Although we believe that the expectations reflected in our forward-looking statements are
reasonable, we cannot guarantee future results, events, levels of activity, performance or
achievement. We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, unless required by
law.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our financial instruments consisted principally of cash, cash equivalents and securities
available-for-sale. These financial instruments, principally comprised of corporate obligations and
U.S. government obligations, are subject to interest rate risk and will decline in value if
interest rates increase. Because of the relatively short maturities of our investments, we do not
expect interest rate fluctuations to materially affect the aggregate value of our financial
instruments. We have not used derivative financial instruments in our investment portfolio.
Additionally, we do not invest in foreign currencies or other foreign investments.
Borrowings under our $18.0 million bank credit facility secured in December 2004 bear interest
at a variable interest rate equal to the banks prime rate or 4.75% (7.75% as of March 31, 2006)
and therefore expose us to interest rate risk. Based on the outstanding borrowings under our $18.0
million bank credit facility at March 31, 2006 of $17.0 million, a 1% hypothetical increase in the
prime rate would result in an approximately $0.2 million increase in our annual interest expense.
Item 4. Controls and Procedures
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions
regarding required disclosure. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired control objectives, and management
is required to apply its judgment in evaluating the cost-benefit relationship of possible controls
and procedures. In addition, the design of any system of controls also is based in part upon
certain assumptions about the likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all potential future conditions; over time,
control may become inadequate because of changes in conditions, or the degree of compliance with
policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective
control system, misstatements due to error or fraud may occur and not be detected.
As required by Securities and Exchange Commission Rule 13a-15(b), we carried out an
evaluation, under the supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of
our disclosure controls and procedures as of the end of the period covered by this report. Based on
the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our
disclosure controls and procedures were effective as of March 31, 2006.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
21
PART II OTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
The following information sets forth factors that could cause our actual results to differ
materially from those contained in forward-looking statements we have made in this report, the
information incorporated herein by reference and those we may make from time to time. References to
we, us and our in these risk factors refer to the operations of the combined company
following the merger of Micromet and CancerVax.
Certain factors may have a material adverse effect on our business, financial condition and results
of operations and you should carefully consider them. It is difficult to predict or identify all
such factors and many of the risk factors identified below have changed from those previously
disclosed in our 2005 Annual Report on Form 10-K. Accordingly, in evaluating our business, we
encourage you to consider the following discussion of risk factors in its entirety, in addition to
other information contained in this report as well as our other public filings with the Securities
and Exchange Commission.
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. Although we believe that we currently have adequate finance
and accounting systems, procedures and controls for our business on a standalone basis, we will
need to upgrade the existing, and implement additional, procedures and controls to incorporate the
operations of Micromet. These updates may require significant time and expense, and there can be no
guarantee that we will be successful in implementing them. Furthermore, the managerial, financial
and accounting personnel who worked for CancerVax prior to its merger with Micromet have either
terminated or are expected to terminate their employment with us soon after the merger. 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.
If we are not successful in integrating our business operations, we may not be able to operate
efficiently.
Achieving the benefits of the merger will depend in part on the successful integration of the
technical and business operations of CancerVax into Micromet in a timely and efficient manner. The
integration process requires coordination of the personnel of both companies, and involves the
integration of systems, applications, policies, procedures, business processes and operations. This
process may be difficult and unpredictable because of possible conflicts and differing opinions on
business, scientific and regulatory matters. Moreover, the integration of the two companies will
present challenges resulting from the transatlantic nature of the combined company. If we cannot
successfully integrate our technical and business operations and personnel, we may not realize the
expected benefits of the merger.
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.
22
We expect to incur significant costs in completing our business integration activities.
We expect to incur significant costs integrating CancerVaxs technical and business operations
into Micromet, which include costs for:
|
|
|
employee redeployment, relocation or severance; |
|
|
|
|
conversion of information systems; |
|
|
|
|
combining administrative teams and processes; |
|
|
|
|
reorganization of facilities and disposition of excess facilities; and |
|
|
|
|
relocation or disposition of excess equipment. |
If we fail to retain key employees, the benefits of the merger could be diminished.
The successful integration of CancerVax into Micromet will depend, in part, on the retention
of key personnel. There can be no assurance that the combined company will be able to retain its
key management and scientific personnel. If we fail to retain such key employees, we may not
realize the anticipated benefits of the merger. Additionally, the voluntary resignation of William
R. LaRue, our Chief Financial Officer, will become effective June 1, 2006. While Mr. LaRue has
agreed to provide consulting services to us through August 15, 2006, we will need to find a
replacement for Mr. LaRue quickly. Any delay or failure in replacing Mr. LaRue could have a
material adverse impact on our business.
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 one additional product candidate in 2006 and at least one 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 U.S. Food and Drug Administration or other
regulatory authorities outside the U.S. 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 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.
Risk Relating to Our Common Stock
We face possible delisting from the Nasdaq National Market, which would result in a limited public
market for our common stock.
Our common stock trades on the Nasdaq National Market, which specifies certain requirements
for the continued listing of common stock. There are several requirements for the continued listing
of our common stock on the Nasdaq National Market including, but not limited to, a minimum
stockholders equity value of $10.0 million and a minimum stock bid price of $1.00 per share. While
we currently are in compliance with these requirements, there can be no guarantee that we will
continue to remain in compliance. As of March 31, 2006,
CancerVax had a stockholders equity value of
approximately $26.2 million, and our closing stock price as of May 8, 2006 was $8.98 per share.
While we expect that our stock would continue to trade on the Over The Counter Bulletin Board
following any delisting from the Nasdaq National Market, any such delisting of our common stock
could have a
23
material adverse effect on the market price of, and the efficiency of the trading market for,
our common stock. Also, if in the future we were to determine that we need to seek additional
equity capital, a delisting could have an adverse effect on our ability to raise such equity
capital.
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 or to include their shares in
registration statements that we may file for ourselves or other stockholders. Within 45 days after
the closing of the merger we are required to file a shelf registration statement on Form S-3 (or,
if we are not eligible to use Form S-3, any other form that we are eligible to use) covering the
resale by former affiliates of Micromet Parent or Micromet of shares of CancerVax Common Stock
issued as merger consideration. 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. If any of these holders cause a large number of
securities to be sold in the public market, the sales could reduce the trading price of our common
stock. These sales also could impede our ability to raise future capital.
Our stock price may be volatile, and you may lose all or a substantial part of your investment.
The market price for our common stock is volatile and may fluctuate significantly in response
to a number of factors, most of which we cannot control, including:
|
|
|
the financial markets acceptance of the merger between Micromet and CancerVax,
and our ability to successfully integrate our operations following the merger; |
|
|
|
|
our ability to successfully develop our product candidates within acceptable timeframes; |
|
|
|
|
changes in the regulatory status of our product candidates; |
|
|
|
|
changes in significant contracts, new technologies, acquisitions, commercial
relationships, joint ventures or capital commitments; |
|
|
|
|
announcements of the results of clinical trials by companies with product
candidates in the same therapeutic category as our product candidates; |
|
|
|
|
events affecting our collaboration partners; |
|
|
|
|
fluctuations in stock market prices and trading volumes of similar companies; |
|
|
|
|
announcements of new products or technologies, clinical trial results, commercial
relationships or other events by us or our competitors; |
|
|
|
|
our ability to successfully complete sublicensing arrangements with respect to our
product candidates that target the EGFR signaling pathway; |
|
|
|
|
variations in our quarterly operating results; |
|
|
|
|
changes in securities analysts estimates of our financial performance; |
|
|
|
|
changes in accounting principles; |
|
|
|
|
sales of large blocks of our common stock, including sales by our executive
officers, directors and significant stockholders; |
|
|
|
|
additions or departures of key personnel; and |
|
|
|
|
discussions of Micromet or our stock price by the financial and scientific press
and online investor communities such as chat rooms. |
24
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:
|
|
|
dividing our board of directors into three classes serving staggered three-year terms; |
|
|
|
|
prohibiting our stockholders from calling a special meeting of stockholders; |
|
|
|
|
permitting the issuance of additional shares of our common stock or preferred stock without stockholder approval; |
|
|
|
|
prohibiting our stockholders from making certain changes to our amended and
restated certificate of incorporation or bylaws except with 66 2/3% stockholder approval;
and |
|
|
|
|
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 Financial Results and Need for Financing
CancerVax and Micromet 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.
CancerVax and Micromet have incurred losses from each of their inceptions through March 31,
2006, and we expect to incur substantial losses for the foreseeable future. We have no current
sources of material ongoing revenue. In October 2005, CancerVax announced restructuring activities
connected with its operations, including workforce reductions, and incurred non-recurring charges
associated with these restructuring activities. We anticipate that we will incur additional costs
as a result of ongoing CancerVax restructuring activities in 2006, including additional employee
severance costs, costs associated with exiting CancerVaxs three facilities
and contract terminations. 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 will 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.
25
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:
|
|
|
continued progress in our research and development programs, as well as the magnitude of these programs; |
|
|
|
|
our ability to establish and maintain collaborative arrangements; |
|
|
|
|
the timing, receipt and amount of research funding and milestone, license, royalty
and other payments, if any, from collaborators; |
|
|
|
|
the timing, receipt and amount of sales revenues and associated royalties to us, if
any, from our product candidates in the market; |
|
|
|
|
the costs of preparing, filing, prosecuting, maintaining and enforcing patent
claims and other patent-related costs, including litigation costs and technology license
fees; |
|
|
|
|
our ability to complete the restructuring activities associated with our former
CancerVax operations; |
|
|
|
|
costs associated with litigation, including our ongoing litigation with Curis,
Inc.; and |
|
|
|
|
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. 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
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.
Micromet
had an outstanding promissory note issued to Curis in the amount of
2,000,000. While
we do not believe that the merger triggers the obligation to repay any substantial amounts under
the terms of this note, Curis has informed us that it does not agree with our interpretation and
has initiated a legal action regarding this matter. In the event that we are required to repay any
substantial portion of the amounts outstanding under this note, it would have a material adverse
effect on our financial resources in the near term.
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, such as the
consummation of CancerVaxs
26
merger with Micromet, however the financing institution consented to the merger without
requiring that the combined company immediately pay down any portion of the note. We are currently
in negotiations with the financing institution, which will culminate in the proposal by the
financing institution of alternative payment plans that could include paying down all, part or none
of the outstanding obligation.
The loan agreement contains various customary affirmative and negative covenants, including,
without limitation:
|
|
|
financial reporting; |
|
|
|
|
limitation on liens; |
|
|
|
|
limitations on the occurrence of future indebtedness; |
|
|
|
|
maintenance of a minimum amount of cash in deposit accounts of our lenders or in
the accounts of affiliates of our lenders; |
|
|
|
|
limitations on mergers and other consolidations; |
|
|
|
|
limitations on dividends; |
|
|
|
|
limitations on investments; and |
|
|
|
|
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:
|
|
|
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; |
|
|
|
|
payments on our indebtedness will reduce the funds that would otherwise be
available for our operations and future business opportunities; |
|
|
|
|
we may be more highly leveraged than our competitors, which may place us at a competitive disadvantage; |
|
|
|
|
our debt level reduces our flexibility in responding to changing business and economic conditions; and |
|
|
|
|
there would be an adverse effect on our business and financial condition if we are
unable to service our indebtedness or obtain additional financing, as needed. |
27
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:
|
|
|
the status of development of our product candidates; |
|
|
|
|
the time at which we enter into research and license agreements with strategic
collaborators that provide for payments to us, and the timing and accounting treatment of
payments to us, if any, under those agreements; |
|
|
|
|
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; |
|
|
|
|
the addition or termination of research programs or funding support; |
|
|
|
|
the timing of milestone and other payments that we may be required to make to others; and |
|
|
|
|
variations in the level of expenses related to our product candidates or potential
product candidates during any given period; and |
|
|
|
|
the progress of our CancerVax restructuring 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 United States generally
accepted accounting principles. 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.
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, of if they fail or delay in developing or
commercializing our product candidates, our anticipated product pipeline and operating results
would suffer.
The success of our strategy for development and commercialization of 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:
|
|
|
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
resources. |
|
|
|
|
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 any collaborator were to terminate an agreement, 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. |
28
|
|
|
Our collaborators may develop and commercialize, either alone or with others,
products and services that are similar to or competitive with the products and services
that are the subject of the collaboration with us. |
|
|
|
|
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. |
If Serono merges with, is acquired by, or acquires another company, it may adversely impact
our development of adecatumumab, or MT201.
Serono was recently rumored to have been the target of potential merger discussions. If Serono
were to merge with, be acquired by, or acquire another company, it is likely that that company
would evaluate whether to continue the development of adecatumumab, or MT201. If Seronos acquiror
or merger partner elected not to continue the collaboration with us, the rights to develop
adecatumumab would revert back to us. Serono has the right to terminate our collaboration upon 180
days written notice. There can be no guarantee that we would be able to find a replacement
collaborator to continue the development of adecatumumab on terms as favorable as the Serono
collaboration, or at all. Additionally, if a replacement collaborator could be located, the process
of identifying and negotiating the terms of the relationship with such a collaborator, would likely
be time consuming and expensive. As a result, we could experience a material delay or complete
cessation in developing adecatumumab, which would likely have a material adverse impact on our
future business prospects, results of operations, liquidity and capital resources.
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 or other regulatory authorities will accept data from the clinical
trials of these products 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
products.
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.
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
29
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.
Risks Related to Our Business, Industry, 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 inflammatory disease 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 products uneconomical or result in therapies
superior to those that we develop 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 products 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 and 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, development and clinical capabilities, to pursue the development of these product
candidates, and we may never develop an approvable product.
Subject to our diligence obligations to our licensors for these product candidates, we are
considering strategic alternatives with respect to certain other of our product candidates given
the substantial reduction in our research and development and clinical resources in connection with
the termination of our Canvaxin development activities. We may be unable to successfully develop
these product candidates ourselves, and we also may be unable to enter into strategic
collaborations with third parties to pursue the development of these product candidates. Even if we
are able to identify potential strategic collaborators or licensees for these product candidates,
we may be unable to obtain required consents from our licensors and the financial terms available
to us may not be acceptable. In any event, we do not anticipate that any of our product candidates
will reach the market for at least several years.
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:
|
|
|
be successfully developed; |
|
|
|
|
prove to be safe and effective in clinical trials; |
|
|
|
|
be approved for marketing by United States or foreign regulatory authorities; |
30
|
|
|
be adequately protected by our intellectual property rights or the rights of our licensors; |
|
|
|
|
be capable of being produced in commercial quantities at acceptable costs; |
|
|
|
|
achieve market acceptance and be commercially viable; or |
|
|
|
|
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.
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.
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.
Risks Relating to Our Intellectual Property and Litigation
Our success depends on whether we are able to maintain and enforce our licensing arrangements with
various third party licensors.
We hold rights to commercialize our anti-angiogenesis product candidates, including D93, under
agreements that require, among other things, royalty payments on future sales, if any, and our
achievement of certain development milestones. For example, under our collaboration agreement with
Applied Molecular Evolution, Inc., or AME, which is now a wholly-owned subsidiary of Eli Lilly and
Company, under which AME utilized its technology to humanize a murine monoclonal antibody to create
D93, AME may terminate the agreement if we fail to make milestone or royalty payments to AME. In
February 2006, we submitted an IND for D93, as required under our agreement with AME; however, AME
may also terminate the agreement if we fail to meet certain other specified clinical development
obligations. In the event of such termination, we will be required to grant to AME an exclusive
license for all of our patent rights relating to the humanized monoclonal antibodies that are the
subject of this agreement and the products that incorporate or are derived from one or more of the
humanized monoclonal antibodies that are the subject of the agreement. AME also received a right of
first negotiation to obtain from us an exclusive license under our intellectual property rights
related to the making, using and selling of any products that incorporate or are derived from one
or more of the humanized monoclonal antibodies that are the subject of the agreement should we
decide to negotiate with or seek a collaborator for the commercialization of such product. The
amended and restated collaboration agreement also obligates us to pay for the preparation, filing,
prosecution, maintenance and enforcement of all patent applications directed at the humanized
monoclonal antibodies that are the subject of the amended agreement.
We also hold exclusive rights through two agreements with CIMAB to develop and commercialize
within a specific territory, which includes the U.S., Canada, Japan, Australia, New Zealand,
Mexico, the countries comprising the European Union and certain other countries in Europe, SAI-EGF,
a product candidate being evaluated in Phase 2 clinical trials that target the EGFR signaling
pathway for the treatment of cancer. In addition, we obtained from CIMAB and YM BioSciences the
exclusive rights to develop and commercialize, within the same territory, SAI-TGF-a, which targets
transforming growth factor-alpha, and SAI-EGFR-ECD, which targets the extracellular domain of the
EGF receptor, both of which are in preclinical development. In exchange for these rights, we
31
will pay to CIMAB and YM BioSciences technology access fees and transfer fees totaling $5.7
million, to be paid over the first three years of the agreement. We will also make future milestone
payments to CIMAB and YM BioSciences up to a maximum of $34.7 million upon meeting certain
regulatory, clinical and commercialization objectives, as well as royalties on future sales of
commercial products, if any. Each agreement terminates upon the later of the expiration of the last
of any patent rights to licensed products that are developed under each respective agreement or 15
years after the date of the first commercial sale of the last product licensed or developed under
the agreements. CIMAB may terminate one or both of the agreements if we have not used reasonable
commercial efforts to submit an IND to the FDA for the leading product candidate by July 12, 2006,
or if the first regulatory approval for marketing this product candidate within our territory is
not obtained by July 12, 2016, provided that CIMAB has timely complied with all of its obligations
under the agreements, or if CIMAB does not receive timely payment of the initial access fees and
technology transfer fees under the agreements. In addition, if CIMAB does not receive payments
under the agreements due to changes in U.S. law, actions by the U.S. government or by order of any
U.S. court for a period of more than one year, CIMAB may terminate our rights to the licensed
product candidates in countries within our territory other than the U.S. and Canada. We may
terminate the agreements for any reason following 180 days written notice to CIMAB. On January 13,
2006, we received a letter from CIMAB notifying us of their belief that we are in breach of our
agreement as a result of our failure to make a milestone payment. On April 21, 2006, we received a
second letter from CIMAB, again notifying us of their belief that we are in breach of our agreement
and that our failure to cure the breach within 60 days will permit CIMAB to terminate the agreement
in its discretion. If we are unable to resolve the dispute, then CIMAB may seek to terminate the
agreement for breach.
Although the license agreements with CIMAB are governed by the laws of England and Wales,
their enforcement may necessitate pursuing legal proceedings and obtaining orders in other
jurisdictions, including the U.S. and the Republic of Cuba. There can be no assurance that a court
judgment or order obtained in one jurisdiction will be enforceable in another. In addition, as is
the case in many developing countries, the commercial and legal environment in Cuba may be subject
to political risk. It is possible that we may not be able to enforce our legal rights in Cuba or
against Cuban entities to the same extent as we would in a country with a commercial and legal
system more consistent with United States or western European practice. Termination of these
license arrangements or difficulties in the enforcement of such arrangements may have a material
adverse effect on our business, operations and financial condition. We have announced our intention
to actively seek to sublicense our rights to the three product candidates licensed from CIMAB, but
there can be no guarantee that we will be successful in our efforts to consummate a sublicense on
terms and conditions that will be acceptable.
We also hold rights to a human monoclonal antibody under a license from M-Tech Therapeutics,
which can be terminated if we determine not to file and obtain approval of an IND application for a
licensed product by a specified date and conduct clinical trials for such product candidate, or if
we determine not to file and obtain approval of an IND application for a licensed product candidate
by a specified date because of negative pre-clinical results.
If we were to materially breach any of our license or collaboration agreements, we could lose our
ability to commercialize the related technologies, and our business could be materially and
adversely affected.
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. For example, although we submitted an IND for
D93 in February 2006, as required under our agreement with AME, AME may also terminate the
agreement if we fail to meet certain other specified clinical development obligations. In the event
of such termination, we will be required to grant to AME an exclusive license for all of our patent
rights relating to the humanized monoclonal antibodies that are the subject of this agreement and
the products that incorporate or are derived from one or more of the humanized monoclonal
antibodies that are the subject of the agreement. Additionally, on January 13, 2006, we received a
letter from CIMAB notifying us of their belief that we are in breach of our agreement as a result
of our failure to make a milestone payment. On April 21, 2006, we received a second letter from
CIMAB again notifying us of their belief that we are in breach of our agreement and that our
failure to cure the breach within 60 days will permit CIMAB to terminate the agreement in its
discretion. If we are unable to resolve the dispute, then CIMAB may seek to terminate the
agreement for breach.
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
32
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.
In March 2004, one of Micromets patents became the subject of an opposition proceeding before
the European Patent Office. The opponent alleged that the patent did not fulfill all of the
applicable requirements for issuance of a patent. In January 2006, the Opposition Division of the
European Patent Office revoked the opposition in oral proceedings and maintained the patent as
granted. The opponent can appeal the decision and request a hearing in front of the Board of Appeal
of the European Patent Office and, it is possible that the Board of Appeal could overrule the
decision of the Opposition Division and rule that the patent is invalid. If this were to occur, it
could have a material adverse impact on our ability to protect our intellectual property.
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 declared by the U.S. Patent and Trademark Office 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:
|
|
|
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; |
|
|
|
|
we or our licensors might not have been the first to file patent applications for these inventions; |
|
|
|
|
others may independently develop similar or alternative technologies or duplicate any of our technologies; |
|
|
|
|
it is possible that none of our pending patent applications will result in issued patents; |
|
|
|
|
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; |
|
|
|
|
any of the issued patents under which we hold rights may not be valid or
enforceable; or |
|
|
|
|
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. |
Additionally, there may be risks related to the licensing of the proprietary rights for the
product candidates that target the EGFR signaling pathway that were developed in Cuba. Under
current Cuban patent law, ownership of the inventions of the Cuban inventors for which patent
applications have been filed rests with the state.
If we are not able to protect and control our unpatented trade secrets, know-how and other
technological innovation, we may suffer competitive harm.
We 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
33
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 products 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 products.
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 products to market, that we use in
producing our products, or that we use in treating patients with our products.
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 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, 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, 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 products. 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.
Risks Relating to Our Clinical and Regulatory Matters
The preliminary results of Micromets Phase 2 clinical trial of adecatumumab, or MT201, in
patients with prostate cancer suggest that the primary endpoint of the trial was not reached and,
if final assessment of the trial results confirms this conclusion, we may be forced to discontinue
development of this product candidate in prostate cancer.
Preliminary results from Micromets Phase 2 clinical trial of adecatumumab, or MT201, in
patients with prostate cancer indicate that the primary endpoint (mean change in prostate specific
antigen, compared to placebo control) was not reached in the trial. A recently performed expert
review meeting has confirmed the inconclusiveness of the current data set and has suggested that
additional post-hoc subanalyses be performed before coming to a final assessment of this trial. If,
upon final assessment, we conclude that the trial did not meet its endpoint, we will be forced to
consider whether to discontinue pursuing the development of adecatumumab for the treatment of
prostate cancer. If we elect to abandon our development of adecatumumab for the treatment of
prostate cancer, this would have a material adverse impact on our future results of operations.
34
Although the preliminary results of Micromets Phase 2 clinical trial of adecatumumab, MT201, in
patients with breast cancer are encouraging, upon review of the final results we may nevertheless
conclude that the trial was unsuccessful.
Based on a review of the preliminary results from Micromets Phase 2 clinical trial of
adecatumumab in patients with breast cancer, it appears that the trial more likely than not
satisfied its primary clinical endpoint (a statistically significant increase in clinical benefit
rate in patients receiving a high dose of the drug, as compared to patients receiving a low dose).
However, the database used to perform this preliminary analysis has not been locked or been subject
to a formal data cleaning process, and the radiographs from the patients in this clinical trial are
still subject to the assessment of an independent review board as some centralized radiology
assessments differ from the radiology assessments performed at the local clinical trial sites. A
final assessment of the study data will not be possible until the study is completed, all data
discrepancies are resolved and the database is locked, which is currently anticipated to occur in
the second half of 2006. Once the database has been locked and a final assessment of the trial data
is performed, we may discover that the trial did not meet its primary endpoint. If, upon final
assessment, we conclude that the trial did not meet its endpoints, we will be forced to consider
whether to discontinue pursuing the development of adecatumumab for the treatment of breast cancer.
If we elect to abandon our development of adecatumumab for the treatment of breast cancer, this
would have a material adverse impact on our future results of operations.
Micromet 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 currenmt continuou- infusion Phase 1 clinical trial of MT103 will produce a
different outcome.
In April 2004, Micromet 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. Micromet 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 dosing regimen for our ongoing Phase 1 clinical trial and, based
upon on the preliminary data, we currently are seeing considerably fewer adverse events in response
to the new dosing regimen, there can be no assurance that our ongoing, continuous-infusion clinical
trial will not produce the same adverse events witnessed in our previous, short-term infusion
clinical trials for MT103.
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 products under development, and if these third parties do not successfully manufacture these
products 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 products, we or our collaborators must be able to manufacture products 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 some of our products 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 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 and corresponding foreign regulatory agencies must approve these manufacturers in advance.
This would involve testing and pre-approval inspections to ensure compliance with FDA and foreign
35
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;
|
|
|
we and our collaborators may not be able to initiate or continue clinical trials of
products that are under development; |
|
|
|
|
we and our collaborators may be delayed in submitting applications for regulatory
approvals for our product candidates; and |
|
|
|
|
we and our collaborators may not be able to meet commercial demands for any
approved products. |
We have no sales or marketing experience and, as such, will depend significantly on third parties
who may not successfully sell our products.
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 Micromets
agreements with Serono and MedImmune, Micromet has granted its 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
products. 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:
|
|
|
we may not be able to attract and build a significant and skilled marketing staff
or sales force; |
|
|
|
|
the cost of establishing a marketing staff or sales force may not be justifiable in
light of the revenues generated by any particular product; and |
|
|
|
|
our direct sales and marketing efforts may not be successful. |
Risks Relating to the Life Sciences Industry
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 European Unions
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 products. 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 mandated current good manufacturing
practices and will require FDA approval. This revalidation may be costly and time consuming. If we
are unable to arrange for third-party manufacturing of our products, or to do so on commercially
reasonable terms, we may not be able to complete development or marketing of our products.
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 products.
The efficacy, safety and cost-effectiveness of our products 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
36
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 products to other available therapies. If reimbursement for our
products 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.
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.
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 and 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.
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 products under development 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, 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
37
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.
Even if our products are approved by regulatory authorities, if we fail to comply with ongoing
regulatory requirements, or if we experience unanticipated problems with our products, these
products could be subject to restrictions or withdrawal from the market.
Any product for which we obtain marketing approval, along with the manufacturing processes,
post-approval clinical data and promotional activities for such product, will be subject to
continual review and periodic inspections by the FDA and other regulatory bodies. Even if
regulatory approval of a product 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 products, including unanticipated adverse events
or adverse events of unanticipated severity or frequency, manufacturer or manufacturing processes,
or failure to comply with regulatory requirements, may result in restrictions on such products or
manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recall,
fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil
or criminal penalties.
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.
The process of obtaining FDA and other required regulatory approvals is expensive. The time
required for FDA 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 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 or
comparable international regulatory authorities to become less supportive of the T-cell related
drugs 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 potential future products 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 approvals. Moreover, approval by the FDA does not ensure approval by regulatory
authorities in other countries, and vice versa.
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. 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, 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,
38
export and customs regulations and certain other local, state or federal regulations. From
time to time, other federal agencies and congressional committees 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.
Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our
products abroad.
We intend to market our drugs in international markets. In order to market our products 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 approval. The foreign
regulatory approval process may include all of the risks associated with obtaining FDA approval. We
may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA 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. We may not be able to file for regulatory approvals and may not receive necessary
approvals to commercialize our products 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:
|
|
|
our ability to generate revenues and achieve profitability; |
|
|
|
|
the future revenues and profitability of our potential customers, suppliers and collaborators; and |
|
|
|
|
the availability of capital. |
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 products 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.
If physicians and patients do not accept the products 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 that we may develop will depend on many factors, including:
|
|
|
our ability to provide acceptable evidence of safety and efficacy; |
|
|
|
|
convenience and ease of administration; |
39
|
|
|
prevalence and severity of adverse side effects; |
|
|
|
|
availability of alternative treatments; |
|
|
|
|
cost effectiveness; |
|
|
|
|
effectiveness of our marketing strategy and the pricing of any product that we may develop; |
|
|
|
|
publicity concerning our products or competitive products; and |
|
|
|
|
our ability to obtain third-party coverage or reimbursement. |
In addition, CancerVaxs decision to discontinue Phase 3 clinical trials of Canvaxin in
patients with advanced-stage melanoma based upon the recommendations of the independent DSMB could
create negative publicity that, although not directly related to our other product candidates,
could nevertheless affect their market acceptance. Even if we receive regulatory approval and
satisfy the above criteria for our product candidates, physicians may be reluctant to recommend, or
patients may be reluctant to use, our products.
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 products in
the market.
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 to a variety of federal, 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.
The life sciences industry is highly competitive and subject to rapid technological change.
The life sciences industry is highly competitive and subject to rapid and profound
technological change. Our present and potential competitors include major pharmaceutical companies,
as well as specialized biotechnology and life sciences firms in the United States and in other
countries. Most of these companies have considerably greater financial, technical and marketing
resources than we do. Additional mergers and acquisitions in the pharmaceutical and biotechnology
industries may result in even more resources being concentrated in our competitors. Our existing or
prospective competitors may develop processes or products that are more effective than ours or be
more effective at implementing their technologies to develop commercial products faster. Our
competitors may succeed in obtaining patent protection and/or receiving regulatory approval for
commercializing products before us. Developments by our competitors may render our product
candidates obsolete or non-competitive.
We also experience competition from universities and other research institutions, and we
frequently compete with others in acquiring technology from those sources. These industries have
undergone, and are expected to continue to undergo, rapid and significant technological change, and
we expect competition to intensify as technical advances in each field are made and become
40
more widely known. There can be no assurance that others will not develop technologies with
significant advantages over those that we are seeking to develop. Any such development could harm
our business.
Legislative or regulatory reform of the healthcare system may affect our ability to sell our
products 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 products 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 products. Such proposals may reduce our revenues, increase our expenses
or limit the markets for our products. In particular, we expect to experience pricing pressures in
connection with the sale of our products due to the trend toward managed health care, the
increasing influence of health maintenance organizations and additional legislative proposals.
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 and abroad. 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. Ultimately, we could be prevented from commercializing a
product, 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 products 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 products 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 drugs 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
41
product candidates or delivery technologies, yet fail to yield product candidates or delivery
technologies for clinical development for any of the following reasons:
|
|
|
research methodology used may not be successful in identifying potential product candidates; |
|
|
|
|
potential delivery technologies may not safely or efficiently deliver our drugs; and |
|
|
|
|
product candidates may on further study be shown to have harmful side effects or
other characteristics that indicate they are unlikely to be safe or effective drugs. |
If we are unable to discover suitable potential product candidates, develop additional
delivery technologies through internal research programs or in-license suitable products 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:
|
|
|
receiving patent protection for our product candidates; |
|
|
|
|
preventing others from infringing our intellectual property rights; and |
|
|
|
|
maintaining our patent rights and trade secrets. |
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, CancerVax and Micromet have sought to protect their proprietary positions by filing
U.S. and foreign patent applications related to our important proprietary technology, inventions
and improvements. Because the patent position of pharmaceutical 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.
42
Micromet and CancerVax have also relied on trade secrets, know-how and technology, which are
not protected by patents, to maintain their competitive positions. Micromet and CancerVax 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 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.
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.
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.
43
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
Amendment to Certificate of Incorporation
At the Annual Meeting of Stockholders of CancerVax Corporation held on May 3, 2006, the
stockholders approved the Certificate of Amendment to the Amended and Restated Certificate of
Incorporation of CancerVax Corporation (the Charter Amendment). The Charter Amendment results in
an increase in the number of authorized shares of common stock from 75,000,000 shares to
150,000,000 shares, a reverse stock split of the CancerVax common stock at a 1-to-3 ratio as
selected by the CancerVax board of directors on May 5, 2006 and the change of the name of
CancerVax Corporation to Micromet, Inc.
A copy of the Charter Amendment is attached as Exhibit 3.2 to this Form 10-Q.
Amendment to By-Laws
At its board meeting held on May 3, 2006, CancerVaxs board of directors approved the First
Amendment to the Second Amended and Restated Bylaws of the company (the Bylaws Amendment),
effective upon consummation of the merger with Micromet. The Bylaws Amendment results in a change
in the number of directors of the company from nine to eight, per Article III, Section 1.
A copy of the Bylaws Amendment is attached as Exhibit 3.4 to this Form 10-Q.
Item 6. Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description |
3.1(1)
|
|
Amended and Restated Certificate of Incorporation |
|
|
|
3.2
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Registrant |
|
|
|
3.3(2)
|
|
Second Amended and Restated Bylaws |
|
|
|
3.4
|
|
First Amendment to Second Amended and Restated Bylaws of the Registrant |
|
|
|
3.5(3)
|
|
Certificate of Designations for Series A Junior Participating Preferred Stock |
|
|
|
10.1
|
|
Fifth Amendment to Lease entered into as of April 18, 2006, between Marina Business Center, LLC,
CancerVax Corporation, and American Bioscience, Inc. |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the
Securities Exchange Act of 1934 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the
Securities Exchange Act of 1934 |
|
|
|
32*
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
Incorporated by reference to CancerVax Corporations Form 10-Q filed with the Securities and
Exchange Commission on December 11, 2003. |
44
|
|
|
(2) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on March 20, 2006. |
|
(3) |
|
Incorporated by reference to CancerVax Corporations Current Report on Form 8-K filed with
the Securities and Exchange Commission on November 8, 2004. |
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
the Registrant, whether made before or after the date hereof, regardless of any general
incorporation language in such filing. |
45
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
Dated: May 9, 2006 |
|
|
|
Micromet, Inc.
(formerly CancerVax Corporation) |
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ William R. LaRue |
|
|
|
|
|
|
|
|
|
|
|
|
|
William R. LaRue |
|
|
|
|
|
|
Senior Vice President and |
|
|
|
|
|
|
Chief Financial Officer |
|
|
|
|
|
|
(Duly authorized Officer and Principal Financial Officer) |
46