As filed
with the Securities and Exchange Commission on December 8, 2008
Registration
No. 333-
UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, DC
20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF
1933
MICROMET, INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or Other Jurisdiction of Incorporation or
Organization)
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52-2243564
(I.R.S.
Employer Identification No.)
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6707 Democracy Blvd., Suite 505
Bethesda, MD
20817
(240) 752-1420
(Address,
including zip code, and telephone number,
including
area code, of Registrant’s principal executive offices)
Barclay A.
Phillips
Senior Vice President and Chief
Financial Officer
Micromet, Inc.
6707 Democracy Blvd., Suite 505
Bethesda, MD
20817
(240) 752-1420
(Name,
address, including zip code, and telephone number,
including
area code, of agent for service)
Copies
to:
Matthias Alder,
Esq.
Senior Vice President, General
Counsel and
Corporate
Secretary
Micromet, Inc.
6707 Democracy Blvd., Suite
505
Bethesda, Maryland
20817
(240)
752-1420
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Christian E. Plaza,
Esq.
Brian F. Leaf,
Esq.
Cooley Godward Kronish
LLP
One Freedom Square, Reston Town
Center
11951 Freedom
Drive
Reston, VA
20190-5656
(703) 456-8000
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Approximate date of commencement of
proposed sale to the public:
From time
to time after the effective date of this registration statement
If the
only securities being registered on this form are being offered pursuant to
dividend or interest reinvestment plans, please check the following box.
o
If any of
the securities being registered on this form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other
than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. þ
If this
form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. ¨
If this
form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. ¨
If this
Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. ¨
If this
Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box. ¨
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 o
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Accelerated filer þ
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Non-accelerated filer o
(Do not check if a smaller reporting
company)
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Smaller reporting
company þ
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CALCULATION OF REGISTRATION
FEE
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Proposed
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Maximum
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Proposed Maximum
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Amount of
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Amount to be
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Offering Price
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Aggregate Offering
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Registration
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Title of Each Class of Securities To Be Registered
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Registered(1)
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Per Share (2)
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Price(2)
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Fee
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Common
Stock, par value $0.00004, including associated Series A Junior
Participating Preferred Stock Purchase Rights
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10,524,109
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(3)
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$
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4.08
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$
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42,938,364.72
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$
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1,687.48
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(1) This
amount represents shares to be offered by the selling stockholder from time to
time after the effective date of this Registration Statement at prevailing
market prices at time of sale. Pursuant to Rule 416 under the Securities
Act, the shares being registered hereunder include such indeterminate number of
shares of common stock as may be issuable with respect to the shares being
registered hereunder as a result of stock splits, stock dividends or similar
transactions.
(2) Estimated
solely for the purpose of calculating the registration fee in accordance with
Rule 457(c) under the Securities Act. The price per share and aggregate offering
price are based on the average of the high and low sales prices of the
registrant’s common stock on December 3, 2008, as reported on the Nasdaq Global
Market.
(3) Includes
420,000 shares of common stock that may be issued upon the exercise of
warrants.
The registrant hereby amends this
registration statement on such date or dates as may be necessary to delay its
effective date until the registrant shall file a further amendment which
specifically states that this registration statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act of 1933 or until
the registration statement shall become effective on such date as the Securities
and Exchange Commission, acting pursuant to said Section 8(a), may
determine.
Subject to Completion, Dated December
8, 2008
The information in this prospectus is
not complete and may be changed. The selling stockholder may not sell these
securities until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to sell these
securities and is not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
PROSPECTUS
10,524,109 Shares of Common
Stock
This
prospectus relates to the resale of up to 10,524,109 shares of our common stock
that we may issue to the selling stockholder listed in the section beginning on
page 28 of this prospectus. The shares of common stock offered under this
prospectus by the selling stockholder are issuable to Kingsbridge Capital
Limited, or Kingsbridge, pursuant to a common stock purchase agreement between
Micromet, Inc. and Kingsbridge, dated December 1, 2008 and warrants we issued to
Kingsbridge on that date and on August 30, 2006. We are not selling any
securities under this prospectus and will not receive any of the proceeds from
the sale of shares by the selling stockholder.
The
selling stockholder, or its donees, pledgees, transferees or successors,
may sell the shares of common stock described in this prospectus from time to
time in a number of different ways and at varying prices determined at the time
of sale or at negotiated prices. We provide more information about how the
selling stockholder may sell its shares of common stock in the section titled
“Plan of Distribution” on page 29. We will not be paying any underwriting
discounts or commissions in this offering.
The
common stock is traded on the NASDAQ Global Market under the symbol “MITI.” On
December 5, 2008 the reported closing price of the common stock was $4.19 per
share.
An investment in the shares offered
hereby involves a high degree of risk. See “Risk Factors” beginning on page 8 of
this prospectus.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of
these securities or passed upon the adequacy or accuracy of this prospectus. Any
representation to the contrary is a criminal offense.
The date of this prospectus is
____________, 2008.
TABLE OF CONTENTS
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Page
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PROSPECTUS
SUMMARY
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2
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RISK
FACTORS
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8
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FORWARD-LOOKING
STATEMENTS
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27
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USE OF
PROCEEDS
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27
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SELLING
STOCKHOLDER
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28
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PLAN OF
DISTRIBUTION
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29
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LEGAL
MATTERS
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31
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EXPERTS
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31
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WHERE YOU CAN FIND MORE
INFORMATION
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31
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ABOUT THIS
PROSPECTUS
You
should rely only on the information contained or incorporated by reference in
this prospectus. We have not, and the selling stockholder has not, authorized
anyone to provide you with information different from that contained in this
prospectus. The selling stockholder is offering to sell, and seeking offers to
buy, shares of our common stock only in jurisdictions where it is lawful to do
so. The selling stockholder should not make an offer of these shares in any
state where the offer is not permitted. Brokers or dealers should confirm the
existence of an exemption from registration or effect a registration in
connection with any offer and sale of these shares.
The
information in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or any sale of
our common stock.
You
should read this prospectus together with the additional information described
under the heading “Where You Can Find More Information.”
PROSPECTUS
SUMMARY
This summary highlights information
contained elsewhere or incorporated by reference into this prospectus. Because
it is a summary, it does not contain all of the information that you should
consider before investing in our securities. You should read this entire
prospectus carefully, including the section entitled “Risk Factors” and the
documents that we incorporate by reference into this prospectus, before making
an investment decision.
MICROMET, INC.
We are a
biopharmaceutical company developing novel, proprietary antibodies for the
treatment of cancer, inflammation and autoimmune diseases. Four of our
antibodies are currently in clinical trials, while the remainder of our product
pipeline is in preclinical development. Blinatumomab, also known as MT103 and
MEDI-538, the most advanced antibody in our product pipeline developed using our
BiTE® antibody technology platform, is being evaluated in a phase 2 clinical
trial for the treatment of patients with acute lymphoblastic leukemia and in a
phase 1 clinical trial for the treatment of patients with non-Hodgkin’s
lymphoma. BiTE antibodies represent a new class of antibodies that activate a
patient’s own cytotoxic T cells, considered the most powerful “killer cells” of
the human immune system, to eliminate cancer cells. We are developing
blinatumomab in collaboration with MedImmune, Inc., a subsidiary of AstraZeneca
plc. MT110, our second BiTE antibody in clinical development, is being evaluated
in a phase 1 clinical trial for the treatment of patients with lung or
gastrointestinal cancer. Our third clinical stage antibody is adecatumumab, also
known as MT201, a human monoclonal antibody that targets epithelial cell
adhesion molecule, or EpCAM-expressing solid tumors. We are developing
adecatumumab in collaboration with Merck Serono in a phase 1b clinical trial
evaluating adecatumumab in combination with docetaxel for the treatment of
patients with metastatic breast cancer. Our fourth clinical stage antibody is
MT293, which is licensed to TRACON and is being developed in a phase 1 clinical
trial for the treatment of patients with cancer. We have additional BiTE
antibodies that are in different stages of preclinical development and that
target CEA, CD33, Her2, EGFR, and MCSP. In addition, we have established a
collaboration with Nycomed for the development and commercialization of 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. To date, we have incurred significant research
and development expenses and have not achieved any product revenues from sales
of our product candidates.
Each of
our programs will require many years and significant costs to advance through
development. Typically it takes many years from the initial identification of a
lead compound to the completion of preclinical and clinical trials, before
applying for marketing approval from the United States Food and Drug
Administration, or FDA, or European Medicines Agency, or EMEA, or equivalent
regulatory agencies. The risk that a program has to be terminated, in part or in
full, for safety reasons or lack of adequate efficacy, is very high. In
particular, we cannot predict which, if any, of our potential product candidates
will be successfully developed or approved, nor can we predict the time and cost
to complete development.
As we
obtain results from preclinical studies or clinical trials, we may elect to
discontinue the development for certain product candidates for safety, efficacy
or commercial reasons. We may also elect to discontinue development of one or
more product candidates in order to focus our resources on more promising
product candidates. Our business strategy includes entering into collaborative
agreements with third parties for the development and commercialization of our
product candidates. Depending on the structure of such collaborative agreements,
a third party may be granted control over the clinical trial process for one of
our product candidates. In such a situation, the third party, rather than us,
may 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, debt financing, and government grants for research, as well as
licensing fees, milestone payments and research-contribution revenues from our
collaborations with pharmaceutical companies, and, more recently, through
private placements of common stock and associated warrants. We intend to
continue to seek funding through public or private financings in the future. If
we are successful in raising additional funds through the issuance of equity
securities, stockholders may experience substantial dilution including as a
result of issuing warrants in connection with the financing, or the equity
securities may have rights, preferences or privileges senior to existing
stockholders. If we are successful in raising additional funds through debt
financings, these financings may involve significant cash payment obligations
and covenants that restrict our ability to operate our business. There can be no
assurance that we will be successful in raising additional capital on acceptable
terms, or at all.
Our
principal executive offices are located at 6707 Democracy Blvd., Suite 505,
Bethesda, MD 20817, and our main telephone number is (240) 752-1420. Our Web
site is located on the world wide web at http://www.micromet-inc.com. We do not
incorporate by reference into this prospectus the information on, or accessible
through, our Web site, and you should not consider it as part of this
prospectus.
EQUITY FINANCING FACILITY WITH
KINGSBRIDGE
On
December 1, 2008, we entered into a committed equity financing facility, or
CEFF, with Kingsbridge, pursuant to which Kingsbridge committed to purchase,
subject to certain conditions, up to $75 million of our common stock. In
connection with the CEFF, we entered into a common stock purchase agreement and
registration rights agreement with Kingsbridge, both dated December 1, 2008, and
on that date we also issued a warrant to Kingsbridge to purchase 135,000 shares
of our common stock at an exercise price of $4.44 per share. This warrant is
exercisable beginning on the six-month anniversary of the date of issuance of
the warrant and, subject to the terms of the warrant, will remain exercisable
for a period of five years thereafter. On August 30, 2006, in connection with a
prior $25 million committed equity financing facility with Kingsbridge, we
issued a warrant to Kingsbridge to purchase 285,000 shares of our common stock
at an exercise price of $3.2145 per share. The new CEFF with Kingsbridge will
replace the August 2006 facility, and the $75 million maximum amount of the new
CEFF will be reduced by any amounts drawn down on the August 2006 facility prior
to the effective date of the registration statement of which this prospectus
forms a part. To date, we have not drawn down any amounts under the August 2006
facility with Kingsbridge.
The 2008
common stock purchase agreement entitles us to sell and obligates Kingsbridge to
purchase, from time to time over a period through December 1, 2011, shares of
our common stock for cash consideration up to an aggregate of $75 million,
subject to certain conditions and restrictions. The shares of common stock that
may be issued to Kingsbridge under the common stock purchase agreement and the
two warrants described in the foregoing paragraph will be issued pursuant to an
exemption from registration under the Securities Act of 1933, as amended, or the
Securities Act. Pursuant to the registration rights agreement, we have filed a
registration statement of which this prospectus is a part, covering the possible
resale by Kingsbridge of any shares that we may issue to Kingsbridge under the
common stock purchase agreement or upon exercise of the warrants. Through this
prospectus, the selling stockholder may offer to the public for resale shares of
our common stock that we may issue to Kingsbridge pursuant to the common stock
purchase agreement, or that Kingsbridge may acquire upon exercise of the
warrants. Upon the effectiveness of the registration statement of which this
prospectus forms a part, the August 2006 facility will terminate
and we will deregister the resale of any shares covered by our
September 2006 registration statement that have not been drawn down under the
August 2006 facility, as well as any shares underlying the August 2006 warrant.
However, the resale of the shares of common stock underlying the August
2006 warrant will continue to be covered by the registration statement of which
this prospectus forms a part.
Following
the effectiveness of the registration statement of which this prospectus is a
part and until December 1, 2011, we may, from time to time, at our discretion,
and subject to certain conditions that we must satisfy, draw down funds under
the CEFF by selling shares of our common stock to Kingsbridge. The purchase
price of these shares will be at a discount of up to 14% from the volume
weighted average price of our common stock for each of the eight trading days
following our election to sell shares, or “draw down” under the CEFF. The
discount on each of these eight trading days will be determined as
follows:
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PERCENT OF
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(APPLICABLE
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VWAP*
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VWAP
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DISCOUNT)
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Greater
than $10.00 per share
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94
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%
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(6
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)%
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Greater
than $8.00 per share but less than or equal to $10.00 per
share
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92
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%
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(8
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)%
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Greater
than $4.35 per share but less than or equal to $8.00 per
share
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90
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%
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(10
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)%
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Greater
than $2.50 per share but less than or equal to $4.35 per
share
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88
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%
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(12
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)%
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Greater
than $2.00 per share but less than or equal to $2.50 per
share
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86
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%
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(14
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)%
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As set
forth in the common stock purchase agreement, “VWAP” means the volume weighted
average price (the aggregate sales price of all trades of our common stock
during each trading day divided by the total number of shares of common stock
traded during that trading day) of our common stock during any trading day as
reported by Bloomberg, L.P. using the AQR function. The VWAP and corresponding
discount will be determined for each of the eight trading days during a draw
down pricing period.
During
the eight trading day pricing period for a draw down, if the VWAP for any one
trading day is less than the greater of (i) $2.00 or (ii) 85% of the
closing price of our common stock on the trading day immediately preceding the
beginning of the draw down period, the VWAP for that trading day will not be
used in calculating the number of shares to be issued in connection with that
draw down, and the draw down amount for that pricing period will be reduced by
one-eighth of the draw down amount initially specified. In addition, if trading
in our common stock is suspended for any reason for more than three consecutive
or non-consecutive hours during any trading day during a draw down pricing
period, that trading day will not be used in calculating the number of shares to
be issued in connection with that draw down, and the draw down amount for that
pricing period will be reduced by one-eighth of the draw down amount initially
specified.
The
maximum number of shares of common stock that we can issue pursuant to the CEFF
is 10,104,109 shares, although this maximum will be reduced by any shares issued
to Kingsbridge under our August 2006 facility prior to the effective date of the
registration statement of which this prospectus forms a part. An additional
135,000 shares of common stock are issuable if Kingsbridge exercises the warrant
that we issued to it in connection with Kingsbridge’s entry into the CEFF, and a
further 285,000 shares of common stock are issuable if Kingsbridge exercises a
warrant that we issued to Kingsbridge in August 2006 in connection with the
August 2006 facility. We intend to exercise our right to draw down amounts
under the CEFF, if and to the extent available, at such times as we have a need
for additional capital and when we believe that sales of stock under the CEFF
provide an appropriate means of raising capital.
Our
ability to require Kingsbridge to purchase our common stock is subject to
various limitations. We can make draw downs up to the greater of 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 our common stock on the
trading day prior to the draw down notice, or a specified percentage of our
market capitalization 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). If either of the foregoing calculations yields a draw down amount in
excess of $10.0 million, then the individual draw down amount is limited to
$10.0 million. Unless we and Kingsbridge agree otherwise, a minimum of ten
trading days must elapse between the expiration of any draw down pricing period
and the beginning of the next succeeding draw down pricing period.
During
the term of the CEFF, without the prior written consent of Kingsbridge, we may
not (i) issue any rights, warrants or options to subscribe for or purchase our
common stock, or any other securities directly or indirectly convertible into or
exchangeable or exercisable into shares of our common stock, at an effective
conversion, exchange or exercise price that varies or may vary with or is
otherwise issuable in relation to the market price of our common stock,
including by way of one or more resets to any fixed price; (ii) make any
“at-the-market offering” (as defined in Rule 415(a)(4) under the Securities
Act or any successor rule thereto) of our securities, other than (A) a
customary, firm-commitment underwritten public offering or (B) an
unregistered private placement of our common stock where the price per share of
such common stock is fixed upon the signing of definitive documentation of the
sale, but not afterwards; or (iii) enter into any equity line or other form
of financing that is substantially similar to the arrangement provided for in
the CEFF. We refer to each such transaction described in this paragraph as a
Prohibited Transaction.
The
issuance of our common stock under the CEFF or upon exercise of the Kingsbridge
warrant will have no effect on the rights or privileges of existing holders of
common stock except that the economic and voting interests of each stockholder
will be diluted as a result of the issuance. Although the number of shares of
common stock that stockholders presently own will not decrease, these shares
will represent a smaller percentage of our total shares that will be outstanding
after any issuances of shares of common stock to Kingsbridge. 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. Such
issuances will have a dilutive effect and may further decrease our stock
price.
Kingsbridge
agreed in the common stock purchase agreement that during the term of the CEFF,
neither Kingsbridge nor any of its affiliates, nor any entity managed or
controlled by it, will enter into any short sale of any shares of our common
stock or engage, through related parties or otherwise, in any derivative
transaction directly related to shares of our common stock. In addition,
Kingsbridge agreed that neither Kingsbridge nor any of its affiliates, nor any
entity managed or controlled by it, will sell during any draw down pricing
period any shares of our common stock, other than shares of our common stock
purchased (or to be purchased) during that draw down pricing
period.
Before
Kingsbridge is obligated to buy any shares of our common stock pursuant to a
draw down, the following conditions, none of which is in the control of
Kingsbridge, must be met as of the draw down exercise date and the date upon
which each settlement of the purchase and sale of our common stock
occurs:
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Each
of our representations and warranties in the common stock purchase
agreement must be true and correct in all material respects as of the date
when made as though made at that time, except for representations and
warranties that are expressly made as of a particular
date.
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·
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We
must have performed, satisfied and complied in all material respects with
all covenants, agreements and conditions required by the common stock
purchase agreement, the registration rights agreement and the 2008 Warrant
to be performed, satisfied or complied with by
us.
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·
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We
must have complied in all respects with all applicable federal, state and
local governmental laws, rules, regulations and ordinances in connection
with the execution, delivery and performance of the common stock purchase
agreement and the consummation of the transactions contemplated by it,
except for any failure to so comply which could not reasonably be expected
to have a material adverse effect on
us.
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The
registration statement, which includes this prospectus, shall have
previously become effective and shall remain
effective.
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We
shall not have knowledge of any event that could reasonably be expected to
have the effect of causing the registration statement of which this
prospectus is a part to be suspended or otherwise
ineffective.
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Trading
in our common stock shall not have been suspended by the Securities and
Exchange Commission, or the SEC, the Nasdaq Stock Market or the Financial
Industry Regulatory Authority and trading in securities generally on the
Nasdaq Stock Market shall not have been suspended or
limited.
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·
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No
statute, rule, regulation, executive order, decree, ruling or injunction
shall have been enacted, entered, promulgated or endorsed by any court or
governmental authority which prohibits the consummation of any of the
transactions contemplated by the common stock purchase
agreement.
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·
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No
action, suit or proceeding before any arbitrator or any governmental
authority shall have been commenced, and no investigation by any
governmental authority shall have been threatened, against us or any of
our officers, directors or affiliates seeking to enjoin, prevent or
challenge the transactions contemplated by the common stock purchase
agreement.
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·
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We
shall have sufficient shares of common stock, calculated using the closing
trade price of the common stock as of the trading day immediately
preceding a draw down, registered under the registration statement of
which this prospectus is a part to issue and sell such shares in
accordance with such draw down.
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·
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The
warrant to purchase 135,000 shares of our common stock shall have been
duly executed, delivered and issued to Kingsbridge, and we shall not be in
default in any material aspect under the
warrant.
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·
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We
shall be current on all undisputed expense invoices that we are required
to pay under Section 10.01 of the common stock purchase
agreement.
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There is
no guarantee that we will be able to meet the foregoing conditions or any other
conditions under the common stock purchase agreement or that we will be able to
draw down any portion of the amounts available under the CEFF. We may terminate
the CEFF on one business day’s notice to Kingsbridge at any time, except that we
may not terminate the CEFF during a draw down pricing period. In addition,
Kingsbridge has the right to terminate the CEFF on one business day’s notice to
us in the event that:
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·
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we
enter into a Prohibited
Transaction;
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·
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the
registration statement, of which this prospectus is a part, is not
declared effective on or before May 30,
2009;
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·
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after
the first twelve-month period of the CEFF we fail to make cumulative draw
downs of at least $1,250,000 during any consecutive twelve-month period;
or
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·
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we
breach a material representation, warranty or covenant under the common
stock purchase agreement, which is not remedied within ten business days
after notice of such breach is delivered to us by
Kingsbridge.
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We also
entered into a registration rights agreement with Kingsbridge, dated December 1,
2008. Pursuant to the registration rights agreement, we have filed a
registration statement, which includes this prospectus, with the SEC relating to
the resale by Kingsbridge of any shares of common stock purchased by Kingsbridge
under the common stock purchase agreement or issued to Kingsbridge as a result
of the exercise of the warrants issued to Kingsbridge in August 2006 and
December 2008. The effectiveness of this registration statement is a condition
precedent to our ability to sell common stock to Kingsbridge under the common
stock purchase agreement. We are entitled in certain circumstances, including
the existence of certain kinds of nonpublic information, to deliver a “blackout”
notice to Kingsbridge to suspend the use of this prospectus and prohibit
Kingsbridge from selling shares under this prospectus. If we deliver a blackout
notice in the 15 trading days following a settlement of a draw down, or if the
registration statement of which this prospectus is a part is not effective in
circumstances not permitted by the registration rights agreement, then we must
pay certain amounts to Kingsbridge (or issue Kingsbridge additional shares in
lieu of payment) as liquidated damages. In addition, in the event that we
deliver a blackout notice at any time on or after the date that we issue a draw
down notice, each subsequent trading day during the applicable draw down pricing
period will be disregarded, subject to waiver by Kingsbridge, for purposes of
calculating the number of shares to be drawn down, and the draw down amount for
that pricing period will be reduced by one-eighth of the draw down amount
initially specified for each trading day that is so disregarded.
The
foregoing summary of the CEFF does not purport to be complete and is qualified
by reference to the common stock purchase agreement, the registration rights
agreement and the warrant, copies of which have been filed as exhibits to our
current report on Form 8-K filed with the SEC on December 2, 2008, which report
has been incorporated by reference into this prospectus.
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 prospectus and the information
incorporated herein by reference 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. You should also consider all other information contained in or
incorporated by reference in this prospectus before deciding to invest in our
common stock.
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 the inception of Micromet through September 30, 2008, 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, 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:
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continued
progress in our research and development programs, as well as the scope of
these programs;
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our
ability to establish and maintain collaborative arrangements for the
discovery, research or development of our product
candidates;
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the
timing, receipt and amount of research funding and milestone, license,
royalty and other payments, if any, from
collaborators;
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the
timing, receipt and amount of sales revenues and associated royalties to
us, if any, from our product candidates in the
market;
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our
ability to sell shares of our common stock under our August 2006 CEFF with
Kingsbridge and, upon termination of that facility, our December 2008 CEFF
with Kingsbridge;
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the
costs of preparing, filing, prosecuting, maintaining, defending and
enforcing patent claims and other patent-related costs, including
litigation costs and technology license
fees;
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costs
associated with
litigation; and
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competing
technological and market
developments.
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We filed
a shelf registration statement, declared effective by the SEC in
December 2004, under which we could have raised up to $80 million
through the sale of our common stock. This shelf registration statement became
inactive in March 2006 and expired in December 2008. We may seek to
file a new shelf registration statement, although our ability to do so will
depend on our eligibility to use a shelf registration statement at such time,
under applicable SEC rules. We expect to seek additional funding through public
or private financings or from new collaborators with whom we enter into research
or development collaborations with respect to programs that are not currently
licensed. However, the market for stock of companies in the biotechnology sector
in general, and the market for our common stock in particular, is highly
volatile. Due to market conditions and the status of our product development
pipeline, additional funding may not be available to us on acceptable terms, or
at all. Having insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or to relinquish
greater or all rights to product candidates at an earlier stage of development
or on less favorable terms than we would otherwise choose. Failure to obtain
adequate financing also may adversely affect our ability to operate as a going
concern.
If we
raise additional funds through the issuance of equity securities, our
stockholders may experience substantial dilution, 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 August
2006, we entered into a CEFF with Kingsbridge. The 2006 CEFF entitled us to sell
and obligated Kingsbridge to purchase, from time to time until September 2009,
shares of our common stock for cash consideration up to an aggregate of
$25 million, subject to certain conditions and restrictions. To date,
we have not made any draw downs under the 2006 CEFF.
In
December 2008, we entered into a new CEFF with Kingsbridge. Upon the
effectiveness of the registration statement of which this prospectus forms a
part, the August 2006 CEFF will terminate. The new CEFF entitles us to sell
and obligates Kingsbridge to purchase, from time to time until December 1, 2011,
shares of our common stock for cash consideration up to an aggregate of
$75 million, subject to certain conditions and restrictions. Kingsbridge
will not be obligated to purchase shares under the CEFF unless certain
conditions are met, which include:
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a
minimum price for our common stock that is not less than 85% of the
closing price of the day immediately preceding the applicable eight-day
pricing period, but in no event less than $2.00 per
share;
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the
accuracy of representations and warranties made to
Kingsbridge;
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our
compliance with all applicable laws which, if we failed to so comply,
would have a Material Adverse Effect (as that term is defined in the
purchase agreement with
Kingsbridge); and
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the
effectiveness of a registration statement registering for resale the
shares of common stock to be issued in connection with the
CEFF.
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Kingsbridge
is permitted to terminate the CEFF by providing written notice to us upon the
occurrence of certain events. For example, we are only eligible to draw down
funds under the CEFF at such times as our stock price is above $2.00 per share.
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:
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the
status of development of our product
candidates;
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the
time at which we enter into research and license agreements with strategic
collaborators that provide for payments to us, and the timing and
accounting treatment of payments to us, if any, under those
agreements;
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whether
or not we achieve specified research, development or commercialization
milestones under any agreement that we enter into with strategic
collaborators and the timely payment by these collaborators of any amounts
payable to us;
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the
addition or termination of research programs or funding support under
collaboration agreements;
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the
timing of milestone payments under license agreements, repayments of
outstanding amounts under loan agreements, and other payments that we may
be required to make to others;
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variations
in the level of research and development expenses related to our clinical
or preclinical product candidates during any given
period;
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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
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general
market conditions affecting companies with our risk profile and market
capitalization.
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These
factors may cause the price of our stock to fluctuate substantially. We believe
that quarterly comparisons of our financial results are not necessarily
meaningful and should not be relied upon as an indication of our future
performance.
If the estimates we make and the
assumptions on which we rely in preparing our financial statements prove
inaccurate, our actual results may vary
significantly.
Our
financial statements have been prepared in accordance with generally accepted
accounting principles in the United States. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported
amounts of our assets, liabilities, revenues and expenses, the amounts of
charges taken by us and related disclosure. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances. We cannot assure you that our estimates, or the
assumptions underlying them, will be correct. Accordingly, our actual financial
results may vary significantly from the estimates contained in our financial
statements.
Changes in, or interpretations of,
accounting rules and regulations could result in unfavorable accounting charges
or require us to change our compensation policies.
Accounting
methods and policies for biopharmaceutical companies, including policies
governing revenue recognition, research and development and related expenses,
accounting for stock options and in-process research and development costs are
subject periodically to further review, interpretation and guidance from
relevant accounting authorities, including the SEC. Changes to, or
interpretations of, accounting methods or policies in the future may require us
to reclassify, restate or otherwise change or revise our financial statements,
including those contained in this filing.
Our operating and financial
flexibility, including our ability to borrow money, is limited by certain debt
arrangements.
Our loan
agreements contain certain customary events of default, which generally include,
among others, non-payment of principal and interest, violation of covenants,
cross defaults, the occurrence of a material adverse change in our ability to
satisfy our obligations under our loan agreements or with respect to one of our
lenders’ security interest in our assets and in the event we are involved in
certain insolvency proceedings. Upon the occurrence of an event of default, our
lenders may be entitled to, among other things, accelerate all of our
obligations and sell our assets to satisfy our obligations under our loan
agreements. In addition, in an event of default, our outstanding obligations may
be subject to increased rates of interest.
In
addition, we may incur additional indebtedness from time to time to finance
acquisitions, investments or strategic alliances or capital expenditures or for
other purposes. Our level of indebtedness could have negative consequences for
us, including the following:
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our
ability to obtain additional financing, if necessary, for working capital,
capital expenditures, acquisitions or other purposes may be impaired or
such financing may not be available on favorable
terms;
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payments
on our indebtedness will reduce the funds that would otherwise be
available for our operations and future business
opportunities;
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we
may be more highly leveraged than our competitors, which may place us at a
competitive disadvantage; and
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our
debt level may reduce our flexibility in responding to changing business
and economic conditions.
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We have determined and further
received an opinion from our independent registered public accounting firm in
connection with our year-end audit for 2007 that our system of internal control
over financial reporting does not meet the requirements of Section 404 of
the Sarbanes-Oxley Act of 2002. As a result, investors could lose confidence in
the reliability of our internal control over financial reporting, which could
have a material adverse effect on our stock price.
As a
publicly traded company, we are required to comply with the Sarbanes-Oxley Act
of 2002, or Sarbanes-Oxley, and the related rules and regulations of the SEC,
including Section 404 of Sarbanes-Oxley. We are in the process of upgrading
our existing, and implementing additional, procedures and controls.
Our
internal control system is designed to provide reasonable assurance to our
management and board of directors regarding the preparation and fair
presentation of published financial statements. In connection with the audit of
our consolidated financial statements for the year ended December 31, 2007,
our independent registered public accounting firm provided us with an
unqualified opinion on our consolidated financial statements, but it identified
material weaknesses in our internal control over financial reporting based on
criteria established in “Internal Control — Integrated Framework,” issued
by the Committee of Sponsoring Organizations, or COSO, of the Treadway
Commission. These material weaknesses relate to certain of our accrual processes
and an insufficient level of management review in our financial statement close
and reporting process. Because of these material weaknesses in our internal
control over financial reporting, there is heightened risk that a material
misstatement of our annual or quarterly financial statements will not be
prevented or detected.
We are in
the process of expanding our internal resources and implementing additional
procedures in order to remediate these material weaknesses in our internal
control over financial reporting; however, we cannot guarantee that these
efforts will be successful. If we do not adequately remedy these material
weaknesses, and if we fail to maintain proper and effective internal control
over financial reporting in future periods, our ability to provide timely and
reliable financial results could suffer, and investors could lose confidence in
our reported financial information, which may have a material adverse effect on
our stock price.
Risks Relating to Our Common
Stock
Substantial sales of shares may
adversely impact the market price of our common stock and our ability to issue
and sell shares in the future.
Substantially
all of the outstanding shares of our common stock are eligible for resale in the
public market. A significant portion of these shares is held by a small number
of stockholders. We have also registered shares of our common stock that we may
issue under our equity incentive compensation plans and our employee stock
purchase plan. 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, a number of which we cannot control. Among the
factors that could cause material fluctuations in the market price for our
common stock are:
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our
ability to upgrade and implement our disclosure controls and our internal
control over financial reporting;
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our
ability to successfully raise capital to fund our continued
operations;
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our
ability to successfully develop our product candidates within acceptable
timeframes;
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changes
in the regulatory status of our product
candidates;
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changes
in significant contracts, strategic collaborations, new technologies,
acquisitions, commercial relationships, joint ventures or capital
commitments;
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the
execution of new collaboration agreements or termination of existing
collaborations related to our clinical or preclinical product candidates
or our BiTE antibody technology
platform;
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announcements
of the invalidity of, or litigation relating to, our key intellectual
property;
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announcements
of the achievement of milestones in our agreements with collaborators or
the receipt of payments under those
agreements;
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announcements
of the results of clinical trials by us or by companies with commercial
products or product candidates in the same therapeutic category as our
product candidates;
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events
affecting our collaborators;
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fluctuations
in stock market prices and trading volumes of similar
companies;
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announcements
of new products or technologies, clinical trial results, commercial
relationships or other events by us, our collaborators or our
competitors;
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our
ability to successfully complete strategic collaboration arrangements with
respect to our product candidates;
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variations
in our quarterly operating results;
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changes
in securities analysts’ estimates of our financial performance or product
development timelines;
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changes
in accounting principles;
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sales
of large blocks of our common stock, including sales by our executive
officers, directors and significant
stockholders;
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additions
or departures of key
personnel; and
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discussions
of Micromet or our stock price by the financial and scientific press and
online investor communities such as chat
rooms.
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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 24% 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. 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 such collaborative and licensing arrangements will depend on, among
other things, such 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 such changes, our
collaborators decrease or fail to increase spending related to such
product candidates, or decide to discontinue the development of our
product candidates and terminate their collaboration or license agreement
with us. In 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 potential termination of the
collaboration agreement, or we may need to reallocate financial resources
that may cause delays in other development programs for our other product
candidates.
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We may not be successful in
establishing additional strategic collaborations, which could adversely affect
our ability to develop and commercialize product
candidates.
As an
integral part of our ongoing research and development efforts, we periodically
review opportunities to establish new collaborations for development and
commercialization of new BiTE antibodies or existing product candidates in our
development pipeline. We face significant competition in seeking appropriate
collaborators and the negotiation process is time-consuming and complex. We may
not be successful in our efforts to establish additional collaborations or other
alternative arrangements. Even if we are successful in our efforts to establish
a collaboration, the terms of the agreement may not be favorable to us. Finally,
such collaborations or other arrangements may not result in successful products
and associated revenue from milestone payments, royalties or profit share
payments.
If the combination of adecatumumab
(MT201) with cytotoxics, such as docetaxel, is not tolerable or safe, if higher
serum levels of adecatumumab cannot be administered safely, or if sufficient
anti-tumor activity cannot be shown, we and our collaborator Merck Serono may
decide to abandon all or part of the development program, and we could
experience a material adverse impact on our business
prospects.
We
previously have reported that the phase 2 clinical trials of adecatumumab
did not reach their respective primary endpoint in patients with metastatic
breast cancer (clinical benefit rate at week 24) and in patients with
prostate cancer (mean change in prostate specific antigen, compared to placebo
control). We have also reported that we are continuing the development of
adecatumumab in a clinical trial in combination with docetaxel with escalating
doses of adecatumumab to investigate the tolerability and the safety of this
combination. If the combination of adecatumumab with docetaxel proves not to be
tolerable or safe or if no higher serum levels of adecatumumab compared to
previous clinical trials can be administered safely or if sufficient anti-tumor
activity cannot be shown in this or future clinical trials, we and our
collaborator Merck Serono may decide to abandon all or part of the development
program of adecatumumab and as a result we may experience a material adverse
impact on our business prospects.
There can be no assurance that our
current continuous infusion phase 1 clinical trial of blinatumomab (MT103)
will establish a dose that is safe and tolerable.
We are
conducting a phase 1 dose finding clinical trial designed to evaluate the
safety and tolerability of a continuous intravenous infusion of blinatumomab
over 4-8 weeks at different dose levels in patients with relapsed
non-Hodgkin’s lymphoma. We have seen objective tumor responses at the 15
µg/m2 and
above per day dose level with the continuous infusion regimens. While this
preliminary data suggest that blinatumomab has anti-tumor activity, there can be
no assurance that we will not encounter unacceptable adverse events during the
continued dose escalation of our ongoing, continuous-infusion phase 1
clinical trial or that the preliminary suggestion of anti-tumor activity will be
confirmed during the ongoing or any future study.
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.
The
process of successfully developing product candidates for the treatment of human
diseases is very time-consuming, expensive and unpredictable and there is a high
rate of failure for product candidates in preclinical development and in
clinical trials. The preclinical studies and clinical trials may produce
negative, inconsistent or inconclusive results, and the results from early
clinical trials may not be statistically significant or predictive of results
that will be obtained from expanded, advanced clinical trials. Further, we or
our collaborators may decide, or the FDA, EMEA or other regulatory authorities
may require us, to conduct preclinical studies or clinical trials or other
development activities in addition to those performed or planned by us or our
collaborators, which may be expensive or could delay the time to market for our
product candidates. In addition, we do not know whether the clinical trials will
result in marketable products.
All of
our product candidates are in early stages of clinical and 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.
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.
Because
our product candidates may have different efficacy profiles in certain clinical
indications, sub-indications or patient profiles, an election by us or our
collaborators to focus on a particular indication, sub-indication or patient
profile may result in a failure to capitalize on other potentially profitable
applications of our product candidates.
Our
product candidates may not be effective in treating any of our targeted 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.
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 certain
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 other than those imposed by the FDA and EMEA, and we
or our collaborators may not be able to comply with these regulations. Any
non-compliance could subject us or our collaborators to penalties and otherwise
result in the limitation of our or our collaborators’
operations.
In
addition to regulations imposed by the FDA, EMEA and other health regulatory
authorities, we and our collaborators are subject to regulation under the
Occupational Safety and Health Act, the Environmental Protection Act, the Toxic
Substances Control Act, the Research Conservation and Recovery Act, as well as
regulations administered by the Nuclear Regulatory Commission, national
restrictions on technology transfer, import, export and customs regulations and
certain other local, state or federal regulations, or their counterparts in
Europe and other countries. From time to time, other governmental agencies and
legislative or international governmental bodies have indicated an interest in
implementing further regulation of biotechnology applications. We are not able
to predict whether any such regulations will be adopted or whether, if adopted,
such regulations will apply to our or our collaborators’ business, or whether we
or our collaborators would be able to comply, without incurring unreasonable
expense, or at all, with any applicable regulations.
Our growth could be limited if we
are unable to attract and retain key personnel and
consultants.
We have
limited experience in filing and prosecuting regulatory applications to obtain
marketing approval from the FDA, EMEA or other regulatory authorities. Our
success depends on the ability to attract, train and retain qualified scientific
and technical personnel, including consultants, to further our research and
development efforts. The loss of services of one or more of our key employees or
consultants could have a negative impact on our business and operating results.
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. 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. 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 payors continually
attempt to contain or reduce the costs of healthcare by challenging the prices
charged for healthcare products and services. Given recent federal and state
government initiatives directed at lowering the total cost of healthcare in the
United States, the U.S. Congress and state legislatures will likely
continue to focus on healthcare reform, the cost of prescription pharmaceuticals
and on the reform of the Medicare and Medicaid systems. In certain countries,
particularly the countries of the European Union, the pricing of prescription
pharmaceuticals is subject to governmental control. In these countries, pricing
negotiations with governmental authorities can take six to twelve months or
longer after the receipt of regulatory marketing approval for a product. To
obtain reimbursement or pricing approval in some countries, we may be required
to conduct clinical trials that compare the cost-effectiveness of our product
candidates to other available therapies. If reimbursement for our product
candidates were unavailable or limited in scope or amount or if reimbursement
levels or prices are set at unsatisfactory levels, our projected and actual
revenues and our prospects for profitability would be negatively
affected.
Another
development that may affect the pricing of drugs in the United States is
regulatory action regarding drug reimportation into the United States. The
Medicare Prescription Drug, Improvement and Modernization Act, 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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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 and 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 distribution 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 are approved for
marketing, we may seek additional insurance coverage. If we are unable to obtain
insurance at acceptable cost or on acceptable terms with adequate coverage or
otherwise protect ourselves against potential product liability claims, we will
be exposed to significant liabilities, which may 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
proprietary technology, inventions and improvements by filing of patent
applications in the U.S., Europe and other jurisdictions. Because the patent
position of pharmaceutical and biopharmaceutical companies involves complex
legal and factual questions, the issuance, scope and enforceability of patents
cannot be predicted with certainty, and we cannot be certain that patents will
be issued on pending or future patent applications that cover our product
candidates and technologies. Claims could be restricted in prosecution that
might lead to a scope of protection which is of minor value for a particular
product candidate. Patents, if issued, may be challenged and sought to be
invalidated by third parties in litigation. In addition, U.S. patents and
patent applications may also be subject to interference proceedings, and
U.S. patents may be subject to reexamination proceedings in the
U.S. Patent and Trademark Office. European patents may be subject to
opposition proceedings in the European Patent Office. Patents might be
invalidated in national jurisdictions. Similar proceedings may be available in
countries outside of Europe or the U.S. These proceedings could result in
either a loss of the patent or a denial of the patent application or loss or
reduction in the scope of one or more of the claims of the patent or patent
application. Thus, any patents that we own or license from others may not
provide any protection against competitors. Furthermore, an adverse decision in
an interference proceeding could result in a third party receiving the patent
rights sought by us, which in turn could affect our ability to market a
potential product or product candidate to which that patent filing was directed.
Our pending patent applications, those that we may file in the future, or those
that we may license from third parties may not result in patents being issued.
If issued, they may not provide us with proprietary protection or competitive
advantages against competitors with similar technology. Furthermore, others may
independently develop similar technologies or duplicate any technology that we
have developed, which fall outside the scope of our patents. Products or
technology could also be copied by competitors after expiration of the patent
life. Furthermore, claims of employees or former employees of Micromet related
to their inventorship or compensation pursuant to the German Act on Employees’
Inventions may lead to legal disputes.
We rely
on third-party payment services and external law firms for the payment of
foreign patent annuities and other fees. Non-payment or delay in payment of such
fees, whether intentional or unintentional, may result in loss of patents or
patent rights important to our business.
We may incur substantial costs
enforcing our patents against third parties. If we are unable to protect our
intellectual property rights, our competitors may develop and market products
with similar features that may reduce demand for our potential
products.
We own or
control a substantial portfolio of issued patents. From time to time, we may
become aware of third parties that undertake activities that infringe on our
patents. We may decide to grant those third parties a license under our patents,
or to enforce the patents against those third parties by pursuing an
infringement claim in litigation. If we initiate patent infringement litigation,
it could consume significant financial and management resources, regardless of
the merit of the claims or the outcome of the litigation. The outcome of patent
litigation is subject to uncertainties that cannot be adequately quantified in
advance, including the demeanor and credibility of witnesses and the identity of
the adverse party, especially in biotechnology-related patent cases that may
turn on the testimony of experts as to technical facts upon which experts may
reasonably disagree. Some of our competitors may be able to sustain the costs of
such litigation or proceedings more effectively than we can because of their
substantially greater financial resources. Uncertainties resulting from the
initiation and continuation of patent litigation or other proceedings could harm
our ability to compete in the marketplace.
Our
ability to enforce our patents may be restricted under applicable law. Many
countries, including certain countries in Europe, have compulsory licensing laws
under which a patent owner may be compelled to grant licenses to third parties.
For example, compulsory licenses may be required in cases where the patent owner
has failed to “work” the invention in that country, or the third-party has
patented improvements. In addition, many countries limit the enforceability of
patents against government agencies or government contractors. In these
countries, the patent owner may have limited remedies, which could materially
diminish the value of the patent. Moreover, the legal systems of certain
countries, particularly certain developing countries, do not favor the
aggressive enforcement of patent and other intellectual property rights, which
makes it difficult to stop infringement. In addition, our ability to enforce our
patent rights depends on our ability to detect infringement. It is difficult to
detect infringers who do not advertise the compounds that are used in their
products or the methods they use in the research and development of their
products. If we are unable to enforce our patents against infringers, it could
have a material adverse effect on our competitive position, results of
operations and financial condition.
If we are not able to protect and
control our unpatented trade secrets, know-how and other technological
innovation, we may suffer competitive harm.
We rely
on proprietary trade secrets and unpatented know-how to protect our research,
development and manufacturing activities and maintain our competitive position,
particularly when we do not believe that patent protection is appropriate or
available. However, trade secrets are difficult to protect. We attempt to
protect our trade secrets and unpatented know-how by requiring our employees,
consultants and advisors to execute confidentiality and non-use agreements. We
cannot guarantee that these agreements will provide meaningful protection, that
these agreements will not be breached, that we will have an adequate remedy for
any such breach, or that our trade secrets or proprietary know-how will not
otherwise become known or independently developed by a third party. Our trade
secrets, 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 taxotere,
which is the combination that we are currently testing in a phase 1 study. We
have filed an opposition proceeding against this patent with the European Patent
Office seeking to have the patent invalidated. We may not be successful in this
proceeding, and if it is not resolved in our favor, we could be required to
obtain a license under this patent from 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 will be available on acceptable terms or at all.
Even if we or our collaborators were able to obtain a license, the rights may be
nonexclusive, which would give our competitors access to the same intellectual
property. Ultimately, we could be prevented from commercializing a product
candidate, or forced to cease some aspect of our business operations as a result
of patent infringement claims, which could harm our business.
Our success depends on our ability
to maintain and enforce our licensing arrangements with various third party
licensors.
We are
party to intellectual property licenses and agreements that are important to our
business, and we expect to enter into similar 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 our business will be harmed.
We have
no manufacturing experience or manufacturing capabilities for the production of
our product candidates for clinical trials or commercial sale. In order to
continue to develop product candidates, apply for regulatory approvals, and
commercialize our product candidates following approval, we or our collaborators
must be able to manufacture or contract with third parties to manufacture our
product candidates in clinical and commercial quantities, in compliance with
regulatory requirements, at acceptable costs and in a timely manner. The
manufacture of our product candidates may be complex, difficult to accomplish
and difficult to scale-up when large-scale production is required. Manufacture
may be subject to delays, inefficiencies and poor or low yields of quality
products. The cost of manufacturing our product candidates may make them
prohibitively expensive. If supplies of any of our product candidates or related
materials become unavailable on a timely basis or at all or are contaminated or
otherwise lost, clinical trials by us and our collaborators could be seriously
delayed. This is due to the fact that such materials are time-consuming to
manufacture and cannot be readily obtained from third-party
sources.
To the
extent that we or our collaborators seek to enter into manufacturing
arrangements with third parties, we and such collaborators will depend upon
these third parties to perform their obligations in a timely and effective
manner and in accordance with government regulations. Contract manufacturers may
breach their manufacturing agreements because of factors beyond our control or
may terminate or fail to renew a manufacturing agreement based on their own
business priorities at a time that is costly or inconvenient for us. If
third-party manufacturers fail to perform their obligations, our competitive
position and ability to generate revenue may be adversely affected in a number
of ways, including:
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we
and our collaborators may not be able to initiate or continue clinical
trials of product candidates that are under
development;
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we
and our collaborators may be delayed in submitting applications for
regulatory approvals for our product
candidates; and
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we
and our collaborators may not be able to meet commercial demands for any
approved products.
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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:
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we
may not be able to attract and build an experienced marketing staff or
sales force;
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the
cost of establishing a marketing staff or sales force may not be
justifiable in light of the revenues generated by any particular
product;
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our
direct sales and marketing efforts may not be successful;
and
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we
may face competition from other products or sales forces with greater
resources than our own sales force.
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CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
Any
statements in this prospectus 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 ability to draw down under the CEFF and the
availability of financing generally, the efficacy, safety and intended
utilization of our product candidates, the conduct and results of future
clinical trials, plans regarding regulatory filings, future research and
clinical trials and plans regarding partnering activities, and our goal of
monitoring our internal controls for financial reporting and making
modifications as necessary. You can 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,” “expect,” “deem,” “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 and 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; our ability to
establish and maintain strategic collaborations or to otherwise obtain
additional financing to support our operations; competition from other
pharmaceutical or biotechnology companies; successful administration of our
business and financial reporting capabilities, including the successful
remediation of material weaknesses in our internal control our financial
reporting; and other risks detailed in the discussions set forth above
under the caption “Risk Factors” and as discussed in our Annual Report on
Form 10-K for the year ended December 31, 2007 filed with the SEC on March 14,
2008 and our Quarterly Reports on Form 10-Q for the quarters ended March
31, 2008, June 30, 2008 and September 30, 2008 filed with the SEC on May 9,
2008, August 8, 2008 and November 6, 2008, respectively.
USE OF PROCEEDS
We
will not receive any of the proceeds from the sale of shares of our common stock
by the selling stockholder pursuant to this prospectus. Any sale of shares by us
to Kingsbridge under the common stock purchase agreement or in connection with
the exercise of the Kingsbridge warrants will be made pursuant to an exemption
from the registration requirements of the Securities Act. We will use the
proceeds from these sales and warrant exercises for general corporate purposes,
including clinical trials, production and supply activities, research and
development activities, regulatory affairs expenses and general and
administrative expenses. The amounts and timing of our actual expenditures will
depend on numerous factors, such as the progress of our product development and
commercialization efforts and the amount of cash used by our operations. We may
also use a portion of the net proceeds to acquire or invest in businesses,
products and technologies that are complementary to our own, although we
currently are not planning or negotiating any such transactions. As of the date
of this prospectus, we cannot specify with certainty all of the particular uses
for the net proceeds to us from the sale of shares to Kingsbridge. Accordingly,
we will retain broad discretion over the use of these proceeds, if
any.
SELLING
STOCKHOLDER
This
prospectus relates to the possible resale by the selling stockholder,
Kingsbridge, of shares of common stock that we may issue pursuant to the common
stock purchase agreement we entered into with Kingsbridge on December 1, 2008,
or upon exercise of the warrants that we issued to Kingsbridge on August 30,
2006 and December 1, 2008. We have filed the registration statement of which
this prospectus is a part with the SEC pursuant to the provisions of the
registration rights agreement we entered into with Kingsbridge.
The
selling stockholder may from time to time offer and sell pursuant to this
prospectus any or all of the shares that it acquires under the common stock
purchase agreement or upon exercise of the warrants.
The
following table presents information regarding Kingsbridge, as the selling
stockholder, and the shares that it may offer and sell from time to time under
this prospectus. This table is prepared based on information supplied to us by
the selling stockholder, and reflects holdings as of December 8, 2008. As used
in this prospectus, the term “selling stockholder” includes Kingsbridge and any
donees, pledges, transferees or other successors in interest selling shares
received after the date of this prospectus from a selling stockholder as a gift,
pledge, or other non-sale related transfer. The number of shares in the column
“Number of Shares Being Offered” represents all of the shares that the
selling stockholder may offer under this prospectus. The selling stockholder may
sell some, all or none of its shares. We do not know how long the selling
stockholder will hold the shares before selling them, and we currently have no
agreements, arrangements or understandings with the selling stockholder
regarding the sale of any of the shares.
The
percentage of shares of common stock beneficially owned prior to the offering
shown in the table below is based both on an aggregate of 50,718,791 shares of
our common stock outstanding on December 8, 2008, and on the assumption that all
shares of common stock issuable under the common stock purchase agreement with
Kingsbridge and all shares of common stock issuable upon exercise of the warrant
are outstanding as of that date.
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Shares of Common Stock
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Number of
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Shares of Common Stock
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Beneficially Owned
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Shares Being
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Beneficially Owned
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Prior to Offering
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Offered
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After Offering
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Stockholder
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Number
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Percent
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Number
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Percent
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Kingsbridge
Capital Limited(1)
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10,524,109
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(2)
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17.2
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%
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10,524,109
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0
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*
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* Less than
one percent.
(1) The
business address of Kingsbridge Capital Limited is Attention: Tony Hillman, PO
Box 1075, Elizabeth House, 9 Castle Street, St Helier, Jersey, JE42QP, Channel
Islands.
(2) Consists
of 10,104,919 shares of common stock, the maximum number of shares of common
stock issuable under the common stock purchase agreement we entered into with
Kingsbridge on December 1, 2008, 285,000 shares of common stock issuable upon
exercise of the warrant we issued to Kingsbridge on August 30, 2006, and
135,000 shares of common stock issuable upon exercise of the warrant we issued
to Kingsbridge on December 1, 2008, which 2008 warrant is not exercisable until
June 1, 2009. For the purposes hereof, we assume the issuance of all 10,524,919
shares. Maria O’Donoghue, Adam Gurney and Tony Hillman have shared voting and
investment control of the securities held by Kingsbridge.
PLAN OF
DISTRIBUTION
We
are registering 10,524,109 shares of common stock under this prospectus on
behalf of Kingsbridge. Except as described below, to our knowledge, the selling
stockholder has not entered into any agreement, arrangement or understanding
with any particular broker or market maker with respect to the shares of common
stock offered hereby, nor, except as described below, do we know the identity of
the brokers or market makers that will participate in the sale of the
shares.
The
selling stockholder may decide not to sell any shares. The selling stockholder
may from time to time offer some or all of the shares of common stock through
brokers, dealers or agents who may receive compensation in the form of
discounts, concessions or commissions from the selling stockholder and/or the
purchasers of the shares of common stock for whom they may act as agent. In
effecting sales, broker-dealers that are engaged by the selling stockholder may
arrange for other broker-dealers to participate. Kingsbridge is an “underwriter”
within the meaning of the Securities Act. Any brokers, dealers or agents who
participate in the distribution of the shares of common stock may also be deemed
to be “underwriters,” and any profits on the sale of the shares of common stock
by them and any discounts, commissions or concessions received by any such
brokers, dealers or agents may be deemed to be underwriting discounts and
commissions under the Securities Act. Kingsbridge has advised us that it may
effect resales of our common stock through any one or more registered
broker-dealers. To the extent the selling stockholder may be deemed to be an
underwriter, the selling stockholder will be subject to the prospectus delivery
requirements of the Securities Act and may be subject to certain statutory
liabilities of, including but not limited to, Sections 11, 12 and 17 of the
Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as
amended, or the Exchange Act.
The
selling stockholder will act independently of us in making decisions with
respect to the timing, manner and size of each sale. Such sales may be made over
the Nasdaq Stock Market, on the over-the-counter market, otherwise, or in a
combination of such methods of sale, at then prevailing market prices, at prices
related to prevailing market prices or at negotiated prices. The shares of
common stock may be sold according to one or more of the following
methods:
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a
block trade in which the broker or dealer so engaged will attempt to sell
the shares of common stock as agent but may position and resell a portion
of the block as principal to facilitate the
transaction;
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purchases
by a broker or dealer as principal and resale by such broker or dealer for
its account pursuant to this
prospectus;
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an
over-the-counter distribution in accordance with the rules of the
Financial Industry Regulatory
Authority;
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ordinary
brokerage transactions and transactions in which the broker solicits
purchasers;
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privately
negotiated transactions;
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a
combination of such methods of sale;
and
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any
other method permitted pursuant to applicable
law.
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Any
shares covered by this prospectus which qualify for sale pursuant to
Rule 144 of the Securities Act may be sold under Rule 144 rather than
pursuant to this prospectus. In addition, the selling stockholder may transfer
the shares by other means not described in this prospectus.
Any
broker-dealer participating in such transactions as agent may receive
commissions from Kingsbridge (and, if they act as agent for the purchaser of
such shares, from such purchaser). Broker-dealers may agree with Kingsbridge to
sell a specified number of shares at a stipulated price per share, and, to the
extent such a broker-dealer is unable to do so acting as agent for Kingsbridge,
to purchase as principal any unsold shares at the price required to fulfill the
broker-dealer commitment to Kingsbridge. Broker-dealers who acquire shares as
principal may thereafter resell such shares from time to time in transactions
(which may involve crosses and block transactions and which may involve sales to
and through other broker-dealers, including transactions of the nature described
above) on the Nasdaq Stock Market, on the over-the-counter market, in
privately-negotiated transactions or otherwise at market prices prevailing at
the time of sale or at negotiated prices, and in connection with such resales
may pay to or receive from the purchasers of such shares commissions computed as
described above. To the extent required under the Securities Act, an amendment
to this prospectus, or a supplemental prospectus will be filed,
disclosing:
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the
name of any such broker-dealers;
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the
number of shares involved;
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the
price at which such shares are to be
sold;
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the
commission paid or discounts or concessions allowed to such
broker-dealers, where applicable;
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that
such broker-dealers did not conduct any investigation to verify the
information set out or incorporated by reference in this prospectus, as
supplemented; and
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other
facts material to the transaction.
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Underwriters
and purchasers that are deemed underwriters under the Securities Act may engage
in transactions that stabilize, maintain or otherwise affect the price of the
securities, including the entry of stabilizing bids or syndicate covering
transactions or the imposition of penalty bids. Kingsbridge and any other
persons participating in the sale or distribution of the shares will be subject
to the applicable provisions of the Exchange Act and the rules and regulations
thereunder including, without limitation, Regulation M. These provisions
may restrict certain activities of, and limit the timing of, purchases by the
selling stockholder or other persons or entities. Furthermore, under
Regulation M, persons engaged in a distribution of securities are
prohibited from simultaneously engaging in market making and certain other
activities with respect to such securities for a specified period of time prior
to the commencement of such distributions, subject to special exceptions or
exemptions. Regulation M may restrict the ability of any person engaged in
the distribution of the securities to engage in market-making and certain other
activities with respect to those securities. In addition, the anti-manipulation
rules under the Exchange Act may apply to sales of the securities in the market.
All of these limitations may affect the marketability of the shares and the
ability of any person to engage in market-making activities with respect to the
securities.
We
have agreed to pay the expenses of registering the shares of common stock under
the Securities Act, including registration and filing fees, printing expenses,
administrative expenses and certain legal and accounting fees, as well as
certain fees of counsel for the selling stockholder incurred in the preparation
of the CEFF agreements and the registration statement of which this prospectus
forms a part. The selling stockholder will bear all discounts, commissions or
other amounts payable to underwriters, dealers or agents, as well as transfer
taxes and certain other expenses associated with the sale of
securities.
Under
the terms of the Kingsbridge common stock purchase agreement and the
registration rights agreement, we have agreed to indemnify the selling
stockholder and certain other persons against certain liabilities in connection
with the offering of the shares of common stock offered hereby, including
liabilities arising under the Securities Act or, if such indemnity is
unavailable, to contribute toward amounts required to be paid in respect of such
liabilities.
At
any time a particular offer of the shares of common stock is made, a revised
prospectus or prospectus supplement, if required, will be distributed. Such
prospectus supplement or post-effective amendment will be filed with the SEC, to
reflect the disclosure of required additional information with respect to the
distribution of the shares of common stock. We may suspend the sale of shares by
the selling stockholder pursuant to this prospectus for certain periods of time
for certain reasons, including if the prospectus is required to be supplemented
or amended to include additional material information.
LEGAL MATTERS
The
validity of the securities being offered hereby will be passed upon by Cooley
Godward Kronish LLP, Reston, Virginia.
EXPERTS
The
consolidated financial statements of Micromet, Inc. appearing in Micromet,
Inc.’s Annual Report on Form 10-K for the year ended December 31, 2007, and the
effectiveness of Micromet, Inc.’s internal control over financial reporting as
of December 31, 2007, have been audited by Ernst & Young AG WPG, independent
registered public accounting firm, as set forth in their reports thereon (which
conclude, among other things, that Micromet, Inc. did not maintain effective
internal control over financial reporting as of December 31, 2007, based on
Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission, because of the effects of the material
weaknesses described therein), included therein, and incorporated herein by
reference. Such consolidated financial statements have been incorporated herein
by reference in reliance upon such reports given on the authority of such firm
as experts in accounting and auditing.
WHERE YOU CAN FIND MORE
INFORMATION
We
file electronically with the SEC our annual reports on Form 10-K, quarterly
interim reports on Form 10-Q, current reports on Form 8-K, and amendments to
those reports filed or furnished pursuant to Section 13(a) or 15(d) of the
Exchange Act. We make available on or through our website, free of charge,
copies of these reports as soon as reasonably practicable after we
electronically file or furnish it to the SEC. You can also request copies of
such documents by contacting our Investor Relations Department at (240) 235-0250
or sending an email to investors@micromet-inc.com. You may read and copy any
document we file at the SEC’s Public Reference Room at 100 F Street, N.E.,
Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for more
information about the operation of the Public Reference Room. The SEC maintains
an Internet site that contains reports, proxy and information statements, and
other information regarding issuers that file electronically with the SEC,
including Micromet. The SEC’s Internet site can be found at http://www.sec.gov.
Except as
set forth below, the SEC file number for the documents incorporated by reference
in this prospectus is 0-50440. We incorporate by reference the following
information that has been filed with the SEC:
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our
current report on Form 8-K filed with the SEC on March 13, 2008 (except
for the information furnished under Item 2.02 or any related
exhibit);
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our
annual report on Form 10-K for the year ended December 31, 2007 filed with
the SEC on March 14, 2008;
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our
current report on Form 8-K filed with the SEC on March 31,
2008;
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our
definitive proxy statement for our 2008 annual meeting of stockholders
filed with the SEC on April 29, 2008 and additional definitive materials
filed on the same date;
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our
current report on Form 8-K filed with the SEC on May 8, 2008 (except for
the information furnished under Item 2.02 or any related
exhibit);
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our
quarterly report on Form 10-Q for the quarterly period ended March 31,
2008 filed with the SEC on May 9,
2008;
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our
current report on Form 8-K filed with the SEC on June 30,
2008;
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our
current report on Form 8-K filed with the SEC on August 7, 2008 (except
for the information furnished under Item 2.02 or any related
exhibit);
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our
quarterly report on Form 10-Q for the quarterly period ended June 30, 2008
filed with the SEC on August 8,
2008;
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our
current report on Form 8-K filed with the SEC on September 2,
2008;
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our
current report on Form 8-K filed with the SEC on September 5,
2008;
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our
current report on Form 8-K filed with the SEC on October 6,
2008;
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our
current report on Form 8-K filed with the SEC on November 6, 2008 (except
for the information furnished under Item 2.02 or any related
exhibit);
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our
quarterly report on Form 10-Q for the quarterly period ended September 30,
2008 filed with the SEC on November 6,
2008;
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our
current report on Form 8-K filed with the SEC on November 19,
2008;
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our
current report on Form 8-K filed with the SEC on December 2,
2008;
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the
description of our common stock contained in our registration statement on
Form 8-A registering our common stock under Section 12 of the Exchange
Act, filed with the SEC on October 24, 2003, including any amendments or
reports filed for the purpose of updating that description;
and
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the
description of our Series A Junior Participating Preferred Stock Purchase
Rights (the “Rights”) contained in our registration statement on Form 8-A
registering the Rights under Section 12 of the Exchange Act, filed with
the SEC on November 12, 2004, including any amendments or reports filed
for the purpose of updating that
description.
|
In
addition, all filings that we make with the SEC pursuant to the Exchange Act
after the initial filing date of the registration statement, of which this
prospectus forms a part, and prior to the effectiveness of the registration
statement shall be deemed to be incorporated by reference into this
prospectus.
Any
information in any of the foregoing documents will automatically be deemed to be
modified or superseded to the extent that information in this prospectus or in a
later filed document that is incorporated or deemed to be incorporated herein by
reference modifies or replaces such information.
We also
incorporate by reference any future filings (other than current reports
furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such
form that are related to such items) made with the SEC pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act, until we file a post-effective
amendment which indicates the termination of the offering of the securities made
by this prospectus. Information in such future filings updates and supplements
the information provided in this prospectus. Any statements in any such future
filings will automatically be deemed to modify and supersede any information in
any document we previously filed with the SEC that is incorporated or deemed to
be incorporated herein by reference to the extent that statements in the later
filed document modify or replace such earlier statements.
We will
provide to each person, including any beneficial owner, to whom a prospectus is
delivered, without charge upon written or oral request, a copy of any or all of
the documents that are incorporated by reference into this prospectus but not
delivered with the prospectus, including exhibits which are specifically
incorporated by reference into such documents. Requests should be directed to:
Investor Relations, Micromet, Inc., 6707 Democracy Boulevard, Suite 505,
Bethesda, Maryland 20817, telephone (240) 752-1420.
PART II
INFORMATION NOT REQUIRED IN THE
PROSPECTUS
Item 14. Other Expenses of
Issuance and Distribution.
The
following table sets forth the estimated costs and expenses payable by the
registrant in connection with the common stock being registered. The selling
stockholder will not bear any portion of such expenses. All the amounts shown
are estimates, except for the SEC registration fee.
SEC
Registration Fee
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|
$
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1,687
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Accounting
Fees and Expenses
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|
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10,000
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|
Legal
Fees and Expenses
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|
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30,000
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|
Printing
and miscellaneous expenses
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|
|
5,000
|
|
Total
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$
|
46,687
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|
Item 15. Indemnification of Directors and
Officers.
As
permitted by Section 102 of the Delaware General Corporation Law (“DGCL”), we
have adopted provisions in our amended and restated certificate of incorporation
and amended and restated bylaws that limit or eliminate the personal liability
of our directors for a breach of their fiduciary duty of care as a director. The
duty of care generally requires that, when acting on behalf of the corporation,
directors exercise an informed business judgment based on all material
information reasonably available to them. Consequently, a director will not be
personally liable to us or our stockholders for monetary damages or breach of
fiduciary duty as a director, except for liability for:
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·
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any
breach of the director’s duty of loyalty to us or our
stockholders;
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|
·
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any
act or omission not in good faith or that involves intentional misconduct
or a knowing violation of law;
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|
·
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any
act related to unlawful stock repurchases, redemptions or other
distributions or payment of dividends;
or
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|
·
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any
transaction from which the director derived an improper personal
benefit.
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These
limitations of liability do not affect the availability of equitable remedies
such as injunctive relief or rescission. Our amended and restated certificate of
incorporation also authorizes us to indemnify our officers, directors and other
agents to the fullest extent permitted under Delaware law.
As
permitted by Section 145 of the DGCL, our amended and restated certificate of
incorporation provides that:
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·
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we
shall indemnify our directors and officers to the fullest extent permitted
by the DGCL, subject to limited
exceptions;
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·
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we
shall advance expenses to our directors and officers in connection with a
legal proceeding to the fullest extent permitted by the Delaware General
Corporation Law, subject to limited exceptions, and upon receipt of an
undertaking by or on behalf of such person to repay such amount if it
shall ultimately be determined that he or she is not entitled to be
indemnified by the Company; and
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·
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the
rights provided in our amended and restated certificate of incorporation
are not exclusive.
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Moreover,
our amended and restated certificate of incorporation and our amended and
restated bylaws also provide that we, to the extent authorized by the board of
directors, may indemnify and advance expenses to our other employees or
agents.
In
addition, we have entered into separate indemnification agreements with our
directors and officers which may be broader than the specific indemnification
provisions contained in the DGCL. These indemnification agreements may require
us, among other things, to indemnify our officers and directors against
liabilities that may arise by reason of their status or service as directors or
officers, other than liabilities arising from willful misconduct. These
indemnification agreements also may require us to advance any expenses incurred
by the directors or officers as a result of any proceeding against them as to
which they could be indemnified. In addition, we have purchased a policy of
directors’ and officers’ liability insurance that insures our directors and
officers against the cost of defense, settlement or payment of a judgment in
some circumstances. These indemnification provisions and the indemnification
agreements may be sufficiently broad to permit indemnification of our officers
and directors for liabilities, including reimbursement of expenses incurred,
arising under the Securities Act.
Item 16.
Exhibits.
A
list of exhibits filed with this registration statement on Form S-3 is set forth
on the Exhibit Index and is incorporated herein by reference.
Item 17. Undertakings.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers and controlling persons of the registrant
pursuant to the provisions set forth in Item 15 above, or otherwise, the
registrant has been advised that in the opinion of the SEC such indemnification
is against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred or
paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
The
undersigned registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act, each filing of the registrant’s annual
report pursuant to Section 13(a) or Section 15(d) of the Exchange Act
(and, where applicable, each filing of an employee benefit plan’s annual report
pursuant to Section 15(d) of the Exchange Act) that is incorporated by
reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
The
undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
a. To
include any prospectus required by Section 10(a)(3) of the Securities
Act;
b. To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding the
foregoing, any increase or decrease in the volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the SEC
pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than 20 percent change in the maximum aggregate offering price
set forth in the “Calculation of Registration Fee” table in the effective
registration statement;
c. To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement;
PROVIDED,
HOWEVER, that paragraphs (1)(a), (1)(b) and (1)(c) do not apply if the
information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or furnished to the SEC
by the registrant pursuant to Section 13 or 15(d) of the Exchange Act that
are incorporated by reference in the registration statement, or is contained in
a form of prospectus filed pursuant to Rule 424(b) that is part of the
registration statement.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this registration statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in Bethesda,
Maryland, on December 8, 2008.
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|
MICROMET, INC.
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|
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By:
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/s/ Barclay A. Phillips
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|
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Barclay A. Phillips
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|
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Senior Vice President and Chief Financial Officer
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POWER OF ATTORNEY
KNOW ALL
PERSONS BY THESE PRESENTS that each individual whose signature appears below
constitutes and appoints Barclay A, Phillips and Matthias Alder, and each of
them, his or her true and lawful attorneys-in-fact and agents with full power of
substitution, for him or her and in his or her name, place and stead, in any and
all capacities, to sign any and all amendments to this registration statement,
and to file the same, with all exhibits thereto and all documents in connection
therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to do
and perform each and every act and thing requisite and necessary to be done in
and about the premises, as fully to all intents and purposes as he or she might
or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents or any of them, or his, her or their substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, this registration
statement has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
Principal Executive
Officer:
/s/
Christian Itin
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|
President
and Chief Executive
Officer
|
|
December
8, 2008
|
Christian
Itin, Ph.D.
|
|
and
Director
|
|
|
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Principal Financial and
Accounting
Officer:
|
|
|
|
|
|
|
|
|
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/s/
Barclay A. Phillips
|
|
Senior
Vice President
and
Chief Financial Officer
|
|
December
8, 2008
|
Barclay
A. Phillips
|
|
|
|
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Additional
Directors:
|
|
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|
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/s/
David F. Hale
|
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Chairman
|
|
December
8, 2008
|
David
F. Hale
|
|
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Director
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|
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Joseph
P. Slattery
|
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/s/
Michael G. Carter
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|
Director
|
|
December
8, 2008
|
Michael
G. Carter, M.B., Ch.B., F.R.C.P.
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|
|
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|
|
|
/s/
Jerry C. Benjamin
|
|
Director
|
|
December
8, 2008
|
Jerry
C. Benjamin
|
|
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|
|
|
/s/
Otello Stampacchia
|
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Director
|
|
December
8, 2008
|
Otello
Stampacchia, Ph.D.
|
|
|
|
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|
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|
|
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/s/ John
E. Berriman
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Director
|
|
December
8, 2008
|
John
E. Berriman
|
|
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/s/ Peter
Johann
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Director
|
|
December
8, 2008
|
Peter
Johann
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EXHIBIT INDEX
Exhibit Number
|
|
Exhibits
|
|
|
|
4.1(1)
|
|
Amended
and Restated Certificate of Incorporation of the
Registrant
|
4.2(2)
|
|
Certificate
of Amendment of the Amended and Restated Certificate of Incorporation of
the Registrant
|
4.3(3)
|
|
Certificate
of Designations for Series A Junior Participating Preferred
Stock of the Registrant
|
4.4(4)
|
|
Amended
and Restated Bylaws effective October 3, 2007
|
4.5(5)
|
|
Form
of Specimen Common Stock Certificate
|
4.6(6)
|
|
Common
Stock Purchase Agreement dated December 1, 2008 between the Company and
Kingsbridge Capital Limited
|
4.7(6)
|
|
Registration
Rights Agreement dated December 1, 2008 between the Company and
Kingsbridge Capital Limited
|
4.8(6)
|
|
Warrant
to Purchase Common Stock dated December 1, 2008 and issued to Kingsbridge
Capital Limited
|
4.9(7)
|
|
Warrant
to Purchase Common Stock dated August 30, 2006 and issued to Kingsbridge
Capital Limited
|
5.1
|
|
Opinion
of Cooley Godward Kronish LLP
|
23.1
|
|
Consent
of Ernst & Young AG WPG, Independent Registered Public Accounting
Firm
|
23.2
|
|
Consent
of Cooley Godward Kronish LLP (included in Exhibit 5.1)
|
24.1
|
|
Power
of Attorney (included on the signature pages
hereto)
|
Key to Exhibits:
(1)
|
Incorporated
by reference to the Registrant’s Quarterly Report on Form 10-Q filed with
the SEC on December 11, 2003.
|
(2)
|
Incorporated
by reference to the Registrant’s Quarterly Report on Form 10-Q filed with
the SEC on May 10, 2006.
|
(3)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K
filed with the SEC on November 8,
2004.
|
(4)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
SEC on October 9, 2007.
|
(5)
|
Incorporated
by reference to the Registrant’s Annual Report on Form 10-K for the year
ended December 31, 2007 filed with the SEC on March 14,
2008.
|
(6)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
SEC on December 2, 2008.
|
(7)
|
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
SEC on August 31, 2006.
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