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 June 30, 2009
OR
|
o
|
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
o 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 o No o
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 R
|
Non-accelerated
filer £
|
Smaller
reporting company o
|
|
(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). o 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 August 4, 2009 was
68,686,875.
MICROMET,
INC.
FORM
10-Q — QUARTERLY REPORT
FOR
THE QUARTERLY PERIOD ENDED June 30, 2009
TABLE
OF CONTENTS
|
|
|
Page No.
|
PART
I — FINANCIAL INFORMATION
|
|
Item 1.
Financial Statements
|
|
Condensed
Consolidated Balance Sheets as of June 30, 2009 (Unaudited) and
December 31, 2008
|
3
|
Condensed
Consolidated Statements of Operations for the three-month and six-month
periods ended June 30, 2009 and 2008 (Unaudited)
|
4
|
Condensed
Consolidated Statements of Cash Flows for the six-month periods ended June
30, 2009 and 2008 (Unaudited)
|
5
|
Notes to Condensed Consolidated
Financial Statements (Unaudited)
|
6
|
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
|
21
|
Item 4.
Controls and Procedures
|
21
|
PART
II — OTHER INFORMATION
|
22
|
Item 1.
Legal Proceedings
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22
|
Item 1A.
Risk Factors
|
22
|
Item 2.
Unregistered Sales of Equity Securities and Use of
Proceeds
|
36
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Item 3.
Defaults Upon Senior Securities
|
36
|
Item 4.
Submission of Matters to a Vote of Security Holders
|
36
|
Item 5.
Other Information
|
36
|
Item 6.
Exhibits
|
37
|
SIGNATURES
|
38
|
PART
I — FINANCIAL INFORMATION
Item 1.
Financial Statements
Micromet,
Inc.
Condensed
Consolidated Balance Sheets
(In
thousands, except par value)
(unaudited)
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2009
|
|
|
2008
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
32,685 |
|
|
$ |
46,168 |
|
Short-term
investments
|
|
|
16,528 |
|
|
|
- |
|
Accounts
receivable
|
|
|
1,838 |
|
|
|
3,424 |
|
Prepaid
expenses and other current assets
|
|
|
1,938 |
|
|
|
1,950 |
|
Total
current assets
|
|
|
52,989 |
|
|
|
51,542 |
|
Property
and equipment, net
|
|
|
3,098 |
|
|
|
3,322 |
|
Goodwill
|
|
|
6,462 |
|
|
|
6,462 |
|
Patents,
net
|
|
|
4,185 |
|
|
|
5,250 |
|
Other
long-term assets
|
|
|
3 |
|
|
|
959 |
|
Restricted
cash
|
|
|
3,137 |
|
|
|
3,140 |
|
Total
assets
|
|
$ |
69,874 |
|
|
$ |
70,675 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
1,566 |
|
|
$ |
710 |
|
Accrued
expenses
|
|
|
5,950 |
|
|
|
6,492 |
|
Common
stock warrants liability
|
|
|
14,123 |
|
|
|
12,294 |
|
Current
portion of long-term debt obligations
|
|
|
2,149 |
|
|
|
- |
|
Current
portion of deferred revenue
|
|
|
6,802 |
|
|
|
4,054 |
|
Total
current liabilities
|
|
|
30,590 |
|
|
|
23,550 |
|
Deferred
revenue, net of current portion
|
|
|
7,314 |
|
|
|
7,555 |
|
Other
non-current liabilities
|
|
|
2,057 |
|
|
|
2,025 |
|
Long-term
debt obligations
|
|
|
- |
|
|
|
2,157 |
|
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; 52,579 shares
issued and outstanding at June 30, 2009; 50,913 shares issued and
outstanding at December 31, 2008
|
|
|
2 |
|
|
|
2 |
|
Additional
paid-in capital
|
|
|
234,997 |
|
|
|
227,806 |
|
Accumulated
other comprehensive income
|
|
|
7,360 |
|
|
|
5,749 |
|
Accumulated
deficit
|
|
|
(212,446 |
) |
|
|
(198,169 |
) |
Total
stockholders' equity
|
|
|
29,913 |
|
|
|
35,388 |
|
Total
liabilities and stockholders' equity
|
|
$ |
69,874 |
|
|
$ |
70,675 |
|
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
|
|
|
Six
months ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
agreements
|
|
$ |
4,594 |
|
|
$ |
7,900 |
|
|
$ |
11,900 |
|
|
$ |
13,649 |
|
License
fees and other
|
|
|
336 |
|
|
|
552 |
|
|
|
493 |
|
|
|
727 |
|
Total
revenues
|
|
|
4,930 |
|
|
|
8,452 |
|
|
|
12,393 |
|
|
|
14,376 |
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
8,950 |
|
|
|
10,992 |
|
|
|
17,639 |
|
|
|
20,712 |
|
General
and administrative
|
|
|
3,629 |
|
|
|
3,383 |
|
|
|
7,316 |
|
|
|
6,917 |
|
Total
operating expenses
|
|
|
12,579 |
|
|
|
14,375 |
|
|
|
24,955 |
|
|
|
27,629 |
|
Loss
from operations
|
|
|
(7,649 |
) |
|
|
(5,923 |
) |
|
|
(12,562 |
) |
|
|
(13,253 |
) |
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(94 |
) |
|
|
(32 |
) |
|
|
(170 |
) |
|
|
(144 |
) |
Interest
income
|
|
|
141 |
|
|
|
199 |
|
|
|
280 |
|
|
|
466 |
|
Change
in fair value of warrants
|
|
|
(6,261 |
) |
|
|
(2,962 |
) |
|
|
(1,829 |
) |
|
|
(1,709 |
) |
Other
(expense) income
|
|
|
(82 |
) |
|
|
91 |
|
|
|
4 |
|
|
|
147 |
|
Net
loss
|
|
$ |
(13,945 |
) |
|
$ |
(8,627 |
) |
|
$ |
(14,277 |
) |
|
$ |
(14,493 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per common share
|
|
$ |
(0.27 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.36 |
) |
Weighted
average shares used to compute basic and diluted net loss per
share
|
|
|
51,480 |
|
|
|
40,824 |
|
|
|
51,198 |
|
|
|
40,802 |
|
The
accompanying notes are an integral part of these financial
statements.
Micromet,
Inc.
Condensed
Consolidated Statements of Cash Flows
(In
thousands)
(Unaudited)
|
|
Six
months ended June 30,
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(14,277 |
) |
|
$ |
(14,493 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
1,619 |
|
|
|
1,959 |
|
Non-cash
interest on long-term debt obligations
|
|
|
166 |
|
|
|
58 |
|
Amortization
of premium/discount on short-term investments
|
|
|
96 |
|
|
|
- |
|
Non-cash
change in fair value of common stock warrants liability
|
|
|
1,829 |
|
|
|
1,709 |
|
Stock-based
compensation expense
|
|
|
2,375 |
|
|
|
1,703 |
|
Net
loss on disposal of property and equipment
|
|
|
27 |
|
|
|
- |
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
1,646 |
|
|
|
2,312 |
|
Prepaid
expenses and other current assets
|
|
|
123 |
|
|
|
533 |
|
Accounts
payable, accrued expenses and other liabilities
|
|
|
(32 |
) |
|
|
607 |
|
Deferred
revenue
|
|
|
2,298 |
|
|
|
943 |
|
Net
cash used in operating activities
|
|
|
(4,130 |
) |
|
|
(4,669 |
) |
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases
of investments
|
|
|
(20,987 |
) |
|
|
- |
|
Proceeds
from the maturity of investments
|
|
|
5,958 |
|
|
|
- |
|
Purchases
of property and equipment
|
|
|
(260 |
) |
|
|
(267 |
) |
Net
cash used in investing activities
|
|
|
(15,289 |
) |
|
|
(267 |
) |
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds
from the issuance of common stock, net
|
|
|
5,112 |
|
|
|
- |
|
Proceeds
from exercise of stock options
|
|
|
522 |
|
|
|
84 |
|
Principal
payments on capital lease obligations
|
|
|
(66 |
) |
|
|
(98 |
) |
Net
cash provided by (used in) financing activities
|
|
|
5,568 |
|
|
|
(14 |
) |
Effect
of exchange rate changes on cash and cash equivalents
|
|
|
368 |
|
|
|
311 |
|
Net
decrease in cash and cash equivalents
|
|
|
(13,483 |
) |
|
|
(4,639 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
46,168 |
|
|
|
27,066 |
|
Cash
and cash equivalents at end of period
|
|
$ |
32,685 |
|
|
$ |
22,427 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of noncash investing and financing activities:
|
|
|
|
|
|
|
|
|
Acquisitions
of equipment purchased through capital leases
|
|
|
191 |
|
|
|
205 |
|
The
accompanying notes are an integral part of these financial
statements.
Note 1.
|
Business
Overview
|
We are a
biopharmaceutical company developing novel, proprietary antibodies for the
treatment of cancer, inflammation and autoimmune diseases. Five of our
antibodies are currently in clinical trials, while the remainder of our product
pipeline is in earlier stages of 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
|
Unless
otherwise noted, all financial information is that of Micromet, Inc. and our
wholly owned subsidiaries: Micromet AG; Micromet Holdings, Inc.; Tarcanta, Inc.;
Tarcanta Limited; 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. All intercompany accounts
and transactions have been eliminated 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.
The
accompanying financial statements have been prepared assuming we will continue
as a going concern. This basis of accounting contemplates the recovery of our
assets and the satisfaction of our liabilities in the normal course of business.
As of June 30, 2009, we had an accumulated deficit of $212.4 million. We
expect that operating losses and negative cash flows from operations will
continue for at least the next several years and we will need to generate
additional funds to achieve our strategic goals. If necessary, we may raise
substantial funds through the sale of our common stock and common stock
warrants, or through debt financing or through establishing additional strategic
collaboration agreements. We do not know whether additional financing will be
available when needed, or whether it will be available on favorable terms, or at
all. Based on our capital resources as of the date of this report and the
proceeds received from the sale of common stock in August 2009 (see Note 9), we
believe that we have adequate resources to fund our operations for at least 24
months, 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 draw downs from our
committed equity financing facility, or CEFF, with Kingsbridge Capital Limited
(see Note 8).
Note 3.
|
Summary
of Significant Accounting Policies
|
Cash
and Cash Equivalents
Cash and
cash equivalents on the balance sheets are comprised of cash at banks, money
market funds and short-term deposits with an original maturity from date of
purchase of three months or less. Our money market funds consist of
at least 80% of net assets in U.S. Treasury obligations and repurchase
agreements secured by U.S. Treasury obligations.
Short-Term
Investments
In
accordance with the Financial Accounting Standards Board (“FASB”) Statement of
Financial Accounting Standards (“SFAS”) No. 115, Accounting for Certain Debt and
Equity Securities, short-term investments are classified as
available-for-sale. Available-for-sale securities are carried at fair value,
with the unrealized gains and losses reported in other comprehensive income
(loss). The amortization of premiums and accretion of discounts to maturity is
included in interest expense or income. Realized gains and losses and
declines in value judged to be other-than-temporary, if any, on
available-for-sale securities are included in other income or expense. The cost
of securities sold is based on the specific identification method. Interest and
dividends on securities classified as available-for-sale are included in
investment income. As of June 30, 2009 our investments are in debt of
foreign governments with maturities of less than one year. The
amortized cost basis is $16.5 million and the aggregate fair value is $16.5
million as of June 30, 2009. Other comprehensive income for the six
months ended June 30, 2009 includes unrealized gains of $23,000 and unrealized
losses of $2,000.
Restricted
Cash
We have
issued 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 June 30, 2009
and December 31, 2008, we had a total of $3.1 million in certificates of
deposit that are classified as non-current restricted cash.
Property
and Equipment
Property
and equipment are stated at cost, less accumulated depreciation and
amortization. Major replacements and improvements that extend the useful life of
assets are capitalized, while general repairs and maintenance are charged to
expense as incurred. Property and equipment are depreciated using the
straight-line method over the estimated useful lives of the assets, ranging from
three to ten years. Leasehold improvements are amortized over the estimated
useful lives of the assets or the related lease term, whichever is
shorter.
Goodwill
In
accordance with SFAS No. 142, Goodwill and Other Intangible
Assets, we review goodwill for impairment at least annually and more
frequently if events or changes in circumstances indicate a reduction in the
fair value of the reporting unit to which the goodwill has been assigned. A
reporting unit is an operating segment for which discrete financial information
is available and segment management regularly reviews the operating results of
that component. We have determined that we have only one reporting
unit, the development of biopharmaceutical products. Goodwill is
determined to be impaired if the fair value of the reporting unit to which the
goodwill has been assigned is less than its carrying amount. We have selected
October 1 as our annual goodwill impairment testing date.
Patents
We hold
patents for single-chain antigen binding molecule technology. Patents are being
amortized over their estimated useful lives through 2011 using the straight-line
method. The patents are utilized in revenue-producing activities as well as in
research and development activities.
Impairment
of Long-Lived and Identifiable Intangible Assets
In
accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, we evaluate the carrying value of long-lived assets and
identifiable intangible assets for potential impairment whenever events or
changes in circumstances indicate that the carrying amount of such assets may
not be recoverable. Recoverability is determined by comparing projected
undiscounted cash flows associated with such assets to the related carrying
value. An impairment loss would be recognized when the estimated undiscounted
future cash flow is less than the carrying amount of the asset. An impairment
loss would be measured as the amount by which the carrying value of the asset
exceeds the fair value of the asset.
Common
Stock Warrants Liability
In June
2007, we completed a private placement of 9,216,709 shares of common stock
and issued warrants to purchase an additional 4,608,356 shares of common
stock. Due to certain provisions in the common stock warrant agreement, these
warrants are required to be classified as a liability. Management believes that
the circumstances requiring cash settlement of the award are
remote. The common stock warrants liability is recorded at fair
value, which is adjusted to its estimated fair value at the end of each
reporting period using the Black-Scholes option-pricing
model. Changes in the estimated fair value from the previous
reporting period are included in the consolidated statements of
operations.
Foreign
Currency Transactions and Translation
Transactions
in foreign currencies are initially recorded at the functional currency rate
ruling at the date of the transaction. Monetary assets and liabilities
denominated in foreign currencies are re-measured into the functional currency
at the exchange rate in effect at the balance sheet date. Transaction gains and
losses are recorded in the consolidated statements of operations in other income
(expense) and amounted to $(13,000) and $93,000 for the three months ended June
30, 2009 and 2008, respectively, and $40,000 and $103,000 for the six months
ended June 30, 2009 and 2008, respectively.
The
accompanying condensed consolidated financial statements are presented in U.S.
dollars. The translation of assets and liabilities to U.S. dollars is made at
the exchange rate in effect at the balance sheet date, while equity accounts are
translated at historical rates. The translation of statement of operations data
is made at the average rate in effect for the period. The translation of
operating cash flow data is made at the average rate in effect for the period,
and investing and financing cash flow data is translated at the rate in effect
at the date of the underlying transaction. Translation gains and losses are
recognized within accumulated other comprehensive income in the accompanying
condensed consolidated balance sheets.
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.
Revenues
under collaborative research agreements are recognized as the services specified
in the related agreement are performed, or as expenses that are passed through
to the collaborator are incurred. Milestone payments are derived from the
achievement of predetermined goals under the collaboration agreements. For
milestones that are deemed substantive, the related contingent revenue is not
recognized until the milestone has been reached and customer acceptance has been
obtained as necessary. Milestones are considered substantive if all the
following criteria are met: 1) milestone payment is non-refundable and relates
solely to past performance; 2) achievement of the milestone was not reasonably
assured at the inception of the arrangements; 3) substantive effort is involved
to achieve the milestone; and 4) the amount of the milestone payment appears
reasonable in relation to the effort expended, other milestones in the
arrangement and the related risk of achieving the milestone. Fees for
research and development services performed under the agreements are generally
stated at a yearly fixed fee per research scientist. We recognize revenue as the
research and development services are performed. Amounts received in advance of
services performed are recorded as deferred revenue until earned. We
have received upfront initial license fees and annual renewal fees each year
under certain license agreements. Revenue is recognized when the above noted
criteria are satisfied, unless we have further obligations associated with the
license granted. We recognize revenue from up front payments on a
straight-line basis over the term of our obligations as specified in
the agreement.
For
arrangements that include multiple deliverables, we identify separate units of
accounting based on the consensus reached on Emerging Issues Task Force Issue
(“EITF”) No. 00-21, Revenue Arrangements with Multiple
Deliverables. EITF No. 00-21 provides that revenue arrangements with
multiple deliverables should be divided into separate units of accounting if
certain criteria are met. The consideration for the arrangement is allocated to
the separated units of accounting based on their relative fair values.
Applicable revenue recognition criteria are considered separately for each unit
of accounting. We recognize revenue on development and collaboration agreements,
including upfront payments, where they are considered combined units of
accounting, over the period specified in the related agreement or as the
services are performed.
Research
and Development
Except
for payments made in advance of services rendered, research and development
expenditures, including direct and allocated expenses, are charged to operations
as incurred.
Comprehensive
Income (Loss)
Comprehensive
income (loss) is comprised of net 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
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Net
loss
|
|
$ |
(13,945 |
) |
|
$ |
(8,627 |
) |
|
$ |
(14,277 |
) |
|
$ |
(14,493 |
) |
Foreign
currency translation adjustments
|
|
|
1,058 |
|
|
|
(88 |
) |
|
|
1,592 |
|
|
|
(266 |
) |
Unrealized
gain on investments available for sale
|
|
|
21 |
|
|
|
— |
|
|
|
20 |
|
|
|
— |
|
Comprehensive
loss
|
|
$ |
(12,866 |
) |
|
$ |
(8,715 |
) |
|
$ |
(12,665 |
) |
|
$ |
(14,759 |
) |
Share-Based
Compensation
We
account for share-based payments in accordance with
SFAS No. 123(R),
Share-Based Payment Awards, utilizing the Black-Scholes option pricing
method for determining the fair value of stock-based awards. The
determination of the estimated fair value of our share-based payment awards on
the date of grant using an option-pricing model is affected by our stock price
as well as assumptions regarding expected volatility, risk-free interest rate,
and expected term.
We
recognize stock-based compensation expense for options granted with graded
vesting over the requisite service period of the individual stock option grants,
which typically equals the vesting period, using the straight-line attribution
method. For share-based awards that contain a performance condition,
expense is recognized using the accelerated attribution
method. Compensation expense related to stock-based compensation is
allocated to research and development or general and administrative based upon
the department to which the associated employee reports.
Options
or stock awards issued to non-employees are measured at their estimated fair
value in accordance with SFAS No. 123(R) and EITF Issue
No. 96-18, Accounting for
Equity Instruments That Are Issued to Other Than Employees for Acquiring or in Conjunction with
Selling Goods or Services. Expense is recognized when service
is rendered; however, the expense may fluctuate with changes in the fair value
of the underlying common stock, until the award is vested.
Income
Taxes
We
account for income taxes under SFAS No. 109, Accounting for Income Taxes,
using the liability method. Deferred income taxes are recognized at the enacted
tax rates for temporary differences between the financial statement and income
tax bases of assets and liabilities. Deferred tax assets are reduced by a
valuation allowance if, based upon the weight of available evidence, it is more
likely than not that some portion or all of the related tax asset will not be
recovered.
We
account for uncertain tax positions pursuant to FASB Interpretation No. 48,
Accounting for Uncertainty in
Income Taxes, an interpretation of FASB Statement No. 109 (“FIN
48”). FIN 48 was adopted on January 1, 2007 with no material impact
on our consolidated financial statements. Financial statement
recognition of a tax position taken or expected to be taken in a tax return is
determined based on a more-likely-than-not threshold of that position being
sustained. If the tax position meets this threshold, the benefit to
be recognized is measured at the largest amount that is more than 50 percent
likely to be realized upon ultimate settlement. In making
such determination, we consider all available positive and negative evidence,
including future reversals of existing taxable temporary differences, projected
future taxable income, tax planning strategies and recent financial
operations. It is our policy to record interest and penalties
related to uncertain tax positions as a component of income tax
expense.
Net
Loss Per Share
We
calculate net loss per share in accordance with SFAS No. 128, Earnings Per Share. Basic net loss per
share is calculated by dividing the net loss by the weighted average number of
common shares outstanding for the period, without consideration for common stock
equivalents. Diluted net loss per share is computed by dividing the net loss by
the weighted average number of common stock equivalents outstanding for the
period determined using the treasury-stock method. For purposes of this
calculation, convertible preferred stock, stock options, and warrants are
considered to be common stock equivalents and are only included in the
calculation of diluted net loss per share when their effect is dilutive. The
outstanding anti-dilutive securities excluded from the diluted net loss
computation consisted of common stock options of 9,296,000 and 7,918,000 shares
and common stock warrants of 8,222,000 and 5,527,000 shares, in each case for
the three and six months ended June 30, 2009 and 2008,
respectively.
Recent
Accounting Standards and Pronouncements
In April
2009, the FASB issued FSP FAS 157-4, Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly (“FSP FAS
157-4”). FSP FAS 157-4 provides additional guidance for estimating fair value in
accordance with SFAS No. 157, Fair Value Measurements (“SFAS 157”), when the volume and level of activity for
the asset or liability have significantly decreased. FSP FAS 157-4 is effective
for interim and annual reporting periods ending after June 15, 2009, and shall
be applied prospectively. The adoption of FSP FAS 157-4 did not have
a material impact on our condensed consolidated financial
statements.
In April
2009, the FASB issued FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments (”FSP FAS 115-2 and FAS 124-2”). This
FSP amends the other-than-temporary impairment guidance in U.S. GAAP for debt
securities to make the guidance more operational and to improve the presentation
and disclosure of other-than-temporary impairments of debt and equity securities
in the financial statements. FSP FAS 115-2 and FAS 124-2 do not amend existing
recognition and measurement guidance related to other-than-temporary impairments
of equity securities. FSP FAS 115-2 and FAS 124-2 are effective for interim and
annual reporting periods ending after June 15, 2009. The adoption FSP
FAS 115-2 and FAS 124-2 did not have a material impact on our condensed
consolidated financial statements.
In April
2009, FASB issued FSP SFAS 107-1 and APB 28-1, Interim Disclosures about Fair Value
of Financial Instruments, (“FSP SFAS 107-1 and APB 28-1”) which amends
SFAS No. 107, Disclosures
about Fair Value of Financial Instruments, to require disclosures about
fair value of financial instruments in interim as well as in annual financial
statements. FSP SFAS 107-1 and APB 28-1 also amends APB Opinion 28, Interim Financial Reporting,
to require those disclosures in all interim financial statements. It is
effective for interim periods ending after June 15, 2009. The adoption FSP SFAS
107-1 and APB 28-1 did not have a material impact on our condensed consolidated
financial statements.
In May
2009, the FASB approved SFAS No. 165, Subsequent Events (“SFAS
165”). SFAS 165 established general standards of accounting for and
disclosures of events that occur after the balance sheet date but before the
financial statements are issued or are available to be issued. It
requires disclosure of the date through which an entity has evaluated subsequent
events. We adopted SFAS 165 in the second quarter of 2009 and the
adoption had no material impact. We evaluated all events or
transactions that occurred after June 30, 2009 through August 6, 2009, the date
we issued these financial statements.
Note 4.
|
Fair
Value Measurements
|
We
include disclosures about fair value measurements pursuant to SFAS
157. SFAS 157 defines fair value as the price that would be received
to sell an asset or paid to transfer a liability in an orderly transaction
between market participants. Such transactions to sell an asset or
transfer a liability are assumed to occur in the principal or most advantageous
market for the asset or liability. Accordingly, fair value as
described by SFAS 157 is determined based on a hypothetical transaction at the
measurement date, considered from the perspective of a market
participant.
SFAS 157
establishes a three-tier fair value hierarchy, which prioritizes the inputs used
in measuring fair value. These tiers include: Level 1, defined as
observable inputs such as quoted prices in active markets; Level 2, defined as
inputs other than quoted prices in active markets that are either directly or
indirectly observable; and Level 3, defined as unobservable inputs in which
little or no market data exists, therefore requiring an entity to develop its
own assumptions. The following table presents information about our
assets and liabilities that are measured at fair value on a recurring basis as
of June 30, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Significant
|
|
|
|
|
|
|
Quoted
Prices in
|
|
|
Significant
Other
|
|
|
Unobservable
|
|
|
|
June
30,
|
|
|
Active
Markets
|
|
|
Observable
inputs
|
|
|
Inputs
|
|
Description
|
|
2009
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
32,685 |
|
|
$ |
32,685 |
|
|
$ |
— |
|
|
$ |
— |
|
Restricted
cash
|
|
|
3,137 |
|
|
|
3,137 |
|
|
|
— |
|
|
|
— |
|
Foreign
government bonds
|
|
|
16,528 |
|
|
|
— |
|
|
|
16,528 |
|
|
|
— |
|
Total
assets
|
|
$ |
52,350 |
|
|
$ |
35,822 |
|
|
$ |
16,528 |
|
|
$ |
— |
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock warrant liability
|
|
$ |
(14,123 |
) |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(14,123 |
) |
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) as defined in
SFAS 157 at June 30, 2009 and 2008:
|
|
June 30, 2009
|
|
|
|
3-months ended
|
|
|
6-months ended
|
|
Beginning
balance,
|
|
$ |
(7,862 |
) |
|
$ |
(12,294 |
) |
Transfers
to (from) Level 3
|
|
|
— |
|
|
|
— |
|
Total
gains/(losses) realized/ unrealized included in
earnings
|
|
|
(6,261
|
) |
|
|
(1,829
|
) |
Purchases/
issuances/ settlements, net
|
|
|
— |
|
|
|
— |
|
Balance
June 30, 2009
|
|
$ |
(14,123 |
) |
|
$ |
(14,123 |
) |
The
carrying value of the common stock warrant liability is calculated using the
Black-Scholes option pricing model, which requires the input of highly
subjective assumptions. These assumptions include the risk-free rate
of interest, expected dividend yield, expected volatility, and the remaining
contractual term of the award. The risk-free rate of interest is
based on the U.S. Treasury rates appropriate for the expected term of the
award. Expected dividend yield is projected at 0%, as we have not
paid any dividends on our common stock since our inception and we do not
anticipate paying dividends on our common stock in the foreseeable
future. Expected volatility is based on our historical volatility and
the historical volatilities of the common stock of comparable publicly traded
companies.
We also
adopted SFAS No. 157 for non-financial assets and liabilities in the first
quarter of 2009. We had no required fair value measurements for non-financial
assets and liabilities during the six months ended June 30, 2009 and no required
additional disclosures upon adoption.
Deferred
revenues were derived from research and development agreements with Nycomed,
Bayer Schering, TRACON Pharmaceuticals, Inc. and Merck Serono as follows
(dollars in thousands):
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
Nycomed
|
|
$ |
6,501 |
|
|
$ |
7,260 |
|
Bayer
Schering
|
|
|
3,161 |
|
|
|
— |
|
TRACON
|
|
|
1,271 |
|
|
|
1,321 |
|
Merck
Serono
|
|
|
2,443 |
|
|
|
2,523 |
|
Other
|
|
|
740 |
|
|
|
505 |
|
Subtotal
|
|
|
14,116 |
|
|
|
11,609 |
|
Current
portion
|
|
|
(6,802 |
) |
|
|
(4,054 |
) |
Long
term portion
|
|
$ |
7,314 |
|
|
$ |
7,555 |
|
The
deferred revenue for Nycomed and TRACON consists mainly of the upfront license
fees that are being recognized over the period that we are required to
participate on joint steering committees of 20 years and 15 years,
respectively. The deferred revenue for Bayer Schering consists of an
option fee that is being recognized over a period of one year, which began in
the first quarter of 2009. Under the terms of the agreement with
Bayer Schering Pharma, we received € 4.5 million, or $6.0 million, as a fee for
a one-year option on a specific BiTE antibody. Bayer Schering Pharma
may exercise this option on or before January 5, 2010 through the additional
payment of an option exercise fee. The exercise of the option would trigger a
formal collaboration for the development of the BiTE antibody through the
completion of phase 1 clinical trials, at which point Bayer Schering Pharma
would assume full control of the further development and commercialization of
the BiTE antibody. The upfront license fees and research and
development service reimbursements in the collaboration agreement with Merck
Serono are considered to be a combined unit of accounting and, accordingly, the
related amounts are recognized ratably over the expected period of the research
and development program, which continues through 2011.
Note 6.
|
Other
Non-Current Liabilities
|
Other
non-current liabilities consist of the following (in thousands):
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2009
|
|
|
2008
|
|
Facility
lease exit liability, net of current portion
|
|
$ |
1,112 |
|
|
$ |
1,215 |
|
GEK
subsidy, net of current portion
|
|
|
107 |
|
|
|
135 |
|
Asset
retirement obligation
|
|
|
513 |
|
|
|
471 |
|
Capital
lease obligations, net of current portion
|
|
|
306 |
|
|
|
187 |
|
Other
|
|
|
19 |
|
|
|
17 |
|
|
|
$ |
2,057 |
|
|
$ |
2,025 |
|
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. As of April 2007, we fully subleased our
former corporate headquarters in Carlsbad, California. We review the
adequacy of our estimated exit accruals on an ongoing basis.
The
following table summarizes the facility lease activity for these obligations for
the six months ended June 30, 2009 (in thousands):
Balance
January 1, 2009
|
|
$ |
1,432 |
|
Amounts
paid in period
|
|
|
(193
|
) |
Accretion
expense
|
|
|
126 |
|
Balance
June 30, 2009
|
|
$ |
1,365 |
|
Of the
$1,365,000 lease exit liability as of June 30, 2009, $253,000 is current and
$1,112,000 is non-current.
Asset
Retirement Obligation
In
February 2001, we entered into a building lease agreement with GEK. Under the
terms of the agreement, GEK agreed to lease laboratory and office space to us
for a period of 10 years beginning on July 1, 2002. Upon termination
of the agreement, we may, under certain conditions, be obligated to remove those
leasehold improvements that will not be assumed by GEK. The fair value of the
asset retirement obligation will increase due to accretion through the term of
the lease agreement. In connection with our sublease with Roche in 2007, certain
leasehold improvements were made to our facility which we will be required to
remove at the end of our lease. The following table summarizes the activity for
the six months ended June 30, 2009 (in thousands):
Balance
January 1, 2009
|
|
$ |
471 |
|
Accretion
expense
|
|
|
41 |
|
Currency
translation adjustment
|
|
|
1 |
|
Balance
June 30, 2009
|
|
$ |
513 |
|
Note 7.
|
Current
Portion of Long-Term Debt
|
Our only
long-term debt obligation at December 31, 2008 was an unsecured promissory note
in favor of an affiliate of MedImmune, Inc. with a maturity date of June 6,
2010. Interest on this note is payable monthly at an interest rate of
4.5% per annum. As of June 30, 2009, the remaining principal amount
of $2.1 million has been reclassified from a long-term to current
liability.
Note 8.
|
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, from time to time through December 2011, 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. We are not eligible to
draw down any funds under the CEFF at any time when our stock price is below
$2.00 per share. In connection with the December 2008 CEFF, we
terminated a prior CEFF with Kingsbridge that had been in place since August
2006. The December 2008 CEFF expanded the amount available to draw from $25.0
million under the August 2006 CEFF to $75.0 million. We did not draw down on the
August 2006 CEFF. In connection with the December 2008 CEFF, we
entered into a common stock purchase agreement and registration rights agreement
and issued a warrant to Kingsbridge to purchase 135,000 shares of our common
stock at a price of $4.44 per share. The warrant is exercisable until June 2014.
In connection with the August 2006 CEFF, we issued to Kingsbridge a warrant to
purchase up to 285,000 shares of common stock at an exercise price of $3.2145
per share, which warrant was not affected by the new CEFF or the issuance of the
new warrant to Kingsbridge. The fair value of the two warrants issued to
Kingsbridge approximates $0.8 million.
During
the second quarter of 2009, we completed two draw downs under the CEFF and
issued a total of 1,420,568 shares for aggregate gross proceeds of $5.3
million. In May 2009, we issued 764,700 shares to Kingsbridge
for gross proceeds of $2.5 million (average price per share of $3.27), and
in June 2009, we issued 655,868 shares to Kingsbridge in exchange for gross
proceeds of $2.8 million (average price per share of
$4.19). Accordingly, the remaining commitment of Kingsbridge under
the CEFF for the potential purchase of our common stock is equal to the lesser
of $69.7 million in cash consideration 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. In
connection with the CEFF, we have incurred legal fees and other financing costs
of approximately $138,000. These costs along with the $0.8 million
fair value of the warrants were recorded as a component of stockholders’ equity
during the second quarter of 2009.
On July
30, 2009, we entered into a definitive agreement with various underwriters to
which we agreed to issue an aggregate of 16,100,000 shares of common stock,
which includes the exercise of an over-allotment option for 2,100,000 shares, in
return for aggregate gross proceeds, before underwriting discount and expenses,
of $80.5 million. After underwriting discount and estimated
expenses payable by us of approximately $0.3 million, net proceeds from the
public offering were approximately $75.0 million. The shares were
issued, and the proceeds were received, on August 4, 2009. The shares
are being sold to the public at a price of $5.00, and the underwriters have
purchased the shares from us under the purchase agreement at a price of
$4.675 per share. Based on our capital resources as of the date of
this report and from the proceeds received from this sale of common stock in
August 2009, we believe that we have adequate resources to fund our operations
for at least 24 months, 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 draw
downs from the CEFF with Kingsbridge.
The
offering was made pursuant to a registration statement on Form S-3 (File No.
333-160130) filed with the Securities and Exchange Commission on June 19, 2009,
which became effective on July 2, 2009 and a registration statement on Form S-3
(File No. 333-160888) filed with the Commission pursuant to Rule 462(b) under
the Securities Act of 1933, as amended, the prospectus included in the
registration statements and a final prospectus supplement relating to the shares
filed pursuant to Rule 424(b)(5) of the Securities Act on July 30,
2009.
We have
evaluated subsequent events through the time of filing these financial
statements on August 6, 2009.
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations
The
following discussion contains forward-looking statements, which involve risks
and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of various factors,
including those set forth in Part II — Item 1A below under
the caption “Risk Factors.”
The
interim financial statements and this Management’s Discussion and Analysis of
the Financial Condition and Results of Operations should be read in conjunction
with the financial statements and notes thereto for the year ended December 31,
2008, 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
16, 2009.
Ongoing
Business Activities
We are a
biopharmaceutical company developing novel, proprietary antibodies for the
treatment of cancer, inflammation and autoimmune diseases. 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 BiTE antibody blinatumomab, also known as MT103, is
being evaluated in a phase 2 clinical trial for the treatment of patients with
acute lymphoblastic leukemia, or ALL, and in a phase 1 clinical trial for the
treatment of patients with non-Hodgkin’s lymphoma, or NHL. We were
previously developing blinatumomab in collaboration with MedImmune LLC, a wholly
owned subsidiary of AstraZeneca plc. As described in further detail under
“Research and Development” below, in March 2009, MedImmune elected to commence
the development of a new BiTE antibody for the treatment of hematological
cancers and to return to us the license to develop and commercialize
blinatumomab in North America. We will continue the development of blinatumomab
in Europe as planned, and are evaluating our strategy for the development of
blinatumomab in the United States. We currently expect to initiate a
pivotal trial of blinatumomab in ALL patients in 2010.
A
second BiTE antibody, MT110, is being tested in a phase 1 clinical trial for the
treatment of patients with solid tumors. MT110 binds to the
epithelial cell adhesion molecule, or EpCAM, which is overexpressed in many
solid tumors. We are also developing our human monoclonal antibody
adecatumumab, also known as MT201, which also binds to EpCAM and is being
developed under a collaboration with Merck Serono. The current clinical
development of this antibody includes a phase 2 clinical trial in colorectal
carcinoma patients after complete resection of liver metastases, and a phase 1b
clinical trial evaluating adecatumumab in combination with docetaxel for the
treatment of patients with metastatic breast cancer. Our monoclonal
antibody MT293, also known as TRC093, is licensed to TRACON Pharmaceuticals,
Inc. and is being developed in a phase 1 clinical trial for the treatment of
patients with cancer. MT203, a human antibody neutralizing the
activity of granulocyte/macrophage colony stimulating factor, or GM-CSF, which
has potential applications in the treatment of various inflammatory and
autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple
sclerosis, is under development in a phase 1 clinical trial being conducted by
our collaboration partner Nycomed. Our licensee Morphotek, a wholly-owned
subsidiary of Eisai, is also expected to commence a phase 1 clinical trial in
2009 to evaluate our glycolipid-binding human antibody MT228 for the treatment
of melanoma.
Our
preclinical product pipeline includes several novel BiTE antibodies generated
with our proprietary BiTE antibody platform technology. A BiTE antibody
targeting carcinoembryonic antigen, or CEA, for the treatment of solid tumors is
being developed in collaboration with MedImmune. In addition, we have entered
into an option, collaboration and license agreement with Bayer Schering Pharma
AG under which Bayer Schering Pharma was granted an exclusive option until
January 2010 to license a specified BiTE antibody against an undisclosed solid
tumor target. Other BiTE antibodies targeting melanoma chondroitin sulfate
proteoglycan, or MCSP, as well as the antigens CD33, HER2, EGFR and other
targets are in various stages of preclinical development.
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 and clinical trials, before
applying for marketing approval from the FDA or EMEA, or equivalent regulatory
agencies in other countries and regions. The risk that a program has to be
terminated, in part or in full, for safety reasons or lack of adequate efficacy
is very high. In particular, we 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.
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 our product candidates. Depending on the structure of such
collaborative agreements, a third party may be granted control over the clinical
trial process, manufacturing process or other key development process, for one
of our product candidates. In such a situation, the third party, rather than us,
may in fact control development and commercialization decisions for the
respective product candidate. Consistent with our business model, we may enter
into additional collaboration agreements in the future. We cannot predict the
terms of such agreements or their potential impact on our capital requirements.
Our inability to complete our research and development projects in a timely
manner, or our failure to enter into new collaborative agreements, when
appropriate, could significantly increase our capital requirements and affect
our liquidity.
Since our
inception, we have financed our operations through private placements of
preferred stock, common stock and associated warrants, government grants for
research, research-contribution revenues from our collaborations with
pharmaceutical companies, debt financing, licensing revenues and milestone
achievements and, more recently, a committed equity financing facility. In addition,
as described below, in August 2009 we issued shares of common stock in a public
offering for net proceeds of approximately $75.0 million. We may seek funding
through public or private financings in the future. If we raise additional funds
through the issuance of equity securities, stockholders may experience
substantial dilution, or the equity securities may have rights, preferences or
privileges senior to existing stockholders. If we raise additional funds through
debt financings, these financings may involve significant cash payment
obligations and covenants that restrict our ability to operate our business.
There can be no assurance that we can raise additional capital on acceptable
terms, or at all.
Research
and Development
Through
June 30, 2009, our research and development expenses consisted of costs
associated with the clinical development of adecatumumab, blinatumomab and
MT110, as well as development costs incurred for MT111 and MT203, and research
conducted with respect to our preclinical BiTE antibodies and the BiTE antibody
platform. The costs incurred include costs associated with clinical trials and
manufacturing processes, quality systems and analytical development, including
compensation and other personnel expenses, supplies and materials, costs for
consultants and related contract research, facility costs, license fees and
depreciation. We charge all research and development expenses to operations as
incurred.
We expect
to incur substantial additional research and development expenses that may
increase from historical levels as we further develop our product candidates
into more advanced stages of clinical development and increase our preclinical
development for certain of our human antibodies and BiTE antibodies in cancer,
anti-inflammatory and autoimmune diseases.
Our
strategic collaborations and license agreements generally provide for our
research, development and commercialization programs to be partly or wholly
funded by our collaborators and provide us with the opportunity to receive
additional payments if specified development or commercialization milestones are
achieved, as well as royalty payments upon the successful commercialization of
any products based upon our collaborations. We also may retain
co-promotion rights in certain of our agreements.
Under our
collaboration agreement with Merck Serono, we have received $22.0 million
in up front and milestone payments from Merck Serono to date, not including
reimbursements for costs and expenses incurred in connection with the
development of adecatumumab. The agreement provides for potential future
clinical development milestone payments of up to an additional
$126.0 million. In a November 2006 amendment to the original agreement, we
and Merck Serono agreed that Micromet would continue to conduct an ongoing phase
1 clinical trial testing the safety of adecatumumab in combination with
docetaxel in patients with metastatic breast cancer. In October 2007, we and
Merck Serono further amended the agreement and reallocated certain of our
respective development responsibilities with respect to adecatumumab. As part of
the revised responsibilities, Micromet now has all decision making authority and
operational responsibility for the clinical trials conducted by us. Merck Serono
will continue to bear the development expenses associated with the collaboration
in accordance with the agreed-upon budget.
Through
March 2009, we developed blinatumomab under a collaboration and license
agreement entered into with MedImmune in 2003. Under this agreement, MedImmune
reimbursed a portion of the clinical development costs incurred by us in our
clinical trials in Europe. Under the terms of the agreement, MedImmune had the
rights and the obligation to develop and commercialize blinatumomab in North
America, while we retained all rights to blinatumomab outside of North America.
MedImmune was also granted the right to develop other BiTE antibodies binding to
specific antigens relevant for hematological cancers in addition to or instead
of blinatumomab. In March 2009, MedImmune elected to commence the development of
a new BiTE antibody for the treatment of hematological cancers and to return to
us the license to develop and commercialize blinatumomab in North America. Under
the terms of the 2003 collaboration and license agreement, we will be
responsible for generating the new BiTE antibody and for certain early
preclinical development activities pursuant to a research plan to be mutually
agreed upon by the parties. MedImmune will bear all of the costs incurred by us
in conducting the research plan for this BiTE antibody, and will be responsible
for all of the development costs of this BiTE antibody in North America. In
addition, MedImmune will be required to make milestone payments upon the
achievement of certain development milestone events related to the new antibody,
and, if it receives marketing approval, to pay a royalty on net sales of this
BiTE antibody in North America. We have retained all rights to this
new BiTE antibody outside of North America, and have the right, at no cost to
us, to use the data generated by MedImmune in the course of the development in
North America for obtaining marketing approvals outside of North
America.
Upon the
establishment of a mutually agreed research plan for the new BiTE antibody,
MedImmune’s obligation to develop blinatumomab in North America will be replaced
with the obligation to develop the new BiTE antibody in that territory, and we
will assume responsibility for the worldwide development and commercialization
of blinatumomab. Under the terms of the 2003 collaboration and license
agreement, MedImmune will remain obligated to develop the commercial scale
manufacturing process for blinatumomab at its cost. Also, MedImmune will remain
obligated to supply our requirements of blinatumomab for the clinical trials
inside and outside of North America. Further, upon the first marketing approval
of blinatumomab in the United States, MedImmune will have a one-time option to
reacquire the commercialization rights to blinatumomab in North
America. If MedImmune were to exercise this option, it would be
required to pay us all of the milestone payments that would have become due if
MedImmune had developed blinatumomab in the United States, the global
development costs incurred by us after the return of the rights to blinatumomab
to us, and an additional payment calculated as a percentage of these development
costs. In addition, MedImmune would then pay a royalty on net sales of
blinatumomab in North America.
A second
agreement with MedImmune under which MedImmune is developing MT111 provides for
potential future milestone payments and royalty payments based on future sales
of MT111. The potential milestone payments are subject to the successful
completion of clinical development and obtaining marketing approval in one or
more national markets.
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.
We are
unable to estimate with any certainty the costs we will incur in the continued
development of our product candidates. However, we expect our research and
development costs associated with these product candidates to increase as we
continue to develop new indications and advance these product candidates through
preclinical and clinical trials.
Clinical
development timelines, the likelihood of success and total costs vary widely. We
anticipate that we will make determinations as to which research and development
projects to pursue and how much funding to direct to each project on an ongoing
basis in response to the scientific and clinical success of each product
candidate as well as relevant commercial factors.
The costs
and timing for developing and obtaining regulatory approvals of our product
candidates vary significantly for each product candidate and are difficult to
estimate. The expenditure of substantial resources will be required for the
lengthy process of clinical development and obtaining regulatory approvals as
well as to comply with applicable regulations. Any failure by us to obtain, or
any delay in obtaining, regulatory approvals could cause our research and
development expenditures to increase and, in turn, could have a material adverse
effect on our results of operations.
Results
of Operations
Comparison
of Three Months Ended June 30, 2009 and 2008
Revenues. The
following table summarizes our primary sources of revenue for the periods
presented (in millions):
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
Collaborative
R&D revenue:
|
|
|
|
|
|
|
Nycomed
|
|
$ |
1.5 |
|
|
$ |
4.8 |
|
Bayer
Schering
|
|
|
1.5 |
|
|
|
— |
|
MedImmune
|
|
|
0.8 |
|
|
|
2.0 |
|
Merck
Serono
|
|
|
0.7 |
|
|
|
0.9 |
|
TRACON
|
|
|
— |
|
|
|
0.1 |
|
Other
|
|
|
— |
|
|
|
0.1 |
|
Total
collaborative R&D revenue
|
|
|
4.5 |
|
|
|
7.9 |
|
License
and other revenue
|
|
|
0.4 |
|
|
|
0.6 |
|
Total
revenues
|
|
$ |
4.9 |
|
|
$ |
8.5 |
|
Collaborative R&D Revenue
Collaborative R&D revenue consists of reimbursements for
full-time equivalents and pass-through expenses we incur under each
collaborative agreement.
Nycomed. Collaborative
research and development revenues from Nycomed reflect Nycomed’s full cost
responsibility for the MT203 product development program. The Nycomed revenue
represents the reimbursement of our preclinical development activities,
including reimbursement for full-time equivalents as well as the portion of the
up-front payment from Nycomed that is being recognized over a 20-year period
ending in 2027. The decrease in revenue for the three months
ended June 30, 2009 compared to the same period in 2008 was due primarily to
lower activity performed by us as Nycomed assumes the later stage development
and from the receipt of a milestone payment of approximately $0.8 in the second
quarter of 2008.
Bayer
Schering. Revenues from Bayer Schering represent a
portion of the upfront option fee of approximately $6.0 million received in
January 2009 under an option, collaboration and license
agreement. The option fee is being recognized over the option period
of one year.
MedImmune. Collaborative
research and development revenues from MedImmune represent MedImmune’s share of
the costs of clinical development of blinatumomab and its full responsibility
for the costs of product development of MT111. The decrease in MedImmune revenue
was primarily due to the diminished activity under the blinatumomab program
after MedImmune’s notice of its intention to commence joint development of a
replacement antibody.
Merck
Serono. Collaborative research and development revenues from
Merck Serono reflect Merck Serono’s full responsibility for the costs for the
development of the adecatumumab program.
TRACON. Collaborative
research and development revenues from TRACON reflect TRACON’s full
responsibility for the costs of the MT293 product development program. Revenue
under this agreement consists of miscellaneous pass-through expenses and the
portion of the upfront payment received from TRACON that is being recognized
over a 15-year period ending in 2022.
License and Other
Revenue. License and other revenue consists primarily of
revenues from licenses of patents relating to single-chain antibody technology,
for which we serve as the exclusive marketing partner under a marketing
agreement with Enzon Pharmaceuticals, Inc.
Research and Development
Expenses. Research and development expense consists of costs
incurred to discover and develop product candidates. These expenses consist
primarily of salaries and related expenses for personnel, outside service costs
including production of clinical material, fees for services in the context of
clinical trials, medicinal chemistry, consulting and sponsored research
collaborations, and occupancy and depreciation charges. Process development
expenses were mainly 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 development of 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.
Research
and development expenses were $9.0 million and $11.0 million for the three
months ended June 30, 2009 and 2008, respectively. The majority of our research
and development expenses are denominated in Euros, and the changes in the Euro
exchange rate accounted for $1.3 million of the decrease from
2008. The decrease was also the result of lower process development
expenses of $1.3 million related to the MT203 program as the responsibility for
the later stage development transfers to Nycomed. Partially
offsetting these decreases were increases in research and development salaries
of $0.3 million and an increase in share-based compensation of $0.2
million.
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, and professional fees for legal and
audit services. General and administrative expenses were $3.6 million and $3.4
million for the three months ended June 30, 2009 and 2008,
respectively. The increase is primarily related to an increase in
share-based compensation expense of $0.1 million related to the vesting of
performance-based stock option grants during the second quarter of 2009, and
increased salaries of $0.1 million.
Interest Expense.
Interest expense for the three months ended June 30, 2009 and 2008
was $94,000 and $32,000, respectively. The increase was due to the amortization
of premiums on our investments, partially offset by the repayment of
indebtedness in July 2008.
Interest Income.
Interest income for the three months ended June 30, 2009 and 2008
was $141,000 and $199,000, respectively. The decrease was due to lower interest
rates during 2009 as compared to 2008.
Change in Fair Value of Common Stock
Warrants Liability. Under the terms of the warrants issued in
connection with a private placement that we closed in June 2007, if at any time
while any of the warrants is outstanding, we are merged or consolidated with or
into another company, we sell all or substantially all of our assets in one or a
series of related transactions, any tender offer or exchange offer is completed
pursuant to which holders of our common stock are permitted to tender or
exchange their shares for other securities, cash or property, or we effect any
reclassification of our common stock or any compulsory share exchange pursuant
to which the common stock is effectively converted into or exchanged for other
securities, cash or property, then we (or any successor entity) are obligated to
purchase any unexercised warrants from the holder for cash in an amount equal to
its value computed using the Black-Scholes option-pricing model with prescribed
guidelines. As a consequence of these provisions, the warrants are classified as
a liability on our balance sheet, and changes in our stock price cause the fair
value of the warrants to change each reporting period, with these changes being
reflected in the statement of operations. Increases in our stock price cause the
warrant liability to increase, and this increase is recorded as a component of
other (expense), while decreases in our stock price cause the liability to
decrease, which is recorded as a component of other income. The expense of $6.3
million recorded during the second quarter of 2009 represents an increase in the
fair value of the warrant as of June 30, 2009 as compared to its value on March
31, 2009. The expense of $3.0 million recorded during the second
quarter of 2008 represents an increase in the fair value of the warrant as of
June 30, 2008 as compared to its value on March 31, 2008.
Comparison
of Six Months Ended June 30, 2009 and 2008
Revenues. The
following table summarizes our primary sources of revenue for the periods
presented (in millions):
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
Collaborative
R&D revenue:
|
|
|
|
|
|
|
Nycomed
|
|
$ |
5.7 |
|
|
$ |
8.0 |
|
Bayer
Schering
|
|
|
3.0 |
|
|
|
— |
|
MedImmune
|
|
|
1.7 |
|
|
|
3.8 |
|
Merck
Serono
|
|
|
1.4 |
|
|
|
1.6 |
|
TRACON
|
|
|
0.1 |
|
|
|
0.2 |
|
Other
|
|
|
— |
|
|
|
0.1 |
|
Total
collaborative R&D revenue
|
|
|
11.9 |
|
|
|
13.7 |
|
License
and other revenue
|
|
|
0.5 |
|
|
|
0.7 |
|
Total
revenues
|
|
$ |
12.4 |
|
|
$ |
14.4 |
|
The
decrease in revenue from Nycomed for the six months ended June 30, 2009 compared
to the same period in 2008 was due primarily to a decrease in ongoing
development revenue of $3.5 million under this collaboration as the program
progresses from the pre-clinical stage to clinical trials, and the
responsibility for the development work shifts to
Nycomed. Partially offsetting this decrease was the receipt of
a milestone payment of approximately $2.0 million recognized as revenue during
2009 as a result of Nycomed’s filing of a clinical trial application for MT203
in Europe, as compared to milestone revenue of $0.8 million received in the same
period in 2008.
Bayer
Schering. Revenues from Bayer Schering represent a
portion of the upfront option fee of approximately $6.0 million received in
January 2009 under an option, collaboration and license
agreement. The option fee is being recognized over the option period
of one year.
MedImmune. Collaborative
research and development revenues from MedImmune represent MedImmune’s share of
the costs of clinical development of blinatumomab and its full responsibility
for the costs of product development of MT111. The decrease in MedImmune revenue
was primarily due to the discontinuation of a research program for EphA2 in the
fourth quarter of 2008 and the diminished activity under the blinatumomab
program.
Merck
Serono. Collaborative research and development revenues from
Merck Serono reflect Merck Serono’s full responsibility for the costs for the
development of the adecatumumab program.
TRACON. Collaborative
research and development revenues from TRACON reflect TRACON’s full
responsibility for the costs of the MT293 product development program. Revenue
under this agreement consists of miscellaneous pass-through expenses and the
portion of the upfront payment received from TRACON that is being recognized
over a 15-year period ending in 2022.
License and Other
Revenue. License and other revenue consists primarily of
revenues from licenses of patents relating to single-chain antibody technology,
for which we serve as the exclusive marketing partner under a marketing
agreement with Enzon Pharmaceuticals, Inc.
Research and Development
Expenses Research and development expenses were $17.6 million
and $20.7 million for the six months ended June 30, 2009 and 2008,
respectively. The majority of our research and development expenses
are denominated in Euros, and changes in the Euro exchange rate from the prior
year accounted for a decrease of $2.4 million compared to 2008. In
addition, there were decreases in manufacturing expenses of $2.1 million
compared to 2008 related to the MT203 program due to the completion of some of
the earlier stage work performed by us under our collaboration agreement with
Nycomed. Partially offsetting these decreases were increases of $0.5
million in the MT103 program, $0.8 million in research and development salaries
and $0.3 million in share-based compensation.
General and Administrative
Expenses. General and administrative expenses were $7.3
million and $6.9 million for the six months ended June 30, 2009 and 2008,
respectively. The increase is primarily related to an increase in
share-based compensation expense of $0.4 million related to the vesting of
performance-based stock option grants during 2009.
Interest Expense.
Interest expense for the six months ended June 30, 2009 and 2008 was
$170,000 and $144,000, respectively. The increase was due to the amortization of
premiums on our investments, partially offset by the repayment of indebtedness
in July 2008.
Interest Income.
Interest income for the six months ended June 30, 2009 and 2008 was
$280,000 and $466,000, respectively. The decrease was due to lower interest
rates during 2009 as compared to 2008.
Change in Fair Value of Common Stock
Warrants Liability. The non-cash expense resulting from the
change in the fair value of the warrants was $1.8 million and $1.7 million for
the six-month periods ending June 30, 2009 and 2008, respectively. In
each case, increases in our stock price during the six-month period caused the
warrant liability to increase.
Liquidity
and Capital Resources
We had
unrestricted cash and cash equivalents and available for sale investments of
$49.2 million and $46.2 million as of June 30, 2009 and December 31, 2008,
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 June 30, 2009, we had $3.1 million of cash and
certificates of deposit relating to these letters of credit that are considered
restricted cash, all of which is recorded as a non-current asset.
Summary of Cash
Flows. Net cash used in operating activities was $4.1 million
for the six months ended June 30, 2009, compared to $4.7 million used in
operating activities for the six months ended June 30, 2008. The majority of our
cash is used to fund our ongoing research and development efforts, which
resulted in a net loss from operations of $14.3 million for the six-months ended
June 30, 2009. Operating loss was adjusted by $6.1 million for non-cash
expenses, including $2.4 million for stock-based compensation, $1.8 million for
the change in the common stock warrant liability and $1.6 million for
depreciation and amortization. Changes in working capital during the
six months ended June 30, 2009 included higher cash balances of $1.6 million
from net decreases in accounts receivable, higher cash balances of $2.3 million
from an increase in deferred revenue, which gives effect to the $6.0 million
option fee received from Bayer Schering in January 2009 that is being recognized
as revenue through January 2010.
Net cash
used in investing activities was $15.3 million for the six months ended June 30,
2009, compared to $267,000 used in investing activities for the six months ended
June 30, 2008. In 2009, we purchased short-term investments
denominated in Euros to maintain liquid assets in the currency in which the
majority of our expenses are denominated.
Net cash
provided by financing activities was $5.6 million for the six months ended June
30, 2009, compared to $14,000 used in financing activities for the six months
ended June 30, 2008. Proceeds of $5.1 million, net of financing costs, were
received from the sale of common stock under our CEFF with Kingsbridge, and we
also received $522,000 from the exercise of stock options during the
quarter. During the same period in 2008 we received $84,000 from
option exercises and paid $98,000 under capital leases.
Sources and Uses of
Cash. To date, we have funded our operations through proceeds
from 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,
equity draws under the CEFF with Kingsbridge, and most recently from a public
offering of common stock in August of 2009 described below. We expect that
operating losses and negative cash flows from operations will continue for at
least the next several years and we will need to generate additional funds to
achieve our strategic goals. If necessary, we may raise substantial funds
through the sale of our common stock, or through debt financing or through
establishing additional strategic collaboration agreements. We do not know
whether additional financing will be available when needed, or whether it will
be available on favorable terms, or at all. Based on our capital resources as of
the date of this report and from the proceeds received from the sale of common
stock in August 2009 described below, we believe that we have adequate resources
to fund our operations for at least 24 months, 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.
If we are
unable to raise additional funds when needed, we may not be able to continue
development of our product candidates or we could be required to delay, scale
back or eliminate some or all of our development programs and other operations.
If we were to raise additional funds through the issuance of common stock,
substantial dilution to our existing stockholders would likely result. If we
were to raise additional funds through additional debt financing, the terms of
the debt may involve significant cash payment obligations as well as covenants
and specific financial ratios that may restrict our ability to operate our
business. Having insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or to relinquish
greater or all rights to product candidates at an earlier stage of development
or on less favorable terms than we would otherwise choose. If we raise funds
through corporate collaborations or licensing arrangements, we may be required
to relinquish, on terms that are not favorable to us, rights to some of our
technologies or product candidates that we would otherwise seek to develop or
commercialize ourselves. Failure to obtain adequate financing may adversely
affect our operating results or our ability to operate as a going
concern.
Our
future capital uses and requirements depend on numerous forward-looking factors
and 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 increased capital outlays and operating expenditures
associated with our current and anticipated clinical trials. Our future funding
requirements will depend on many factors, including:
|
•
|
the
number, scope, rate of progress, results and costs of our preclinical
studies, clinical trials and other research and development
activities;
|
|
•
|
the
terms and timing of any corporate collaborations that we may establish,
and the success of these
collaborations;
|
|
•
|
the
cost, timing and outcomes of regulatory
approvals;
|
|
•
|
the
number and characteristics of product candidates that we
pursue;
|
|
•
|
the
cost and timing of establishing manufacturing, marketing and sales, and
distribution capabilities;
|
|
•
|
the
cost of establishing clinical and commercial supplies of our product
candidates;
|
|
•
|
the
cost of preparing, filing, prosecuting, defending and enforcing any patent
claims and other intellectual property rights;
and
|
|
•
|
the
extent to which we acquire or invest in businesses, products or
technologies, although we currently have no commitments or agreements
relating to any of these types of
transactions.
|
Committed
Equity Financing Facility
In
December 2008, we entered into a committed equity financing facility, or CEFF,
with Kingsbridge Capital Limited, or Kingsbridge, pursuant to which Kingsbridge
committed to purchase, subject to certain conditions, up to $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
to purchase up to 135,000 shares of our common stock with an exercise price of
$4.44 per share. The warrant is exercisable until June 2014. Under
the CEFF, the maximum number of shares that we may sell to Kingsbridge is
10,104,109 shares (exclusive of the shares underlying the warrant issued to
Kingsbridge). Subject to certain conditions and limitations, from time to
time under the CEFF, we may require Kingsbridge to purchase shares of our common
stock at a price that is between 86% and 94% of the volume weighted average
price on each trading day during an eight-day pricing period, provided that if
the average market price on any day during the pricing period is less than the
greater of $2.00 or 85% of the closing price of the day preceding the first day
of the pricing period, then such day would not be used in determining the number
of shares that would be issued in the draw down and the aggregate amount of such
draw down would be decreased by one-eighth.
The
maximum dollar amount of shares that we may require Kingsbridge to purchase in
any pricing period is equal to the greater of (a) a percentage of our market
capitalization as determined at the time of the draw down (which percentage
ranges from 1.0% to 1.5% depending upon our market capitalization at the time of
the draw down) or (b) four times the average trading volume of our common stock
for a specified period prior to the draw down notice, multiplied by the closing
price of the common stock on the trading day prior to the draw down notice, in
each case subject to certain conditions. If either of the foregoing calculations
yields a draw down amount in excess of $10 million, then the individual draw
down amount is limited to $10 million.
We filed
a registration statement which became effective in December 2008 with respect to
the resale of shares issuable 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. We are not
obligated to sell any of the $75.0 million of common stock available under the
CEFF and there are no minimum commitments or minimum use penalties. The CEFF
does not contain any restrictions on our operating activities, automatic pricing
resets or minimum market volume restrictions.
As
described in this report, during the second quarter of 2009 we made the first
draw downs under the CEFF. In May and June 2009, we issued a total of
1,420,568 shares of common stock to Kingsbridge for aggregate gross proceeds of
$5.3 million. Accordingly, the remaining amount available under the CEFF
decreased to the lesser of $69.7 million or 8,684,351 shares of common
stock.
Public Offering of Common
Stock
On August
4, 2009, we completed an underwritten public offering of 16,100,000 shares of
common stock at a public offering price of $5.00 per share for net proceeds
of approximately $75.0 million after deducting the underwriters'
discount and other estimated offering expenses payable by us.
Contractual
Obligations
We have
contractual obligations related to our facility leases, research agreements and
financing agreements. The following table sets forth our significant
contractual obligations as of June 30, 2009 (in thousands):
|
|
|
|
|
Payment Due by Period
|
|
|
|
|
|
|
Less Than
|
|
|
|
|
|
|
|
|
More Than
|
|
Contractual
Obligations
|
|
Total
|
|
|
1 Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
5 Years
|
|
Operating
leases(1)
|
|
$ |
15,516 |
|
|
$ |
5,124 |
|
|
$ |
10,389 |
|
|
$ |
3 |
|
|
$ |
— |
|
Short-term
debt — MedImmune
|
|
|
2,149 |
|
|
|
2,149 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Contractual
payments under licensing agreements (2)
|
|
|
416 |
|
|
|
80 |
|
|
|
162 |
|
|
|
106 |
|
|
|
68 |
|
Capital
leases
|
|
|
554 |
|
|
|
146 |
|
|
|
257 |
|
|
|
124 |
|
|
|
27 |
|
|
|
$ |
18,635 |
|
|
$ |
7,499 |
|
|
$ |
10,808 |
|
|
$ |
233 |
|
|
$ |
95 |
|
|
(1)
|
The
amounts shown in operating leases excludes expected sub-lease
income.
|
|
(2)
|
We
are a party to technology transfer, licensing and research and development
agreements with various universities, research organizations and other
third parties under which we have received licenses to certain
intellectual property, scientific know-how and technology. In
consideration for the licenses received, we are required to pay license
and research support fees, milestone payments upon the achievement of
certain success-based objectives and/or royalties on future sales of
commercialized products, if any. We may also be required to pay minimum
annual royalties and the costs associated with the prosecution and
maintenance of the patents covering the licensed
technology.
|
Cautionary
Note Regarding Forward-Looking Statements
Any
statements in this report about our expectations, beliefs, plans, objectives,
assumptions or future events or performance are not historical facts and are
forward-looking statements. Such forward-looking statements include statements
regarding our available cash resources, 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 and the future development of a BiTE antibody under our
collaboration with MedImmune, the conduct, timing and results of future clinical
trials, plans regarding regulatory filings, our ability to draw down under the
CEFF and the availability of financing, 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 loss of key scientific, management or commercial
personnel; the size and growth potential of the potential markets for our
product candidates and our ability to serve those markets; the scope and
validity of patent protection for our product candidates; competition from other
pharmaceutical or biotechnology companies; our ability to establish and maintain
strategic collaborations or to otherwise obtain additional financing to support
our operations on commercially reasonable terms; successful administration of
our business and financial reporting capabilities; and other risks detailed in
this report, including those below in Part II, Item 1A, “Risk
Factors.”
Although
we believe that the expectations reflected in our forward-looking statements are
reasonable, we cannot guarantee future results, events, levels of activity,
performance or achievement. We undertake no obligation to publicly update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise, unless required by law.
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
Interest
Rates
Our
financial instruments consist primarily of cash and cash equivalents. These
financial instruments, principally comprised of corporate obligations and U.S.
and foreign government obligations, are subject to interest rate risk and will
decline in value if interest rates increase. Because of the relatively short
maturities of our investments, we do not expect interest rate fluctuations to
materially affect the aggregate value of our financial instruments. We do not
have derivative financial instruments in our investment portfolio.
A
significant portion of our cash and cash equivalents, and all of our short-term
investments, are currently denominated in Euros. A majority of our
operating expenses, including our research and development expenses, are
incurred in Europe pursuant to arrangements that are generally denominated in
Euros. By aligning our cash, cash equivalents and investments in the
same currency as our expenses, we minimize the potential negative impact of
foreign currency fluctuations relative to our operating
budgets. However, we do maintain a significant portion of our cash
and cash equivalents in U.S. dollars.
As a
result, our financial results and capital resources will be affected by changes
in the U.S. dollar/Euro exchange rate. As of June 30, 2009, we had U.S.
dollar-denominated cash and cash equivalents of approximately $24.9 million and
Euro-denominated cash and investments of approximately €19.0 million, or
approximately $26.7 million using the exchange rate as of that
date. As of June 30, 2009, we had Euro-denominated liabilities of
approximately €15.3 million, or approximately $21.5 million, using the exchange
rate as of that date. The following table shows the hypothetical impact of a
change to the Euro/U.S. Dollar exchange rate:
Change in Euro/$ U.S. Exchange Rate
|
|
|
10 |
% |
|
|
15 |
% |
|
|
20 |
% |
Increase
in reported net operating loss for the six months ended June 30, 2009 (in
thousands)
|
|
$ |
611 |
|
|
$ |
917 |
|
|
$ |
1,223 |
|
Item 4.
Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our Exchange Act reports is recorded,
processed, summarized and reported within the time periods specified in the
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 June 30, 2009, the end of
the period covered by this report. Based on the evaluation of our disclosure
controls and procedures as of June 30, 2009, our chief executive officer and
chief 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. During the second quarter of 2009 we
implemented a new accounting system at both of our locations in the United
States and Germany. Other than this system implementation, there were
no changes in our internal control over financial reporting during the quarter
ended June 30, 2009 that materially affected, or were reasonably likely to
materially affect, our internal control over financial reporting.
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. 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 from our inception through June 30, 2009, and we expect to incur
substantial losses for the foreseeable future. We have no current sources of
material ongoing revenue, other than the reimbursement of development expenses
and potential future milestone payments from our current collaborators or
licensees, including Merck Serono, MedImmune, Nycomed and TRACON. We have not
commercialized any products to date, either alone or with a third party
collaborator. If we are not able to commercialize any products, whether alone or
with a collaborator, we may not achieve profitability. Even if our collaboration
agreements provide funding for a portion of our research and development
expenses for some of our programs, we expect to spend significant capital to
fund our internal research and development programs for the foreseeable future.
As a result, we will need to generate significant revenues in order to achieve
profitability. We cannot be certain whether or when this will occur because of
the significant uncertainties that affect our business. Even if we do achieve
profitability, we may not be able to sustain or increase profitability on a
quarterly or annual basis. Our failure to become and remain profitable may
depress the market value of our common stock and could impair our ability to
raise capital, expand our business, diversify our product offerings or continue
our operations and, as a result, you could lose part or all of your
investment.
We
will require additional financing, which may be difficult to obtain and may
dilute your ownership interest in us. If we fail to obtain the capital necessary
to fund our operations, we will be unable to develop or commercialize our
product candidates and our ability to operate as a going concern may be
adversely affected.
We will
require substantial funds to continue our research and development programs and
our future capital requirements may vary from what we expect. There are factors,
many of which are outside our control, that may affect our future capital
requirements and accelerate our need for additional financing. Among the factors
that may affect our future capital requirements and accelerate our need for
additional financing are:
|
•
|
Continued
progress in our research and development programs, as well as the scope of
these programs;
|
|
•
|
our
ability to establish and maintain collaborative arrangements for the
discovery, research or development of our product
candidates;
|
|
•
|
the
timing, receipt and amount of research funding and milestone, license,
royalty and other payments, if any, from
collaborators;
|
|
•
|
the
timing, receipt and amount of sales revenues and associated royalties to
us, if any, from our product candidates in the
market;
|
|
•
|
our
ability to sell shares of our common stock under our December 2008
committed equity financing facility, or CEFF, with Kingsbridge Capital
Limited, or Kingsbridge;
|
|
•
|
the
costs of preparing, filing, prosecuting, maintaining, defending and
enforcing patent claims and other patent-related costs, including
litigation costs and technology license
fees;
|
|
|
|
|
•
|
costs
associated with litigation;
and
|
|
•
|
Competing
technological and market
developments.
|
We expect
to seek funding through public or private financings or from existing or new
collaborators with whom we enter into research or development collaborations
with respect to programs that are not currently licensed. As
described in this report, in August 2009, we completed an underwritten public
offering of our common stock for net proceeds of approximately $75.0
million. 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, in the event that we seek additional funding. Having
insufficient funds may require us to delay, scale back or eliminate some or all
of our research or development programs or to relinquish greater or all rights
to product candidates at an earlier stage of development or on less favorable
terms than we would otherwise choose. Failure to obtain adequate financing also
may adversely affect our ability to operate as a going concern.
If we
raise additional funds through the issuance of equity securities, our
stockholders may experience substantial dilution, including as a result of the
issuance of warrants in connection with the financing, or the equity securities
may have rights, preferences or privileges senior to those of existing
stockholders. If we raise additional funds through debt financings, these
financings may involve significant cash payment obligations and covenants that
restrict our ability to operate our business and make distributions to our
stockholders. We also could elect to seek funds through arrangements with
collaborators or others that may require us to relinquish rights to certain
technologies, product candidates or products.
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:
|
•
|
a
minimum price for our common stock that is not less than 85% of the
closing price of the day immediately preceding the applicable eight-day
pricing period, but in no event less than $2.00 per
share;
|
|
•
|
the
accuracy of representations and warranties made to
Kingsbridge;
|
|
•
|
our
compliance with all applicable laws which, if we failed to so comply,
would have a Material Adverse Effect (as that term is defined in the
purchase agreement with Kingsbridge);
and
|
|
•
|
the
effectiveness of a registration statement registering for resale the
shares of common stock to be issued in connection with the
CEFF.
|
Kingsbridge
is permitted to terminate the CEFF by providing written notice to us upon the
occurrence of certain events. 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.
Kingsbridge is also able to terminate the CEFF at any time that we have not
drawn down at least $1.25 million in funds over a consecutive 12-month period.
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 are
entitled, in certain circumstances, to deliver a blackout notice to Kingsbridge
to suspend the use of the resale registration statement and prohibit Kingsbridge
from selling shares under the resale registration statement for a certain period
of time. If we deliver a blackout notice during the fifteen trading days
following our delivery of shares to Kingsbridge in connection with any draw
down, then we may be required to make a payment to Kingsbridge, or issue to
Kingsbridge additional shares in lieu of this payment, calculated on the basis
of the number of shares purchased by Kingsbridge in the most recent draw down
and held by Kingsbridge immediately prior to the blackout period and the decline
in the market price, if any, of our common stock during the blackout period. If
the trading price of our common stock declines during a blackout period, this
blackout payment could be significant.
In
addition, if we fail to maintain the effectiveness of the resale registration
statement or related prospectus in circumstances not permitted by our agreement
with Kingsbridge, we may be required to make a payment to Kingsbridge,
calculated on the basis of the number of shares held by Kingsbridge during the
period that the registration statement or prospectus is not effective,
multiplied by the decline in market price, if any, of our common stock during
the ineffective period. If the trading price of our common stock declines during
a period in which the resale registration statement or related prospectus is not
effective, this payment could be significant.
Should we
sell shares to Kingsbridge under the CEFF or issue shares in lieu of a blackout
payment, it will have a dilutive effect on the holdings of our current
stockholders and may result in downward pressure on the price of our common
stock. If we draw down under the CEFF, we will issue shares to Kingsbridge at a
discount of 6% to 14% from the volume weighted average price of our common
stock. If we draw down amounts under the CEFF when our share price is
decreasing, we will need to issue more shares to raise the same amount than if
our stock price was higher. Issuances in the face of a declining share price
will have an even greater dilutive effect than if our share price were stable or
increasing and may further decrease our share price. Moreover, the number of
shares that we will be able to issue to Kingsbridge in a particular draw down
may be materially reduced if our stock price declines significantly during the
applicable eight-day pricing period.
Our
quarterly operating results and stock price may fluctuate
significantly.
We expect
our results of operations to be subject to quarterly fluctuations. The level of
our revenues, if any, and results of operations for any given period, will be
based primarily on the following factors:
|
•
|
the
status of development of our product
candidates;
|
|
•
|
the
time at which we enter into research and license agreements with strategic
collaborators that provide for payments to us, the timing and accounting
treatment of payments to us, if any, under those agreements, and the
progress made by our strategic collaborators in moving forward the
development of our product
candidates;
|
|
•
|
whether
or not we achieve specified research, development or commercialization
milestones under any agreement that we enter into with strategic
collaborators and the timely payment by these collaborators of any amounts
payable to us;
|
|
•
|
the
addition or termination of research programs or funding support under
collaboration agreements;
|
|
•
|
the
timing of milestone payments under license agreements, repayments of
outstanding amounts under loan agreements, and other payments that we may
be required to make to others;
|
|
•
|
variations
in the level of research and development expenses related to our clinical
or preclinical product candidates during any given
period;
|
|
•
|
the
change in fair value of the common stock warrants issued to investors in
connection with our 2007 private placement financing, remeasured at each
balance sheet date using a Black-Scholes option-pricing model, with the
change in value recorded as other income or expense;
and
|
|
•
|
general
market conditions affecting companies with our risk profile and market
capitalization.
|
These
factors may cause the price of our stock to fluctuate substantially. We believe
that quarterly comparisons of our financial results are not necessarily
meaningful and should not be relied upon as an indication of our future
performance.
If
the estimates we make and the assumptions on which we rely in preparing our
financial statements prove inaccurate, our actual results may vary
significantly.
Our
financial statements have been prepared in accordance with generally accepted
accounting principles in the United States. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported
amounts of our assets, liabilities, revenues and expenses, the amounts of
charges taken by us and related disclosure. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances. We cannot assure you that our estimates, or the
assumptions underlying them, will be correct. Accordingly, our actual financial
results may vary significantly from the estimates contained in our financial
statements.
Changes
in, or interpretations of, accounting rules and regulations could result in
unfavorable accounting charges or require us to change our compensation
policies.
Accounting
methods and policies for biopharmaceutical companies, including policies
governing revenue recognition, research and development and related expenses,
accounting for stock options and in-process research and development costs are
subject periodically to further review, interpretation and guidance from
relevant accounting authorities, including the SEC. Changes to, or
interpretations of, accounting methods or policies in the future may require us
to reclassify, restate or otherwise change or revise our financial statements,
including those contained in this filing.
Risks
Relating to Our Common Stock
Substantial
sales of shares may adversely impact the market price of our common stock and
our ability to issue and sell shares in the future.
Substantially
all of the outstanding shares of our common stock are eligible for resale in the
public market. A significant portion of these shares is held by a small number
of stockholders. We have also registered shares of our common stock that we may
issue under our equity incentive compensation plans and our employee stock
purchase plan. In addition, any shares issued under our CEFF with Kingsbridge
will be eligible for resale in the public market. These shares generally can be
freely sold in the public market upon issuance. If our stockholders sell
substantial amounts of our common stock, the market price of our common stock
may decline, which might make it more difficult for us to sell equity or
equity-related securities in the future at a time and price that we deem
appropriate. We are unable to predict the effect that sales of our common stock
may have on the prevailing market price of our common stock.
Our
stock price may be volatile, and you may lose all or a substantial part of your
investment.
The
market price for our common stock is volatile and may fluctuate significantly in
response to a number of factors, many of which we cannot control. Among the
factors that could cause material fluctuations in the market price for our
common stock are:
|
•
|
our
ability to successfully raise capital to fund our continued
operations;
|
|
•
|
our
ability to successfully develop our product candidates within acceptable
timeframes;
|
|
•
|
changes
in the regulatory status of our product
candidates;
|
|
•
|
changes
in significant contracts, strategic collaborations, new technologies,
acquisitions, commercial relationships, joint ventures or capital
commitments;
|
|
•
|
the
execution of new collaboration agreements or termination of existing
collaborations related to our clinical or preclinical product candidates
or our BiTE antibody technology
platform;
|
|
•
|
announcements
of the invalidity of, or litigation relating to, our key intellectual
property;
|
|
•
|
announcements
of the achievement of milestones in our agreements with collaborators or
the receipt of payments under those
agreements;
|
|
•
|
announcements
of the results of clinical trials by us or by companies with commercial
products or product candidates in the same therapeutic category as our
product candidates;
|
|
•
|
events
affecting our collaborators;
|
|
•
|
fluctuations
in stock market prices and trading volumes of similar
companies;
|
|
•
|
announcements
of new products or technologies, clinical trial results, commercial
relationships or other events by us, our collaborators or our
competitors;
|
|
•
|
our
ability to successfully complete strategic collaboration arrangements with
respect to our product candidates, BiTE antibodies or our BiTE antibody
platform;
|
|
•
|
variations
in our quarterly operating results;
|
|
•
|
changes
in securities analysts’ estimates of our financial performance or product
development timelines;
|
|
•
|
changes
in accounting principles;
|
|
•
|
sales
of large blocks of our common stock, including sales by our executive
officers, directors and significant
stockholders;
|
|
•
|
additions
or departures of key personnel; and
|
|
•
|
discussions
of Micromet or our stock price by the financial and scientific press and
online investor communities such as chat
rooms.
|
If
our officers and directors choose to act together, they can significantly
influence our management and operations in a manner that may be in their best
interests and not in the best interests of other stockholders.
Our
officers and directors, together with their affiliates, collectively own an
aggregate of approximately 17% of our outstanding common stock. As a result, if
they act together, they may significantly influence all matters requiring
approval by our stockholders, including the election of directors and the
approval of mergers or other business combination transactions. The interests of
this group of stockholders may not always coincide with our interests or the
interests of other stockholders, and this group may act in a manner that
advances their best interests and not necessarily those of other
stockholders.
Our
stockholder rights plan, anti-takeover provisions in our organizational
documents and Delaware law may discourage or prevent a change in control, even
if an acquisition would be beneficial to our stockholders, which could affect
our stock price adversely and prevent attempts by our stockholders to replace or
remove our current management.
Our
stockholder rights plan and provisions contained in our amended and restated
certificate of incorporation and amended and restated bylaws may delay or
prevent a change in control, discourage bids at a premium over the market price
of our common stock and adversely affect the market price of our common stock
and the voting and other rights of the holders of our common stock. The
provisions in our amended and restated certificate of incorporation and amended
and restated bylaws include:
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dividing
our board of directors into three classes serving staggered three-year
terms;
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prohibiting
our stockholders from calling a special meeting of
stockholders;
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permitting
the issuance of additional shares of our common stock or preferred stock
without stockholder approval;
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prohibiting
our stockholders from making certain changes to our amended and restated
certificate of incorporation or amended and restated bylaws except with
66 2/3% stockholder approval;
and
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requiring
advance notice for raising matters of business or making nominations at
stockholders’ meetings.
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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 and our insurance coverage may not
be sufficient to cover all costs and damages.
The stock
market has from time to time experienced significant price and volume
fluctuations that have affected the market prices for the common stock of
pharmaceutical and biotechnology companies. These broad market fluctuations may
cause the market price of our common stock to decline. In the past, following
periods of volatility in the market price of a particular 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
future product candidates, our operating results would suffer.
The
success of our strategy for development and commercialization of our product
candidates depends upon our ability to form and maintain productive strategic
collaborations and license arrangements. We currently have strategic
collaborations or license arrangements with Merck Serono, MedImmune, Nycomed and
TRACON. In addition, we have an option, collaboration and license agreement with
Bayer Schering Pharma, under which Bayer Schering may elect to commence a
development collaboration for a BiTE antibody targeting a solid tumor until
January 2010. 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 and services that are similar to or competitive with the product
candidates and services that are the subject of their collaborations with
us or programs licensed from us.
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Our
collaborators may discontinue the development of our product candidates in
specific indications, for example as a result of their assessment of the
results obtained in clinical trials, or fail to initiate the development
in indications that have a significant commercial
potential.
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Pharmaceutical
and biotechnology companies from time to time re-evaluate their research
and development priorities, including in connection with mergers and
consolidations, which have been common in recent years. 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 incur delays in the development for 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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As noted
elsewhere in this report, pursuant to the terms of our collaboration and license
agreement with MedImmune, MedImmune has notified us of its election to develop a
new BiTE antibody and to discontinue the development of blinatumomab in North
America. There can be no assurances that we will be able to successfully develop
blinatumomab in North America, that such development will not be delayed as a
result of contractual or financial constraints, that MedImmune will comply with
its continuing contractual obligations to develop the commercial scale
manufacturing process for blinatumomab and to supply us with blinatumomab for
clinical trials, on a timeline or in a manner that is consistent with our
development plans for blinatumomab that we would be successful in enforcing
MedImmune’s continuing obligations under the collaboration and license
agreement, or that we will be able to enter into a new collaboration agreement
with respect to blinatumomab with another industry partner if we desire to do
so.
We
may not be successful in establishing additional strategic collaborations, which
could adversely affect our ability to develop and commercialize product
candidates.
As an
integral part of our ongoing research and development efforts, we periodically
review opportunities to establish new collaborations for development and
commercialization of new BiTE antibodies or existing product candidates in our
development pipeline. We face significant competition in seeking appropriate
collaborators and the negotiation process is time-consuming and complex. We may
not be successful in our efforts to establish additional collaborations or other
alternative arrangements. Even if we are successful in our efforts to establish
a collaboration, the terms of the agreement may not be favorable to us. Finally,
such collaborations or other arrangements may not result in successful products
and associated revenue from milestone payments, royalties or profit share
payments.
Our
clinical stage product candidates adecatumumab, blinatumomab and MT110 have not
yet been proven to be safe or to be effective at the currently tested dose
levels. If we discontinue the development of any of our clinical stage product
candidates due to adverse events or lack of efficacy, our business could suffer
and the value of our company may be adversely affected.
We
previously have reported that two phase 2 clinical trials of adecatumumab did
not reach their respective primary endpoint in patients with metastatic breast
cancer (clinical benefit rate at week 24) and in patients with prostate cancer
(mean change in prostate specific antigen, compared to placebo control). We have
also reported that the treatment with blinatumomab was discontinued permanently
in some patients due to adverse events that included infections, central nervous
system events, and liver enzyme increases. MT110 is in a phase 1 dose-escalation
clinical trial, and we may reach the maximum tolerated dose without reaching a
dose level at which MT110 shows a clinically meaningful anti-tumor
effect. We are continuing the development of these product candidates
in phase 1 and/or phase 2 clinical trials, but there can be no assurance that we
will not encounter unacceptable adverse events or that any preliminary
suggestion of anti-tumor activity of these product candidates will be confirmed
during the ongoing or any future clinical trials.
Risks
Relating to Our Operations, Business Strategy, and the Life Sciences
Industry
We
face substantial competition, which may result in our competitors discovering,
developing or commercializing products before or more successfully than we
do.
Our
product candidates face competition with existing and new products being
developed by biotechnology and pharmaceutical companies, as well as universities
and other research institutions. For example, research in the fields of
antibody-based therapeutics for the treatment of cancer, and autoimmune and
inflammatory diseases, is highly competitive. A number of entities are seeking
to identify and patent antibodies, potentially active proteins and other
potentially active compounds without specific knowledge of their therapeutic
functions. Our competitors may discover, characterize and develop important
inducing molecules or genes in advance of us.
Many of
our competitors have substantially greater capital resources, research and
development staffs and facilities than we have. Efforts by other biotechnology
and pharmaceutical companies could render our programs or product candidates
uneconomical or result in therapies that are superior to those that we are
developing alone or with a collaborator. We and our collaborators face
competition from companies that may be more experienced in product development
and commercialization, obtaining regulatory approvals and product manufacturing.
As a result, they may develop competing products more rapidly that are safer,
more effective, or have fewer side effects, or are less expensive, or they may
discover, develop and commercialize products, which render our product
candidates non-competitive or obsolete. We expect competition to intensify in
antibody research as technical advances in the field are made and become more
widely known.
We
may not be successful in our efforts to expand our portfolio of product
candidates.
A key
element of our strategy is to discover, develop and commercialize a portfolio of
new antibody therapeutics. We are seeking to do so through our internal research
programs and in-licensing activities, which could place a strain on our human
and capital resources. A significant portion of the research that we are
conducting involves new and unproven technologies. Research programs to identify
new disease targets and product candidates require substantial technical,
financial and human resources regardless of whether or not any suitable
candidates are ultimately identified. Our research programs may initially show
promise in identifying potential product candidates, yet fail to yield product
candidates suitable for clinical development. If we are unable to discover
suitable potential product candidates, develop additional delivery technologies
through internal research programs or in-license suitable product candidates or
delivery technologies on acceptable business terms, our business prospects will
suffer.
The
product candidates in our pipeline are in early stages of development and our
efforts to develop and commercialize these product candidates are subject to a
high risk of delay and failure. If we fail to successfully develop our product
candidates, our ability to generate revenues will be substantially
impaired.
All of
our product candidates are in early stages of clinical and preclinical
development, so we will require substantial additional financial resources, as
well as research, product development and clinical development capabilities, to
pursue the development of these product candidates, and we may never develop an
approvable or commercially viable product. The process of successfully
developing product candidates for the treatment of human diseases is very
time-consuming, expensive and unpredictable and there is a high rate of failure
for product candidates in preclinical development and in clinical trials. The
preclinical studies and clinical trials may produce negative, inconsistent or
inconclusive results, and the results from early clinical trials may not be
statistically significant or predictive of results that will be obtained from
expanded, advanced clinical trials. Further, we or our collaborators may decide,
or the FDA, EMEA or other regulatory authorities may require us, to conduct
preclinical studies or clinical trials or other development activities in
addition to those performed or planned by us or our collaborators, which may be
expensive or could delay the time to market for our product candidates. In
addition, we do not know whether the clinical trials will result in marketable
products.
We do not
know whether our planned preclinical development or clinical trials for our
product candidates will begin on time or be completed on schedule, if at all.
The timing and completion of clinical trials of our product candidates depend
on, among other factors, the number of patients that will be required to enroll
in the clinical trials, the inclusion and exclusion criteria used for selecting
patients for a particular clinical trial, and the rate at which those patients
are enrolled. Any increase in the required number of patients, tightening of
selection criteria, or decrease in recruitment rates or difficulties retaining
study participants may result in increased costs, delays in the development of
the product candidate, or both.
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 EMEA, may hold, suspend or
terminate our clinical research or the clinical trials of our product candidates
for various reasons, including non-compliance with regulatory requirements or
if, in their opinion, the participating subjects are being exposed to
unacceptable health risks, or if additional information may be required for the
regulatory authority to assess the proposed development activities. Further,
regulators may not approve study protocols at all or in a timeframe anticipated
by us if they believe that the study design or the mechanism of action of our
product candidates poses an unacceptable health risk to study
participants.
We have
limited financial and managerial resources. These limitations require us to
focus on a select group of product candidates in specific therapeutic areas and
to forego the exploration of other product opportunities. While our technologies
may permit us to work in multiple areas, resource commitments may require
trade-offs resulting in delays in the development of certain programs or
research areas, which may place us at a competitive disadvantage. Our decisions
as to resource allocation may not lead to the development of viable commercial
products and may divert resources away from other market opportunities, which
would otherwise have ultimately proved to be more profitable.
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, EMEA and other
regulatory authorities that our product candidates are safe and effective. We
have limited experience and internal resources for conducting certain
preclinical studies and clinical trials and rely primarily on collaborators and
contract research organizations for the performance and management of
preclinical studies and clinical trials of our product candidates.
We are
responsible for confirming that our preclinical studies are conducted in
accordance with applicable regulations and that each of our clinical trials is
conducted in accordance with its general investigational plan and protocol. Our
reliance on third parties does not relieve us of responsibility for ensuring
compliance with appropriate regulations and standards for conducting,
monitoring, recording and reporting of preclinical and clinical trials. If our
collaborators or contractors fail to properly perform their contractual or
regulatory obligations with respect to conducting or overseeing the performance
of our preclinical studies or clinical trials, do not meet expected deadlines,
fail to comply with the good laboratory practice guidelines or good clinical
practice regulations, do not adhere to our preclinical and clinical trial
protocols, suffer an unforeseen business interruption unrelated to our agreement
with them that delays the clinical trial, or otherwise fail to generate reliable
clinical data, then the completion of these studies or trials may be delayed,
the results may not be useable and the studies or trials may have to be
repeated, and we may need to enter into new arrangements with alternative third
parties. Any of these events could cause our clinical trials to be extended,
delayed, or terminated or create the need for them to be repeated, or otherwise
create additional costs in the development of our product candidates and could
adversely affect our and our collaborators’ ability to market a product after
marketing approvals have been obtained.
Even
if we complete the lengthy, complex and expensive development process, there is
no assurance that we or our collaborators will obtain the regulatory approvals
necessary for the launch and commercialization of our product
candidates.
To the
extent that we or our collaborators are able to successfully complete the
clinical development of a product candidate, we or our collaborators will be
required to obtain approval by the FDA, EMEA or other regulatory authorities
prior to marketing and selling such product candidate in the United States, the
European Union or other countries. The process of preparing and filing
applications for regulatory approvals with the FDA, EMEA and other regulatory
authorities, and of obtaining the required regulatory approvals from these
regulatory authorities, is lengthy and expensive, and may require two years or
more. This process is further complicated because some of our product candidates
use non-traditional or novel materials in non-traditional or novel ways, and the
regulatory officials have little precedent to follow.
Any
marketing approval by the FDA, EMEA or other regulatory authorities may be
subject to limitations on the indicated uses for which we or our collaborators
may market the product candidate. These limitations could restrict the size of
the market for the product and affect reimbursement levels by third-party
payers.
As a
result of these factors, we or our collaborators may not successfully begin or
complete clinical trials and launch and commercialize any product candidates in
the time periods estimated, if at all. Moreover, if we or our collaborators
incur costs and delays in development programs or fail to successfully develop
and commercialize products based upon our technologies, we may not become
profitable and our stock price could decline.
We
and our collaborators are subject to governmental regulations in addition to
those imposed by the FDA and EMEA, and we or our collaborators may not be able
to comply with these regulations. Any non-compliance could subject us or our
collaborators to penalties and otherwise result in the limitation of our
operations.
In
addition to regulations imposed by the FDA, EMEA and other health regulatory
authorities, we and our collaborators are subject to regulation under the
Occupational Safety and Health Act, the Environmental Protection Act, the Toxic
Substances Control Act, the Research Conservation and Recovery Act, as well as
regulations administered by the Nuclear Regulatory Commission, national
restrictions on technology transfer, import, export and customs regulations and
certain other local, state or federal regulations, or their counterparts in
Europe and other countries. From time to time, other governmental agencies and
legislative or international governmental bodies have indicated an interest in
implementing further regulation of biotechnology applications. We are not able
to predict whether any such regulations will be adopted or whether, if adopted,
such regulations will apply to our or our collaborators’ business, or whether we
or our collaborators would be able to comply, without incurring unreasonable
expense, or at all, with any applicable regulations.
Our
growth could be limited if we are unable to attract and retain key personnel and
consultants.
We have
limited experience in filing and prosecuting regulatory applications to obtain
marketing approval from the FDA, EMEA or other regulatory authorities. Our
success depends on the ability to attract, train and retain qualified scientific
and technical personnel, including consultants, to further our research and
development efforts. The loss of services of one or more of our key employees or
consultants could have a negative impact on our business and operating results.
Competition for skilled personnel is intense and the turnover rate can be high.
Competition for experienced management and clinical, scientific and engineering
personnel from numerous companies and academic and other research institutions
may limit our ability to attract and retain qualified personnel on acceptable
terms. As a result, locating candidates with the appropriate qualifications can
be difficult, and we may not be able to attract and retain sufficient numbers of
highly skilled employees.
Any
growth and expansion into areas and activities that may require additional
personnel or expertise, such as in regulatory affairs, quality assurance, and
control and compliance, would require us to either hire new key personnel or
obtain such services from a third party. The pool of personnel with the skills
that we require is limited, and we may not be able to hire or contract such
additional personnel. Failure to attract and retain personnel would prevent us
from developing and commercializing our product candidates.
If
our third-party manufacturers do not follow current good manufacturing practices
or do not maintain their facilities in accordance with these practices, our
product development and commercialization efforts may be
harmed.
We have
no manufacturing experience or manufacturing capabilities for the production of
our product candidates for clinical trials or commercial sale. For this reason,
we contract with a number of third-party manufacturers for the production of our
product candidates. In certain instances, manufacturing responsibilities are
defined in collaboration agreements with our pharmaceutical
partners. For example, as discussed in this report, the obligation to
manufacture blinatumomab remains with MedImmune, even though MedImmune returned
North American rights to blinatumomab to Micromet in March 2009.
Product
candidates used in clinical trials or sold after marketing approval has been
obtained must be manufactured in accordance with current good manufacturing
practices regulations. There are a limited number of manufacturers that operate
under these regulations, including the FDA’s and EMEA’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, the EMEA, and other regulatory agencies or
authorities, to ensure strict compliance with current good manufacturing
practices and other governmental regulations and standards. A failure of
third-party manufacturers to follow current good manufacturing practices or
other regulatory requirements 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, it may require additional
clinical trials and the revalidation of the manufacturing process and procedures
in accordance with applicable current good manufacturing practices and may
require FDA or EMEA approval. This revalidation may be costly and
time-consuming. If we are unable to arrange for third-party manufacturing of our
product candidates, or to do so on commercially reasonable terms, we may not be
able to complete development or marketing of our product
candidates.
Even
if regulatory authorities approve our product candidates, we may fail to comply
with ongoing regulatory requirements or experience unanticipated problems with
our product candidates, and these product candidates could be subject to
restrictions or withdrawal from the market following approval.
Any
product candidates for which we obtain marketing approval, along with the
manufacturing processes, post-approval clinical trials and promotional
activities for such product candidates, will be subject to continual review and
periodic inspections by the FDA, EMEA and other regulatory authorities. Even if
regulatory approval of a product candidate is granted, the approval may be
subject to limitations on the indicated uses for which the product may be
marketed or contain requirements for costly post-marketing testing and
surveillance to monitor the safety or efficacy of the product. Post-approval
discovery of previously unknown problems with any approved products, including
unanticipated adverse events or adverse events of unanticipated severity or
frequency, difficulties with a manufacturer or manufacturing processes, or
failure to comply with regulatory requirements, may result in restrictions on
such approved products or manufacturing processes, limitations in the scope of
our approved labeling, withdrawal of the approved products from the market,
voluntary or mandatory recall and associated publicity requirements, fines,
suspension or withdrawal of regulatory approvals, product seizures, injunctions
or the imposition of civil or criminal penalties.
The
procedures and requirements for granting marketing approvals vary among
countries, which may cause us to incur additional costs or delays or may prevent
us from obtaining marketing approvals in different countries and regulatory
jurisdictions.
We intend
to market our product candidates in many countries and regulatory jurisdictions.
In order to market our product candidates in the United States, the European
Union and many other jurisdictions, we must obtain separate regulatory approvals
in each of these countries and territories. The procedures and requirements for
obtaining marketing approval vary among countries and regulatory jurisdictions,
and can involve additional clinical trials or other tests. Also, the time
required to obtain approval may differ from that required to obtain FDA and EMEA
approval. The various regulatory approval processes may include all of the risks
associated with obtaining FDA and EMEA approval. We may not obtain all of the
desirable or necessary regulatory approvals on a timely basis, if at all.
Approval by a regulatory authority in a particular country or regulatory
jurisdiction, such as the FDA in the United States and the EMEA in the European
Union, generally does not ensure approval by a regulatory authority in another
country. We may not be able to file for regulatory approvals and may not receive
necessary approvals to commercialize our product candidates in any or all of the
countries or regulatory jurisdictions in which we desire to market our product
candidates.
If
we fail to obtain an adequate level of reimbursement for any approved products
by third-party payers, there may be no commercially viable markets for these
products or the markets may be much smaller than expected. The continuing
efforts of the government, insurance companies, managed care organizations and
other payers of health care costs to contain or reduce costs of healthcare may
adversely affect our ability to generate revenues and achieve profitability, the
future revenues and profitability of our potential customers, suppliers and
collaborators, and the availability of capital.
Our
ability to commercialize our product candidates successfully will depend in part
on the extent to which governmental authorities, private health insurers and
other organizations establish appropriate reimbursement levels for the price
charged for our product candidates and related treatments. The efficacy, safety
and cost-effectiveness of our product candidates as well as the efficacy, safety
and cost-effectiveness of any competing products will determine in part the
availability and level of reimbursement. These third-party 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 healthcare reform, the cost of prescription pharmaceuticals and on the
reform of the Medicare and Medicaid systems. In certain countries, particularly
the countries of the European Union, the pricing of prescription pharmaceuticals
is subject to governmental control. In these countries, pricing negotiations
with governmental authorities can take six to twelve months or longer after the
receipt of regulatory marketing approval for a product. To obtain reimbursement
or pricing approval in some countries, we may be required to conduct clinical
trials that compare the cost-effectiveness of our product candidates to other
available therapies. If reimbursement for our product candidates were
unavailable or limited in scope or amount or if reimbursement levels or prices
are set at unsatisfactory levels, our projected and actual revenues and our
prospects for profitability would be negatively affected.
Another
development that may affect the pricing of drugs in the United States is
regulatory action regarding drug reimportation into the United States. The
Medicare Prescription Drug, Improvement and Modernization Act requires the
Secretary of the U.S. Department of Health and Human Services to promulgate
regulations allowing drug reimportation from Canada into the United States under
certain circumstances. These provisions will become effective only if the
Secretary certifies that such imports will pose no additional risk to the
public’s health and safety and result in significant cost savings to consumers.
Proponents of drug reimportation may also attempt to pass legislation that would
remove the requirement for the Secretary’s certification or allow reimportation
under circumstances beyond those anticipated under current law. If legislation
is enacted, or regulations issued, allowing the reimportation of drugs, it could
decrease the reimbursement we would receive for any product candidates that we
may commercialize, or require us to lower the price of our product candidates
then on the market that face competition from lower-priced supplies of that
product from other countries. These factors would negatively affect our
projected and actual revenues and our prospects for profitability.
We are
unable to predict what additional legislation or regulation, if any, relating to
the healthcare industry or third-party coverage and reimbursement may be enacted
in the future or what effect such legislation or regulation would have on our
business. Any cost containment measures or other healthcare system reforms that
are adopted could have a material adverse effect on our ability to commercialize
successfully any future products or could limit or eliminate our spending on
development projects and affect our ultimate profitability.
If
physicians and patients do not accept the product candidates that we may
develop, our ability to generate product revenue in the future will be adversely
affected.
Our
product candidates, if successfully developed and approved by the regulatory
authorities, may not gain market acceptance among physicians, healthcare payers,
patients and the medical community. Market acceptance of and demand for any
product candidate that we may develop will depend on many factors,
including:
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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 market entry relative to competitive
treatments;
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effectiveness
of our marketing and pricing strategy for any product candidates that we
may develop;
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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 related devices. Although
we have product liability and clinical trial liability insurance that we believe
is appropriate, this insurance is subject to deductibles and coverage
limitations. We may not be able to obtain or maintain adequate protection
against potential liabilities. If any of our product candidates 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 will
be exposed to significant liabilities, which may cause a loss of revenue or
otherwise harm our business. These liabilities could prevent or interfere with
our product commercialization efforts. Defending a suit, regardless of merit,
could be costly, could divert management attention and might result in adverse
publicity, injury to our reputation, or reduced acceptance of our product
candidates in the market. If we are sued for any injury caused by any future
products, our liability could exceed our total assets.
Our
operations involve hazardous materials and we must comply with environmental
laws and regulations, which can be expensive.
Our
research and development activities involve the controlled use of hazardous
materials, including chemicals and radioactive and biological materials. Our
operations also produce hazardous waste products. We are subject in the United
States to a variety of federal, state and local regulations, and in Europe to
European, national, state and local regulations, relating to the use, handling,
storage and disposal of these materials. We generally contract with third
parties for the disposal of such substances and store certain low-level
radioactive waste at our facility until the materials are no longer considered
radioactive. We cannot eliminate the risk of accidental contamination or injury
from these materials. We may be required to incur substantial costs to comply
with current or future environmental and safety regulations which could impose
greater compliance costs and increased risks and penalties associated with
violations. If an accident or contamination occurred, we would likely incur
significant costs associated with civil penalties or criminal fines, substantial
investigation and remediation costs, and costs associated with complying with
environmental laws and regulations. There can be no assurance that violations of
environmental laws or regulations will not occur in the future as a result of
the inability to obtain permits, human error, accident, equipment failure or
other causes. We do not have any insurance for liabilities arising from
hazardous materials. Compliance with environmental and safety laws and
regulations is expensive, and current or future environmental regulation may
impair our research, development or production efforts.
Risks
Relating to Our Intellectual Property and Litigation
We
may not be able to obtain or maintain adequate patents and other intellectual
property rights to protect our business and product candidates against
competitors.
Our value
will be significantly enhanced if we are able to obtain adequate patents and
other intellectual property rights to protect our business and product
candidates against competitors. For that reason, we allocate significant
financial and personnel resources to the filing, prosecution, maintenance and
defense of patent applications, patents and trademarks claiming or covering our
product candidates and key technology relating to these product
candidates.
To date,
we have sought to protect our proprietary positions related to our important
technology, inventions and improvements by filing patent applications in the
U.S., Europe and other jurisdictions. Because the patent position of
pharmaceutical and biopharmaceutical companies involves complex legal and
factual questions, the issuance, scope and enforceability of patents cannot be
predicted with certainty, and we cannot be certain that patents will be issued
on pending or future patent applications that cover our product candidates and
technologies. Claims could be restricted in prosecution that might lead to a
scope of protection which is of minor value for a particular product candidate.
Patents, if issued, may be challenged and sought to be invalidated by third
parties in litigation. In addition, U.S. patents and patent applications may
also be subject to interference proceedings, and U.S. patents may be subject to
reexamination proceedings in the U.S. Patent and Trademark Office. European
patents may be subject to opposition proceedings in the European Patent Office.
Patents might be invalidated in national jurisdictions. Similar proceedings may
be available in countries outside of Europe or the U.S. These proceedings could
result in either a loss of the patent or a denial of the patent application or
loss or reduction in the scope of one or more of the claims of the patent or
patent application. Thus, any patents that we own or license from others may not
provide any protection against competitors. Furthermore, an adverse decision in
an interference proceeding could result in a third party receiving the patent
rights sought by us, which in turn could affect our ability to market a
potential product or product candidate to which that patent filing was directed.
Our pending patent applications, those that we may file in the future, or those
that we may license from third parties may not result in patents being issued.
If issued, they may not provide us with proprietary protection or competitive
advantages against competitors with similar technology. Furthermore, others may
independently develop similar technologies or duplicate any technology that we
have developed, which fall outside the scope of our patents. Products or
technology could also be copied by competitors after expiration of the patent
life. Furthermore, claims of employees or former employees of Micromet related
to their inventorship or compensation pursuant to the German Act on Employees’
Inventions may lead to legal disputes.
We rely
on third-party payment services and external law firms for the payment of
foreign patent annuities and other fees. Non-payment or delay in payment of such
fees, whether intentional or unintentional, may result in loss of patents or
patent rights important to our business.
We
may incur substantial costs enforcing our patents against third parties. If we
are unable to protect our intellectual property rights, our competitors may
develop and market products with similar features that may reduce demand for our
potential products.
We own or
control a substantial portfolio of issued patents. From time to time, we may
become aware of third parties that undertake activities that infringe on our
patents. We may decide to grant those third parties a license under our patents,
or to enforce the patents against those third parties by pursuing an
infringement claim in litigation. If we initiate patent infringement litigation,
it could consume significant financial and management resources, regardless of
the merit of the claims or the outcome of the litigation. The outcome of patent
litigation is subject to uncertainties that cannot be adequately quantified in
advance, including the demeanor and credibility of witnesses and the identity of
the adverse party, especially in biotechnology-related patent cases that may
turn on the testimony of experts as to technical facts upon which experts may
reasonably disagree. Some of our competitors may be able to sustain the costs of
such litigation or proceedings more effectively than we can because of their
substantially greater financial resources. Uncertainties resulting from the
initiation and continuation of patent litigation or other proceedings could harm
our ability to compete in the marketplace.
Our
ability to enforce our patents may be restricted under applicable law. Many
countries, including certain countries in Europe, have compulsory licensing laws
under which a patent owner may be compelled to grant licenses to third parties.
For example, compulsory licenses may be required in cases where the patent owner
has failed to “work” the invention in that country, or the third-party has
patented improvements. In addition, many countries limit the enforceability of
patents against government agencies or government contractors. In these
countries, the patent owner may have limited remedies, which could materially
diminish the value of the patent. Moreover, the legal systems of certain
countries, particularly certain developing countries, do not favor the
aggressive enforcement of patent and other intellectual property rights, which
makes it difficult to stop infringement. In addition, our ability to enforce our
patent rights depends on our ability to detect infringement. It is difficult to
detect infringers who do not advertise the compounds that are used in their
products or the methods they use in the research and development of their
products. If we are unable to enforce our patents against infringers, it could
have a material adverse effect on our competitive position, results of
operations and financial condition.
If
we are not able to protect and control our unpatented trade secrets, know-how
and other technological innovation, we may suffer competitive harm.
We rely
on proprietary trade secrets and unpatented know-how to protect our research,
development and manufacturing activities and maintain our competitive position,
particularly when we do not believe that patent protection is appropriate or
available. However, trade secrets are difficult to protect. We attempt to
protect our trade secrets and unpatented know-how by requiring our employees,
consultants and advisors to execute confidentiality and non-use agreements. We
cannot guarantee that these agreements will provide meaningful protection, that
these agreements will not be breached, that we will have an adequate remedy for
any such breach, or that our trade secrets or proprietary know-how will not
otherwise become known or independently developed by a third party. Our trade
secrets, and those of our present or future collaborators that we utilize by
agreement, may become known or may be independently discovered by others, which
could adversely affect the competitive position of our product candidates. If
any trade secret, know-how or other technology not protected by a patent or
intellectual property right were disclosed to, or independently developed by a
competitor, our business, financial condition and results of operations could be
materially adversely affected.
If
third parties claim that our product candidates or technologies infringe their
intellectual property rights, we may become involved in expensive patent
litigation, which could result in liability for damages or require us to stop
our development and commercialization of our product candidates after they have
been approved and launched in the market, or we could be forced to obtain a
license and pay royalties under unfavorable terms.
Our
commercial success will depend in part on not infringing the patents or
violating the proprietary rights of third parties. Competitors or third parties
may obtain patents that may claim the composition, manufacture or use of our
product candidates, or the technology required to perform research and
development activities relating to our product candidates.
From time
to time we receive correspondence inviting us to license patents from third
parties. While we believe that our pre-commercialization activities fall within
the scope of an available exemption against patent infringement provided in the
United States by 35 U.S.C. § 271(e) and by similar research exemptions in
Europe, claims may be brought against us in the future based on patents held by
others. Also, we are aware of patents and other intellectual property rights of
third parties relating to our areas of practice, and we know that others have
filed patent applications in various countries that relate to several areas in
which we are developing product candidates. Some of these patent applications
have already resulted in patents and some are still pending. The pending patent
applications may also result in patents being issued. In addition, the
publication of patent applications occurs with a certain delay after the date of
filing, so we may not be aware of all relevant patent applications of third
parties at a given point in time. Further, publication of discoveries in the
scientific or patent literature often lags behind actual discoveries, so we may
not be able to determine whether inventions claimed in patent applications of
third parties have been made before or after the date on which inventions
claimed in our patent applications and patents have been made. All issued
patents are entitled to a presumption of validity in many countries, including
the United States and many European countries. Issued patents held by others may
therefore limit our freedom to operate unless and until these patents expire or
are declared invalid or unenforceable in a court of applicable jurisdiction. For
example, we are aware that GlaxoSmithKline holds a European patent covering the
administration of adecatumumab in combination with docetaxel, which is the
combination that we are currently testing in a phase 1b clinical trial. We have
filed an opposition proceeding against this patent with the European Patent
Office seeking to have the patent invalidated. We may not be successful in this
proceeding, and if it is not resolved in our favor, we could be required to
obtain a license under this patent from GlaxoSmithKline, which we may not be
able to obtain on commercially reasonable terms, if at all.
We and
our collaborators may not have rights under some patents that may cover the
composition of matter, manufacture or use of product candidates that we seek to
develop and commercialize, drug targets to which our product candidates bind, or
technologies that we use in our research and development activities. As a
result, our ability to develop and commercialize our product candidates may
depend on our ability to obtain licenses or other rights under these patents.
The third parties who own or control such patents may be unwilling to grant
those licenses or other rights to us or our collaborators under terms that are
commercially viable or at all. Third parties who own or control these patents
could bring claims based on patent infringement against us or our collaborators
and seek monetary damages and to enjoin further clinical testing, manufacturing
and marketing of the affected product candidates or products. There has been,
and we believe that there will continue to be, significant litigation in the
pharmaceutical industry regarding patent and other intellectual property rights.
If a third party sues us for patent infringement, it could consume significant
financial and management resources, regardless of the merit of the claims or the
outcome of the litigation.
If a
third party brings a patent infringement suit against us and we do not settle
the patent infringement suit and are not successful in defending against the
patent infringement claims, we could be required to pay substantial damages or
we or our collaborators could be forced to stop or delay research, development,
manufacturing or sales of the product or product candidate that is claimed by
the third 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, we could be prevented from
commercializing a product candidate, or forced to cease some aspect of our
business operations as a result of patent infringement claims, which could harm
our business.
Our
success depends on our ability to maintain and enforce our licensing
arrangements with various third party licensors.
We are
party to intellectual property licenses and agreements that are important to our
business, and we expect to enter into similar licenses and agreements in the
future. These licenses and agreements impose various research, development,
commercialization, sublicensing, milestone 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 otherwise breach obligations thereunder, our
licensors may terminate these agreements, we could lose licenses to intellectual
property rights that are important to our business and we 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, which could have a material adverse impact on our results of
operations.
If
licensees or assignees of our intellectual property rights breach any of the
agreements under which we have licensed or assigned our intellectual property to
them, we could be deprived of important intellectual property rights and future
revenue.
We are a
party to intellectual property out-licenses, collaborations and agreements that
are important to our business, and we expect to enter into similar agreements
with third parties in the future. Under these agreements, we license or transfer
intellectual property to third parties and impose various research, development,
commercialization, sublicensing, royalty, indemnification, insurance, and other
obligations on them. If a third party fails to comply with these requirements,
we generally retain the right to terminate the agreement and to bring a legal
action in court or in arbitration. In the event of breach, we may need to
enforce our rights under these agreements by resorting to arbitration or
litigation. During the period of arbitration or litigation, we may be unable to
effectively use, assign or license the relevant intellectual property rights and
may be deprived of current or future revenues that are associated with such
intellectual property, which could have a material adverse effect on our results
of operations and financial condition.
We
may be subject to damages resulting from claims that we or our employees have
wrongfully used or disclosed alleged trade secrets of their former
employers.
Many of
our employees were previously employed at other biotechnology or pharmaceutical
companies, including our competitors or potential competitors. Although no
claims against us are currently pending, we may be subject to claims that these
employees or we have inadvertently or otherwise used or disclosed trade secrets
or other proprietary information of their former employers. Litigation may be
necessary to defend against these claims. Even if we are successful in defending
against these claims, litigation could result in substantial costs and be a
distraction to management. If we fail in defending such claims, in addition to
paying money claims, we may lose valuable intellectual property rights or
personnel. A loss of key personnel or their work product could hamper or prevent
our ability to commercialize certain product candidates.
Risks
Relating to Manufacturing and Sales of Products
We
depend on our collaborators and third-party manufacturers to produce most, if
not all, of our product candidates and if these third parties do not
successfully manufacture these product candidates, 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. The
manufacture of our product candidates may be complex, difficult to accomplish
and difficult to scale-up when large-scale production is required. Manufacture
may be subject to delays, inefficiencies and poor or low yields of quality
products. The cost of manufacturing our product candidates may make them
prohibitively expensive. If supplies of any of our product candidates or related
materials become unavailable on a timely basis or at all or are contaminated or
otherwise lost, clinical trials by us and our collaborators could be seriously
delayed. This is due to the fact that such materials are time-consuming to
manufacture and cannot be readily obtained from third-party
sources.
Product
candidates used in clinical trials or sold after marketing approval has been
obtained must be manufactured in accordance with current good manufacturing
practices regulations. There are a limited number of manufacturers that operate
under these regulations, including the FDA’s and EMEA’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, the EMEA, and other regulatory agencies or
authorities, to ensure strict compliance with current good manufacturing
practices and other governmental regulations and standards. A failure of
third-party manufacturers to follow current good manufacturing practices or
other regulatory requirements and to document their adherence to such practices
may lead to significant delays in the availability of product candidates for use
in a clinical trial or for commercial sale, the termination of, or hold on, a
clinical trial, or may delay or prevent filing or approval of marketing
applications for our product candidates. In addition, as a result of such a
failure, we could be subject to sanctions, including fines, injunctions and
civil penalties, refusal or delays by regulatory authorities to grant marketing
approval of our product candidates, suspension or withdrawal of marketing
approvals, seizures or recalls of product candidates, operating restrictions and
criminal prosecutions, any of which could significantly and adversely affect our
business.
To the
extent that we or our collaborators seek to enter into manufacturing
arrangements with third parties, we and such collaborators will depend upon
these third parties to perform their obligations in a timely and effective
manner and in accordance with government regulations. Contract manufacturers may
breach their manufacturing agreements because of factors beyond our control or
may terminate or fail to renew a manufacturing agreement based on their own
business priorities at a time that is costly or inconvenient for us. If
third-party manufacturers fail to perform their obligations, our competitive
position and ability to generate revenue may be adversely affected in a number
of ways, including:
|
•
|
we
and our collaborators may not be able to initiate or continue clinical
trials of product candidates that are under
development;
|
|
•
|
we
and our collaborators may be delayed in submitting applications for
regulatory approvals for our product candidates;
and
|
|
•
|
we
and our collaborators may not be able to meet commercial demands for any
approved products.
|
If we
were required to change manufacturers, it may require additional clinical trials
and the revalidation of the manufacturing process and procedures in accordance
with applicable current good manufacturing practices and may require FDA or EMEA
approval. This revalidation may be costly and time-consuming. If we are unable
to arrange for third-party manufacturing of our product candidates, or to do so
on commercially reasonable terms, we may not be able to complete development or
marketing of our product candidates.
We
have no sales, marketing or distribution experience and will depend
significantly on third parties who may not successfully sell our product
candidates following approval.
We have
no sales, marketing or product distribution experience. If we receive required
regulatory approvals to market any of our product candidates, we plan to rely
primarily on sales, marketing and distribution arrangements with third parties,
including our collaborators. For example, as part of our agreements with Merck
Serono, MedImmune, Nycomed and TRACON, we have granted these companies the right
to market and distribute products resulting from such collaborations, if any are
ever successfully developed. We may have to enter into additional marketing
arrangements in the future and we may not be able to enter into these additional
arrangements on terms that are favorable to us, if at all. In addition, we may
have limited or no control over the sales, marketing and distribution activities
of these third parties, and sales through these third parties could be less
profitable to us than direct sales. These third parties could sell competing
products and may devote insufficient sales efforts to our product candidates
following approval. As a result, our future revenues from sales of our product
candidates, if any, will be materially dependent upon the success of the efforts
of these third parties.
We may
seek to co-promote products with our collaborators, or to independently market
products that are not already subject to marketing agreements with other
parties. If we determine to perform sales, marketing and distribution functions
ourselves, then we could face a number of additional risks,
including:
|
•
|
we
may not be able to attract and build an experienced marketing staff or
sales force;
|
|
•
|
the
cost of establishing a marketing staff or sales force may not be
justifiable in light of the revenues generated by any particular
product;
|
|
•
|
our
direct sales and marketing efforts may not be successful;
and
|
|
•
|
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.
Submission of Matters to a Vote of Security Holders
On June 17, 2009, we held an annual
meeting of our stockholders. The proxy materials related to the
meeting were distributed on or about May 8, 2009. As of the
record date of April 29, 2009, 50,924,347 shares of our common stock were
outstanding and entitled to vote at the meeting. Of these shares,
39,222,235 shares were present at the meeting in person or by proxy,
representing approximately 77% of our outstanding shares of common
stock.
The following sets forth the matters
presented for a vote by the stockholders and the votes cast for, withheld,
abstained, and broker non-votes:
Matter
|
|
|
|
Votes
For
|
|
|
Votes
Against
|
|
|
Votes
Withheld
|
|
|
Abstentions
|
|
|
Broker
Non-Votes
|
|
(1)
|
|
Election
of David Hale as a Class III director with a term serving until the 2012
Annual Meeting
|
|
|
39,133,063 |
|
|
|
— |
|
|
|
89,172 |
|
|
|
— |
|
|
|
— |
|
(2)
|
|
Election
of Michael Carter as a Class III director with a term serving until the
2012 Annual Meeting
|
|
|
38,969,495 |
|
|
|
— |
|
|
|
252,740 |
|
|
|
— |
|
|
|
— |
|
(3)
|
|
Election
of John Berriman as a Class III director with a term serving until the
2012 Annual Meeting
|
|
|
38,948,081 |
|
|
|
— |
|
|
|
274,154 |
|
|
|
— |
|
|
|
— |
|
(4)
|
|
Ratification
of the appointment of Ernst & Young LLP as our independent registered
public accounting firm for the current fiscal year
|
|
|
37,041,613 |
|
|
|
49,241 |
|
|
|
— |
|
|
|
139,564 |
|
|
|
— |
|
Item 5.
Other Information
None.
Item 6. Exhibits
Exhibit
Number
|
|
Description
|
|
|
|
3.1(1)
|
|
Amended
and Restated Certificate of Incorporation of the
Registrant
|
|
|
|
3.2(2)
|
|
Certificate
of Amendment of the Amended and Restated Certificate of Incorporation of
the Registrant
|
|
|
|
3.3(3)
|
|
Certificate
of Designations for Series A Junior Participating Preferred Stock of the
Registrant
|
|
|
|
3.4(4)
|
|
Amended
and Restated Bylaws effective October 3, 2007
|
|
|
|
10.1(#)
|
|
Non-Employee
Director Compensation Policy
|
|
|
|
31.1
|
|
Certification
of Principal Executive Officer pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange Act of 1934
|
|
|
|
31.2
|
|
Certification
of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange Act of 1934
|
|
|
|
32(*)
|
|
Certifications
of Principal Executive Officer and Principal Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of
2002
|
__________
|
|
(1)
|
Incorporated
by reference from the Registrant’s Quarterly Report on Form 10-Q
filed with the SEC on December 11, 2003
|
|
|
(2)
|
Incorporated
by reference from the Registrant’s Quarterly Report on Form 10-Q
filed with the SEC on May 10, 2006
|
|
|
(3)
|
Incorporated
by reference from the Registrant’s Current Report on Form 8-K filed
with the SEC on November 8, 2004
|
|
|
(4)
|
Incorporated
by reference from the Registrant’s Current Report on Form 8-K filed
with the SEC on October 9, 2007
|
|
|
#
|
Indicates
management contract or compensatory plan.
|
*
|
These
certifications are being furnished solely to accompany this annual report
pursuant to 18 U.S.C. Section 1350, and are not being filed for
purposes of Section 18 of the Securities Exchange Act of 1934 and are
not to be incorporated by reference into any filing of the Registrant,
whether made before or after the date hereof, regardless of any general
incorporation language in such
filing
|
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:
August 6, 2009
|
Micromet,
Inc.
|
|
|
|
|
|
|
|
|
By:
|
/s/
Barclay A. Phillips
|
|
|
|
|
Barclay
A. Phillips
|
|
|
|
|
Senior
Vice President and Chief Financial Officer
|
|
|
|
|
(Duly
authorized officer and Principal Financial Officer)
|
|
|
Exhibit List
Exhibit
Number
|
|
Description
|
|
|
|
3.1(1)
|
|
Amended
and Restated Certificate of Incorporation of the
Registrant
|
|
|
|
3.2(2)
|
|
Certificate
of Amendment of the Amended and Restated Certificate of Incorporation of
the Registrant
|
|
|
|
3.3(3)
|
|
Certificate
of Designations for Series A Junior Participating Preferred Stock of the
Registrant
|
|
|
|
3.4(4)
|
|
Amended
and Restated Bylaws effective October 3, 2007
|
|
|
|
10.1(#)
|
|
Non-Employee
Director Compensation Policy
|
|
|
|
31.1
|
|
Certification
of Principal Executive Officer pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange Act of 1934
|
|
|
|
31.2
|
|
Certification
of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14
promulgated under the Securities Exchange Act of 1934
|
|
|
|
32(*)
|
|
Certifications
of Principal Executive Officer and Principal Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of
2002
|
__________
|
|
(1)
|
Incorporated
by reference from the Registrant’s Quarterly Report on Form 10-Q
filed with the SEC on December 11, 2003
|
|
|
(2)
|
Incorporated
by reference from the Registrant’s Quarterly Report on Form 10-Q
filed with the SEC on May 10, 2006
|
|
|
(3)
|
Incorporated
by reference from the Registrant’s Current Report on Form 8-K filed
with the SEC on November 8, 2004
|
|
|
(4)
|
Incorporated
by reference from the Registrant’s Current Report on Form 8-K filed
with the SEC on October 9, 2007
|
#
|
Indicates
management contract or compensatory plan.
|
|
|
*
|
These
certifications are being furnished solely to accompany this annual report
pursuant to 18 U.S.C. Section 1350, and are not being filed for
purposes of Section 18 of the Securities Exchange Act of 1934 and are
not to be incorporated by reference into any filing of the Registrant,
whether made before or after the date hereof, regardless of any general
incorporation language in such
filing
|