
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;
events affecting our collaborators;
fluctuations in stock market prices and trading volumes of similar companies;
announcements of new products or technologies, clinical trial results, commercial
relationships or other events by us, our collaborators or our competitors;
our ability to successfully complete strategic collaboration arrangements with respect to
our product candidates;
variations in our quarterly operating results;
changes in securities analysts estimates of our financial performance or product
development timelines;
changes in accounting principles;
sales of large blocks of our common stock, including sales by our executive officers,
directors and significant stockholders;
additions or departures of key personnel; and
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, and, as a result, may significantly influence
all matters requiring approval by our stockholders, including the election of directors and the
approval of mergers or other business combination transactions. The interests of this group of
stockholders may not always coincide with our interests or the interests of other stockholders, and
this group may act in a manner that advances their best interests and not necessarily those of
other stockholders.
35
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:
dividing our board of directors into three classes serving staggered three-year terms;
prohibiting our stockholders from calling a special meeting of stockholders;
permitting the issuance of additional shares of our common stock or preferred stock
without stockholder approval;
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
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. 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 MedImmune,
Merck Serono, TRACON and Nycomed. 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:
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.
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.
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.
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 June 2007, our collaborator MedImmune was acquired by AstraZeneca plc. If MedImmune or
AstraZeneca were to perform a review of their development programs and re-evaluate their priorities
in the development of their product candidates, this could result in a delay in the development of
and the commercialization of our product candidate MT103, MT111, or the EphA2 BiTE antibody that in
each case we are developing in collaboration with MedImmune, or in a termination of one or both of
the collaboration agreements we have with MedImmune for our product candidates that are the subject
of strategic collaborations with MedImmune. 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 with MedImmune, or we may need to reallocate financial
resources that may cause delays in other development programs for our other product candidates.
Similarly, in January 2007, our collaborator Serono announced that it was acquired by Merck
KGaA to form Merck Serono. If Merck Serono re-evaluates its priorities in the development of its
product candidates, this could result in a delay in the development and the launch of adecatumumab
(if successfully developed and approved for commercial sale) or termination of the collaboration
agreement with us. We may not be able to identify and enter into a collaboration agreement for
adecatumumab with another pharmaceutical company, and we may not have sufficient financial
resources to continue the development program on our own. As a result, we could be required to
delay or abandon the development of adecatumumab following any termination of the collaboration
agreement with Merck Serono.
We may not be successful in establishing additional strategic collaborations, which could adversely
affect our ability to develop and commercialize product candidates.
As an integral part of our ongoing research and development efforts, we periodically review
opportunities to establish new collaborations for development and commercialization of new BiTE
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. We have also
reported that we, in collaboration with Merck Serono, are planning to start a new phase 1
monotherapy study for the treatment of patients with solid tumors estimated to begin in 2007. If
the combination of adecatumumab with docetaxel proves not to be tolerable or safe or if no higher
serum levels of adecatumumab compared to previous clinical trials can be administered safely or if
sufficient anti-tumor activity cannot be shown, we and our collaborator Merck Serono may decide to
abandon all or part of the development program of adecatumumab and as a result we may experience a
material adverse impact on our results of operations.
We previously terminated three phase 1 trials involving short-term infusion regimens of MT103 due
to adverse side effects and a lack of perceived tumor response, and there can be no assurance that
our current continuous infusion phase 1 clinical trial of MT103 will produce a different outcome.
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In April 2004, we initiated a phase 1, dose finding clinical trial designed to evaluate the
safety and tolerability of a continuous intravenous infusion of MT103 over 4-8 weeks at different
dose levels in patients with relapsed non-Hodgkins lymphoma. We previously terminated three other
phase 1 clinical trials for MT103, which involved a short-term infusion, as opposed to a continuous
infusion dosing regimen of MT103, due to adverse side effects and the lack of observed tumor
responses. We have redesigned the dosing regimen for our ongoing phase 1 clinical trial and, based
upon the preliminary clinical data, we currently are seeing a considerably more favorable safety
profile in response to the new continuous infusion dosing regimen 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 per day dose level with the continuous infusion regimens.
While this preliminary data suggest that MT103 has anti-tumor activity, there can be no assurance
that we will not encounter unacceptable adverse events during the continued dose escalation of our
ongoing, continuous-infusion phase 1 clinical trial or that the preliminary suggestion of
anti-tumor activity will be confirmed during the ongoing or any future study.
Changes in the laws or regulations of the United States or Cuba related to the conduct of our
business with CIMAB may adversely affect our ability to sublicense or otherwise transfer our rights
to SAI-EGF and our two other product candidates that we have licensed from that company.
The United States government has maintained an embargo against Cuba for more than 40 years.
The embargo is administered by the Office of Foreign Assets Control, or OFAC, of the
U.S. Department of Treasury. Without a license from OFAC, U.S. individuals and companies may not
engage in any transaction in which Cuba or Cubans have an interest. In order to enter into and
carry out our licensing agreements with CIMAB S.A., a Cuban company, we have obtained from OFAC a
license authorizing us to carry out all transactions set forth in the license agreements that we
have entered into with CIMAB for the development, testing, licensing and commercialization of our
product candidate SAI-EGF, and with CIMAB and its affiliate YM BioSciences, Inc., a Canadian
company, for our two other product candidates that target the EGF receptor signaling pathway. In
the absence of such a license from OFAC, the execution of and our performance under these
agreements could have exposed us to legal and criminal liability. At any time, there may occur for
reasons beyond our control a change in United States or Cuban law, or in the regulatory environment
in the U.S. or Cuba, or a shift in the political attitudes of either the U.S. or Cuban governments,
that could result in the suspension or revocation of our OFAC license or in our inability to carry
out part or all of the licensing agreements with CIMAB. There can be no assurance that the U.S. or
Cuban governments will not modify existing law or establish new laws or regulations that may
adversely affect our ability to develop, test, license and commercialize these product candidates.
Our OFAC license may be revoked or amended at anytime in the future, or the U.S. or Cuban
governments may restrict our ability to carry out all or part of our respective duties under the
licensing agreements between us, CIMAB and YM BioSciences. Similarly, any such actions may
restrict CIMABs ability to carry out all or part of its licensing agreements with us. In
addition, we cannot be sure that the FDA, EMEA or other regulatory authorities will accept data
from the clinical trials of these product candidates that were conducted in Cuba as the basis for
our applications to conduct additional clinical trials, or as part of our application to seek
marketing authorizations for such product candidates.
In 1996, a significant change to the United States embargo against Cuba resulted from
congressional passage of the Cuban Liberty and Democratic Solidarity Act, also known as the
Helms-Burton Bill. That law authorizes private lawsuits for damages against anyone who traffics in
property confiscated, without compensation, by the government of Cuba from persons who at the time
were, or have since become, nationals of the United States. We do not own any property in Cuba and
do not believe that any of CIMABs properties or any of the scientific centers that are or have
been involved in the development of the technology that we have licensed from CIMAB were
confiscated by the government of Cuba from persons who at the time were, or who have since become,
nationals of the U.S. However, there can be no assurance that our understanding in this regard is
correct. We do not intend to traffic in confiscated property, and we have included provisions in
our licensing agreements to preclude the use of such property in association with the performance
of CIMABs obligations under those agreements, although we cannot ensure that CIMAB or other third
parties will comply with these provisions.
As part of our interactions with CIMAB, we are subject to the U.S. Commerce Departments
export administration regulations that govern the transfer of technology to foreign nationals.
Specifically, we or our sublicensees, if any, will require a license from the Commerce Departments
Bureau of Industry and Security, or BIS, in order to export or otherwise transfer to CIMAB any
information that constitutes technology under the definitions of the Export Administration
Regulations, or EAR, administered by BIS. The export licensing process may take months to be
completed, and the technology transfer in question may not take place unless and until a license is
granted by the Commerce Department. Due to the unique status of the Republic of Cuba, technology
that might otherwise be transferable to a foreign national without a Commerce Department license
requires a license for export or transfer to a Cuban national. If we or our sublicensees fail to
comply with the export administration regulations, we may be subject to both civil and criminal
penalties. There can be no guarantee that any license application will be approved by BIS or that
a license, once issued, will not be revoked, modified, suspended or otherwise restricted for
reasons beyond our control due to a change in U.S.-Cuba policy or for other reasons.
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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 and at a lower cost, or may discover, develop and
commercialize products, which render our product candidates non-competitive or obsolete. We expect
competition to intensify in antibody research as technical advances in the field are made and
become more widely known.
We may not be successful in our efforts to expand our portfolio of product candidates.
A key element of our strategy is to discover, develop and commercialize a portfolio of new
antibody therapeutics. We are seeking to do so through our internal research programs and
in-licensing activities. A significant portion of the research that we are conducting involves new
and unproven technologies. Research programs to identify new disease targets and product
candidates require substantial technical, financial and human resources regardless of whether or
not any suitable candidates are ultimately identified. Our research programs may initially show
promise in identifying potential product candidates, yet fail to yield product candidates suitable
for clinical development. If we are unable to discover suitable potential product candidates,
develop additional delivery technologies through internal research programs or in-license suitable
product candidates or delivery technologies on acceptable business terms, our business prospects
will suffer.
The product candidates in our pipeline are in early stages of development and our efforts to
develop and commercialize these product candidates are subject to a high risk of delay and failure.
If we fail to successfully develop our product candidates, our ability to generate revenues will be
substantially impaired.
The process of successfully developing product candidates for the treatment of human diseases
is very time-consuming, expensive and unpredictable and there is a high rate of failure for product
candidates in preclinical development and in clinical trials. The preclinical studies and clinical
trials may produce negative, inconsistent or inconclusive results, and the results from early
clinical trials may not be statistically significant or predictive of results that will be obtained
from expanded, advanced clinical trials. Further, we or our collaborators may decide, or 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 pre-clinical 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.
39
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.
We rely heavily on third parties for the conduct of preclinical and clinical studies of our product
candidates, and we may not be able to control the proper performance of the studies or trials.
In order to obtain regulatory approval for the commercial sale of our product candidates, we
and our collaborators are required to complete extensive preclinical studies as well as clinical
trials in humans to demonstrate to the FDA, EMEA and other regulatory authorities that our product
candidates are safe and effective. We have limited experience and internal resources for
conducting certain preclinical studies and clinical trials and rely primarily on collaborators and
contract research organizations for the performance and management of certain preclinical studies
and clinical trials of our product candidates. If our collaborators or contractors fail to
properly perform their contractual or regulatory obligations with respect to conducting or
overseeing the performance of our preclinical studies or clinical trials, the completion of these
studies or trials may be delayed, or the results may not be useable and the studies or trials may
have to be repeated. Any of these events could delay or create additional costs in the development
of our product candidates and could adversely affect our and our collaborators ability to market a
product after marketing approvals have been obtained.
Even if we complete the lengthy, complex and expensive development process, there is no assurance
that we or our collaborators will obtain the regulatory approvals necessary for the launch and
commercialization of our product candidates.
To the extent that we or our collaborators are able to successfully complete the clinical
development of a product candidate, we or our collaborators will be required to obtain approval by
the FDA, EMEA or other regulatory authorities prior to marketing and selling such product candidate
in the United States, the European Union or other countries.
The process of preparing and filing applications for regulatory approvals with the FDA, EMEA
and other regulatory authorities, and of obtaining the required regulatory approvals from these
regulatory authorities is lengthy and expensive, and may require two years or more. This process
is further complicated because some of our product candidates use non-traditional or novel
materials in non-traditional or novel ways, and the regulatory officials have little precedent to
follow. Moreover, an unrelated biotech company recently observed multiple severe adverse reactions
in a phase 1 trial of an antibody that stimulates T cells. This development could cause the FDA
and EMEA or other regulatory authorities to require additional preclinical data or certain
precautions in the designs of clinical protocols that could cause a delay in the development of our
BiTE product candidates or make the development process more expensive.
Any marketing approval by the FDA, EMEA or other regulatory authorities may be subject to
limitations on the indicated uses for which we or our collaborators may market the product
candidate. These limitations could restrict the size of the market for the product and affect
reimbursement levels by third-party payers.
As a result of these factors, we or our collaborators may not successfully begin or complete
clinical trials and launch and commercialize any product candidates in the time periods estimated,
if at all. Moreover, if we or our collaborators incur costs and delays in development programs or
fail to successfully develop and commercialize products based upon our technologies, we may not
become profitable and our stock price could decline.
40
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. 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.
If our third-party manufacturers do not follow current good manufacturing practices or do not
maintain their facilities in accordance with these practices, our product development and
commercialization efforts may be harmed.
Product candidates used in clinical trials or sold after marketing approval has been obtained
must be manufactured in accordance with current good manufacturing practices regulations. There
are a limited number of manufacturers that operate under these regulations, including the FDAs and
EMEAs good manufacturing practices regulations, and that are capable of manufacturing our product
candidates. Third-party manufacturers may encounter difficulties in achieving quality control and
quality assurance and may experience shortages of qualified personnel. Also, manufacturing
facilities are subject to ongoing periodic, unannounced inspection by the FDA, the EMEA, and other
regulatory agencies or authorities, to ensure strict compliance with current good manufacturing
practices and other governmental regulations and standards. A failure of third-party manufacturers
to follow current good manufacturing practices or other regulatory requirements and to document
their adherence to such practices may lead to significant delays in the availability of product
candidates for use in a clinical trial or for commercial sale, the termination of, or hold on a
clinical trial, or may delay or prevent filing or approval of marketing applications for our
product candidates. In addition, as a result of such a failure, we could be subject to sanctions,
including fines, injunctions and civil penalties, refusal or delays by regulatory authorities to
grant marketing approval of our product candidates, suspension or withdrawal of marketing
approvals, seizures or recalls of product candidates, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect our business. If we were
required to change manufacturers, it may require additional clinical trials and the revalidation of
the manufacturing process and procedures in accordance with applicable current good manufacturing
practices and may require FDA or EMEA approval. This revalidation may be costly and
time-consuming. If we are unable to arrange for third-party manufacturing of our product
candidates, or to do so on commercially reasonable terms, we may not be able to complete
development or marketing of our product candidates.
Even if regulatory authorities approve our product candidates, we may fail to comply with ongoing
regulatory requirements or experience unanticipated problems with our product candidates, and these
product candidates could be subject to restrictions or withdrawal from the market following
approval.
Any product candidates for which we obtain marketing approval, along with the manufacturing
processes, post-approval clinical trials and promotional activities for such product candidates,
will be subject to continual review and periodic inspections by the FDA, EMEA and other regulatory
authorities. Even if regulatory approval of a product candidate is granted, the approval may be
subject to limitations on the indicated uses for which the product may be marketed or contain
requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy
of the product. Post-approval discovery of previously unknown problems with any approved products,
including unanticipated adverse events or adverse events of unanticipated severity or frequency,
difficulties with a
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manufacturer or manufacturing processes, or failure to comply with regulatory requirements,
may result in restrictions on such approved products or manufacturing processes, withdrawal of the
approved products from the market, voluntary or mandatory recall, fines, suspension of regulatory
approvals, product seizures, injunctions or the imposition of civil or criminal penalties.
The procedures and requirements for granting marketing approvals vary among countries, which may
cause us to incur additional costs or delays or may prevent us from obtaining marketing approvals
in different countries and regulatory jurisdictions.
We intend to market our product candidates in many countries and regulatory jurisdictions. In
order to market our product candidates in the United States, the European Union and many other
jurisdictions, we must obtain separate regulatory approvals in each of these countries and
territories. The procedures and requirements for obtaining marketing approval vary among countries
and regulatory jurisdictions, and can involve additional clinical trials or other tests. Also, the
time required to obtain approval may differ from that required to obtain FDA and EMEA approval.
The various regulatory approval processes may include all of the risks associated with obtaining
FDA and EMEA approval. We may not obtain all of the desirable or necessary regulatory approvals on
a timely basis, if at all. Approval by a regulatory authority in a particular country or
regulatory jurisdiction, such as the FDA in the United States and the EMEA in the European Union,
generally does not ensure approval by a regulatory authority in another country. We may not be
able to file for regulatory approvals and may not receive necessary approvals to commercialize our
product candidates in any or all of the countries or regulatory jurisdictions in which we desire to
market our product candidates.
If we fail to obtain an adequate level of reimbursement for any approved products by third-party
payers, there may be no commercially viable markets for these products or the markets may be much
smaller than expected. The continuing efforts of the government, insurance companies, managed care
organizations and other payers of health care costs to contain or reduce costs of healthcare may
adversely affect our ability to generate revenues and achieve profitability, the future revenues
and profitability of our potential customers, suppliers and collaborators, and the availability of
capital.
Our ability to commercialize our product candidates successfully will depend in part on the
extent to which governmental authorities, private health insurers and other organizations establish
appropriate reimbursement levels for the price charged for our product candidates and related
treatments. The efficacy, safety and cost-effectiveness of our product candidates as well as the
efficacy, safety and cost-effectiveness of any competing products will determine in part the
availability and level of reimbursement. These third-party payors continually attempt to contain
or reduce the costs of healthcare by challenging the prices charged for healthcare products and
services. Given recent federal and state government initiatives directed at lowering the total
cost of healthcare in the United States, the U.S. Congress and state legislatures will likely
continue to focus on healthcare reform, the cost of prescription pharmaceuticals and on the reform
of the Medicare and Medicaid systems. In certain countries, particularly the countries of the
European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In
these countries, pricing negotiations with governmental authorities can take six to twelve months
or longer after the receipt of regulatory marketing approval for a product. To obtain
reimbursement or pricing approval in some countries, we may be required to conduct clinical trials
that compare the cost-effectiveness of our product candidates to other available therapies. If
reimbursement for our product candidates were unavailable or limited in scope or amount or if
reimbursement levels or prices are set at unsatisfactory levels, our projected and actual revenues
and our prospects for profitability would be negatively affected.
Another development that may affect the pricing of drugs in the United States is regulatory
action regarding drug reimportation into the United States. The Medicare Prescription Drug,
Improvement and Modernization Act of 2003, which became law in December 2003, requires the
Secretary of the U.S. Department of Health and Human Services to promulgate regulations allowing
drug reimportation from Canada into the United States under certain circumstances. These
provisions will become effective only if the Secretary certifies that such imports will pose no
additional risk to the publics health and safety and result in significant cost savings to
consumers. Proponents of drug reimportation may also attempt to pass legislation that would remove
the requirement for the Secretarys certification or allow reimportation under circumstances beyond
those anticipated under current law. If legislation is enacted, or regulations issued, allowing
the reimportation of drugs, it could decrease the reimbursement we would receive for any product
candidates that we may commercialize, or require us to lower the price of our product candidates
then on the market that face competition from lower-priced supplies of that product from other
countries. These factors would negatively affect our projected and actual revenues and our
prospects for profitability.
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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:
our ability to provide acceptable evidence of safety and efficacy;
convenience and ease of administration;
prevalence and severity of adverse side effects;
availability of alternative treatments;
cost effectiveness;
effectiveness of our marketing and pricing strategy for any product candidates that we
may develop;
publicity concerning our product candidates or competitive products; and
our ability to obtain third-party coverage or reimbursement.
If any product candidates for which we may receive marketing approval fail to gain market
acceptance, our ability to generate product revenue in the future will be adversely affected.
We face the risk of product liability claims and may not be able to obtain insurance.
Our business exposes us to the risk of product liability claims that is inherent in the
testing, manufacturing, and marketing of drugs and related devices. Although we have product
liability and clinical trial liability insurance that we believe is appropriate, this insurance is
subject to deductibles and coverage limitations. We may not be able to obtain or maintain adequate
protection against potential liabilities. If any of our product candidates are approved for
marketing, we may seek additional insurance coverage. If we are unable to obtain insurance at
acceptable cost or on acceptable terms with adequate coverage or otherwise protect ourselves
against potential product liability claims, we will be exposed to significant liabilities, which
may harm our business. These liabilities could prevent or interfere with our product
commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert
management attention and might result in adverse publicity or reduced acceptance of our product
candidates in the market.
Our operations involve hazardous materials and we must comply with environmental laws and
regulations, which can be expensive.
Our research and development activities involve the controlled use of hazardous materials,
including chemicals and radioactive and biological materials. Our operations also produce hazardous
waste products. We are subject in the United States to a variety of federal, state and local
regulations, and in Europe to European, national, state and local regulations, relating to the use,
handling, storage and disposal of these materials. We generally contract with third parties for
the disposal of such substances and store certain low-level radioactive waste at our facility until
the materials are no longer considered radioactive. We cannot eliminate the risk of accidental
contamination or injury from these materials. We may be required to incur substantial costs to
comply with current or future environmental and safety regulations. If an accident or
contamination occurred, we would likely incur significant costs associated with civil penalties or
criminal fines and in complying with environmental laws and regulations. We do not have any
insurance for liabilities arising from hazardous materials. Compliance with environmental laws and
regulations is expensive, and current or future environmental regulation may impair our research,
development or production efforts.
Risks Relating to Our Intellectual Property and Litigation
We may not be able to obtain or maintain adequate patents and other intellectual property rights to
protect our business and product candidates against competitors.
Our value will be significantly enhanced if we are able to obtain adequate patents and other
intellectual property rights to protect our business and product candidates against competitors.
For that reason, we allocate significant financial and personnel resources to the filing,
prosecution, maintenance and defense of patent applications, patents and trademarks claiming or
covering our product candidates and key technology relating to these product candidates.
43
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.
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,
44
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 docetaxel, 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 GSK,
which we may not be able to obtain on commercially reasonable terms, if at all.
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
45
licenses and agreements in the future. These licenses and agreements impose various research,
development, commercialization, sublicensing, milestone and royalty payment, indemnification,
insurance and other obligations on us. If we or our collaborators fail to perform under these
agreements or otherwise breach obligations thereunder, our licensors may terminate these agreements
and we could lose licenses to intellectual property rights that are important to our business. Any
such termination could materially harm our ability to develop and commercialize the product
candidate that is the subject of the agreement, which could have a material adverse impact on our
results of operations.
If licensees or assignees of our intellectual property rights breach any of the agreements under
which we have licensed or assigned our intellectual property to them, we could be deprived of
important intellectual property rights and future revenue.
We are a party to intellectual property out-licenses, collaborations and agreements that are
important to our business, and we expect to enter into similar agreements with third parties in the
future. Under these agreements, we license or transfer intellectual property to third parties and
impose various research, development, commercialization, sublicensing, royalty, indemnification,
insurance, and other obligations on them. If a third party fails to comply with these
requirements, we generally retain the right to terminate the agreement and to bring a legal action
in court or in arbitration. In the event of breach, we may need to enforce our rights under these
agreements by resorting to arbitration or litigation. During the period of arbitration or
litigation, we may be unable to effectively use, assign or license the relevant intellectual
property rights and may be deprived of current or future revenues that are associated with such
intellectual property, which could have a material adverse effect on our results of operations and
financial condition.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or
disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at other biotechnology or pharmaceutical
companies, including our competitors or potential competitors. Although no claims against us are
currently pending, we may be subject to claims that these employees or we have inadvertently or
otherwise used or disclosed trade secrets or other proprietary information of their former
employers. Litigation may be necessary to defend against these claims. Even if we are successful
in defending against these claims, litigation could result in substantial costs and be a
distraction to management. If we fail in defending such claims, in addition to paying money
claims, we may lose valuable intellectual property rights or personnel. A loss of key personnel or
their work product could hamper or prevent our ability to commercialize certain product candidates.
Risks Relating to Manufacturing and Sales of Products
We depend on our collaborators and third-party manufacturers to produce most, if not all, of our
product candidates and if these third parties do not successfully manufacture these product
candidates our business will be harmed.
We have no manufacturing experience or manufacturing capabilities for the production of our
product candidates for clinical trials or commercial sale. In order to continue to develop product
candidates, apply for regulatory approvals, and commercialize our product candidates following
approval, we or our collaborators must be able to manufacture or contract with third parties to
manufacture our product candidates in clinical and commercial quantities, in compliance with
regulatory requirements, at acceptable costs and in a timely manner. The manufacture of our
product candidates may be complex, difficult to accomplish and difficult to scale-up when
large-scale production is required. Manufacture may be subject to delays, inefficiencies and poor
or low yields of quality products. The cost of manufacturing our product candidates may make them
prohibitively expensive. If supplies of any of our product candidates or related materials become
unavailable on a timely basis or at all or are contaminated or otherwise lost, clinical trials by
us and our collaborators could be seriously delayed. This is due to the fact that such materials
are time-consuming to manufacture and cannot be readily obtained from third-party sources.
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:
we and our collaborators may not be able to initiate or continue clinical trials of
product candidates that are under development;
we and our collaborators may be delayed in submitting applications for regulatory
approvals for our product candidates; and
we and our collaborators may not be able to meet commercial demands for any approved
products.
46
We have no sales, marketing or distribution experience and will depend significantly on third
parties who may not successfully sell our product candidates following approval.
We have no sales, marketing or product distribution experience. If we receive required
regulatory approvals to market any of our product candidates, we plan to rely primarily on sales,
marketing and distribution arrangements with third parties, including our collaborators. For
example, as part of our agreements with MedImmune, Merck Serono, TRACON and Nycomed, we have
granted these companies the right to market and distribute products resulting from such
collaborations, if any are ever successfully developed. We may have to enter into additional
marketing arrangements in the future and we may not be able to enter into these additional
arrangements on terms that are favorable to us, if at all. In addition, we may have limited or no
control over the sales, marketing and distribution activities of these third parties, and sales
through these third parties could be less profitable to us than direct sales. These third parties
could sell competing products and may devote insufficient sales efforts to our product candidates
following approval. As a result, our future revenues from sales of our product candidates, if any,
will be materially dependent upon the success of the efforts of these third parties.
We may seek to co-promote products with our collaborators, or to independently market products
that are not already subject to marketing agreements with other parties. If we determine to perform
sales, marketing and distribution functions ourselves, we could face a number of additional risks,
including:
we may not be able to attract and build an experienced marketing staff or sales force;
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
our direct sales and marketing efforts may not be successful.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
3.1 (2)
|
|
Amended and Restated Certificate of Incorporation of the Registrant |
|
|
|
3.2 (3)
|
|
Certificate of Amendment of the Amended and Restated Certificate of
Incorporation of the Registrant |
|
|
|
3.3 (4)
|
|
Certificate of Designations for Series A Junior Participating
Preferred Stock of the Registrant |
|
|
|
3.4 (11)
|
|
Amended and Restated Bylaws |
|
|
|
4.1 (9)
|
|
Form of Specimen Common Stock Certificate |
|
|
|
4.2 (1)
|
|
Warrant to Purchase Vendor Preferred Stock, Series 2, issued to
Venture Lending & Leasing III, LLC, dated September 6, 2002 |
|
|
|
4.3 (4)
|
|
Rights Agreement, by and between the Registrant and Mellon Investor
Services LLC, which includes the form of Certificate of
Designations of the Series A Junior Participating |
47
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
Preferred Stock
of the Registrant as Exhibit A, the form of Right Certificate as
Exhibit B and the Summary of Rights to Purchase Preferred Shares as
Exhibit C, dated as of November 3, 2004 |
|
|
|
4.4 (5)
|
|
First Amendment to Rights Agreement, by and between the Registrant
and Mellon Investor Services LLC, dated as of March 17, 2006 |
|
|
|
4.5 (7)
|
|
Second Amended and Restated Note, in favor of MedImmune Ventures,
Inc., dated as of December 27, 2006 |
|
|
|
4.6 (8)
|
|
Registration Rights Agreement, by and between the Registrant and
Kingsbridge Capital Limited, dated as of August 30, 2006 |
|
|
|
4.7 (8)
|
|
Warrant to purchase 285,000 shares of Common Stock, issued to
Kingsbridge Capital Limited, dated August 30, 2006 |
|
|
|
4.8 (9)
|
|
Form of Warrant to Purchase Common Stock, dated May 5, 2006 |
|
|
|
4.9 (6)
|
|
Form of Warrants to purchase an aggregate of 555,556 shares of
Common Stock, in favor of funds affiliated with NGN Capital, LLC,
dated July 24, 2006 |
|
|
|
4.10 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag)
with tbg Technologie Beteiligungsgesellschaft mbH, dated March 2,
1999 |
|
|
|
4.11 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag)
with tbg Technologie Beteiligungsgesellschaft mbH, dated March 2,
1999 |
|
|
|
4.12 (9) &
|
|
Amendment to Silent Partnership Participation Agreements with tbg
Technologie Beteiligungsgesellschaft mbH, dated February 6, 2006 |
|
|
|
4.13 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag)
with Technologie Beteiligungsfond Bayern GmbH, dated January 17,
2000 |
|
|
|
4.14 (9) &
|
|
Amendment to Silent Partnership Participation Agreement with
Technologie Beteiligungsfond Bayern GmbH, dated February 6, 2006 |
|
|
|
4.15 (10)
|
|
Registration Rights Agreement, dated June 19, 2007 |
|
|
|
4.16 (10)
|
|
Form of Warrant, dated June 19, 2007 |
|
|
|
4.17 (10)
|
|
Alternate Form of Warrant, dated June 19, 2007 |
|
|
|
10.1
|
|
Employment Agreement with Mark L. Reisenauer dated September 9, 2007 |
|
|
|
31.1
|
|
Certification of principal executive officer pursuant to
Rules 13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
31.2
|
|
Certification of principal financial officer pursuant to
Rules 13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
32**
|
|
Certifications of principal executive officer and principal
financial officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to the Registrants Registration Statement on Form S-1
filed with the Securities and Exchange Commission on October 24, 2003. |
|
(2) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on December 11, 2003. |
|
(3) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on May 10, 2006. |
|
(4) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
(5) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(6) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on July 26, 2006. |
|
(7) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on January 4, 2007. |
|
(8) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on August 31, 2006. |
|
(9) |
|
Incorporated by reference to the Registrants Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 16, 2007. |
|
(10) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on June 21, 2007. |
|
(11) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on October 8, 2007. |
|
& |
|
Indicates that the exhibit is an English translation of a foreign language document. |
48
|
|
|
|
** |
|
These certifications are being furnished solely to accompany this quarterly report
pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of
Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by
reference into any filing of the Registrant, whether made before or after the date
hereof, regardless of any general incorporation language in such filing.
|
49
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
Dated: November 8, 2007 |
Micromet, Inc.
|
|
|
By: |
/s/ Christopher P. Schnittker
|
|
|
|
Christopher P. Schnittker |
|
|
|
Senior Vice President and Chief Financial Officer
(Duly authorized officer and Principal Financial Officer) |
|
50
Exhibit List
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
3.1 (2)
|
|
Amended and Restated Certificate of Incorporation of the Registrant |
|
|
|
3.2 (3)
|
|
Certificate of Amendment of the Amended and Restated Certificate of
Incorporation of the Registrant |
|
|
|
3.3 (4)
|
|
Certificate of Designations for
Series A Junior Participating Preferred Stock of the Registrant |
|
|
|
3.4 (11)
|
|
Amended and Restated Bylaws |
|
|
|
4.1 (9)
|
|
Form of Specimen Common Stock Certificate |
|
|
|
4.2 (1)
|
|
Warrant to Purchase Vendor Preferred Stock, Series 2, issued to
Venture Lending & Leasing III, LLC, dated September 6, 2002 |
|
|
|
4.3 (4)
|
|
Rights Agreement, by and between the Registrant and Mellon Investor
Services LLC, which includes the form of Certificate of
Designations of the Series A Junior Participating Preferred Stock
of the Registrant as Exhibit A, the form of Right Certificate as
Exhibit B and the Summary of Rights to Purchase Preferred Shares as
Exhibit C, dated as of November 3, 2004 |
|
|
|
4.4 (5)
|
|
First Amendment to Rights Agreement, by and between the Registrant
and Mellon Investor Services LLC, dated as of March 17, 2006 |
|
|
|
4.5 (7)
|
|
Second Amended and Restated Note, in favor of MedImmune Ventures,
Inc., dated as of December 27, 2006 |
|
|
|
4.6 (8)
|
|
Registration Rights Agreement, by and between the Registrant and
Kingsbridge Capital Limited, dated as of August 30, 2006 |
|
|
|
4.7 (8)
|
|
Warrant to purchase 285,000 shares of Common Stock, issued to
Kingsbridge Capital Limited, dated August 30, 2006 |
|
|
|
4.8 (9)
|
|
Form of Warrant to Purchase Common Stock, dated May 5, 2006 |
|
|
|
4.9 (6)
|
|
Form of Warrants to purchase an aggregate of 555,556 shares of
Common Stock, in favor of funds affiliated with NGN Capital, LLC,
dated July 24, 2006 |
|
|
|
4.10 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag)
with tbg Technologie Beteiligungsgesellschaft mbH, dated March 2,
1999 |
|
|
|
4.11 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag)
with tbg Technologie Beteiligungsgesellschaft mbH, dated March 2,
1999 |
|
|
|
4.12 (9) &
|
|
Amendment to Silent Partnership Participation Agreements with tbg
Technologie Beteiligungsgesellschaft mbH, dated February 6, 2006 |
|
|
|
4.13 (9) &
|
|
Silent Partnership Participation Agreement (Beteiligungsvertrag)
with Technologie Beteiligungsfond Bayern GmbH, dated January 17,
2000 |
|
|
|
4.14 (9) &
|
|
Amendment to Silent Partnership Participation Agreement with
Technologie Beteiligungsfond Bayern GmbH, dated February 6, 2006 |
|
|
|
4.15 (10)
|
|
Registration Rights Agreement, dated June 19, 2007 |
|
|
|
4.16 (10)
|
|
Form of Warrant, dated June 19, 2007 |
|
|
|
4.17 (10)
|
|
Alternate Form of Warrant, dated June 19, 2007 |
|
|
|
10.1
|
|
Employment Agreement with Mark L. Reisenauer dated September 9, 2007 |
|
|
|
31.1
|
|
Certification of principal executive officer pursuant to
Rules 13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
31.2
|
|
Certification of principal financial officer pursuant to
Rules 13a-14 and 15d-14 promulgated under the Securities Exchange
Act of 1934 |
|
|
|
32**
|
|
Certifications of principal executive officer and principal
financial officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to the Registrants Registration Statement on Form S-1
filed with the Securities and Exchange Commission on October 24, 2003. |
|
(2) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on December 11, 2003. |
|
(3) |
|
Incorporated by reference to the Registrants Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on May 10, 2006. |
|
(4) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
51
|
|
|
|
(5) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(6) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on July 26, 2006. |
|
(7) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on January 4, 2007. |
|
(8) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on August 31, 2006. |
|
(9) |
|
Incorporated by reference to the Registrants Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 16, 2007. |
|
(10) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on June 21, 2007. |
|
(11) |
|
Incorporated by reference to the Registrants Current Report on Form 8-K filed with
the Securities and Exchange Commission on October 8, 2007. |
|
& |
|
Indicates that the exhibit is an English translation of a foreign language document. |
|
** |
|
These certifications are being furnished solely to accompany this quarterly report
pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of
Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by
reference into any filing of the Registrant, whether made before or after the date
hereof, regardless of any general incorporation language in such filing. |
52