UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
|
þ
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended June 30, 2011
OR
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from to
Commission File Number: 0-50440
MICROMET, INC.
(Exact name of registrant as specified in its charter)
Delaware
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52-2243564
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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|
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9201 Corporate Boulevard, Suite 400, Rockville, MD
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20850
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(Address of principal executive offices)
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(Zip Code)
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(240) 752-1420
(Registrant’s 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 ¨ No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ¨
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Accelerated filer þ
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Non-accelerated filer ¨
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Smaller reporting company ¨
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(Do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ¨ Yes þ No
The number of outstanding shares of the registrant’s common stock, par value $0.00004 per share, as of the close of business on July 29, 2011 was 92,046,415.
FORM 10-Q — QUARTERLY REPORT
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2011
TABLE OF CONTENTS
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Page No.
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PART I — FINANCIAL INFORMATION
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3
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Item 1. Financial Statements
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3
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Condensed Consolidated Balance Sheets as of June 30, 2011 (Unaudited) and December 31, 2010
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3
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Condensed Consolidated Statements of Operations for the three-month and six-month periods ended June 30, 2011 and 2010 (Unaudited)
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4
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Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, 2011 and 2010 (Unaudited)
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5
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Notes to Condensed Consolidated Financial Statements (Unaudited)
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6
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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16
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
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26
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Item 4. Controls and Procedures
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26
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PART II — OTHER INFORMATION
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27
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Item 1. Legal Proceedings
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27
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Item 1A. Risk Factors
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27
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
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46
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Item 3. Defaults Upon Senior Securities
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46
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Item 4. Reserved
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46
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Item 5. Other Information
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46
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Item 6. Exhibits
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46
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SIGNATURES
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48
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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
Micromet, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except per share amounts)
|
|
June 30,
|
|
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December 31,
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|
|
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2011
|
|
|
2010
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|
|
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(unaudited)
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|
|
|
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ASSETS
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|
|
|
|
|
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Current assets:
|
|
|
|
|
|
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Cash and cash equivalents
|
|
$ |
50,689 |
|
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$ |
97,509 |
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Short-term investments
|
|
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136,587 |
|
|
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123,458 |
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Accounts receivable
|
|
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1,629 |
|
|
|
1,047 |
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Prepaid expenses and other current assets
|
|
|
6,071 |
|
|
|
3,850 |
|
Total current assets
|
|
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194,976 |
|
|
|
225,864 |
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Property and equipment, net
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|
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7,489 |
|
|
|
5,577 |
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Goodwill
|
|
|
6,462 |
|
|
|
6,462 |
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Patents, net
|
|
|
161 |
|
|
|
300 |
|
Long-term investments
|
|
|
1,000 |
|
|
|
1,705 |
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Restricted cash
|
|
|
1,107 |
|
|
|
2,396 |
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Total assets
|
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$ |
211,195 |
|
|
$ |
242,304 |
|
|
|
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
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Current liabilities:
|
|
|
|
|
|
|
|
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Accounts payable
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$ |
2,515 |
|
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$ |
5,150 |
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Accrued expenses
|
|
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13,423 |
|
|
|
11,314 |
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Common stock warrants liability
|
|
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13,572 |
|
|
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23,858 |
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Current portion of deferred revenue
|
|
|
4,471 |
|
|
|
5,695 |
|
Total current liabilities
|
|
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33,981 |
|
|
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46,017 |
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Deferred revenue, net of current portion
|
|
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19,389 |
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|
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20,538 |
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Other non-current liabilities
|
|
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1,180 |
|
|
|
1,160 |
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Stockholders' equity:
|
|
|
|
|
|
|
|
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Preferred stock, $0.00004 par value; 10,000 shares authorized; no shares issued and outstanding
|
|
|
- |
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- |
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Common stock, $0.00004 par value; 150,000 shares authorized; 91,942 shares issued and outstanding at June 30, 2011 and 91,160 shares issued and outstanding at December 31, 2010
|
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital
|
|
|
477,798 |
|
|
|
470,368 |
|
Accumulated other comprehensive income
|
|
|
8,675 |
|
|
|
8,569 |
|
Accumulated deficit
|
|
|
(329,832 |
) |
|
|
(304,352 |
) |
Total stockholders' equity
|
|
|
156,645 |
|
|
|
174,589 |
|
Total liabilities and stockholders' equity
|
|
$ |
211,195 |
|
|
$ |
242,304 |
|
The accompanying notes are an integral part of these financial statements.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
|
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Three months ended
|
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Six months ended
|
|
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June 30,
|
|
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June 30,
|
|
|
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2011
|
|
|
2010
|
|
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2011
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|
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2010
|
|
|
|
|
|
|
|
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|
|
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Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
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Collaboration agreements
|
|
$ |
6,791 |
|
|
$ |
6,523 |
|
|
$ |
12,174 |
|
|
$ |
12,563 |
|
License fees and other
|
|
|
271 |
|
|
|
26 |
|
|
|
435 |
|
|
|
296 |
|
Total revenues
|
|
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7,062 |
|
|
|
6,549 |
|
|
|
12,609 |
|
|
|
12,859 |
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Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development
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19,587 |
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|
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12,013 |
|
|
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38,220 |
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|
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24,216 |
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General and administrative
|
|
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7,536 |
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5,388 |
|
|
|
14,204 |
|
|
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10,608 |
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Total operating expenses
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|
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27,123 |
|
|
|
17,401 |
|
|
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52,424 |
|
|
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34,824 |
|
Loss from operations
|
|
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(20,061 |
) |
|
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(10,852 |
) |
|
|
(39,815 |
) |
|
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(21,965 |
) |
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest expense
|
|
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(20 |
) |
|
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(61 |
) |
|
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(42 |
) |
|
|
(148 |
) |
Interest income
|
|
|
197 |
|
|
|
115 |
|
|
|
375 |
|
|
|
230 |
|
Change in fair value of warrants
|
|
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(48 |
) |
|
|
7,878 |
|
|
|
10,094 |
|
|
|
2,271 |
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Other (expense) income
|
|
|
2,638 |
|
|
|
(1,142 |
) |
|
|
3,908 |
|
|
|
(2,754 |
) |
Net loss
|
|
$ |
(17,294 |
) |
|
$ |
(4,062 |
) |
|
$ |
(25,480 |
) |
|
$ |
(22,366 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted net loss per common share
|
|
$ |
(0.19 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.29 |
) |
Weighted average shares used to compute basic and diluted net loss per share
|
|
|
91,544 |
|
|
|
80,857 |
|
|
|
91,381 |
|
|
|
75,954 |
|
The accompanying notes are an integral part of these financial statements.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
Six months ended June 30,
|
|
|
|
2011
|
|
|
2010
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
Net loss
|
|
|
(25,480 |
) |
|
$ |
(22,366 |
) |
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
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Non-cash impact of foreign currency transactions
|
|
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(3,960 |
) |
|
|
3,066 |
|
Depreciation and amortization
|
|
|
1,086 |
|
|
|
1,165 |
|
Accretion on lease liability
|
|
|
399 |
|
|
|
159 |
|
Amortization of premium on investments
|
|
|
993 |
|
|
|
22 |
|
Non-cash change in fair value of common stock warrants liability
|
|
|
(10,094 |
) |
|
|
(2,271 |
) |
Stock-based compensation expense
|
|
|
5,340 |
|
|
|
3,563 |
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(422 |
) |
|
|
(2,818 |
) |
Prepaid expenses and other assets
|
|
|
(754 |
) |
|
|
1,035 |
|
Accounts payable, accrued expenses and other liabilities
|
|
|
(1,916 |
) |
|
|
(5,709 |
) |
Deferred revenue
|
|
|
(4,421 |
) |
|
|
11,786 |
|
Net cash used in operating activities
|
|
|
(39,229 |
) |
|
|
(12,368 |
) |
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases of investments
|
|
|
(97,065 |
) |
|
|
(73,329 |
) |
Proceeds from the maturity of investments
|
|
|
87,856 |
|
|
|
15,254 |
|
Purchases of property and equipment
|
|
|
(2,369 |
) |
|
|
(1,104 |
) |
Net cash used in investing activities
|
|
|
(11,578 |
) |
|
|
(59,179 |
) |
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock, net
|
|
|
3 |
|
|
|
75,382 |
|
Proceeds from exercise of stock options
|
|
|
1,782 |
|
|
|
675 |
|
Proceeds from exercise of warrants
|
|
|
112 |
|
|
|
327 |
|
Principal payments on capital lease obligations
|
|
|
(125 |
) |
|
|
(96 |
) |
Net cash provided by financing activities
|
|
|
1,772 |
|
|
|
76,288 |
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
2,214 |
|
|
|
(5,442 |
) |
Net decrease in cash and cash equivalents
|
|
|
(46,820 |
) |
|
|
(701 |
) |
Cash and cash equivalents at beginning of period
|
|
|
97,509 |
|
|
|
113,435 |
|
Cash and cash equivalents at end of period
|
|
|
50,689 |
|
|
$ |
112,734 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$ |
22 |
|
|
$ |
165 |
|
Supplemental disclosure of noncash investing and financing activities:
|
|
|
|
|
|
|
|
|
Acquisitions of equipment purchased through capital leases
|
|
|
— |
|
|
$ |
28 |
|
The accompanying notes are an integral part of these financial statements.
Note 1. Business Overview
We are a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Our product development pipeline includes novel antibodies generated with our proprietary BiTE® antibody platform, as well as conventional monoclonal antibodies. Three of our BiTE antibodies and three of our monoclonal antibodies are currently in clinical development, while the remainder of our product pipeline is in preclinical development. To date, we have incurred significant research and development expenses and have not achieved any revenues from product sales.
Note 2. Basis of Presentation
The accompanying unaudited consolidated financial statements of Micromet, Inc. have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. In the opinion of management, the consolidated financial statements reflect all adjustments necessary to present fairly our results of operations for the three and six months ended June 30, 2011 and 2010, our financial position at June 30, 2011 and our cash flows for the six months ended June 30, 2011 and 2010. These adjustments are of a normal recurring nature.
Certain notes and other information have been condensed or omitted from the interim consolidated financial statements presented in this Quarterly Report on Form 10-Q. Therefore, these financial statements should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2010, as amended. The results of operations for the three and six months ended June 30, 2011 are not necessarily indicative of our future financial results.
Unless otherwise noted, all financial information is that of Micromet, Inc. and our wholly owned subsidiaries: Micromet AG; Micromet Holdings, Inc.; and Cell-Matrix, Inc. Substantially all of our operating activities are conducted through Micromet AG, a wholly-owned subsidiary of Micromet Holdings, Inc. and an indirect wholly-owned subsidiary of Micromet, Inc. The accompanying condensed consolidated financial statements include the accounts of our wholly owned subsidiaries. We have eliminated all intercompany accounts and transactions in consolidation. Unless specifically noted otherwise, as used throughout these notes to the condensed consolidated financial statements, “Micromet,” “we,” “us,” and “our” refers to the business of Micromet, Inc. and its subsidiaries as a whole.
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition, the valuation of goodwill, intangibles and other long-lived assets, lease exit liabilities, asset retirement obligations and assumptions in the valuation of stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates.
Note 3. Summary of Significant Accounting Policies
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 from date of purchase of three months or less.
Restricted Cash
We have issued irrevocable standby letters of credit in connection with property that we currently sublease, as well as our current property leases in Munich, Germany and Rockville and Bethesda, Maryland. As of June 30, 2011 and December 31, 2010, we had a total of $2.5 million and $3.4 million, respectively, in certificates of deposit relating to these letters of credit. As of June 30, 2011, $1.4 million is classified as prepaid expenses and other current assets and $1.1 million is classified as non-current restricted cash. As of December 31, 2010, $1.0 million of restricted cash is classified as prepaid expenses and other current assets and the remaining balance of $2.4 million is classified as non-current restricted cash. During the three months ended June 30, 2011, we paid $1.0 million that was previously held as restricted cash under our obligation related to a previous lease. As of June 30, 2011, we have no further obligations under that lease.
The amortized cost, net unrealized gain or loss attributed to market pricing changes and estimated fair value of investments by security type of our available-for-sale securities were as follows at June 30, 2011 and December 31, 2010 (in thousands):
Securities at June 30, 2011:
|
|
Amortized
Cost
|
|
|
Unrealized
Gain
|
|
|
Unrealized
Loss
|
|
|
Fair
Value
|
|
Foreign government bonds
|
|
$
|
77,059
|
|
|
$
|
—
|
|
|
$
|
(64
|
)
|
|
$
|
76,995
|
|
U.S. Government agencies
|
|
|
1,000
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,000
|
|
Commercial paper
|
|
|
25,481
|
|
|
|
17
|
|
|
|
—
|
|
|
|
25,498
|
|
U.S. corporate bonds
|
|
|
30,057
|
|
|
|
—
|
|
|
|
(13
|
)
|
|
|
30,044
|
|
Municipal bonds*
|
|
|
4,050
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,050
|
|
Total
|
|
$
|
137,647
|
|
|
$
|
17
|
|
|
$
|
(77
|
)
|
|
$
|
137,587
|
|
Securities at December 31, 2010:
|
|
Amortized
Cost
|
|
|
Unrealized
Gain
|
|
|
Unrealized
Loss
|
|
|
Fair
Value
|
|
Foreign government bonds
|
|
$
|
48,417
|
|
|
$
|
11
|
|
|
$
|
(25
|
)
|
|
$
|
48,403
|
|
U.S. Government agencies
|
|
|
7,000
|
|
|
|
—
|
|
|
|
(4
|
)
|
|
|
6,996
|
|
Commercial paper
|
|
|
27,928
|
|
|
|
13
|
|
|
|
(3
|
)
|
|
|
27,938
|
|
U.S. corporate bonds
|
|
|
34,651
|
|
|
|
3
|
|
|
|
(23
|
)
|
|
|
34,631
|
|
Municipal bonds*
|
|
|
7,195
|
|
|
|
—
|
|
|
|
—
|
|
|
|
7,195
|
|
Total
|
|
$
|
125,191
|
|
|
$
|
27
|
|
|
$
|
(55
|
)
|
|
$
|
125,163
|
|
|
Issued by a state level entity
|
As of June 30, 2011, we held securities in an unrealized loss position whose fair value approximated at $102.9 million. All of these securities with an unrealized loss have been in a continuous unrealized loss position for less than one year. We have determined that the decline in fair value of these investments is temporary. We do not intend to sell these securities and it is not more likely than not we will be required to sell the securities before the recovery of their amortized cost basis.
The following table summarizes the contractual maturities of marketable investments at June 30, 2011 and December 31, 2010 (in thousands):
Securities at June 30, 2011:
|
|
Amortized
Cost
|
|
|
Fair
Value
|
|
Due in less than one year
|
|
$ |
136,647 |
|
|
$ |
136,587 |
|
Due in one to two years
|
|
|
1,000 |
|
|
|
1,000 |
|
Due after two years
|
|
|
— |
|
|
|
— |
|
Total
|
|
$ |
137,647 |
|
|
$ |
137,587 |
|
Securities at December 31, 2010:
|
|
Amortized
Cost
|
|
|
Fair
Value
|
|
Due in less than one year
|
|
$ |
123,486 |
|
|
$ |
123,458 |
|
Due in one to two years
|
|
|
1,705 |
|
|
|
1,705 |
|
Due after two years
|
|
|
— |
|
|
|
— |
|
Total
|
|
$ |
125,191 |
|
|
$ |
125,163 |
|
Fair Value Measurements
The fair value of an asset or liability should represent the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Such transactions to sell an asset or transfer a liability are assumed to occur in the principal or most advantageous market for the asset or liability. Accordingly, fair value is determined based on a hypothetical transaction at the measurement date, considered from the perspective of a market participant rather than from a reporting entity’s perspective. New fair value measurements are not required if existing accounting guidance in the Financial Accounting Standard Board (FASB) codification require or permit fair value measurements.
Disclosure of assets and liabilities subject to fair value disclosures are to be classified according to a three level fair value hierarchy with respect to the inputs (or assumptions) used in fair value measurements. Observable inputs such as unadjusted quoted market prices for identical assets or liabilities are given the highest priority within the hierarchy (Level 1). When observable inputs are unavailable, the use of unobservable inputs is permitted — i.e., inputs that a reporting entity believes market participants would use in pricing that are developed based on the best information available (Level 2). Unobservable inputs are given the lowest priority within the hierarchy (Level 3). The level within the hierarchy at which a fair value measurement lies is determined based on the lowest level input that is significant to the fair value measurement in its entirety. Refer to related disclosures at Note 4 of these consolidated financial statements for additional information about fair value measurements.
Accounts Receivable
Accounts receivable are recorded at the amount invoiced and generally do not bear interest. The allowance for doubtful accounts is our best estimate of the amount of probable credit losses from the existing accounts receivable. We determine the allowance based on historical experience, review of specific accounts, and significant past due balances. Account balances are written off against the allowance after all reasonable means of collection have been exhausted and recovery is considered remote.
Property and equipment are stated at cost, less accumulated depreciation and amortization. Major replacements and improvements that extend the useful life of assets are capitalized, while general repairs and maintenance are charged to expense as incurred. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, ranging from three to ten years. Leasehold improvements are amortized over the estimated useful lives of the assets or the related lease term, whichever is shorter.
Goodwill
We 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. A reporting unit is an operating segment for which discrete financial information is available and segment management regularly reviews the operating results of that component. We have determined that we have only one reporting unit, the development of biopharmaceutical products. Goodwill is determined to be impaired if the fair value of the reporting unit is less than its carrying amount. We have selected October 1 as our annual goodwill impairment testing date.
Patents
Our patent portfolio consists primarily of internally developed patents covering our BiTE antibody platform and the composition of our BiTE antibody product candidates and conventional antibodies. The costs of generating our internally developed patent portfolio have been expensed as incurred.
We also acquired patents in 2001 covering single-chain antibody technology. These purchased patents are being amortized over their estimated useful lives through 2011 using the straight-line method. These patents are utilized in revenue-producing activities through license agreements.
Impairment of Long-Lived and Identifiable Intangible 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 may be recognized when the estimated undiscounted future cash flow is less than the carrying amount of the asset. An impairment loss is measured as the amount by which the carrying value of the asset exceeds the fair value of the asset.
Common Stock Warrants Liability
We previously issued certain warrants to purchase shares of our common stock. Due to certain provisions in the common stock warrant agreement, these warrants are required to be classified as a liability. Management believes that the circumstances requiring cash settlement of the award are remote. The common stock warrants liability is recorded at fair value, which is adjusted at the end of each reporting period using the Black-Scholes option-pricing model, with changes in value included in the consolidated statements of operations.
Foreign Currency Transactions and Translation
Transactions in foreign currencies are initially recorded at the functional currency rate ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are re-measured into the functional currency at the exchange rate in effect at the balance sheet date. Transaction gains (losses) are recorded in the consolidated statements of operations in other income (expense) and amounted to $2.7 million and $(1.2) million for the three-month periods ended June 30, 2011 and 2010, respectively, and $3.9 million and $(2.8) million for the six-month periods ended June 30, 2011 and 2010, respectively.
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 exchange rate in effect for the period. The translation of operating cash flow data is made at the average exchange rate in effect for the period, and investing and financing cash flow data is translated at the exchange rate in effect at the date of the underlying transaction. Translation gains and losses are recognized as a component of accumulated other comprehensive income in the accompanying consolidated balance sheets. The foreign currency translation adjustment balance included in accumulated other comprehensive income was $5.4 million and $7.4 million at June 30, 2011 and December 31, 2010, respectively.
Revenue Recognition
Our revenues consist of licensing fees, milestone payments and fees for research services earned from license agreements or from research and development collaboration agreements. We recognize revenue in accordance with the Securities and Exchange Commission’s (SEC) Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition, upon the satisfaction of 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 revenues under collaborative research agreements as we perform the services specified in the related agreement, or as we incur expenses that are passed through to the collaborator. Fees for research and development services performed under an agreement are generally stated at a yearly fixed fee per research scientist, and are recognized as revenues as the services are provided. We record any amounts received in advance of services performed as deferred revenue and recognize it as revenues if and when earned.
Under certain license agreements, we may receive initial license fees and annual renewal fees, which are recognized as revenue when the SAB 104 criteria have been satisfied, unless we have further obligations associated with the license granted. We recognize revenue from payments received at the time of entering into an agreement on a straight-line basis over the term of our obligations under the agreement.
We are entitled to receive royalty payments on the sale of products developed under our license and collaboration agreements. Any such royalties are based upon the volume of products sold and would be recognized as revenue upon notification by our collaborator or licensee that is commercializing the product that sales have occurred. There have been no product sales to date that would result in any royalty payments to us.
Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones are achieved and the milestone payments are due and collectible. If not deemed substantive, we would recognize such milestone payments as revenue on a straight-line basis over the remaining expected term of continued involvement in the research and development process. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is non-refundable; (2) achievement of the milestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with the achievement of the milestone and any ongoing research and development or other services are priced at fair value. Payments received in advance of work performed are recorded as deferred revenue.
For revenue arrangements including multiple deliverables and entered into prior to January 1, 2011, revenue was allocated among the separate elements based on their relative fair values, provided the elements had value on a stand-alone basis and there was objective and reliable evidence of fair value. Applicable revenue recognition criteria are considered separately for each unit of accounting. We recognize revenue on development and collaboration agreements, including upfront payments, where they are considered combined units of accounting, over the period specified in the related agreement or as we perform services under the agreement
For multiple element arrangements entered into or materially modified on or subsequent to January 1, 2011, the total consideration for an arrangement is allocated among the separate elements in the arrangement based on a selling price hierarchy. The selling price hierarchy for a deliverable is based on (i) vendor specific objective evidence (VSOE), if available; (ii) third party evidence of selling price if VSOE is not available; or (iii) an estimated selling price, if neither VSOE nor third party evidence is available. Since we did not enter into or materially modify any multiple-element arrangements during the six months ended June 30, 2011, the adoption of this new accounting guidance did not have a material impact on our consolidated financial statements as of and for the three- and six-month periods ended June 30, 2011. We do anticipate that when we enter into new multiple-element arrangements or materially modify existing multiple-element arrangements, including the collaboration and license agreement with Amgen described in Note 8 below, this new guidance will change the revenue recognition methodology for these arrangements, as compared to past practice.
Research and Development
Except for payments made in advance of services rendered, research and development expenditures, including direct and allocated expenses, are charged to operations as incurred.
Comprehensive Income (Loss)
Comprehensive income (loss) is comprised of net loss and other comprehensive income (loss). Other comprehensive income (loss) is the result of foreign currency exchange translation adjustments and unrealized gains on available for sale investments. The following table sets forth the components of comprehensive income (loss) (in thousands):
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
Net loss
|
|
$ |
(17,294 |
) |
|
$ |
(4,062 |
) |
|
$ |
(25,480 |
) |
|
$ |
(22,366 |
) |
Realized foreign currency transactions
|
|
|
1,915 |
|
|
|
(1,060 |
) |
|
|
2,138 |
|
|
|
(847 |
) |
Unrealized foreign currency transactions
|
|
|
(2,837 |
) |
|
|
(2,109 |
) |
|
|
97 |
|
|
|
(3,813 |
) |
Foreign currency translation adjustments
|
|
|
(686 |
) |
|
|
1,976 |
|
|
|
(2,101 |
) |
|
|
3,134 |
|
Unrealized gain (loss) on available-for-sale investments
|
|
|
6 |
|
|
|
(20 |
) |
|
|
(28 |
) |
|
|
(10 |
) |
Comprehensive loss
|
|
$ |
(18,896 |
) |
|
$ |
(5,275 |
) |
|
$ |
(25,374 |
) |
|
$ |
(23,902 |
) |
Stock-Based Compensation
We account for stock-based payments to employees by estimating the fair value of the grant and recognizing the resulting value ratably over the requisite service period. The estimated fair value is determined by utilizing the Black-Scholes option pricing model. The determination of the estimated fair value of our stock-based payment awards on the date of grant using an option-pricing model is affected by our stock price as well as assumptions regarding expected volatility, risk-free interest rate, dividend yield and expected term.
We recognize stock-based compensation expense for options granted with graded vesting over the requisite service period of the individual stock option grants, which typically equals the vesting period, using the straight-line attribution method. For stock-based awards that contain a performance condition, expense is recognized using the accelerated attribution 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.
Options or stock awards issued to non-employees are measured at their estimated fair value. Expense is recognized when service is rendered; however, the expense may fluctuate with changes in the fair value of the underlying common stock, until the award is vested.
Income Taxes
We account for income taxes using the liability method. Deferred income taxes are recognized at the enacted tax rates for temporary differences between the financial statement and income tax bases of assets and liabilities. Deferred tax assets are reduced by a valuation allowance if, based upon the weight of available evidence, it is more likely than not that some portion or all of the related tax asset will not be recovered.
We account for uncertain tax positions pursuant to ASC Topic 740. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured at the largest amount that is more than 50 percent likely to be realized upon ultimate settlement. In making such determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. It is our policy to record interest and penalties related to uncertain tax positions as a component of income tax expense.
Net Loss 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, 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 following options and warrants to purchase additional shares were excluded from the weighted average share calculation for the three- and six-month periods ended June 30, 2011 and 2010, respectively, as their effect would be anti-dilutive (share amounts in thousands):
|
|
Three months ended June 30,
|
|
|
Six months ended June 30,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
Options outstanding
|
|
|
13,339 |
|
|
|
12,119 |
|
|
|
13,339 |
|
|
|
12,119 |
|
Warrants outstanding
|
|
|
8,023 |
|
|
|
8,070 |
|
|
|
8,023 |
|
|
|
8,070 |
|
Total shares excluded from calculation
|
|
|
21,362 |
|
|
|
20,189 |
|
|
|
21,362 |
|
|
|
20,189 |
|
During the six months ended June 30, 2011, 745,000 shares of our common stock were issued upon the exercise of stock options in exchange for cash proceeds of $1,782,000 and 36,331 shares of our common stock were issued upon the exercise of warrants in exchange for cash proceeds of $112,000.
Note 4. Fair Value Measurements
We include disclosures about fair value measurements pursuant to ASC Topic 820. ASC Topic 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Such transactions to sell an asset or transfer a liability are assumed to occur in the principal or most advantageous market for the asset or liability. Accordingly, fair value as described by ASC Topic 820 is determined based on a hypothetical transaction at the measurement date, considered from the perspective of a market participant.
ASC Topic 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.
For Level 2 financial investments, our investment advisor provides us with monthly account statements documenting the value of each investment based on prices received from an independent third-party valuation service provider. This third party evaluates the types of securities in our investment portfolio to determine their proper classification in the fair value hierarchy based on trading activity and the observability of market inputs. Our Level 2 instruments are valued using a multi-dimensional pricing model that includes a variety of inputs, including quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, interest rates and yield curves observable at commonly quoted intervals, volatilities, prepayment speeds, loss severities, credit risks and default rates that are observable at commonly quoted intervals. As we are ultimately responsible for the determination of the fair value of these instruments, we perform quarterly analyses using prices obtained from another independent third-party provider of financial instrument valuations, to establish that the prices we have used are reasonable estimates of fair value.
We do not hold auction rate securities, loans held for sale, mortgage-backed securities backed by sub-prime or Alt-A collateral or any other investments which require us to determine fair value using a discounted cash flow approach. Therefore, we do not adjust our analysis or change our assumptions specifically to factor illiquidity in the markets into our Level 2 fair value measurements.
The following table presents information about our assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2011 (in thousands):
|
|
|
|
|
Quoted Prices in
|
|
|
Significant Other
|
|
|
Significant
Unobservable
|
|
|
|
June 30,
|
|
|
Active Markets
|
|
|
Observable Inputs
|
|
|
Inputs
|
|
Description
|
|
2011
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
50,689
|
|
|
$
|
50,689
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted cash
|
|
|
1,350
|
|
|
|
1,350
|
|
|
|
—
|
|
|
|
—
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign government bonds
|
|
|
76,995
|
|
|
|
—
|
|
|
|
76,995
|
|
|
|
—
|
|
U.S. Government agencies
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Commercial paper
|
|
|
25,498
|
|
|
|
—
|
|
|
|
25,498
|
|
|
|
—
|
|
U.S. corporate bonds
|
|
|
30,044
|
|
|
|
—
|
|
|
|
30,044
|
|
|
|
—
|
|
Municipal bonds
|
|
|
4,050
|
|
|
|
—
|
|
|
|
4,050
|
|
|
|
—
|
|
Restricted cash, long-term
|
|
|
1,107
|
|
|
|
1,107
|
|
|
|
—
|
|
|
|
—
|
|
Long-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government agencies
|
|
|
1,000
|
|
|
|
—
|
|
|
|
1,000
|
|
|
|
—
|
|
Total assets
|
|
$
|
190,733
|
|
|
$
|
53,146
|
|
|
$
|
137,587
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock warrant liability
|
|
$
|
(13,572
|
))
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(13,572
|
)
|
There were no transfers of financial assets or liabilities between Level 1 and Level 2 during the six months ended June 30, 2011. The following table presents information about our common stock warrant liability, which was our only financial instrument measured at fair value on a recurring basis using significant unobservable inputs (Level 3) as defined in ASC Topic 820 during the three and six months ended June 30, 2011 and 2010 (in thousands):
|
|
Three months ended June 30,
|
|
|
Six months ended June 30,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
Beginning balance
|
|
$ |
(13,524 |
) |
|
$ |
(25,851 |
) |
|
$ |
(23,858 |
) |
|
$ |
(20,244 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transfers to (from) Level 3
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Realized gains/( losses) included in earnings
|
|
|
(48 |
) |
|
|
7,878 |
|
|
|
10,094 |
|
|
|
2,271 |
|
Purchases
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Issuances
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Settlements
|
|
|
— |
|
|
|
— |
|
|
|
192 |
|
|
|
— |
|
Ending balance
|
|
$ |
(13,572 |
) |
|
$ |
(17,973 |
) |
|
$ |
(13,572 |
) |
|
$ |
(17,973 |
) |
The settlement above represents a warrant exercise and the corresponding decrease in the liability. The settlement is valued as of the actual transaction date. The fair value of the common stock warrant liability is calculated using the Black-Scholes option pricing model, which requires the input of highly subjective assumptions. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. The risk-free rate of interest is based on the U.S. Treasury rates appropriate for the expected term of the award. Expected dividend yield is projected at 0%, as we have not paid any dividends on our common stock since our inception and we do not anticipate paying dividends on our common stock in the foreseeable future. Expected volatility is based on our historical volatility. The expected term is determined based on the contractual period of the warrants.
We have recorded deferred revenues from our research and development agreements as follows (in thousands):
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2011
|
|
|
2010
|
|
Nycomed
|
|
$ |
5,696 |
|
|
$ |
6,310 |
|
Sanofi
|
|
|
5,745 |
|
|
|
5,640 |
|
Bayer Schering Pharma
|
|
|
5,222 |
|
|
|
5,155 |
|
Boehringer Ingelheim
|
|
|
6,775 |
|
|
|
6,405 |
|
Merck Serono
|
|
|
— |
|
|
|
1,368 |
|
TRACON
|
|
|
— |
|
|
|
1,121 |
|
Other
|
|
|
422 |
|
|
|
234 |
|
Subtotal
|
|
|
23,860 |
|
|
|
26,233 |
|
Current portion
|
|
|
(4,471 |
) |
|
|
(5,695 |
) |
Long-term portion
|
|
$ |
19,389 |
|
|
$ |
20,538 |
|
The deferred revenue from agreements with Boehringer Ingelheim, Nycomed, sanofi and Bayer Schering consists mainly of the upfront license fees that are being recognized over the periods that we are required to participate on joint steering committees, which are 20 years, 20 years, 6 years and 4.5 years, respectively. The remaining balance of deferred revenue under the Merck Serono agreement has been recognized during the second quarter of 2011. TRACON provided notice of termination to the license and collaboration agreement during the second quarter of 2011, and we recognized the remaining deferred revenue under that agreement at that time as we had no further performance obligations under the terms of the arrangement.
Note 6. Other Liabilities
Other liabilities consist of the following (in thousands):
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2011
|
|
|
2010
|
|
Facility lease exit liability
|
|
$ |
497 |
|
|
$ |
1,504 |
|
Asset retirement obligation
|
|
|
970 |
|
|
|
620 |
|
Capital lease obligations
|
|
|
438 |
|
|
|
521 |
|
Other
|
|
|
88 |
|
|
|
89 |
|
Subtotal
|
|
|
1,993 |
|
|
|
2,734 |
|
Less current portion included in accrued expenses
|
|
|
(813 |
) |
|
|
(1,574 |
) |
Other non-current liabilities
|
|
$ |
1,180 |
|
|
$ |
1,160 |
|
During the second quarter of 2011, we made additional modifications to our leased space in Munich, Germany and also extended the lease for another 5 years. This resulted in an increase in the asset retirement obligation of approximately $279,000.
Facility Lease Exit Liability and Restructuring Provision
We review the adequacy of our estimated exit accruals on an ongoing basis. The following table summarizes the facility lease activity for these obligations for the three and six month periods ended June 30, 2011 and 2010 (in thousands):
|
|
Three months ended June 30,
|
|
|
Six months ended June 30,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
Beginning balance
|
|
$ |
1,460 |
|
|
$ |
1,228 |
|
|
$ |
1,504 |
|
|
$ |
1,276 |
|
Increase to reserve
|
|
|
68 |
|
|
|
— |
|
|
|
68 |
|
|
|
— |
|
Amounts paid in period
|
|
|
(1,118 |
) |
|
|
(104 |
) |
|
|
(1,229 |
) |
|
|
(208 |
) |
Accretion expense
|
|
|
87 |
|
|
|
55 |
|
|
|
154 |
|
|
|
111 |
|
Ending balance
|
|
$ |
497 |
|
|
$ |
1,179 |
|
|
$ |
497 |
|
|
$ |
1,179 |
|
The accretion expense is included in general and administrative expenses. During the second quarter of 2011, we relocated our U.S. corporate headquarters. The increase to the reserve was equal to the remaining lease obligation on the prior headquarters. The full amount of the lease exit liability is a current liability as of June 30, 2011.
Note 7. Committed Equity Financing Facility
In December 2008, we entered into a Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited (Kingsbridge) which entitles us to sell, and obligates Kingsbridge to purchase, shares of our common stock from time to time through December 2011 for up to $75.0 million, subject to certain conditions and restrictions. As of June 30, 2011, Kingsbridge’s remaining commitment under the CEFF is equal to the lesser of $69.7 million or 8,684,351 shares (which shares would be priced at a discount ranging from 6% to 14% of the average market price during any future draw down), subject to certain conditions and restrictions.
Note 8. Milestone Revenue
In 2007, we entered into an agreement with TRACON Pharmaceuticals, Inc., or TRACON, under which we granted TRACON an exclusive, worldwide license to develop and commercialize the conventional antibody candidate MT293. Under the terms of the agreement, TRACON was responsible for the development and commercialization of MT293 on a worldwide basis, as well as the costs and expenses associated with such activities.
We recognized revenues of approximately $0.8 million related to the achievement of a milestone under this agreement during the three months ended June 30, 2011. Based on our revenue recognition policy related to milestone payments, we considered the milestone to be significant, specifically concluding that the milestone payment was non-refundable, achievement of the milestone was not reasonably assured at the inception of the agreement, there was substantive effort to achieve the milestone, and the milestone payment was considered reasonable in relation to the efforts expended.
Also during the three months ended June 30, 2011, TRACON sent us a notice of termination of the license agreement. The termination became effective in the third quarter, and we intend to discontinue the development of MT293.
Note 9. Subsequent Event
On July 11, 2011, we entered into a Collaboration and License Agreement with Amgen Inc. under which the two companies will collaborate on the research of BiTE antibodies against three undisclosed solid tumor targets and the subsequent development and commercialization of BiTE antibodies against up to two of these targets, to be selected by Amgen. We received an up-front payment of €10 million, or $14.5 million using the exchange rate as of the payment date, of which €4 million (approximately $5.8 million using the exchange rate as of the payment date) was an advanced payment to us for research and development expenses to be incurred. We will be primarily responsible for the generation and pre-clinical research of the BiTE antibodies, and Amgen will lead the clinical development, manufacturing, and commercialization of any products resulting from the collaboration. We are eligible to receive up to €342 million in clinical and commercial milestone payments and up to double-digit royalties on worldwide net sales. If Amgen elects to develop a BiTE antibody against a second target, we will be eligible to receive an additional cash payment upon initiation of the program, as well as milestones, royalties and development funding comparable to the first program.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Any statements in the discussion below, and elsewhere 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 our expectations regarding future revenue and expense levels, the efficacy, safety and intended utilization of our product candidates, the development of our clinical stage product candidates and our BiTE antibody technology, the future development of blinatumomab by us, the conduct, timing and results of future clinical trials, plans regarding regulatory filings, our available cash resources and the availability of financing generally, including our ability to draw down under our committed equity financing facility, and our plans regarding partnering activities. You can identify these forward-looking statements by the use of words or phrases such as “believe,” “may,” “could,” “will,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,” “plan,” “project,” “expect,” “should,” “would,” or “assume” or the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words.
Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties inherent in our business including, without limitation, the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments in the United States or in foreign countries; the risks associated with our reliance on collaborations for the development and commercialization of our product candidates; unexpected adverse side effects or inadequate therapeutic efficacy of our product candidates that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; our ability to attract and retain key scientific, management or commercial personnel; the size and growth potential of the markets for our product candidates and our ability to serve those markets; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; our ability to establish and maintain strategic collaborations or to otherwise obtain additional financing to support our operations on commercially reasonable terms; successful administration of our business and financial reporting capabilities; and other risks detailed in this report, including those below in Part II, Item 1A, “Risk Factors.”
Although we believe that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance or achievement. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
The interim financial statements included in this report and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our audited consolidated financial statements and notes thereto for the year ended December 31, 2010, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 4, 2011, as amended on April 15, 2011.
We are a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Our product development pipeline includes novel antibodies generated with our proprietary BiTE® antibody platform, as well as conventional monoclonal antibodies. BiTE antibodies represent a new class of antibodies that activate the T cells of a patient’s immune system to eliminate cancer cells. T cells are considered the most powerful “killer cells” of the human immune system. Six of our antibodies are currently in clinical trials, while the remainder of our product pipeline is in preclinical development.
Our lead product candidate is the BiTE antibody blinatumomab, also known as MT103. Blinatumomab targets the human protein molecule CD19, which is expressed on the surface of tumor cells of certain cancers. In a phase 2 clinical trial evaluating blinatumomab as a treatment for patients with acute lymphoblastic leukemia, or ALL, 16 of 20 evaluable patients experienced elimination of cancerous cells in their bone marrow, which was the primary endpoint of the trial. We have initiated a pivotal, multi-center, single-arm study — referred to as BLAST (Blinatumomab Adult ALL MRD Study of T cell engagement) — which, if successful, has the potential to support the filing of a marketing authorization application in Europe. We have initiated a phase 2 trial in adult patients with relapsed or refractory B-precursor ALL; interim results from this trial showed that 9 of 12 patients achieved a complete remission or remission with partial recovery of blood counts following treatment with blinatumomab. All nine responding patients also achieved a complete molecular response, meaning that they had no evidence of remaining leukemic cells in their bone marrow, a key prognostic factor for patient survival. We are also evaluating blinatumomab in an ongoing phase 1 clinical trial for the treatment of patients with non-Hodgkin’s lymphoma, or NHL.
We are evaluating a second BiTE antibody, MT110, in a phase 1 clinical trial for the treatment of patients with advanced solid tumors. MT110 targets the epithelial cell adhesion molecule, or EpCAM, which is overexpressed in many solid tumors. Our collaboration partner MedImmune, LLC has initiated a phase 1 clinical trial of MT111, a BiTE antibody targeting carcinoembryonic antigen, or CEA, in patients with advanced solid tumors. Additional BiTE antibodies are at different stages of lead candidate selection and preclinical development. In addition to the collaboration with MedImmune, we have also entered into collaboration agreements with Bayer Schering Pharma, sanofi and Amgen for the development of BiTE antibodies targeting other solid tumor targets, and with Boehringer Ingelheim for the development of a BiTE antibody for the treatment of multiple myeloma.
Our conventional monoclonal antibody MT203, a human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor, or GM-CSF, which has potential applications in the treatment of various inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis, is under development in a phase 1 clinical trial being conducted by our collaboration partner Nycomed. Our other conventional antibodies include adecatumumab, also known as MT201, which binds to EpCAM and is the subject of a collaboration with Merck Serono, and MT228, which is licensed to Morphotek, Inc. and is the subject of an ongoing phase 1 clinical trial in patients with advanced melanoma. The development of the conventional antibody candidate MT293, which was formerly licensed to TRACON Pharmaceuticals, Inc., will be discontinued following the termination of our license agreement with TRACON during the second quarter of 2011.
To date, we have incurred significant research and development expenses and have not achieved any revenues from sales of our product candidates. Each of our programs will require a number of years and significant costs to advance through development. Typically, it takes many years from the initial identification of a lead antibody target to the completion of preclinical and clinical trials, before applying for marketing approval from the U.S. Food and Drug Administration, or FDA, or the European Medicines Agency, or EMA, or equivalent regulatory agencies in other countries and regions. The risk that a program has to be terminated, in part or in full, for safety reasons or lack of adequate efficacy is very high. In particular, we cannot predict which, if any, product candidates can be successfully developed and for which marketing approval may be obtained, or the time and cost to complete development and receive marketing approvals.
As we obtain results from preclinical studies or clinical trials, we may elect to discontinue the development of one or more product candidates for safety, efficacy or commercial reasons. We may also elect to discontinue or delay 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 certain of our product candidates. Depending on the structure of these collaborative agreements, we may grant a third party control over the clinical trial process, manufacturing process or other development processes or activities for one or more of our product candidates. In such a situation, the third party, rather than us, could control development and commercialization decisions with respect to the product candidate. We cannot predict the terms of future 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 adversely affect our liquidity.
Research and Development
Our research and development expenses consist of costs associated with the clinical development of blinatumomab, adecatumumab and MT110, as well as development costs incurred for MT111 and MT203, and research conducted with respect to our preclinical BiTE antibodies and the BiTE antibody platform generally. This includes costs associated with clinical trials and manufacturing processes, quality systems and analytical development, compensation and other personnel expenses, supplies and materials, consultant fees and related contract research, facility costs, license fees and depreciation. We charge all research and development expenses to operations as incurred.
Since 2007, we have tracked our external research and development expenses by major project candidate development program or allocated the expenses to our BiTE antibody platform generally. We do not allocate salary and overhead costs or stock-based compensation expense to specific research and development projects or product candidates. Our research and development expenses for the three and six months ended June 30, 2011 and 2010 and cumulative amounts expended since 2007 are summarized in the table below (in millions):
|
|
Three months ended
June 30,
|
|
|
Six months ended
June 30,
|
|
|
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
|
Cumulative
|
|
Blinatumomab
|
|
$
|
6.9
|
|
|
$
|
3.1
|
|
|
$
|
12.8
|
|
|
$
|
5.8
|
|
|
$
|
44.0
|
|
MT203
|
|
|
1.3
|
|
|
|
0.8
|
|
|
|
3.2
|
|
|
|
2.1
|
|
|
|
20.0
|
|
Adecatumumab
|
|
|
0.1
|
|
|
|
0.2
|
|
|
|
0.3
|
|
|
|
0.5
|
|
|
|
6.9
|
|
MT110
|
|
|
0.6
|
|
|
|
0.6
|
|
|
|
1.2
|
|
|
|
1.9
|
|
|
|
9.4
|
|
BiTE antibody platform and other
|
|
|
1.1
|
|
|
|
0.8
|
|
|
|
2.0
|
|
|
|
1.6
|
|
|
|
12.0
|
|
Unallocated salary and overhead
|
|
|
8.0
|
|
|
|
5.2
|
|
|
|
15.8
|
|
|
|
10.5
|
|
|
|
101.6
|
|
Stock-based compensation
|
|
|
1.5
|
|
|
|
1.3
|
|
|
|
2.9
|
|
|
|
1.8
|
|
|
|
13.2
|
|
Total
|
|
$
|
19.6
|
|
|
$
|
12.0
|
|
|
$
|
38.2
|
|
|
$
|
24.2
|
|
|
$
|
207.1
|
|
We expect to incur substantial additional research and development expenses that may increase from historical levels as we further develop our product candidates into more advanced stages of clinical development and increase our preclinical development for certain of our BiTE antibodies and conventional antibodies.
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. We also may retain co-promotion rights in certain of our agreements. We intend to pursue additional collaborations to provide resources for further development of our product candidates and may 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.
Results of Operations
Comparison of Three Months Ended June 30, 2011 and 2010
Revenues. Collaborative research and development revenue consists of reimbursements for full-time equivalents and pass-through expenses we incur under each of our collaboration agreements. License and other revenue consists primarily of revenues from licenses of patents relating to single-chain antibody technology, for which we serve as the exclusive marketing partner under a marketing agreement with Enzon Pharmaceuticals, Inc. The following table summarizes our sources of revenue for the periods presented (in millions):
|
|
Three Months Ended June 30,
|
|
|
|
2011
|
|
|
2010
|
|
Research and development revenue by collaborator:
|
|
|
|
|
|
|
Bayer Schering Pharma
|
|
$
|
0.9
|
|
|
$
|
3.4
|
|
Nycomed
|
|
|
2.0
|
|
|
|
0.8
|
|
Sanofi
|
|
|
1.0
|
|
|
|
1.3
|
|
Merck Serono
|
|
|
0.7
|
|
|
|
0.7
|
|
Boehringer Ingelheim
|
|
|
0.1
|
|
|
|
0.2
|
|
TRACON
|
|
|
2.1
|
|
|
|
0.1
|
|
Total collaborative R&D revenue
|
|
|
6.8
|
|
|
|
6.5
|
|
License and other revenue
|
|
|
0.3
|
|
|
|
—
|
|
Total revenues
|
|
$
|
7.1
|
|
|
$
|
6.5
|
|
Bayer Schering Pharma. Revenues under this agreement represent Bayer Schering Pharma’s responsibility for the full cost of the product development program under this collaboration, plus a portion of the approximately $7.0 million in up-front payments received that are being recognized as revenue on a straight-line basis over a 54-month period ending in 2014. During the quarter ended June 30, 2011, we recognized $0.5 million in revenue as payment for our preclinical development activities and $0.4 million of the up-front fee. During the same period of 2010, we recognized milestone revenue of $1.3 million, $1.8 million as payment for our preclinical development activities and $0.3 million of the up-front fee.
Nycomed. Revenues under this agreement reflect Nycomed’s responsibility for the full cost of the MT203 product development program under this collaboration. In addition to revenue recognized from the reimbursement of our preclinical development activities, we are recognizing a $6.7 million up-front payment from Nycomed into revenue on a straight-line basis over a 20-year period ending in 2027, or approximately $0.3 million per year based on the current exchange rate. The $2.0 million of revenue recorded during the three months ended June 30, 2011 represented a higher level of activity under this program than for the same period in 2010, primarily due to the manufacturing of MT203. However, we expect to see a decrease in this revenue in the second half of 2011, as the future development work will be performed by Nycomed, and the responsibility for manufacturing has been transferred to Nycomed.
Sanofi. Revenues under this agreement represent sanofi’s responsibility for the full cost of the product development program under this collaboration. In addition to revenue recognized from the reimbursement of our preclinical development activities, we are recognizing a $7.3 million up-front payment from sanofi into revenue on a straight-line basis over a 74-month period ending in 2015, or approximately $1.2 million per year based on the current exchange rate. For the three months ended June 30, 2011, we recognized $0.7 million for our preclinical development activities and $0.3 million of the up-front fee. During the same period in 2010, we recognized $1.0 million for our preclinical development activities and $0.3 million of the up-front fee.
Merck Serono. Revenues of $0.7 million for each of the three months ended June 30, 2011 and 2010 under this agreement reflect a portion of the up-front payment we received from Merck Serono that is being recognized on a straight-line basis through 2012. During 2010, the development expenses reimbursable by Merck Serono for the current stage of development reached a pre-negotiated maximum. Accordingly, we do not expect to receive any further reimbursement of expenses under this program pending our and Merck Serono’s determination of the next steps for the development of this product candidate.
Boehringer Ingelheim. We entered into the collaboration agreement with Boehringer Ingelheim during the second quarter of 2010. The revenues recognized for the period represent a portion of the up-front payment to us of approximately $6.1 million that is being recognized over a 20-year period ending in 2030, or approximately $0.3 million per year, based on the current exchange rate.
TRACON. The revenues recognized during the three months ended June 30, 2011 include the receipt of a milestone payment for the successful completion of a Phase 1 clinical trial in the amount of $0.8 million, the collection of various pass-through expenses of $0.2 million, and the remaining $1.1 million of deferred up-front license fees, as this collaboration has been terminated. We will not record any further revenue under this collaboration.
License and Other Revenue. License and other revenue consists primarily of revenues from licenses of our patents relating to single-chain antibody technology, for which we serve as the exclusive marketing partner under a marketing agreement with Enzon Pharmaceuticals, Inc. We do not expect future revenue from these licenses to be material. There was a slight increase in license and other revenue during the three months ended June 30, 2011 as compared to the same period of 2010.
Research and Development Expenses. Research and development expense consists of costs incurred to discover and develop product candidates. These expenses consist primarily of salaries and related expenses for personnel, outside service costs including production of clinical material, fees for services in the context of clinical trials, medicinal chemistry, consulting and sponsored research collaborations, and occupancy and depreciation charges. Research and development expenses increased by $7.6 million, or 63%, to $19.6 million for the three months ended June 30, 2011 from $12.0 million for the same period of 2010. The increase was largely the result of increased spending on our MT103 program of $3.3 million, primarily for manufacturing and clinical expenses, an increase in the MT203 program of $0.5 million primarily for manufacturing related expenses, an increase in salary and related expenses of $2.2 million due to increased staff, increases in stock-based compensation expenses of $0.3 million and higher facility costs of $0.9 million primarily due to expansion of laboratory space and for repairs and maintenance.
General and Administrative Expenses. General and administrative expense consists primarily of salaries and related costs for personnel in executive, finance, accounting, legal, information technology, corporate communications and human resource functions. Other costs include allocated facility costs not otherwise included in research and development expense, insurance and professional fees for legal and audit services. General and administrative expenses increased by $2.1 million, or 29%, to $7.5 million for the three months ended June 30, 2011 from $5.4 million for the same period in 2010. The increase was the result of higher commercial expenses for our MT103 program of $0.5 million, an increase in patent-related expenses for our BiTE program of $0.3 million, increases in salary and related expenses of $0.2 million, increases in recruiting costs of $0.3 million and increases in legal and consulting fees of $0.5 million.
Interest Expense. Interest expense consists primarily of amortization of premiums on our investments and capital leases and amounted to $20,000 and $61,000 for the three months ended June 30, 2011 and 2010, respectively.
Interest Income. Interest income for the three months ended June 30, 2011 and 2010 was $197,000 and $115,000, respectively. The increase is due to higher investment balances during the three months ended June 30, 2011 as compared to the same period in 2010.
Change in Fair Value of Common Stock Warrants Liability. We have issued warrants to purchase our common stock that require us, or any successor entity, to purchase each unexercised warrant for a cash amount equal to its fair value (computed using the Black-Scholes option-pricing model with prescribed guidelines) in any of the following circumstances: we are merged or consolidated with or into another company, we sell all or substantially all of our assets in one or a series of related transactions, any tender offer or exchange offer is completed pursuant to which holders of our common stock are permitted to tender or exchange their shares for other securities, cash or property, or we effect any reclassification of our common stock or any compulsory share exchange pursuant to which the common stock is effectively converted into or exchanged for other securities, cash or property. As a consequence of these provisions, the warrants are classified as a liability on our consolidated balance sheets, and changes in our stock price cause the fair value of the warrants to change each reporting period, with these changes being reflected in our consolidated statements of operations. Increases in our stock price cause the warrant liability to increase, and this increase is charged to expense, while decreases in our stock price cause the liability to decrease, which is recorded as a reduction to other income.
During the three months ended June 30, 2011, the market value of our common stock increased from $5.61 per share on March 31, 2011 to $5.74 per share on June 30, 2011, resulting in an increase in the fair value of the warrant liability on our balance sheet, and a corresponding decrease in other income, of $48,000. During the three months ended June 30, 2010, the market value of our common stock decreased from $8.08 per share on March 31, 2010 to $6.24 per share on June 30, 2010, resulting in a decrease in the fair value of the warrant liability on our balance sheet, and a corresponding increase to other income, of $7.9 million.
Other Income (Expense), Net. Other income (expense), net includes foreign currency transaction gains and losses and miscellaneous other items. The increase in income of $3.8 million for the three months ending June 30, 2011 as compared to 2010 resulted from the realization of gains from foreign currency exchange rate fluctuations due to maturities of our foreign-denominated available-for-sale securities, as well as changes in foreign currency exchange rates for foreign-denominated cash equivalents held by the U.S. entity.
Comparison of Six Months Ended June 30, 2011 and 2010
Revenues. The following table summarizes our sources of revenue for the periods presented (in millions):
|
|
Six Months Ended June 30,
|
|
|
|
2011
|
|
|
2010
|
|
Research and development revenue by collaborator:
|
|
|
|
|
|
|
Bayer Schering Pharma
|
|
$
|
2.2
|
|
|
$
|
5.6
|
|
Nycomed
|
|
|
4.1
|
|
|
|
2.6
|
|
Sanofi
|
|
|
2.1
|
|
|
|
2.5
|
|
Merck Serono
|
|
|
1.4
|
|
|
|
1.4
|
|
MedImmune
|
|
|
0.1
|
|
|
|
0.2
|
|
Boehringer Ingelheim
|
|
|
0.2
|
|
|
|
0.2
|
|
TRACON
|
|
|
2.1
|
|
|
|
0.1
|
|
Total collaborative R&D revenue
|
|
|
12.2
|
|
|
|
12.6
|
|
License and other revenue
|
|
|
0.4
|
|
|
|
0.3
|
|
Total revenues
|
|
$
|
12.6
|
|
|
$
|
12.9
|
|
Bayer Schering Pharma. During the six months ended June 30, 2011, we recognized $1.4 million in revenue as payment for our preclinical development activities and $0.8 million of the up-front fee. During the same period of 2010, we recognized milestone revenue of $1.3 million, $3.6 million as payment for our preclinical development activities and $0.7 million of the up-front fee.
Nycomed. The $4.1 million of revenue recorded during the six months ended June 30, 2011 consisted of $3.9 million for development activities primarily related to manufacturing and $0.2 million of the up-front fee. We expect to see a decrease in this revenue in the second half of 2011, as the future development work will be performed by Nycomed.
Sanofi. For the six months ended June 30, 2011, we recognized $1.5 million for our preclinical development activities and $0.6 million of the up-front fee. During the same period in 2010, we recognized $1.9 million for our preclinical development activities and $0.6 million of the up-front fee.
Merck Serono. Revenues of $1.4 million for each of the six months ended June 30, 2011 and 2010 under this agreement reflect a portion of the up-front payment we received from Merck Serono that is being recognized on a straight-line basis through 2012. During 2010, the development expenses reimbursable by Merck Serono for the current stage of development reached a pre-negotiated maximum. Accordingly, we do not expect to receive any further reimbursement of expenses under this program pending our and Merck Serono’s determination of the next steps for the development of this product candidate.
MedImmune. Revenues under this agreement generally represent payments from MedImmune for our costs incurred in the development of MT111. The slight decrease in revenue of $0.1 million for the six-month period ended June 30, 2011 as compared to the same period in 2010 is due to the lower activity by us under this program. We expect full year 2011 collaborative revenue from MedImmune for MT111 to decrease compared to 2010 due to our limited development obligations while MedImmune conducts the ongoing phase 1 clinical trial with MT111.
Boehringer Ingelheim. The revenues recognized for each period represent a portion of the up-front payment to us of approximately $6.1 million that is being recognized over a 20-year period ending in 2030, or approximately $0.3 million per year, based on the current exchange rate.
TRACON. The revenues recognized during the six months ended June 30, 2011 include the receipt of a milestone payment for the successful completion of a Phase 1 clinical trial in the amount of $0.8 million, the collection of various pass-through expenses of $0.2 million, and the remaining $1.1 million of deferred up-front license fees, as this collaboration has been terminated. We will not record any further revenue under this collaboration.
License and Other Revenue. We do not expect future revenue from these licenses to be material. There was a slight increase in license and other revenue during the six months ended June 30, 2011 as compared to the same period of 2010.
Research and Development Expenses. Research and development expenses increased by $14.0 million, or 37%, to $38.2 million for the six months ended June 30, 2011 from $24.2 million for the same period of 2010. The increase was largely the result of increased spending on our MT103 program of $6.6 million, primarily for manufacturing and clinical expenses, increases to salary and related expenses of $3.3 million due to increased staff, increases in stock-based compensation expenses of $1.2 million and higher facility costs of $1.5 million primarily due to laboratory expansion and for repairs and maintenance, and increases in consulting fees of $0.3 million.
General and Administrative Expenses. General and administrative expenses increased by $3.6 million, or 25 %, to $14.2 million for the six months ended June 30, 2011 from $10.6 million for the same period in 2010. The increase was the result of higher personnel costs due to new hires of $0.7 million, higher stock-based compensation expense of $0.5 million, increases in recruiting expenses of $0.7 million, increases in consulting expenses of $0.6 million, increases in facility charges of $0.3 million and increases in legal fees and other outside services of $0.5 million.
Interest Expense. Interest expense consists primarily of amortization of premiums on our investments and capital leases and amounted to $42,000 and $148,000 for the six months ended June 30, 2011 and 2010, respectively.
Interest Income. Interest income for the six months ended June 30, 2011 and 2010 was $375,000 and $230,000, respectively. The increase is due to higher investment balances during the six months ended June 30, 2011 over the same period in 2010.
Change in Fair Value of Common Stock Warrants Liability. During the six months ended June 30, 2011, the market value of our common stock decreased from $8.12 per share on December 31, 2010 to $5.74 per share on June 30, 2011, resulting in a decrease in the fair value of the warrant liability on our balance sheet, and a corresponding increase in other income, of $10.1 million. During the six months ended June 30, 2010, the market value of our common stock decreased from $6.66 per share on December 31, 2009 to $6.24 per share on June 30, 2010, resulting in an decrease in the fair value of the warrant liability on our balance sheet, and a corresponding increase to other income, of $2.3 million.
Other Income (Expense), Net. Other income (expense), net includes foreign currency transaction gains and losses and miscellaneous other items. The increase in income of $6.7 million for the six months ending June 30, 2011 as compared to 2010 resulted from the realization of gains from foreign currency exchange rate fluctuations due to maturities of our foreign-denominated available-for-sale securities, as well as changes in foreign currency exchange rates for foreign-denominated cash equivalents held by the U.S. entity.
Liquidity and Capital Resources
Summary of Cash Flows. We had unrestricted cash and cash equivalents and available-for-sale investments of $188.3 million and $222.7 million as of June 30, 2011 and December 31, 2010, respectively. This net decrease resulted from our net loss for the six months ended June 30, 2011, adjusted for non-cash charges and changes in operating assets and liabilities.
Our net cash used in operating activities was $39.2 million for the six months ended June 30, 2011, as compared to $12.4 million used in operating activities for the six months ended June 30, 2010. The majority of our cash is used to fund our ongoing research and development efforts, which resulted in a net loss of $25.5 million for the six months ended June 30, 2011, which loss was $3.1 million more than the net loss of $22.4 million during the same period of the prior year. During the six months ended June 30, 2011, net loss included $6.2 million in net non-cash gains, primarily the result of a $10.1 million gain from the change in the fair value of our common stock warrant liability and $4.0 million non-cash gain from foreign currency translation, partially offset by $5.3 million in non-cash expenses for stock-based compensation, $1.1 million for depreciation and amortization and $1.0 million for amortization of premiums on investments. This compares to $5.7 million in net non-cash expenses during the six months ended June 30, 2010, including $3.6 million in stock-based compensation,$3.1 million of non-cash losses from foreign currency translation and $1.2 million in depreciation and amortization, partially offset by $(2.3) million in income due to the decrease in the fair value of our common stock warrant liability.
Changes in our working capital during the six months ended June 30, 2011 resulted in lower cash balances of $7.5 million, including a $0.4 million net outflow due to increases in our accounts receivable, a $0.8 million net outflow due a reduction in prepaid expenses and other assets, $1.9 million net outflow due to a decrease in accounts payable and accrued expenses, and an outflow due to a decrease in deferred revenue of $4.4 million. During 2011, we made a payment to MedImmune of $2.5 million that had been accrued as of December 31, 2010. During the six months ended June 30, 2010, we had a $4.3 million increase in cash flows from changes in working capital, resulting primarily from a $11.8 million increase in our deferred revenue and an increase of $1.0 million in our prepaid expenses and other assets, partially offset by outflows resulting from decreases in accounts payable and accrued expenses of an aggregate of $5.7 million, and a decrease in accounts receivable of $2.8 million.
Our net cash used in investing activities was $11.6 million for the six months ended June 30, 2011, as compared to $59.2 million used in investing activities for the six months ended June 30, 2010. In both periods the changes were primarily the result of maturities of investments in our investment portfolio. During the six months ended June 30, 2011, we purchased a net $9.2 million of investments denominated in Euros in order to maintain liquid assets in the currency in which the majority of our expenses are denominated. As these investments mature, some have been reinvested in similar securities. During the same period of 2010, we purchased a net $58.1 million of these investments. Our investment in property and equipment was $2.4 million during the first six months of 2011, primarily for research and process development equipment, as compared to property and equipment investments of $1.1 million during the same period of 2010.
Our net cash provided by financing activities was $1.8 million for the six months ended June 30, 2011, as compared to $76.3 million for the six months ended June 30, 2010. In March 2010, we completed a public offering of our common stock, which resulted in proceeds of $75.4 million, net of financing costs. During the six months ended June 30, 2011, we also received $1.9 million from the exercise of stock options and warrants, as compared to $1.0 million from the exercise of stock options and warrants during the prior year period.
Sources and Uses of Cash. We have funded our recent operations through public offerings and private placements of common stock and associated warrants, equity draws under the CEFF with Kingsbridge, research-contribution revenues from our collaborations with pharmaceutical companies and licensing and milestone payments related to our product candidate partnering activities. We expect that operating losses and negative cash flows from operations will continue for at least the next several years. If appropriate, we may raise substantial funds through the sale of our common stock or debt securities or through establishing 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. Based on our capital resources and our current operating plan as of the date of this report, we believe that we have adequate resources to fund operations into the second half of 2013, without considering any potential future milestone payments that we may receive under our current or any new collaborations we may enter into in the future, any future capital raising transactions or any additional drawdowns from our CEFF with Kingsbridge, which is scheduled to expire in December 2011.
If we are unable to raise additional funds when needed, we may not be able to continue development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and other operations. If we were to raise additional funds through the issuance of common stock, it could result in substantial dilution to our existing stockholders. 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 financial ratios that could restrict our ability to operate our business. Having insufficient funds could require us to delay, scale back or eliminate some or all of our research or development programs or to relinquish some or all of our rights to our product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. If we raise funds through corporate collaborations or licensing arrangements, we may be required to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize ourselves. Failure to obtain adequate financing may also adversely affect our operating results or our ability to operate as a going concern.
Our future capital uses and requirements depend on numerous forward-looking factors and involve risks and uncertainties. Actual results could vary as a result of a number of factors, including the factors discussed in “Risk Factors” in this report. In light of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of capital outlays and operating expenditures associated with our current and anticipated clinical trials. Our future funding requirements will depend on many factors, including:
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the number, scope, rate of progress, results and costs of our preclinical studies, clinical trials and other research and development activities;
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the terms and timing of any corporate collaborations that we may establish, and the success of these collaborations;
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the cost, timing and outcomes of regulatory approvals;
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the number and characteristics of product candidates that we pursue;
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the cost and timing of establishing manufacturing, marketing, sales and distribution capabilities;
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the cost of establishing clinical and commercial supplies of our product candidates;
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the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
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the cost of preparing for, defending against and the ultimate resolution of litigation or other claims brought against us; and
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the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.
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Committed Equity Financing Facility. On December 1, 2008, we entered into the CEFF with Kingsbridge pursuant to which Kingsbridge committed to purchase, subject to certain conditions, up to $75.0 million of our common stock through December 2011. The facility is subject to early termination in specified circumstances. In connection with this CEFF, we issued a warrant to Kingsbridge to purchase up to 135,000 shares of our common stock with an exercise price of $4.44 per share. The warrant is exercisable until June 2014. Under the CEFF, the maximum number of shares that we may sell to Kingsbridge is 10,104,919 shares, exclusive of the shares underlying the warrant issued to Kingsbridge. Subject to specified conditions and limitations, from time to time under the CEFF, we may require Kingsbridge to purchase shares of our 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, provided that if the average market price on any day during the pricing period is less than the greater of $2.00 or 85% of the closing price of the day preceding the first day of the pricing period, then that day would not be used in determining the number of shares that would be issued in the draw down and the aggregate amount of the draw down would be decreased by one-eighth.
The maximum dollar amount of shares that we may require Kingsbridge to purchase in any pricing period is equal to the greater of (a) a percentage of our market capitalization as determined at the time of the draw down, which percentage ranges from 1.0% to 1.5% depending upon our market capitalization at the time of the draw down, or (b) four times the average trading volume of our common stock for a specified period prior to the draw down notice, multiplied by the closing price of the common stock on the trading day prior to the draw down notice, in each case subject to specified conditions. If either of the foregoing calculations yields a draw down amount in excess of $10 million, then the individual draw down amount is limited to $10 million.
We filed a registration statement which became effective in December 2008 with respect to the resale of shares issuable under the CEFF and underlying the warrant issued to Kingsbridge, and the registration rights agreement requires us to maintain the effectiveness of the registration statement. If we fail to maintain the effectiveness of the registration statement, or if we suspend the use of the registration statement, then under certain circumstances we may be required to pay certain amounts to Kingsbridge, or issue to Kingsbridge additional shares of common stock in lieu of cash payment, in each case as liquidated damages. We are not obligated to sell any of the $75.0 million of common stock available under the CEFF and there are no minimum commitments or minimum use penalties. The CEFF does not contain any restrictions on our operating activities, automatic pricing resets or minimum market volume restrictions. The remaining amount available under the CEFF is the lesser of $69.7 million or 8,684,351 shares of common stock.
Public Offerings of Common Stock. On November 10, 2010, we entered into a purchase agreement with Piper Jaffray & Co. pursuant to which we sold 9,900,000 shares of our common stock at a price per share of $7.15. Our gross proceeds from the sale were $70.8 million. We incurred investment banking fees, legal fees and other financing costs of approximately $0.3 million, resulting in net proceeds of $70.5 million. On March 11, 2010, we entered into an underwriting agreement with Goldman, Sachs & Co., as representative of the several underwriters, pursuant to which we issued an aggregate of 11,500,000 shares of common stock, including the exercise of an over-allotment option for 1,500,000 shares, at a public offering price of $7.00 per share, for gross proceeds of $80.5 million. After underwriting discount and estimated expenses payable by us of approximately $5.1 million, net proceeds from the public offering were approximately $75.4 million.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rates
Our financial instruments consist primarily of cash, cash equivalents, and short-term and long-term investments. Our cash equivalents and investments, 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 do not have derivative financial instruments in our investment portfolio.
Exchange Rates
A substantial portion of our operating expenses are incurred in Euros. Thus, our financial results and capital resources are affected by changes in the U.S. dollar/Euro exchange rate. We partially hedge our Euro-denominated expenses budgeted over the next twelve months by maintaining an equivalent portfolio of Euro-denominated cash, cash equivalents and short-term investments. In addition, several of our current collaboration agreements provide for our collaborators to reimburse us in Euros for our development expenses incurred under those collaborations. These collaboration agreements also provide for milestone payments to be paid in Euros, which also hedges against currency fluctuations associated with our future Euro-denominated operating expenses and obligations.
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 our Euro-denominated expenses into U.S. dollars, and such changes would negatively impact the length of time that our existing capital resources would be sufficient to finance our operations.
As of June 30, 2011, we had U.S. dollar-denominated cash and investments of approximately $103.4 million and Euro-denominated cash and investments of approximately €59.0 million, or approximately $84.9 million using the exchange rate as of that date. As of June 30, 2011, we had Euro-denominated liabilities of approximately €26.2 million, or approximately $37.8 million, using the exchange rate as of that date. The following table shows the hypothetical impact of a change to the Euro/U.S. Dollar exchange rate as of June 30, 2011:
Change in Euro/$ U.S. Exchange Rate
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10%
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15%
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20%
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Increase in reported net operating loss for the six months ended June 30, 2011 (in thousands)
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$
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2,971
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$
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4,457
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$
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5,943
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Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of June 30, 2011, management performed, with the participation of our Chief Executive Officer and our Chief Financial Officer, an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures. Based on our evaluation and the identification of the material weaknesses in our internal control over financial reporting, as previously disclosed in our Annual Report on Form 10-K/A for the year ended December 31, 2010, our disclosure controls and procedures were not effective as of June 30, 2011. During 2011, we have taken a number of steps to strengthen our internal control over financial reporting in order to address the weaknesses. The improvements include additional procedures relating to foreign currency and investment activity. We completed the full implementation of our remediation measures during the second quarter of 2011.
Our management, including the Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected.
Changes in Internal Control over Financial Reporting
During the quarter ended March 31, 2011, we determined that a deficiency in controls relating to the accounting for foreign currency related to our investments existed as of the previous assessment date and have further concluded that such a deficiency represented a material weakness as of December 31, 2010. As a result, we concluded that our internal controls over financial reporting were not effective as of December 31, 2010. We have implemented additional substantive procedures over financial reporting during the three months ended June 30, 2010, including adding additional review procedures on complex accounting issues such as foreign currency transactions relating to foreign-denominated available-for-sale securities, to ensure that our consolidated condensed financial statements are fairly stated in all material respects in accordance with GAAP.
PART II — OTHER INFORMATION
Item 1. Legal Proceedings
None.
Investing in our common stock involves a high degree of risk. 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 those we may make from time to time in our other filings with the Securities and Exchange Commission. If any of the following risks actually occur, the market price of our common stock could decline, and you could lose all or part of your investment. Additional risks not presently known to us or that we currently believe are immaterial may also significantly impair our business operations and could result in a complete loss of your investment. Certain factors individually or in combination with others may have a material adverse effect on our business, financial condition and results of operations and you should carefully consider them.
Risks Relating to Our Financial Results, Financial Reporting and Need for Financing
We have identified a material weakness in our internal controls over financial reporting related to the accounting for foreign currency transactions, which has resulted in the restatement of our financial statements and could cause investors to lose confidence in the reliability of our financial statements.
During the first quarter of 2011 our management identified a material weakness in our internal control over financial reporting as of December 31, 2010 with respect to the accounting for foreign currency transactions. As a result of the material weakness, our management concluded that, as of December 31, 2010, our disclosure controls and procedures were not effective. Further, the material weakness resulted in the restatement of our consolidated financial statements as of and for the years ended December 31, 2010 and 2009.
While we will continue to review our disclosure controls and procedures and our internal control over financial reporting and to make changes, as necessary, to ensure the quality of our financial reporting, we cannot guarantee that this material weakness has been fully remediated or that no future material weaknesses, significant deficiencies or other errors or omissions will be discovered. If we do not adequately remedy the material weakness, or if we fail to maintain proper and effective internal control over financial reporting in future periods, including any failure to implement or difficulty in implementing new or improved controls, our ability to provide timely and reliable financial results could suffer, and investors could lose confidence in our reported financial information, which may have a material adverse effect on our stock price.
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 or maintain profitability.
We have incurred losses since our inception and expect to incur substantial losses for the foreseeable future. We have no current sources of material ongoing revenue, other than upfront license fees, the reimbursement of development expenses and potential future milestone payments from our collaborators or licensees, which currently include Amgen, Boehringer Ingelheim, Bayer Schering Pharma, sanofi, Nycomed, Merck Serono, MedImmune and Morphotek. We have not commercialized any products to date, and if we are not able to do so, whether alone or with a collaborator, we will likely never achieve profitability.
Even if our collaboration agreements provide funding for a portion of our research and development expenses for some of our programs, we expect to spend significant capital to fund our internal research and development programs for the foreseeable future. As a result, we will need to generate significant revenues in order to achieve profitability. We cannot be certain whether or when this will occur because of the significant uncertainties that affect our business. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable may depress the market value of our common stock and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations and, as a result, you could lose part or all of your investment.
We will require additional financing, which may be difficult to obtain and may dilute your ownership interest in us. If we fail to obtain the capital necessary to fund our operations, we will be unable to develop or commercialize our product candidates and our ability to operate as a going concern may be adversely affected.
We will require substantial funds to continue our research and development programs and our future capital requirements may vary from what we expect. There are a number of factors, many of which are outside our control, that may affect our future capital requirements and accelerate our need for additional financing, such as:
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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, development and commercialization of our product candidates;
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the timing, receipt and amount of research funding and milestone, license, royalty and other payments, if any, from collaborators;
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the timing, receipt and amount of revenues and associated royalties to us, if any, from sales of our product candidates;
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our ability to sell shares of our common stock under the CEFF with Kingsbridge, which is scheduled to expire in December 2011;
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the costs of preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other patent-related costs, including litigation costs and technology license fees; and
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competing technological and market developments.
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We expect to seek funding through public or private offerings of equity or debt securities or from existing or new strategic collaborations with respect to programs that are not currently licensed. However, the market for stock of companies in the biotechnology sector in general, and the market for our common stock in particular, is highly volatile. Due to market conditions and the status of our product development pipeline, additional funding may not be available to us on acceptable terms, or at all. Having insufficient funds may require us to delay, scale back or eliminate some or all of our research or development programs or to relinquish certain 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 would experience dilution of their ownership interest in our company, including as a result of the issuance of warrants in connection with the financing, or the equity securities may have rights, preferences or privileges senior to those of existing stockholders. If we raise additional funds through debt financing, the debt 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 December 2008, we entered into a CEFF with Kingsbridge, which entitles us to sell and obligates Kingsbridge to purchase, from time to time over a period of three years, up to 10,104,919 shares of our common stock for cash consideration of up to $75.0 million, subject to certain conditions and restrictions. To date, we have sold 1,420,568 shares of common stock for gross proceeds of $5.3 million under this agreement. Kingsbridge will not be obligated to purchase additional shares under the CEFF unless certain conditions are met, which include:
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a minimum price for our common stock that is not less than 85% of the closing price of the day immediately preceding the applicable eight-day pricing period, but in no event less than $2.00 per share;
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the accuracy of representations and warranties made to Kingsbridge;
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our compliance with all applicable laws which, if we failed to so comply, would have a Material Adverse Effect (as that term is defined in the purchase agreement with Kingsbridge); and
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the effectiveness of a registration statement registering for resale the shares of common stock to be issued in connection with the CEFF.
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Kingsbridge is permitted to terminate the CEFF by providing written notice to us upon the occurrence of certain events. For example, we are only eligible to draw down funds under the CEFF at such times as our stock price is above $2.00 per share.
We filed a registration statement, which became effective in December 2008, with respect to the resale of shares issuable pursuant to the CEFF and underlying a warrant issued to Kingsbridge, and the registration rights agreement requires us to maintain the effectiveness of the registration statement. We are entitled, in certain circumstances, to deliver a blackout notice to Kingsbridge to suspend the use of the registration statement and to prohibit Kingsbridge from selling shares under the registration statement for a certain period of time. If we deliver a blackout notice during the 15 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 registration statement 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 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 registration statement 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 would 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 would 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 would 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.
The CEFF is scheduled to expire in December 2011 in accordance with its terms. Once the CEFF expires, or if Kingsbridge terminates the CEFF prior to its expiration or we are otherwise unable to access funds through the CEFF, we may be unable to access capital from other sources on favorable terms, or at all.
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 and results of operations for any given period are 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, the timing and accounting treatment of payments to us, if any, under those agreements, and the progress made by our strategic collaborators in advancing the development of our product candidates;
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whether or not we achieve specified research, development or commercialization milestones under any agreement that we enter into with strategic collaborators, and the timely payment by these collaborators of any amounts payable to us;
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the addition or termination of research programs or funding support under collaboration agreements;
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the timing of milestone payments under license agreements and other payments that we may be required to make to others;
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variations in the level of research and development expenses related to our clinical or preclinical product candidates during any given period;
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quarterly fluctuations in the fair value of our common stock warrant liability that are recorded as other income or expense; and
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general market conditions affecting companies with our risk profile and market capitalization.
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These factors may cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.
If the estimates we make and the assumptions on which we rely in preparing our financial statements prove inaccurate, our actual results may vary significantly.
Our financial statements have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and expenses, the amounts of charges taken by us and related disclosure. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. We cannot assure you that our estimates, or the assumptions underlying them, will be correct. Accordingly, our actual financial results may vary significantly from the estimates contained in our financial statements.
Changes in, or interpretations of, accounting rules and regulations could result in unfavorable accounting charges or require us to change our compensation policies.
Accounting methods and policies for biopharmaceutical companies, including policies governing revenue recognition, research and development and related expenses and accounting for stock-based compensation, are subject to further review, interpretation and guidance from relevant accounting authorities, including the SEC. Changes to, or interpretations of, accounting methods or policies may require us to reclassify, restate or otherwise change or revise our financial statements, including those contained in this filing.
Risks Relating to Our Common Stock
Substantial sales of shares, or the perception that such sales may occur, could adversely impact the market price of our common stock and our ability to issue and sell shares in the future.
Substantially all of the outstanding shares of our common stock are eligible for resale in the public market. A significant portion of these shares is held by a small number of stockholders. We have also registered shares of our common stock that we may issue under our equity incentive plans and our employee stock purchase plan. In addition, any shares issued to Kingsbridge under our CEFF will be eligible for immediate resale in the public market.
If our stockholders sell substantial amounts of our common stock, or the market perceives that such sales may occur, the market price of our common stock may decline, which could make it more difficult for us to sell equity securities at a time and price that we deem advantageous, which could adversely affect our ability to raise needed capital.
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, many of which we cannot control, including:
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our ability to successfully raise capital to fund our continued operations;
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our ability to successfully develop our product candidates within acceptable timeframes;
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changes in the regulatory status of our product candidates;
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changes in significant contracts, strategic collaborations, new technologies, acquisitions, commercial relationships, joint ventures or capital commitments;
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the execution of new collaboration agreements or termination of existing collaborations related to our clinical or preclinical product candidates or our BiTE antibody technology platform;
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announcements of the invalidity of, or litigation relating to, our key intellectual property;
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announcements of the achievement of milestones in our agreements with collaborators or the receipt of payments under those agreements;
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announcements of the results of clinical trials by us or by companies with commercial products or product candidates in the same therapeutic categories as our product candidates;
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events affecting our collaborators;
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fluctuations in stock market prices and trading volumes generally and those of companies in our industry and companies with similar risk profiles;
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announcements of new products or technologies, clinical trial results, commercial relationships or other corporate developments by us, our collaborators or our competitors;
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our ability to successfully complete strategic collaboration arrangements with respect to our product candidates, including our BiTE antibodies and our BiTE antibody platform generally;
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variations in our quarterly operating results;
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changes in securities analysts’ estimates of our financial performance or product development timelines;
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changes in accounting principles;
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sales of large amounts 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.
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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 affect the voting and other rights of the holders of our common stock, any of which could adversely affect the market price 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;
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requiring advance notice for raising matters of business or making nominations at stockholders’ meetings;
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requiring any stockholder submitting a director nomination or proposal to furnish information regarding recent derivative transactions made by the proponent related to our stock; and
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