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
|
For
the quarterly period ended September 30, 2010
OR
|
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period from
to
Commission
File Number: 0-50440
MICROMET,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
52-2243564
|
(State
or other jurisdiction of
|
|
(I.R.S.
Employer
|
incorporation
or organization)
|
|
Identification
No.)
|
|
|
|
6707 Democracy Boulevard, Suite 505, Bethesda,
MD
|
|
20817
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
(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 ¨
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 ¨
|
Accelerated
filer þ
|
Non-accelerated
filer ¨
|
Smaller
reporting company ¨
|
|
(Do
not check if a smaller reporting
company)
|
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 November 2, 2010 was
80,999,320.
MICROMET,
INC.
FORM
10-Q — QUARTERLY REPORT
FOR
THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2010
TABLE
OF CONTENTS
|
|
Page
No.
|
PART
I — FINANCIAL INFORMATION
|
|
3
|
Item 1.
Financial Statements
|
|
3
|
Condensed
Consolidated Balance Sheets as of September 30, 2010 (Unaudited) and
December 31, 2009
|
|
3
|
Condensed
Consolidated Statements of Operations for the three-month and nine-month
periods ended September 30, 2010 and 2009 (Unaudited)
|
|
4
|
Condensed
Consolidated Statements of Cash Flows for the nine-month periods ended
September 30, 2010 and 2009 (Unaudited)
|
|
5
|
Notes
to Condensed Consolidated Financial Statements (Unaudited)
|
|
6
|
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations
|
|
12
|
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
|
|
20
|
Item 4.
Controls and Procedures
|
|
20
|
PART
II — OTHER INFORMATION
|
|
21
|
Item 1.
Legal Proceedings
|
|
21
|
Item 1A.
Risk Factors
|
|
21
|
Item 2.
Unregistered Sales of Equity Securities and Use of
Proceeds
|
|
35
|
Item 3.
Defaults Upon Senior Securities
|
|
35
|
Item 4.
Reserved
|
|
35
|
Item 5.
Other Information
|
|
35
|
Item 6.
Exhibits
|
|
35
|
SIGNATURES
|
|
36
|
PART
I — FINANCIAL INFORMATION
Item 1.
Financial Statements
Micromet,
Inc.
Condensed
Consolidated Balance Sheets
(In
thousands, except per share amounts)
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
99,746 |
|
|
$ |
113,434 |
|
Short-term
investments
|
|
|
61,820 |
|
|
|
4,169 |
|
Accounts
receivable
|
|
|
2,460 |
|
|
|
464 |
|
Prepaid
expenses and other current assets
|
|
|
3,284 |
|
|
|
2,156 |
|
Total
current assets
|
|
|
167,310 |
|
|
|
120,223 |
|
Property
and equipment, net
|
|
|
5,157 |
|
|
|
3,959 |
|
Goodwill
|
|
|
6,462 |
|
|
|
6,462 |
|
Patents,
net
|
|
|
485 |
|
|
|
1,016 |
|
Long-term
investments
|
|
|
2,751 |
|
|
|
- |
|
Restricted
cash
|
|
|
2,114 |
|
|
|
3,153 |
|
Total
assets
|
|
$ |
184,279 |
|
|
$ |
134,813 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
5,479 |
|
|
$ |
6,053 |
|
Accrued
expenses
|
|
|
9,697 |
|
|
|
16,360 |
|
Common
stock warrants liability
|
|
|
18,726 |
|
|
|
20,244 |
|
Current
portion of deferred revenue
|
|
|
8,813 |
|
|
|
9,838 |
|
Total
current liabilities
|
|
|
42,715 |
|
|
|
52,495 |
|
Deferred
revenue, net of current portion
|
|
|
21,934 |
|
|
|
13,281 |
|
Other
non-current liabilities
|
|
|
1,348 |
|
|
|
2,196 |
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock, $0.00004 par value; 10,000 shares authorized; no shares issued and
outstanding
|
|
|
- |
|
|
|
- |
|
Common
stock, $0.00004 par value; 150,000 shares authorized; 80,999 shares
issued and outstanding at September 30, 2010 and 69,178 shares issued and
outstanding at December 31, 2009
|
|
|
3 |
|
|
|
3 |
|
Additional
paid-in capital
|
|
|
396,865 |
|
|
|
314,627 |
|
Accumulated
other comprehensive income
|
|
|
7,080 |
|
|
|
8,062 |
|
Accumulated
deficit
|
|
|
(285,666 |
) |
|
|
(255,851 |
) |
Total
stockholders' equity
|
|
|
118,282 |
|
|
|
66,841 |
|
Total
liabilities and stockholders' equity
|
|
$ |
184,279 |
|
|
$ |
134,813 |
|
The
accompanying notes are an integral part of these financial
statements.
Micromet,
Inc.
Condensed
Consolidated Statements of Operations
(In
thousands, except per share amounts)
(Unaudited)
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
agreements
|
|
$ |
6,464 |
|
|
$ |
3,361 |
|
|
$ |
19,027 |
|
|
$ |
15,261 |
|
License
fees and other
|
|
|
194 |
|
|
|
660 |
|
|
|
490 |
|
|
|
1,153 |
|
Total
revenues
|
|
|
6,658 |
|
|
|
4,021 |
|
|
|
19,517 |
|
|
|
16,414 |
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
11,468 |
|
|
|
12,871 |
|
|
|
35,684 |
|
|
|
30,151 |
|
General
and administrative
|
|
|
4,650 |
|
|
|
4,261 |
|
|
|
15,258 |
|
|
|
11,936 |
|
Total
operating expenses
|
|
|
16,118 |
|
|
|
17,132 |
|
|
|
50,942 |
|
|
|
42,087 |
|
Loss
from operations
|
|
|
(9,460 |
) |
|
|
(13,111 |
) |
|
|
(31,425 |
) |
|
|
(25,673 |
) |
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(230 |
) |
|
|
(52 |
) |
|
|
(378 |
) |
|
|
(222 |
) |
Interest
income
|
|
|
303 |
|
|
|
66 |
|
|
|
533 |
|
|
|
346 |
|
Change
in fair value of warrants
|
|
|
(753 |
) |
|
|
(6,354 |
) |
|
|
1,518 |
|
|
|
(8,183 |
) |
Other
expense, net
|
|
|
(278 |
) |
|
|
(441 |
) |
|
|
(63 |
) |
|
|
(437 |
) |
Net
loss
|
|
$ |
(10,418 |
) |
|
$ |
(19,892 |
) |
|
$ |
(29,815 |
) |
|
$ |
(34,169 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
|
$ |
(0.13 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.62 |
) |
Weighted
average shares used to compute basic and diluted net loss per
share
|
|
|
80,992 |
|
|
|
62,655 |
|
|
|
77,652 |
|
|
|
55,058 |
|
The
accompanying notes are an integral part of these financial
statements.
Micromet,
Inc.
Condensed
Consolidated Statements of Cash Flows
(In
thousands)
(Unaudited)
|
|
Nine months ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(29,815 |
) |
|
$ |
(34,169 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
1,647 |
|
|
|
2,484 |
|
Accretion
on lease liability
|
|
|
435 |
|
|
|
374 |
|
Non-cash
change in fair value of common stock warrants liability
|
|
|
(1,518 |
) |
|
|
8,183 |
|
Stock-based
compensation expense
|
|
|
5,828 |
|
|
|
4,344 |
|
Impairment
of long-term assets
|
|
|
— |
|
|
|
2,585 |
|
Net
loss on disposal of property and equipment
|
|
|
— |
|
|
|
36 |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(1,863 |
) |
|
|
1,571 |
|
Prepaid
expenses and other assets
|
|
|
(135 |
) |
|
|
75 |
|
Accounts
payable, accrued expenses and other liabilities
|
|
|
(7,000 |
) |
|
|
627 |
|
Deferred
revenue
|
|
|
8,583 |
|
|
|
744 |
|
Net
cash used in operating activities
|
|
|
(23,838 |
) |
|
|
(13,146 |
) |
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases
of investments
|
|
|
(93,942 |
) |
|
|
(27,974 |
) |
Proceeds
from the maturity of investments
|
|
|
33,861 |
|
|
|
15,900 |
|
Purchases
of property and equipment
|
|
|
(2,483 |
) |
|
|
(666 |
) |
Net
cash used in investing activities
|
|
|
(62,564 |
) |
|
|
(12,740 |
) |
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds
from the issuance of common stock, net
|
|
|
75,387 |
|
|
|
80,029 |
|
Proceeds
from exercise of stock options
|
|
|
697 |
|
|
|
1,110 |
|
Proceeds
from exercise of warrants
|
|
|
327 |
|
|
|
— |
|
Principal
payments on debt obligations
|
|
|
— |
|
|
|
(2,187 |
) |
Principal
payments on capital lease obligations
|
|
|
(145 |
) |
|
|
(92 |
) |
Net
cash provided by financing activities
|
|
|
76,266 |
|
|
|
78,860 |
|
Effect
of exchange rate changes on cash and cash equivalents
|
|
|
(3,552 |
) |
|
|
887 |
|
Net
(decrease) increase in cash and cash equivalents
|
|
|
(13,688 |
) |
|
|
53,861 |
|
Cash
and cash equivalents at beginning of period
|
|
|
113,434 |
|
|
|
46,168 |
|
Cash
and cash equivalents at end of period
|
|
$ |
99,746 |
|
|
$ |
100,029 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$ |
395 |
|
|
$ |
236 |
|
Supplemental
disclosure of noncash investing and financing activities:
|
|
|
|
|
|
|
|
|
Acquisitions
of equipment purchased through capital leases
|
|
$ |
28 |
|
|
$ |
653 |
|
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. Five of our antibodies are currently in clinical trials, while the
remainder of our product pipeline is in preclinical development. To date, we
have incurred significant research and development expenses and have not
achieved any 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 nine months ended September
30, 2010 and 2009, our financial position at September 30, 2010 and our cash
flows for the nine months ended September 30, 2010 and 2009. 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 2009 Annual Report on Form 10-K. The results of operations for
the three and nine months ended September 30, 2010 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 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 Bethesda, Maryland. As of September 30, 2010 and December 31, 2009, we had a
total of $3.1 million and $3.2 million, respectively, in certificates of deposit
relating to these letters of credit. As of September 30, 2010, $1.0
million of restricted cash is classified as prepaid expenses and other current
assets and the remaining balance of $2.1 million is classified as non-current
restricted cash. As of December 31, 2009 total restricted cash of
$3.2 million is classified as non-current restricted cash.
We
classify our investments as available-for-sale and record them at fair value,
with any unrealized gains and losses reported in other comprehensive income
(loss). We include interest and dividends and the amortization of premiums and
accretion of discounts to maturity in interest income and any realized gains and
losses in other income or expense. We base the cost of securities
sold on the specific identification method.
We
monitor our investment portfolio for impairment quarterly, and more frequently
if circumstances warrant. In the event that the carrying value of an investment
exceeds its fair value and we determine the decline in value to be
other-than-temporary, we would record an impairment charge as other expense. In
determining whether a decline in the value of an investment is
other-than-temporary, we evaluate available quantitative and qualitative
factors, including general market conditions, the duration and extent to which
fair value has been less than the carrying value, the investment issuer’s
financial condition and business outlook and our assessment as to whether it is
more likely than not that we will be required to sell a security prior to
recovery of its carrying value.
The
amortized cost, net unrealized gain or loss and estimated fair value of
investments by security type were as follows at September 30, 2010 and December
31, 2009 (in thousands):
Securities at September 30, 2010:
|
|
Amortized
Cost
|
|
|
Unrealized
Gain
|
|
|
Unrealized
Loss
|
|
|
Fair
Value
|
|
Foreign
government bonds
|
|
$
|
49,970
|
|
|
$
|
2
|
|
|
$
|
(46
|
)
|
|
$
|
49,926
|
|
U.S.
corporate bonds
|
|
|
14,642
|
|
|
|
5
|
|
|
|
(2
|
)
|
|
|
14,645
|
|
Total
|
|
$
|
64,612
|
|
|
$
|
7
|
|
|
$
|
(48
|
)
|
|
$
|
64,571
|
|
Securities at December 31, 2009:
|
|
Amortized
Cost
|
|
|
Unrealized
Gain
|
|
|
Unrealized
Loss
|
|
|
Fair
Value
|
|
Foreign
government bonds
|
|
$
|
4,174
|
|
|
$
|
—
|
|
|
$
|
(5
|
)
|
|
$
|
4,169
|
|
U.S.
corporate bonds
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Total
|
|
$
|
4,174
|
|
|
$
|
—
|
|
|
$
|
(5
|
)
|
|
$
|
4,169
|
|
The
following table summarizes the contractual maturities of marketable investments
at September 30, 2010 and December 31, 2009 (in thousands):
Securities at September 30, 2010:
|
|
Amortized
Cost
|
|
|
Fair
Value
|
|
Due
in less than one year
|
|
$ |
61,860 |
|
|
$ |
61,820 |
|
Due
in one to two years
|
|
|
2,752 |
|
|
|
2,751 |
|
Due
after two years
|
|
|
— |
|
|
|
— |
|
Total
|
|
$ |
64,612 |
|
|
$ |
64,571 |
|
Securities at December 31, 2009:
|
|
Amortized
Cost
|
|
|
Fair
Value
|
|
Due
in less than one year
|
|
$ |
4,174 |
|
|
$ |
4,169 |
|
Due
in one to two years
|
|
|
— |
|
|
|
— |
|
Due
after two years
|
|
|
— |
|
|
|
— |
|
Total
|
|
$ |
4,174 |
|
|
$ |
4,169 |
|
Fair
Value Measurements
We
include disclosures about fair value measurements pursuant to the Financial
Accounting Standard Board’s (FASB) Accounting Standards Codification (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. 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.
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. See Note 4 for additional information on our fair value
measurements.
Property
and Equipment
We record
property and equipment at cost, less accumulated depreciation and amortization.
We capitalize major replacements and improvements that extend the useful life of
an asset and expense general repairs and maintenance as incurred. We depreciate
property and equipment using the straight-line method over the estimated useful
lives of the assets, which range from three to ten years. We amortize leasehold
improvements 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. We have selected October 1 as our
annual goodwill impairment testing date. A reporting unit is an
operating segment for which discrete financial information is available and
segment management regularly reviews the operating results of that unit. We have
determined that we have only one reporting unit, the development of
biopharmaceutical products. We would determine the amount of impairment to be
recognized if the fair value of the reporting unit is less than its carrying
amount.
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 that we perform under license
agreements.
Impairment
of Long-Lived Assets
We
evaluate long-lived assets for potential impairment whenever events or changes
in circumstances indicate that the carrying amount of such assets may not be
recoverable. We determine recoverability by comparing projected undiscounted
cash flows associated with such assets to their carrying values. If carrying
value exceeds the undiscounted cash flows, then we would determine the fair
value of the asset. The excess between carrying value and fair value
would be recognized as an impairment charge.
Common
Stock Warrants Liability
In 2007,
we completed a private placement of common stock and issued warrants to purchase
additional shares of common stock. Due to provisions in the
common stock warrant agreement requiring cash settlement of the warrants in
certain circumstances, these warrants are required to be classified as a
liability, although management believes that the circumstances requiring cash
settlement are remote. The warrant liability is recorded at fair value and is
adjusted each reporting period using the Black-Scholes option pricing model (see
Note 4), with changes in value included as a change in fair value of warrants in
other income (expense).
Other
Income
Other
income consists primarily of realized foreign currency gains and
losses. We initially record transactions in foreign currencies at the
functional currency at the date of the transaction. We then remeasure
monetary assets and liabilities denominated in foreign currencies into the
functional currency at the exchange rate in effect at the balance sheet date.
Transaction losses amounted to $283,000 and $285,000 for the three months ended
September 30, 2010 and 2009, respectively, and $56,000 and $325,000 for the nine
months ended September 30, 2010 and 2009, respectively.
The
accompanying consolidated financial statements are presented in U.S. dollars. We
translate assets and liabilities into U.S. dollars at the exchange rate in
effect at the balance sheet date, while equity accounts are translated at
historical rates. We translate statement of operations and operating cash data
at the average exchange rate in effect for the period and investing and
financing cash flow data at the exchange rate in effect at the date of any
applicable underlying transaction. We recognize translation gains and losses as
a component of accumulated other comprehensive income.
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 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.
For
revenue arrangements that include multiple deliverables, we identify separate
units of accounting based on the consensus reached on ASC Topic 605-25, Revenue Arrangements with Multiple
Deliverables. ASC Topic 605-25 provides that revenue
arrangements with multiple deliverables should be divided into separate units of
accounting if certain criteria are met. The consideration for the arrangement is
allocated to the separated units of accounting based on their relative fair
values. Applicable revenue recognition criteria are considered separately for
each unit of accounting. We recognize revenue on development and collaboration
agreements, including upfront payments, where they are considered combined units
of accounting, over the period specified in the related agreement or as we
perform services under the agreement.
Research
and Development
Except
for payments made in advance of services rendered, we expense research and
development, including direct and allocated expenses, as incurred.
Comprehensive
Income (Loss)
Comprehensive
income (loss) is comprised of net income (loss) and other comprehensive income
(loss). Other comprehensive income (loss) is primarily the result of foreign
currency exchange translation adjustments. The following table sets forth the
components of comprehensive income (loss) (in thousands):
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
Net
loss
|
|
$ |
(10,418 |
) |
|
$ |
(19,892 |
) |
|
$ |
(29,815 |
) |
|
$ |
(34,169 |
) |
Foreign
currency translation adjustments
|
|
|
3,544 |
|
|
|
974 |
|
|
|
(952
|
) |
|
|
2,566 |
|
Unrealized
loss on available-for-sale investments
|
|
|
(22 |
) |
|
|
(42
|
) |
|
|
(32
|
) |
|
|
(22 |
) |
Comprehensive
loss
|
|
$ |
(6,896 |
) |
|
$ |
(18,960 |
) |
|
$ |
(30,799 |
) |
|
$ |
(31,625 |
) |
Stock-Based
Compensation
We
account for the expense related to employee stock option grants by estimating
their fair values as of the date of grant and recognizing the resulting value
ratably over the requisite service period. We estimate fair value in accordance
with the Black-Scholes option pricing model, which relies on our assumptions
regarding our expected dividend yield, the expected volatility of our common
stock, the risk-free interest rate and the expected term of the
option.
We
recognize stock-based compensation expense for options granted with graded
vesting over the requisite service period of each individual stock option grant,
which typically equals the vesting period, using the straight-line attribution
method. For stock-based awards that contain a performance condition, we
recognize expense using the accelerated attribution method. We allocate
compensation stock-based compensation expense to research and development
expense or general and administrative expense based upon the employee’s
department.
Income
Taxes
We
account for income taxes using the liability method and record deferred income
taxes at enacted tax rates for any temporary differences between the financial
statement and income tax bases of our assets and liabilities. We reduce the
deferred tax assets by a valuation allowance if, based upon the weight of
available evidence, it is more likely than not that all or some portion of the
related tax asset will not be recovered.
We
account for uncertain tax positions pursuant to ASC Topic 740 (formerly FASB
Interpretation No. 48, Accounting for Uncertainty in Income
Taxes, an interpretation of FASB Statement No. 109 ). Under 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 our recent financial
operations. It is our policy to record interest and penalties related to
uncertain tax positions, if any, as a component of income tax
expense.
Net
Loss Per Share
Basic net
loss per share is calculated by dividing our net loss by the weighted average
number of common shares outstanding for the period, without considering common
stock equivalents. Diluted net loss per share is calculated by dividing our 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. As a result of our net loss for the three
and nine months ended September 30, 2010 and 2009, our basic and diluted net
loss per share are the same. The following options and warrants to
purchase additional shares were excluded from the diluted net loss per share
calculation, as their effect would be anti-dilutive (in thousands):
|
|
Three months ended September 30,
|
|
|
Nine months ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
Options
outstanding
|
|
|
12,069 |
|
|
|
9,099 |
|
|
|
12,069 |
|
|
|
9,099 |
|
Warrants
outstanding
|
|
|
8,058 |
|
|
|
8,222 |
|
|
|
8,058 |
|
|
|
8,222 |
|
Total
shares excluded from calculation
|
|
|
20,127 |
|
|
|
17,321 |
|
|
|
20,127 |
|
|
|
17,321 |
|
Recent
Accounting Standards and Pronouncements
In
October 2009, the FASB issued ASU No. 2009-13, Revenue Recognition
(Topic 605)—Multiple-Deliverable Revenue Arrangements: a consensus of the
FASB Emerging Issues Task Force. ASU No. 2009-13 establishes a
selling price hierarchy for determining the selling price of each element within
a multiple-deliverable arrangement. Specifically, the selling price assigned to
each deliverable is to be based on vendor-specific objective evidence (VSOE), if
available; third-party evidence, if VSOE is unavailable; and estimated selling
prices, if neither VSOE nor third-party evidence is available. In addition,
ASU No. 2009-13 eliminates the residual method of allocating arrangement
consideration and instead requires allocation using the relative selling price
method. ASU No. 2009-13 will be effective prospectively for
multiple-deliverable revenue arrangements entered into, or materially modified,
in fiscal years beginning on or after June 15, 2010. We are assessing what
impact, if any, the adoption of ASU No. 2009-13 may have on our
consolidated financial statements.
In April
2010, the FASB issued ASU No. 2010-17, Milestone Method of Revenue
Recognition, to (1) limit the scope of this ASU to research or
development arrangements and (2) require that guidance in this ASU be met for an
entity to record milestone payments in their entirety in the period received.
However, the FASB clarified that, even if the requirements in this ASU are met,
entities would not be precluded from making an accounting policy election to
apply another appropriate accounting policy that results in the deferral of some
portion of the arrangement consideration. The ASU will be effective for interim
periods for fiscal years beginning on or after June 15, 2010. Entities can apply
this guidance prospectively to milestones achieved after adoption. However,
retrospective application for all prior periods is also permitted. This ASU will
be effective for the Company on January 1, 2011. We are assessing the
potential impact, if any, ASU No. 2010-17 may have on our consolidated
financial statements.
The
following table presents information about our assets and liabilities that are
measured at fair value on a recurring basis as of September 30, 2010 (in
thousands):
|
|
|
|
|
Quoted Prices
in
|
|
|
Significant Other
|
|
|
Significant
Unobservable
|
|
|
|
September 30,
|
|
|
Active Markets
|
|
|
Observable Inputs
|
|
|
Inputs
|
|
Description
|
|
2010
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
99,746
|
|
|
$
|
99,746
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restricted
cash
|
|
|
3,114
|
|
|
|
3,114
|
|
|
|
—
|
|
|
|
—
|
|
Short-term
investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
government bonds
|
|
|
49,926
|
|
|
|
—
|
|
|
|
49,926
|
|
|
|
—
|
|
U.S.
corporate bonds
|
|
|
11,894
|
|
|
|
—
|
|
|
|
11,894
|
|
|
|
—
|
|
Long-term
investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
corporate bonds
|
|
|
2,751
|
|
|
|
—
|
|
|
|
2,751
|
|
|
|
—
|
|
Total
assets
|
|
$
|
167,431
|
|
|
$
|
102,860
|
|
|
$
|
64,571
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock warrant liability
|
|
$
|
(18,726
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(18,726
|
)
|
There
were no transfers of financial assets or liabilities between Level 1 and Level 2
during the nine months ended September 30, 2010. The following table
presents information about our common stock warrant liability, which was our
only financial asset or liability measured at fair value on a recurring basis
using significant unobservable inputs (Level 3) at September 30, 2010 and
2009:
|
|
Three months ended September 30,
|
|
|
Nine months ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
Beginning
balance
|
|
$ |
(17,973 |
) |
|
$ |
(14,123 |
) |
|
$ |
(20,244 |
) |
|
$ |
(12,294 |
) |
Transfers
to (from) Level 3
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total
gains/(losses) realized/ unrealized included in
earnings
|
|
|
(753
|
) |
|
|
(6,354
|
) |
|
|
1,518 |
|
|
|
(8,183
|
) |
Purchases/
issuances/ settlements, net
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Ending
balance
|
|
$ |
(18,726 |
) |
|
$ |
(20,477 |
) |
|
$ |
(18,726 |
) |
|
$ |
(20,477 |
) |
We
estimate the fair value of the common stock warrant liability 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 estimated life
of the warrant. The risk-free rate of interest is based on the
interest rate of U.S. Treasury obligations that approximate the expected term of
the warrant. The expected dividend yield is projected at 0%, as we
have not paid any dividends on our common stock since our inception and do not
anticipate paying dividends on our common stock in the foreseeable
future. Expected volatility is based on our historical
volatility.
We have
recorded deferred revenues from our research and development agreements as
follows (in thousands):
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
Boehringer
Ingelheim
|
|
$ |
6,664 |
|
|
$ |
— |
|
Nycomed
|
|
|
7,536 |
|
|
|
6,493 |
|
Sanofi-aventis
|
|
|
6,478 |
|
|
|
11,042 |
|
Bayer
Schering Pharma
|
|
|
6,280 |
|
|
|
608 |
|
TRACON
|
|
|
1,146 |
|
|
|
1,221 |
|
Merck
Serono
|
|
|
2,102 |
|
|
|
3,331 |
|
Other
|
|
|
541 |
|
|
|
424 |
|
Subtotal
|
|
$ |
30,747 |
|
|
$ |
23,119 |
|
Current
portion
|
|
|
(8,813
|
) |
|
|
(9,838
|
) |
Long-term
portion
|
|
$ |
21,934 |
|
|
$ |
13,281 |
|
The
deferred revenue from agreements with Boehringer Ingelheim, Nycomed,
sanofi-aventis, Bayer Schering and TRACON 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,
4.5 years and 15 years, respectively.
The
upfront license fees and research and development service reimbursements under
our collaboration agreement with Merck Serono are considered to be a combined
unit of accounting and, accordingly, we are recognizing the related amounts into
revenue ratably over the expected period of the research and development
program, which continues through 2011.
Note 6.
|
Other
Liabilities
|
Other
liabilities consist of the following (in thousands):
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
Facility
lease exit liability
|
|
$ |
1,119 |
|
|
$ |
1,276 |
|
GEK
subsidy
|
|
|
90 |
|
|
|
137 |
|
Asset
retirement obligation
|
|
|
613 |
|
|
|
567 |
|
Capital
lease obligations
|
|
|
595 |
|
|
|
757 |
|
Other
|
|
|
14 |
|
|
|
18 |
|
Subtotal
|
|
|
2,431 |
|
|
|
2,755 |
|
Less
current portion included in accrued expenses
|
|
|
(1,083
|
) |
|
|
(559
|
) |
Other
non-current liabilities
|
|
$ |
1,348 |
|
|
$ |
2,196 |
|
Facility
Lease Exit Liability and Restructuring Provision
We
acquired a facility lease exit liability as of May 2006, the date of our merger
with CancerVax Corporation. In April 2007, we fully subleased this
facility. We review the adequacy of our estimated exit accruals on an
ongoing basis.
The
following table summarizes the activity for these facility lease exit
obligations during the three and nine months ended September 30, 2010 and 2009
(in thousands):
|
|
Three months ended September 30,
|
|
|
Nine months ended September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
Beginning
balance
|
|
$ |
1,179 |
|
|
$ |
1,365 |
|
|
$ |
1,276 |
|
|
$ |
1,432 |
|
Amounts
paid in period
|
|
|
(112
|
) |
|
|
(105
|
) |
|
|
(320
|
) |
|
|
(298
|
) |
Accretion
expense
|
|
|
52 |
|
|
|
61 |
|
|
|
163 |
|
|
|
187 |
|
Ending
balance
|
|
$ |
1,119 |
|
|
$ |
1,321 |
|
|
$ |
1,119 |
|
|
$ |
1,321 |
|
The
accretion expense is included in general and administrative
expenses. Of the $1,119,000 lease exit liability as of September 30,
2010, $786,000 is current and included in accrued expenses and $333,000 is
included in other non-current liabilities.
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 September 30, 2010, 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.
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, 2009, 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 5, 2010.
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. Five 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, including acute
lymphoblastic leukemia, or ALL. Although CD19 is widely expressed on cancer
cells of ALL patients, no treatments targeting CD19 are currently commercially
available. In December 2009, we presented final data indicating that
80% of the evaluable ALL patients participating in a phase 2 clinical trial with
blinatumomab had achieved the primary endpoint of the trial, which was the
elimination of residual cancer cells to an undetectable level.
In
September 2010, we initiated a European pivotal, multi-center, single-arm
study—which we refer to as BLAST (Blinatumomab Adult ALL MRD Study of T cell engagement)—in adult
patients with minimal residual disease (MRD) positive B-precursor ALL, as well
as a phase 2, single-arm trial in adult patients with relapsed or refractory
B-precursor ALL. 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 were
previously developing blinatumomab under a collaboration and license agreement
with MedImmune, LLC. We terminated this agreement in 2009 and
acquired MedImmune’s remaining rights to commercialize blinatumomab in North
America. We now fully own the rights to develop and commercialize
blinatumomab throughout the world. MedImmune has sold to us the remaining
stock of blinatumomab clinical trial material and is in the process
of transferring the manufacturing process for this product candidate to us
and our contract manufacturer.
We are
evaluating a second BiTE antibody, MT110, in a phase 1 clinical trial for the
treatment of solid tumors. MT110 binds to the epithelial cell
adhesion molecule, or EpCAM, which is overexpressed in many solid
tumors. We recently recalled a batch of diluent, a liquid used to
dilute MT110 drug product for administration to patients, due to potential
damage to the primary packaging material of the diluent. Due to the batch
recall, we currently do not have diluent available for the ongoing phase 1
clinical trial with MT110 and are therefore not treating patients in the trial.
Production of a new batch of diluent is ongoing at a third party manufacturer
and we expect to resume treatment of patients in the phase 1 trial in the first
quarter of 2011. We expect to provide an update on data from the
clinical trial in the second half of 2011.
We have
several additional BiTE antibodies at different stages of lead candidate
selection, preclinical and clinical development and have entered into strategic
collaborations with pharmaceutical companies for four of these BiTE antibodies,
as follows. We are developing the BiTE antibody MT111, targeting
carcinoembryonic antigen, or CEA, for the treatment of solid tumors in
collaboration with MedImmune. MedImmune plans to initiate a phase 1 clinical
trial with MT111 in patients with advanced gastrointestinal cancers, based on an
investigational new drug application, or IND, accepted by the U.S. Food and Drug
Administration, or FDA. We are collaborating with Bayer Schering
Pharma and sanofi-aventis for the development of BiTE antibodies targeting other
solid tumor targets. Most recently, in May 2010, we entered into a
collaboration and license agreement with Boehringer Ingelheim for the
development and commercialization of a BiTE antibody for the treatment of
multiple myeloma.
Our human
monoclonal antibody MT203, which neutralizes the activity of
granulocyte/macrophage colony stimulating factor, or GM-CSF, has potential
applications in the treatment of various inflammatory and autoimmune diseases,
such as rheumatoid arthritis, psoriasis, or multiple sclerosis. MT203
is under development in a phase 1 clinical trial being conducted by our
collaboration partner Nycomed. We have licensed our monoclonal antibody MT293,
also known as TRC093, to TRACON Pharmaceuticals, Inc. TRACON has
reported final results from its phase 1 clinical trial of MT293 for the
treatment of cancer patients. Another conventional monoclonal
antibody, adecatumumab, also known as MT201, binds to EpCAM and is being
developed in collaboration with Merck Serono. We recently
discontinued enrollment in a phase 2 trial of adecatumumab in patients with
resected liver metastases from colorectal cancer, due to a change in the
standard of care in this disease setting which resulted in slower recruitment
than was planned. All patients currently enrolled in the trial will
continue to be treated according to the clinical trial protocol.
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 compound to the completion of preclinical studies and clinical trials,
before applying for marketing approval from the FDA, 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 discovery
and clinical development of our product candidates and research conducted with
respect to our preclinical BiTE antibodies and the BiTE antibody platform. These
costs consist primarily of salaries and related expenses for personnel, outside
service costs including production of clinical material, fees for services in
the context of clinical trials, medicinal chemistry, consulting and sponsored
research collaborations, and occupancy and depreciation charges. Process
development expenses are incurred for production of GMP-grade clinical trial
material, as well as fermentation, purification and formulation development.
Preclinical development expenses cover pharmacological in vitro and in vivo experiments, as well
as the cost of developing analytical testing procedures. Except for payments
made in advance of services rendered, we expense research and development costs
as incurred. Payments made in advance of services are recognized as research and
development expense as the related services are 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 nine months ended September 30, 2010 and 2009 and
cumulative amounts expended since 2007 are summarized in the table below (in
millions):
|
|
Three months ended
September 30,
|
|
|
Nine months ended
September 30,
|
|
|
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
|
Cumulative
|
|
Blinatumomab
|
|
$
|
2.3
|
|
|
$
|
1.3
|
|
|
$
|
8.1
|
|
|
$
|
3.1
|
|
|
$
|
27.3
|
|
MT203
|
|
|
0.8
|
|
|
|
—
|
|
|
|
2.9
|
|
|
|
1.6
|
|
|
|
16.1
|
|
Adecatumumab
|
|
|
0.2
|
|
|
|
0.9
|
|
|
|
0.7
|
|
|
|
1.7
|
|
|
|
6.4
|
|
MT110
|
|
|
0.8
|
|
|
|
0.5
|
|
|
|
2.7
|
|
|
|
1.2
|
|
|
|
7.5
|
|
BiTE
antibody platform and other
|
|
|
0.7
|
|
|
|
1.0
|
|
|
|
2.3
|
|
|
|
2.2
|
|
|
|
9.4
|
|
Unallocated
salary and overhead
|
|
|
5.4
|
|
|
|
7.7
|
|
|
|
15.9
|
|
|
|
18.0
|
|
|
|
79.7
|
|
Stock-based
compensation
|
|
|
1.3
|
|
|
|
1.4
|
|
|
|
3.1
|
|
|
|
2.4
|
|
|
|
9.0
|
|
Total
|
|
$
|
11.5
|
|
|
$
|
12.9
|
|
|
$
|
35.7
|
|
|
$
|
30.2
|
|
|
$
|
155.4
|
|
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 our BiTE antibodies for various cancers. In
particular, we expect significant increases in research and development expenses
going forward as we initiate later-stage trials of
blinatumomab. However, we are unable to estimate with any certainty
the costs we will incur in the continued development of our product
candidates. Clinical development timelines, the likelihood of success
and total costs vary significantly for each product candidate and are difficult
to estimate. We anticipate that we will make determinations as to which research
and development projects to pursue and how much funding to direct to each
project on an ongoing basis in response to the scientific and clinical success
of each product candidate as well as relevant commercial
factors.
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 September 30, 2010 and 2009
Revenues. The
following table summarizes our sources of revenue for the periods presented (in
millions):
|
|
Three Months Ended
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
Research
and development revenue by collaborator:
|
|
|
|
|
|
|
Bayer
Schering Pharma
|
|
$
|
2.3
|
|
|
$
|
1.6
|
|
Nycomed
|
|
|
0.9
|
|
|
|
0.7
|
|
Sanofi-aventis
|
|
|
1.5
|
|
|
|
—
|
|
Merck
Serono
|
|
|
0.7
|
|
|
|
0.7
|
|
MedImmune
|
|
|
1.0
|
|
|
|
0.3
|
|
Boehringer
Ingelheim
|
|
|
0.1
|
|
|
|
—
|
|
TRACON
|
|
|
—
|
|
|
|
0.1
|
|
Total
collaborative R&D revenue
|
|
|
6.5
|
|
|
|
3.4
|
|
License
and other revenue
|
|
|
0.2
|
|
|
|
0.6
|
|
Total
revenues
|
|
$
|
6.7
|
|
|
$
|
4.0
|
|
Collaborative R&D
Revenue. Collaborative R&D revenue generally consists of
reimbursements for full-time equivalents and pass-through expenses we incur
under each collaborative agreement.
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 up-front payments we have
received that are being amortized into revenue over time. During the
quarter ended September 30, 2010, we recognized $1.9 million in
revenue as reimbursement for our preclinical development activities, and we
recognized an additional $0.4 million during the quarter, which represents a
portion of the up-front payment of approximately $7.0 million from Bayer
Schering Pharma that is being recognized over a 54-month period ending in
2014. As the development program did not commence until January 2010,
we did not recognize any reimbursement revenue under this agreement during
2009. The $1.6 million in revenue recognized for the three months
ended September 30, 2009 represents approximately one-fourth of the $6.0 million
option fee received in January 2009 that we recognized as revenue over the
option period of one year.
Nycomed. Revenues
under this agreement reflect Nycomed’s responsibility for the full cost of the
MT203 product development program. In addition to revenue recognized from the
reimbursement of our preclinical development activities, we are
recognizing the up-front payment we received from Nycomed into revenue over
a 20-year period ending in 2027. The increase in revenue of $0.2
million for the three months ended September 30, 2010, as compared to the same
period in 2009, was due to pass-through expenses related to manufacturing of
MT203.
Sanofi-aventis.
Revenues under this agreement represent sanofi-aventis’ responsibility for the
full cost of the product development program under this collaboration, which
began in the second half of 2009. For the three months ended September 30, 2010,
we recognized $1.2 million in revenue as reimbursement for our preclinical
development activities and an additional $0.3 million representing a portion of
the up-front payment of approximately $7.3 million from sanofi-aventis that is
being recognized over a 74-month period ending in 2015.
Merck
Serono. Revenues under this agreement reflect a portion of the
up-front payment we received from Merck Serono that is being recognized over
time, as well as Merck Serono’s responsibility for the full cost of the
adecatumumab development program up to a predetermined maximum
amount. This maximum amount has been reached and Micromet is now
responsible for further expenses associated with the wind-down of the phase 2
trial of adecatumumab in patients with resected liver metastases from colorectal
cancer. As discussed above, enrollment in this study has been
discontinued. We expect no further reimbursement revenues pending our and
Merck Serono’s determination of the next steps for the development of this
product candidate. The revenue of $0.7 million for the three months
ended September 30, 2010 and 2009 represents a portion of the up-front payment
that is being recognized through 2012.
MedImmune. Revenues
under this agreement generally represent reimbursements from MedImmune for our
costs incurred in the development of MT111. The $1.0 million of revenue recorded
during the third quarter of 2010 resulted from a milestone payment due to us
upon MedImmune’s filing of an IND for a phase 1 clinical trial of
MT111.
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.
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. The
reduction in license and other revenue during the three months ended September
30, 2010 as compared to the same period of 2009 resulted from the election by
some of our licensees not to renew their licenses.
Research and Development
Expenses. Research and development expenses decreased by
$1.4 million, or 10.9%, to $11.5 million for the three months ended September
30, 2010 from $12.9 million for the same period of 2009. The decrease
was largely the result of a patent impairment charge of $2.6 million recorded
during the three months ended September 30, 2009, and decreases in the cost of
our MT201 program of $0.8 million due to the wind-down of the Phase 2 clinical
trial. These decreases were partially offset by increases in the
MT103 program of $1.0 million due to increased manufacturing and clinical
activities, an increase of $0.8 million in the MT203 program primarily due to
manufacturing costs and an increase of $0.3 million in the Bayer Schering Pharma
program as formal collaboration activities commenced during 2010.
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 facility costs not otherwise included in
research and development expense, insurance costs and professional fees for
legal and audit services. General and administrative expenses increased by $0.4
million, or 9.1%, to $4.7 million for the three months ended September 30, 2010
from $4.3 million for the same period in 2009. The increase was the
result of higher stock-based compensation expense of $0.4 million and increases
in personnel costs due to new hires of $0.4 million, partially offset by a
decrease in legal fees of $0.2 million due to the settlement of a legal dispute
that was ongoing during the same period in 2009.
Interest Expense.
Interest expense consists primarily of amortization of premiums on
our investments and amounted to $230,000 and $52,000 for the three months ended
September 30, 2010 and 2009, respectively.
Interest Income.
Interest income for the three months ended September 30, 2010 and
2009 was $303,000 and $66,000, respectively. The increase is due to higher
investment balances during the three months ended September 30, 2010 over the
same period in 2009.
Change in Fair Value of Common Stock
Warrants Liability. In 2007, we completed a private placement
of common stock and issued warrants to purchase additional shares of common
stock. Due to provisions in the common stock warrant agreement
requiring cash settlement of the warrants in certain circumstances, these
warrants are required to be classified as a liability on our balance sheet,
although management believes that the circumstances requiring cash settlement
are remote. The warrant liability is recorded at fair value and is adjusted at
the end of each reporting period using the Black-Scholes option-pricing model,
with changes in fair value included as income or expense. Increases
in the market value of our common stock cause the warrant liability to increase,
with the increase charged to other expense, while decreases in the market value
of our common stock cause the liability to decrease, with the decrease recorded
as other income. During the three months ended September 30, 2010,
the market value of our common stock increased from $6.24 per share on June 30,
2010 to $6.72 per share on September 30, 2010, resulting in an increase in the
fair value of the warrant liability on our balance sheet, and a corresponding
other expense, of $0.8 million. During the three months ended
September 30, 2009, the market value of our common stock increased from $4.98
per share on June 30, 2009 to $6.66 per share on September 30, 2009, resulting
in an increase in the fair value of the warrant liability on our balance sheet,
and a corresponding other expense, of $6.4 million.
Other Expense.
During the three months ended September 30, 2010 and 2009, we
recorded other expense of $0.3 million and $0.4 million, respectively, primarily
as a result of remeasuring our monetary assets and liabilities denominated in
foreign currencies into U.S. dollars at the exchange rate in effect at the
balance sheet date.
Comparison
of Nine Months Ended September 30, 2010 and 2009
Revenues. The
following table summarizes our sources of revenue for the periods presented (in
millions):
|
|
Nine Months Ended
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
Research
and development revenue by collaborator:
|
|
|
|
|
|
|
Bayer
Schering Pharma
|
|
$
|
7.9
|
|
|
$
|
4.6
|
|
Nycomed
|
|
|
3.5
|
|
|
|
6.4
|
|
Sanofi-aventis
|
|
|
4.0
|
|
|
|
—
|
|
Merck
Serono
|
|
|
2.0
|
|
|
|
2.1
|
|
MedImmune
|
|
|
1.3
|
|
|
|
2.0
|
|
Boehringer
Ingelheim
|
|
|
0.2
|
|
|
|
—
|
|
TRACON
|
|
|
0.1
|
|
|
|
0.2
|
|
Total
collaborative R&D revenue
|
|
|
19.0
|
|
|
|
15.3
|
|
License
and other revenue
|
|
|
0.5
|
|
|
|
1.1
|
|
Total
revenues
|
|
$
|
19.5
|
|
|
$
|
16.4
|
|
Bayer Schering
Pharma. In addition to the $1.3 million of revenue recognized
for achieving a milestone during the second quarter of 2010, we recognized
revenues of $5.5 million during the nine months ended September 30, 2010 as
reimbursement for our preclinical development costs and $1.1 million that
represents a portion of the up-front payment received from Bayer Schering
Pharma. The only revenue recognized under this agreement in 2009 was
the option fee of $6.0 million received in January 2009 that was recognized over
the option period of one year. Three-quarters of this amount was
recognized during the nine months ended September 30, 2009. We
expect revenues under this agreement to increase as additional development work
is performed.
Sanofi-aventis.
During the nine months ended September 30, 2010, we recognized $3.2 million in
revenue for the reimbursement of our preclinical development activities, as well
as $0.8 million of the up-front payment of approximately $7.3 million from
sanofi-aventis that is being recognized over a 74-month period ending in
2015.
Merck
Serono. Revenues under this agreement were $2.0 million for
the first nine months ended September 30, 2010 and were consistent with the
revenues for the same period of 2009, although, as described above, we expect
revenues under this collaboration to decrease in the short term due to the
achievement of Merck Serono’s maximum contribution amount.
MedImmune. The
decrease in revenue under this agreement for the nine months ended September 30,
2010, as compared to the same period of the prior year, was due to lower
development activity for MT111, partially offset by the $1.0 million milestone
payment recorded during the third quarter of 2010.
Boehringer Ingelheim.
The revenues recognized for the nine months ended September 30, 2010
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.
TRACON. The
revenues recognized for the nine months ended September 30, 2009 and 2010 each
include a portion of the up-front payment to us of approximately $1.5 million
that is being recognized over a 15-year period ending in 2030. During
the nine months ended September 30, 2009, we also received $0.1 million of
revenue as reimbursement for pass-through legal expenses.
License and Other
Revenue. The reduction in license and other revenue during the nine
months ended September 30, 2010 as compared to the same period of 2009 resulted
from the election by some of our licensees not to renew their
licenses.
Research and Development
Expenses. Research and development expenses increased by $5.5
million, or 18.3%, to $35.7 million for the nine months ended September 30, 2010
from $30.2 million for the same period of 2009. The increase is due
to higher spending of $4.9 million on our MT103 program, primarily for
manufacturing and the preparation for the initiation of new clinical studies, an
increase of $1.5 million in our MT110 program due to regulatory and
manufacturing costs, and an increase of $1.4 million in our MT203 program also
due to manufacturing costs, partially offset by the $2.6 million patent
impairment charge recorded during the nine month period ended September 30, 2009
that is non-recurring in 2010.
General and Administrative
Expenses. General and administrative expenses increased by
$3.3 million, or 27.8%, to $15.3 million for the nine months ended September 30,
2010 from $11.9 million for the same period in 2009. The increase
results from higher stock-based compensation expense of $0.7 million due to new
hires and a higher share price of our stock which impacts the Black-Scholes
valuation, higher personnel costs of $1.5 million primarily due to new hires, an
increase in market research expenses of $0.5 million and an increase in
amortization of leasehold improvements of $0.2 million due to our acquisition of
additional office space in Munich.
Interest Expense.
Interest expense, consisting of amortization of premiums on our
investments, was $378,000 and $222,000 for the nine months ended September 30,
2010 and 2009, respectively.
Interest Income.
Interest income for the nine months ended September 30, 2010 and
2009 was $533,000 and $346,000, respectively. The increase is
due to the increase in investments during the nine months ended September 30,
2010 over the same period in 2009.
Change in Fair Value of Common Stock
Warrants Liability. For the nine months ended September 30,
2010, the market value of our common stock increased from $6.66 per share on
December 31, 2009 to $6.72 per share on September 30, 2010, which would
typically result in an increase in the fair value of the warrant liability;
however, lower interest rates used in the Black-Scholes calculation resulted in
a decrease in the warrant liability on our balance sheet, and corresponding
other income, of $1.5 million. For the nine months ended September
30, 2009, the market value of our common stock increased from $4.36 per share on
December 31, 2008 to $6.66 per share on September 30, 2009, resulting in an
increase in the fair value of the warrant liability on our balance sheet, and a
corresponding other expense, of $8.2 million.
Other Expense. We
recorded other expense of $64,000 and $0.4 million for the nine months ended
September 30, 2010 and 2009, respectively, primarily as a result of gains
realized on the translation of Euros into U.S. dollars as of the balance sheet
dates.
Liquidity
and Capital Resources
We had
unrestricted cash and cash equivalents and available-for-sale investments of
$164.3 million and $117.6 million as of September 30, 2010 and December 31,
2009, respectively. We are also parties to irrevocable standby
letters of credit in connection with prior building leases for properties that
are currently subleased, as well as our current building leases in Munich,
Germany and Bethesda, Maryland. As of September 30, 2010, we had $3.1 million in
certificates of deposit relating to these letters of credit that is classified
as non-current restricted cash.
Summary of Cash
Flows. Our net cash used in operating activities was $23.8
million for the nine months ended September 30, 2010, as compared to $13.1
million used in operating activities for the nine months ended September 30,
2009. The majority of our cash is used to fund our ongoing research and
development efforts, which resulted in a net loss of $29.8 million for the nine
months ended September 30, 2010, which loss was $4.4 million less than the net
loss of $34.2 million during the same period of the prior year. During the nine
months ended September 30, 2010, net loss was adjusted by $6.4 million in net
non-cash expenses, including $5.8 million for stock-based compensation and $1.7
million for depreciation and amortization, offset by a $1.5 million non-cash
gain from the change in the fair value of our common stock warrant
liability. This compares to $18.0 million in net non-cash
expenses during the nine months ended September 30, 2009, including $4.3
million in stock-based compensation, $2.5 million in depreciation and
amortization, a $2.6 million patent impairment charge and $8.1 million in
expense due to the increase in the fair value of our common stock warrant
liability. Changes in our working capital during the nine months ended
September 30, 2010 resulted in lower cash balances of $9.0 million, consisting
of a $1.9 million increase in our accounts receivable and a $7.0 million
reduction in accounts payable and accrued expenses including payments to Curis
of $4.0 million in connection with a legal settlement and to MedImmune of $4.0
million in connection with the termination of our blinatumomab
collaboration. This compares to a $2.3 million increase in cash flows
from changes in working capital during the nine months ended September 30, 2009,
resulting primarily from a $1.6 million decrease in our accounts receivable, and
an increase of $0.6 million in accounts payable and accrued
liabilities. During the nine months ended September 30, 2010, our
deferred revenue increased by $8.6 million from December 31, 2009, which
includes cash received from the $6.7 million option exercise fee received from
Bayer Schering in January 2010 and the $6.1 million upfront license payment from
Boehringer Ingelheim in June 2010, partially offset by the portion of deferred
revenue under all of our agreements that we recognized as revenue during the
period. During the nine months ended September 30, 2009, our deferred
revenue increased by $0.7 million from December 31, 2008, representing the $6.0
million option fee paid to us by Bayer Schering in January 2009, offset by the
portion of deferred revenue under all of our agreements that we recognized as
revenue during the nine months ended September 30, 2009.
Our net
cash used in investing activities was $62.6 million for the nine months ended
September 30, 2010, as compared to $12.7 million used in investing activities
for the nine months ended September 30, 2009. This increase was the
result of purchases of Euro-denominated and Dollar-denominated investments in
our investment portfolio. During the nine months ended September 30,
2010, we purchased a net $60.1 million of investments denominated in Euros in
order to maintain liquid assets in the currency in which the majority of our
expenses are denominated. Some of these investments matured and were
reinvested. During the same period of 2009, we purchased a net $12.1
million of these investments. Our investment in property and
equipment was $2.5 million during the first nine months of 2010, primarily for
research and process development equipment, as compared to property and
equipment investments of $0.7 million during the same period of
2009.
Our net
cash provided by financing activities was $76.3 million for the nine months
ended September 30, 2010, as compared to $78.9 million provided by financing
activities for the nine months ended September 30, 2009. 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 same
period in 2009, we received net proceeds of $74.9 million in a public offering
and also received $5.1 million, net of financing costs, from the sale of common
stock under our committed equity financing facility, or CEFF, with Kingsbridge
Capital Limited, or Kingsbridge. During the nine months ended
September 30, 2010, we also received $1.0 million from the exercise of stock
options and warrants, as compared to $1.1 million from the exercise of stock
options during the prior year period.
Sources and Uses of
Cash. To date, we have funded our operations through proceeds
from public offerings and private placements of preferred stock, common stock
and associated warrants, government grants for research, research-contribution
revenues from our collaborations with pharmaceutical companies, licensing and
milestone payments related to our product candidate partnering activities, debt
financing and equity draws under the CEFF with Kingsbridge described
below. We expect that our operating losses and negative cash flows
from operations will continue for at least the next several years and that we
will need to generate additional funds to achieve our strategic goals. We may
seek to raise substantial funds through the sale of equity 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, if at all. Based on our capital resources
as of the date of this report, we believe that we have adequate resources to
fund our operations into late 2012, 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 draw downs from our CEFF with
Kingsbridge.
Our
future capital uses and requirements depend on numerous forward-looking factors
and involves risks and uncertainties. Actual results could vary as a result of a
number of factors, including the factors discussed in “Risk Factors” 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;
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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If we are
unable to raise additional funds when needed, we may not be able to continue
development of our product candidates, we could be required to delay, scale back
or eliminate some or all of our development programs and other operations or we
could be required to relinquish greater or all rights to product candidates at
an earlier stage of development or on less favorable terms than we would
otherwise choose. If we were to raise additional funds through the issuance of
common stock, substantial dilution to our existing stockholders would likely
result. If we were to raise additional funds through debt financing, the terms
of the debt may involve significant cash payment obligations, as well as
covenants and specific financial ratios that may restrict our ability to operate
our business. 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.
Committed Equity Financing
Facility. In December 2008, we entered into the CEFF with
Kingsbridge, under which Kingsbridge is committed to purchase, subject to
certain conditions, up to the lesser of 10,104,109 shares or $75.0 million of
our common stock through December 2011, subject to early termination in certain
circumstances. In connection with this CEFF, we issued a warrant to Kingsbridge,
exercisable until June 2014, to purchase up to 135,000 shares of our common
stock with an exercise price of $4.44 per share. Any drawdowns under the
CEFF are generally issued at a price between 86% and 94% of the volume-weighted
average price on each trading day during an eight-day pricing
period.
The
maximum dollar amount of shares that we may require Kingsbridge to purchase in
any pricing period is generally based on a percentage, between 1.0% and 1.5%, of
our market capitalization at the time of the drawdown and the average trading
volume of our common stock for a specified period prior to the drawdown notice.
The maximum individual drawdown amount is $10 million.
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 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, 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, as liquidated damages. There are no
minimum commitments or minimum use penalties, and the CEFF does not contain any
restrictions on our operating activities, automatic pricing resets or minimum
market volume restrictions.
During
2009, we made two drawdowns under the CEFF in which we issued a total of
1,420,568 shares of common stock for gross proceeds of $5.3 million.
Accordingly, the remaining amount available under the CEFF has decreased to the
lesser of $69.7 million or 8,684,351 shares of common stock.
Public Offering of Common
Stock. On March 17, 2010, we completed an underwritten public offering of
11,500,000 shares of common stock at a public offering price of $7.00 per share
for net proceeds of approximately $75.4 million, after deducting the
underwriters’ discount and other offering expenses paid by us.
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
Our
financial results and capital resources are affected by changes in the U.S.
dollar/Euro exchange rate. As of September 30, 2010, we had U.S.
dollar-denominated cash and investments of approximately $104.2 million and
Euro-denominated cash and investments of approximately €44.2 million, or
approximately $60.1 million using the exchange rate as of that
date. As of September 30, 2010, we had Euro-denominated liabilities
of approximately €31.8 million, or approximately $43.2 million, using the
exchange rate as of that date. The following table shows the hypothetical impact
of a change to the Euro/U.S. Dollar exchange rate as of September 30,
2010:
Change
in Euro/$ 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 nine months ended September 30,
2010 (in thousands)
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$ |
1,911 |
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$ |
2,866 |
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$ |
3,821 |
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Item 4.
Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our reports required to be filed under
the Securities Exchange Act of 1934, as amended, or 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 (our
principal executive officer) and our Chief Financial Officer (our principal
financial officer), as appropriate, to allow for timely decisions regarding
required disclosure. In designing and evaluating the disclosure controls and
procedures, we recognize that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, and we apply judgment in evaluating the cost-benefit
relationship of possible controls and procedures. In addition, the design of any
system of controls also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future
conditions. Over time, controls may become inadequate because of
changes in conditions, or the degree of compliance with policies or procedures
may deteriorate. Because of the inherent limitations in a control system,
misstatements due to error or fraud may occur and not be detected.
Under the
supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we conducted an
evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures as such term is defined under Rules 13a-15(e) and
15d-15(e) promulgated under the Exchange Act, as of September 30, 2010, the end
of the period covered by this report. Based on the evaluation of our disclosure
controls and procedures as of September 30, 2010, our principal executive
officer and principal financial officer concluded that, as of such date, our
disclosure controls and procedures were effective at the reasonable assurance
level.
Changes
in Internal Control over Financial Reporting
Our
principal executive officer and principal financial officer also evaluated
whether any change in our internal control over financial reporting, as such
term is defined under Rules 13a-15(f) and 15d-15(f) promulgated under the
Exchange Act, occurred during our most recent fiscal quarter covered by this
report that has materially affected, or is likely to materially affect, our
internal control over financial reporting. Our principal executive
officer and principal financial officer concluded that no such change
occurred.
PART
II — OTHER INFORMATION
Item 1.
Legal Proceedings
None.
Item 1A. Risk
Factors
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 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 Boehringer Ingelheim, Bayer Schering Pharma, sanofi-aventis,
Nycomed, Merck Serono, MedImmune and TRACON. 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;
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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. Prior to April 30, 2010, Kingsbridge had the right to terminate the
CEFF at the end of any consecutive 12-month period during which we failed to
draw down at least $1.25 million in funds. We and Kingsbridge have subsequently
amended the CEFF to remove Kingsbridge’s right to terminate the CEFF in these
circumstances. All other terms and provisions of the CEFF remain in
effect and are unaffected by this amendment. However, if we are unable to
access funds through the CEFF, or if Kingsbridge terminates the CEFF or it
otherwise expires, we may be unable to access capital from other sources on
favorable terms, or at all.
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.
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 adverse 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; and
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requiring advance notice for
raising matters of business or making nominations at stockholders’
meetings.
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We are
also subject to provisions of the Delaware corporation law that, in general,
prohibit any business combination with a beneficial owner of 15% or more of our
common stock for five years unless the holder’s acquisition of our stock was
approved in advance by our board of directors.
We
may become involved in securities class action litigation that could divert
management’s attention and harm our business.
The stock
market has from time to time experienced significant price and volume
fluctuations that have affected the market prices for the common stock of
pharmaceutical and biotechnology companies. These broad market fluctuations may
cause the market price of our common stock to decline. In the past, following
periods of volatility in the market price of a particular company’s securities,
securities class action litigation has often been brought against that company.
We may become involved in this type of litigation in the future. Litigation
often is expensive and diverts management’s attention and resources, which could
adversely affect our business.
Risks
Relating to Our Collaborations and Clinical Programs
We
are dependent on collaborators for the development and commercialization of many
of our product candidates. If we lose any of these collaborators, or if they
fail or incur delays in the development or commercialization of our current and
any future product candidates, our operating results would suffer.
The
success of our strategy for development and commercialization of our product
candidates depends upon our ability to enter into and maintain
productive strategic collaborations and license arrangements. We currently have
strategic collaborations or license arrangements with Boehringer Ingelheim,
Bayer Schering Pharma, sanofi-aventis, Nycomed, Merck Serono, MedImmune and
TRACON. We expect to enter into additional collaborations and license
arrangements in the future. Our existing and any future collaborations and
licensed programs may not be scientifically or commercially successful. The
risks that we face in connection with these collaborations and licensed programs
include the following:
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Each of our collaborators has
significant discretion in determining the efforts and resources that it
will apply to the collaboration. The timing and amount of any future
royalty and milestone revenue that we may receive under collaborative and
licensing arrangements will depend on, among other things, each
collaborator’s efforts and allocation of
resources.
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All of our strategic
collaboration and license agreements are for fixed terms and are subject
to termination under various circumstances, including, in some cases, on
short notice without cause. If any of our collaborative partners were to
terminate its agreement with us, we may attempt to identify and enter into
an agreement with a new collaborator with respect to the product candidate
covered by the terminated agreement. If we are not able to do so, we may
not have the funds or capability to undertake the development,
manufacturing and commercialization of that product candidate, which could
result in a discontinuation or delay of the development of that product
candidate.
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Our collaborators may develop and
commercialize, either alone or with others, products that are similar to
or competitive with the product candidates that are the subject of their
collaborations with us or programs licensed from
us.
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Our collaborators may discontinue
the development of our product candidates in specific indications, for
example as a result of their assessment of the results obtained in
clinical trials, or fail to initiate development in indications that have
a significant commercial
potential.
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Pharmaceutical and biotechnology
companies from time to time re-evaluate their research and development
priorities, including in connection with mergers and consolidations, which
have been common in recent years. The ability of our product candidates
involved in strategic collaborations to reach their potential could be
limited if, as a result of changes in priorities, our collaborators
decrease or fail to increase spending related to our product candidates,
or decide to discontinue the development of our product candidates and
terminate their collaboration or license agreement with us. In the event
of such a termination, we may not be able to identify and enter into a
collaboration agreement for our product candidates with another
pharmaceutical or biotechnology company on terms favorable to us or at
all, and we may not have sufficient financial resources to continue the
development program for these product candidates on our own. As a result,
we may fail or incur delays in the development of these product candidates
following any termination of the collaboration agreement, or we may need
to reallocate financial resources that could cause delays in other
development programs for our other product
candidates.
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We
may not be successful in establishing additional strategic collaborations, which
could adversely affect our ability to develop and commercialize product
candidates.
As an
integral part of our ongoing research and development efforts, we periodically
review opportunities to establish new collaborations for development and
commercialization of new BiTE antibodies or existing product candidates in our
development pipeline. We face significant competition in seeking appropriate
collaborators, and the negotiation process is time-consuming and complex. We may
not be successful in our efforts to establish additional collaborations or other
alternative arrangements. Even if we are successful in establishing a
collaboration, the terms of the agreement may not always be favorable to us.
Finally, such collaborations or other arrangements may not result in successful
products and associated revenue from milestone payments, royalties or profit
share payments.
If
we cannot successfully establish clinical and regulatory operations in the
United States, or if we do not obtain the necessary regulatory approvals from
the FDA, the development and commercialization of blinatumomab in the United
States may be delayed or may not occur at all.
In
November 2009, we and MedImmune terminated our collaboration and license
agreement relating to blinatumomab. As a result, we now control the rights to
develop and commercialize blinatumomab in the United States. However, we will
need to hire personnel in order to prepare and execute our clinical development
plan and to obtain the necessary regulatory approvals from the FDA or other
regulatory authorities for the development and marketing of blinatumomab in the
United States. No patients have been enrolled in clinical trials of blinatumomab
in the United States. If we are not able to hire the appropriate personnel, or
if the FDA does not grant the necessary approvals, the development of
blinatumomab in the United States could be delayed or may never occur. There can
be no assurances that we will be able to successfully develop blinatumomab or
that such development will not be delayed as a result of financial constraints
or if the FDA does not agree with our clinical development plans. There can also
be no assurance that we will be able to enter into a new collaboration agreement
with respect to blinatumomab with another industry partner for the development
of blinatumomab in the United States or in any other territories if we desire to
do so, or that we will ever be successful, alone or with a collaborator, in
commercializing blinatumomab in the United States or in any other
territories.
Our
planned pivotal clinical trial of blinatumomab may not be sufficient to obtain
marketing approval for the treatment of acute lymphoblastic
leukemia.
As noted
elsewhere in this report, we have initiated a single-arm, non-blinded pivotal
clinical trial of blinatumomab in adult patients with MRD-positive ALL.
Depending on the results of this trial, we intend to seek marketing approval of
blinatumomab in Europe for the treatment of ALL. The FDA, as well as the
European Medicines Agency, or EMA, and regulatory authorities in other countries
generally require two randomized, blinded clinical trials in order to grant
marketing approval for pharmaceutical products. Based on our discussions with
the EMA, we believe that we will be required to demonstrate more robust efficacy
results from our planned single-arm, non-blinded pivotal trial than if we were
to conduct multiple, well-controlled trials. Furthermore, our planned pivotal
trial will have both primary and secondary endpoints, each of which will likely
be required to be achieved with robust results in order to sufficiently
demonstrate efficacy. In addition, based on initial discussions with the FDA, we
expect that the study as currently designed (single-arm, non-blinded pivotal
clinical trial of blinatumomab with a primary endpoint of MRD response), without
a randomized companion study, will not by itself support FDA approval of
blinatumomab in this specific setting. Accordingly, we have initiated an
exploratory trial in adult patients with relapsed refractory ALL that may serve
as the basis for a pivotal trial in that indication. We believe this
development program, considered as a whole, may be sufficient to support FDA
approval of blinatumomab in this setting. If the EMA and FDA conclude
that our trial design or the data from our planned pivotal clinical trials are
not sufficient to approve blinatumomab for marketing in Europe or the United
States, as applicable, they may require us to conduct expanded or additional
clinical trials. This could significantly increase the cost required to develop
blinatumomab and would substantially delay, or could prevent, marketing approval
for blinatumomab.
Our
clinical-stage product candidates have not yet been proven to be safe or
effective in confirmatory studies. If we discontinue the development of any of
our clinical-stage product candidates due to adverse events, lack of efficacy,
or any other reason, the value of your investment may be adversely
affected.
Our
product candidates have not yet been proven safe or effective in clinical
trials. For example, in 2006 and 2007 we completed two phase 2
clinical trials of adecatumumab in patients with metastatic breast cancer and in
patients with prostate cancer but did not achieve the primary endpoints of the
trials. In 2003 and 2004, we terminated early stage clinical trials utilizing
short-term infusions with blinatumomab due to adverse events that included
infections, neurological events, and liver enzyme increases. Also, in our
ongoing phase 1 clinical trial utilizing continuous infusion with blinatumomab
in patients with non-Hodgkin’s lymphoma (NHL), we have observed adverse events
that required premature discontinuation of treatment of
patients. Events leading to discontinuation of blinatumomab have
included neurological disorders in dosing schedules tested to date, including
flat dosing and dosing schedules using gradually increasing doses. We
are working to define the optimal dose and schedule to optimize the safety and
efficacy of blinatumomab in this setting. We may not be able to treat all NHL
patients with a uniform dosing schedule.
With all
of our product candidates, there can be no assurance that we will not encounter
unacceptable adverse events, that any preliminary suggestion of anti-tumor
activity will be confirmed in ongoing or future clinical trials, or that ongoing
clinical trials will not be suspended or ended for any other
reason. If we are unable to continue the development of any of our
clinical-stage product candidates, it would negatively affect our business
prospects and could impair your investment in our company.
Many
of the product candidates in our pipeline are in early stages of development,
and our efforts to develop and commercialize these product candidates are
subject to a high risk of delay and failure. If we fail to successfully develop
our product candidates, our ability to generate revenues will be substantially
impaired.
Many of
our product candidates are in early stages of clinical and preclinical
development, so we will require substantial additional financial resources, as
well as research, product development and clinical development capabilities, to
pursue the development of these product candidates, and we may never develop an
approvable or commercially viable product. The process of successfully
developing product candidates for the treatment of human diseases is very
time-consuming, expensive and unpredictable, and there is a high rate of failure
for product candidates in preclinical development and in clinical trials.
Preclinical studies and clinical trials may produce negative, inconsistent or
inconclusive results, and the results from early clinical trials may not be
statistically significant or predictive of results that will be obtained from
expanded, advanced clinical trials. Further, we or our collaborators may decide,
or the FDA, EMA or other regulatory authorities may require us, to conduct
preclinical studies or clinical trials or other development activities in
addition to those performed or planned by us or our collaborators, which may be
expensive or could delay the time to market for our product candidates. In
addition, we do not know whether the clinical trials will result in marketable
products.
We do not
know whether our planned preclinical development or clinical trials for our
product candidates will begin on time or be completed on schedule, if at all.
The timing and completion of clinical trials of our product candidates depend
on, among other factors, the number of patients that will be required to enroll
in the clinical trials, the inclusion and exclusion criteria used for selecting
patients for a particular clinical trial, and the rate at which those patients
are enrolled. Any increase in the required number of patients, tightening of
selection criteria, or decrease in recruitment rates or difficulties retaining
trial participants may result in increased costs, delays in the development of
the product candidate, or both. For example, as described elsewhere
in this report, we recently discontinued enrollment in a phase 2 trial of
adecatumumab in patients with resected liver metastases from colorectal cancer
due to a change in the standard of care in this disease setting, which resulted
in slower recruitment than was planned.
Our
product candidates may not be effective in treating any of our targeted diseases
or may prove to have undesirable or unintended side effects, toxicities or other
characteristics that may prevent or limit their commercial use. Institutional
review boards or regulators, including the FDA and EMA, may hold, suspend or
terminate our clinical research or the clinical trials of our product candidates
for various reasons, including non-compliance with regulatory requirements or
if, in their opinion, participating patients are being exposed to unacceptable
health risks, or if additional information may be required for the regulatory
authority to assess our proposed development activities. Further, regulators may
not approve study protocols at all or in a timeframe anticipated by us if they
believe that the study design or the mechanism of action of our product
candidates poses an unacceptable health risk to participants in the
trial.
We have
limited financial and managerial resources. These limitations require us to
focus on a select group of product candidates in specific therapeutic areas and
to forego the exploration of other product opportunities. While our technologies
may permit us to work in multiple areas, resource commitments may require
trade-offs resulting in delays in the development of certain programs or
research areas, which may place us at a competitive disadvantage. Our decisions
as to resource allocation may not lead to the development of viable commercial
products and may divert resources away from other market opportunities, which
would otherwise have ultimately proved to be more profitable. In
addition, our product candidates may have different efficacy profiles in certain
clinical indications, sub-indications or patient profiles, and an election by us
or our collaborators to focus on a particular indication, sub-indication or
patient profile may result in a failure to capitalize on other potentially
profitable applications of our product candidates.
We
rely heavily on third parties for the conduct of preclinical studies and
clinical trials of our product candidates, and we may not be able to control the
proper performance of the studies or trials.
In order
to obtain regulatory approval for the commercial sale of our product candidates,
we and our collaborators are required to complete extensive preclinical studies
as well as clinical trials in humans to demonstrate to the FDA, EMA and other
regulatory authorities that our product candidates are safe and effective. We
have limited experience and internal resources for conducting certain
preclinical studies and clinical trials and rely primarily on collaborators and
contract research organizations for the performance and management of these
studies and trials.
We are
responsible for confirming that our preclinical studies are conducted in
accordance with applicable regulations and that each of our clinical trials is
conducted in accordance with its general investigational plan and protocol. Our
reliance on third parties does not relieve us of responsibility for ensuring
compliance with appropriate regulations and standards for conducting,
monitoring, recording and reporting of preclinical and clinical trials. If our
collaborators or contractors fail to properly perform their contractual or
regulatory obligations with respect to conducting or overseeing the performance
of our preclinical studies or clinical trials, do not meet expected deadlines,
fail to comply with the good laboratory practice guidelines or good clinical
practice regulations, do not adhere to our preclinical and clinical trial
protocols, suffer an unforeseen business interruption unrelated to our agreement
with them that delays the clinical trial, or otherwise fail to generate reliable
clinical data, then the completion of these studies or trials may be delayed,
the results may not be useable and the studies or trials may have to be
repeated, and we may need to enter into new arrangements with alternative third
parties. Any of these events could cause our clinical trials to be extended,
delayed, or terminated or create the need for them to be repeated, or otherwise
create additional costs in the development of our product candidates and could
adversely affect our and our collaborators’ ability to market a product if
marketing approvals are obtained.
Even
if we complete the lengthy, complex and expensive development process, there is
no assurance that we or our collaborators will obtain the regulatory approvals
necessary for the launch and commercialization of our product
candidates.
To the
extent that we or our collaborators are able to successfully complete the
clinical development of a product candidate, we or our collaborators will be
required to obtain approval by the FDA, EMA or other regulatory authorities
prior to marketing and selling the product candidate in the United States, the
European Union or other countries. The process of preparing and filing
applications for regulatory approvals with the FDA, EMA and other regulatory
authorities, and of obtaining the required regulatory approvals from these
regulatory authorities, is expensive and may take several years or more. This
process is further complicated because some of our product candidates use
non-traditional materials in novel ways, and regulatory officials may have
little precedent to follow.
Any
marketing approval by the FDA, EMA or other regulatory authorities may be
subject to limitations on the indicated uses for which we or our collaborators
can market the product candidate. These limitations could restrict the size of
the market for the product and affect reimbursement levels by third-party
payers.
As a
result of these factors, we or our collaborators may not successfully launch and
commercialize any product candidates in the time periods estimated, if at all.
Moreover, if we or our collaborators incur costs and delays in development
programs or fail to successfully develop and commercialize products based upon
our technologies, we may not become profitable and our stock price could
decline.
Risks
Relating to Our Operations, Business Strategy, and the Life Sciences
Industry
We
face substantial competition, which may result in our competitors discovering,
developing or commercializing products before or more successfully than we
do.
Our
product candidates face competition with existing and new products being
developed by biotechnology and pharmaceutical companies, as well as universities
and other research institutions. Research in the field of antibody-based
therapeutics for the treatment of cancers is highly competitive. A number of
entities are seeking to identify and patent antibodies, as well as potentially
active proteins and other potentially active compounds without specific
knowledge of their therapeutic functions. Our competitors may discover,
characterize or develop molecules or genes into therapeutic product candidates
in advance of us.
Many of
our competitors have substantially greater capital resources, research and
development staffs and facilities than we have. Efforts by other biotechnology
and pharmaceutical companies could render our programs or product candidates
uneconomical or result in therapies that are superior to those that we are
developing alone or with a collaborator. We and our collaborators face
competition from companies that may be more experienced in product development
and commercialization, obtaining regulatory approvals and product manufacturing.
As a result, they may develop competing products more rapidly that are safer,
more effective, or have fewer side effects, or are less expensive, or they may
discover, develop and commercialize products that render our product candidates
non-competitive or obsolete. We expect competition to intensify in antibody
research as technical advances in the field are made and become more widely
known.
We
may not be successful in our efforts to expand our portfolio of product
candidates.
A key
element of our strategy is to discover, develop and commercialize a portfolio of
new BiTE antibody therapeutics. We are seeking to do so through our internal
research programs, which could place a strain on our human and capital
resources. A significant portion of the research that we are conducting involves
new and unproven technologies. Research programs to identify new disease targets
and product candidates require substantial technical, financial and human
resources, regardless of whether or not any suitable candidates are ultimately
identified. Our research programs may initially show promise in identifying
potential product candidates, yet fail to yield product candidates suitable for
clinical development. If we are unable to discover, develop or in-license
suitable potential product candidates on acceptable business terms, our business
prospects will suffer.
We and our
collaborators are subject to governmental regulations in addition to those
imposed by the FDA and EMA and may not be able to comply with these regulations.
Any non-compliance could subject us or our collaborators to penalties and
otherwise result in the limitation of our operations.
In
addition to regulations imposed by the FDA, EMA and other health regulatory
authorities, we and our collaborators are subject to regulation in the United
States under the Occupational Safety and Health Act, the Environmental
Protection Act, the Toxic Substances Control Act and the Research Conservation
and Recovery Act, as well as regulations administered by the Nuclear Regulatory
Commission, national restrictions on technology transfer, import, export and
customs regulations and certain other local, state or federal regulations, or
comparable laws and regulations in Europe and other countries. From time to
time, other governmental agencies and legislative or international governmental
bodies have indicated an interest in implementing further regulation of
biotechnology applications. We are not able to predict whether any such
regulations will be adopted or whether, if adopted, such regulations will apply
to our or our collaborators’ businesses, or whether we or our collaborators
would be able to comply, without incurring unreasonable expense, or at all, with
any applicable regulations.
Our
growth could be limited if we are unable to attract and retain key personnel and
consultants.
We have
limited experience in filing and prosecuting regulatory applications to obtain
marketing approval from the FDA, EMA or other regulatory authorities. Our
success depends on our ability to attract, train and retain qualified scientific
and technical personnel, including consultants, to further our research and
development efforts. The loss of services of one or more of our key employees or
consultants could have a negative impact on our business or our ability to
expand our development programs. Competition for skilled personnel is intense
and the turnover rate can be high. Competition for experienced management and
clinical, scientific and engineering personnel from numerous companies and
academic and other research institutions may limit our ability to attract and
retain qualified personnel on acceptable terms. As a result, locating candidates
with the appropriate qualifications can be difficult, and we may not be able to
attract and retain sufficient numbers of highly skilled employees in order to
operate our business.
Any
growth and expansion into areas and activities that may require additional
personnel or expertise, such as in regulatory affairs, quality assurance and
control, or compliance, would require us to either hire new personnel or to
obtain such services from a third party. The pool of personnel with the skills
that we require could be limited, and we may not be able to hire or contract
such additional personnel on commercially reasonable terms, or at all. Failure
to attract and retain personnel would likely prevent us from developing and
commercializing our product candidates.
Even
if regulatory authorities approve our product candidates for marketing, we may
fail to comply with ongoing regulatory requirements or experience unanticipated
problems with marketed products, which could then be subject to restrictions or
withdrawal from the market.
Any
product candidates for which we obtain marketing approval, along with the
manufacturing processes, post-approval clinical trials and promotional
activities for such product candidates, will be subject to periodic review and
inspection by the FDA, EMA and other regulatory authorities. Even if regulatory
approval of a product candidate is granted, the approval may be subject to
limitations on the indicated uses for which the product may be marketed or
contain requirements for costly post-marketing testing and surveillance to
monitor the safety or efficacy of the product. Post-approval discovery of
previously unknown problems, including unanticipated adverse events or adverse
events of unanticipated severity or frequency, difficulties with a manufacturer
or manufacturing processes, or failure to comply with regulatory requirements,
may result in restrictions on such approved products or manufacturing processes,
limitations in the scope of our approved labeling, withdrawal of the approved
products from the market, voluntary or mandatory recall and associated publicity
requirements, fines, suspension or withdrawal of regulatory approvals, product
seizures, injunctions or the imposition of civil or criminal penalties, any of
which would have a material and adverse effect on our business.
The
procedures and requirements for granting marketing approvals vary among
countries, which may cause us to incur additional costs or delays or may prevent
us from obtaining marketing approvals in different countries and regulatory
jurisdictions.
We intend
to market our product candidates in many countries and regulatory jurisdictions.
In order to market our product candidates in the United States, the European
Union and many other jurisdictions, we must obtain separate regulatory approvals
in each of these countries and territories. The procedures and requirements for
obtaining marketing approval vary among countries and regulatory jurisdictions,
and can involve additional clinical trials or other tests. Also, the time
required to obtain approval in markets outside of the United States and Europe
may differ from that required to obtain FDA and EMA approval, while still
including all of the risks associated with obtaining FDA and EMA approval. We
may not be able to obtain all of the desirable or necessary regulatory approvals
on a timely basis, if at all. Approval by a regulatory authority in a particular
country or regulatory jurisdiction, such as the FDA in the United States or the
EMA in the European Union, does not ensure approval by a regulatory authority in
another country. We may not be able to file for regulatory approvals and may not
receive necessary approvals to commercialize our product candidates in any or
all of the countries or regulatory jurisdictions in which we desire to market
our product candidates.
If
we fail to obtain an adequate level of reimbursement from third-party payers for
any approved products, there may be no commercially viable markets for these
products or the markets may be much smaller than expected. The continuing
efforts of the government, insurance companies, managed care organizations and
other payers of healthcare costs to contain or reduce costs of healthcare may
adversely affect our ability to generate revenues and achieve profitability, the
future revenues and profitability of our potential customers, suppliers and
collaborators, and the availability of capital.
Our
ability to commercialize our product candidates successfully will depend in part
on the extent to which governmental authorities, private health insurers and
other organizations establish appropriate reimbursement levels for the price
charged for our product candidates and related treatments. The efficacy, safety
and cost-effectiveness of our product candidates, as well as the efficacy,
safety and cost-effectiveness of any competing products, will determine in part
the availability and level of reimbursement. These third-party payers
continually attempt to contain or reduce the costs of healthcare by challenging
the prices charged for healthcare products and services. Given recent federal
and state government initiatives directed at lowering the total cost of
healthcare in the United States, the U.S. Congress and state legislatures will
likely continue to focus on reducing the cost of prescription drugs and on the
reform of the Medicare and Medicaid systems. In certain countries, particularly
the countries of the European Union, the pricing of prescription pharmaceuticals
is subject to governmental control. In these countries, pricing negotiations
with governmental authorities can take between six and twelve months, or longer,
after the receipt of regulatory marketing approval for a product. To obtain
reimbursement or pricing approval in some countries, we may be required to
conduct clinical trials that compare the cost-effectiveness of our product
candidates to other available therapies. If reimbursement for our product
candidates becomes unavailable or limited in scope or amount, or if
reimbursement levels or prices are set at unsatisfactory levels, our projected
and actual revenues and our prospects for profitability would be negatively
affected.
We are
unable to predict what additional legislation or regulation, if any, relating to
the healthcare industry, drug importation from foreign countries, or third-party
coverage and reimbursement may be enacted in the future or what effect such
legislation or regulation would have on our business. Any cost containment
measures or other healthcare system reforms that are adopted or implemented
could have a material adverse effect on our ability to commercialize
successfully any future products or could limit or eliminate our spending on
development projects and affect our ultimate profitability.
If
our product candidates are not accepted by physicians and patients, our ability
to generate product revenue in the future will be adversely
affected.
Our
product candidates, if successfully developed and approved by regulatory
authorities, may not gain market acceptance among physicians, healthcare payers,
patients and the medical community. Market acceptance of and demand for any
product candidate that we may develop will depend on many factors,
including:
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our ability to provide acceptable
evidence of safety and
efficacy;
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convenience and ease of
administration;
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prevalence and severity of
adverse side effects;
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the timing of our market entry
relative to competitive
treatments;
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effectiveness of our marketing
and pricing strategy;
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publicity concerning our product
candidates or competitive
products;
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the strength of marketing and
sales support; and
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our ability to obtain third-party
coverage or reimbursement.
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If any
product candidates for which we may receive marketing approval fail to gain
market acceptance, our ability to generate product revenue in the future will be
adversely affected.
We
face the risk of product liability claims and may not be able to obtain
insurance.
Our
business exposes us to the risk of product liability claims that is inherent in
the testing, manufacturing, and marketing of drugs and biologics. Although we
have product liability and clinical trial liability insurance that we believe is
appropriate, this insurance is subject to deductibles and coverage limitations.
We may not be able to obtain or maintain adequate protection against potential
liabilities. If any of our product candidates is approved for marketing, we may
seek additional insurance coverage. If we are unable to obtain insurance at
acceptable cost or on acceptable terms with adequate coverage or otherwise
protect ourselves against potential product liability claims, we could be
exposed to significant liabilities, which may cause a loss of revenue or
otherwise harm our business. These liabilities could prevent or interfere with
our product commercialization efforts. Defending a suit, regardless of merit,
could be costly, could divert management attention and might result in adverse
publicity, injury to our reputation, or reduced acceptance of our product
candidates in the market. If we are sued for any injury caused by any future
products, any resulting liability could exceed our total assets.
Our
operations involve hazardous materials that require us to comply with
environmental laws and regulations, which can be expensive.
Our
research and development activities involve the controlled use of hazardous
materials, including chemicals and radioactive and biological materials. Our
operations also produce hazardous waste products. We are subject in the United
States to a variety of federal, state and local regulations, and in Europe to
European, national, state and local regulations, relating to the use, handling,
storage and disposal of these materials. We generally contract with third
parties for the disposal of such substances, and we may store certain low-level
radioactive waste at our facilities until the materials are no longer considered
radioactive. We cannot, however, eliminate the risk of accidental contamination
or injury from these materials. We may be required to incur substantial costs to
comply with current or future environmental and safety regulations that could
impose greater compliance costs and increased risks and penalties associated
with violations. If an accident or contamination occurred, we would likely incur
significant costs associated with civil penalties or criminal fines, substantial
investigation and remediation costs, and costs associated with complying with
environmental laws and regulations. There can be no assurance that violations of
environmental laws or regulations will not occur in the future as a result of
the inability to obtain permits, human error, accident, equipment failure or
other causes. We do not have any insurance for liabilities arising from
hazardous materials. Compliance with environmental and safety laws and
regulations is expensive, and current or future environmental regulation may
impair our research, development or production efforts.
Risks
Relating to Our Intellectual Property and Litigation
We
may not be able to obtain or maintain adequate patents and other intellectual
property rights to protect our business and product candidates against
competitors.
We
believe that the value of our company will be significantly enhanced if we are
able to obtain adequate patents and other intellectual property rights that
protect our business and product candidates against competitors. For that
reason, we allocate significant financial and personnel resources to the filing,
prosecution, maintenance and defense of patent applications, patents and
trademarks claiming or covering our product candidates and key technology
relating to these product candidates.
To date,
we have sought to protect our proprietary positions related to our important
technology, inventions and improvements by filing patent applications in the
United States, Europe and other jurisdictions throughout the world. Because the
patent position of pharmaceutical and biopharmaceutical companies involves
complex legal and factual questions, the issuance, scope and enforceability of
patents cannot be predicted with certainty, and we cannot be certain that
patents will issue on pending or future patent applications that cover our
product candidates and technologies. Claims could be restricted in prosecution
that might lead to a scope of protection that is of minor value for a particular
product candidate. Patents, even if issued, may be challenged and sought to be
invalidated by third parties in litigation. In addition, U.S. patents and patent
applications may be subject to interference proceedings, and U.S. patents may be
subject to reexamination proceedings in the U.S. Patent and Trademark Office,
while European patents may be subject to opposition proceedings in the European
Patent Office. Similar proceedings to challenge patents may be
available in countries outside of Europe or the United States.
Any
interference, reexamination or opposition proceedings could result in either a
loss of the patent or a denial of the patent application or loss or reduction in
the scope of one or more of the claims of the patent or patent application.
Thus, any patents that we own or license from others may not ultimately provide
any protection against competitors. Furthermore, an adverse decision in an
interference proceeding could result in a third party receiving the patent
rights sought by us, which in turn could affect our ability to market a
potential product or product candidate to which that patent filing was directed.
Our pending patent applications, those that we may file in the future, or those
that we may license from third parties may not result in patents being issued
for a number of reasons. In addition, we rely on third-party payment
services and external law firms for the payment of foreign patent annuities and
other fees, and non-payment or delay in payment of such fees, whether
intentional or unintentional, could result in the loss of patents or other
rights important to our business.
Even if
patents issue, they may not provide us with sufficient proprietary protection or
competitive advantages against competitors with similar technology. Furthermore,
others may independently develop similar technologies or duplicate any
technology that we have developed, which fall outside the scope of our patents.
Our products or technology could also be copied by competitors after expiration
of the patent life. Furthermore, claims of our current or former employees
related to their inventorship or compensation pursuant to the German Act on
Employees’ Inventions could lead to legal disputes.
We
may incur substantial costs in enforcing our patents against third parties. If
we are unable to protect our intellectual property rights, our competitors may
develop or market products with similar features that may reduce demand for our
potential products.
We own or
control a substantial portfolio of issued patents. From time to time, we may
become aware of third parties that undertake activities that infringe our
patents. We may decide to grant those third parties a license under our patents,
or to enforce the patents against those third parties by pursuing an
infringement claim in litigation. If we initiate patent infringement litigation,
it could consume significant financial and management resources, regardless of
the merit of the claims or the outcome of the litigation. In addition, the
outcome of patent litigation is subject to uncertainties that cannot be
adequately quantified in advance, including the demeanor and credibility of
witnesses and the identity of the adverse party, especially in
biotechnology-related patent cases that may turn on the testimony of experts as
to technical facts upon which experts may reasonably disagree. Some of our
competitors may be able to sustain the costs of such litigation or proceedings
more effectively than we can because of their substantially greater financial
resources. Uncertainties resulting from the initiation and continuation of
patent litigation or other proceedings could harm our ability to compete in the
marketplace.
Our
ability to enforce our patents may also be restricted under applicable law. Many
countries, including certain countries in Europe, have compulsory licensing laws
under which a patent owner may be compelled to grant licenses to third parties.
For example, compulsory licenses may be required in cases where the patent owner
has failed to “work” the invention in that country, or the third party has
patented improvements. In addition, many countries limit the enforceability of
patents against government agencies or government contractors. In these
countries, the patent owner may have limited remedies, which could materially
diminish the value of the patent. Moreover, the legal systems of certain
countries, particularly certain developing countries, do not favor the
aggressive enforcement of patent and other intellectual property rights, which
makes it difficult to stop infringement. In addition, our ability to enforce our
patent rights depends on our ability to detect infringement. It is difficult to
detect infringers who do not advertise the compounds used in their products or
the methods used in the research and development of their products. If we are
unable to enforce our patents against infringers, it could have a material
adverse effect on our competitive position and our ability to develop and
commercialize our product candidates.
If
we are not able to protect and control our unpatented trade secrets, know-how
and other technology, we may suffer competitive harm.
We rely
on proprietary trade secrets and unpatented know-how to protect our research,
development and manufacturing activities and maintain our competitive position,
particularly when we do not believe that patent protection is appropriate or
available. However, trade secrets are difficult to protect. Although we attempt
to protect our trade secrets and unpatented know-how by requiring our employees,
consultants and advisors to execute confidentiality and non-use agreements, we
cannot guarantee that these agreements will provide meaningful protection or
will not be breached, that we will have an adequate remedy for any such breach,
or that our trade secrets or proprietary know-how will not otherwise become
known or independently developed by a third party. Our trade secrets, and those
of our present or future collaborators that we utilize by agreement, may become
known or may be independently discovered by others, which could adversely affect
the competitive position of our product candidates. If any trade secret,
know-how or other technology not protected by a patent or intellectual property
right were disclosed to, or independently developed by a competitor, our
business, financial condition and results of operations could be materially and
adversely affected.
If
third parties claim that our product candidates or technologies infringe their
intellectual property rights, we may become involved in expensive patent
litigation, which could result in liability for damages or require us to stop
the development or commercialization of our product candidates, even if they
have been approved and launched in the market, or we could be forced to obtain a
license and pay royalties under unfavorable terms.
Our
commercial success will depend in part on not infringing the patents or
violating the proprietary rights of third parties. Our competitors or other
third parties may obtain patents that may claim the composition, manufacture or
use of our product candidates or the technology required to perform research and
development activities relating to our product candidates.
From time
to time we receive correspondence inviting us to license patents from third
parties. While we believe that our pre-commercialization activities fall within
the scope of an available exemption against patent infringement provided by U.S.
federal statutes and by similar research exemptions in Europe, claims may be
brought against us in the future based on patents held by others. Also, we are
aware of patents and other intellectual property rights of third parties
relating to our areas of practice, and we know that others have filed patent
applications in various countries that relate to areas in which we are
developing product candidates. Some of these patent applications have already
resulted in patents and some are still pending. In addition, there is a delay
between the filing of a patent application and its publication, and as a result
we may not be aware of all relevant patent applications of third parties at a
given point in time. Further, publication of discoveries in the scientific or
patent literature often lags behind actual discoveries, so we may not be able to
determine whether inventions claimed in patent applications of third parties
have been made before or after the date on which inventions claimed in our
patent applications and patents have been made.
All
issued patents are entitled to a presumption of validity in many countries,
including the United States and many European countries. Issued patents held by
others may therefore limit our freedom to operate unless and until these patents
expire or are declared invalid or unenforceable in a court of applicable
jurisdiction. For example, we are aware that GlaxoSmithKline holds
U.S. and European patents claiming the administration of anti-EpCAM antibodies
with certain chemotherapeutic agents. We have completed a phase 1b clinical
trial evaluating adecatumumab in combination with docetaxel under our
collaboration agreement with Merck Serono and, while we have no current plans to
continue the development of this combination, if we and Merck Serono were to
pursue further development and seek marketing approval for this combination at a
time when this patent remains in effect, GlaxoSmithKline could attempt to enjoin
Merck Serono from commercializing the combination of adecatumumab and docetaxel
or require Merck Serono to take a license under its patent, which Merck Serono
may not be able to obtain on commercially reasonable terms, if at all. If Merck
Serono were required to make royalty payments to GlaxoSmithKline or other third
parties that hold patents that would be infringed by the manufacture, use or
sale of adecatumumab, and if these royalty payments to third parties were to
exceed a threshold percentage specified in our collaboration agreement, Merck
Serono would have the right to credit a portion of these royalty payments
against royalty payments due to us, which would adversely affect our
revenues.
We and
our collaborators may not have rights under some patents that cover the
composition of matter, manufacture or use of product candidates that we seek to
develop and commercialize, drug targets to which our product candidates bind, or
technologies that we use or may seek to use in our research and development
activities. As a result, our ability to develop and commercialize our product
candidates may depend on our ability to obtain licenses or other rights under
these patents. The third parties who own or control such patents may be
unwilling to grant those licenses or other rights to us or our collaborators
under terms that are commercially viable, if at all. Third parties who own or
control these patents could bring patent infringement claims against us or our
collaborators and seek monetary damages or to enjoin further clinical testing,
manufacturing and marketing of our product candidates.
If a
third party brings a patent infringement suit against us, and we do not settle
the suit and are not successful in defending against the patent infringement
claims, we could be required to pay substantial damages or to stop or delay
research, development, manufacturing or sales of the product or product
candidate that is claimed by the third party’s patent. We or our collaborators
may choose to seek, or be required to seek, a license from the third party and
would most likely be required to pay license fees or royalties or both. However,
there can be no assurance that any such license would be available on acceptable
terms or at all. Even if we or our collaborators were able to obtain a license,
the rights may be nonexclusive, which would give our competitors access to the
same intellectual property. Ultimately, as a result of patent
infringement claims, we could be prevented from commercializing a product
candidate or forced to cease some aspect of our business operations, which would
harm our business.
Our success
depends on our ability to maintain and enforce our licensing arrangements with
various third party licensors.
We are
party to intellectual property licenses and agreements that are important to our
business, and we expect to enter into similar licenses and agreements in the
future. These licenses and agreements impose various research, development,
commercialization, sublicensing, milestone payments, indemnification, insurance
and other obligations on us. Moreover, certain of our license agreements contain
an obligation for us to make payments to our licensors based upon revenues
received in connection with such licenses. If we or our collaborators fail to
perform under these agreements or we otherwise breach our obligations, our
licensors may terminate these agreements, we could lose licenses to intellectual
property rights that are important to our business and could be required to pay
damages to our licensors. Any such termination could materially harm our ability
to develop and commercialize the product candidate that is the subject of the
agreement.
If
licensees or assignees of our intellectual property rights breach any of the
agreements under which we have licensed or assigned our intellectual property to
them, we could be deprived of important intellectual property rights and future
revenue.
We are a
party to intellectual property out-licenses, collaborations and agreements that
are important to our business, and we expect to enter into similar agreements
with third parties in the future. Under these agreements, we license or transfer
intellectual property to third parties and impose various research, development,
commercialization, sublicensing, royalty, indemnification, insurance and other
obligations on them. If a third party fails to comply with its obligations, we
generally retain the right to terminate the agreement. In the event of breach,
we may also enforce our rights under these agreements by resorting to
arbitration or litigation. During the period of arbitration or litigation, we
may be unable to effectively use, assign or license the relevant intellectual
property rights and may be deprived of current or future revenues that are
associated with such intellectual property, which could have a material adverse
effect on our results of operations and financial condition.
We may be subject
to damages resulting from claims that we or our employees have wrongfully used
or disclosed alleged trade secrets of their former
employers.
Many of
our employees were previously employed at other biotechnology or pharmaceutical
companies, including our competitors or potential competitors. Although no
claims against us are currently pending or, to our knowledge, threatened, we may
be subject to claims that these employees or we have inadvertently or otherwise
used or disclosed trade secrets or other proprietary information of their former
employers. Litigation may be necessary to defend against these claims. Even if
we are successful in defending against potential claims, litigation could result
in substantial costs and be a distraction to management. If we fail in defending
such claims, in addition to paying money claims, we may lose valuable
intellectual property rights or personnel. A loss of key personnel or their work
product could hamper or prevent our ability to commercialize certain product
candidates.
Risks
Relating to Manufacturing and Sales
We
depend on our collaborators and third-party manufacturers to produce our product
candidates, and if these third parties do not successfully manufacture these
product candidates, or do not follow current good manufacturing practices or do
not maintain their facilities in accordance with these practices, our product
development and commercialization efforts may be harmed.
We have
no manufacturing experience or manufacturing capabilities for the production of
our product candidates for clinical trials or commercial sale. In order to
continue to develop product candidates, apply for regulatory approvals, and
commercialize our product candidates following approval, we or our collaborators
must be able to manufacture or contract with third parties to manufacture our
product candidates in clinical and commercial quantities, in compliance with
regulatory requirements, at acceptable costs and in a timely manner. For
example, as a result of the termination of our collaboration with MedImmune
relating to blinatumomab, we have assumed the responsibility for the manufacture
of blinatumomab for clinical trials and have engaged Lonza AG as our contract
manufacturer. To the extent that we or our collaborators seek to
enter into manufacturing arrangements with third parties such as our agreement
with Lonza, we are dependent upon these third parties to perform their
obligations in a timely and effective manner and in accordance with government
regulations. Lonza or other contract manufacturers may breach their
manufacturing agreements because of factors beyond our control or may terminate
or fail to renew a manufacturing agreement based on their own business
priorities at a time that is costly or inconvenient for us.
The
manufacture of our product candidates may be complex, difficult to accomplish
and difficult to scale up if and when large-scale production is required, which
could impair our ability to meet commercial demands for any approved products.
Manufacture of our product candidates may also be subject to delays,
inefficiencies and poor or low yields of quality products. Furthermore, the cost
of manufacturing our product candidates may make them prohibitively expensive.
If supplies of any of our product candidates or related materials become
unavailable on a timely basis or are contaminated or otherwise lost, we may not
be able to obtain an alternative source of the materials on commercially
reasonable terms or at all, which could cause the initiation or completion of
our clinical trials to be seriously delayed. For example, we recently
recalled a batch of diluent, a liquid used to dilute MT110 drug product for
administration to patients, because of potential damage to the primary packaging
material of the diluent. Due to the batch recall, we currently do not have
diluent available for the ongoing phase 1 clinical trial with MT110 and,
consequently, are unable to treat patients in the trial until replacement
quantities of diluent are available from our third party
manufacturer.
Product
candidates used in clinical trials or sold after marketing approval has been
obtained must also be manufactured in accordance with current good manufacturing
practices, or cGMP, regulations. There are a limited number of manufacturers
that operate under these regulations, including the FDA’s and EMA’s good
manufacturing practices regulations, and that are capable of manufacturing our
product candidates. Third-party manufacturers may encounter difficulties in
achieving quality control and quality assurance and may experience shortages of
qualified personnel. Also, manufacturing facilities are subject to ongoing
periodic, unannounced inspection by the FDA, EMA and other regulatory agencies
or authorities, to ensure strict compliance with cGMP and other governmental
regulations and standards.
A failure
of third-party manufacturers to follow cGMP or other regulatory requirements, or
to document their adherence to such practices, may lead to significant delays in
the availability of product candidates for use in a clinical trial or for
commercial sale, the termination of, or hold on, a clinical trial, or may delay
or prevent filing or approval of marketing applications for our product
candidates. In addition, as a result of such a failure, we could be subject to
sanctions, including fines, injunctions and civil penalties, refusal or delays
by regulatory authorities to grant marketing approval of our product candidates,
suspension or withdrawal of marketing approvals, seizures or recalls of product
candidates, operating restrictions and criminal prosecutions, any of which could
significantly and adversely affect our business.
If we
were required to change manufacturers for any reason, we may be required to
conduct additional clinical trials and the revalidation of the manufacturing
process and procedures in accordance with applicable current good manufacturing
practices, which could require further FDA or EMA approval. This revalidation
may be costly and time-consuming, and if we are unable to arrange for
third-party manufacturing of our product candidates, or to do so on commercially
reasonable terms, we may not be able to complete development or marketing of our
product candidates.
The
transfer of the manufacturing process for blinatumomab from MedImmune may not be
successful, which could result in a shortage of clinical trial materials and a
delay in the development of blinatumomab.
As
described above, we are responsible for the manufacture of blinatumomab for
clinical trials and have engaged Lonza as our contract manufacturer. We do not
expect Lonza to initiate the manufacture of clinical supply of blinatumomab
until at least the end of 2010. Until then, we plan to utilize the inventory of
blinatumomab produced by MedImmune prior to the termination of the
collaboration.
We
believe that the existing stock of blinatumomab will be sufficient to supply our
ongoing and planned clinical trials of blinatumomab until Lonza-supplied
blinatumomab becomes available. However, if there is a delay in
Lonza’s ability to provide us with blinatumomab, we may have to delay our
planned clinical trials, which could have a material adverse effect on our
business. Furthermore, as part of the termination of our collaboration,
MedImmune is required to perform studies confirming that the stock of
blinatumomab supplied by MedImmune to us is stable and within our required
specifications. If MedImmune ceases to perform these stability studies or to
deliver the data from the stability studies as required, or if the data indicate
that the stock of blinatumomab has degraded to an extent that it no longer meets
the required specifications, we may not have sufficient quantities of the
product candidate required to perform the planned clinical trials with
blinatumomab. There can be no assurance that the transferred materials will be
sufficient for use in our clinical trials, or that we or Lonza will be able to
implement the manufacturing process transferred from MedImmune in a manner that
results in clinical trial materials with specifications comparable to the
clinical trial materials produced by MedImmune during the course of our
collaboration. Any of these or similar or other events could cause delays in the
development and potential regulatory approval of blinatumomab, which would have
an adverse effect on its commercial potential.
We
have no sales, marketing or distribution experience and will depend
significantly on third parties who may not be able to successfully sell our
product candidates following approval.
We have
no sales, marketing or product distribution experience. If we receive required
regulatory approvals to market any of our product candidates, we plan to rely
primarily on sales, marketing and distribution arrangements with third parties,
including our collaborators. For example, as part of our existing collaboration
agreements with Boehringer Ingelheim, Bayer Schering Pharma, sanofi-aventis,
Nycomed, Merck Serono, MedImmune and TRACON, we have granted these companies the
right to market and distribute products resulting from such collaborations, if
any are ever successfully developed. We may have to enter into additional
marketing arrangements in the future, and we may not be able to enter into these
additional arrangements on terms that are favorable to us, if at all. In
addition, we may have limited or no control over the sales, marketing and
distribution activities of these third parties, and sales through these third
parties could be less profitable to us than direct sales by us. Third parties
with whom we have marketing or distribution agreements could sell competing
products and may devote insufficient sales efforts to our product candidates
following their approval. As a result, our future revenues from sales of our
product candidates, if any, will be materially dependent upon the success of the
efforts of these third parties.
We may
seek to co-promote products with our collaborators, or to independently market
products that are not already subject to marketing agreements with other
parties. For example, under our collaboration agreement with Boehringer
Ingelheim, we have the right to co-promote in the United States any approved
products resulting from the collaboration. If we determine to perform sales,
marketing and distribution functions ourselves, then we could face a number of
additional risks, including:
|
•
|
we may not be able to attract and
build an experienced marketing staff or sales
force;
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|
•
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the cost of establishing a
marketing staff or sales force may not be justifiable in light of the
revenues generated by any particular
product;
|
|
•
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our direct sales and marketing
efforts may not be successful;
and
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|
•
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we may face competition from
other products or sales forces with greater resources than our own sales
force.
|
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3.
Defaults Upon Senior Securities
None.
Item 4.
Reserved
Item 5.
Other Information
None.
Item 6.
Exhibits
Exhibit
Number
|
|
Description
|
|
|
|
3.1
|
|
Amended
and Restated Certificate of Incorporation of the Registrant, incorporated
by reference from the Registrant’s Quarterly Report on Form 10-Q
filed with the SEC on December 11, 2003.
|
|
|
|
3.2
|
|
Certificate
of Amendment of the Amended and Restated Certificate of Incorporation of
the Registrant, incorporated by reference from the Registrant’s Quarterly
Report on Form 10-Q filed with the SEC on May 10,
2006.
|
|
|
|
3.3
|
|
Certificate
of Designations for Series A Junior Participating Preferred Stock of the
Registrant, incorporated by reference from the Registrant’s Current Report
on Form 8-K filed with the SEC on November 8,
2004.
|
|
|
|
3.4
|
|
Amended
and Restated Bylaws effective October 3, 2007, incorporated by reference
from the Registrant’s Current Report on Form 8-K filed with the SEC
on October 9, 2007.
|
|
|
|
31.1
|
|
Certification
of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as adopted pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
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31.2
|
|
Certification
of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as adopted pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32(*)
|
|
Certifications
of Principal Executive Officer and Principal Financial Officer pursuant to
Rules 13a-14(b) and 15d-14(b) promulgated under the Securities Exchange
Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
*
|
These
certifications are being furnished solely to accompany this quarterly
report pursuant to 18 U.S.C. Section 1350, and are not being filed for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended,
and are not to be incorporated by reference into any filing of the
Registrant, whether made before or after the date hereof, regardless of
any general incorporation language in such
filing.
|
SIGNATURES
Pursuant
to the requirements of the Securities and Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
Dated:
November 9, 2010
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Micromet,
Inc.
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|
|
|
By:
|
/s/
Barclay A. Phillips
|
|
|
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Barclay
A. Phillips
|
|
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Senior Vice President and Chief Financial Officer
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|
|
(Duly
authorized officer and Principal Financial
Officer)
|
Exhibit List
Exhibit
Number
|
|
Description
|
|
|
|
3.1
|
|
Amended
and Restated Certificate of Incorporation of the Registrant, incorporated
by reference from the Registrant’s Quarterly Report on Form 10-Q
filed with the SEC on December 11, 2003.
|
|
|
|
3.2
|
|
Certificate
of Amendment of the Amended and Restated Certificate of Incorporation of
the Registrant incorporated by reference from the Registrant’s Quarterly
Report on Form 10-Q filed with the SEC on May 10,
2006.
|
|
|
|
3.3
|
|
Certificate
of Designations for Series A Junior Participating Preferred Stock of the
Registrant, incorporated by reference from the Registrant’s Current Report
on Form 8-K filed with the SEC on November 8,
2004.
|
|
|
|
3.4
|
|
Amended
and Restated Bylaws effective October 3, 2007, incorporated by reference
from the Registrant’s Current Report on Form 8-K filed with the SEC
on October 9, 2007.
|
|
|
|
31.1
|
|
Certification
of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as adopted pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification
of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as adopted pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32(*)
|
|
Certifications
of Principal Executive Officer and Principal Financial Officer pursuant to
Rules 13a-14(b) and 15d-14(b) promulgated under the Securities Exchange
Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
*
|
These certifications are being
furnished solely to accompany this quarterly report pursuant to 18 U.S.C.
Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, and are not to be
incorporated by reference into any filing of the Registrant, whether made
before or after the date hereof, regardless of any general incorporation
language in such filing.
|