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, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-50440
MICROMET, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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52-2243564 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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2110 Rutherford Road, Carlsbad, CA
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92008 |
(Address of principal executive offices)
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(Zip Code) |
(760) 494-4200
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. þ Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
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 October 31, 2006 was 31,413,032.
MICROMET, INC.
FORM 10-Q QUARTERLY REPORT
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2006
TABLE OF CONTENTS
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Page No |
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3 |
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4 |
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19 |
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27 |
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27 |
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30 |
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30 |
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46 |
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46 |
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46 |
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46 |
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47 |
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49 |
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EXHIBIT 10.13 |
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EXHIBIT 10.14 |
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EXHIBIT 31.1 |
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EXHIBIT 31.2 |
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EXHIBIT 32 |
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2
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
Micromet, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except per share amounts)
(Unaudited)
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September 30, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash
equivalents |
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$ |
21,291 |
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$ |
11,414 |
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Accounts receivable |
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2,609 |
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2,170 |
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Prepaid expenses and other current assets |
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2,464 |
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1,043 |
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Total current assets |
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26,364 |
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14,627 |
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Property and equipment, net |
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3,448 |
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3,513 |
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Loans to related parties |
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213 |
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Loans to employees |
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75 |
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70 |
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Goodwill |
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6,917 |
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Patents, net |
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8,978 |
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9,705 |
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Deposits and other assets |
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160 |
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113 |
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Restricted cash |
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3,031 |
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636 |
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Total assets |
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$ |
48,973 |
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$ |
28,877 |
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LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable |
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$ |
1,406 |
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$ |
1,287 |
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Accrued expenses |
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9,100 |
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6,534 |
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Other liabilities |
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468 |
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1,927 |
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Short-term note |
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3,055 |
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2,852 |
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Current portion of long-term debt obligations |
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2,081 |
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3,638 |
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Current portion of convertible notes payable |
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2,761 |
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Current portion of
deferred revenue |
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3,220 |
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6,035 |
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Total current liabilities |
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19,330 |
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25,034 |
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Convertible notes payable, net of current portion |
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1,941 |
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11,844 |
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Deferred revenue, net of
current portion |
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97 |
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52 |
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Other non-current
liabilities |
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2,035 |
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949 |
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Long-term debt obligations, net of current portion |
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5,090 |
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5,531 |
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Commitments |
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Stockholders equity
(deficit): |
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Preferred stock, $0.00004 par value; 10,000 shares
authorized; no shares issued and
outstanding |
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Common stock, $0.00004 par value; 150,000 shares authorized;
31,413 and 17,915 shares
issued and outstanding at September 30, 2006 and December
31, 2005, respectively |
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1 |
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1 |
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Additional paid-in
capital |
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163,021 |
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67,181 |
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Stock subscription from
conversion |
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23,108 |
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Stock subscriptions
receivable |
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(27 |
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(242 |
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Accumulated other comprehensive income |
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5,687 |
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6,234 |
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Accumulated deficit |
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(148,202 |
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(110,815 |
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Total stockholders equity
(deficit) |
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20,480 |
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(14,533 |
) |
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Total liabilities and stockholders equity (deficit) |
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$ |
48,973 |
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$ |
28,877 |
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The accompanying notes are an integral part of these financial statements.
3
Micromet, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three months ended September 30, |
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Nine months ended September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Collaboration agreements |
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$ |
4,466 |
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$ |
5,460 |
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$ |
12,853 |
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$ |
16,332 |
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License fees |
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153 |
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60 |
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874 |
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664 |
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Other |
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17 |
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6 |
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49 |
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48 |
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Total revenues |
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4,636 |
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5,526 |
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13,776 |
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17,044 |
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Operating expenses: |
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Research and development |
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6,835 |
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6,668 |
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20,866 |
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20,865 |
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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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3,317 |
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2,151 |
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8,517 |
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5,129 |
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Total operating expenses |
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10,152 |
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8,819 |
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50,273 |
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25,994 |
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Loss from operations |
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(5,516 |
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(3,293 |
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(36,497 |
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(8,950 |
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Other income (expense): |
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Interest expense |
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(508 |
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(1,256 |
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(1,532 |
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(4,029 |
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Interest income |
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272 |
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79 |
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581 |
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245 |
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Other income (expense) |
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(14 |
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6 |
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61 |
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409 |
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Net loss |
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$ |
(5,766 |
) |
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$ |
(4,464 |
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$ |
(37,387 |
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$ |
(12,325 |
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Basic and diluted net loss per common share |
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$ |
(0.19 |
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$ |
(2.96 |
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$ |
(1.52 |
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$ |
(8.18 |
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Weighted average shares used to compute
basic and diluted net loss per share |
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30,833 |
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1,506 |
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24,665 |
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1,506 |
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The
accompanying notes are an integral part of these financial statements.
4
Micromet, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Nine months ended September 30, |
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2006 |
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2005 |
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Operating activities: |
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Net loss |
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$ |
(37,387 |
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$ |
(12,325 |
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Adjustments to reconcile net loss to net cash (used in) provided
by operating activities: |
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Depreciation and amortization |
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2,276 |
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2,431 |
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In-process research and development |
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20,890 |
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Non-cash interest on convertible notes payable |
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2,276 |
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Non-cash interest on long-term debt obligations |
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428 |
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457 |
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Net gain on debt restructuring |
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(315 |
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Stock-based compensation expense |
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5,050 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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133 |
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13,574 |
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Prepaid expenses and other current assets |
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(1,005 |
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673 |
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Accounts payable, accrued expenses and other liabilities |
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(7,955 |
) |
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(2,357 |
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Deferred revenue |
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(3,149 |
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(4,097 |
) |
Restricted cash |
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(70 |
) |
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(118 |
) |
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Net cash (used in) provided by operating activities |
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(21,104 |
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514 |
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Investing activities: |
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Proceeds from disposals of property and equipment |
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129 |
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Proceeds from loans to related parties |
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226 |
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Purchases of property and equipment |
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(517 |
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(52 |
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Cash acquired in connection with merger, net of costs |
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37,401 |
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Net cash provided by (used in) investing activities |
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37,239 |
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(52 |
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Financing activities: |
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Proceeds from capital contributions from stockholders |
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4,796 |
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Proceeds from issuance of common stock, net of costs |
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7,397 |
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Proceeds from exercise of stock options |
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84 |
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Proceeds from stock subscriptions receivable |
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346 |
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3 |
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Principal payments on long-term debt obligations |
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(19,599 |
) |
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(1,122 |
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Principal payments on capital lease obligations |
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(50 |
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(48 |
) |
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Net cash used in financing activities |
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(7,026 |
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(1,167 |
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Effect of exchange rate changes on cash and cash equivalents |
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768 |
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(1,703 |
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Net increase in cash and cash equivalents |
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9,877 |
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(2,408 |
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Cash and cash equivalents at beginning of period |
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11,414 |
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12,749 |
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Cash and cash equivalents at end of period |
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$ |
21,291 |
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$ |
10,341 |
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Supplemental disclosure of non-cash investing and financing activities: |
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Issuance of warrant in connection with committed equity financing facility |
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$ |
472 |
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$ |
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Issuance of warrant in connection with common stock issuance |
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$ |
1,446 |
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$ |
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Conversion of 2004 convertible notes |
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$ |
2,764 |
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$ |
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Acquisitions of equipment purchased through capital leases |
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$ |
66 |
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$ |
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The accompanying notes are an integral part of these financial statements.
5
Micromet, Inc.
Notes to Condensed Consolidated Financial Statements
1. Organization
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly-owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly-owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders an aggregate of 19,761,688
shares of CancerVax common stock and CancerVax assumed all of the stock options, stock warrants and
restricted stock of Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet
AG stockholders, option holders, warrant holders and note holders owned, as of the closing,
approximately 67.5% of the combined company on a fully-diluted basis and former CancerVax
stockholders, option holders and warrant holders owned, as of the closing, approximately 32.5% of
the combined company on a fully-diluted basis. CancerVax was renamed Micromet, Inc. and our
Nasdaq National Market ticker symbol was changed to MITI.
Subsequent to the completion of the merger, we are a biopharmaceutical company focusing on the
development of novel, proprietary antibody-based products for cancer, inflammatory and autoimmune
diseases. We operate in only one business segment, which primarily focuses on the discovery and
development of antibody-based drug candidates using proprietary technologies.
2. Basis of Presentation
As
former Micromet AG security holders 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 in accordance with accounting principles
generally accepted in the United States. Accordingly, unless otherwise noted, all pre-merger
financial information is that of Micromet AG and all post-merger financial information is that of
Micromet, Inc. and its wholly owned subsidiaries: Micromet AG; Micromet Holdings, Inc.; Tarcanta,
Inc.; Tarcanta Limited; and Cell-Matrix, Inc. Substantially all of the post-merger operating
activities are conducted through Micromet AG, a wholly-owned subsidiary of Micromet Holdings, Inc.
and an indirect wholly-owned subsidiary of Micromet, Inc.
Unless specifically noted otherwise, as used throughout these consolidated financial
statements, Micromet, we, us, 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 Corporation or CancerVax
refers to the business of CancerVax prior to the merger.
The condensed consolidated financial statements as of September 30, 2006, and for the three
and nine months ended September 30, 2006 and 2005 are unaudited. In the opinion of management,
these condensed consolidated financial statements include all adjustments, consisting of normal
recurring adjustments, necessary for a fair presentation of results for the interim periods
presented. We have condensed or omitted certain information and disclosures normally included in
financial statements presented in accordance with accounting principles generally accepted in the
United States. We believe the disclosures made are adequate to make the information presented not
misleading. However, you should read these condensed consolidated financial statements in
conjunction with the Micromet AG audited financial statements as of December 31, 2005 and 2004, and
each of the three years in the period ended December 31, 2005 included at pages F-26 through F-60
of our proxy statement/prospectus dated March 31, 2006, filed by CancerVax with the Securities and
Exchange Commission (the SEC) on April 3, 2006.
The accompanying unaudited condensed consolidated financial statements include the accounts of
our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in
consolidation.
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires us to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. On an ongoing basis, we evaluate our
estimates, including those related to revenue recognition, the valuation of goodwill, intangibles
and other long-lived assets and assumptions in the valuation of stock-based compensation. We base
our estimates on historical experience and on various other assumptions that we believe to be
reasonable under the circumstances. Actual results could differ from those estimates. Interim
results are not necessarily indicative of results for a full year or for any subsequent interim
period.
Unless otherwise indicated, the pre-merger financial information of Micromet AG has been
restated to reflect the closing of our merger and the related conversion of all Micromet AG capital
stock into Micromet Holdings common stock, the conversion of each share of Micromet Holdings common
stock into 15.74176 shares of Micromet, Inc. common stock, a 1-for-3 reverse stock split that
became effective upon the closing of the merger and a final par value of $0.00004 per common share.
6
The accompanying financial statements have been prepared assuming we will continue as a going
concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of
our liabilities in the normal course of business. As of September 30, 2006, we had an accumulated
deficit of $148.2 million, and expect to continue to incur substantial, and possibly increasing,
operating losses for the next several years. These conditions create substantial doubt about our
ability to continue as a going concern. We are continuing our efforts in research and development,
preclinical studies and clinical trials of our drug candidates. These efforts, and obtaining
requisite regulatory approval prior to commercialization, will require substantial expenditures.
Once requisite regulatory approval has been obtained, substantial additional financing will be
required to manufacture, market and distribute our products in order to achieve a level of revenues
adequate to support our cost structure. Management believes we have sufficient resources to fund
our required expenditures into the third quarter of 2007, without considering any potential future
milestone payments, which we may receive under current or future collaborations or the committed
equity financing facility, or CEFF, with Kingsbridge Capital Limited.
3. Summary of Significant Accounting Policies
Foreign Currency Translation
Each legal entity in our consolidated group that maintains monetary assets and liabilities in
foreign currencies initially translates such assets and liabilities into their functional currency
at the exchange rate in effect at the date of transaction. Monetary assets and liabilities
denominated in foreign currencies are translated into the functional currency at the exchange rate
in effect at the balance sheet date. Transaction gains and losses are recorded in the statement of
operations.
The accompanying consolidated financial statements are presented in U.S. dollars. The
translation of assets and liabilities to U.S. dollars is made at the exchange rate in effect at the
balance sheet date while equity accounts are translated at historical rates. The translation of
statement of operations data is made at the average rate in effect for the period. The translation
of operating cash flow data is made at the average rate in effect for the period and investing and
financing cash flow data is translated at the rate in effect at the date of the underlying
transaction. Translation gains and losses are recognized within accumulated other comprehensive
income (loss) in the accompanying balance sheets.
Cash and Cash Equivalents
Cash and cash equivalents on the balance sheets are comprised of cash at banks, money market
funds and short-term deposits with an original maturity of three months or less.
Restricted Cash
As of September 30, 2006 and December 31, 2005, the U.S. dollar equivalent of restricted cash
related to our building lease in Munich, Germany, is $0.7 million and $0.6 million, respectively,
and is disclosed as a non-current asset.
As a result of our merger with CancerVax we assumed three irrevocable standby letters of
credit in connection with three building leases. The letters of credit totaled $2.3 million at the
merger date and were secured by certificates of deposit for similar amounts that are disclosed as
restricted cash. During May 2006, we entered into a lease assignment agreement related to a
manufacturing facility lease that resulted in (i) the issuance of a $1.0 million standby letter of
credit, collateralized by a certificate of deposit in the same amount, to cover restoration costs
that we may be obligated for in the future and (ii) the release of the landlords security interest
in $650,000 of certificates of deposit in August 2006. In addition, during June 2006, we entered
into a lease termination agreement for a warehouse facility that resulted in the release of the
landlords security interest in $280,000 of certificates of deposit in August 2006.
As of September 30, 2006, we have a consolidated total of $3.0 million of certificates of
deposit that are disclosed as restricted cash in our non-current assets.
Accounts Receivable
Receivables are stated at their cost less an allowance for any uncollectible amounts. The
allowance for doubtful accounts is based on managements assessment of the collectibility of
specific customer accounts. If there is a deterioration of a customers credit worthiness or actual
defaults are higher than historical experience, managements estimates of the recoverability of
amounts due to us could be adversely affected. Based on
managements assessment, no allowances were recorded as of
September 30, 2006 and December 31, 2005.
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.
7
Goodwill
We have goodwill with a carrying value of $6.9 million at September 30, 2006, which resulted
from our merger with CancerVax in May 2006. In accordance with Statement of Financial Accounting
Standards (SFAS) No. 142, Goodwill and Other Intangible Assets, we do not amortize goodwill.
Instead, we review goodwill for impairment at least annually and more frequently if events or
changes in circumstances indicate a reduction in the fair value of the reporting unit to which the
goodwill has been assigned. Goodwill is determined to be impaired if the fair value of the
reporting unit to which the goodwill has been assigned is less than its carrying amount, including
the goodwill. We have selected October 1 as our annual goodwill impairment testing date.
Patents
We hold patents for single-chain antigen binding molecule technology, which we acquired from
Curis, Inc. in 2001. Patents are amortized over their estimated useful life of ten years using the
straight-line method. The patents are utilized in revenue-producing activities as well as in
research and development activities.
Impairment of Long-Lived and Identifiable Intangible Assets
In accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal
of Long-Lived Assets, we evaluate the carrying value of long-lived assets and identifiable
intangible assets for potential impairment whenever events or changes in circumstances indicate
that the carrying amount of such assets may not be recoverable. Recoverability is determined by
comparing projected undiscounted cash flows associated with such assets to the related carrying
value. An impairment loss would be recognized when the estimated undiscounted future cash flow is
less than the carrying amount of the asset. An impairment loss would be measured as the amount by
which the carrying value of the asset exceeds the fair value of the asset. No impairment charges
have been recognized for the three and nine months ended September 30, 2006 and 2005.
Revenue Recognition
Our revenues generally consist of licensing fees, milestone payments, royalties and fees for
research services earned from license agreements or from research and development collaboration
agreements. We recognize revenue upon satisfying the following four criteria: persuasive evidence
of an arrangement exists, delivery has occurred, the price is fixed or determinable, and
collectibility is reasonably assured.
We
recognize revenue on up-front payments over the expected life of the development and
collaboration agreement on a straight-line basis. Milestone payments are derived from the
achievement of predetermined goals under the collaboration agreements. For milestones that are
subject to contingencies, the related contingent revenue is not recognized until the milestone has
been reached and customer acceptance has been obtained as necessary. Fees for research and
development services performed under the agreements are generally stated at a yearly fixed fee per
research scientist. We recognize revenue as the services are performed. Amounts received in advance
of services performed are recorded as deferred revenue until earned.
We have received initial license fees
and annual renewal fees upfront each
year under license agreements. Revenue is recognized when the above noted criteria are satisfied
unless we have further obligations associated with the license granted.
We are entitled to receive royalty payments on the sale of products under license and
collaboration agreements. Royalties are based upon the volume of products sold and are recognized
as revenue upon notification of sales from the customer. Through September 30, 2006, we have not
received or recognized any royalty payments.
For arrangements that include multiple deliverables, we identify separate units of accounting based
on the consensus reached on Emerging Issues Task Force Issue (EITF) No. 00-21, Revenue
Arrangements with Multiple Deliverables. EITF No. 00-21 provides that revenue arrangements with
multiple deliverables should be divided into separate units of accounting if certain criteria are
met. The consideration for the arrangement is allocated to the separated units of accounting based
on their relative fair values. Applicable revenue recognition criteria are considered separately
for each unit of accounting. We recognize revenue on development and collaboration agreements, including upfront payments,
where they are considered combined units of accounting, over the expected life of the development
and collaboration agreement on a straight-line basis.
Research and Development
Research and development expenditures, including direct and allocated expenses, are charged to
operations as incurred.
Total Comprehensive Loss
For the three and nine months ended September 30, 2006 and 2005, comprehensive loss consists
of the following (in thousands):
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss |
|
$ |
(5,766 |
) |
|
$ |
(4,464 |
) |
|
$ |
(37,387 |
) |
|
$ |
(12,325 |
) |
Unrealized gain on investments, net |
|
|
|
|
|
|
|
|
|
|
38 |
|
|
|
|
|
Foreign currency translation adjustments |
|
|
124 |
|
|
|
114 |
|
|
|
(585 |
) |
|
|
4,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(5,642 |
) |
|
$ |
(4,350 |
) |
|
$ |
(37,934 |
) |
|
$ |
(7,871 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation
2000 and 2002 Stock Option Plans:
In December 2000, we adopted the 2000 Stock Option Plan (2000 Plan) and in November 2002, we
adopted the 2002 Stock Option Plan (2002 Plan). The 2000 and 2002 Plans provide for the granting
of incentive stock options to selected employees, executives of Micromet AG and its affiliates. The
2000 Plan authorized the grant of options to purchase up to 600,305 shares of our common stock and
the 2002 Plan authorized the grant of options to purchase up to 11,932 shares of our common stock.
Options granted under the 2000 and 2002 Plans were exercisable after two years and in general
vested ratably over a three-year period commencing with the grant date and expired no later than
eight years from the date of grant. During the second quarter of 2006, all outstanding options
under the 2000 and 2002 Plans were cancelled and were partially replaced with options granted under
the 2006 Equity Incentive Plan described below. The cancellation and partial replacement resulted
in compensation expense of $2.7 million being recorded in the second quarter of 2006 and is
included in the compensation expense for the nine months ended September 30, 2006. An aggregate of
612,237 options were available for grant under the 2000 and 2002
Plans as of September 30, 2006;
however, we do not intend to grant any options under those plans in the future.
2000 and 2003 Stock Option Plans Assumed in Merger:
In connection with the merger with CancerVax, we assumed CancerVaxs Third Amended and
Restated 2000 Stock Incentive Plan (2000 Stock Incentive Plan) and CancerVaxs 2003 Amended and
Restated Equity Incentive Award Plan (2003 Plan). The 2000 Stock Incentive Plan was effectively
terminated on June 10, 2004 by the approval of the 2003 Plan. Prior to its termination, the 2000
Stock Incentive Plan allowed for the grant of options and restricted stock to employees, outside
directors and consultants. Options granted under the 2000 Stock Incentive Plan generally expire no
later than ten years from date of grant and vest over a period of four years. Under the 2003 Plan,
stock options, stock appreciation rights, restricted or deferred stock awards and other awards may
be granted to employees, outside directors and consultants. Options issued under the 2003 Plan may
be issued to purchase a fixed number of shares of our common stock at prices not less than 100% of
the fair market value at the date of grant. Options generally become exercisable one-fourth
annually beginning one year after the grant date with monthly vesting thereafter and expire ten
years from the grant date. Some options allow for vesting in full upon the termination of the
recipients employment or service with us. The initial options granted to our non-employee
directors under the 2003 Plan during 2006 have a three-year vesting period. Options granted to the
chairpersons of our board committees have a one-year vesting period. At September 30, 2006,
options to purchase approximately 1,575,000 shares of our common stock were outstanding, and there
were approximately 2,111,000 additional shares remaining available for future grants, under these
plans.
2006 Stock Option Plan:
In April 2006, we adopted a 2006 Equity Incentive Award Plan (2006 Plan) that provides for
the granting of stock options to certain officers, directors, founders, employees and consultants
to acquire up to approximately 1,923,000 shares of our common stock. Of this amount, options to
purchase an aggregate of 1,761,880 shares of our common stock were issued upon the closing of the
merger with CancerVax to incentivize such individuals and were issued, in part, to replace the
options issued under the 2000 and 2002 Plans described above. For a given participant under the
2006 Plan, 50% of the options granted to such individual vested upon grant, with the remaining 50%
vesting ratably on a monthly basis over the 24 months following the date of grant. The exercise
price for such options was set at approximately 25% of the closing price of a share of CancerVax
common stock on the date immediately preceding the date of grant of the option (as adjusted for the
exchange ratio in the merger). As of September 30, 2006, there were approximately 161,000 shares
remaining available for future option grants under this plan.
Adoption of Statement of Financial Accounting Standards No. 123(R)
We adopted SFAS No. 123R as of January 1, 2006. As permitted by SFAS No. 123R, we utilized the
Black-Scholes option-pricing model (Black-Scholes model) as our method of valuation for
share-based awards granted. The Black-Scholes model was previously utilized for our expense
recorded under SFAS No. 123. We adopted SFAS No. 123R using the modified prospective transition
method. Based on the terms of our plans, we did not have a cumulative effect related to our plans.
The determination of the
fair value of our share-based payment awards on the date of grant using an option-pricing
model is affected by our stock price as well as assumptions regarding a number of highly complex
and subjective variables. These variables include, but are not limited to, our
9
expected stock price
volatility over the term of the awards, and actual and projected employee stock option exercise
behaviors. Option-pricing models were developed for use in estimating the value of traded options
that have no vesting or hedging restrictions and are fully transferable. Because our employee stock
options have certain characteristics that are significantly different from traded options, and
because changes in the subjective assumptions can materially affect the estimated value, in
managements opinion, the existing valuation models may not provide an accurate measure of the fair
value of our employee stock options. Although the fair value of employee stock options is
determined in accordance with SFAS No. 123R using an option-pricing model, that value may not be
indicative of the fair value observed in a willing buyer/willing seller market transaction.
The weighted-average estimated fair value of employee stock options granted during the three
and nine month periods ended September 30, 2006 was $2.66 and $3.39 per share, respectively, using
the Black-Scholes model with the following assumptions (annualized percentages):
|
|
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|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 30, 2006 |
|
September 30, 2006 |
|
|
|
Expected volatility 2006 and 2003 Plans |
|
|
78.8 |
% |
|
|
78.8%80.0 |
% |
Risk-free interest rate 2006 and 2003 Plans |
|
|
4.8 |
% |
|
|
4.8%5.0 |
% |
Dividend yield 2006 and 2003 Plans |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected term 2006 Plan (years) |
|
No grants |
|
|
5.2 |
|
Expected term 2003 Plan (years) |
|
|
6.1 |
|
|
|
5.86.1 |
|
There were no employee stock options granted during the three months and nine months ended
September 30, 2005.
Expected
volatility is based on our historical volatility and the historical volatilities of the common stock of comparable
publicly traded companies. The risk-free interest rate is based on the U.S. Treasury rates in
effect at the time of grant for periods within the expected term of the award. 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. The
expected term of at-the-money options granted is derived from the average midpoint between vesting
and the contractual term, as described in U. S. Securities and Exchange Commission (SEC) Staff
Accounting Bulletin (SAB) No. 107, Share-Based Payment. The expected term for other options
granted was determined by comparison to peer companies. As stock-based compensation expense
recognized in our consolidated statement of operations for the nine months ended September 30, 2006 is based on
awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS No. 123R
requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. The pre-vesting forfeiture rate for the
three months ended September 30, 2006, was based on historical forfeiture experience for similar
levels of employees to whom the options were granted.
During the second quarter of 2006, stock options were granted which in part replaced the stock
options that were outstanding as of December 31, 2005. Under the guidance of SFAS No. 123R, a
modification of an option award is treated as an exchange of the previously issued option award for
a new option award. Any incremental fair value in measuring the new award would be amortized along
with any remaining unamortized compensation for the original award over the new vesting period. The
original grant and the modification resulted in a total compensation cost of $4.9 million. For the
three and nine months ended September 30, 2006, share-based compensation expense related to these
stock options amounted to $0.3 million and $3.0 million, respectively. As of September 30, 2006,
there was $1.9 million of unamortized compensation cost related to these stock option awards, which
is expected to be recognized over a remaining average vesting period of 1.6 years.
In conjunction with the adoption of SFAS No. 123R, we continued our method of attributing the
value of stock-based compensation to expense using the straight-line single option method.
Compensation expense related to stock-based compensation is allocated to research and development
or general and administrative based upon the department to which the associated employee reports.
10
Reported share-based compensation is classified, in the condensed consolidated interim
financial statements, as follows (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, 2006 |
|
|
September 30, 2006 |
|
Research and development |
|
$ |
235 |
|
|
$ |
2,323 |
|
General and administrative |
|
|
801 |
|
|
|
1,728 |
|
|
|
|
|
|
|
|
Employee stock-based compensation expense |
|
$ |
1,036 |
|
|
$ |
4,051 |
|
|
|
|
|
|
|
|
Employee stock-based compensation expense, per common share, basic and diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
For the three and nine months ended September 30, 2005 there was no share-based compensation
expense recorded.
Prior to adopting the provisions of SFAS No. 123R, we recorded estimated compensation expense
for employee stock-based compensation under the provisions of SFAS No. 123, Accounting for
Stock-Based Compensation (SFAS No. 123). Under the guidance of SFAS No. 123, we estimated the
value of stock options issued to employees using the Black-Scholes options pricing model with a
near-zero volatility assumption (a minimum value model). The value was determined based on the
stock price of our stock on the date of grant and was recognized as expense over the vesting period
using the straight-line method. Prior to January 1, 2006 there was no significant stock-based
compensation expense recorded.
Options or stock awards issued to non-employees were recorded at their fair value in
accordance with SFAS No. 123 and EITF Issue No. 96-18, Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring or in Conjunction with Selling Goods or Services, and
expense is recognized upon measurement date commensurate with the determination of when service has
been completed. For the three and nine months ended September 30, 2006, stock-based compensation
related to stock options issued to non-employees was approximately $0 and $1.0 million,
respectively. There was no stock-based compensation related to the vesting of non-employee stock
options for the three and nine months ended September 30, 2005.
Stock Option Activity
The following is a summary of stock option activity under the 2003 and 2006 Plans for the nine
months ended September 30, 2006 (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of Options |
|
Exercise Price |
Outstanding at January 1, 2006 |
|
|
3,029 |
|
|
$ |
8.49-67.93 |
Granted |
|
|
2,342 |
|
|
$ |
2.65 |
|
Exercised |
|
|
(18 |
) |
|
$ |
4.40 |
|
Assumed in merger |
|
|
1,384 |
|
|
$ |
13.13 |
|
Cancelled |
|
|
(3,400 |
) |
|
$ |
3.23-67.93 |
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2006 |
|
|
3,337 |
|
|
$ |
5.32 |
|
|
|
|
|
|
|
|
|
|
Included
in the shares granted for the nine month period ended
September 30, 2006 were approximately 1,762,000 shares granted
under the 2006 Plan with an exercise price below fair market value at a weighted average
exercise price of $1.66 per share.
11
The following is a further breakdown of the options outstanding as of September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
Weighted |
|
|
|
|
|
Weighted |
|
|
Number |
|
Contractual |
|
Average |
|
Number |
|
Average |
Range of |
|
Outstanding |
|
Life |
|
Exercise |
|
Exercisable |
|
Exercise |
Exercise Prices |
|
(thousands) |
|
(years) |
|
Price |
|
(thousands) |
|
Price |
$1.66 $1.66 |
|
|
1,762 |
|
|
|
9.59 |
|
|
$ |
1.66 |
|
|
|
1,064 |
|
|
$ |
1.66 |
|
$3.23 3.88 |
|
|
392 |
|
|
|
8.29 |
|
|
$ |
3.59 |
|
|
|
107 |
|
|
$ |
3.23 |
|
$4.44 $4.44 |
|
|
224 |
|
|
|
9.09 |
|
|
$ |
4.44 |
|
|
|
219 |
|
|
$ |
4.44 |
|
$6.47 $6.63 |
|
|
295 |
|
|
|
9.65 |
|
|
$ |
6.63 |
|
|
|
1 |
|
|
$ |
6.47 |
|
$8.46 $9.90 |
|
|
459 |
|
|
|
7.82 |
|
|
$ |
9.18 |
|
|
|
432 |
|
|
$ |
9.21 |
|
$19.71 $28.95 |
|
|
92 |
|
|
|
8.15 |
|
|
$ |
23.94 |
|
|
|
88 |
|
|
$ |
24.04 |
|
$31.05 $38.61 |
|
|
113 |
|
|
|
7.43 |
|
|
$ |
36.05 |
|
|
|
111 |
|
|
$ |
36.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1.66 $38.61 |
|
|
3,337 |
|
|
|
9.05 |
|
|
$ |
5.32 |
|
|
|
2,022 |
|
|
$ |
6.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended September 30, 2006, share-based compensation expense related to
stock options granted to employees was $4.1 million. As of September 30, 2006, there was $4.0
million of unamortized compensation cost related to unvested stock option awards, which is expected
to be recognized over a remaining weighted-average vesting period of 2.0 years. The aggregate
intrinsic value of options exercised during the period ended September 30, 2006, outstanding at
September 30, 2006 and exercisable at September 30, 2006 was approximately $0, $1.8 million and
$1.1 million, respectively.
Employee Stock Purchase Plan
As of September 30, 2006, there are no participants in the Employee Stock Purchase Plan. At
September 30, 2006, approximately 84,000 shares were available for future purchase under this plan.
Net Loss Per Share
We calculate net loss per share in accordance with SFAS No. 128, Earnings Per Share. Basic net
loss per share is calculated by dividing the net loss by the weighted average number of common
shares outstanding for the period, without consideration for common stock equivalents. Diluted net
loss per share is computed by dividing the net loss by the weighted average number of common stock
equivalents outstanding for the period determined using the treasury-stock method. For purposes of
this calculation, convertible preferred stock, stock options, and warrants are considered to be
common stock equivalents and are only included in the calculation of diluted net loss per share
when their effect is dilutive. The outstanding anti-dilutive securities excluded from the diluted
net loss computation consisted of common stock options and warrants in the amount of 3,337,000 and
924,408, respectively, as of September 30, 2006 and 3,029,000 common stock options as of September
30, 2005.
Reclassifications
Certain amounts in the previous period financial statements have been reclassified to conform
to the current period presentation.
Recent Accounting Pronouncements
In July 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation 48,
Accounting for Uncertain Tax Positions, (FIN 48) to clarify the criteria for recognizing tax
benefits under SFAS No. 109, Accounting for Income Taxes, and to require additional financial
statement disclosure. FIN 48 requires that we recognize, in our consolidated financial statements,
the impact of a tax position if that position is more likely than not to be sustained on audit,
based on the technical merits of the position. We currently recognize the impact of a tax position
if it is probable of being sustained. The provisions of FIN 48 are effective for us beginning
January 1, 2007, with the cumulative effect of the change in accounting principle recorded as an
adjustment to opening retained earnings. We are currently evaluating the impact of the adoption of
FIN 48 on our financial statements.
In September 2006, the SEC released SAB No. 108, Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial Statements. SAB 108 provides
interpretive guidance on the SECs views regarding the process of quantifying the materiality of
financial statement misstatements. SAB 108 is effective for fiscal years ending after
12
November 15, 2006, with early application for the first interim period ending after November 15,
2006. We do not believe that the application of SAB 108 will have a material effect on our results
of operations or financial position.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. SFAS No. 157 defines fair
value, establishes a framework and gives guidance regarding the methods used for measuring fair
value, and expands disclosures about fair value measurements. SFAS 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and interim periods within
those fiscal years. We are currently assessing the impact that SFAS 157 will have on our results of
operations and financial position.
4. Merger
On May 5, 2006, we completed our merger with CancerVax, a biotechnology company focused on the
research, development and commercialization of novel biological products for the treatment and
control of cancer. The acquisition of unrestricted cash, a Nasdaq listing, and selected ongoing
product development programs were the primary reasons for the merger. The primary driver in the
recognition of goodwill was the acquisition of selected ongoing product development programs.
Because former Micromet AG security holders owned approximately 67.5% of the voting stock of the
combined company 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 for business combinations in accordance
with accounting principles generally accepted in the United States. Accordingly, CancerVaxs assets
and liabilities are recorded as of the merger closing date at their estimated fair values.
The fair value of the 9,380,457 outstanding shares of CancerVax common stock used in
determining the purchase price was $41.0 million, or $4.38 per share, based on the average of the
closing prices for a range of trading days (January 5, 2006 through January 11, 2006, inclusive)
around and including the announcement date of the merger transaction. The fair value of the
CancerVax stock options and stock warrants assumed by Micromet was determined using the
Black-Scholes option-pricing model with the following assumptions: stock price of $4.38, which is
the value ascribed to the CancerVax common stock in determining the purchase price; volatility of
75%; dividend rate of 0%; risk-free interest rate of 4.0%; and a weighted average expected option
life of 0.88 years.
The purchase price is summarized as follows (in thousands):
|
|
|
|
|
Fair value of CancerVax common stock |
|
$ |
41,030 |
|
Estimated fair value of CancerVax stock options and stock warrants assumed |
|
|
710 |
|
Estimated transaction costs incurred by Micromet |
|
|
2,257 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
|
|
|
|
Under the purchase method of accounting, the total purchase price is allocated to the acquired
tangible and intangible assets and assumed liabilities of CancerVax based on their estimated fair
values as of the merger closing date. The excess of the purchase price over the fair value of
assets acquired and liabilities assumed is allocated to goodwill.
The preliminary allocation of the total purchase price, as shown above, to the acquired
tangible and intangible assets and assumed liabilities of CancerVax based on their fair values as
of the merger date are as follows (in thousands):
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,645 |
|
Receivables under collaborations |
|
|
447 |
|
Restricted cash |
|
|
2,280 |
|
Other assets |
|
|
569 |
|
Accounts payable |
|
|
(2,639 |
) |
Accrued expenses |
|
|
(5,764 |
) |
Current portion of long-term debt obligations |
|
|
(16,816 |
) |
Long-term liabilities |
|
|
(1,532 |
) |
|
|
|
|
Net book value of acquired assets and liabilities |
|
|
16,190 |
|
In-process research and development |
|
|
20,890 |
|
Goodwill |
|
|
6,917 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
|
|
|
|
The acquired in-process research and development (IPR&D) projects consist of the following:
D93 and other denatured
13
collagen related anti-angiogenesis programs that potentially target various solid tumors;
SAI-EGF and related programs that target the epidermal growth factor receptor, or EGFR, signaling
pathway that potentially target non-small cell lung cancer and various solid tumors; GD2, a
humanized, monoclonal antibody that appears to target tumor-associated antigens that are expressed
in a variety of solid tumor cancers; and certain other non-denatured collagen related humanized,
monoclonal antibodies and peptides that potentially target various solid tumors.
The fair value of the IPR&D projects was determined utilizing the income approach, assuming
that the rights to the IPR&D projects will be sub-licensed to third parties in exchange for certain
up-front, milestone and royalty payments, and the combined company will have no further involvement
in the ongoing development and commercialization of the projects. Under the income approach, the
expected future net cash flows from sub-licensing for each IPR&D project are estimated,
risk-adjusted to reflect the risks inherent in the development process and discounted to their net
present value. Significant factors considered in the calculation of the discount rate are the
weighted-average cost of capital and return on assets. Management believes that the discount rate
utilized is consistent with the projects stage of development and the uncertainties in the
estimates described above. Because the acquired IPR&D projects are in the early stages of the
development cycle, the amount allocated to IPR&D was recorded as an expense immediately upon
completion of the merger.
We expect to finalize our purchase price allocation by May 2007.
Pro Forma Results of Operations
The
results of operations of CancerVax are included in Micromet, Inc.s condensed consolidated
financial statements from the closing date of the merger on May 5, 2006. The following table
presents pro forma results of operations and gives effect to the merger transaction as if the
merger had been consummated at the beginning of the period presented. The unaudited pro forma results of
operations are not necessarily indicative of what would have occurred had the business combination
been completed at the beginning of the period or of the results that may occur in the future.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Revenues |
|
$ |
4,636 |
|
|
$ |
31,541 |
|
|
$ |
14,228 |
|
|
$ |
55,932 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,766 |
) |
|
$ |
(14,768 |
) |
|
$ |
(48,794 |
) |
|
$ |
(38,236 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.19 |
) |
|
$ |
(1.36 |
) |
|
$ |
(1.68 |
) |
|
$ |
(3.51 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The pro forma results for the nine months ended September 30, 2006 include $20.9 million of
nonrecurring charges for the write-off of in-process research and development.
5. Convertible Notes Payable
Convertible notes payable consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
MedImmune, Inc. convertible promissory note, due June 6, 2010 |
|
$ |
1,941 |
|
|
$ |
11,844 |
|
2004 convertible promissory notes, including accrued interest of
$572,000 at December 31, 2005 |
|
|
|
|
|
|
2,761 |
|
|
|
|
|
|
|
|
Total convertible notes payable |
|
|
1,941 |
|
|
|
14,605 |
|
Less: current portion |
|
|
|
|
|
|
(2,761 |
) |
|
|
|
|
|
|
|
Convertible notes payable, net of current portion |
|
$ |
1,941 |
|
|
$ |
11,844 |
|
|
|
|
|
|
|
|
MedImmune, Inc.
In
May 2006, approximately
8.5 million, or
$10.7 million, of the convertible note issued to MedImmune was
converted into an aggregate of 1,660,483 shares of our common stock.
2004 Convertible Notes
In January 2006, we issued 98,145 shares of our common stock in satisfaction of both the stock
subscription from conversion and the conversion notices received from the remaining note holders
that had not converted as of December 31, 2005. See Note 9.
6. Other Non-Current Liabilities
Included in the September 30, 2006 other non-current liabilities balance of $2.0 million is a
lease exit liability for the Munich
14
facility as a consequence of the restructuring of operations during 2004. Activity of the
restructuring provision in 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued |
|
|
|
|
|
|
|
|
|
|
|
Balance as of |
|
Amounts |
|
|
|
|
|
Currency |
|
Accrued |
|
December 31, |
|
Paid in |
|
Accretion |
|
Translation |
|
Balance as of |
|
2005 |
|
Period |
|
Expense |
|
Adjustment |
|
September 30, 2006 |
|
$599,000 |
|
$ |
(237,000 |
) |
|
$ |
66,000 |
|
|
$ |
37,000 |
|
|
$ |
465,000 |
|
Of the $465,000 lease exit liability as of September 30, 2006, $49,000 is current and $416,000
is non-current.
7. Long-Term Debt
Long-term debt obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Technologie-Fonds Bayern borrowings due December 31, 2008; interest payable
quarterly at 6.00% |
|
$ |
3,200 |
|
|
$ |
2,831 |
|
Bayern Kapital borrowings due December 31, 2006; interest payable quarterly at 6.75% |
|
|
2,001 |
|
|
|
1,761 |
|
tbg borrowings due December 31, 2008; interest payable semi-annually at rates
ranging from 6.00% to 7.00% |
|
|
1,943 |
|
|
|
2,700 |
|
tbg borrowings due December 31, 2006; interest payable semi-annually at 6.00% |
|
|
|
|
|
|
1,593 |
|
GEDO borrowings due December 31, 2006; interest payable monthly at 7.50% |
|
|
27 |
|
|
|
175 |
|
ETV borrowings due 36 months after drawdown; interest payable monthly at rates
ranging from 11.55% to 12.81% |
|
|
|
|
|
|
109 |
|
|
|
|
|
|
|
|
Total long-term debt obligations |
|
|
7,171 |
|
|
|
9,169 |
|
Less: current portion |
|
|
(2,081 |
) |
|
|
(3,638 |
) |
|
|
|
|
|
|
|
Long-term debt obligations, net of current portion |
|
$ |
5,090 |
|
|
$ |
5,531 |
|
|
|
|
|
|
|
|
Scheduled repayment of principal for the debt agreements is as follows as of September 30,
2006 (in thousands):
|
|
|
|
2006 (October 1, 2006 December 31, 2006) |
|
$ |
2,081 |
2007 |
|
|
|
2008 |
|
|
5,090 |
|
|
|
Total |
|
$ |
7,171 |
|
|
|
Loan and Security Agreement
As a result of the merger with CancerVax, we assumed an $18 million loan and security
agreement entered into by CancerVax in December 2004 with Silicon Valley Bank. We repaid the loan
and terminated the agreement during the third quarter of 2006 and have no remaining credit
available or obligations under the agreement.
Amendment to the Silent Partnership Agreements
In May 2006, upon consummation of our merger with CancerVax, and subsequent to a January 2006
amendment of four of the six silent partnership agreements with Technologie-Beteiligungs-Gesellschaft mbH
(tbg), we repaid 2.0 million,
or $2.5 million, in satisfaction of debt obligations to tbg aggregating
2.3 million, or $2.8 million. This payment
satisfied in full: (i) our obligation to pay $1.7 million
that was originally due December 31, 2006, the value of which had been recorded at $1.6 million,
including accrued interest, as of December 31, 2005, plus $0.1 million of interest that accrued after
December 31, 2005; and (ii) our obligation to pay $1.1 million to tbg that was originally due December 31, 2008.
As a result, we recorded a gain on extinguishment of debt of 251,000, or $315,000. As of
September 30, 2006, borrowings due to tbg on December 31, 2008 consist of $1.3 million in principal
amount and $0.6 million of accrued interest.
In January 2006, the silent partnership agreements with Bayern Kapital GmbH and Technologie
Beteiligungsfonds Bayern GmbH & Co. KG were amended to accelerate repayment of amounts due
(principal, accrued interest, and one-time payments) upon the occurrence of future rounds of
financing after the consummation of the merger with CancerVax, whereby 20% of the net
proceeds of such future rounds of financing be used for repayment of
silent partnership debts until such silent partnership debts are
repaid in full. As a result of these amendments, silent partnership
debt in principal amount equal to 20% of the net
proceeds from the private placement equity transaction with NGN
Capital, LLC (See Note 9), or $1.5 million, was accelerated as of July
24, 2006, although this amount has not yet been paid. Additionally, 20% of any draw downs under the
CEFF and any future financings will be used for repayment of accelerated silent
15
partnership debt. As of September 30, 2006, the total amount subject to accelerated repayment,
including the $1.5 million accelerated in July 2006, is $5.2 million.
8. Commitments
Leases
In May 2006, we repaid $623,000 of deferred rental payments to GEK, the lessor of our Munich
facility that became due upon the consummation of our merger with CancerVax.
Future minimum lease payments under non-cancelable operating and capital leases as of
September 30, 2006 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Capital |
|
|
Operating |
|
|
|
Leases |
|
|
Leases |
|
2006 (October 1, 2006 December 31, 2006) |
|
$ |
19 |
|
|
$ |
721 |
|
2007 |
|
|
73 |
|
|
|
2,874 |
|
2008 |
|
|
50 |
|
|
|
2,857 |
|
2009 |
|
|
7 |
|
|
|
2,687 |
|
2010 |
|
|
|
|
|
|
2,688 |
|
Thereafter |
|
|
|
|
|
|
4,310 |
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
|
149 |
|
|
$ |
16,137 |
|
|
|
|
|
|
|
|
|
Less: amount representing imputed interest |
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease payments |
|
|
141 |
|
|
|
|
|
Less: current portion |
|
|
68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligation, less current portion |
|
$ |
73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The current and long-term portions of capital leases are included on the balance sheet in
other current liabilities and other non-current liabilities, respectively.
License and Research and Development Agreements
Upon the closing of our merger with CancerVax we became party to several license and research
and development agreements as discussed in Note 10.
Annual future minimum payments under our license and research and development agreements,
including those assumed from CancerVax, are as follows at September 30, 2006 (in thousands):
|
|
|
|
|
2006 (October 1, 2006 December 31, 2006) |
|
$ |
1,425 |
|
2007 |
|
|
455 |
|
2008 |
|
|
155 |
|
2009 |
|
|
55 |
|
2010 |
|
|
55 |
|
Thereafter |
|
|
330 |
|
|
|
|
|
|
|
$ |
2,475 |
|
|
|
|
|
9. Stockholders Equity (Deficit)
Committed Equity Financing Facility
In August 2006, we entered into a Committed Equity Financing Facility (CEFF), with Kingsbridge
Capital Limited (Kingsbridge), which entitles us to sell
and obligates Kingsbridge to purchase,
from time to time over a period of three years, up to 6,251,193 shares
of our common stock for cash consideration of up to $25.0 million, subject to certain conditions and
restrictions. In connection with the CEFF, we entered into a common stock purchase agreement and
registration rights agreement, and we also issued a warrant to Kingsbridge to purchase 285,000
shares of our common stock at a price of $3.2145 per share. The warrant is exercisable
beginning six months after the date of grant, which was August 30,
2006, and for a period of five years thereafter.
The warrant was valued on the date of grant using the Black-Scholes method using the following
assumptions: a risk-free interest rate of 4.8%, a volatility factor of 79%, a life of 5.5 years and
a dividend yield of zero. The estimated value of the warrant at the
date of grant was approximately $0.5 million.
16
On September 12, 2006, we filed a resale shelf registration statement on Form S-3 with the SEC
to facilitate Kingsbridges public resale of shares of our common stock, which it may acquire from
us from time to time in connection with our draw downs under the CEFF or upon the exercise of the
warrant. The resale shelf registration statement was declared effective on September 28, 2006. In
the event that an effective registration statement is not available for the resale of securities
purchased by Kingsbridge, we may be required to pay liquidated damages. In connection with the
CEFF, we incurred legal fees and other financing costs of approximately $61,000. As of September
30, 2006, we have not sold any shares to Kingsbridge under the CEFF.
Private Placements
On July 24, 2006, we closed a private placement pursuant to which we issued an aggregate of
2,222,222 shares of common stock and warrants to purchase an additional 555,556 shares of common
stock to funds managed by NGN Capital, LLC in return for aggregate gross proceeds, before expenses,
of $8.0 million. We incurred investment banking fees, legal fees and other financing costs of
approximately $0.6 million, resulting in net proceeds of approximately $7.4 million. The warrants
are exercisable beginning six months after issuance through the six year anniversary of the date of
issuance and have an exercise price of $5.00 per share. The warrants were valued on the date of
grant using the Black-Scholes method using the following assumptions: a risk-free interest rate of
4.8%, a volatility factor of 79%, a life of 6 years and a dividend yield of zero. The estimated
value of the warrants was approximately $1.4 million.
In October 2005, the Micromet AG stockholders resolved to invest up to 8.0 million in
Micromet AG. On October 11, 2005, Micromet AG received proceeds of 4.0 million, or $4.8
million, in return for the issuance of 16,408,660 shares of its common stock to existing
stockholders at approximately 0.24, or $0.29, per share as a first tranche of that financing.
In March and April 2006, we received an aggregate of 4.0 million, or $4.8 million, from these stockholders as a second tranche of that
financing.
MedImmune, Inc.
On May 4, 2006, convertible notes in the aggregate nominal amount of $10.7 million were
converted into an aggregate of 1,660,483 shares of our common stock.
Enzon, Inc. Convertible Promissory Note
As of December 31, 2005 the carrying amount of the Enzon convertible note was included in
stock subscription from conversion in stockholders equity due to the irrevocable notice received
from Enzon and our irrevocable obligation to issue shares to Enzon in accordance with the terms of
the amended convertible note agreement. On January 3, 2006, we issued 88,343 shares of our common
stock and classified the carrying amount of the note as common stock and additional paid-in capital
in the amount of $11.0 million.
2004 Convertible Notes
As of December 31, 2005, 10.2 million, or $12.1 million, including accrued interest, was
included in stock subscription from conversion in stockholders equity due to the irrevocable
notice received from certain note holders in December 2005 and our irrevocable obligation to issue
shares to these note holders in accordance with the terms of the note agreements. As of December
31, 2005, 2.3 million, or $2.8 million, including accrued interest, remained in current
liabilities related to the 2004 convertible notes, as the notice from certain note holders was not
received until subsequent to December 31, 2005. In January 2006, we issued 98,145 shares of our
common stock in satisfaction of both the stock subscription from conversion and the conversion
notices received from the remaining note holders that had not converted as of December 31, 2005. We
classified the aggregate carrying amount of the note and the stock subscription from conversion as
common stock and additional paid-in capital in the amount of 12.5 million, or $14.8 million.
Stock Warrants Assumed in Merger
As a result of our merger with CancerVax we assumed outstanding, fully-exercisable stock
warrants that, upon cash exercise, would result in the issuance of approximately 29,000 shares of
our common stock. The exercise prices of the warrants range from $32.34 to $35.25 per share and the
warrants will expire between November 2006 and June 2013. The warrant holders have the option to
exercise the warrants in one of the following ways: (i) cash
payment; (ii) cancellation of our indebtedness, if any, to the holder;
or (iii) net issuance exercise based on the fair market value of our common stock on the date of
exercise.
10. License Agreements
CIMAB, S.A. and YM BioSciences, Inc.
As a result of our merger with CancerVax we assumed a license agreement with CIMAB, S.A., a
Cuban corporation, and YM BioSciences, Inc., a Canadian corporation, whereby we obtained the
exclusive rights to develop and commercialize in a specific territory, which includes the U.S.,
Canada, Japan, Australia, New Zealand, Mexico and certain countries in Europe, three specific
active immunotherapeutic product candidates that target the epidermal growth factor receptor, or
EGFR, signaling pathway for the treatment of cancer. Of CancerVaxs original obligation to pay
CIMAB and YM BioSciences technology access and transfer fees
17
totaling $5.7 million, we assumed the remaining $1.7 million of such obligation, which is
required to be paid through July 2007.
Pursuant
to letter agreements executed on October 24, 2006 and November 3,
2006, our wholly-owned subsidiaries Tarcanta, Inc. and Tarcanta, Ltd.
and CIMAB and YM Biosciences have amended certain terms of our license
agreements with CIMAB and YM Biosciences. We have agreed to postpone the payment of a $1 million
milestone payment that became due in the first quarter of 2006 upon completion of certain
technology transfer activities until the earlier of (1) the closing
of a transaction in which a new partner obtains the rights to
develop and commercialize the products pursuant to the EGF Agreement,
and (2) June 12, 2007. The payment will include interest of 1% per
month from June 13, 2006.
Further, we have agreed that these letter agreements will terminate on December 31, 2006, if we have not found a sublicensee or otherwise transferred
the agreements to a new partner or if there are no active sublicensing discussions at that time.
Other Licensing and Research and Development Agreements
As a result of our merger with CancerVax we also assumed licensing and research and
development agreements with various universities, research organizations and other third parties
under which we have received licenses to certain intellectual property, scientific know-how and
technology. In consideration for the licenses received, we are required to pay license and research
support fees, milestone payments upon the achievement of certain success-based objectives and/or
royalties on future sales of commercialized products, if any. We may also be required to pay
minimum annual royalties and the costs associated with the prosecution and maintenance of the
patents covering the licensed technology. If all of our product candidates currently being pursued
under these agreements were successfully developed and commercialized, the aggregate amount of
milestone payments we would be required to pay is approximately $63.0 million over the term of the
related agreements as well as royalties on net sales of each commercialized product.
11. Subsequent Events
Litigation Concerning Curis, Inc.
On
October 2, 2006, a court-proposed settlement agreement with Curis, Inc. became effective
that resolves a lawsuit initiated by Curis against Micromet AG in a German court regarding the
repayment of an outstanding promissory note in the remaining principal amount of 2.0 million.
Curis had requested immediate repayment of the remaining 2.0 million at the time of the closing
of the merger between CancerVax and Micromet AG in May 2006. We had disagreed with Curiss
interpretation of the repayment terms of the promissory note. In accordance with the settlement, we
paid Curis 1.0 million, or approximately $1.3 million, in October 2006, and will pay 1.0
million on or before May 31, 2007. The second payment will be reduced to 0.8 million if payment
is made on or before April 30, 2007. The payments will be made by us without any interest charges.
Both Micromet and Curis will each bear their own costs incurred in connection with the litigation.
Compensation Arrangement with David F. Hale
On October 2, 2006, we entered into an agreement with David F. Hale, the chairman of our board
of directors, to reimburse Mr. Hale for 50% of the current annual salary of his executive
assistant, or $38,000 per year. This agreement has retroactive effect to May 2006, and will,
subject to annual review by the compensation committee of our board of directors, continue in
effect during such time as Mr. Hale continues to serve as our chairman. Mr. Hales executive
assistant is not employed by us, and we are not responsible for the payment of any employee
benefits to Mr. Hales executive assistant or for the withholding of any payroll or other taxes on
the reimbursements paid to Mr. Hale.
18
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements, which involve risks and
uncertainties. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including those set forth in Part II
Item 1A, below, under the caption Risk Factors.
The interim financial statements and this Managements Discussion and Analysis of Financial
Condition and Results of Operations should be read in conjunction with the financial statements of
Micromet AG and the notes thereto for the year ended December 31, 2005, and the related
Managements Discussion and Analysis of Financial Condition and Results of Operations relating to
Micromet AG, both of which are contained in our S-4 proxy statement/prospectus dated March 31,
2006, filed with the Securities and Exchange Commission on April 3, 2006 and in conjunction with
CancerVaxs financial statements and notes thereto for the year ended December 31, 2005, and the
related Managements Discussion and Analysis of Financial Condition and Results of Operations, both
of which are contained in CancerVaxs Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 16, 2006.
For periods prior to May 4, 2006, the results of operations and cash flows presented in the
interim financial statements contained herein reflect Micromet AG only. For periods from May 5, 2006 (the
date of the closing of the merger) through September 30, 2006, 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 entire period presented.
Overview
The formation of Micromet, Inc. through the merger of CancerVax Corporation and Micromet AG
created a biopharmaceutical company focusing on the development of novel, proprietary
antibody-based products for cancer, inflammatory and autoimmune diseases.
Merger of CancerVax Corporation and Micromet AG
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly-owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly-owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders shares of CancerVax common
stock and CancerVax assumed all of the stock options, stock warrants and restricted stock of
Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet AG stockholders,
option holders, warrant holders and note holders owned, as of the closing, approximately 67.5% of
the combined company on a fully-diluted basis and former CancerVax stockholders, option holders and
warrant holders owned, as of the closing, approximately 32.5% of the combined company on a
fully-diluted basis. In connection with the merger, CancerVax was renamed Micromet, Inc. and our
Nasdaq National Market ticker symbol was changed to MITI.
Unless specifically noted otherwise, as used throughout this report:
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CancerVax Corporation or CancerVax refers to
the business, operations and financial results of
CancerVax Corporation prior to the closing of the
merger between CancerVax Corporation and Micromet
AG on May 5, 2006, at which time CancerVaxs name
was changed to Micromet, Inc.; |
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Micromet AG refers to the business, operations
and financial results of Micromet AG, a
privately-held German company, prior to the closing
of the merger and after the merger, as the context
requires; and |
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Micromet, we, our, or us refers to the
operations and financial results of Micromet, Inc.
and Micromet AG on a consolidated basis after the
closing of the merger, and Micromet AG prior to the
closing of the merger, as the context requires. |
Ongoing Business Activities
We are a biopharmaceutical company focusing on the development of novel, proprietary
antibody-based products for cancer, inflammatory and autoimmune diseases.
Our product pipeline consists of two clinical product candidates, adecatumumab (MT201) developed in
collaboration with Serono, and MT103 developed in collaboration with MedImmune, and five preclinical
product candidates, MT110, MT203, MT204, as well as a BiTEÒ molecule binding to EphA2 and a
BiTEÒ molecule binding
to CEA developed in collaboration with MedImmune. In addition, we
hold licenses or own the rights to clinical candidate (SAI-EGF) and
preclinical product candidates (SAI-TGF, SAI-EGFR and D93) which we plan to out-license. To date, we have incurred significant expenses and have not achieved
any product revenues from sales of our product candidates.
We began our clinical program for our lead product candidate adecatumumab with a Phase 1
clinical trial in patients with hormone-
19
refractory prostate cancer in September 2001 in Germany.
Phase 2 clinical trials were started in February 2004 in patients with prostate cancer and in March
2004 in patients with metastatic breast cancer. Adecatumumab (MT201) was evaluated as a monotherapy
in these two clinical trials testing the impact of dose and target expression level on the activity
of the drug candidate. We announced the final results of the two trials in the third quarter of
2006. The Phase 2 clinical trial of adecatumumab in patients with metastatic breast cancer did not
meet its primary clinical endpoint (clinical benefit rate at week 24). However, based on the data
that we have reviewed, we believe that the results of the trial are encouraging nevertheless as
they appear to indicate clinical activity of adecatumumab, particularly in patients with high EpCAM
expression. Moreover, based upon our current assessment, the safety profile observed does not
appear to raise any significant concerns regarding the further development of adecatumumab in this
indication. We and our collaborator Serono are in the process of developing the plans for future
clinical development activities with respect to the treatment of breast cancer. The Phase 2
clinical trial of adecatumumab in patients with prostate cancer did not reach its primary endpoint
(mean change in prostate specific antigen, compared to placebo control). However, based on
sub-analyses performed at the recommendation of clinical experts, a measurable level of biological
activity was observed in patients with high EpCAM expression receiving a high dose of adecatumumab.
Nevertheless, based on a number of factors, including the cost and length of the clinical development path, we
and our partner Serono have decided to put the development of adecatumumab in prostate cancer on
hold at this time. Instead, we are evaluating other cancer indications in which adecatumumab could
be developed. A Phase 1b trial investigating the safety and tolerability of MT201 in combination
with docetaxel is currently ongoing.
A second clinical program, MT103, a BiTEÒ compound, is currently in a Phase 1 dose
escalation clinical trial in patients with indolent non-Hodgkins Lymphoma.
In addition, we have product candidates in pre-clinical development including therapeutic
human antibodies and BiTEÒ molecules that may be used to treat patients with inflammatory
diseases and cancer.
We believe that our novel technologies, product candidates and clinical development experience
in these fields will continue to enable us to identify and develop promising new product candidates
in these important markets.
Each of our programs will require many years and significant costs to advance through
development. Typically it takes many years from the initial identification of a lead compound to
the completion of pre-clinical and clinical trials, before applying for possible marketing approval
from the FDA, the European Medicines Agency (the EMEA) or other equivalent international
regulatory agencies. The risk that a program has to be terminated, in part or in full, for safety
reasons, or lack of adequate efficacy is very high. In particular, we
can neither predict which, if any, potential product candidates can be successfully developed and for which marketing
approval may be obtained, nor predict the time and cost to complete development.
As we obtain results from pre-clinical studies or clinical trials, we may elect to discontinue
clinical trials for certain product candidates for safety and/or efficacy reasons. We may also
elect to discontinue development of one or more product candidates in order to focus our resources
on more promising product candidates. Our business strategy includes entering into collaborative
agreements with third parties for the development and commercialization of our product candidates.
Depending on the structure of such collaborative agreements, a third party may take over the
clinical trial process for one of our product candidates. In such a situation, the third party,
rather than us, may in fact control development and commercialization decisions for the respective
product candidate. Consistent with our business model, we may enter into additional collaboration
agreements in the future. We cannot predict the terms of such agreements or their potential impact
on our capital requirements. Our inability to complete our research and development projects in a
timely manner, or our failure to enter into new collaborative agreements, when appropriate, could
significantly increase our capital requirements and affect our liquidity.
Since our inception, we have financed our operations through private placements of preferred
stock, government grants for research, research-contribution revenues from our collaborations with
pharmaceutical companies, debt financing, licensing revenues and milestone achievements and, more
recently, by accessing the capital resources of CancerVax through the merger and a private
placement of common stock and associated warrants. We intend to continue to seek funding through
public or private financings in the future. If we are successful in raising additional funds
through the issuance of equity securities, stockholders may experience substantial dilution, or the
equity securities may have rights, preferences or privileges senior to existing stockholders. If we
are successful in raising additional funds through debt financings, these financings may involve
significant cash payment obligations and covenants that restrict our ability to operate our
business. There can be no assurance that we will be successful in raising additional capital on
acceptable terms, or at all. Based on our capital resources as of the date of this report, we
believe that we have adequate resources to fund our operations into the third quarter of 2007,
without considering any potential future milestone payments, which we may receive under current or
future collaborations or the committed equity financing facility, or CEFF, with Kingsbridge Capital
Limited.
Currently, we have strategic collaborations with Serono and MedImmune to develop therapeutic
antibodies in cancer. We also have an exclusive marketing agreement with Enzon to market and
license to third parties the companies respective single-chain antibody patent estates.
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Research and Development and In-Process Research and Development
Through September 30, 2006, our research and development expenses consisted of costs
associated with the clinical development of adecatumumab (MT201) and MT103, as well as pre-clinical
development costs for a new BiTEÒ molecule called MT110 and a new human antibody against
GM-CSF called MT203. The costs incurred include costs associated with clinical trials and
manufacturing process, quality systems and analytical development, including compensation and other
personnel expenses, supplies and materials, costs for consultants and related contract research,
facility costs, license fees and depreciation. We charged all research and development expenses to
operations as they were incurred.
In addition, as a result of our merger with CancerVax, we acquired in-process research and
development (IPR&D) projects with an assigned value of $20.9 million. The fair value of the IPR&D
projects was determined utilizing the income approach, assuming that the rights to the IPR&D
projects will be sub-licensed to third parties in exchange for certain up-front, milestone and
royalty payments, and the combined company will have no further involvement in the ongoing
development and commercialization of the projects. Under the income approach, the expected future
net cash flows from sub-licensing for each IPR&D project are estimated, risk-adjusted to reflect
the risks inherent in the development process and discounted to their net present value.
Significant factors considered in the calculation of the discount rate are the weighted-average
cost of capital and return on assets. Management believes that the discount rate utilized is
consistent with the projects stage of development and the uncertainties in the estimates described
above. Because the acquired IPR&D projects are in the early stages of the development cycle, the
amount allocated to IPR&D were recorded as an expense immediately upon completion of the merger.
We expect to incur substantial additional research and development expenses that may increase
from historical levels as we further develop our compounds into more advanced stages of clinical
development and increase our pre-clinical efforts for our human antibodies and BiTEÒ
molecules in cancer, anti-inflammatory and autoimmune diseases.
Our strategic collaborations and license agreements generally provide for our research,
development and commercialization programs to be partly or wholly funded by our collaborators and
provide us with the opportunity to receive additional payments if specified development or
commercialization milestones are achieved, as well as royalty payments upon the successful
commercialization of any products based upon our collaborations.
Under our adecatumumab, or MT201, collaboration agreement with Ares Trading, S.A., a
wholly-owned subsidiary of Serono International, S.A., we received
$12.0 million in up-front and milestone payments from Serono in 2005 not including other collaborative reimbursements. The agreement provides for potential future clinical development milestone
payments of up to an additional $136.0 million. Our collaboration agreement with MedImmune for
MT103 provides for potential future milestone payments and royalty payments based on net sales from
MT103. A second agreement with MedImmune for the development of new BiTEÒ product candidates
provides for potential future milestone payments and royalty payments based on future sales of the
BiTEÒ product candidates currently under development. The potential milestone payments are
subject to the successful completion of development and obtaining marketing approval for one or
more indications in one or more national markets.
We intend to pursue additional collaborations to provide resources for further development of
our product candidates and expect to continue to grant technology access licenses. However, we
cannot forecast with any degree of certainty whether we will be able to enter into collaborative
agreements, and if we do, on what terms we might do so.
We are unable to estimate with any certainty the costs we will incur in the continued
development of our other product candidates. However, we expect our research and development costs
associated with these product candidates to increase as we continue to develop new indications and
move these product candidates through preclinical and clinical trials.
Clinical development timelines, 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.
The costs and timing for developing and obtaining regulatory approvals of our product
candidates vary significantly for each product candidate and are difficult to estimate. The
expenditure of substantial resources will be required for the lengthy process of clinical
development and obtaining regulatory approvals as well as to comply with applicable regulations.
Any failure by us to obtain, or any delay in obtaining, regulatory approvals could cause our
research and development expenditures to increase and, in turn, could have a material adverse effect on
our results of operations.
Critical Accounting Policies and the Use of Estimates
Our financial statements are prepared in conformity with accounting principles generally
accepted in the United States. Such statements require management to make estimates and assumptions
that affect the amounts reported in our financial statements and accompanying notes. Actual results
could differ materially from those estimates. The critical accounting policies used in the
preparation of our financial statements which require significant estimates and judgments are as
follows:
21
Revenue Recognition
Our revenues generally consist of licensing fees, milestone payments, royalties and fees for
research services earned from license agreements or from research and development collaboration
agreements. We recognize revenue upon satisfying the following four criteria: persuasive evidence
of an arrangement exists, delivery has occurred, the price is fixed or determinable, and
collectibility is reasonably assured.
We
recognize revenue on up-front payments over the expected life of the development and
collaboration agreement on a straight-line basis. Milestone payments are derived from the
achievement of predetermined goals under the collaboration agreements. For milestones that are
subject to contingencies, the related contingent revenue is not recognized until the milestone has
been reached and customer acceptance has been obtained as necessary. Fees for research and
development services performed under the agreements are generally stated at a yearly fixed fee per
research scientist. We recognize revenue as the services are performed. Amounts received in advance
of services performed are recorded as deferred revenue until earned.
We have received initial license fees
and annual renewal fees upfront each
year under license agreements. Revenue is recognized when the above noted criteria are satisfied
unless we have further obligations associated with the license granted.
We are entitled to receive royalty payments on the sale of products under license and
collaboration agreements. Royalties are based upon the volume of products sold and are recognized
as revenue upon notification of sales from the customer. Through September 30, 2006, we have not
received or recognized any royalty payments.
For arrangements that include multiple deliverables, we identify separate units of accounting based
on the consensus reached on Emerging Issues Task Force Issue (EITF) No. 00-21, Revenue
Arrangements with Multiple Deliverables. EITF No. 00-21 provides that revenue arrangements with
multiple deliverables should be divided into separate units of accounting if certain criteria are
met. The consideration for the arrangement is allocated to the separated units of accounting based
on their relative fair values. Applicable revenue recognition criteria are considered separately
for each unit of accounting. We recognize revenue on development and collaboration agreements, including upfront payments,
where they are considered combined units of accounting, over the expected life of the development
and collaboration agreement on a straight-line basis.
Goodwill
In accordance with Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and
Other Intangible Assets, we do not amortize goodwill. Instead, we review goodwill for impairment at
least annually and whenever events or changes in circumstances indicate a reduction in the fair
value of the reporting unit to which the goodwill has been assigned. Conditions that would
necessitate a goodwill impairment assessment include a significant adverse change in legal factors
or in the business climate, an adverse action or assessment by a regulator, unanticipated
competition, a loss of key personnel, or the presence of other indicators that would indicate a
reduction in the fair value of the reporting unit to which the goodwill has been assigned. SFAS No.
142 prescribes a two-step process for impairment testing of goodwill. The first step of the
impairment test is used to identify potential impairment by comparing the fair value of the
reporting unit to which the goodwill has been assigned to its carrying amount, including the
goodwill. Such a valuation requires significant estimates and assumptions including but not limited
to: determining the timing and expected costs to complete in-process projects, projecting
regulatory approvals, estimating future cash inflows from product sales and other sources, and
developing appropriate discount rates and success probability rates by project. If the carrying
value of the reporting unit exceeds the fair value, the second step of the impairment test is
performed in order to measure the impairment loss. As a result of our merger with CancerVax, we
recorded $6.9 million of goodwill. Through September 30, 2006, there have been no indicators of
impairment noted and no impairment analysis has been performed.
Long-Lived and Intangible Assets
The evaluation for impairment of long-lived and intangible assets requires significant
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.
Share-Based Compensation
On January 1, 2006, we adopted the provisions of SFAS No. 123R and SEC Staff Accounting
Bulletin No. 107, Share-Based Payment, or SAB 107, requiring the measurement and recognition of all
share-based compensation under the fair value method. Effective January 1, 2006, we began
recognizing share-based compensation, under SFAS No. 123R, for all awards granted during 2006 based
on each awards grant date fair value. Prior to adopting the provisions of SFAS No. 123R, we
recorded estimated compensation expense for employee stock-based compensation under the provisions
of SFAS No. 123, Accounting for Stock-Based Compensation, (SFAS 123) following the minimum value
method. Under the guidance of SFAS 123, we estimated the value of stock options issued to employees
using the Black-Scholes options pricing model with a near-zero volatility assumption (a minimum
value model). The value was determined based on the stock price of our stock on the date of grant
and was recognized to expense over the vesting period using the straight-line method. We
implemented SFAS No. 123R using the modified prospective transition method. Under this transition
method our financial statements and related information presented pertaining to periods prior to
our adoption of SFAS No. 123R have not been adjusted to reflect
fair value of the share-based
compensation expense. Prior to January 1, 2006, there was no significant stock compensation expense
recorded.
We estimate the fair value of each share-based award on the grant date using the Black-Scholes
option-pricing model. To facilitate our adoption of SFAS No. 123R, we applied the provisions of SAB
107 in developing our methodologies to estimate our Black-Scholes model inputs. Option valuation
models, including Black-Scholes, require the input of highly subjective assumptions, and changes in
the assumptions used can materially affect the grant date fair value of an award. These assumptions
include the risk free rate of interest, expected dividend yield, expected volatility, and the
expected life of the award. The risk free rate of interest is based on the U.S. Treasury rates
appropriate for the expected term of the award. Expected dividend yield is projected at 0% as we
have not
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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. 123R also requires
that forfeitures be estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates. The pre-vesting forfeiture rate for the three
months ended September 30, 2006, was based on historical forfeiture experience for similar levels
of employees to whom the options were granted. As of September 30, 2006, total unrecognized
compensation cost related to stock options was approximately $4.0 million, and the weighted average
period over which it is expected to be recognized is 2.0 years.
Recent Accounting Pronouncements
In July 2006, the FASB issued FASB Interpretation 48, Accounting for Uncertain Tax Positions,
(FIN 48) to clarify the criteria for recognizing tax benefits under SFAS No. 109, Accounting for
Income Taxes and to require additional financial statement disclosure. FIN 48 requires that we
recognize in our consolidated financial statements the impact of a tax position if that position
is more likely than not to be sustained on audit, based on the technical merits of the position. We
currently recognize the impact of a tax position if it is probable of being sustained. The
provisions of FIN 48 are effective for us beginning January 1, 2007, with the cumulative effect of
the change in accounting principle recorded as an adjustment to opening retained earnings. We are
currently evaluating the impact of the adoption of FIN 48 on our financial statements.
In September 2006, the SEC released SAB No. 108, Considering the Effects of Prior Year
Misstatements when Quantifying Misstatements in Current Year Financial Statements. SAB 108 provides
interpretive guidance on the SECs views regarding the process of quantifying the materiality of
financial statement misstatements. SAB 108 is effective for fiscal years ending after November 15,
2006, with early application for the first interim period ending after November 15, 2006. We do not
believe that the application of SAB 108 will have a material effect on our results of operations or
financial position.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. SFAS No. 157 defines
fair value, establishes a framework and gives guidance regarding the methods used for measuring
fair value, and expands disclosures about fair value measurements. SFAS No. 157 is effective for
financial statements issued for fiscal years beginning after November 15, 2007, and interim periods
within those fiscal years. We are currently assessing the impact that SFAS No. 157 will have on our
results of operations and financial position.
Results of Operations
Subsequent to September 30, 2005, we have engaged in a number of significant transactions,
including a recapitalization in October 2005 and the merger with CancerVax in May 2006. As a
result, our results of operations for the three and nine months ended September 30, 2006 are very
difficult to compare to the results of operations for the three and nine months ended September 30,
2005.
Comparison of the Three Months and Nine Months Ended September 30, 2006 and 2005
Revenues. Total revenues were $4.6 million and $13.8 million, respectively, for the three and
nine months ended September 30, 2006, compared to $5.5 million and $17.0 million, respectively, for
the three and nine months ended September 30, 2005. Revenues for the three and nine months ended
September 30, 2006 consisted of collaborative research and development revenues of $1.9 million and
$6.8 million, respectively, from our collaboration agreement with Serono and $0.9 million and $2.5
million, respectively, from our collaboration agreement with MedImmune. In addition, a milestone
payment of $1.7 million from MedImmune was recognized during the three months ended September 30,
2006. Revenues from our licensing activities for the three and nine months ended September 30, 2006
amounted to $0.2 million and $0.9 million, respectively. Revenues for the three and nine months
ended September 30, 2005 consisted of collaborative research and development revenues of $3.3
million and $10.4 million, respectively, from our collaboration agreement with Serono and $1.6
million and $4.9 million, respectively, from our collaboration agreement with MedImmune. Revenues
from our licensing activities for the three and nine months ended September 30, 2005 amounted to
$0.1 million and $0.7 million, respectively. Collaborative research and development revenues from
Serono reflect its full cost responsibility for the adecatumumab (MT201) program. Collaborative
research and development revenues from MedImmune represent its share of the costs of clinical
development of MT103 and its full cost responsibility for the development of certain new
BiTEÒ candidates.
Research and Development Expenses. Research and development expenses were $6.8 million and
$20.9 million, respectively, for the three and nine months ended September 30, 2006, compared to
$6.7 million and $20.9 million, respectively, for the three and nine months ended September 30,
2005.
Research and development expenses for the three months ended September 30, 2006 include a $0.2
million share-based compensation expense. Research and development expenses net of share-based
compensation expenses were $0.1 million lower compared to the
23
prior year due to lower expenses for our clinical trials, manufacturing services and lower
patenting costs by $1.5 million, largely offset by higher costs for personnel, facility and
preclinical studies. Research and development expenses for the nine months ended September 30, 2006
include a $2.3 million share-based compensation expense related to the issuance of options.
Research and development expenses net of share-based compensation expenses were $2.3 million lower
compared to the prior year due to lower expenses for manufacturing services, clinical trials,
clinical trial material and supplies of $3.9 million, partly offset by higher costs for personnel,
facility and preclinical studies.
In-Process
Research and Development. As a result of our merger with CancerVax, we acquired in-process research and development
(IPR&D) projects with an assigned value of $20.9 million. The fair value of the IPR&D projects
was determined utilizing the income approach, assuming that the rights to the IPR&D projects will
be sub-licensed to third parties in exchange for certain up-front, milestone and royalty payments,
and the combined company will have no further involvement in the ongoing development and
commercialization of the projects. Under the income approach, the expected future net cash flows
from sub-licensing for each IPR&D project were 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 were the weighted-average cost of capital and
return on assets. Management believes that the discount rate utilized is consistent with the
projects stage of development and the uncertainties in the estimates described above. Because the
acquired IPR&D projects are in the early stages of the development cycle, the amount allocated to
IPR&D were recorded as an expense immediately upon completion of the merger.
General and Administrative Expenses. General and administrative expenses were $3.3 million and
$8.5 million, respectively, for the three and nine months ended September 30, 2006, compared to
$2.2 million and $5.1 million, respectively, for the three and nine months ended September 30,
2005.
General and administrative expenses for the three months ended September 30, 2006 include a
$0.8 million share-based compensation expense. General and administrative expenses net of
share-based compensation expenses were $0.4 million higher compared to the prior year due to a $0.7
million increase in expenses for services related to information technology, investor relations and
auditing and other operating costs, partly offset by a reduction of personnel costs.
General and administrative expenses for the nine months ended September 30, 2006 include a
$2.7 million share-based compensation expense. General and administrative expenses net of
share-based compensation expenses were $0.7 million higher compared to the prior year due to a $1.2
million increase in other operating costs, including legal and other services related to
information technology, investor relations and auditing, partly offset by a reduction of personnel
cost.
Other Income (Expense)
Interest Expense. Interest expense for the three and nine months ended September 30, 2006 was
$0.5 million and $1.5 million, respectively, compared to $1.3 million and $4.0 million,
respectively, for the three and nine months ended September 30, 2005. The $0.8 million and $2.5
million decreases were primarily due to the conversion of all but $1.9 million of the convertible
notes that had been outstanding during 2005, partly offset by the interest expense incurred as a
result of our assumption of the Silicon Valley Bank loan in connection with the merger.
Interest Income. Interest income for the three and nine months ended September 30, 2006 was
$0.3 million and $0.6 million, respectively, compared to $0.1 million and $0.2 million,
respectively, for the three and nine months ended September 30, 2005. The increase in interest
income was primarily due to an increase in invested balances in 2006 as a result of the cash
acquired in connection with the merger.
Other
Income (Expense). Other income (expense) for the three and nine months ended September 30, 2006
was $(14,000) and $61,000, respectively, compared to $6,000 and $409,000, respectively, for
the three and nine months ended September 30, 2005. The decrease in other income was primarily due
to a realized exchange rate gain in 2005.
Liquidity and Capital Resources
As of September 30, 2006, we had $21.3 million in cash and cash equivalents as compared to
$11.4 million as of December 31, 2005, an increase of $9.9 million. This increase was primarily the
result of our merger with CancerVax in which cash and cash equivalents of $39.6 million were part
of an acquired net book value of $16.2 million. This inflow of cash was partially offset by payment
of $2.2 million in transaction costs, continued investment to fund ongoing operations and increased
spending as a result of our becoming a public company upon completion of our merger with CancerVax.
Net cash used in operating activities was $21.1 million for the nine months ended September
30, 2006, compared to $0.5 million provided by operating activities for the nine months ended
September 2005. The decrease in cash flows from operating
activities was primarily due to the receipt of $14.2 million from Serono
in 2005 for up-front license fee and other receipts under our
collaboration agreement and the pay down of $3.7 million of
liabilities and accrued expenses that had been assumed in the merger
with CancerVax.
Net cash provided by investing activities was $37.2 million for the nine months
ended
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September 30, 2006, compared to $52,000 used in investing activities for the nine months ended
September 30, 2005. Cash flows from investing activities for the nine months ended September 30,
2006 consisted almost entirely of $37.4 million of cash, net of costs paid, acquired in connection
with our merger with CancerVax.
Net cash used in financing activities was $7.0 million for the nine months ended September 30,
2006, compared to $1.2 million used in financing activities for the nine months ended September 30,
2005. Significant components of cash used in financing activities for the nine months ended
September 30, 2006 included the repayment of the Silicon Valley Bank loan of $16.8 million, which
had been assumed in connection with the merger, and repayment of an aggregate of $2.8 million of
long term debt to silent partnerships, partly offset by net proceeds of $7.4 million from the
issuance of common stock to funds affiliated with NGN Capital LLC and $4.8 million in capital contributions from
stockholders. In connection with the issuance of common stock to funds affiliated with NGN Capital LLC, we issued
warrants to such funds to purchase up to an aggregate of
555,556 shares of our common stock. The
warrants become exercisable six months following their date of
issuance, expire six years after
issuance, and are exercisable at a price of $5.00 per share.
In January 2006, the silent partnership agreements with Bayern Kapital GmbH and Technologie
Beteiligungsfonds Bayern GmbH & Co. KG were amended to accelerate repayment of amounts due
(principal, accrued interest, and one-time payments) upon the occurrence of future rounds of
financing after the consummation of the merger with CancerVax, but limited to 20% of the net
proceeds for repayment of silent partnership debts. As a result of
these amendments, until the silent partnership debt has been repaid
in full, 20% of the
proceeds from the private placement equity transaction with NGN Capital, LLC, any draw downs under the CEFF and any
future financings will be used for repayment of accelerated silent partnership debt. The total
amount subject to accelerated repayment as of September 30, 2006 is $5.2 million, of which $1.5
million was triggered by the financing with NGN Capital, LLC in
July 2006, and will be paid in the fourth quarter of 2006.
On August 30, 2006, we entered into a Committed Equity Financing Facility with Kingsbridge
Capital Limited pursuant to which Kingsbridge committed to purchase up to $25 million of our common
stock. Subject to certain restrictions we may require Kingsbridge to purchase newly-issued common
stock at a price that is between 86% and 94% of the volume weighted average price on each trading
day during an eight day pricing period. Under the terms of the CEFF,
the maximum number of shares we may sell to Kingsbridge is 6,251,193 shares, exclusive of the
shares underlying the related warrant issued, and subject to certain limitations. In connection
with the CEFF, we issued a warrant to Kingsbridge to purchase 285,000 shares of our common stock at
an exercise price of $3.2145 per share. The warrant is exercisable beginning six months after the
date of issuance, which was August 30, 2006, and for a period of five years thereafter.
As a result of the merger with CancerVax, we had assumed an $18.0 million loan and security
agreement between CancerVax and Silicon Valley Bank. On September 7, 2006, we paid all amounts due
and owing under the agreement and terminated the agreement. Effective immediately upon the
termination of the agreement, all security interests and other liens held by the lender in all of
our properties, rights and other assets were discharged.
To date, we have funded our operations through proceeds from private placements of preferred
stock, government grants for research, research-contribution revenues from our collaborations with
pharmaceutical companies, licensing and milestone payments related to our product candidate
partnering activities, debt financing and, more recently, by accessing the capital resources of
CancerVax through the merger and through a private placement of common stock and associated
warrants.
We expect that operating losses and negative cash flows from operations will continue for at
least the next several years and we will need to raise additional funds to meet future working
capital and capital expenditure needs. We may wish to raise substantial funds through the sale of
our common stock or raise additional funds through debt financing or through additional strategic
collaboration agreements. We do not know whether additional financing will be available when
needed, or whether it will be available on favorable terms, or at all. If we were to raise
additional funds through the issuance of common stock, substantial dilution to our existing
stockholders would likely result. If we were to raise additional funds through additional debt
financing, the terms of the debt may involve significant cash payment obligations as well as
covenants and specific financial ratios that may restrict our ability to operate our business.
Having insufficient funds may require us to delay, scale back or eliminate some or all of our
research or development programs or to relinquish greater or all rights to product candidates at an
earlier stage of development or on less favorable terms than we would otherwise choose. Failure to
obtain adequate financing may adversely affect our ability to operate as a going concern.
As a result of our merger with CancerVax we assumed three building leases associated with a
manufacturing facility, a warehouse facility and CancerVaxs former corporate headquarters. During
the second quarter of 2006 CancerVax entered into a lease assignment related to the manufacturing
facility, a lease termination related to the warehouse facility and a sublease agreement pursuant
to which 46,527 rentable square feet of the 61,618 total rentable
square feet of CancerVaxs former corporate headquarters was subleased. Our estimated lease exit liability related to
these facilities amounted to $1.7 million at September 30, 2006 and is included in accrued
expenses.
In connection with the three building leases described above, we also assumed three
irrevocable standby letters of credit. The letters of credit associated with these three leases
totaled $2.3 million at the merger date and were secured by certificates of deposit for similar
amounts that are recorded as restricted cash. As of September 30, 2006, we have $3.0 million of
cash and certificates of deposit that are recorded as restricted cash, all of which is recorded as
a non-current asset.
25
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. If all potential product candidates under our licensing and research and
development agreements were successfully developed and commercialized, the aggregate amount of
milestone payments we would be required to pay would be approximately $63.0 million over the terms
of the related agreements in addition to royalties on net sales of each commercialized product.
On October 2, 2006, a court-proposed settlement agreement with Curis, Inc. became effective
that resolves a lawsuit initiated by Curis against Micromet AG in a German court regarding the
repayment of an outstanding promissory note in the remaining principal amount of 2.0 million.
Curis had requested immediate repayment of the remaining 2.0 million at the time of the closing
of the merger between CancerVax and Micromet AG in May 2006. We had disagreed with Curiss
interpretation of the repayment terms of the promissory note. In accordance with the settlement, we
paid Curis 1.0 million, or approximately $1.3 million, in October 2006, and will pay 1.0
million on or before May 31, 2007. The second payment will be reduced to 0.8 million if payment
is made on or before April 30, 2007. The payments will be made by us without any interest charges.
Each of Micromet and Curis will bear their own costs incurred in connection with the litigation.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
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the progress of our clinical trials; |
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|
the progress of our research activities; |
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the number and scope of our research programs; |
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the progress of our preclinical development activities; |
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|
the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent
and other intellectual property claims; |
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|
the costs related to development and manufacture of pre-clinical, clinical and validation lots for
regulatory purposes and commercialization of drug supply associated with our product candidates; |
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|
our ability to enter into corporate collaborations and the terms and success of these collaborations; |
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the costs and timing of regulatory approvals; and |
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the costs of establishing manufacturing, sales and distribution capabilities. |
Contractual Obligations
We have contractual obligations, some of which were assumed in our merger with CancerVax,
related to our facility lease, research agreements and financing agreements. The following table
sets forth our significant contractual obligations as of September 30, 2006:
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Payment Due by Period |
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|
|
|
|
|
|
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|
2007 - |
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|
2009 - |
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|
2011 and |
|
Contractual Obligations (in thousands) |
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Total |
|
|
2006(1) |
|
|
2008 |
|
|
2010 |
|
|
Beyond |
|
Convertible note obligations |
|
$ |
1,941 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,941 |
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|
$ |
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|
Silent partnership obligations |
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|
7,144 |
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|
|
2,054 |
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|
5,090 |
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|
|
|
|
|
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|
Curis loan |
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|
3,055 |
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|
|
1,786 |
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|
|
1,269 |
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|
|
|
|
|
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GEDO loan |
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|
27 |
|
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27 |
|
|
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|
Contractual payments under licensing and
research and development agreements |
|
|
2,475 |
|
|
|
1,425 |
|
|
|
610 |
|
|
|
110 |
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|
|
330 |
|
Operating leases |
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16,137 |
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|
|
721 |
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|
5,731 |
|
|
|
5,375 |
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|
4,310 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
30,779 |
|
|
$ |
6,013 |
|
|
$ |
12,700 |
|
|
$ |
7,426 |
|
|
$ |
4,640 |
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|
|
|
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|
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|
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(1) |
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Includes amounts payable from October 1, 2006 through December 31, 2006. |
26
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, and plans regarding regulatory filings, future
research and clinical trials and plans regarding partnering activities. You can identify these
forward-looking statements by the use of words or phrases such as believe, may, could,
will, estimate, continue, anticipate, intend, seek, plan, expect, should, or
would. Among the factors that could cause actual results to differ materially from those
indicated in the forward-looking statements are risks and uncertainties inherent in our business
including, without limitation, statements about the progress and timing of our clinical trials;
difficulties or delays in development, testing, obtaining regulatory
approval for producing and
marketing our products; unexpected adverse side effects or inadequate therapeutic efficacy of our
products that could delay or prevent product development or commercialization, or that could result
in recalls or product liability claims; the scope and validity of patent protection for our product
candidates; competition from other pharmaceutical or biotechnology companies; our ability to obtain
additional financing to support our operations; and other risks detailed in our Annual Report on
Form 10-K for the year ended December 31, 2005 filed with the Securities and Exchange Commission on
March 16, 2006, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2006 and June
30, 2006 filed with the Securities and Exchange Commission on May 10, 2006 and August 8, 2006,
respectively, in the proxy statement/prospectus dated March 31, 2006, filed with the Securities and
Exchange Commission on April 3, 2006, and the discussions set forth below under the caption Risk
Factors.
Although we believe that the expectations reflected in our forward-looking statements are
reasonable, we cannot guarantee future results, events, levels of activity, performance or
achievement. We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, unless required by
law.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rates
Our financial instruments consist principally of cash and cash equivalents. These financial
instruments, principally comprised of corporate obligations and U.S. and foreign government
obligations, are subject to interest rate risk and will decline in value if interest rates
increase. Because of the relatively short maturities of our investments, we do not expect interest
rate fluctuations to materially affect the aggregate value of our financial instruments. We have
not used derivative financial instruments in our investment portfolio.
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, 2006, we had U.S. dollar-denominated cash and
cash equivalents of $20.4 million and Euro-denominated commitments of approximately 12.8 million
Euros. The Euro amount as of September 30, 2006 is equivalent to
approximately $16.2 million, using the
exchange rate as of that date. A decrease in the value of the U.S. dollar relative to the Euro
would result in an increase in our reported operating expenses due to the translation of the
Euro-denominated expenses into U.S. dollars, and would negatively impact the length of time that
our existing capital resources would be sufficient to finance our operations. We have not engaged
in foreign currency hedging transactions to manage this exchange rate exposure.
Item 4. Controls and Procedures
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and
27
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, management
recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving the desired control objectives, and management is required
to apply its judgment in evaluating the cost-benefit relationship of possible controls and
procedures. In addition, the design of any system of controls also is based in part upon certain
assumptions about the likelihood of future events, and there can be no assurance that any design
will succeed in achieving its stated goals under all potential future conditions; over time,
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.
Prior
to the merger with CancerVax Corporation in May 2006, Micromet
AG, was a private company based in Germany, and, was not
required to, nor did it, maintain disclosure controls and procedures or internal control
over financial reporting that would be deemed appropriate for a U.S. public company filing reports with
the Securities and Exchange Commission. We have undergone significant changes in our corporate and
financial reporting structure in 2006 as a result of the merger. As a result of
the merger, we are now a trans-Atlantic company with a multi-tier reporting and consolidation
process with related currency translations. These transactions and the operations of our company
involve complex accounting issues. Following the merger, we have expended significant resources on
financial reporting activities and integration of operations, including expansion of our disclosure
controls and procedures and internal control systems to address, among other things, operations at
multiple sites and in multiple countries.
Under the supervision and with the participation of our management, including our principal
executive officer and principal financial officer, we conducted an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures as such term is defined under
Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended
(the Exchange Act), as of September 30, 2006, the end of the period covered by this report. Based
on their evaluation, our principal executive officer and principal financial officer concluded that
our disclosure controls and procedures were not effective as of the evaluation date.
During
this evaluation, we noted deficiencies relating to monitoring and oversight of the
work performed by our accounting personnel, which did not provide adequate review of transactions
by accounting personnel with sufficient technical accounting expertise. We also noted a lack of
sufficiently skilled personnel within our accounting and financial reporting functions to ensure
that all transactions are accounted for in accordance with U.S. generally accepted accounting
principles.
Notwithstanding the deficiencies cited above that existed as of September 30, 2006, management
believes that (i) this Quarterly Report on Form 10-Q does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which they were made, not misleading with respect to the periods covered by
this report and (ii) the financial statements, and other financial information included in this
report, fairly present in all material respects our financial condition, results of operations and
cash flows as of, and for, the dates and periods presented in this report. As previously described
in greater detail in Item 4 of our Form 10-Q for the quarter ended June 30, 2006, management has
identified a number of deficiencies in our internal control over financial reporting following the
merger between CancerVax and Micromet AG, as a result of the following:
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Micromet AG, as a private company based in Germany was not required to, nor did it,
maintain a system of internal control over financial reporting prior to the
merger that would be deemed appropriate for a U.S. public company filing reports with the
Securities and Exchange Commission; |
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a lack of sufficiently skilled personnel within our accounting and financial reporting
functions to ensure that all transactions are accounted for in accordance with U.S.
generally accepted accounting principles; and |
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the departure of CancerVaxs chief financial officer shortly after the completion of the
merger. |
Our
management currently believes that the combination of these deficiencies
constitutes a material weakness in our internal control over financial reporting. Following the merger, we have taken a number of steps to strengthen our
internal control over our financial reporting.
However, material weaknesses in our internal control over financial reporting process continue
to exist, and we need to take additional steps to remediate these situations. We intend to address
the remaining actions required to remediate our existing weaknesses as part of our ongoing efforts
to upgrade our control environment following the merger. As discussed below, we have been and
continue to be engaged in efforts to improve our internal control over financial reporting.
Measures we have taken or are taking to remediate our identified material weaknesses include:
28
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consolidating operating and financial reporting locations and structure; |
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implementing additional review and approval procedures over accruals; |
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the hiring of a chief financial officer with significant public company experience in October 2006; |
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formalizing process and documentation related to financial statement closing and
consolidation review, including face-to-face meetings of all members of our financial staff
involved in preparation of financial statements and a review of those financial statements
by the entire staff as a group; |
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formalizing and enhancing documentation, oversight and review procedures related to
accounting records of Micromet AG to ensure compliance with U.S. generally accepted
accounting principles; |
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reviewing and making appropriate staffing adjustments at all company locations to enhance accounting expertise; |
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supplementing our accounting and financial staff to improve the breadth and depth of experience; |
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hiring of consultants to aid us in the implementation of controls; and |
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improving training for, and integration and communication among, accounting and financial staff. |
While management believes that the foregoing actions have had a positive effect on our
internal control over financial reporting, the
changes necessary to remediate the material weakness in our internal control over financial
reporting will not be in place by year-end 2006.
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, 2006 that materially affected, or were reasonably
likely to materially affect, our internal control over financial reporting.
29
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Patent Opposition in Europe
Micromet AGs patent EP1071752B1 was
opposed under Articles 99 and 100 of the European Patent
Convention, or EPC, by Affimed Therapeutics AG in March 2004. The opponent alleged that the patent
does not fulfill the requirements of the EPC. On January 19, 2006, the Opposition Division of the
European Patent Office (EPO) revoked the opposition in oral proceedings according to Article 116 of
the EPC and maintained the patent as granted. The opponent filed a notice of appeal on May 30,
2006. On August 7, 2006, Micromet AG and Affimed entered into a settlement agreement pursuant to
which Micromet AG reimbursed Affimed for a portion of its legal costs
in the amount of 75,000 Euros, and Affimed agreed to withdraw the opposition.
Curis, Inc.
On March 6, 2006, Curis, Inc. filed a
lawsuit against Micromet AG in the Local Court of Munich
I. Curis claimed that Micromet AG was obligated to pay Curis the outstanding amount of Curiss
promissory note of 2.0 million, or $2.5 million, within 30 days after the completion of the
merger with CancerVax. We disputed Curiss position, but agreed that an amount of 533,000, or
$667,000, of the loan would have become payable in October 2006. Our maximum exposure was the
amount claimed 2.0 million, or approximately $2.5 million based on the Euro/U.S. dollar
exchange rate as of June 30, 2006, plus the costs of the proceedings. In addition, if had Curis
prevailed in the proceeding, it would have been entitled to interest on the claimed amount of
2.0 million, or $2.5 million at the base rate of the European Central Bank plus 8%, accruing
from the time of default.
On October 2, 2006, a court-proposed settlement agreement with Curis became effective that
resolves a lawsuit initiated by Curis against Micromet AG in a German court regarding the repayment
of an outstanding promissory note in the remaining principal amount of 2.0 million. In accordance with the settlement, we paid Curis
1.0 million, or approximately $1.3 million, in October 2006, and will pay 1.0 million on or
before May 31, 2007. The second payment will be reduced to 0.8 million if payment is made on or
before April 30, 2007. The payments will be made by us without any interest charges. Each party
will bear its own costs incurred in connection with the litigation.
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. It
is difficult to predict or identify all such factors and many of the risk factors identified below
have changed from those previously disclosed in our 2005 Annual Report on Form 10-K and our proxy
statement/prospectus dated March 31, 2006, as filed on April 3, 2006, as supplemented by the risk
factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2006 and the quarter
ended June 30, 2006, and the risk factors in our Forms S-3 filed on August 22, 2006 and September
13, 2006. Accordingly, in evaluating our business, we encourage you to consider the following
discussion of risk factors in its entirety, in addition to other information contained in this
report as well as our other public filings with the Securities and Exchange Commission.
Risks Relating to Our 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, 2006, 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, Serono and MedImmune. We have not commercialized
any products to date, either alone or with a third party collaborator. If we are not able to
commercialize any products, whether alone or with a collaborator, we may not achieve profitability.
Even if our collaboration agreements provide funding for a portion of our research and development
expenses for some of our programs, we expect to spend significant capital to fund our internal
research and development programs for the foreseeable future. As a result, we will need to generate
significant revenues in order to achieve profitability. We cannot be certain whether or when this
will occur because of the significant uncertainties that affect our business. Our failure to become
and remain profitable may depress the market price of our common stock and could impair our
30
ability to raise capital, expand our business, diversify our product offerings or continue our
operations.
We will require additional financing, which may be difficult to obtain and may dilute your
ownership interest in us. If we fail to obtain the capital necessary to fund our operations, we
will be unable to develop or commercialize our product candidates and our ability to operate as a
going concern may be adversely affected.
We will require substantial funds to continue our research and development programs and our
future capital requirements may vary from what we expect. There are factors, many of which are
outside our control, that may affect our future capital requirements and accelerate our need for
additional financing. Among the factors that may affect our future capital requirements and
accelerate our need for additional financing are:
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continued progress in our research and development programs, as well as the scope of
these programs; |
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our ability to establish and maintain collaborative arrangements for the discovery,
research or development of product candidates; |
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the timing, receipt and amount of research funding and milestone, license, royalty and
other payments, if any, from collaborators; |
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the timing, receipt and amount of sales revenues and associated royalties to us, if any,
from our product candidates in the market; |
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our ability to sell shares of our common stock under our committed equity financing
facility, or CEFF, with Kingsbridge Capital Limited, or Kingsbridge; |
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the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and
other patent-related costs, including litigation costs and technology license fees; |
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costs associated with litigation; and |
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competing technological and market developments. |
We filed a shelf registration statement, declared effective by the 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 and
may seek additional funding for programs that are not currently licensed to collaborators, from new
strategic collaborators. However, the biotechnology market in general, and the market for our
common stock, in particular, is likely to be highly volatile. Due to market conditions and the
status of our product development pipeline, additional funding may not be available to us on
acceptable terms, or at all. Having insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or to relinquish greater or all
rights to product candidates at an earlier stage of development or on less favorable terms than we
would otherwise choose. Failure to obtain adequate financing also may adversely affect our ability
to operate as a going concern.
If we raise additional funds through the issuance of equity securities, our stockholders may
experience substantial dilution, or the equity securities may have rights, preferences or
privileges senior to existing stockholders. If we raise additional funds through debt financings,
these financings may involve significant cash payment obligations and covenants that restrict our
ability to operate our business and make distributions to our stockholders. We also could elect to
seek funds through arrangements with collaborators or others that may require us to relinquish
rights to certain technologies, product candidates or products.
Our committed equity financing facility with Kingsbridge may not be available to us if we elect to
make a draw down, may require us to make additional blackout or other payments to Kingsbridge and
may result in dilution to our stockholders.
In August 2006, we entered into a CEFF with Kingsbridge. The CEFF entitles us to sell and
obligates Kingsbridge to purchase, from time to time over a period of three years, shares of our
common stock for cash consideration up to an aggregate of $25 million, subject to certain
conditions and restrictions. Kingsbridge will not be obligated to purchase shares under the CEFF
unless certain conditions are met, which include:
31
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a minimum price for our common stock that is not less than 85% of the closing price of
the day immediately preceding the applicable eight-day pricing period, but in no event
less than $2.00 per share; |
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the accuracy of representations and warranties made to Kingsbridge; |
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our compliance with all applicable laws which, if we failed to so comply, would have a
Material Adverse Effect (as that term is defined in the purchase agreement with
Kingsbridge); and |
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the effectiveness of a registration statement registering for resale the shares of
common stock to be issued in connection with the CEFF. |
Kingsbridge is permitted to terminate the CEFF by providing written notice to us upon the
occurrence of certain events. If we are unable to access funds through the CEFF, or if Kingsbridge
terminates the CEFF, we may be unable to access capital from other
sources on favorable terms, or at all.
We are entitled, in certain circumstances, to deliver a blackout notice to Kingsbridge to
suspend the use of the resale registration statement and prohibit Kingsbridge from selling shares
under the resale registration statement for a certain period of time. If we deliver a blackout
notice during the fifteen trading days following our delivery of shares to Kingsbridge in
connection with any draw down, then we may be required to make a payment to Kingsbridge, or issue
to Kingsbridge additional shares in lieu of this payment, calculated on the basis of the number of
shares purchased by Kingsbridge in the most recent draw down and held by Kingsbridge immediately
prior to the blackout period and the decline in the market price, if any, of our common stock
during the blackout period. If the trading price of our common stock declines during a blackout
period, this blackout payment could be significant.
In addition, if we fail to maintain the effectiveness of the resale registration statement or
related prospectus in circumstances not permitted by our agreement with Kingsbridge, we may be
required to make a payment to Kingsbridge, calculated on the basis of the number of shares held by
Kingsbridge during the period that the registration statement or prospectus is not effective,
multiplied by the decline in market price, if any, of our common stock during the ineffective
period. If the trading price of our common stock declines during a period in which the resale
registration statement or related prospectus is not effective, this payment could be significant.
Should we sell shares to Kingsbridge under the CEFF or issue shares in lieu of a blackout
payment, it will have a dilutive effect on the holdings of our current stockholders and may result
in downward pressure on the price of our common stock. If we draw down under the CEFF, we will
issue shares to Kingsbridge at a discount of 6% to 14% from the volume weighted average price of
our common stock. If we draw down amounts under the CEFF when our share price is decreasing, we
will need to issue more shares to raise the same amount than if our stock price was higher.
Issuances in the face of a declining share price will have an even greater dilutive effect than if
our share price were stable or increasing and may further decrease our share price. Moreover, the
number of shares that we will be able to issue to Kingsbridge in a particular draw down may be
materially reduced if our stock price declines significantly during the applicable eight-day
pricing period.
Our quarterly operating results and stock price may fluctuate significantly.
We expect our results of operations to be subject to quarterly fluctuations. The level of our
revenues, if any, and results of operations at any given time, will be based primarily on the
following factors:
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the status of development of our product candidates; |
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the time at which we enter into research and license agreements with strategic
collaborators that provide for payments to us, and the timing and accounting treatment of
payments to us, if any, under those agreements; |
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whether or not we achieve specified research, development or commercialization
milestones under any agreement that we enter into with collaborators and the timely
payment by commercial collaborators of any amounts payable to us; |
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the addition or termination of research programs or funding support; |
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the timing of milestone payments under license agreements, repayments of outstanding
amounts under loan agreements, and other payments that we may be required to make to
others; and |
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variations in the level of research and development expenses related to our product
candidates or potential product candidates during any given period. |
These factors may cause the price of our stock to fluctuate substantially. We believe that
quarterly comparisons of our financial results are not necessarily meaningful and should not be
relied upon as an indication of our future performance.
If the estimates we make and the assumptions on which we rely in preparing our financial statements
prove inaccurate, our actual results may vary significantly.
Our financial statements have been prepared in accordance with generally accepted accounting
principles in the United States. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and
expenses, the amounts of charges taken by us and related disclosure. We base our estimates on
historical experience and on various other assumptions that we believe to be reasonable under the
circumstances. We cannot assure you that our estimates, or the assumptions underlying them, will be
correct. Accordingly, our actual financial results may vary significantly from the estimates
contained in our financial statements.
Changes in, or interpretations of, accounting rules and regulations, such as expensing of stock
options, could result in unfavorable accounting charges or require us to change our compensation
policies.
Accounting methods and policies for biopharmaceutical companies, including policies governing
revenue recognition, expenses, accounting for stock options and in-process research and development
costs are subject to further review, interpretation and guidance from relevant accounting
authorities, including the SEC. Changes to, or
interpretations of, accounting methods or policies in the future may require us to reclassify,
restate or otherwise change or revise our financial statements, including those contained in this
filing.
Our operating and financial flexibility, including our ability to borrow money, is limited by
certain debt arrangements.
Our loan agreements contain certain customary events of default, which generally include,
among others, non-payment of principal and interest, violation of covenants, cross defaults, the
occurrence of a material adverse change in our ability to satisfy our obligations under our loan
agreements or with respect to one of our lenders security interest in our assets and in the event
we are involved in certain insolvency proceedings. Upon the occurrence of an event of default, our
lenders may be entitled to, among other things, accelerate all of our obligations and sell our
assets to satisfy our obligations under our loan agreements. In addition, in an event of default,
our outstanding obligations may be subject to increased rates of interest.
In addition, we may incur additional indebtedness from time to time to finance acquisitions,
investments or strategic alliances or capital expenditures or for other purposes. Our level of
indebtedness could have negative consequences for us, including the following:
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our ability to obtain additional financing, if necessary, for working capital, capital
expenditures, acquisitions or other purposes may be impaired or such financing may not be
available on favorable terms; |
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payments on our indebtedness will reduce the funds that would otherwise be available for
our operations and future business opportunities; |
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we may be more highly leveraged than our competitors, which may place us at a competitive disadvantage; and |
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our debt level may reduce our flexibility in responding to changing business and economic conditions. |
We do not expect that we will be able to obtain an opinion of our independent auditor in connection
with our year-end audit for 2006 that our internal controls meet the requirements of Section 404 of
the Sarbanes-Oxley Act of 2002.
As a public reporting company, we are required to comply with the Sarbanes-Oxley Act of 2002
and the related rules and regulations of the SEC, including Section 404 of the Sarbanes-Oxley Act
of 2002. As a result of the merger between CancerVax Corporation and Micromet AG, we are in the
process of upgrading the existing, and implementing additional procedures and controls to incorporate
the operations of our operating subsidiary, Micromet AG. The process of updating the procedures and
controls is requiring significant time and expense. The integration of our finance and accounting
systems, procedures and controls with those of Micromet AG, and the implementation of procedures
and controls at Micromet AG required to comply with the Sarbanes-Oxley Act of 2002 and the related
rules and regulations of the SEC are more time consuming and
expensive than were previously anticipated. Given the
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available to plan and implement these procedures and controls since the closing of the merger in
May of this year, we expect that we will not complete the process in time to obtain an opinion of
our independent auditor in connection with our year-end audit for 2006 that our procedures and
controls 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.
Risks Relating to Our Common Stock
Substantial sales of shares may adversely impact the market price of our common stock and our
ability to issue and sell shares in the future.
Substantially all of the outstanding shares of our common stock are eligible for resale in the
public market and certain holders of our shares have the right to require us to file a registration
statement for purposes of registering their shares for resale. A significant portion of these
shares is held by a small number of stockholders. We have also registered shares of our common
stock that we may issue under our stock incentive plans and an employee stock purchase plan. These
shares generally can be freely sold in the public market upon issuance. If our stockholders sell
substantial amounts of our common stock, the market price of our common stock may decline, which
might make it more difficult for us to sell equity or equity-related securities in the future at a
time and price that we deem appropriate. We are unable to predict the effect that sales of our
common stock may have on the prevailing market price of our common stock.
Our stock price may be volatile, and you may lose all or a substantial part of your investment.
The market price for our common stock is volatile and may fluctuate significantly in response
to a number of factors, a number of which we cannot control. Among the factors that could cause
material fluctuations in the market price for our common stock are:
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our ability to upgrade and implement our disclosure controls and our internal control over financial reporting; |
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our ability to successfully raise capital to fund our continued operations; |
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our ability to successfully develop our product candidates within acceptable timeframes; |
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changes in the regulatory status of our product candidates; |
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changes in significant contracts, new technologies, acquisitions, commercial
relationships, joint ventures or capital commitments; |
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the execution of new contracts or termination of existing contracts related to our
clinical or preclinical product candidates; |
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announcements of the results of clinical trials by us or by companies with product
candidates in the same therapeutic category as our product candidates; |
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events affecting our collaborators; |
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fluctuations in stock market prices and trading volumes of similar companies; |
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announcements of new products or technologies, clinical trial results, commercial
relationships or other events by us or our competitors; |
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our ability to successfully complete sublicensing arrangements with respect to our
product candidates that target the EGFR signaling pathway, denatured collagen, GM-CSF and
interleukin-2; |
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variations in our quarterly operating results; |
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changes in securities analysts estimates of our financial performance; |
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changes in accounting principles; |
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sales of large blocks of our common stock, including sales by our executive officers,
directors and significant stockholders; |
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additions or departures of key personnel; and |
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discussions of Micromet or our stock price by the financial and scientific press and
online investor communities such as chat rooms. |
If our officers and directors choose to act together, they can significantly influence our
management and operations in a manner that may be in their best interests and not in the best
interests of other stockholders.
Our officers and directors, together with their affiliates, collectively own an aggregate of
approximately 25% of our outstanding common stock, and, as a result, may significantly influence all matters
requiring approval by our stockholders, including the election of directors and the approval of
mergers or other business combination transactions. The interests of this group of stockholders may
not always coincide with our interests or the interests of other stockholders, and this group may
act in a manner that advances their best interests and not necessarily those of other stockholders.
Our stockholder rights plan, anti-takeover provisions in our organizational documents and Delaware
law may discourage or prevent a change in control, even if an acquisition would be beneficial to
our stockholders, which could affect our stock price adversely and prevent attempts by our
stockholders to replace or remove our current management.
Our stockholder rights plan and provisions contained in our amended and restated certificate
of incorporation and amended and restated bylaws may delay or prevent a
change in control, discourage bids at a premium over the market price of our common stock and
adversely affect the market price of our common stock and the voting and other rights of the
holders of our common stock. The provisions in our amended and restated certificate of
incorporation and amended and restated bylaws include:
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dividing our board of directors into three classes serving staggered three-year terms; |
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prohibiting our stockholders from calling a special meeting of stockholders; |
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permitting the issuance of additional shares of our common stock or preferred stock without stockholder approval; |
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prohibiting our stockholders from making certain changes to our amended and restated
certificate of incorporation or amended and restated bylaws except with 66 2/3% stockholder approval; and |
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requiring advance notice for raising matters of business or making nominations at
stockholders meetings. |
We are also subject to provisions of the Delaware corporation law that, in general, prohibit
any business combination with a beneficial owner of 15% or more of our common stock for five years
unless the holders acquisition of our stock was approved in advance by our board of directors.
Risks Relating to Our Collaborations and Clinical Programs
We are dependent on collaborators for the development and commercialization of many of our product
candidates. If we lose any of these collaborators, or if they fail or incur delays in the
development or commercialization of our current and future product candidates, our operating
results would suffer.
The success of our strategy for development and commercialization of our product candidates
depends upon our ability to form and maintain productive strategic collaborations. We currently
have strategic collaborations with Serono and MedImmune. We expect to enter into additional
collaborations in the future. Our existing and any future collaborations may not be scientifically
or commercially successful. The risks that we face in connection with these collaborations include
the following:
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Each of our collaborators has significant discretion in determining the efforts and
resources that it will apply to the collaboration. The timing and amount of any future
royalty and milestone revenue that we may receive under such collaborative arrangements
will depend on, among other things, such collaborators efforts and allocation of
resources. |
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All of our strategic collaboration agreements are for fixed terms and are subject to
termination under various circumstances, including, in some cases, on short notice without
cause. If either Serono or MedImmune 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 |
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candidate covered by the terminated agreement. If we are not able to do so, we may not have
the funds or capability to undertake the development, manufacturing and commercialization of
that product candidate, which could result in a discontinuation or delay of the development
of that product candidate. |
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Our collaborators may develop and commercialize, either alone or with others, products
and services that are similar to or competitive with the product candidates and services
that are the subject of their collaborations with us. |
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Our collaborators may change the focus of their development and commercialization
efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their
research and development priorities, including in connection with mergers and
consolidations, which have been common in recent years in these industries. The ability of
our partnered product candidates to reach their potential could be limited if, as a result
of such changes, our collaborators decrease or fail to increase spending related to such
product candidates, or decide to discontinue the development of our product candidates and
terminate their collaboration agreement with us. On September 21, 2006, our collaborator
Serono announced that it has agreed to be acquired by Merck KGaA. If Serono or Merck KGaA
re-evaluate their priorities in the development of their product candidates, this may
result in a delay in the development and the launch of the product candidate (if
successfully developed and approved for commercial sale) or termination of their
collaboration agreement with us. We may not be able to identify and enter into a
collaboration agreement for adecatumumab with another pharmaceutical company, and may not
have sufficient financial resources to continue the development program on our own. As a
result, we may delay or abandon the development of MT201 following any termination of the
collaboration agreement with 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, joint ventures and strategic collaborations for the
development and commercialization of 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 strategic collaborations
or other alternative arrangements. Even if we are successful in our efforts to establish a
collaboration or agreement, the terms that we establish may not be favorable to us. Finally, such
strategic alliances or other arrangements may not result in successful products and associated
revenue from milestone payments, royalties or profit share payments.
If we and our collaborator Serono determine that the results of the Phase 2 clinical trial of
adecatumumab, or MT201, in patients with metastatic breast cancer trial do not warrant continuation
of the development program in this indication, we may discontinue development of this product
candidate in breast cancer.
We previously have reported that the Phase 2 clinical trial of adecatumumab in patients with
metastatic breast cancer did not meet its primary clinical endpoint (clinical benefit rate at week
24). However, based on the data that we have reviewed, we believe that the results of the trial are
encouraging nevertheless as they appear to indicate clinical activity of adecatumumab, particularly
in patients with high EpCAM expression. Moreover, based upon our current assessment, the safety
profile observed in our Phase 2 clinical trials does not appear to raise significant concerns for
the further development of adecatumumab in this indication. If we and our partner Serono conclude
that the results of the trial do not warrant continuation of the development of adecatumumab for
the treatment of breast cancer and we do not identify and develop adecatumumab in a suitable
alternative indication, this would have a material adverse impact on our future results of
operations.
If we and our collaborator Serono do not identify a suitable alternative indication to prostate
cancer in which adecatumumab, or MT201, may be developed, we may experience a material adverse
impact on our results of operations.
We have previously reported that the Phase 2 clinical trial of adecatumumab, or MT201, in
patients with prostate cancer did not reach its primary endpoint (mean change in prostate specific
antigen, compared to placebo control). However, based on sub-analyses performed at the
recommendation of clinical experts, a measurable level of biological activity was observed in
patients with high EpCAM expression receiving a high dose of
adecatumumab. Nevertheless, based on a number of
factors, including the cost and length of the clinical development program, we and our partner
Serono have decided to put the development of adecatumumab in prostate cancer on hold at this time.
Instead, we are evaluating other cancer indications in which adecatumumab could be developed. If
we do not identify and develop adecatumumab in a suitable alternative indication (or in the future
resume the development of adecatumumab for the treatment of prostate cancer), we may experience a
material adverse impact on our future results of operations.
We previously terminated three Phase 1 trials involving short-term infusion regimens of MT103 due
to the adverse event profile and a lack of perceived tumor response, and there can be no assurance
that our current continuous infusion Phase 1 clinical trial
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of MT103 will produce a different outcome.
In April 2004, we initiated a Phase 1, dose finding clinical trial designed to evaluate the
safety and tolerability of a continuous intravenous infusion of MT103 over 4-8 weeks at different
dose levels in patients with relapsed non-Hodgkins lymphoma. We previously terminated three other
Phase 1 clinical trials for MT103, which involved a short-term infusion, as opposed to a continuous
infusion dosing regimen of MT103, due to adverse events and the lack of observed tumor responses.
We have redesigned the dosing regimen for our ongoing Phase 1 clinical trial and, based upon the
preliminary clinical data, we currently are seeing a considerably more favorable safety profile in
response to the new continuous infusion dosing regimen. We have also seen objective tumor responses
at the highest dose level tested (15 µg/m2/d). While this preliminary data suggest that the product
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.
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 the two other product candidates that we have licensed from that company.
The United States government has maintained an embargo against Cuba for more than 40 years.
The embargo is administered by the Office of Foreign Assets Control, or OFAC, of the U.S.
Department of Treasury. Without a license from OFAC, U.S. individuals and companies may not engage
in any transaction in which Cuba or Cubans have an interest. In order to enter into and carry out
our licensing agreements with CIMAB, we have obtained from OFAC a license authorizing us to carry
out all transactions set forth in the license agreements that we have entered into with CIMAB for
the development, testing, licensing and commercialization of SAI-EGF, and with CIMAB and YM
BioSciences for the two other product candidates that target the EGF receptor signaling pathway. In
the absence of such a license from OFAC, the execution of and our performance under these
agreements could have exposed us to legal and criminal liability. At any time, there may occur for
reasons beyond our control a change in United States or Cuban law, or in the regulatory environment
in the U.S. or Cuba, or a shift in the political attitudes of either the U.S. or Cuban governments,
that could result in the suspension or revocation of our OFAC license or in our inability to carry
out part or all of the licensing agreements with CIMAB. There can be no assurance that the U.S. or
Cuban governments will not modify existing law or establish new laws or regulations that may
adversely affect our ability to develop, test, license and commercialize these product candidates.
Our OFAC license may be revoked or amended at anytime in the future, or the U.S. or Cuban
governments may restrict our ability to carry out all or part of our respective duties under the
licensing agreements between us, CIMAB and YM BioSciences. Similarly, any such actions may restrict
CIMABs ability to carry out all or part of its licensing agreements with us. In addition, we
cannot be sure that the FDA, EMEA or other regulatory authorities will accept data from the
clinical trials of these product candidates that were conducted in Cuba as the basis for our
applications to conduct additional clinical trials, or as part of our application to seek marketing
authorizations for such product candidates.
In 1996, a significant change to the United States embargo against Cuba resulted from
congressional passage of the Cuban Liberty and Democratic Solidarity Act, also known as the
Helms-Burton Bill. That law authorizes private lawsuits for damages against anyone who traffics in
property confiscated, without compensation, by the government of Cuba from persons who at the time
were, or have since become, nationals of the United States. We do not own any property in Cuba and
do not believe that any of CIMABs properties or any of the scientific centers that are or have
been involved in the development of the technology that we have licensed from CIMAB were
confiscated by the government of Cuba from persons who at the time were, or who have since become,
nationals of the U.S. However, there can be no assurance that our understanding in this regard is
correct. We do not intend to traffic in confiscated property, and we have included provisions in our
licensing agreements to preclude the use of such property in association with the performance of
CIMABs obligations under those agreements, although we cannot ensure that CIMAB or other third
parties will comply with these provisions.
As part of our interactions with CIMAB, we are subject to the U.S. Commerce Departments
export administration regulations that govern the transfer of technology to foreign nationals.
Specifically, we or our sublicensees, if any, will require a license from the Commerce Departments
Bureau of Industry and Security, or BIS, in order to export or otherwise transfer to CIMAB any
information that constitutes technology under the definitions of the Export Administration
Regulations, or EAR, administered by BIS. The export licensing process may take months to be
completed, and the technology transfer in question may not take place unless and until a license is
granted by the Commerce Department. Due to the unique status of the Republic of Cuba, technology
that might otherwise be transferable to a foreign national without a Commerce Department license
requires a license for export or transfer to a Cuban national. If we or our sublicensees fail to
comply with the export administration regulations, we may be subject to both civil and criminal
penalties. There can be no guarantee that any license application will be approved by BIS or that a
license, once issued, will not be revoked, modified, suspended or otherwise restricted for reasons
beyond our control due to a change in U.S.-Cuba policy or for other reasons.
Risks Relating to Our Operations, Business Strategy, and the Life Sciences Industry
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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 function. Our competitors may discover,
characterize and develop important inducing molecules or genes in advance of us.
Many of our competitors have substantially greater capital resources, research and development
staffs and facilities than we have. Efforts by other biotechnology and pharmaceutical companies
could render our programs or product candidates uneconomical or result in therapies that are
superior to those that we are developing alone or with a collaborator. We and our collaborators
face competition from companies that may be more experienced in product development and
commercialization, obtaining regulatory approvals and product manufacturing. As a result, they may
develop competing products more rapidly and at a lower cost, or may discover, develop and
commercialize products, which render our product candidates non-competitive or obsolete. We expect
competition to intensify in antibody research as technical advances in the field are made and
become more widely known.
We may not be successful in our efforts to expand our portfolio of product candidates.
A key element of our strategy is to discover, develop and commercialize a portfolio of new
drugs. We are seeking to do so through our internal research programs
and in-licensing activities. A
significant portion of the research that we are conducting involves new and unproven technologies.
Research programs to identify new disease targets and product candidates require substantial
technical, financial and human resources regardless of whether or not
any suitable candidates are ultimately identified.
Our research programs may initially show promise in identifying potential product candidates, yet
fail to yield product candidates suitable for clinical development. If we are unable to discover
suitable potential product candidates, develop additional delivery technologies through internal
research programs or in-license suitable product candidates or delivery technologies on acceptable
business terms, our business prospects will suffer.
The product candidates in our pipeline are in early stages of development and our efforts to
develop and commercialize these product candidates are subject to a high risk of delay and failure.
If we fail to successfully develop our product candidates, our ability to generate revenues will be
substantially impaired.
The process of successfully developing product candidates for the treatment of human diseases
is very time-consuming, expensive and unpredictable and there is a high rate of failure for product
candidates in preclinical development and in clinical trials. The preclinical studies and clinical
trials may produce negative, inconsistent or inconclusive results, and the results from early
clinical trials may not be statistically significant or predictive of results that will be obtained
from expanded, advanced clinical trials. Further, we or our collaborators may decide, or
regulators may require us, to conduct preclinical studies or clinical trials in addition to those
planned by us or our collaborators, which may be expensive or could delay the time to market for
our product candidates. In addition, we do not know whether the clinical trials will result in
marketable products.
All of our product candidates are in early stages of development, so we will require
substantial additional financial resources, as well as research, product development and clinical
development capabilities, to pursue the development of these product candidates, and we may never
develop an approvable or commercially viable product.
We do not know whether our planned preclinical development or clinical trials for our product
candidates will begin on time or be completed on schedule, if at all. The timing and completion of
clinical trials of our product candidates depend on, among other factors, the number of patients
that will be required to enroll in the clinical trials, the inclusion and exclusion criteria used
for selecting patients for a particular clinical trial, and the rate at which those patients are
enrolled. Any increase in the required number of patients, tightening
of selection criteria, or
decrease in recruitment rates or difficulties retaining study participants may result in increased
costs, delays in the development of the product candidate, or both.
Since our product candidates may have different efficacy profiles in certain clinical
indications, sub-indications or patient profiles, an election by us or our collaborators to focus
on a particular indication, sub-indication or patient profile may result in a failure to
capitalize on other potentially profitable applications of our product candidates.
Our product candidates may not be effective in treating any of our targeted disorders or may
prove to have undesirable or unintended side effects, toxicities or other characteristics that may
prevent or limit their commercial use. Institutional review boards or regulators, including the FDA
and the EMEA, may hold, suspend or terminate our clinical research or the clinical trials of our
product
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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. Following the filing by our collaborator MedImmune of the IND for MT103 in
the United States in August of this year, the FDA requested additional information, and MedImmune is currently
working with the FDA on finalizing the protocol for the planned Phase 1 clinical trial of MT103 in
the United States.
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 contracts.
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 collaborator are able to successfully complete the clinical
development of a product candidate, we or our collaborator 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 BiTEâ
product candidates or make the development process more expensive.
Any marketing approval by the FDA, EMEA or other regulatory authorities may be subject to
limitations on the indicated uses for which we or our collaborators may market the product
candidate. These limitations could restrict the size of the market for the product and affect
reimbursement levels by third-party payers.
As a result of these factors, we or our collaborators may not successfully begin or complete
clinical trials and launch and commercialize any product candidates in the time periods estimated,
if at all. Moreover, if we or our collaborators incur costs and delays in development programs or
fail to successfully develop and commercialize products based upon our technologies, we may not
become profitable and our stock price could decline.
We and our collaborators are subject to governmental regulations other than those imposed by the
FDA and EMEA, and we 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,
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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 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 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 a such failure, we could be subject to sanctions,
including fines, injunctions and civil penalties, refusal or delays by regulatory authorities to
grant marketing approval of our product candidates, suspension or withdrawal of marketing
approvals, seizures or recalls of product candidates, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect our business. If we were
required to change manufacturers, it may require additional clinical trials and the revalidation of
the manufacturing process and procedures in accordance with applicable current good manufacturing
practices and may require FDA or EMEA approval. This revalidation may be costly and time consuming.
If we are unable to arrange for third-party manufacturing of our product candidates, or to do so on
commercially reasonable terms, we may not be able to complete
development or marketing of our product
candidates.
Even if regulatory authorities approve our product candidates, we may fail to comply with ongoing
regulatory requirements or experience unanticipated problems with our product candidates, and these
product candidates could be subject to restrictions or withdrawal from the market following
approval.
Any product candidates for which we obtain marketing approval, along with the manufacturing
processes, post-approval clinical trials and promotional activities for such product candidates,
will be subject to continual review and periodic inspections by the FDA, EMEA and other regulatory
authorities. Even if regulatory approval of a product candidate is granted, the approval may be
subject to limitations on the indicated uses for which the product may be marketed or contain
requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy
of the product. Post-approval discovery of previously unknown problems with any approved products,
including unanticipated adverse events or adverse events of unanticipated severity or frequency,
difficulties with a manufacturer or manufacturing processes, or failure to comply with regulatory
requirements, may result in restrictions on such approved products or manufacturing processes,
withdrawal of the approved products from the market, voluntary or mandatory recall, fines,
suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or
criminal penalties.
The procedures and requirements for granting marketing approvals vary among countries, which may
cause us to incur additional costs or delays or may prevent us from obtaining marketing approvals
in different countries and regulatory jurisdictions.
We intend to market our product candidates in many countries and regulatory jurisdictions. In
order to market our product
40
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
payors, 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 payors of health care costs to contain or reduce costs of health care 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 health care in the United States, the U.S. Congress and state legislatures will likely continue
to focus on health care reform, the cost of prescription pharmaceuticals and on the reform of the
Medicare and Medicaid systems. In certain countries, particularly the countries of the European
Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these
countries, pricing negotiations with governmental authorities can take six to twelve months or
longer after the receipt of regulatory marketing approval for a product. To obtain reimbursement or
pricing approval in some countries, we may be required to conduct clinical trials that compare the
cost-effectiveness of our product candidates to other available therapies. If reimbursement for our
product candidates were unavailable or limited in scope or amount or if reimbursement levels or
prices are set at unsatisfactory levels, our projected and actual revenues and our prospects for
profitability would be negatively affected.
Another development that may affect the pricing of drugs in the United States is regulatory
action regarding drug reimportation into the United States. The Medicare Prescription Drug,
Improvement and Modernization Act of 2003, which became law in December 2003, requires the
Secretary of the U.S. Department of Health and Human Services to promulgate regulations allowing
drug reimportation from Canada into the United States under certain circumstances. These provisions
will become effective only if the Secretary certifies that such imports will pose no additional
risk to the publics health and safety and result in significant cost savings to consumers.
Proponents of drug reimportation may also attempt to pass legislation that would remove the
requirement for the Secretarys certification or allow reimportation under circumstances beyond
those anticipated under current law. If legislation is enacted, or regulations issued, allowing the
reimportation of drugs, it could decrease the reimbursement we would receive for any product
candidates that we may commercialize, or require us to lower the price of our product candidates
then on the market that face competition from lower priced supplies of that product from other
countries. These factors would negatively affect our projected and actual revenues and our
prospects for profitability.
If physicians and patients do not accept the product candidates that we may develop, our ability to
generate product revenue in the future will be adversely affected.
Our product candidates, if successfully developed and approved by the regulatory authorities,
may not gain market acceptance among physicians, healthcare payors, patients and the medical
community. Market acceptance of and demand for any product candidate that we may develop will
depend on many factors, including:
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our ability to provide acceptable evidence of safety and efficacy; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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availability of alternative treatments; |
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cost effectiveness; |
41
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effectiveness of our marketing and pricing strategy of any product candidate that we may develop; |
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publicity concerning our product candidates or competitive products; and |
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our ability to obtain third-party coverage or reimbursement. |
If any product candidates for which we may receive marketing approval fail to gain market
acceptance, our ability to generate product revenue in the future will be adversely affected.
We face the risk of product liability claims and may not be able to obtain insurance.
Our business exposes us to the risk of product liability claims that is inherent in the
testing, manufacturing, and marketing of drugs and related devices. Although we have product
liability and clinical trial liability insurance that we believe is appropriate, this insurance is
subject to deductibles and coverage limitations. We may not be able to obtain or maintain adequate
protection against potential liabilities. If any of our product candidates are approved for
marketing, we may seek additional insurance coverage. If we are unable to obtain insurance at
acceptable cost or on acceptable terms with adequate coverage or otherwise protect ourselves
against potential product liability claims, we will be exposed to significant liabilities, which
may harm our business. These liabilities could prevent or interfere with our product
commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert
management attention and might result in adverse publicity or reduced acceptance of our product
candidates in the market.
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 and maintenance of patent applications, patents and trademarks claiming or covering our
product candidates.
To date, we have sought to protect our proprietary positions related to our important
proprietary technology, inventions and improvements by filing of patent applications in the U.S.,
Europe and other jurisdictions. Because the patent position of pharmaceutical and biopharmaceutical
companies involves complex legal and factual questions, the issuance, scope and enforceability of
patents cannot be predicted with certainty, and we cannot be certain that patents will be issued on
pending or future patent applications that cover our product candidates and technologies. 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. 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 can result in a third party receiving the patent
rights sought by us, which in turn could affect our ability to market a potential product to which
that patent filing was directed. Our pending patent applications, those that we may file in the
future, or those that we may license from third parties may not
42
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.
We rely on third-party payment services for the payment of foreign patent annuities and other
fees. Non-payment or delay in payment of such fees, whether intentional or unintentional, may
result in loss of patents or patent rights important to our business.
We may incur substantial costs enforcing our patents against third parties. If we are unable to
protect our intellectual property rights, our competitors may develop and market products with
similar features that may reduce demand for our potential products.
We own or control a substantial portfolio of issued patents. From time to time, we may become
aware of third parties that undertake activities that infringe on our patents. We may decide to
grant those third parties a license under our patents, or to enforce the patents against those
third parties by pursuing an infringement claim in litigation. If we initiate patent infringement
litigation, it could consume significant financial and management resources, regardless of the
merit of the claims or the outcome of the litigation. The outcome of patent litigation is subject
to uncertainties that cannot be adequately quantified in advance, including the demeanor and
credibility of witnesses and the identity of the adverse party, especially in biotechnology related
patent cases that may turn on the testimony of experts as to technical facts upon which experts may
reasonably disagree. Some of our competitors may be able to sustain the costs of such litigation or
proceedings more effectively than we can because of their substantially greater financial
resources. Uncertainties resulting from the initiation and continuation of patent litigation or
other proceedings could harm our ability to compete in the marketplace.
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 will not otherwise become known or independently developed by a third party. Our trade
secrets, and those of our present or future collaborators that we utilize by agreement, may become
known or may be independently discovered by others, which could adversely affect the competitive
position of our product candidates. If any trade secret, know-how or other technology not protected
by a patent 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
43
held by others. Also, we are aware of patents and other intellectual property rights of third
parties relating to our areas of practice, and we know that others have filed patent applications
in various countries that relate to several areas in which we are developing product candidates.
Some of these patent applications have already resulted in patents and some are still pending. The
pending patent applications may also result in patents being issued. In addition, the publication
of patent applications occurs with a certain delay after the date of filing, so we may not be aware
of all relevant patent applications of third parties. 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. 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.
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 expect to enter into similar licenses and agreements in the future. These licenses and
agreements impose various research, development, commercialization, sublicensing, milestone and
royalty payment, indemnification, insurance and other obligations on us. If we or our collaborators
fail to perform under these agreements or otherwise breach obligations thereunder, our licensors
may terminate these agreements and we could lose licenses to intellectual property rights that are
important to our business. Any such termination could materially harm our ability to develop and
commercialize the product candidate that is the subject of the agreement, which could have a
material adverse impact on our results of operations.
If licensees or assignees of our intellectual property rights breach any of the agreements under
which we have licensed or assigned our intellectual property to them, we could be deprived of
important intellectual property rights and future revenue.
We are a party to intellectual property out-licenses, collaborations and agreements that are
important to our business and 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.
44
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.
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 Manufacturing and Sales of Products
We will depend on our collaborators and third-party manufacturers to produce most, if not all, of
our product candidates and if these third parties do not successfully manufacture these product
candidates our business will be harmed.
We have no manufacturing experience or manufacturing capabilities for the production of our
product candidates for clinical trials or commercial sale. In order to continue to develop product
candidates, apply for regulatory approvals, and commercialize our product candidates following
approval, we or our collaborators must be able to manufacture or contract with third parties to
manufacture our product candidates in clinical and commercial quantities, in compliance with
regulatory requirements, at acceptable costs and in a timely manner. The manufacture of our product
candidates may be complex, difficult to accomplish and difficult to scale-up when large-scale
production is required. Manufacture may be subject to delays, inefficiencies and poor or low yields
of quality products. The cost of manufacturing our product candidates may make them prohibitively
expensive. If supplies of any of our product candidates or related materials become unavailable on
a timely basis or at all or are contaminated or otherwise lost, clinical trials by us and our
collaborators could be seriously delayed. This is due to the fact that such materials are
time-consuming to manufacture and cannot be readily obtained from third-party sources.
To the extent that we, or our collaborators, seek to enter into manufacturing arrangements
with third parties, we and such collaborators will depend upon these third parties to perform their
obligations in a timely and effective manner and in accordance with government regulations.
Contract manufacturers may breach their manufacturing agreements because of factors beyond our
control or may terminate or fail to renew a manufacturing agreement based on their own business
priorities at a time that is costly or inconvenient for us. If third-party manufacturers fail to
perform their obligations, our competitive position and ability to generate revenue may be
adversely affected in a number of ways, including:
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we and our collaborators may not be able to initiate or continue clinical trials of
product candidates that are under development; |
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we and our collaborators may be delayed in submitting applications for regulatory
approvals for our product candidates; and |
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we and our collaborators may not be able to meet commercial demands for any approved
products. |
We have no sales or marketing 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 Serono and MedImmune, we have granted these companies the
right to
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market and distribute products resulting from such collaborations, if any are ever successfully
developed. We may have to enter into additional marketing arrangements in the future and we may not
be able to enter into these additional arrangements on terms that are favorable to us, if at all.
In addition, we may have limited or no control over the sales, marketing and distribution
activities of these third parties and sales through these third parties could be less profitable to
us than direct sales. These third parties could sell competing products and may devote insufficient
sales efforts to our product candidates following approval. As a result, our future revenues from
sales of our product candidates, if any, will be materially dependent upon the success of the
efforts of these third parties.
We may seek to co-promote products with our collaborators, or to independently market products
that are not already subject to marketing agreements with other parties. If we determine to perform
sales, marketing and distribution functions ourselves, we could face a number of additional risks,
including:
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we may not be able to attract and build a significant and skilled marketing staff or
sales force; |
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the cost of establishing a marketing staff or sales force may not be justifiable in
light of the revenues generated by any particular product; and |
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our direct sales and marketing efforts may not be successful. |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
Christian Itin
On
June 2, 2006, we entered into an employment agreement with our Chief
Executive Officer Christian Itin, effective as of June 2, 2006, which
replaced the letter employment agreement entered into on May 5, 2006.
Mr. Itins employment agreement provides for an initial term
expiring on June 1, 2010, with automatic one-year extensions
thereafter. Mr. Itin will receive a base salary of 268,000 per
year. In addition, Mr. Itin is eligible to participate in our 2006
Management Incentive Compensation Plan, under which he may earn a
bonus of up to 50% of his base salary based on the achievement of
certain corporate performance criteria. Mr. Itin will also be
eligible to participate in any other incentive plan offered generally
to the Companys senior executive officers. The Company did not
grant any options in connection with the execution of the employment
agreement.
If
we terminate Mr. Itins employment agreement without cause or if
Mr. Itin terminates the employment agreement for good reason, we may
be obligated to make certain severance payments to Mr. Itin, including
the acceleration of certain equity awards, as outlined in the
employment agreement. We may also be obligated to make certain
payments to Mr. Itin in the event of the termination of his
employment agreement as a result of his permanent disability or
death, as outlined in the employment agreement.
Mr.
Itins employment agreement is filed herewith as Exhibit 10.13
and is incorporated by reference herein.
Matthias Alder
On July 1, 2006, we entered into an employment agreement with Matthias Alder, effective as of
July 1, 2006, pursuant to which Mr. Alder was appointed as our Senior Vice President, General
Counsel and Secretary. Mr. Alders employment agreement provides for an initial term expiring on
June 30, 2010, with automatic one-year extensions thereafter. Mr. Alder will receive a base salary
of $300,000 per year, and a transition payment in the amount of $16,666 per month for the first six
months. In addition, we granted Mr. Alder an option to purchase 250,000 shares of our common stock,
exercisable at a price per share of $3.70, equal to the fair market value of our common stock on
the date of grant. Options to purchase 25% of the shares will vest on the 12 month anniversary of
the effective date of Mr. Alders employment agreement, and the remainder of the options will vest
in 36 equal monthly installments thereafter, such that all of the options will be vested by the
fourth anniversary of the effective date of the agreement. In addition, Mr. Alder is eligible to participate
in our 2006 Management Incentive Compensation Plan, under which he may earn a bonus of up to 35% of
his base salary based on the achievement of certain individual and corporate performance criteria.
Mr. Alder will also be eligible to participate in any other incentive plan offered generally to our
senior executive officers.
In the
event of a change of control, as that term is defined in his employment agreement, 50%
of all unvested equity awards held by Mr. Alder will vest and become exercisable. In the event Mr.
Alders employment is terminated by us without cause or by Mr. Alder for good reason, as those
terms are defined in his employment agreement, any time within six months prior to or 12 months
following a change of control, all unvested equity awards held by Mr. Alder will vest and become
exercisable. In addition, if we terminate Mr. Alders employment agreement without cause or if Mr.
Alder terminates the employment agreement for good reason, we may be obligated to make certain
severance payments to Mr. Alder, including the acceleration of certain equity awards, as outlined
in his employment agreement. We may also be obligated to make certain payments to Mr. Alder in the
event of the termination of his employment agreement as a result of his permanent disability or
death, as outlined in the employment agreement.
Mr. Alders employment agreement is filed herewith as Exhibit 10.14 and is incorporated by
reference herein.
Non-employee
Director Compensation
During
the quarter ended September 30, 2006, our board of directors
determined that non-employee directors would no longer receive
compensation for attending telephonic board meetings lasting less
than two hours. Under our non-employee director compensation policy,
non-employee directors previously were compensated for attending
telephonic board meetings to the same extent as in person board
meetings, regardless of length.
46
Item 6. Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
3.1(1)
|
|
Amended and Restated Certificate of Incorporation |
|
|
|
3.2(2)
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Registrant |
|
|
|
3.3(3)
|
|
Second Amended and Restated Bylaws |
|
|
|
3.4(2)
|
|
First Amendment to Second Amended and Restated Bylaws of the Registrant |
|
|
|
3.5(4)
|
|
Second Amendment to Second Amended and Restated Bylaws of the Registrant |
|
|
|
3.6(5)
|
|
Certificate of Designations for Series A Junior Participating Preferred Stock |
|
|
|
4.1(4)
|
|
Form of Warrant to Purchase Common Stock granted to funds managed by NGN Capital LLC |
|
|
|
4.2(6)
|
|
Warrant to Purchase Common Stock granted to Kingsbridge Capital Limited |
|
|
|
10.9(4)
|
|
Securities Purchase Agreement with funds managed by NGN Capital LLC |
|
|
|
10.10(6)
|
|
Common Stock Purchase Agreement with Kingsbridge Capital Limited |
|
|
|
10.11(6)
|
|
Registration Rights Agreement with Kingsbridge Capital Limited |
|
|
|
10.12(7)*
|
|
Executive Employment Agreement with Christopher L. Schnittker |
|
|
|
10.13*
|
|
Executive Employment Agreement with Christian Itin |
|
|
|
10.14*
|
|
Executive Employment Agreement with Matthias Alder |
|
|
|
31.1
|
|
Certification of principal executive officer pursuant to Rules 13a-14 and 15d-14 promulgated
under the Securities Exchange Act of 1934 |
|
|
|
31.2
|
|
Certification of principal financial officer pursuant to Rules 13a-14 and 15d-14 promulgated
under the Securities Exchange Act of 1934 |
|
|
|
32**
|
|
Certifications of principal executive officer and principal financial officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on December 11, 2003. |
|
(2) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on May 10, 2006. |
|
(3) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(4) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on July 26, 2006. |
|
(5) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
(6) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on August 30, 2006. |
|
(7) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on October 16, 2006. |
47
|
|
|
* |
|
Management contract or compensatory plan or arrangement. |
|
** |
|
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. |
48
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 9, 2006 |
|
Micromet, Inc. |
|
|
|
|
|
|
|
|
|
|
|
By: |
|
/s/ Christopher P. Schnittker |
|
|
|
|
|
|
|
|
|
|
|
Christopher P. Schnittker |
|
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
|
|
(Duly authorized officer and Principal Financial Officer) |
|
|
49
Exhibit List
|
|
|
Exhibit Number |
|
Description |
|
|
|
3.1(1)
|
|
Amended and Restated Certificate of Incorporation |
|
|
|
3.2(2)
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Registrant |
|
|
|
3.3(3)
|
|
Second Amended and Restated Bylaws |
|
|
|
3.4(2)
|
|
First Amendment to Second Amended and Restated Bylaws of the Registrant |
|
|
|
3.5(4)
|
|
Second Amendment to Second Amended and Restated Bylaws of the Registrant |
|
|
|
3.6(5)
|
|
Certificate of Designations for Series A Junior Participating Preferred Stock |
|
|
|
4.1(4)
|
|
Form of Warrant to Purchase Common Stock granted to funds managed by NGN Capital LLC |
|
|
|
4.2(6)
|
|
Warrant to Purchase Common Stock granted to Kingsbridge Capital Limited |
|
|
|
10.9(4)
|
|
Securities Purchase Agreement with funds managed by NGN Capital LLC |
|
|
|
10.10(6)
|
|
Common Stock Purchase Agreement with Kingsbridge Capital Limited |
|
|
|
10.11(6)
|
|
Registration Rights Agreement with Kingsbridge Capital Limited |
|
|
|
10.12(7)*
|
|
Executive Employment Agreement with Christopher L. Schnittker |
|
|
|
10.13*
|
|
Executive Employment Agreement with Christian Itin |
|
|
|
10.14*
|
|
Executive Employment Agreement with Matthias Alder |
|
|
|
31.1
|
|
Certification of principal executive officer pursuant to Rules 13a-14 and 15d-14 promulgated
under the Securities Exchange Act of 1934 |
|
|
|
31.2
|
|
Certification of principal financial officer pursuant to Rules 13a-14 and 15d-14 promulgated
under the Securities Exchange Act of 1934 |
|
|
|
32**
|
|
Certifications of principal executive officer and principal financial officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on December 11, 2003. |
|
(2) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on May 10, 2006. |
|
(3) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(4) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on July 26, 2006. |
|
(5) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
(6) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on August 30, 2006. |
|
(7) |
|
Incorporated by reference to Micromet, Inc.s Current Report on Form 8-K filed with the
Securities and Exchange Commission on October 16, 2006. |
50
|
|
|
* |
|
Management contract or compensatory plan or arrangement. |
|
** |
|
These certifications are being furnished solely to accompany this quarterly report pursuant to
18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities
Exchange Act of 1934 and are not to be incorporated by reference into any filing of the Registrant,
whether made before or after the date hereof, regardless of any general incorporation language in
such filing. |
51