sv3
As
filed with the Securities and Exchange Commission on August 22, 2006
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)
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Delaware
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52-2243564 |
(State or Other Jurisdiction of
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(I.R.S. Employer Identification No.) |
Incorporation or Organization) |
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2110 Rutherford Road
Carlsbad, California 92008
(760) 494-4200
(Address, including zip code, and telephone number,
including area code, of Registrants principal executive offices)
Christian Itin
President and Chief Executive Officer
Micromet, Inc.
2110 Rutherford Road
Carlsbad, CA 92008
(760) 494-4200
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
Christian E. Plaza, Esq.
Darren K. DeStefano, Esq.
Cooley Godward LLP
One Freedom Square, Reston Town Center
11951 Freedom Drive
Reston, VA 20190-5656
(703) 456-8000
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. o
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. o
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. o
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. o
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 to be |
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Offering Price |
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Aggregate Offering |
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Amount of |
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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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Registration Fee |
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Common Stock, par value $0.00004 |
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12,644,284(3) |
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$2.525 |
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$31,926,817 |
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$3,416.17 |
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(1) |
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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. |
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(2) |
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Estimated solely for the purpose of calculating the registration fee in accordance with Rule
457 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 registrants common stock on August 17,
2006, as reported on the Nasdaq Global Market. |
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Includes 555,556 shares of the registrants common stock issuable 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 August 22, 2006
The information in this prospectus is not complete and may be changed. The selling
stockholders 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
12,644,284 Shares
MICROMET, INC.
Common Stock
This prospectus relates to the resale from time to time of up to 12,644,284 shares of our
outstanding common stock in the aggregate, including 555,556 shares of our common stock issuable
upon the exercise of warrants, which are held by certain of the selling stockholders named in this
prospectus and such stockholders donees, pledgees or successors. Of the shares of common stock
offered under this prospectus, 9,866,506 shares were issued in connection with the business
combination between the registrant (formerly known as CancerVax Corporation) and Micromet AG,
2,222,222 shares were issued in connection with a private placement of our shares to two
institutional investors and 555,556 shares are issuable upon the exercise of warrants issued to the
institutional investors in the private placement. 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
stockholders, although we may receive proceeds upon the exercise of the warrants.
The selling stockholders may sell the shares of common stock described in this prospectus in a
number of different ways and at varying prices. We provide more information about how the selling
stockholders may sell their shares of common stock in the section entitled Plan of Distribution
on page 25. 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 August 21,
2006, the reported closing price of the common stock was $2.69 per share.
An investment in the shares offered hereby involves a high degree of risk. See Risk
Factors beginning on page 3 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 August , 2006.
TABLE OF CONTENTS
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PROSPECTUS SUMMARY |
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1 |
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RISK FACTORS |
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FORWARD-LOOKING STATEMENTS |
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USE OF PROCEEDS |
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SELLING STOCKHOLDERS |
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PLAN OF DISTRIBUTION |
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LEGAL MATTERS |
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EXPERTS |
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MATERIAL
CHANGES |
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UNAUDITED
PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS |
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WHERE YOU CAN FIND MORE INFORMATION |
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30 |
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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 stockholders have not, authorized anyone to provide you
with information different from that contained in this prospectus. The selling stockholders are
offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where
it is lawful to do so. 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.
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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 focusing on the development of novel, proprietary
antibody-based products for cancer, inflammatory and autoimmune diseases.
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders shares of CancerVax common
stock and CancerVax assumed all of the stock options, stock warrants and restricted stock of
Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet AG stockholders,
option holders, warrant holders and note holders owned, as of the closing, approximately 67.5% of
the combined company on a fully-diluted basis and former CancerVax stockholders, option holders and
warrant holders owned, as of the closing, approximately 32.5% of the combined company on a
fully-diluted basis. In connection with the merger, CancerVax was renamed Micromet, Inc. and our
Nasdaq National Market ticker symbol was changed to MITI.
Our product pipeline consists of two clinical product candidates, adecatumumab (MT201) and
MT103, and six preclinical product candidates, D93, MT110, MT203, MT204, BiTE®-I and BiTE®-II. This
does not include a clinical candidate, SAI-EGF, and preclinical product
candidates SAI-TGF and SAI-EGFR,
which we plan to out-license. To date, we have incurred significant expenses and have not achieved
any revenues from sales of products.
We began our clinical program for our lead product candidate (adecatumumab) with a Phase 1
clinical trial in patients with hormone-refractory prostate cancer in September 2001 in Germany.
Phase 2 clinical trials were started in February 2004 in patients with prostate cancer and in March
2004 in patients with metastatic breast cancer. Adecatumumab (MT201) is being evaluated as a
monotherapy in these two clinical trials. In addition, adecatumumab (MT201) is being evaluated in a
Phase 1 clinical trial in combination with docetaxel in patients with metastatic breast cancer. An
Investigational New Drug Application, or IND, was approved by the Food and Drug Administration, or
FDA, in November 2004 for a Phase 2 clinical trial in patients with metastatic breast cancer.
A second clinical program, MT103, a BiTE® compound, is currently in a Phase 1 dose escalation
clinical trial in patients with indolent non-Hodgkins Lymphoma,
or NHL. In August 2006, MedImmune, our collaborator for MT103, filed
an IND with the FDA for MT103. Pending FDA review, MedImmune intends
to conduct a Phase 1 dose escalation trial in the United States,
in patients with B-cell-derived NHL who have not responded to or have
become refractory to previous therapies
In addition, we have product candidates in pre-clinical development including therapeutic
human antibodies and
BiTE®
molecules that may be used to treat patients with cancer and
inflammatory and autoimmune diseases.
We believe that our novel technologies, product candidates and clinical development experience
in these fields will continue to enable us to identify and develop promising new product candidates
in these important markets.
Each of our programs will require many years and significant costs to advance through
development. Typically it takes many years from the initial identification of a lead compound to
the completion of pre-clinical and clinical trials, before applying for possible marketing approval
from the FDA, the European Medicines Agency (the EMEA) or other
equivalent international regulatory agencies. The risk that a program has to be terminated, in
part or in full, for safety reasons, or lack of adequate efficacy is very high. In particular, we
can neither predict which if any potential product candidates can be successfully developed and
for which marketing approval may be obtained, nor predict the time and cost to complete
development.
As we obtain results from pre-clinical studies or clinical trials, we may elect to discontinue
clinical trials for certain product candidates for safety and/or efficacy reasons. We may also
elect to discontinue development of one or more product candidates in order to focus our resources
on more promising product candidates. Our business strategy includes entering into collaborative
agreements with third parties for the development and commercialization of our product candidates.
Depending on the structure of such collaborative agreements, a third party may take over the
clinical trial process for one of our product candidates. In such a
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situation,
the third party, rather than us, may in fact control clinical development and
commercialization decisions for the respective product candidate. Consistent with our business
model, we may enter into additional collaboration agreements in the future. We cannot predict the
terms of such agreements or their potential impact on our capital requirements. Our inability to
complete our research and development projects in a timely manner, or our failure to enter into new
collaborative agreements, when appropriate, could significantly increase our capital requirements
and affect our liquidity.
Since our inception, we have financed our operations through private placements of preferred
stock, government grants for research, research-contribution revenues from our collaborations with
pharmaceutical companies, debt financing and, more recently by accessing the capital resources of
CancerVax through the merger and through a private placement of common stock and associated
warrants. We intend to continue to seek funding through public or private financings in the future.
If we are successful in raising additional funds through the issuance of equity securities,
stockholders may experience substantial dilution, or the equity securities may have rights,
preferences or privileges senior to existing stockholders. If we are successful in raising
additional funds through debt financings, these financings may involve significant cash payment
obligations and covenants that restrict our ability to operate our business. There can be no
assurance that we will be successful in raising additional capital on acceptable terms, or at all.
Based on our capital resources as of the date of this prospectus, we believe that we have adequate
resources to fund our operations into the third quarter of 2007.
Currently, we have strategic collaborations with Serono International S.A. and MedImmune, Inc.
to develop therapeutic antibodies in cancer. We also have an exclusive marketing agreement with
Enzon, Inc. to market and license to third parties the companies respective single-chain antibody
patent estates. See Risk Factors for a discussion of risks relating to our business and owning
our capital stock.
We were incorporated in Delaware in 1998. Our principal executive offices are located at 2110
Rutherford Road, Carlsbad, California 92008, and our main telephone number is (760) 494-4200. 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.
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RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider
the risk factors described below, and all other information contained in or incorporated by
reference in this prospectus, before deciding to invest in our common stock. 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.
Risks Relating to Our Clinical and Regulatory Matters
Our preliminary review of the final results of our Phase 2 clinical trial of adecatumumab, or
MT201, in patients with prostate cancer suggests that the primary endpoint of the trial was not
reached and, if final assessment of the trial results do not warrant continuation of the
development program in this indication, we may discontinue development of this product candidate in
prostate cancer.
Our preliminary review of the final results from our Phase 2 clinical trial of adecatumumab,
or MT201, in patients with prostate cancer indicates that the primary endpoint (mean change in
prostate specific antigen, compared to placebo control) was not reached in the trial. An expert
review meeting performed earlier this year suggested that additional post-hoc sub-analyses be
performed before coming to a final assessment of this trial. These sub-analyses have been performed
and, although a final assessment has not yet been completed, it appears that some measurable level
of biological activity was observed in patients with high EpCAM expression. If, upon final
assessment, we, and our partner Serono conclude that the results of the trial do not warrant
continuation of the development of adecatumumab for the treatment of prostate cancer (or a suitable
alternative indication), this would have a material adverse impact on our future results of
operations.
Based upon our preliminary review of the final results of our Phase 2 clinical trial of
adecatumumab, or MT201, in patients with metastatic breast cancer, it appears that the trial did
not reach its primary endpoint and, if final assessment of the trial results do not warrant
continuation of the development program in this indication, we may discontinue development of this
product candidate in breast cancer.
We previously have reported that our initial review of the preliminary radiography assessments
from our Phase 2 clinical trial of adecatumumab in patients with metastatic breast cancer suggested
that the trial had more likely than not met its primary clinical endpoint (clinical benefit rate at
week 24). We also reported that the radiographs from the patients in this clinical trial would be
subjected to the assessment of an independent review board, as some centralized radiology
assessments differed from the radiology assessments performed at the local clinical trial sites.
Such radiographs have now been reviewed and the database used to perform the analysis has now
been locked and is currently subject to a formal assessment, which will not be completed until
later this year. Based upon our initial assessment of the final data set, it now appears that the
trial more likely than not failed to satisfy its primary clinical endpoint. However, based on the
data that we have reviewed thus far, we believe that the results of the trial are nevertheless
encouraging as they appear to indicate clinical activity for adecatumumab, particularly in patients
with high EpCAM expression. Moreover, based upon our current assessment, it does not appear that
there were significant safety concerns observed during the trial.
A final assessment of the study data will not be possible until a full analysis of the data
has been performed, which is currently anticipated to occur in the second half of 2006. Based upon
our preliminary review of the final results of this trial, we currently expect to continue with the
development of adecatumumab. However, if upon final assessment we and our partner Serono conclude
that the results of the trial do not warrant continuation of the development of adecatumumab for
the treatment of breast cancer (or a suitable alternative indication), this would have a material
adverse impact on our future results of operations.
We previously terminated three Phase 1 trials involving short-term infusion regimens of MT103 due
to the adverse event profile and a lack of perceived tumor response, and there can be no assurance
that our current continuous infusion Phase 1 clinical trial of MT103 will produce a different
outcome.
In April 2004, we initiated a Phase 1, dose finding clinical trial designed to evaluate the
safety and tolerability of a continuous intravenous infusion of MT103 over 4-8 weeks at different
dose levels in patients with relapsed Non-Hodgkins Lymphoma. We previously terminated three other
Phase 1 clinical trials for MT103, which involved a short-term, as opposed to a continuous,
infusion of MT103, due to adverse events and the lack of observed tumor responses. Although we have
redesigned the
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dosing regimen for our ongoing Phase 1 clinical trial and, based upon the preliminary data, we
currently are seeing considerably fewer adverse events in response to
the new dosing regimen. We have also seen objective tumor responses
at the current highest dose level tested (15 µg/m2/d). There can be no assurance that our ongoing, continuous-infusion clinical trial will not produce an
unacceptable level of adverse events or that the final evaluation
will not indicate a lack of efficacy.
Risks Relating to Our Financial Results and Need for Financing
We have a history of losses, we expect to incur substantial losses and negative operating cash
flows for the foreseeable future and we may never achieve profitability.
We have incurred losses from the inception of Micromet through June 30, 2006, and we expect to
incur substantial losses for the foreseeable future. We have no current sources of material ongoing
revenue, other than expense reimbursement and milestone payments from our current collaborators, Serono and
MedImmune. We have not commercialized any products to date, either alone or with a third party
collaborator. If we are not able to commercialize any products, whether alone or with a
collaborator, we may not achieve profitability. Even if our collaboration agreements provide
funding for a portion of our research and development expenses for some of our programs, we expect
to spend significant capital to fund our internal research and development programs for the
foreseeable future. As a result, we will need to generate significant revenues in order to achieve
profitability. We cannot be certain whether or when this will occur because of the significant
uncertainties that affect our business. Our failure to become and remain profitable may depress the
market price of our common stock and could impair our ability to raise capital, expand our
business, diversify our product offerings or continue our operations.
We will require additional financing, which may be difficult to obtain and may dilute your
ownership interest in us. If we fail to obtain the capital necessary to fund our operations, we
will be unable to develop or commercialize our product candidates and our ability to operate as a
going concern may be adversely affected.
We will require substantial funds to continue our research and development programs and our
future capital requirements may vary from what we expect. There are factors that may affect our
future capital requirements and accelerate our need for additional financing. Many of these factors
are outside our control, including the following:
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continued progress in our research and development programs, as well as the magnitude of these programs; |
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our ability to establish and maintain collaborative arrangements; |
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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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the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and
other patent-related costs, including litigation costs and technology license fees; |
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our ability to complete our post-merger integration; |
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costs associated with litigation, including our ongoing litigation with Curis, Inc.; and |
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competing technological and market developments. |
We have filed a shelf registration statement, declared effective by the Securities and
Exchange Commission on December 9, 2004, under which we may raise up to $80 million through the
sale of our common stock. This shelf registration statement became inactive in March 2006, and we
may decide to activate it by filing a post-effective amendment in the future. We expect to seek
additional funding through public or private financings and may seek additional funding for
programs that are not currently licensed to collaborators, from new strategic collaborators.
However, the biotechnology market in general, and the market for our common stock, in particular,
is likely to be highly volatile. Due to market conditions and the status of our product development
pipeline, additional funding may not be available to us on acceptable terms, or at all. Having
insufficient funds may require us to delay, scale back or
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eliminate some or all of our research or development programs or to relinquish greater or all
rights to product candidates at an earlier stage of development or on less favorable terms than we
would otherwise choose. Failure to obtain adequate financing also may adversely affect our ability
to operate as a going concern.
If we raise additional funds through the issuance of equity securities, our stockholders may
experience substantial dilution, or the equity securities may have rights, preferences or
privileges senior to existing stockholders. If we raise additional funds through debt financings,
these financings may involve significant cash payment obligations and covenants that restrict our
ability to operate our business and make distributions to our stockholders. We also could elect to
seek funds through arrangements with collaborators or others that may require us to relinquish
rights to certain technologies, product candidates or products.
We have an outstanding promissory note issued to Curis in the amount of 2.0 million, or
$2.5 million. Curis has filed a lawsuit against us claiming that the merger triggered our
obligation to repay the note. We dispute Curis position, but agree that an amount of 533,000,
or $667,000, of the loan will become payable in October 2006. Our maximum exposure is the amount
claimed of 2.0 million, or approximately $2.5 million based on the Euro/U.S. dollar exchange
rate as of June 30, 2006, plus the costs of the proceedings. In addition, if Curis prevails in the
proceeding, it would be entitled to interest on the claimed amount of 2.0 million, or $2.5
million, at the base rate of the European Central Bank plus 8%, accruing from the time of default.
In the event that we are required to immediately repay any substantial portion or all of the
amounts outstanding under this note, it would have a material adverse effect on our financial
resources in the near term.
Our quarterly operating results and stock price may fluctuate significantly.
We expect our results of operations to be subject to quarterly fluctuations. The level of our
revenues, if any, and results of operations at any given time, will be based primarily on the
following factors:
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the status of development of our product candidates; |
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the time at which we enter into research and license agreements with strategic
collaborators that provide for payments to us, and the timing and accounting treatment of
payments to us, if any, under those agreements; |
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whether or not we achieve specified research or commercialization milestones under any
agreement that we enter into with collaborators and the timely payment by commercial
collaborators of any amounts payable to us; |
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the addition or termination of research programs or funding support; |
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the timing of milestone and other payments that we may be required to make to others; |
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variations in the level of expenses related to our product candidates or potential
product candidates during any given period; and |
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the progress of our integration activities. |
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.
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Changes in, or interpretations of, accounting rules and regulations, such as expensing of stock
options, could result in unfavorable accounting charges or require us to change our compensation
policies.
Accounting methods and policies for biopharmaceutical companies, including policies governing
revenue recognition, expenses, accounting for stock options and in-process research and development
costs are subject to further review, interpretation and guidance from relevant accounting
authorities, including the Securities and Exchange Commission. 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.
In December 2004, CancerVax entered into a loan and security agreement with a financing
institution, and borrowed the full $18.0 million available under this credit facility. In order to
secure its obligations under this loan and security agreement, CancerVax granted the bank a first
priority security interest in substantially all of its assets, excluding its intellectual property.
CancerVax used the proceeds from the loan agreement primarily to construct and equip an additional
production suite in its manufacturing facility and to create additional warehouse and laboratory
space to support its manufacturing operations. The terms of our loan and security agreement require
that it be repaid in full upon the occurrence of a change of control event.
The loan agreement contains various customary affirmative and negative covenants, including,
without limitation:
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financial reporting; |
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limitation on liens; |
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limitations on the occurrence of future indebtedness; |
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maintenance of a minimum amount of cash in deposit accounts of our lenders or in the
accounts of affiliates of our lenders; |
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limitations on mergers and other consolidations; |
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limitations on dividends; |
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limitations on investments; and |
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limitations on transactions with affiliates. |
In addition, under this loan agreement, we are generally obligated to maintain, as of the last
day of each quarter, cash, cash equivalents and securities available-for-sale in an amount at least
equal to the greater of (i) our quarterly cash burn multiplied by 2 or (ii) the then outstanding
principal amount of the obligations under such agreement multiplied by 1.5. In the event that we
breach this financial covenant, we are obligated to pledge and deliver to the bank a certificate of
deposit in an amount equal to the aggregate outstanding principal amount of the obligations under
such agreement.
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; |
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our debt level reduces our flexibility in responding to changing business and economic conditions; and |
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our business and financial condition would be adversely effected if we are unable to
service our indebtedness or obtain additional financing, as needed. |
Risks Relating to Our Common Stock
Future sales of our common stock may cause our stock price to decline.
Our current stockholders hold a substantial number of shares of our common stock that they
will be able to sell in the public market. A significant portion of these shares are held by a
small number of stockholders. Sales by our current stockholders of a substantial number of our
shares could significantly reduce the market price of our common stock. Moreover, the holders of a
substantial number of shares of our common stock have rights, subject to some conditions, to
require us to file registration statements covering their shares, including the registration
statement of which this prospectus is a part. We have also registered shares of our common stock
that we may issue under our stock incentive plans and employee stock purchase plan. These shares
generally can be freely sold in the public market upon issuance. Sales of a large number of these
shares in the public market, or the mere availability of these shares for resale, could reduce the
trading 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, most of which we cannot control, including:
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the financial markets acceptance of the merger between Micromet and CancerVax, and our
ability to successfully integrate our operations following the merger; |
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our ability to upgrade and implement our disclosure controls and our internal control over financial reporting; |
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our ability to successfully raise capital to fund our continued operations; |
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our ability to successfully develop our product candidates within acceptable timeframes; |
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changes in the regulatory status of our product candidates; |
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changes in significant contracts, new technologies, acquisitions, commercial
relationships, joint ventures or capital commitments; |
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the execution of new contracts or termination of existing contracts related to our
clinical or preclinical product candidates; |
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announcements of the results of clinical trials by companies with product candidates in
the same therapeutic category as our product candidates; |
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events affecting our collaboration partners; |
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fluctuations in stock market prices and trading volumes of similar companies; |
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announcements of new products or technologies, clinical trial results, commercial
relationships or other events by us or our competitors; |
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our ability to successfully complete sublicensing arrangements with respect to our
product candidates that target the EGFR signaling pathway, denatured collagen, GM-CSF and
interleukin-2; |
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variations in our quarterly operating results; |
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changes in securities analysts estimates of our financial performance; |
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changes in accounting principles; |
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sales of large blocks of our common stock, including sales by our executive officers,
directors and significant stockholders; |
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additions or departures of key personnel; and |
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discussions of Micromet or our stock price by the financial and scientific press and
online investor communities such as chat rooms. |
If our officers and directors choose to act together, they can significantly influence our
management and operations in a manner that may be in their best interests and not in the best
interests of other stockholders.
Our officers and directors, together with their affiliates, 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
they 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 contain provisions that 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 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 bylaws except with 662/3% stockholder approval; and |
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requiring advance notice for raising matters of business or making nominations at
stockholders meetings. |
We are also subject to provisions of the Delaware corporation law that, in general, prohibit
any business combination with a beneficial owner of 15% or more of our common stock for five years
unless the holders acquisition of our stock was approved in advance by our board of directors.
Risks Relating to Our Collaborations
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 delay in developing or
commercializing our product candidates, our anticipated product pipeline and operating results
would suffer.
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The
success of our strategy for development and commercialization of our product candidates
depends upon our ability to form and maintain productive strategic collaborations. We currently
have strategic collaborations with Serono and MedImmune. We expect to enter into additional
collaborations in the future. Our existing and any future collaborations may not be scientifically
or commercially successful.
The risks that we face in connection with these collaborations include the following:
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Each of our collaborators has significant discretion in determining the efforts and
resources that it will apply to the collaboration. The timing and amount of any future
royalty and milestone revenue that we may receive under such collaborative arrangements
will depend on, among other things, such collaborators efforts and allocation of
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All of our strategic collaboration agreements are for fixed terms and are subject to
termination under various circumstances, including in some cases, on short notice without
cause. If Serono or Medimune were to terminate our agreement with them, we may be required to undertake
product development, manufacturing and commercialization and we may not have the funds or
capability to do this, which could result in a discontinuation or delay of such program. |
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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 the collaboration with us. |
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Our collaborators may change the focus of their development and commercialization
efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their
priorities following mergers and consolidations, which have been common in recent years in
these industries. The ability of certain of our product candidates to reach their potential
could be limited if our collaborators decrease or fail to increase spending related to such
product candidates. |
Changes in the laws or regulations of the United States or Cuba related to the conduct of our
business with CIMAB may adversely affect our ability to develop and commercialize or sublicense our
rights to SAI-EGF and the two other product candidates that we have licensed from that company.
The United States government has maintained an embargo against Cuba for more than 40 years.
The embargo is administered by the Office of Foreign Assets Control, or OFAC, of the U.S.
Department of Treasury. Without a license from OFAC, U.S. individuals and companies may not engage
in any transaction in which Cuba or Cubans have an interest. In order to enter into and carry out
our licensing agreements with CIMAB, we have obtained from OFAC a license authorizing us to carry
out all transactions set forth in the license agreements that we have entered into with CIMAB for
the development, testing, licensing and commercialization of SAI-EGF, and with CIMAB and YM
BioSciences for the two other product candidates that target the EGF receptor signaling pathway. In
the absence of such a license from OFAC, the execution of and our performance under these
agreements could have exposed us to legal and criminal liability. At any time, there may occur for
reasons beyond our control a change in United States or Cuban law, or in the regulatory environment
in the U.S. or Cuba, or a shift in the political attitudes of either the U.S. or Cuban governments,
that could result in the suspension or revocation of our OFAC license or in our inability to carry
out part or all of the licensing agreements with CIMAB. There can be no assurance that the U.S. or
Cuban governments will not modify existing law or establish new laws or regulations that may
adversely affect our ability to develop, test, license and commercialize these product candidates.
Our OFAC license may be revoked or amended at anytime in the future, or the U.S. or Cuban
governments may restrict our ability to carry out all or part of our respective duties under the
licensing agreements between us, CIMAB and YM BioSciences. Similarly, any such actions may restrict
CIMABs ability to carry out all or part of its licensing agreements with us. In addition, we
cannot be sure that the FDA, EMEA or other regulatory authorities will accept data from the
clinical trials of these product candidates that were conducted in Cuba as the basis for our applications to
conduct additional clinical trials, or as part of our application to seek marketing authorizations
for such product candidates.
In 1996, a significant change to the United States embargo against Cuba resulted from
congressional passage of the Cuban Liberty and Democratic Solidarity Act, also known as the
Helms-Burton Bill. That law authorizes private lawsuits for damages against anyone who traffics in
property confiscated, without compensation, by the government of Cuba from persons who at the time
were, or have since become, nationals of the United States. We do not own any property in Cuba and
do not believe that any of CIMABs properties or any of the scientific centers that are or have
been involved in the development of the technology that we have licensed from CIMAB were
confiscated by the government of Cuba from persons who at the time were, or who have since become,
nationals of the U.S. However, there can be no assurance that our understanding in this regard is
correct. We do not intend to traffic in confiscated property, and have included provisions in our
licensing agreements to preclude the use of such property in association with the performance of
CIMABs obligations under those agreements.
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As part of our interactions with CIMAB, we will be subject to the U.S. Commerce Departments
export administration regulations that govern the transfer of technology to foreign nationals.
Specifically, we or our sublicensees, if any, will require a license from the Commerce Departments
Bureau of Industry and Security, or BIS, in order to export or otherwise transfer to CIMAB any
information that constitutes technology under the definitions of the Export Administration
Regulations, or EAR, administered by BIS. The export licensing process may take months to be
completed, and the technology transfer in question may not take place unless and until a license is
granted by the Commerce Department. Due to the unique status of the Republic of Cuba, technology
that might otherwise be transferable to a foreign national without a Commerce Department license
requires a license for export or transfer to a Cuban national. If we or our sublicensees fail to
comply with the export administration regulations, we may be subject to both civil and criminal
penalties. There can be no guarantee that any license application will be approved by BIS or that a
license, once issued, will not be revoked, modified, suspended or otherwise restricted for reasons
beyond our control due to a change in U.S.-Cuba policy or for other reasons.
We may not be successful in establishing additional strategic collaborations, which could adversely
affect our ability to develop and commercialize products.
As an integral part of our ongoing research and development efforts, we periodically review
opportunities to establish new collaborations, joint ventures and strategic collaborations for the
development and commercialization of products in our development pipeline. We face significant
competition in seeking appropriate collaborators and the negotiation process is time-consuming and
complex. We may not be successful in our efforts to establish additional strategic collaborations
or other alternative arrangements. Even if we are successful in our efforts to establish a
collaboration or agreement, the terms that we establish may not be favorable to us. Finally, such
strategic alliances or other arrangements may not result in successful products and associated
revenue.
Risks Relating to the Life Sciences Industry, Our Business, Strategy and Operations
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, medical device and pharmaceutical companies, as well as universities and other
research institutions. For example, research in the fields of antibody-based therapeutics for the
treatment of cancer and autoimmune and inflammatory diseases is highly competitive. A number of entities are
seeking to identify and patent antibodies, potentially active proteins and other potentially active
compounds without specific knowledge of their therapeutic function. Our competitors may discover,
characterize and develop important inducing molecules or genes in advance of us.
Many of our competitors have substantially greater capital resources, research and development
staffs and facilities than we have. Efforts by other biotechnology, medical device 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. For those programs that we have
selected for further internal development, we face competition from companies that are more
experienced in product development and commercialization, obtaining regulatory approvals and
product manufacturing. As a result, they may develop competing products more rapidly and at a lower
cost. For those programs that are subject to a collaboration agreement, competitors 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.
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 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 attrition for
product candidates in preclinical development and in clinical trials. All of our product candidates are in early
stages of development, so we will require substantial additional financial resources, as well as
research, product development and clinical development capabilities, to pursue the development of these product
candidates, and we may never develop an approvable 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. In addition, we do not know
whether these clinical trials will result in marketable products. We cannot assure you that any of
our product candidates will:
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be successfully developed; |
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prove to be safe and effective in clinical trials; |
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be approved for marketing by United States or foreign regulatory authorities; |
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be adequately protected by our intellectual property rights or the rights of our licensors; |
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be capable of being produced in commercial quantities at acceptable costs; |
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achieve market acceptance and be commercially viable; or |
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be eligible for third party reimbursement from governmental or private insurers. |
Since our product candidates may have different efficacy profiles in certain clinical
indications, sub-indications or patient profiles and we have limited resources, our election to
focus on a particular indication, sub-indication and patient profile may result in our failure to
capitalize on other potentially profitable applications of our product candidates.
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 ultimately prove to be more profitable.
The development process necessary to obtain regulatory approval is lengthy, complex and expensive.
If we and our collaborative partners do not obtain necessary regulatory approvals, then our
business will be unsuccessful and the market price of our common stock will substantially decline.
To the extent that we, or our collaborative partners, are able to successfully advance a
product candidate through the clinic, we, or such partner, will be required to obtain regulatory
approval prior to marketing and selling such product candidate.
The process of obtaining FDA and EMEA and other required regulatory approvals is expensive.
The time required for FDA and EMEA and other approvals is uncertain and typically takes a number of
years, depending on the complexity and novelty of the product candidate. The process of obtaining
FDA and EMEA and other required regulatory approvals for many of our product candidates under
development is further complicated because some of these product candidates use non-traditional or
novel materials in non-traditional or novel ways, and the regulatory officials have little
precedent to follow. Moreover, an unrelated biotech company recently observed multiple severe
adverse reactions in a Phase 1 trial of an antibody that stimulates T cells. This development could
cause the FDA and EMEA or comparable international regulatory authorities to become less supportive
of the T-cell related product candidates in our portfolio. With respect to internal programs to date, we have
limited experience in filing and prosecuting applications to obtain marketing approval.
Any regulatory approval to market a product may be subject to limitations on the indicated
uses for which we, or our collaborative partners, may market the product. These limitations may
restrict the size of the market for the product and affect reimbursement by third-party payers. In
addition, regulatory agencies may not grant approvals on a timely basis or may revoke or
significantly modify previously granted approvals.
We and our collaborative partners also are subject to numerous foreign regulatory requirements
governing the manufacturing and marketing of our product candidates outside of the United
States. The approval procedure varies among countries, additional testing may be required in some
jurisdictions, and the time required to obtain foreign approvals often differs from that required
to obtain FDA and EMEA approvals. Moreover, approval by the FDA and EMEA does not ensure approval
by regulatory authorities in other countries, and vice versa.
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As a result of these factors, we or our collaborators may not successfully begin or complete
clinical trials 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. We, and any of our collaborators, may not be able to comply with these regulations,
which could subject us, or such collaborators, to penalties and otherwise result in the limitation
of our or such collaborators operations.
In addition to regulations imposed by the FDA, EMEA and other international regulatory
agencies, 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 foreign counterparts. From time to
time, other federal agencies and congressional committees or international governmental bodies have
indicated an interest in implementing further regulation of biotechnology applications. We are not
able to predict whether any such regulations will be adopted or whether, if adopted, such
regulations will apply to our business, or whether we or our collaborators would be able to comply
with any applicable regulations.
We expect to rely heavily on third parties for the conduct of clinical trials of our product
candidates. If these clinical trials are not successful, or if we or our collaborators are not able
to obtain the necessary regulatory approvals, we will not be able to commercialize our product
candidates.
In order to obtain regulatory approval for the commercial sale of our product candidates, we
and our collaborators will be required to complete extensive preclinical studies as well as
clinical trials in humans to demonstrate to the FDA, EMEA and other foreign regulatory authorities
that our product candidates are safe and effective. We have limited experience in conducting
clinical trials and expect to rely primarily on collaborative partners and contract research
organizations for their performance and management of clinical trials of our product candidates.
Clinical development, including preclinical testing, is a long, expensive and uncertain
process. Accordingly, preclinical testing and clinical trials, if any, of our product candidates
under development may not be successful. We and our collaborators could experience delays in
preclinical or clinical trials of any of our product candidates, obtain unfavorable results in a
development program, or fail to obtain regulatory approval for the
commercialization of a product candidate.
Preclinical studies or clinical trials may produce negative, inconsistent or inconclusive results,
and we or our collaborators may decide, or regulators may require us, to conduct additional
preclinical studies or clinical trials. The results from early clinical trials may not be
statistically significant or predictive of results that will be obtained from expanded, advanced
clinical trials.
Furthermore, the timing and completion of clinical trials, if any, of our product candidates
depend on, among other factors, the number of patients we will be required to enroll in the
clinical trials and the rate at which those patients are enrolled. Any increase in the required
number of patients, decrease in recruitment rates or difficulties retaining study participants may
result in increased costs, program delays or both.
Also,
our product candidates may not be effective in treating any of our targeted
disorders or may prove to have undesirable or unintended side effects, toxicities or other
characteristics that may prevent or limit their commercial use. Institutional review boards or
regulators, including the FDA and the EMEA, may hold, suspend or terminate our clinical research or
the clinical trials of our product 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. Additionally, the failure of third parties conducting or overseeing the
operation of the clinical trials to perform their contractual or regulatory obligations in a timely
fashion could delay the clinical trials. Failure of clinical trials can occur at any stage of
testing. Any of these events would adversely affect our ability to market a product candidate.
Our growth could be limited if we are unable to attract and retain key personnel and consultants.
Our success depends on the ability to attract, train and retain qualified scientific and
technical personnel to further our research and development efforts. The loss of services of one or
more of our key employees or consultants could have a negative impact on our business and operating
results. Locating candidates with the appropriate qualifications can be difficult. Although we
expect to be able to attract and retain sufficient numbers of highly skilled employees for the
foreseeable future, we may not be able to do so.
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Any growth and expansion into areas and activities that may require additional human resources
or expertise, such as regulatory affairs and compliance, would require us to either hire new key
personnel or obtain such services via an outsourcing arrangement. The pool of personnel with the
skills that we require is limited, and we may not be able to hire or contract such additional
personnel.
If our third-party manufacturers facilities do not follow current good manufacturing practices,
our product development and commercialization efforts may be harmed.
There are a limited number of manufacturers that operate under the FDAs and EMEAs good
manufacturing practices regulations and are capable of manufacturing products. Third-party
manufacturers may encounter difficulties in achieving quality control and quality assurance and may
experience shortages of qualified personnel. 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 products for
commercial use or clinical study, the termination of, or hold on a clinical study, or may delay or
prevent filing or approval of marketing applications for our product
candidates. In addition we could be
subject to sanctions being imposed on us, including fines, injunctions and civil penalties.
Changing manufacturers may require additional clinical trials and the revalidation of the
manufacturing process and procedures in accordance with FDA and EMEA mandated current good
manufacturing practices and will require FDA and 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.
If we fail to obtain an adequate level of reimbursement for our products by third-party payors,
there may be no commercially viable markets for our products or the markets may be much smaller
than expected.
If any of our product candidates are approved for marketing, the availability and levels of
reimbursement by governmental and other third-party payors will
affect the market for our product candidates.
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 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. 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 is unavailable or limited in scope or
amount or if pricing is set at unsatisfactory levels, our revenues would be reduced.
Another development that may affect the pricing of drugs is regulatory action regarding drug
reimportation into the United States. The Medicare Prescription Drug, Improvement and Modernization
Act of 2003, which became law in December 2003, requires the Secretary of the U.S. Department of
Health and Human Services to promulgate regulations allowing drug reimportation from Canada into
the United States under certain circumstances. These provisions will become effective only if the
Secretary certifies that such imports will pose no additional risk to the publics health and
safety and result in significant cost savings to consumers. To date, the Secretary has made no such
finding, but he could do so in the future. Proponents of drug reimportation may also attempt to
pass legislation that would remove the requirement for the Secretarys certification or allow
reimportation under circumstances beyond those anticipated under current law. If legislation is
enacted, or regulations issued, allowing the reimportation of drugs, it could decrease the
reimbursement we would receive for any products that we may commercialize, negatively affecting our
anticipated revenues and prospects for profitability.
Even
if our product candidates are approved by regulatory authorities, if we fail to comply with ongoing
regulatory requirements, or if we experience unanticipated problems
with our product candidates, 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 data and promotional activities for such
product candidates, will be subject to
continual review and periodic inspections by the FDA, EMEA and other regulatory bodies. 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. Later
discovery of previously unknown problems with our approved product candidates, including unanticipated adverse events
or adverse events of unanticipated severity or frequency, manufacturer or manufacturing processes,
or failure to comply with
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regulatory
requirements, may result in restrictions on such approved product
candidates or manufacturing processes,
withdrawal of the approved product candidates from the market, voluntary or mandatory recall, fines, suspension of
regulatory approvals, product seizures, injunctions or the imposition of civil or criminal
penalties.
Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our
product candidates abroad.
We
intend to market our product candidates in international markets. In
order to market our product candidates in the
European Union and many other foreign jurisdictions, we must obtain separate regulatory approvals.
The approval procedure varies among countries and can involve additional testing, and the time
required to obtain approval may differ from that required to obtain FDA and EMEA approval. The
foreign regulatory approval process may include all of the risks associated with obtaining FDA and
EMEA approval. We may not obtain foreign regulatory approvals on a timely basis, if at all.
Approval by the FDA and EMEA does not ensure approval by regulatory authorities in other countries,
and approval by one foreign regulatory authority does not ensure approval by regulatory authorities
in other foreign countries or by the FDA and EMEA. We may not be able to file for regulatory
approvals and may not receive necessary approvals to commercialize
our product candidates in any market.
We are subject to uncertainty relating to health care reform measures and reimbursement policies
which, if not favorable to our product candidates, could hinder or prevent our product candidates
commercial success.
The continuing efforts of the government, insurance companies, managed care organizations and
other payors of health care costs to contain or reduce costs of health care may adversely affect:
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our ability to generate revenues and achieve profitability; |
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the future revenues and profitability of our potential customers, suppliers and collaborators; and |
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the availability of capital. |
In certain foreign markets, the pricing of prescription pharmaceuticals is subject to
government control. In the United States, given recent federal and state government initiatives
directed at lowering the total cost of health care, the U.S. Congress and state legislatures will
likely continue to focus on health care reform, the cost of prescription pharmaceuticals and on the
reform of the Medicare and Medicaid systems. For example, legislation was enacted on December 8,
2003, which provides a new Medicare prescription drug benefit that began in 2006 and mandates other
reforms. While we cannot predict the full effects of the implementation of this new legislation or
whether any legislative or regulatory proposals affecting our business will be adopted, the
implementation of this legislation or announcement or adoption of these proposals could have a
material and adverse effect on our business, financial condition and results of operations.
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 cost of our product
candidates and related treatments. Third-party
payors are increasingly challenging the prices charged for medical products and services. Also, the
trend toward managed health care in the United States, which could significantly influence the
purchase of health care services and products, as well as legislative proposals to reform health
care or reduce government insurance programs, may result in lower prices for our product candidates
or exclusion of our product candidates from reimbursement programs. The cost containment measures
that health care payors and providers are instituting and the effect of any health care reform
could materially and adversely affect our results of operations.
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. In addition, 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
against potential product liability claims, we will be exposed to significant liabilities, which
may harm our business. These liabilities could prevent or interfere with our product
commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert
management attention and might result in adverse publicity or reduced
acceptance of our product candidates in
the market.
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Our operations involve hazardous materials and we must comply with environmental laws and
regulations, which can be expensive.
Our research and development activities involve the controlled use of hazardous materials,
including chemicals and radioactive and biological materials. Our operations also produce hazardous
waste products. We are subject in the United States to a variety of federal, state and local
regulations, and in Europe to European, national, state and local regulations, relating to the use,
handling, storage and disposal of these materials. We generally contract with third parties for the
disposal of such substances and store certain low-level radioactive waste at our facility until the
materials are no longer considered radioactive. We cannot eliminate the risk of accidental
contamination or injury from these materials. We may be required to incur substantial costs to
comply with current or future environmental and safety regulations. If an accident or contamination
occurred, we would likely incur significant costs associated with civil penalties or criminal fines
and in complying with environmental laws and regulations. We do not have any insurance for
liabilities arising from hazardous materials. Compliance with environmental laws and regulations is
expensive, and current or future environmental regulation may impair our research, development or
production efforts.
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.
The product candidates that we may develop may not gain market acceptance among physicians,
healthcare payors, patients and the medical community. Market acceptance of and demand for any
product candidate that we may develop will depend on many factors, including:
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our ability to provide acceptable evidence of safety and efficacy; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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availability of alternative treatments; |
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cost effectiveness; |
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effectiveness of our marketing strategy and the pricing of any product candidate that we may develop; |
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publicity concerning our product candidates or competitive products; and |
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our ability to obtain third-party coverage or reimbursement. |
Legislative or regulatory reform of the healthcare system may affect our ability to sell our
approved product candidates profitably.
In both the United States and certain foreign jurisdictions, there have been a number of
legislative and regulatory changes to the healthcare system in ways that could impact upon our
ability to sell our approved product candidates profitably. In the United States in recent years, new legislation has
been enacted at the federal and state levels that would effect major changes in the healthcare
system, either nationally or at the state level. These new laws include a prescription drug benefit
for Medicare beneficiaries and certain changes in Medicare reimbursement. Given the recent
enactment of these laws, it is still too early to determine its impact on the pharmaceutical
industry and our business. Further federal and state proposals are likely. More recently,
administrative proposals are pending and others have become effective that would change the method
for calculating the reimbursement of certain drugs. The adoption of these proposals and potential
adoption of pending proposals may affect our ability to raise capital, obtain additional
collaborators or market our approved product candidates. Such proposals may reduce our revenues, increase our expenses
or limit the markets for our approved product candidates. In particular, we expect to experience pricing pressures in
connection with the sale of our approved product candidates due to the trend toward managed health care, the
increasing influence of health maintenance organizations and additional legislative proposals.
Risks Relating to Our Intellectual Property and Litigation
Our success depends on our ability to maintain and enforce our licensing arrangements with various
third party licensors.
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We are party to intellectual property licenses and agreements that are important to our
business and expect to enter into similar licenses and agreements in the future. These licenses and
agreements impose various research, development, commercialization, sublicensing, royalty,
indemnification, insurance and other obligations on us. If we or our collaborators fail to perform
under these agreements or otherwise breach obligations thereunder, we could lose intellectual
property rights that are important to our business.
We may become involved in expensive patent litigation or other intellectual property proceedings,
which could result in liability for damages or require us to stop our development and
commercialization efforts.
There has been significant litigation in the biotechnology industry over patents and other
proprietary rights. Our patents and patents that we have licensed the rights to may be the subject
of other challenges by our competitors in Europe, the United States and elsewhere. Furthermore, our
patents and the patents that we have licensed the rights to may be circumvented, challenged,
narrowed in scope, declared invalid, or unenforceable. Legal standards relating to the scope of
claims and the validity of patents in the biotechnology field are still evolving, and no assurance
can be given as to the degree of protection any patents issued to or licensed to us would provide.
The defense and prosecution of intellectual property suits and related legal and administrative
proceedings can be both costly and time consuming. Litigation and interference proceedings could
result in substantial expense to us and significant diversion of effort by our technical and
management personnel. Further, 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. This is especially true in biotechnology related patent cases
that may turn on the testimony of experts as to technical facts upon which experts may reasonably
disagree. An adverse determination in an interference proceeding or litigation to which we may
become a party could subject us to significant liabilities to third parties or require us to seek
licenses from third parties. If required, the necessary licenses may not be available on acceptable
terms or at all. Adverse determinations in a judicial or administrative proceeding or failure to
obtain necessary licenses could prevent us from commercializing our product candidates, which could
have a material and adverse effect on our business, financial condition and results of operations.
We cannot be certain we will be able to obtain additional patent protection to protect our product
candidates and technology.
We cannot be certain that patents will be issued on our product candidates as a result of
pending applications filed to date. If a third party has also filed a patent application relating
to an invention claimed by us or our licensors, we may be required to participate in an
interference proceeding in the United States or in one or more foreign jurisdictions to determine
priority of invention, which could result in substantial uncertainties and cost for us, even if the
eventual outcome is favorable to us. The degree of future protection for our proprietary rights is
uncertain. For example:
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we or our licensors might not have been the first to make the inventions covered by each
of our patents and our pending patent applications; |
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we or our licensors might not have been the first to file patent applications for these inventions; |
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others may independently develop similar or alternative technologies or duplicate any of our technologies; |
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it is possible that none of our pending patent applications will result in issued patents; |
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any patents under which we hold rights may not provide us with a basis for
commercially-viable products, may not provide us with any competitive advantages or may be
challenged by third parties as not infringed, invalid, or unenforceable under United States
or foreign laws; |
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any of the issued patents under which we hold rights may not be valid or enforceable; or |
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we may develop additional proprietary technologies that are not patentable and which may
not be adequately protected through trade secrets, for example, if a competitor
independently develops duplicative, similar, or alternative technologies. |
If we are not able to protect and control our unpatented trade secrets, know-how and other
technological innovation, we may suffer competitive harm.
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We also rely on proprietary trade secrets and unpatented know-how to protect our research,
development and manufacturing activities, 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 a confidentiality and non-use agreement. We cannot guarantee that these
agreements will provide meaningful protection, that these agreements will not be breached, that we
will have an adequate remedy for any such breach, or that our trade secrets will not otherwise
become known or independently developed by a third party. Our trade secrets, and those of our
present or future collaborators that we utilize by agreement, may become known or may be
independently discovered by others, which could adversely affect the competitive position of our
product candidates.
If
our product candidates violate third party patents or were derived from a patients cell lines without the
patients consent, we could be forced to pay royalties or cease
selling our approved product candidates.
Our commercial success will depend in part on not infringing the patents or violating the
proprietary rights of third parties. We are aware of competing intellectual property relating to
our areas of practice. Competitors or third parties may obtain patents that may cover subject
matter we use in developing the technology required to bring our
product candidates to market, that we use in
producing our product candidates, or that we use in treating patients
with our product candidates.
In addition, from time to time we receive correspondence inviting us to license patents from
third parties. 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.
While we believe that our pre-commercialization activities fall within the scope of an available
exemption against patent infringement provided by 35 U.S.C. § 271(e), and that our subsequent
manufacture of our commercial products, if any, will also not require the license of any of these
patents, claims may be brought against us in the future based on these or other patents held by
others.
Third parties could bring legal actions against us claiming we infringe their patents or
proprietary rights, and seek monetary damages and seeking to enjoin clinical testing, manufacturing
and marketing of the affected product candidates or products. If we become involved in any litigation, it
could consume a substantial portion of our resources, regardless of the outcome of the litigation.
If any of these actions are successful, in addition to any potential liability for damages, we
could be required to obtain a license to continue to manufacture or
market the affected product candidates or products, in
which case we may be required to pay substantial royalties or grant cross-licenses to our patents.
However, there can be no assurance that any such license will be available on acceptable terms or
at all. Ultimately, we could be prevented from commercializing a
product candidate, or forced to cease some
aspect of our business operations, as a result of claims of patent infringement or violation of
other intellectual property rights, which could harm our business.
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, patent applications are secret until patents are published in the United
States or foreign countries, and in certain circumstances applications are not published until a
patent issues, so it may not be possible to be fully informed of all relevant third party patents.
Publication of discoveries in the scientific or patent literature often lags behind actual
discoveries. All issued patents are entitled to a presumption of validity under the laws of the
United States and certain other countries. Issued patents held by others may therefore limit our
ability to develop commercial products. If we need licenses to such patents to permit us to develop
or market our product candidates, we may be required to pay significant fees or royalties and we
cannot be certain that we would be able to obtain such licenses at all.
We may incur substantial costs enforcing our patents, defending against third-party patents,
invalidating third-party patents or licensing third-party intellectual property, as a result of
litigation or other proceedings relating to patent and other intellectual property rights.
We may not have rights under some patents or patent applications that may cover technologies
that we use in our research, drug targets that we select, or product candidates that we seek to
develop and commercialize. Third parties may own or control these patents and patent applications
in the United States, the European Union or any other countries. These third parties could bring claims against us, or our
collaborators that would cause us to incur substantial expenses and, if successful against us,
could cause us to pay substantial damages. Further, if a patent infringement suit were brought
against us, or our collaborators, we or they could be forced to stop or delay research,
development, manufacturing or sales of the product or product candidate that is the subject of the
suit. We, or our collaborators therefore 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. These
licenses may not 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.
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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.
There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries. Although we are
not currently a party to any patent litigation or any other adversarial proceeding, including any
interference proceeding declared before the United States Patent and Trademark Office, regarding
intellectual property rights with respect to our product candidates and technology, we may become so in the
future. We are not currently aware of any actual or potential third party infringement claim
involving our product candidates. The cost to us of any patent litigation or other proceeding, even
if resolved in our favor, could be substantial. 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. If a patent or other proceeding is resolved against us, we may be enjoined from
researching, developing, manufacturing or commercializing our product
candidates without a license from the
other party and we may be held liable for significant damages. We may not be able to obtain any
required license on commercially acceptable terms or at all.
Uncertainties resulting from the initiation and continuation of patent litigation or other
proceedings could harm our ability to compete in the marketplace. Patent litigation and other
proceedings may also absorb significant management time.
We
may not be successful in our efforts to expand our portfolio of
product candidates and develop additional
delivery technologies.
A key element of our strategy is to discover, develop and commercialize a portfolio of new
drugs and technologies to deliver those drugs safely and efficiently. We are seeking to do so
through our internal research programs and in-licensing. A significant portion of the research that
we are conducting involves new and unproven technologies. Research programs to identify new disease
targets, product candidates and delivery technologies require substantial technical, financial and
human resources whether or not any candidates or technologies are ultimately identified. Our
research programs may initially show promise in identifying potential product candidates or
delivery technologies, yet fail to yield product candidates or delivery technologies for clinical
development for any of the following reasons:
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research methodology used may not be successful in identifying potential product candidates; |
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potential delivery technologies may not safely or efficiently
deliver our product candidates; and |
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product candidates may on further study be shown to have
adverse side effects or other
characteristics that indicate they are unlikely to be safe or effective. |
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.
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.
The following factors are important to our success:
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receiving patent protection for our product candidates; |
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preventing others from infringing our intellectual property rights; |
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maintaining our patent rights and trade secrets; and |
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protecting our trademarks. |
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We will be able to protect our intellectual property rights in patents and trade secrets from
unauthorized use by third parties only to the extent that such intellectual property rights are
covered by valid and enforceable patents or are effectively maintained as trade secrets.
To date, we have sought to protect our proprietary positions by
filing U.S., European Union and foreign patent
applications related to our important proprietary technology, inventions and improvements. 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. Patents, if
issued, may be challenged, invalidated or circumvented. 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 and foreign patents may be subject to
opposition or comparable proceedings in corresponding foreign patent offices, which proceedings
could result in either loss of the patent or 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. In addition, such
interference, reexamination and opposition proceedings may be costly. Thus, any patents that we own
or license from others may not provide any protection against competitors. Furthermore, an adverse
decision in an interference proceeding can result in a third-party receiving the patent rights
sought by us, which in turn could affect our ability to market a potential product to which that
patent filing was directed. Our pending patent applications, those that we may file in the future,
or those that we may license from third parties may not 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. We rely on third-party payment services for the
payment of foreign patent annuities and other fees. Non-payment or delay in payment of such fees,
whether intentional or unintentional, may result in loss of patents or patent rights important to
our business. 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 protection, which makes it difficult to stop infringement.
In addition, our ability to enforce our patent rights depends on our ability to detect
infringement. We are not currently aware of any actual or potential infringement claim involving
our intellectual property rights. It is difficult to detect infringers who do not advertise the
compounds that are used in their products. Any litigation to enforce or defend our patent rights,
even if we prevail, could be costly and time-consuming and would divert the attention of management
and key personnel from business operations.
We have also relied on trade secrets, know-how and technology, which are not protected by
patents, to maintain our competitive positions. We have sought to protect this information by
entering into confidentiality agreements with parties that have access to it, such as strategic
partners, collaborators, employees and consultants. Any of these parties may breach these
agreements and disclose our confidential information or our competitors might learn of the
information in some other way. If any trade secret, know-how or other technology not protected by a
patent were disclosed to, or independently developed by a competitor, our business, financial
condition and results of operations could be materially adversely affected.
If licensees or assignees of our intellectual property rights breach any of the agreements under
which we have licensed or assigned our intellectual property to them, we could be deprived of
important intellectual property rights and future revenue.
We are a party to intellectual property out-licenses, collaborations and agreements that are
important to our business and expect to enter into similar agreements with third parties in the
future. Under these agreements, we license or transfer intellectual property to third parties and
impose various research, development, commercialization, sublicensing, royalty, indemnification,
insurance, and other obligations on them. If a third party fails to comply with these requirements,
we generally retain the right to terminate the agreement, and to bring a legal action in court or
in arbitration. In the event of breach, we may need to enforce our rights under these agreements by
resorting to arbitration or litigation. During the period of arbitration or litigation, we may be
unable to effectively use, assign or license the relevant intellectual property rights and may be
deprived of current or future revenues that are associated with such intellectual property.
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
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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, which would adversely affect commercial development efforts.
We may become involved in securities class action litigation that could divert managements
attention and harm our business.
The stock market has from time to time experienced significant price and volume fluctuations
that have affected the market prices for the common stock of pharmaceutical and biotechnology
companies. These broad market fluctuations may cause the market price of our common stock to
decline. In the past, following periods of volatility in the market price of a particular companys
securities, securities class action litigation has often been brought against that company. We may
become involved in this type of litigation in the future. Litigation often is expensive and diverts
managements attention and resources, which could adversely affect our business.
Risks Relating to the Merger
We will need to modify our finance and accounting systems, procedures and controls to integrate the
operations of CancerVax into the operations of Micromet, which modifications may be time consuming
and expensive to implement, and there is no guarantee that we will be able to do so.
As a public reporting company, we are required to comply with the Sarbanes-Oxley Act of 2002
and the related rules and regulations of the Securities and Exchange Commission, including Section
404 of the Sarbanes-Oxley Act of 2002. As a result of the merger between CancerVax and Micromet AG,
we will need to upgrade the existing, and implement additional, procedures and controls to
incorporate the operations of Micromet AG. These updates may require significant time and expense,
and there can be no guarantee that we will be successful in implementing them. Furthermore, certain
of the managerial, financial and accounting personnel who worked for CancerVax prior to its merger
with Micromet AG have terminated their employment with us. The loss of these personnel could limit
our ability to successfully complete these updates. If we are unable to complete the required
modifications to our internal control reporting or if our independent registered public accounting
firm is unable to provide us with an unqualified report as to the effectiveness of our internal
control over financial reporting, 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.
Integrating our business operations may divert managements attention away from our operations.
The successful integration of CancerVax into Micromets technical and business operations may
place a significant burden on our management and internal resources. The diversion of managements
attention and any difficulties encountered in the transition and integration process could result
in delays in our clinical trials and product development programs and could otherwise harm our
business, financial condition and operating results.
If one or more of our product candidates cannot be shown to be safe and effective in clinical
trials, is not approvable or not commercially successful, then the benefits of the merger may not
be realized.
Following the merger, we have two product candidates in clinical trials, and we plan to
commence clinical trials for at least one additional product candidate in 2007. All of these
product candidates must be rigorously tested in clinical trials, and be shown to be safe and
effective before the FDA, the EMEA or other regulatory authorities. will consider them for
approval. Failure to demonstrate that one or more of our product candidates is safe and effective,
or significant delays in demonstrating such safety and efficacy, could diminish the benefits of the
merger. Failure to obtain marketing approval of one or more of our product candidates from
appropriate regulatory authorities, or significant delays in obtaining such approval, could
diminish the benefits of the merger. If approved for sale, our product candidates must be
successfully commercialized. Failure to successfully commercialize one or more of our product
candidates could diminish the benefits of the merger.
The merger may result in dilution of future earnings per share to the former stockholders of
CancerVax and Micromet.
The merger may result in greater net losses or a weaker financial condition compared to that,
which would have been achieved by either CancerVax or Micromet on a stand-alone basis. The merger
could fail to produce the benefits that the companies
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anticipated, or could have other adverse effects that the companies did not foresee. In addition,
some of the assumptions that either company made in connection with the decision to complete the
merger, such as the achievement of operating synergies, may not be realized. In this event, the
merger could result in greater losses as compared to the losses that would have been incurred by
either CancerVax or Micromet if the merger had not occurred.
Risks Relating to Our Product Manufacturing and Sales
We will depend on our collaborators and third-party manufacturers to produce most, if not all, of
our product candidates and if these third parties do not successfully manufacture these
product candidates our business will be harmed.
We have no manufacturing experience or manufacturing capabilities for clinical or commercial
material. 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. Contract manufacturers are subject to
ongoing periodic, unannounced inspection by the FDA and EMEA and corresponding state and foreign
agencies or their designees to ensure strict compliance with current good manufacturing practices
and other governmental regulations and corresponding foreign standards. Failure of contract
manufacturers or our collaborators or us to comply with applicable regulations could result in
sanctions being imposed, including fines, injunctions, civil penalties, failure of regulatory
authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal
of approvals, seizures or recalls of product candidates, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect our business. If we need to
change manufacturers, the FDA, EMEA and corresponding foreign regulatory agencies must approve
these manufacturers in advance. This would involve testing and pre-approval inspections to ensure
compliance with FDA, EMEA and other foreign regulations and standards. If third-party manufacturers
fail to perform their obligations, our competitive position and ability to generate revenue may be
adversely affected in a number of ways, including:
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we and our collaborators may not be able to initiate or continue clinical trials of
product candidates that are under development; |
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we and our collaborators may be delayed in submitting applications for regulatory
approvals for our product candidates; and |
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we and our collaborators may not be able to meet commercial demands for any approved
products. |
We have no sales or marketing experience and, as such, 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, we plan to rely primarily on sales, marketing and distribution arrangements
with third parties, including our collaborative partners. For example, as part of our agreements
with Serono and MedImmune, we have granted our collaborators rights to distribute certain 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 which 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.
Our future revenues will be materially dependent upon the success of the efforts of these third
parties.
We may seek to independently market products that are not already subject to marketing
agreements with other parties. If we determine to perform sales, marketing and distribution
functions ourselves, we could face a number of additional risks, including:
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we may not be able to attract and build a significant and skilled marketing staff or
sales force; |
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the cost of establishing a marketing staff or sales force may not be justifiable in
light of the revenues generated by any particular product; and |
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our direct sales and marketing efforts may not be successful. |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Any statements in this prospectus about our expectations, beliefs, plans, objectives,
assumptions or future events or performance that are not historical facts are forward-looking
statements. Such forward-looking statements include statements regarding the effects of the merger
between CancerVax and Micromet AG, the ongoing integration activities following the merger, the
efficacy, safety and intended utilization of our product candidates, the conduct and results of
future clinical trials, and plans regarding regulatory filings, future research and clinical trials
and plans regarding partnering activities. You can identify these forward-looking statements by the
use of words or phrases such as believe, may, could, will, estimate, continue,
anticipate, intend, seek, plan, expect, should, or would. Among the factors that
could cause actual results to differ materially from those indicated in the forward-looking
statements are risks and uncertainties inherent in our business including, without limitation,
statements about the progress and timing of our clinical trials; difficulties or delays in
development, testing, obtaining regulatory approval, producing and marketing 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; the scope and validity of patent protection for our
product candidates; competition from other pharmaceutical or biotechnology companies; our ability
to obtain additional financing to support our operations; and other risks detailed in our Annual
Report on Form 10-K for the year ended December 31, 2005 filed with the Securities and Exchange
Commission on March 16, 2006; our Quarterly Report on Form 10-Q for the quarters ended March 31,
2006 and June 30, 2006 filed with the Securities and Exchange Commission on May 10, 2006 and August
8, 2006, respectively; in the proxy statement/prospectus dated March 31, 2006, filed with the
Securities and Exchange Commission on April 3, 2006; and the discussions set forth above under the
caption Risk Factors.
Although we believe that the expectations reflected in our forward-looking statements are
reasonable, we cannot guarantee future results, events, levels of activity, performance or
achievement. We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, unless required by
law.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of shares by the selling stockholders
pursuant to this prospectus.
Some of the shares covered by this prospectus are issuable upon exercise of warrants to
purchase our common stock. Upon any exercise of the warrants for cash, the selling stockholders
would pay us the exercise price of the warrants. The cash exercise price of the warrants is $5.00
per share of our common stock. Under certain conditions set forth in the warrants, the warrants are
exercisable on a cashless basis. If any warrants are exercised on a cashless basis, we would not
receive any cash payment from the selling stockholders upon the exercise of these warrants.
SELLING STOCKHOLDERS
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly owned subsidiary of CancerVax and was the surviving
corporation in the merger. In the merger, CancerVax issued to Micromet AG stockholders shares of
CancerVax common stock. Of the shares issued to Micromet AG stockholders, 9,866,506 shares were
issued to persons and entities deemed to be affiliates of Micromet AG prior to the merger,
including officers and directors, as well as principal stockholders, of Micromet AG. Under the
merger agreement, we agreed to file a registration statement, of
which this prospectus is a part,
with the Securities and Exchange Commission to register the disposition of the shares of our common
stock that were issued to the former affiliates of Micromet AG, and to keep the registration
effective until the earlier of (a) such time as all such shares issued to former affiliates of
Micromet AG have been sold by such persons and entities, or (b) the date upon which all of the
shares issued to the former affiliates of Micromet AG first become eligible for resale pursuant to
Rule 145 under the Securities Act of 1933, as amended, without restriction.
22
On July 24, 2006, we issued 2,222,222 shares of common stock and warrants to purchase an
additional 555,556 shares of common stock in a private placement to two institutional investors
managed by NGN Capital LLC. Pursuant to a Securities Purchase Agreement related to this private
placement, we agreed to file a registration statement, of which this
prospectus is a part, with the
Securities and Exchange Commission to register the disposition of the shares of our common stock we
issued in the private placement and shares of common stock underlying
the exercise of the warrants, and
to keep the registration statement effective until the earlier of
(a) such time as all such shares, and the shares issuable upon
exercise of the warrants,
have been sold by the selling stockholders, or (b) the date upon which all of the shares, and the
shares issuable upon the exercise of the warrants, assuming net exercise of the warrants pursuant
to the provisions hereof, may be sold publicly under Rule 144(k) of the Securities Act of 1933, as
amended.
The warrants issued to the purchasers in the private placement are exercisable after January
21, 2007 at an exercise price of $5.00 per share, and expire July 24, 2012. Pursuant to conditions
set forth in the warrants, the warrants are exercisable under certain circumstances on a cashless
basis. If certain changes occur to our capitalization, such as a stock split or stock dividend of
the common stock, then the exercise price and number of shares issuable upon exercise of the
warrants will be adjusted appropriately.
We have included the shares issuable upon exercise of the warrants issued in the private
placement to the selling stockholders in this prospectus and related registration statement.
The following table sets forth:
|
|
|
the name of each of the selling stockholders; |
|
|
|
|
the number of shares of our common stock beneficially owned by each such selling stockholder prior to this offering; |
|
|
|
|
the percentage (if one percent or more) of our common stock owned by each such selling stockholder prior to this offering; |
|
|
|
|
the number of shares of our common stock being offered pursuant to this prospectus; |
|
|
|
|
the number of shares of our common stock owned upon completion of this offering; and |
|
|
|
|
the percentage (if one percent or more) of common stock owned by each such selling stockholder after this offering. |
This table is prepared based on information supplied to us by the selling stockholders,
and reflects holdings as of August 17, 2006. As used in this prospectus, the term selling
stockholder includes each of the selling stockholders listed below, 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 a
selling stockholder may offer under this prospectus. Each selling stockholder may sell some, all or
none of his or its shares. The number of shares in the column Shares of Common Stock Beneficially Owned
After Offering assumes that the selling stockholder sells all of the shares covered by this
prospectus. We do not know how long the selling stockholders will hold the shares before selling
them, and we currently have no agreements, arrangements or understandings with the selling
stockholders regarding the sale of any of the shares.
Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC
under the Securities Exchange Act of 1934, as amended. The percentage of shares beneficially owned
prior to the offering is based on 31,413,032 shares of our common stock actually outstanding as of
August 17, 2006.
Except as noted in the footnotes to the table below, no selling stockholder has had, within
the past three years, any position, office, or material relationship with us or any of our
predecessors or affiliates.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Common Stock |
|
Number of |
|
Shares of Common Stock |
|
|
Beneficially Owned |
|
Shares Being |
|
Beneficially Owned After |
|
|
Prior to Offering |
|
Offered |
|
Offering |
Security Holder |
|
Number |
|
Percent |
|
|
|
|
|
Number |
|
Percent |
Funds associated with NGN Capital LLC (1) |
|
|
2,777,778 |
(1) |
|
|
8.7 |
% |
|
|
2,777,778 |
(1) |
|
|
0 |
|
|
|
* |
|
Omega Fund I, L.P. (2) |
|
|
3,257,936 |
|
|
|
10.4 |
% |
|
|
3,257,936 |
|
|
|
0 |
|
|
|
* |
|
3i Group plc (3) |
|
|
2,940,435 |
|
|
|
9.4 |
% |
|
|
2,940,435 |
|
|
|
0 |
|
|
|
* |
|
Funds associated with Advent Venture Partners (4) |
|
|
3,528,875 |
(4) |
|
|
11.2 |
% |
|
|
3,528,875 |
(4) |
|
|
0 |
|
|
|
* |
|
Gerhard Riethmüller (5) |
|
|
221,112 |
(5) |
|
|
* |
|
|
|
105,942 |
|
|
|
115,170 |
|
|
|
* |
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Common Stock |
|
Number of |
|
Shares of Common Stock |
|
|
Beneficially Owned |
|
Shares Being |
|
Beneficially Owned After |
|
|
Prior to Offering |
|
Offered |
|
Offering |
Security Holder |
|
Number |
|
Percent |
|
|
|
|
|
Number |
|
Percent |
Patrick Baeuerle (6) |
|
|
187,049 |
(6) |
|
|
* |
|
|
|
22,563 |
|
|
|
164,486 |
|
|
|
* |
|
Christian Itin (7) |
|
|
208,768 |
(7) |
|
|
* |
|
|
|
2,885 |
|
|
|
205,883 |
|
|
|
* |
|
Gregor Mirow (8) |
|
|
145,856 |
(8) |
|
|
* |
|
|
|
7,870 |
|
|
|
137,986 |
|
|
|
* |
|
|
TOTAL |
|
|
13,267,809 |
|
|
|
41.4 |
% |
|
|
12,644,284 |
|
|
|
623,525 |
|
|
|
1.9 |
% |
* |
|
Represents less than 1%. |
|
(1) |
|
Includes 1,289,778 shares held of record by NGN BioMed Opportunity I, L.P. and a warrant held
by NGN BioMed Opportunity I, L.P. to purchase 322,445 shares. Also includes 932,444 shares
held of record by NGN Biomed Opportunity I GmbH & Co. Beteiligungs KG and a warrant held by
NGN Biomed Opportunity I GmbH & Co. Beteiligungs KG to purchase 233,111 shares. Peter Johann,
Ph.D., a Managing General Partner of NGN Capital LLC, which is the sole general partner of
the general partner of NGN BioMed Opportunity I, L.P. and the managing limited partner of NGN
Biomed Opportunity I GmbH & Co. Beteiligungs KG, is a member of our board of directors. Dr.
Johann disclaims beneficial ownership of these shares except to the extent of his pecuniary
interest in the named fund. The foregoing information is based upon information contained in
a Schedule 13D filed with the SEC by the foregoing entities on August 3, 2006. |
|
(2) |
|
Otello Stampacchia is a member of our board of directors and is the Chief Investment Advisor
of Omega Fund I, L.P. As a result, Mr. Stampacchia shares voting and dispositive power with
respect to the shares held by this entity and disclaims beneficial ownership of the shares in
which he has no pecuniary interest. Mr. Stampacchia was also a
member of the supervisory board of Micromet AG prior to the merger. |
|
(3) |
|
An individual associated with 3i Group plc was a member of the supervisory board of Micromet
AG prior to the merger. |
|
(4) |
|
Consists of 1,785,787 shares held of record by Advent Private Equity Fund III A Limited
Partnership, 874,759 shares held of record by Advent Private Equity Fund III B Limited
Partnership, 244,118 shares held of record by Advent Private Equity Fund III C Limited
Partnership, 480,071 shares held of record by Advent Private Equity Fund III D Limited
Partnership, 69,111 shares held of record by Advent Private Equity Fund III GmbH & Co KG,
57,189 shares held of record by Advent Private Equity Fund III Affiliates Limited Partnership,
and 17,840 shares held of record by Advent Management III Limited Partnership. Jerry
Benjamin, a member of our board of directors, is a general partner of each of the foregoing
entities, and as a result, Mr. Benjamin shares voting and dispositive power with respect to
the shares held by these entities and disclaims beneficial ownership of the shares in which he
has no pecuniary interest. Mr. Benjamin was also a
member of the supervisory board of Micromet AG prior to the merger. |
|
(5) |
|
Dr. Riethmüller was a member of the supervisory board of Micromet AG prior to the merger.
Consists of 105,942 shares held of record by Dr. Riethmüller and options to purchase 115,170
shares that are exercisable within 60 days of August 17, 2006. |
|
(6) |
|
Dr. Baeuerle is our Senior Vice President and Chief Scientific Officer and was an executive
officer of Micromet AG prior to the merger. Consists of 22,563 shares held of record by Dr.
Baeuerle and options to purchase 164,486 shares that are exercisable within 60 days of August
17, 2006. |
|
(7) |
|
Dr. Itin is our President and Chief Executive Officer and a member of our board of directors.
Dr. Itin was an executive officer of Micromet AG prior to the merger. Consists of 2,885
shares held of record by Dr. Itin and options to purchase 205,883 shares that are exercisable
within 60 days of August 17, 2006. |
|
(8) |
|
Mr. Mirow is our Senior Vice President of Operations. Mr. Mirow was an executive officer of
Micromet AG prior to the merger. Consists of 7,870 shares held of record by Mr. Mirow and
options to purchase 137,986 shares that are exercisable within 60 days of August 17, 2006. |
24
PLAN OF DISTRIBUTION
The selling stockholders may, from time to time, sell any or all of their shares of common
stock on any stock exchange, market or trading facility on which the shares are traded or in
private transactions. These sales may be at fixed or negotiated prices. The selling stockholders
may use any one or more of the following methods when selling shares:
|
|
|
ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers; |
|
|
|
|
block trades in which the broker-dealer will attempt to sell the shares as
agent but may position and resell a portion of the block as principal to
facilitate the transaction; |
|
|
|
|
purchases by a broker-dealer as principal and resale by the broker-dealer for
its account under this prospectus; |
|
|
|
|
an exchange distribution in accordance with the rules of the applicable exchange; |
|
|
|
|
privately negotiated transactions; |
|
|
|
|
short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
|
|
|
|
broker-dealers may agree with the selling stockholders to sell a specified
number of such shares at a stipulated price per share; |
|
|
|
|
a combination of any such methods of sale; and |
|
|
|
|
any other method permitted pursuant to applicable law. |
The selling stockholders may also sell shares under Rule 144 or Rule 145(d) under the
Securities Act, if available, rather than under this prospectus, provided that they meet the
criteria and conform to the requirements of the applicable rule.
Broker-dealers engaged by the selling stockholders may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the selling
stockholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated. The selling stockholders do not expect these commissions
and discounts to exceed what is customary in the types of transactions involved. Any profits on
the resale of shares of common stock by a broker-dealer acting as principal might be deemed to be
underwriting discounts or commissions under the Securities Act. Discounts, concessions,
commissions and similar selling expenses, if any, attributable to the sale of shares will be borne
by a selling stockholder. The selling stockholders may agree to indemnify any agent, dealer or
broker-dealer that participates in transactions involving sales of the shares if liabilities are
imposed on that person under the Securities Act.
The selling stockholders may from time to time pledge or grant a security interest in some or
all of the shares of common stock owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer and sell the shares of common stock
from time to time under this prospectus after we have filed a supplement to this prospectus under
Rule 424(b)(3) or other applicable provision of the Securities Act of 1933 supplementing or
amending the list of selling stockholders to include the pledgee, transferee or other successors in
interest as selling stockholders under this prospectus.
The selling stockholders also may transfer the shares of common stock in other circumstances,
in which case the transferees, pledgees or other successors in interest will be the selling
beneficial owners for purposes of this prospectus and may sell the shares of common stock from time
to time under this prospectus after we have filed a supplement to this prospectus under Rule
424(b)(3) or other applicable provision of the Securities Act of 1933 supplementing or amending the
list of selling stockholders to include the pledgee, transferee or other successors in interest as
selling stockholders under this prospectus.
The selling stockholders and any broker-dealers or agents that are involved in selling the
shares of common stock may be deemed to be underwriters within the meaning of the Securities Act
in connection with such sales. In such event, any commissions received by such broker-dealers or
agents and any profit on the resale of the shares of common stock purchased by them may be deemed
to be underwriting commissions or discounts under the Securities Act.
25
We are required to pay all fees and expenses incident to the registration of the shares of
common stock. We have agreed to indemnify the selling stockholders against certain losses, claims,
damages and liabilities, including liabilities under the Securities Act.
The selling stockholders have advised us that they have not entered into any agreements,
understandings or arrangements with any underwriters or broker-dealers regarding the sale of their
shares of common stock, nor is there an underwriter or coordinating broker acting in connection
with a proposed sale of shares of common stock by any selling stockholder. If we are notified by
any selling stockholder that any material arrangement has been entered into with a broker-dealer
for the sale of shares of common stock, if required, we will file a supplement to this prospectus.
If the selling stockholders use this prospectus for any sale of the shares of common stock, they
will be subject to the prospectus delivery requirements of the Securities Act.
The anti-manipulation rules of Regulation M under the Securities Exchange Act of 1934 may
apply to sales of our common stock and activities of the selling stockholders.
LEGAL MATTERS
The validity of the securities being offered hereby will be passed upon by Cooley Godward LLP,
Reston, Virginia.
EXPERTS
The financial statements of Micromet AG at December 31, 2005 and 2004, and for each of the
three years in the period ended December 31, 2005, included in the registration statement and
related proxy statement/ prospectus of CancerVax Corporation, which are incorporated by reference
and made a part of this Prospectus and Registration Statement, have been audited by Ernst & Young
AG, Wirtschaftsprüfungsgesellschaft, independent auditors, as set forth in their report (which
contains an explanatory paragraph describing conditions that raise substantial doubt about Micromet
AGs ability to continue as a going concern as described in Note 2 to the financial statements)
incorporated by reference herein, and are included in reliance upon such report given on the
authority of such firm as experts in accounting and auditing.
Ernst & Young LLP, independent registered public accounting firm, has audited the consolidated
financial statements of CancerVax Corporation included in its Annual Report on Form 10-K for the
year ended December 31, 2005, and managements assessment of the effectiveness of internal control
over financial reporting of CancerVax Corporation as of December 31, 2005, as set forth in their
report, which is incorporated by reference in this prospectus and elsewhere in the registration
statement. Our financial statements and managements assessment of CancerVax Corporation are
incorporated by reference in reliance on Ernst & Young LLPs reports, given on their authority as
experts in accounting and auditing.
MATERIAL CHANGES
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders shares of CancerVax common
stock and CancerVax assumed all of the stock options, stock warrants and restricted stock of
Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet AG stockholders,
option holders, warrant holders and note holders owned, as of the closing, approximately 67.5% of
the combined company on a fully-diluted basis and former CancerVax stockholders, option holders and
warrant holders owned, as of the closing, approximately 32.5% of the combined company on a
fully-diluted basis. In connection with the merger, CancerVax was renamed Micromet, Inc.
Included below is an unaudited pro forma condensed combined statement of operations for the six
months ended June 30, 2006, which reflects financial results as if the merger had taken place on
January 1, 2006.
UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS
The following unaudited pro forma condensed combined statement of operations gives effect to
the merger between CancerVax Corporation and Micromet AG. For accounting purposes, Micromet AG is
considered to have acquired CancerVax in the transaction. Accordingly, the purchase price is
allocated among the fair values of the assets and liabilities of CancerVax, while the historical
results of Micromet AG are reflected in the results of the combined company. The transaction was
accounted for under the purchase method of accounting in accordance with Statement of Financial
Accounting Standards, or SFAS, No. 141, Business Combinations. Under the purchase method of
accounting, the total purchase price, calculated as described in Note 2 to this unaudited
26
pro forma condensed combined statement of operations, was allocated to the tangible and intangible
assets acquired and liabilities assumed in connection with the transaction based on their estimated
fair values as of the completion of the transaction. The excess of the purchase price over the
fair value of assets acquired and liabilities assumed is allocated to goodwill. Our unaudited
balance sheet as of June 30, 2006, which reflects the completion of the transaction, is
incorporated herein by reference from our Form 10-Q for the quarter ended June 30, 2006, and our
pro forma statement of operations for the year ended December 31, 2005 is incorporated by reference
to CancerVaxs proxy statement/prospectus dated March 31, 2006. Accordingly, the only pro forma
financial statement presented herein is our pro forma statement of operations for the six months
ended June 30, 2006.
For
purposes of this unaudited pro forma condensed combined statement of operations, management has made a
preliminary allocation of the total purchase price to the tangible and intangible assets acquired
and liabilities assumed based on their fair values as of the merger date, as described in Note 2 to
this unaudited pro forma condensed combined statement of operations.
The unaudited pro forma condensed combined statement of operations presented below is based
upon the historical statements of operations of CancerVax and
Micromet, Inc. formerly Micromet AG,
adjusted to give effect to the acquisition of CancerVax by Micromet AG for accounting purposes. The
pro forma adjustments are described Note 3 to this unaudited pro forma condensed combined statement
of operations.
The unaudited pro forma condensed combined statement of operations for the six months ended
June 30, 2006 is presented as if the transaction was consummated on January 1, 2006 and combines
the historical results of CancerVax and Micromet Inc. for the six months ended June 30, 2006. The
historical results of Micromet, Inc., were derived from its unaudited statement of operations for
the six months ended June 30, 2006 incorporated herein. The historical results of CancerVax were
derived from CancerVaxs unaudited consolidated statement of operations and are not included or
incorporated herein for the period January 1 to May 4, 2006.
The unaudited pro forma condensed combined statement of operations has been prepared by
management for illustrative purposes only and is not necessarily indicative of the results of
operations in future periods or the results that actually would have been realized had CancerVax
and Micromet, Inc. been a combined company during the specified period. The unaudited pro forma
condensed combined statement of operations, including the notes thereto, is qualified in its
entirety by reference to, and should be read in conjunction with, the historical financial
statements of CancerVax and Micromet AG for the year ended December 31, 2005 and of Micromet, Inc.
of the six months ended June 30, 2006, which are incorporated by reference herein.
27
Unaudited Pro Forma Condensed Combined Statement of Operations
For the Six Months Ended June 30, 2006
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Micromet |
|
|
CancerVax |
|
|
Pro Forma |
|
|
|
|
|
|
Pro Forma |
|
|
|
Historical |
|
|
Historical(1) |
|
|
Adjustments |
|
|
|
|
|
|
Combined |
|
Revenues |
|
$ |
9,140 |
|
|
$ |
452 |
|
|
|
|
|
|
|
|
|
|
$ |
9,592 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
14,032 |
|
|
|
2,480 |
|
|
|
(53 |
) |
A |
|
|
|
|
|
16,459 |
|
In-process research and development |
|
|
20,890 |
|
|
|
|
|
|
|
(20,890 |
) |
B |
|
|
|
|
|
|
|
General and administrative |
|
|
5,200 |
|
|
|
6,603 |
|
|
|
(10 |
) |
A |
|
|
|
|
|
10,636 |
|
|
|
|
|
|
|
|
|
|
|
|
(1,157 |
) |
E |
|
|
|
|
|
|
|
Restructuring charges |
|
|
|
|
|
|
3,658 |
|
|
|
|
|
|
|
|
|
|
|
3,658 |
|
Impairment of long-lived assets |
|
|
|
|
|
|
577 |
|
|
|
|
|
|
|
|
|
|
|
577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
40,122 |
|
|
|
13,318 |
|
|
|
(22,110 |
) |
|
|
|
|
|
|
31,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(639 |
) |
|
|
170 |
|
|
|
(32 |
) |
C |
|
|
|
|
|
(400 |
) |
|
|
|
|
|
|
|
|
|
|
|
101 |
|
D |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(31,621 |
) |
|
$ |
(12,696 |
) |
|
$ |
22,179 |
|
|
|
|
|
|
$ |
(22,138 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(1.47 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(0.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shared used to compute
basic and diluted net loss per share |
|
|
21,529 |
|
|
|
|
|
|
|
6,478 |
|
F |
|
|
|
|
|
28,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Reflects CancerVax historical results of operations for the period from January 1, 2006
through May 4, 2006. |
Notes to Unaudited Pro Forma Condensed Combined Statement of Operations
1. Basis of Presentation
On May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a privately-held
German company, pursuant to which CancerVaxs wholly owned subsidiary, Carlsbad Acquisition
Corporation, merged with and into Micromet Holdings, Inc., a newly created parent corporation of
Micromet AG. Micromet Holdings became a wholly owned subsidiary of CancerVax and was the surviving
corporation in the merger. CancerVax issued to Micromet AG stockholders shares of CancerVax common
stock and CancerVax assumed all of the stock options, stock warrants and restricted stock of
Micromet Holdings outstanding as of May 5, 2006, such that the former Micromet AG stockholders,
option holders, warrant holders and note holders owned, as of the closing, approximately 67.5% of
the combined company on a fully-diluted basis and former CancerVax stockholders, option holders and
warrant holders owned, as of the closing, approximately 32.5% of the combined company on a
fully-diluted basis. In connection with the merger, CancerVax was renamed Micromet, Inc.
As former Micromet AG security holders own approximately 67.5% of the voting stock of the
combined company after the merger, Micromet AG is deemed to be the acquiring company for accounting
purposes and the transaction was accounted for as a reverse acquisition under the purchase method
of accounting for business combinations in accordance with accounting principles generally accepted
in the United States. Accordingly, CancerVaxs assets and liabilities are recorded as of the
merger closing date at their estimated fair values.
28
2. Purchase Price
The fair value of the 9,380,457 outstanding shares of CancerVax common stock used in
determining the purchase price was $41.0 million or $4.38 per share, based on the average of the
closing prices for a range of trading days (January 5, 2006 through January 11, 2006, inclusive)
around and including the announcement date of the merger transaction. The fair value of the
CancerVax stock options and stock warrants assumed by Micromet was determined using the
Black-Scholes option pricing model with the following assumptions: stock price of $4.38, which is
the value ascribed to the CancerVax common stock in determining the purchase price; volatility of
75%; dividend rate of 0%; risk-free interest rate of 4.0%; and a weighted average expected option
life of 0.88 years.
The purchase price is summarized as follows (in thousands):
|
|
|
|
|
Fair value of CancerVax common stock |
|
$ |
41,030 |
|
Estimated fair value of CancerVax stock options and stock warrants assumed |
|
|
710 |
|
Estimated transaction costs incurred by Micromet |
|
|
2,257 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
Under the purchase method of accounting, the total purchase price is allocated to the
acquired tangible and intangible assets and assumed liabilities of CancerVax based on their
estimated fair values as of the merger closing date. The excess of the purchase price over the fair
value of assets acquired and liabilities assumed is allocated to goodwill.
The preliminary allocation of the total purchase price, as shown above, to the acquired
tangible and intangible assets and assumed liabilities of CancerVax based on their fair values as
of the merger date are as follows (in thousands):
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,645 |
|
Receivables under collaborations |
|
|
447 |
|
Restricted cash |
|
|
2,280 |
|
Other assets |
|
|
569 |
|
Accounts payable |
|
|
(2,639 |
) |
Accrued expenses |
|
|
(5,764 |
) |
Current portion of long-term debt obligations |
|
|
(16,816 |
) |
Long-term liabilities |
|
|
(1,532 |
) |
|
|
|
|
Net book value of acquired assets and liabilities |
|
|
16,190 |
|
In-process research and development |
|
|
20,890 |
|
Goodwill |
|
|
6,917 |
|
|
|
|
|
Total purchase price |
|
$ |
43,997 |
|
|
|
|
|
The acquired in-process research and development (IPR&D) projects consists of the
following: D93 and other denatured collagen related anti-angiogenesis programs that potentially
target various solid tumors; SAI-EGF and related programs that target the epidermal growth factor
receptor, or, EGFR, signaling pathway that potentially target non-small cell lung cancer and
various solid tumors; GD2, a humanized, monoclonal antibody that appears to target tumor-associated
antigens that are expressed in a variety of solid tumor cancers; and certain other non-denatured
collagen related humanized, monoclonal antibodies and peptides that potentially target various
solid tumors.
The fair value of the IPR&D projects was determined utilizing the income approach, assuming
that the rights to the IPR&D projects will be sub-licensed to third parties in exchange for certain
up-front, milestone and royalty payments, and the combined company will have no further involvement
in the ongoing development and commercialization of the projects. Under the income approach, the
expected future net cash flows from sub-licensing for each IPR&D project are estimated,
risk-adjusted to reflect the risks inherent in the development process and discounted to their net
present value. Significant factors considered in the calculation of the discount rate are the
weighted-average cost of capital and return on assets. Management believes that the discount rate
utilized is consistent with the projects stage of development and the uncertainties in the
estimates described above. Because the acquired
IPR&D projects are in the early stages of the development cycle, the amount allocated to IPR&D was
recorded as an expense immediately upon completion of the merger.
We expect to finalize our purchase price allocation by May 2007.
29
3. Pro Forma Adjustments
The unaudited pro forma condensed combined statement of operations includes certain pro forma
adjustments to give effect to certain significant capital transactions of Micromet occurring as a
direct result of the merger, and the acquisition of CancerVax by Micromet for accounting purposes.
The unaudited pro forma condensed combined statement of operations does not include any
adjustments for income taxes as the combined company is anticipated to incur taxable losses for the
foreseeable future.
The pro forma adjustments are as follows (in thousands, except share and per share amounts):
(A) To eliminate the historical depreciation expense on property and equipment recognized by
CancerVax for the six months ended June 30, 2006. The depreciation expense associated with the
value of CancerVax property and equipment acquired in the merger has not been reflected in the pro
forma statement of operations because there has been no value
assigned to the assets during purchase accounting and, therefore, the depreciation expense will not have a material impact on
continuing operations.
(B) To eliminate the estimated fair value of in-process research and development acquired in
the merger. Because the in-process research and development charge is directly attributable to the
merger and will not have a continuing impact, it is being eliminated in the pro forma statement of
operations.
(C) To
eliminate the estimated interest income earned during the six months ended June 30,
2006 by Micromet as a result of borrowing approximately
2.0 million, or
$2.5 million, from Technologie-Beteiligungs-Gesellschaft mbH, or
tbg,
in lieu of using existing cash and cash equivalents.
(D) To eliminate the interest expense recognized during the six months ended June 30, 2006
associated with certain of Micromets long-term debt obligations with tbg as a result of the
settlement of the debt upon completion of the merger.
(E) To eliminate the severance obligations due to David F. Hale, CancerVaxs President and
Chief Executive Officer, and certain other CancerVax employees upon completion of the merger. Mr.
Hales employment was terminated effective upon completion of the merger, although Mr. Hale is
continuing as the chairman of the board of directors of the combined company. Because the expense
associated with the severance obligation is directly attributable to the merger and will not have a
continuing impact, it is being eliminated in the pro forma statement of operations.
(F) To
reflect the pro rata portion of the 9,380,457 shares held by CancerVax stockholders immediately prior to the
merger as if they were all outstanding as of January 1, 2006.
WHERE YOU CAN FIND MORE INFORMATION
We file electronically with the Securities and Exchange Commission 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 Securities Exchange Act of
1934. 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 (760) 494-4235
or sending an email to investors@micromet-inc.com. You may read and copy any document we file at
the SECs 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 SECs
Internet site can be found at http://www.sec.gov.
We incorporate by reference into this prospectus the documents listed below and any future
filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange
Act of 1934, including any filings after the date of this prospectus but before the end of any
offering made under this prospectus. 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:
|
|
|
our current report on Form 8-K filed by CancerVax with the SEC on
January 9, 2006 (except for the information furnished under Item 7.01 or any
related exhibit); |
30
|
|
|
our annual report on Form 10-K for the year ended December 31, 2005
filed by CancerVax with the SEC on March 16, 2006; |
|
|
|
|
our current report on Form 8-K filed by CancerVax with the SEC on March 20, 2006; |
|
|
|
|
our current report on Form 8-K filed by CancerVax with the SEC on March 24, 2006; |
|
|
|
|
our current report on Form 8-K filed by CancerVax with the SEC on March 31, 2006; |
|
|
|
|
information included in the proxy statement/prospectus filed by
CancerVax pursuant to Rule 424(b)(3) of the Securities Act with the SEC on April
3, 2006 (Reg. No. 333-131817) under the headings Micromet Selected Historical
Consolidated Financial Data, Unaudited Pro Forma Condensed Combined Financial
Statements, Micromet Executive Compensation and Other Information, Management
of the Combined Company After the Merger, Certain Relationships and Related
Transactions, Combined Company Security Ownership by Certain Beneficial
Owners, Information Regarding Micromets Business, Managements Discussion
and Analysis of Financial Condition and Results of Operations of Micromet and
Micromet Quantitative and Qualitative Disclosures About Market Risk, and the
audited financial statements of Micromet AG contained therein; |
|
|
|
|
our current report on Form 8-K filed by CancerVax with the SEC on April 20, 2006; |
|
|
|
|
our current report on Form 8-K filed by CancerVax with the SEC on May 1, 2006; |
|
|
|
|
our current report on Form 8-K filed with the SEC on May 9, 2006; |
|
|
|
|
our quarterly report on Form 10-Q for the quarterly period ended
March 31, 2006 filed with the SEC on May 10, 2006; |
|
|
|
|
our current report on Form 8-K filed with the SEC on May 11, 2006
(except for the information furnished under Item 2.02 or any related exhibit); |
|
|
|
|
our current report on Form 8-K filed with the SEC on July 26, 2006; |
|
|
|
|
our quarterly report on Form 10-Q for the quarterly period ended
June 30, 2006 filed with the SEC on August 8, 2006; and |
|
|
|
|
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 by CancerVax with the SEC on October 24, 2003. |
In addition, all filings that we make with the SEC pursuant to the Exchange Act of 1934 after
the initial filing date of the registration statement, of which this prospectus forms a part, and
prior to 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
31
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., 2110 Rutherford Road, Carlsbad, California 92008,
telephone (760) 494-4235.
32
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 stockholders will not bear any
portion of such expenses. All the amounts shown are estimates, except for the SEC registration
fee.
|
|
|
|
|
SEC Registration Fee |
|
$ |
3,416 |
|
Accounting Fees and Expenses |
|
|
10,000 |
|
Legal Fees and Expenses |
|
|
20,000 |
|
Printing and miscellaneous expenses |
|
|
5,000 |
|
|
|
|
|
Total |
|
$ |
38,416 |
|
|
|
|
|
Item 15. Indemnification of Directors and Officers.
As permitted by Section 102 of the Delaware General Corporation Law, 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:
|
|
|
any breach of the directors duty of loyalty to us or our stockholders; |
|
|
|
|
any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
|
|
|
|
any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or |
|
|
|
|
any transaction from which the director derived an improper personal benefit. |
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 Delaware General Corporation Law, our amended and restated
bylaws provide that:
|
|
|
we may indemnify our directors, officers, and employees to the fullest extent
permitted by the Delaware General Corporation Law, subject to limited exceptions; |
|
|
|
|
we may advance expenses to our directors, officers and employees in connection with a
legal proceeding to the fullest extent permitted by the Delaware General Corporation
Law, subject to limited exceptions; and |
|
|
|
|
the rights provided in our amended and restated bylaws are not exclusive. |
Our amended and restated certificate of incorporation and our amended and restated bylaws
provide for the indemnification provisions described above and elsewhere herein. 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 Delaware General Corporation
Law. 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
II-1
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 of 1933, as amended.
The Securities Purchase Agreement between the registrant and the investors provides for
cross-indemnification in connection with registration of the registrants common stock on behalf of
such investors.
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 of 1933 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 Securities and Exchange Commission such indemnification is against public policy as
expressed in the 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 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 of 1933, each filing of the registrants annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing
of an employee benefit plans annual report pursuant to Section 15(d) of the Securities Exchange
Act of 1934) 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 of
1933;
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 Commission 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 Commission by the registrant pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934 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.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment 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.
II-2
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser, if the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b)
as part of a registration statement relating to an offering, other than registration statements
relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to
be part of and included in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a registration statement or prospectus
that is part of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale prior to such first
use, supersede or modify any statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such document immediately prior to such
date of first use.
II-3
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 Carlsbad, California, on August 21, 2006.
|
|
|
|
|
|
|
MICROMET, INC.
|
|
|
By: |
/s/ Christian Itin
|
|
|
|
Christian Itin |
|
August 21, 2006 |
|
President and Chief Executive Officer |
|
|
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS that each individual whose signature appears below
constitutes and appoints Christian Itin 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
Christian Itin, Ph.D.
|
|
President and Chief Executive Officer
and Director
|
|
August 21, 2006 |
Principal Financial and Accounting Officer:
|
|
|
|
|
/s/ Gregor Mirow
Gregor K. Mirow, M.D., M.B.A.
|
|
Senior Vice President of Operations
|
|
August 21, 2006 |
Additional Directors:
|
|
|
|
|
/s/ David F. Hale
David F. Hale
|
|
Chairman
|
|
August 21, 2006 |
|
|
|
|
|
/s/ Phillip M. Schneider
Phillip M. Schneider
|
|
Director
|
|
August 21, 2006 |
|
|
|
|
|
/s/ Michael G. Carter
Michael G. Carter, M.B., Ch.B., F.R.C.P.
|
|
Director
|
|
August 21, 2006 |
|
|
|
|
|
/s/ Barclay A. Phillips
Barclay A. Phillips
|
|
Director
|
|
August 21, 2006 |
II-4
|
|
|
|
|
/s/
Jerry C. Benjamin
Jerry C. Benjamin
|
|
Director
|
|
August 21, 2006 |
|
|
|
|
|
Otello Stampacchia, Ph.D.
|
|
Director
|
|
|
|
|
|
|
|
/s/ John E. Berriman
John E. Berriman
|
|
Director
|
|
August 21, 2006 |
|
|
|
|
|
/s/ Peter Johann
Peter Johann, Ph.D.
|
|
Director
|
|
August 21, 2006 |
II-5
EXHIBIT INDEX
|
|
|
Exhibit Number |
|
Exhibits |
2.1(1)
|
|
Agreement and Plan of Merger, dated as of January 6, 2006 and amended as of March 17, 2006,
by and among CancerVax Corporation, Carlsbad Acquisition Corporation, Micromet, Inc., and
Micromet AG |
3.1(2)
|
|
Registrants Amended and Restated Certificate of Incorporation |
3.2(3)
|
|
Registrants Certificate of Amendment of Amended and Restated Certificate of Incorporation |
3.3(4)
|
|
Registrants Second Amended and Restated Bylaws |
3.4(3)
|
|
First Amendment to Registrants Second Amended and Restated Bylaws |
3.5(5)
|
|
Second Amendment to
Registrants Second Amended and Restated Bylaws |
3.6(6)
|
|
Registrants Certificate of Designations for Series A Junior Participating Preferred Stock |
4.1(7)
|
|
Form of Specimen Common Stock Certificate |
5.1
|
|
Opinion of Cooley Godward LLP |
10.1(5)
|
|
Form of Securities Purchase Agreement |
10.2(5)
|
|
Form of Warrant to Purchase Common Stock |
23.1
|
|
Consent of Ernst & Young AG, Wirtschaftsprüfungsgesellschaft, Independent Auditors |
23.2
|
|
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm |
23.3
|
|
Consent of Cooley Godward LLP (included in Exhibit 5.1) |
24.1
|
|
Power of Attorney (included on the signature pages hereto) |
|
|
|
|
|
Keys to Exhibits: |
|
(1) |
|
Incorporated by reference from such document filed with the SEC as Exhibit 2.01 to the
Registrants Registration Statement on Form S-4 filed with the SEC on March 31, 2006. |
|
(2) |
|
Incorporated by reference from such document filed with the SEC as Exhibit 3.01 to the
Registrants Quarterly Report on Form 10-Q for the quarter ended September 30, 2003 filed with
the SEC on December 11, 2003. |
|
(3) |
|
Incorporated by reference from such document filed with the SEC as Exhibit 3.2 to the
Registrants Quarterly Report on Form 10-Q for the quarter ended March 31, 2006 filed with the
SEC on May 10, 2006. |
|
(4) |
|
Incorporated by reference from such document filed with the SEC as Exhibit 3.02 to the
Registrants Current Report on Form 8-K filed with the SEC on March 20, 2006. |
|
(5) |
|
Incorporated by reference from such document filed with the SEC as Exhibit 3.1 to the
Registrants Current Report on Form 8-K filed with the SEC on July 26, 2006. |
|
(6) |
|
Incorporated by reference from such document filed with the SEC as Exhibit 3.3 to the
Registrants Current Report on Form 8-K filed with the SEC on November 8, 2004. |
|
(7) |
|
Incorporated by reference from such document filed with the SEC as Exhibit 4.1 to the
Registrants Registration Statement on Form S-3 filed with the SEC on December 9, 2004. |