Form F-10
As filed with the Securities and Exchange Commission on
August 28, 2006.
Registration
No.
U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form F-10
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
ANORMED INC.
(Exact name of Registrant as specified in its charter)
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Canada |
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2834 |
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98-0171581 |
(Province or other Jurisdiction of
Incorporation or Organization) |
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(Primary Standard Industrial Classification
Code Number) |
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(I.R.S. Employer Identification
Number, if any) |
200 20353 64th
Avenue
Langley, British Columbia
Canada V2Y 1N5
(604) 530-1057
(Address and telephone number of Registrants principal
executive offices)
CT Corporation System
111 Eighth Avenue
New York, New York 10011
(212) 894-8600
(Name, address (including zip code) and telephone number
(including area code) of agent for service in the United
States)
Copies to:
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Daniel M. Miller
Dorsey & Whitney LLP
Suite 1605
777 Dunsmuir Street
P.O. Box 10444, Pacific Centre
Vancouver, B.C.
Canada V7Y 1K4 |
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William J. Adams
Vice President, Finance, Chief Financial
Officer, Secretary and Treasurer
AnorMED Inc.
200 20353 64th Avenue
Langley, British Columbia
Canada V2Y 1N5 |
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R. Hector MacKay-Dunn, Q.C.
Trevor R. Scott, Esq.
Farris, Vaughan, Wills & Murphy LLP
25th Floor
700 West Georgia Street
Vancouver, B.C.
Canada V7Y 1B3 |
Approximate date of commencement of proposed sale to the
public:
From time to time after the effective date of this Registration
Statement.
Province of British Columbia, Canada
(Principal jurisdiction regulating this offering)
It is proposed that this filing shall become effective (check
appropriate box below):
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A. o |
upon filing with the Commission, pursuant to Rule 467(a)
(if in connection with an offering being made contemporaneously
in the United States and Canada). |
B. þ |
at some future date (check appropriate box below) |
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1. o |
pursuant to Rule 467(b) on
( )
at
( )
(designate a time not sooner than seven calendar days after
filing). |
2. o |
pursuant to Rule 467(b) on
( )
at
( )
(designate a time seven calendar days or sooner after filing)
because the securities regulatory authority in the review
jurisdiction has issued a receipt or notification of clearance
on
( ). |
3. o |
pursuant to Rule 467(b) as soon as practicable after
notification of the Commission by the Registrant or the Canadian
securities regulatory authority of the review jurisdiction that
a receipt or notification of clearance has been issued with
respect hereto. |
4. þ |
after the filing of the next amendment to this Form (if
preliminary material is being filed). |
If any of the
securities being registered on this form are to be offered on a
delayed or continuous basis pursuant to the home
jurisdictions shelf prospectus offering procedures, check
the following
box. þ
CALCULATION OF REGISTRATION FEE
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Proposed Maximum |
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Proposed Maximum |
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Title of Each Class of |
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Amount to be |
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Offering Price |
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Aggregate Offering |
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Amount of |
Securities to be Registered |
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Registered (1) |
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per Unit |
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Price (2) |
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Registration Fee |
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Common Shares
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U.S.$100,000,000 |
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(1) |
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U.S.$100,000,000 |
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U.S.$10,700 |
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(1) |
There are being registered under this registration statement
such indeterminate number of common shares of the Registrant as
shall have an aggregate initial aggregate offering price of
U.S.$100,000,000. The proposed maximum initial offering price
per security will be determined, from time to time, by the
Registrant in connection with the sale of the securities under
this registration statement. |
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(2) |
Estimated solely for the purpose of calculating the amount of
the registration fee pursuant to Rule 457 of the Securities
Act of 1933, as amended. |
The Registrant hereby amends this registration statement on
such date or dates as may be necessary to delay its effective
date until the registration statement shall become effective as
provided in Rule 467 under the Securities Act of 1933 or on
such date as the Commission, acting pursuant to
Section 8(a) of the Act, may determine.
PART I
INFORMATION REQUIRED TO BE DELIVERED TO OFFEREES OR
PURCHASERS
I-1
The
information in this prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the United States Securities and Exchange
Commission is effective. This prospectus is not an offer to sell
these securities and not soliciting an offer to buy these
securities in any state where the offer or sale is
not permitted.
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SUBJECT TO COMPLETION, DATED AUGUST 28,
2006
PROSPECTUS
AnorMED Inc.
U.S.$100,000,000
Common Shares
We
may offer from time to time, during the 25 month period
that this short form base shelf prospectus, including any
amendments hereto, remains effective, up to U.S.$100,000,000 (or
its equivalent in any other currency) in aggregate of our common
shares.
The
specific terms of any offering of our common shares will be
described in supplements to this prospectus. You should read
this prospectus and any applicable prospectus supplement
carefully before you invest.
Our
common shares are listed on the Toronto Stock Exchange under the
symbol AOM and on August 21, 2006, the NASDAQ
Stock Market Inc. approved the listing of our common shares on
the NASDAQ Global Market (formerly the NASDAQ National Market)
under the symbol ANOR. Our common shares will begin
trading on the NASDAQ Global Market (NASDAQ) upon
completion of certain final regulatory requirements, which we
expect to occur prior to the end of September 2006. Upon our
shares becoming listed on the NASDAQ our common shares will be
de-listed from the American Stock Exchange (AMEX).
On August 25, 2006, the closing price of our common shares
was CDN$6.08 per share on the Toronto Stock Exchange and
U.S.$5.51 per share on the AMEX. Our legal name is AnorMED
Inc., our head office is located at Suite 200, 20353
64th Avenue, Langley, British Columbia, Canada V2Y 1N5
and our registered office is located at 2500 700
West Georgia Street, Vancouver, British Columbia, Canada
V7Y 1B3.
Our
business and an investment in our common shares involve
significant risks. See Risk Factors.
Neither
the United States Securities and Exchange Commission
(SEC) nor any state securities regulator has
approved or disapproved of these securities or determined if
this prospectus is truthful or complete. Any representation to
the contrary is a criminal offence.
We
are permitted, under a multi-jurisdictional disclosure system
adopted by the United States, to prepare this prospectus in
accordance with Canadian disclosure requirements, which are
different from those of the United States. We prepare our
financial statements, which are incorporated by reference in
this prospectus, in accordance with Canadian generally accepted
accounting principles, and they are subject to Canadian auditing
and auditor independence standards. Our financial statements may
not be comparable to the financial statements of U.S.
companies.
Purchasing
our securities may subject you to tax consequences both in the
United States and Canada. This prospectus or any prospectus
supplement may not describe these tax consequences fully. You
should read the tax discussion in any applicable prospectus
supplement fully.
Your
ability to enforce civil liabilities under United States federal
securities laws may be affected adversely because we are
incorporated or organized under the laws of Canada, certain of
our directors are not U.S. residents, a majority of our officers
and the experts named in this prospectus are residents of
Canada, and a substantial portion of our assets are located
outside the United States.
The
date of this prospectus is
August , 2006.
TABLE OF CONTENTS
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As used in this prospectus, the terms AnorMED,
we, our and us refer to
AnorMED Inc. and, depending on the context, its subsidiary, and
the term common shares refers to our common shares.
CURRENCY
In this prospectus and in any prospectus supplement, unless
otherwise specified or the context otherwise requires, all
dollar amounts are expressed in Canadian dollars, all references
to dollars, CDN$ or $ are to
Canadian dollars and all references to U.S.$ are to
United States dollars.
PRESENTATION OF FINANCIAL INFORMATION
Unless otherwise indicated, all financial information included
and incorporated by reference in this prospectus or included in
any prospectus supplement is determined using Canadian generally
accepted accounting principles, referred to as Canadian
GAAP. U.S. GAAP means generally accepted
accounting principles in the United States. We prepare our
consolidated financial statements in accordance with Canadian
GAAP, which differs from U.S. GAAP. Therefore, our consolidated
financial statements incorporated by reference in this
prospectus, in any applicable prospectus supplement and in the
documents incorporated by reference in this prospectus may not
be comparable to financial statements prepared in accordance
with U.S. GAAP. For a description of the material differences
between accounting principals generally accepted in Canada and
accounting principles generally accepted in the United States,
as they relate to our financial statements, see note 13 to
our audited consolidated financial statements for the financial
year ended March 31, 2006, incorporated by reference in
this prospectus.
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DOCUMENTS INCORPORATED BY REFERENCE
We are incorporating by reference in this short form prospectus
certain information contained in documents filed by us with the
securities commissions or securities regulatory authorities in
each of the provinces of Canada. This means that we are
disclosing important information to you by referring you to
those documents. You may obtain copies of the documents
incorporated by reference in this prospectus on request without
charge from our Secretary at Suite 200, 20353
64th Avenue, Langley, British Columbia, Canada,
V2Y 1N5, telephone: (604) 530-1057, and are also
available electronically at www.sedar.com. For the purpose of
the Province of Québec, this simplified prospectus contains
information to be completed by consulting the permanent
information record. A copy of the permanent information record
may be obtained without change from our Secretary at the
above-mentioned address and telephone number and is also
available electronically at www.sedar.com.
The following documents are specifically incorporated by
reference in this prospectus:
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(a) our annual information form for the financial year
ended March 31, 2006, dated June 27, 2006; |
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(b) our audited consolidated balance sheets as at
March 31, 2006 and 2005 and the consolidated statements of
operations, changes in shareholders equity, and cash flows
for each of the years in the three year period ended
March 31, 2006, together with the notes thereto and the
auditors report thereon; |
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(c) our managements discussion and analysis for the
financial year ended March 31, 2006; |
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(d) our unaudited consolidated balance sheet as at
June 30, 2006 and consolidated statements of operations,
changes in shareholders equity, and cash flows for the
three month periods ended June 30, 2006 and 2005; |
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(e) our managements discussion and analysis for the
three month period ended June 30, 2006; |
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(f) our material change report dated April 28, 2006
relating to the election and appointment of our directors; |
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(g) our material change report dated May 26, 2006
relating to Dr. Michael Abrams stepping down as our President
and Chief Executive Officer; |
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(h) our material change report dated June 14, 2006
relating to the appointment of Paul Brennan, our Acting
President and Vice President, Business Development, as one of
our directors; and |
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(i) our management proxy circular dated August 10,
2006 prepared in connection with the annual and special meeting
of our shareholders to be held on September 19, 2006. |
Any documents of the type referred to in the above paragraph,
including annual information forms, financial statements,
managements discussion and analysis, material change
reports (excluding any confidential material change reports),
management proxy circulars and business acquisition reports
filed by us with the securities regulatory authorities in each
of the provinces in Canada after the date of this prospectus and
prior to the completion or withdrawal of this offering will be
deemed to be incorporated by reference in this prospectus.
2
In addition, to the extent that any document or information
incorporated by reference into this prospectus is included in
any report on
Form 6-K,
Form 40-F,
Form 20-F,
Form 10-K,
Form 10-Q or
Form 8-K (or any
respective successor form) that is filed with or furnished to
the SEC after the date of this prospectus, such document or
information shall be deemed to be incorporated by reference as
an exhibit to the registration statement of which this
prospectus forms a part. In addition, we may incorporate by
reference into the registration statement of which this
prospectus forms a part other information from documents that we
file with or furnish to the SEC if and to the extent expressly
provided therein.
A prospectus supplement containing the specific terms of any
securities offered will be delivered to purchasers of such
securities together with this prospectus and will be deemed to
be incorporated by reference in this prospectus as of the date
of the prospectus supplement solely for the purposes of the
offering of securities to which that prospectus supplement
pertains.
Any statement contained in this prospectus or in a document
incorporated or deemed to be incorporated by reference in this
prospectus shall be deemed to be modified or superseded for
purposes of this prospectus to the extent that a statement
contained herein or in any other subsequently filed document
which also is or is deemed to be incorporated by reference
herein modifies or supersedes such statement. The modifying or
superseding statement need not state that it has modified or
superseded a prior statement or include any other information
set forth in the document that it modifies or supersedes. The
making of a modifying or superseding statement shall not be
deemed an admission for any purposes that the modified or
superseded statement, when made, constituted a
misrepresentation, an untrue statement of a material fact or an
omission to state a material fact that is required to be stated
or that is necessary to make a statement not misleading in light
of the circumstances in which it was made. Any statement so
modified or superseded shall not be deemed, except as so
modified or superseded, to constitute a part of this prospectus.
Upon a new annual information form and the related annual
financial statements being filed by us with, and, where
required, accepted by, the applicable securities regulatory
authorities during the currency of this prospectus, the previous
annual information form, the previous annual financial
statements and all quarterly financial statements, material
change reports and information circulars filed prior to the
commencement of our financial year in which the new annual
information form is filed shall be deemed no longer to be
incorporated into this prospectus for purposes of future offers
and sales of common shares under this prospectus.
You should rely only on the information contained in or
incorporated by reference in this prospectus or any applicable
prospectus supplement and on the other information included in
the registration statement of which this prospectus forms a
part. We have not authorized anyone to provide you with
different or additional information. We are not making an offer
of these common shares in any jurisdiction where the offer is
not permitted by law. You should not assume that the information
in this prospectus or any applicable prospectus supplement is
accurate as of any date other than the date on the front of
those documents.
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WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on
Form F-10 of which the prospectus forms a part. Under the
registration statement, we may, from time to time, sell common
shares in one or more offerings up to an aggregate principal
amount of US$100,000,000. This prospectus provides you with a
general description of our common shares. Each time we sell
common shares under the registration statement, we will provide
a prospectus supplement that will contain specific information
about the terms of that offering of common shares. The
prospectus supplement may also add, update or change information
contained in this prospectus. Before you invest, you should read
both this prospectus and any applicable prospectus supplement
together with additional information described in this
prospectus. This prospectus does not contain all of the
information set out in the registration statement. For further
information about us and the common shares, please refer to the
registration statement, including the exhibits to the
registration statement.
We are subject to the information requirements of the United
States Securities Exchange Act of 1934, as amended (the
Exchange Act), and applicable securities legislation
in each of the provinces of Canada, and in accordance therewith,
we file and furnish reports and other information with the SEC
and with the securities regulatory authorities of each of the
provinces of Canada. Under a multijurisdictional disclosure
system adopted by the United States and Canada, we may generally
prepare these reports and other information (including financial
information) in accordance with the disclosure requirements of
Canada. These requirements are different from those of the
United States. As a foreign private issuer, we are exempt from
the rules under the Exchange Act prescribing the furnishing and
content of proxy statements, and our officers, directors and
principal shareholders are exempt from the reporting and
shortswing profit recovery provisions contained in
Section 16 of the Exchange Act.
The reports and other information filed or furnished by us with
the SEC may be read and copied at the SECs public
reference room at 100 F Street, N.E., Washington, D.C.
20549. Copies of the same documents can also be obtained from
the public reference room of the SEC in Washington by paying a
fee. Please call the SEC at
1-800-SEC-0330 for
further information on the public reference room. The SEC also
maintains a web site, which can be accessed at www.sec.gov, that
makes available reports and other information that we file or
furnish electronically with it, including the registration
statement of which this prospectus forms a part.
Copies of reports, statements and other information that we file
with the Canadian provincial securities regulatory authorities
are electronically available from the Canadian System for
Electronic Document Analysis and Retrieval, or SEDAR, which can
be accessed at www.sedar.com.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, and the documents incorporated by reference
herein, contains forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of
1995, and forward looking information within the meaning of
applicable securities laws in Canada, (collectively referred to
as forward-looking statements). Statements, other
than statements of historical fact, are forward-looking
statements and include, without limitation, statements regarding
the Companys strategy, future operations, timing and
completion of clinical trials, prospects and plans and
objectives of management. The words anticipates,
believes, budgets, could,
estimates, expects,
forecasts, intends, may,
might, plans, projects,
schedule, should, will,
would and similar expressions are often intended to
identify forward-looking statements, which include underlying
assumptions, although not all forward-looking statements contain
these identifying words.
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By their nature, forward-looking statements involve numerous
assumptions, known and unknown risks and uncertainties, both
general and specific, that contribute to the possibility that
the predictions, forecasts, projections and other things
contemplated by the forward-looking statements will not occur.
We caution readers not to place undue reliance on these
statements as a number of important factors could cause our
actual results to differ materially from the beliefs, outlooks,
plans, objectives, expectations, anticipations, estimates and
intentions expressed in such forward-looking statements.
Although our management believes that the expectations
represented by such forward-looking statements are reasonable,
there is significant risk that the forward-looking statements,
and the underlying assumptions thereto, will not prove to be
accurate. Forward-looking statements in this prospectus, and the
documents incorporated by reference herein, include but are not
limited to, statements pertaining to the following:
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our business strategy, including for the commercialization of
our products; |
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our expected satisfaction of regulatory requirements; |
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our expectations with respect to increasing our workforce and
completing executive searches; |
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our estimates of the market potential for our products; |
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our patent expiration dates; |
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our dividend policy; |
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revenue and expense expectations; |
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the effect of interest rates on our results of operations and
cash flow; |
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our expectations with respect to the timing, progress and
success of the various stages comprising our drug discovery and
preclinical, clinical and regulatory development programs; |
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our expectations with respect to existing and future
collaborations and licensing transactions with third parties,
and the receipt and timing of any payments from such
arrangements; |
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our plans to commence building commercial infrastructure for our
lead drug candidate, MOZOBIL; |
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our intentions relating to the future of the CCR5 research
program; |
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our plans for an E.U. development organization; |
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the availability of further financing and our plans in the event
sufficient capital is not available from alternative sources of
funding. |
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our ability to obtain raw materials and manufacture products in
commercial quantities at acceptable costs; |
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the benefits and efficacy of our products; and |
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our expectations with respect to future growth and revenue. |
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With respect to the forward-looking statements contained in this
prospectus and the documents incorporated by reference herein,
we have made numerous assumptions regarding, among other things:
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our ability to raise substantial additional financing required
to fund further research and development, conduct planned
preclinical and clinical studies, and obtain regulatory
approvals; |
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our ability to obtain patents and other intellectual property
rights for our drug candidates; |
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our ability to protect our intellectual property rights and to
not infringe on the intellectual property rights of others; |
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our ability to comply with applicable governmental regulations
and standards; |
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our ability to succeed at establishing a successful
commercialization program for any of our products; |
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our ability to successfully attract and retain skilled and
experienced personnel; and |
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our ability to maintain adequate insurance at acceptable costs. |
The foregoing list of assumptions is not exhaustive.
Actual results or events could differ materially from the plans,
intentions and expectations expressed or implied in any
forward-looking statements, including the underlying assumptions
thereto, as a result of numerous risks, uncertainties and other
factors relating to:
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general business and economic conditions; |
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our early stage of development, particularly the inherent risks
and uncertainties associated with (i) developing new drug
candidates generally and specifically drug candidates that
interact with chemokine receptors (the area of cellular and
molecular biology where we are primarily focused),
(ii) demonstrating the safety and efficacy of these drug
candidates in clinical studies in humans, and
(iii) obtaining regulatory approval to commercialize these
drug candidates; |
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clinical studies and regulatory approvals of our drug candidates
are subject to delays, and may not be completed or granted on
expected timetables, if at all, and such delays may increase our
costs and could delay our ability to generate revenue; |
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our lack of product revenues and history of operating losses; |
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the substantial additional financing required to fund further
research and development, conduct planned preclinical and
clinical studies, and obtain regulatory approvals; |
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obtaining patents and other intellectual property rights for our
drug candidates; |
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protecting our intellectual property rights and to not
infringing on the intellectual property rights of others; |
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compliance with applicable governmental regulations and
standards; |
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development or commercialization of similar products by our
competitors, many of which are more established and have greater
financial resources than we do; |
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establishing successful commercialization programs for any of
our products; |
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our reliance on third parties for raw materials and
manufacturing products in commercial quantities at acceptable
costs; |
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attracting and retaining skilled and experienced personnel; |
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changes in government regulation, medical and healthcare
standards, and drug reimbursement policies of government and
other third party payors; |
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changes in foreign currency exchange rates; |
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our business is subject to potential product liability and other
claims; |
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our dependence on collaborative partners; and |
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further equity financing which may substantially dilute the
interests of our shareholders. |
The section entitled Risk Factors discusses these
and other risks, uncertainties and factors that our management
believes could cause actual results or events to differ
materially from the forward-looking statements. Although we have
attempted to identify the forward-looking statements, the
underlying assumptions, and the risks, uncertainties and other
factors that could cause actual results or events to differ
materially from those expressed or implied in the
forward-looking statements, there may be other factors that
cause actual results or events to differ from those expressed or
implied in the forward-looking statements. We undertake no
obligation to revise or update any forward-looking statements as
a result of new information, future events or otherwise, after
the date hereof, except as may be required by law.
RISK FACTORS
You should carefully consider the risks described below,
together with all of the information disclosed in this short
form prospectus, including all documents incorporated by
reference, prior to making an investment in our common shares.
If any of the following risks materialize, our business,
financial condition, results of operations and future prospects
will likely be materially and adversely affected. In that event,
the market price for our common shares could decline and you
could lose all or part of your investment. The risks described
below are not the only ones that may exist. Additional risks not
currently known by us or that we consider immaterial at the
present time may also impair our business, financial condition,
results of operations and future prospects.
Risks Related to our Business and our Industry
We are at an early stage of development and have not yet
demonstrated an ability to successfully overcome the risks and
uncertainties associated with our business.
We were founded in 1996 and are at an early stage of
development. As a development stage company, we have limited
experience and have not yet demonstrated an ability to
successfully overcome many of the risks and uncertainties
frequently encountered by companies in new and rapidly evolving
fields, particularly in the biopharmaceutical area. There are
inherent risks and uncertainties associated with
(i) developing new drug candidates generally and
specifically drug candidates that interact with chemokine
receptors (the area of cellular and molecular biology where we
are primarily focused), (ii) demonstrating the safety and
efficacy of these drug candidates in clinical studies in humans,
(iii) obtaining regulatory approval to commercialize these
drug candidates, and (iv) obtaining, enforcing and
defending patents claiming our inventions and operating without
infringing the patents or other intellectual property rights of
third parties. In order to execute our business plan, we will
need to successfully advance our core products and programs
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through the development process, select and develop further drug
candidates, build and maintain a strong intellectual property
portfolio and avoid infringing the intellectual property rights
of third parties, develop and maintain successful strategic
relationships, manage costs associated with our research and
product development plans, conduct preclinical and clinical
trials, obtain regulatory approvals and deliver pharmaceutical
products to the market. If we are unsuccessful in accomplishing
these objectives, we may not be able to develop drug candidates,
raise capital, expand our business or continue our operations.
Our drug candidates require time-consuming and costly
preclinical and clinical testing and regulatory approvals prior
to commercialization.
The development and commercialization of our products, including
MOZOBIL, are subject to extensive regulation by government
agencies. These drug regulatory agencies include the U.S. Food
and Drug Administration, or FDA, Health Canada, the European
Medicines Agency, or EMEA, and country-by-country market
regulators in Europe, the Japanese Ministry of Health, Labour
and Welfare, the Chinese State Food and Drug Administration, and
counterparts of these agencies in other countries. Before we can
market a drug product in any of these countries, the applicable
regulatory authority in that country must approve a marketing
authorization application that we submit for that product. In
the United States, the applications for the type of products we
are developing are called New Drug Applications, or
NDA. In some countries there are also provincial, state and
other local government agencies with authority over the
marketing of drugs in their jurisdictions. Although the U.S.,
Europe and Japan, together with other nations, have for a number
of years been engaged in an ongoing process to harmonize their
respective drug testing and marketing authorization approval
regulations, there are still substantial variances in these
regulations as well as varying scientific and medical opinions
among these regulators as to what constitutes proof of safety
and efficacy. Consequently, variances among regulatory approval
procedures from country to country may, in some circumstances,
require us to conduct additional preclinical or clinical studies
that could delay or prevent marketing approval of any of our
drug candidates on a country-by-country basis. In response to
well-publicized recent events relating to the safety of approved
drugs, drug regulators around the world are increasing their
focus on pharmacovigilance (drug safety) during the conduct of
clinical trials as well as following the approval of marketing
authorization applications, such as NDAs in the United
States. In addition, in the United States and other
jurisdictions, the study protocol to be followed, the informed
consent form to be signed by patients, the medical ethics of the
study, and related matters for any clinical trial to be
conducted at any particular medical center must be approved by
the institutional review board at that medical center.
Our drug candidates require significant additional preclinical
and clinical testing and investment prior to commercialization.
Conducting preclinical and clinical trials is a lengthy,
time-consuming and expensive process, and the results of these
trials are inherently uncertain. We and, where applicable, our
collaborators must commit substantial resources to conduct
research and clinical trials in order to complete the
development of our portfolio of drug candidates. We cannot
assure that any of our drug candidates will meet applicable
regulatory standards, obtain required regulatory approvals, be
capable of being produced in commercial quantities at reasonable
costs or be successfully marketed. We do not expect our
products, with the exception of FOSRENOL, which is commercially
available in the U.S., to be commercially available in the next
two years.
8
Clinical studies and regulatory approvals of our drug
candidates are subject to delays and may not be completed or
granted on expected timetables, if at all, and such delays may
increase our costs and could delay our ability to generate
revenue.
The process of completing preclinical and clinical testing and
obtaining regulatory approvals generally takes many years and
requires the expenditure of substantial resources, and we do not
know whether any preclinical or clinical studies by us or our
collaborators will be successful, or that regulatory approvals
will be received in a timely manner, or at all, for any of our
drug candidates under development. The commencement and
completion of clinical trials for any of our drug candidates may
be delayed or prevented by many factors, many of which are
beyond our control, including:
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ineffectiveness of our drug candidate or perceptions that the
candidate is not safe or effective for a particular indication; |
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data from our preclinical and clinical studies may be subject to
varying interpretations by regulators which could result in
failure to obtain regulatory approval for any or all of our drug
candidates; |
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delays or failures in obtaining regulatory clearance to commence
a clinical trial; |
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delays or failures in obtaining sufficient clinical materials; |
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delays or failures in reaching agreement on acceptable clinical
trial agreement terms or clinical trial protocols with
prospective sites; |
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delays or failures in the regulatory process we must follow,
such as the Investigational New Drug process in the United
States, in order to commence any clinical trial or in obtaining
approval of our clinical trial protocols and related matters
from institutional review boards; |
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slower than expected rates of patient recruitment or failure to
reach full enrollment; |
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failure of patients to complete the clinical trial; |
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death of, or serious adverse effects experienced by, one or more
patients during a clinical trial even if the reasons are not
related to our drug candidate; |
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inability to monitor patients adequately during or after
treatment and, where we rely on third parties for data
collection and analysis, inability or unwillingness of such
third parties to do so in a timely or accurate manner in
accordance with our clinical trial protocols or good clinical
practices generally; |
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inconclusive or negative results as to efficacy and unforeseen
safety issues; |
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clinical costs that are greater than we anticipate; and |
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government or regulatory delays. |
Even if we achieve positive interim results in any clinical
trials for any of our drug candidates, these results do not
necessarily predict final results, and positive results in early
trials may not be indicative of success in later trials. A
number of companies in the pharmaceutical industry have suffered
significant setbacks in advanced clinical trials, even after
promising results in earlier trials. Negative or inconclusive
results or adverse medical events during a clinical trial could
cause us or any of our applicable collaborators to repeat or
terminate a clinical trial or conduct additional trials. We do
not know whether our existing or any future clinical trials of
our drug candidates will demonstrate safety and efficacy
sufficiently to result in marketable products. Any one or more
of our
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clinical trials may be suspended at any time for a variety of
reasons, including the occurrence of any events or results that
cause us, any of our collaborators or any drug regulatory agency
to believe that the patients participating in these trials are
exposed to unacceptable health risks or that there are
deficiencies in the conduct of these trials. Failures or
perceived failures in our clinical trials may directly delay our
product development and regulatory approval process, damage our
business prospects, make it difficult for us to establish
collaborations and negatively affect our reputation and
competitive position in the pharmaceutical community.
Even if we receive approval to market any product from any
regulatory authorities on the basis of successful clinical
studies of that product, following the market introduction of
that product we or others may discover safety and efficacy
problems not observed in the clinical studies. In this respect,
as a condition to granting approval to market any of our
products or at any time after granting such approval, one or
more regulatory authorities may require us to conduct further
studies (referred to as Phase IV studies) to
determine the safety and efficacy of the product following
market introduction. If such problems arise, one or more
regulatory authorities may withdraw the approval for that
product or we may otherwise voluntarily withdraw the product
from the market.
Despite the time and resources expended by us, regulatory
approval of drug candidates is never guaranteed. If any of our
development programs are not successfully completed in a timely
fashion, required regulatory approvals are not obtained in a
timely fashion, or products for which approvals are obtained are
not commercially successful or are ultimately found to not be
safe or effective, our business could be seriously harmed.
We have not recorded any revenues from the sale of products,
have a history of operating losses and expect to incur
additional losses in the future.
To date, we have not recorded any revenues from the sale of
products. From our date of incorporation to March 31, 2006,
we have accumulated net losses of approximately
$131 million. Although we have received certain milestone
and royalty payments in the past, we cannot assure you that we
will receive any milestone or royalty payments in the future.
Consequently, we expect losses to increase in the near term as
we fund our preclinical and clinical trials and eventually seek
regulatory approval for the sale of our products. We expect to
continue to incur substantial operating losses unless and until
such time as product sales and milestone and royalty payments
generate sufficient revenues to fund our continuing operations.
We cannot predict if we will ever achieve and sustain
profitability.
We need to raise substantial additional financing to fund
further research and development, conduct preclinical and
clinical studies, and obtain regulatory approvals.
Since inception, we have raised approximately $174 million,
net of offering costs, from the sale of equity securities in
private placements and public offerings. We will require
substantial additional funds to fund further research and
development, conduct planned preclinical and clinical trials and
obtain regulatory approvals. Further funding for these purposes
may be achieved through public or private equity or debt
financings, collaborative arrangements with pharmaceutical
companies and/or from other sources. We have no established bank
financing arrangements, and there can be no assurance that we
will be able to establish such arrangements on satisfactory
terms. There can be no assurance that additional funding will be
available at all or on acceptable terms to permit successful
commercialization of our products. If adequate funds are not
available, we may be required to delay, reduce the scope of, or
eliminate one or more of our research or development programs or
commercialization efforts.
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Our success will depend, in part, on our ability to obtain
and protect patents and other intellectual property rights for
our drug candidates.
Our success will depend, in part, on our ability to obtain and
enforce patents and other intellectual property rights and
maintain trade secret protection. We have filed and are actively
pursuing applications for patents in the United States, Canada,
various countries in Europe, Japan and other countries. The
patent rights of biotechnology and pharmaceutical companies can
be highly uncertain and involve complex legal and factual
questions. Thus, we cannot assure that any of our patent
applications will result in the issuance of patents, that we
will develop additional proprietary products that are
patentable, that any patents issued to us or those that already
have been issued will provide us with any competitive advantages
or will not be challenged by any third parties, that the patents
of others will not impede our ability to do business or that
third parties will not be able to circumvent our patents.
Furthermore, there can be no assurance that others will not
independently develop similar products, duplicate any of our
products not under patent protection, or design around the
inventions we claim in any of our existing patents, existing
patent applications or future patents or patent applications.
A number of pharmaceutical and biotechnology companies and
research and academic institutions have developed technologies,
filed patent applications or received patents on various
technologies that are related to or affect our business. Some of
these technologies, applications or patents may conflict with
our technologies or patent applications. Such conflict could
limit the scope of the patents, if any, that we may be able to
obtain or result in the denial of our patent applications.
Patent applications in the United States are maintained in
secrecy and not published if either: (i) the application is
a provisional application or, (ii) the application is filed
and we request no publication, and certify that the invention
disclosed has not and will not be the subject of a
published foreign application. Otherwise, U.S. applications or
foreign counterparts, if any, publish 18 months after the
priority application has been filed. Since publication of
discoveries in the scientific or patent literature often lag
behind actual discoveries, we cannot be certain that we or any
of our licensors were the first creator of inventions covered by
pending patent applications or that we or such licensor was the
first to file patent applications for such inventions. Moreover,
we might have to participate in interference proceedings
declared by the U.S. Patent and Trademark Office to determine
priority of invention or opposition proceedings in the European
Patent Office to determine whether any patent issued to us or
any third party should be maintained, amended or revoked, which
could result in substantial cost to us, even if the eventual
outcome were favourable to us. There can be no assurance that
our patents, if issued, would be held valid or enforceable by a
court or that a competitors technology or product would be
found to infringe such patents.
Much of our know-how and technology may not be patentable. To
protect our rights, we require employees, consultants, advisors
and collaborators to enter into confidentiality agreements.
There can be no assurance, however, that these agreements will
provide meaningful protection for our trade secrets, know-how or
other proprietary information in the event of any unauthorized
use or disclosure. Further, our business may be adversely
affected by competitors who independently develop competing
technologies, especially if we obtain no, or only narrow, patent
protection.
Our success will depend, in part, on our ability to operate
without infringing the intellectual property rights of
others.
Our success will depend, in part, on our ability to operate
without infringing the patents and other proprietary rights of
third parties. Infringement proceedings in the pharmaceutical
and biotechnology industries can be lengthy, costly and
time-consuming and their outcome is uncertain. If we become
involved in any patent litigation, interference, opposition or
other administrative
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proceedings, we may incur substantial expense and the efforts of
our technical and management personnel may be significantly
diverted. As a result of such litigation or proceedings we could
lose our proprietary position and be restricted or prevented
from developing, manufacturing and selling the affected
products, incur significant damage awards, including punitive
damages, or be required to seek third-party licenses. If patents
that cover our activities are issued to other companies, we
cannot assure that we would be able to obtain licenses to these
patents at a reasonable cost or be able to develop or obtain
alternative technology. We cannot assure that that any such
licenses required under third-party patents or proprietary
rights would be made available, if at all, on terms we find
acceptable. If we need but cannot obtain such licenses on terms
that are acceptable to us, we could encounter delays in the
introduction of our products or be prohibited from developing,
manufacturing, using, selling or otherwise commercializing our
own products.
We may incur substantial costs, delays and difficulties in
complying with government regulations, including drug
manufacturing regulations and environmental regulations.
The manufacture and sale of human therapeutic and diagnostic
products in countries around the world, including those in North
America, Europe and Asia, are governed by a variety of statutes
and regulations. In addition to the statutes and regulations
described above relating to the preclinical and clinical studies
that we must conduct to demonstrate the safety and efficacy of
our drug candidates, we must also comply with statutes and
regulations relating to current Good Manufacturing Practices, or
cGMP, that regulate the production and storage of drugs, the
control of advertising, labelling and other marketing
activities, the protection of the environment, and the
protection of occupational safety and health of manufacturing
personnel.
We believe that the manufacturing processes and facilities by
and in which the drug candidates that we are currently studying
in clinical trials are manufactured and stored comply with cGMP
as adopted by the FDA, Health Canada, the EMEA and Europe
national drug regulatory agencies, and counterparts of these
regulatory agencies in other countries. Under cGMP, the
manufacturing processes and facilities in which our drug
candidates are manufactured and stored are subject to periodic
review by the FDA, Health Canada and, in the case of the EMEA,
authorized third parties. We cannot assure, however, that any of
these processes, facilities or future such processes or
facilities that we utilize will remain in or be able to achieve
such compliance. The failure to comply with cGMP of any of the
processes or facilities by or in which our drug candidates are
manufactured or stored is more than likely to result in our
failure to obtain or maintain regulatory approval to market the
applicable drug candidate or product. In the United States, the
FDA has been engaged during the past several years in revising
its cGMP regulatory program to encourage the early adoption of
new technological advances by the pharmaceutical industry,
facilitate industry application of modern quality management
techniques, including implementation of quality systems
approaches, to all aspects of pharmaceutical production and
quality assurance, encourage implementation of risk-based
approaches that focus on critical areas, ensure that regulatory
review and inspection policies are based on state-of-the-art
pharmaceutical science, and enhance the consistency and
coordination of the FDAs drug quality regulatory programs,
in part, by integrating enhanced quality systems approaches into
the FDAs business processes and regulatory policies
concerning review and inspection activities. This program, as
well as similar programs under consideration by drug regulators
in other countries, may result in revisions in the cGMP
regulations in the United States and elsewhere that require us
or any third party contract manufacturers that we use to modify
the facilities in which our drug candidates are manufactured and
stored. We cannot assure that we will be able to do so if so
required.
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Our discovery and development processes also involve the
controlled use of hazardous and radioactive materials. We are
subject to federal, provincial and local laws and regulations
governing the use, manufacture, storage, handling and disposal
of such materials and certain waste products. Although we
believe that our safety procedures for handling and disposing of
such materials comply with the standards prescribed by such laws
and regulations, the risk of accidental contamination or injury
from these materials cannot be completely eliminated. In the
event of such an accident, we could be held liable for any
damages that result and any such liability could exceed our
resources. We are not specifically insured with respect to this
liability. Although we believe that we are in compliance in all
material respects with applicable environmental laws and
regulations and currently do not expect to make material capital
expenditures for environmental control facilities in the
near-term, we cannot assure that we will not be required to
incur significant costs to comply with environmental laws and
regulations in the future, or that our operations, business or
assets will not be materially adversely affected by current or
future environmental laws or regulations.
We currently face and will continue to face significant
competition.
We are engaged in a rapidly changing field. Other products and
therapies that will compete directly with the products that we
are seeking to develop and market currently exist or are being
developed. Competition from fully integrated pharmaceutical
companies and more established biotechnology companies is
intense and is expected to increase. Most of these companies
have significantly greater financial resources and expertise in
discovery and development, manufacturing, preclinical and
clinical testing, obtaining regulatory approvals and marketing
than ourselves. Smaller companies may also prove to be
significant competitors, particularly through collaborative
arrangements with large pharmaceutical and established
biotechnology companies. Many of these competitors have
significant products that have been approved or are in
development and operate large, well-funded discovery and
development programs. Academic institutions, governmental
agencies and other public and private research organizations
also conduct research, seek patent protection and establish
collaborative arrangements for therapeutic products and clinical
development and marketing. These companies and institutions
compete with us in recruiting and retaining highly qualified
scientific and management personnel. In addition to the above
factors, we will face competition based on product efficacy and
safety, the timing and scope of regulatory approvals,
availability of supply, marketing and sales capability,
reimbursement coverage, price and patent position. We cannot
assure that our competitors will not develop more effective or
more affordable products, or achieve earlier patent protection
or product commercialization, than our own.
Other companies may succeed in developing products earlier than
ourselves, obtaining government regulatory approvals for such
products more rapidly than we will, or in developing products
that are more effective than products we propose to develop.
While we will seek to expand our technological capabilities in
order to remain competitive, there can be no assurance that
research and development by others will not render our
technology or products obsolete or non-competitive or result in
treatments or cures superior to any therapy we develop, or that
any therapy we develop will be preferred to any existing or
newly developed technologies.
We may not succeed at establishing a successful
commercialization program for any of our products either through
resources that we will have to establish or through outsourcing
contracts with third parties.
We have not yet introduced any products to market and have
limited manufacturing, sales, marketing and distribution
experience. To develop internal sales, distribution and
marketing capabilities, we would have to invest significant
amounts of financial and management resources. If
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we decide to perform sales, marketing and distribution functions
for certain drugs ourselves, we would face a number of risks,
including:
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we may not be able to build a significant marketing or sales
force; |
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the cost of establishing, training and providing oversight for a
marketing or sales force may not be justifiable in light of the
revenues generated by any particular product; |
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our sales and marketing efforts may not be successful; and |
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there are significant legal and regulatory risks in drug
marketing and sales that we have never faced, and any failure to
comply with legal and regulatory requirements for sales,
marketing and distribution could result in enforcement action by
drug regulatory authorities, such as the FDA or Health Canada,
that could jeopardize our ability to market the product or
subject us to liability. |
If we rely on third parties to launch and market our drug
candidates, if approved, we may have limited or no control over
the sales, marketing and distribution activities of these third
parties and our future revenue may depend on the success of
these third parties. In addition, if these parties fail to
comply with applicable regulatory requirements, the FDA, Health
Canada or other authorities could take enforcement action that
could jeopardize our ability to market the drug candidate.
We believe that there will be many different applications for
our products. We also believe that the anticipated market for
our products will continue to expand. However, these assumptions
may prove to be incorrect for a variety of reasons, including
competition from other products and the degree of our
products commercial viability.
Our success depends, in part, on our ability to obtain raw
materials and manufacture products in commercial quantities at
acceptable costs.
To be commercially successful, our drug candidates, if approved,
must be manufactured in commercial quantities in compliance with
regulatory requirements and at acceptable costs. In order to
manufacture any of our products in commercial quantities, if we
elect to do so, we will need to develop our own manufacturing
facilities or contract with third parties to do so. We cannot
assure that we will be able to make the transition to commercial
production of any of our products either by manufacturing them
on our own or through contract manufacturers.
In addition, production of our products may require raw
materials for which the sources and amount of supply are limited
or could be limited in the future. Any inability to obtain
adequate supplies of such raw materials on acceptable terms,
could significantly delay the development, regulatory approval
and marketing of our products.
If we fail to hire and retain key management and scientific
personnel, we may be unable to successfully implement our
business plan.
We are dependent on certain members of our management and
scientific staff, the loss of services of one or more of whom
could materially adversely affect us. Currently, five members of
our management and scientific staff are permitted to work in
Canada pursuant to employment authorizations issued by
Immigration Canada. Employment authorizations are required to be
renewed periodically. We cannot assure that these employment
authorizations will be renewed.
Our ability to manage growth effectively will require us to
continue to implement and improve our management systems and to
recruit and train new employees. Although we have done so in the
past and expect to do so in the future, we cannot assure that we
will be able to successfully attract and retain skilled and
experienced personnel.
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Healthcare reform and cost control initiatives by third-party
payors could reduce the prices that can be charged for drugs,
which could limit the commercial success of our drug candidates
and reduce or revenues and profitability.
Our ability to commercialize products successfully will depend
in significant part on the extent to which reimbursement for the
cost of such products and related treatments will be available
from government health administration authorities, private
health coverage insurers and other organizations. Both the
federal and state governments in the United States, federal and
provincial governments in Canada and governments in other
countries continue to propose and pass new legislation, rules
and regulations affecting third-party payors coverage and
reimbursement policies, which are designed to contain or reduce
the cost of health care. There may be future changes that result
in reductions in current coverage and reimbursement levels for
the type of products we are developing, and we cannot predict
the full scope of the changes or the impact that those changes
would have on our operations. In addition, third-party payors in
the United States and elsewhere are increasingly challenging the
price and cost-effectiveness of medical products and services.
Significant uncertainty exists as to the coverage and
reimbursement status of newly approved healthcare products, and
we cannot assure that adequate third-party coverage will be
available to establish price levels sufficient for us to realize
an appropriate return.
We may incur losses associated with foreign currency
fluctuation and may not be able to effectively hedge our
exposure.
We maintain our accounts in Canadian dollars. A portion of our
revenue and expenditures are in foreign currencies, most notably
in U.S. dollars, and therefore we are subject to foreign
currency fluctuations, which may, from time to time, impact our
financial position and results. We currently do not hedge for
foreign currency fluctuations. In the future, we may enter into
hedging arrangements under specific circumstances, typically
through the use of forward or futures contracts, to minimize the
impact of decreases in the value of the U.S. dollar.
If product liability lawsuits are successfully brought
against us, we will incur significant liabilities and may be
required to limit the commercialization of our product
candidates.
Our business exposes us to potential product liability risks,
which are inherent in the testing, manufacturing, marketing and
sale of therapeutic products. Human therapeutic products involve
an inherent risk of product liability claims and associated
adverse publicity. While we will continue to take precautions we
deem appropriate, there can be no assurance that we will be able
to avoid significant product liability exposure.
Our success may depend, in part, on our ability to maintain
adequate insurance at acceptable costs.
We have product liability insurance coverage to a maximum of
$5 million per incident and an aggregate of
$10 million. Such insurance is expensive, difficult to
obtain and may not continue to be available on acceptable terms,
if at all. An inability to obtain sufficient insurance coverage
on reasonable terms or to otherwise protect against potential
product liability claims could prevent or inhibit the
commercialization of our current or potential products. A
product liability claim brought against us in a clinical trail
or a product withdrawal could have a material adverse effect
upon us and our financial condition.
If we are not successful in establishing and maintaining
existing and additional collaborations with third parties, our
business will be adversely affected.
Our strategy is to enter into various arrangements with
corporate and academic collaborators, licensors, licensees and
others for the research, development, clinical testing,
manufacturing,
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marketing and commercialization of our products. To date, we
have also entered into research collaborations for the potential
development and commercialization of our product candidates with
pharmaceutical firms, pursuant to which we could receive
additional funding, including milestone payments from those
parties. We intend to enter into additional corporate partnering
agreements to develop and commercialize products based upon our
products and technology. We cannot assure, however, that we will
be able to establish such additional collaborations on
favourable terms, if at all, or that our current or future
collaborative arrangements will be successful.
Should any collaborative partner fail to develop or
commercialize successfully any product to which we have rights,
or any of the partners products to which we have rights,
our business may be adversely affected. In addition, while we
believe that our collaborative partners will have sufficient
economic motivation to continue their funding, we cannot assure
that any of these collaborations will be continued or result in
successfully commercialized products. Failure of a collaborative
partner to continue funding any particular program could delay
or halt the development or commercialization of any products
arising out of such program. In addition, we cannot assure that
the collaborative partners will not pursue alternative
technologies or develop alternative products either on their own
or in collaboration with others, including our competitors, as a
means for developing treatments for the diseases and conditions
targeted by our programs.
Risks Related to our Common Shares
Further equity financing may substantially dilute the
interests of our shareholders.
We will require substantial additional funds to fund further
research and development, conduct planned preclinical and
clinical trials and obtain regulatory approvals. If we raise
additional funding by issuing additional equity securities, such
financing may substantially dilute the interests of our
shareholders and reduce the value of their investment.
Our common shares may experience price and volume
fluctuations and the market price for our common shares may drop
below the price you pay.
The market price of our common shares could be subject to
significant fluctuations. Market prices for securities of early
stage companies like ours have historically been particularly
volatile. As a result of this volatility, you may not be able to
sell your common shares at or above the price you pay. The
market price of our common shares may fluctuate substantially
due to a variety of factors, many of which are beyond our
control, including:
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announcements concerning the results of clinical trials for our
drug candidates; |
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announcements regarding regulatory approval or rejection of
NDAs in the United States and marketing authorization
applications in other countries, if any, that we file for any of
our drug candidates; |
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market acceptance of each of our products, if approved for
marketing by government regulators; |
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the amount of reimbursement for our products under government
programs, such as Medicare and Medicaid in the United States,
and by other third party payors, as well as the prices for our
products that we are able to negotiate with government
regulators in those countries where we are required to do so; |
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the need to recall any of our products after they have been
approved and introduced into the market; |
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reports and publications by drug regulatory, health or medical
authorities, academic or other researchers, the media or other
third parties regarding the potential benefits, side effects or
other disadvantages of our drug candidates in particular, the
general type of products we are developing, or biopharmaceutical
products in general; |
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announcements of technological innovations or new products by us
or our competitors; |
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announcements concerning our competitors or the
biopharmaceutical industry in general; |
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new regulatory pronouncements and changes in regulatory
guidelines; |
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the timing of our achievement, if at all, of profitability and
positive cash flow from operations; |
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actual or anticipated variations in our quarterly operating
results; and |
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changes in financial estimates or recommendations by securities
analysts, or the failure to meet or exceed securities analyst
recommendations. |
The market prices of securities of pharmaceutical and
biotechnology companies have been highly volatile and are likely
to remain highly volatile in the future. This volatility has
often been unrelated or disproportionate to the operating
performance of the particular companies. These broad market
fluctuations could result in extreme fluctuations in the price
of our common shares, which could cause a decline in the value
of a shareholders investment.
In the past, following periods of volatility in the market price
of a companys securities, shareholders have often
instituted class action securities litigation against those
companies. Such litigation, if instituted, could result in
substantial costs and diversion of management attention and
resources, which could significantly harm our profitability and
reputation.
We do not expect to pay dividends on our common shares in the
foreseeable future.
We have never paid cash dividends on our common shares. We
currently intend to retain our future earnings, if any, to fund
the development and growth of our business, and do not
anticipate paying any cash dividends on our common shares for
the foreseeable future. As a result, you will have to rely on
capital appreciation, if any, to earn a return on your
investment in our common shares in the foreseeable future.
Furthermore, we may in the future become subject to contractual
restrictions on, or prohibitions against, the payment of
dividends.
Sales of substantial amounts of our securities may have an
adverse effect on the market price of our securities.
Sales of substantial amounts of our securities, or the
availability of such securities for sale, could adversely affect
the prevailing market prices for our securities. A decline in
the market prices of our securities could impair our ability to
raise additional capital through the sale of securities should
we desire to do so.
Our articles and certain Canadian laws could delay or deter a
change of control.
Our authorized share capital consists of an unlimited number of
common shares without par value and an unlimited number of
preferred shares issuable in one or more series, without par
value. Our authorized preferred shares are available for
issuance from time to time at the discretion of our board of
directors, without shareholder approval. Our articles grant our
board of directors the authority, subject to the corporate laws
of Canada, to determine or alter the special rights and
restrictions granted to or imposed on any wholly unissued series
of preferred shares, and such rights may be superior to those of
our common shares.
17
Limitations on the ability to acquire and hold our common shares
may be imposed by the Competition Act (Canada). This legislation
permits the Commissioner of Competition of Canada to review any
acquisition of a significant interest in us. This legislation
grants the Commissioner jurisdiction to challenge such an
acquisition before the Canadian Competition Tribunal if the
Commissioner believes that it would, or would be likely to,
result in a substantial lessening or prevention of competition
in any market in Canada. The Investment Canada Act (Canada)
subjects an acquisition of control of a company by a
non-Canadian to government review if the value of our assets as
calculated pursuant to the legislation exceeds a threshold
amount. A reviewable acquisition may not proceed unless the
relevant minister is satisfied that the investment is likely to
be a net benefit to Canada.
Any of the foregoing could prevent or delay a change of control
and may deprive or limit strategic opportunities for our
shareholders to sell their shares.
We follow corporate governance requirements of Canadian
corporate and securities laws.
Non-Canadian residents holding our common shares should be aware
that we follow the corporate governance requirements of
applicable Canadian corporate and securities laws which may
differ from corporate governance requirements under laws
applicable in their place of residence. In addition, although we
substantially comply with the corporate governance guidelines of
the NASDAQ, we are permitted to follow the shareholder meeting
quorum requirements of our bylaws, which provide that a quorum
is met by two persons holding or representing not less than 10%
of the outstanding voting shares (as compared to
331/3%
under NASDAQ requirements).
We may be a passive foreign investment company under U.S.
federal income tax laws in the current or future tax years.
Special United States federal income tax rules apply to U.S.
taxpayers directly or indirectly owning shares of a passive
foreign investment company, or PFIC. We may constitute a PFIC in
the current or a future tax year. However, since PFIC status
will be determined on an annual basis and depends on the
composition of the our income and assets and the nature of the
our activities from time to time, there can be no assurance that
we will not be considered a PFIC for the current or any future
taxable year. Moreover, we will not obtain an opinion of
counsel, and no ruling will be sought from the U.S. Internal
Revenue Service, regarding the United States federal income tax
characterization of us as a PFIC. If we are treated as a PFIC
for any taxable year during which a U.S. taxpayer holds, or is
treated as holding, our common shares, certain adverse
consequences could apply to the U.S. taxpayer.
Certain adverse PFIC rules described above will not apply to a
U.S. shareholder if the U.S. shareholder timely elects to have
us treated as a qualified electing fund, or QEF, for
the first taxable year in which the U.S. taxpayer is treated as
owning an interest in a PFIC, and we provide specified
information to U.S. shareholders. If we are treated as a PFIC, a
U.S. taxpayer may not be able to avoid the adverse consequences
described above by electing to treat us as a QEF because we may
not provide the information that a holder requires to make such
an election effective.
As an alternative to the QEF election, a U.S. taxpayer of
marketable stock in a PFIC may make a
mark-to-market election, provided the PFIC stock is
regularly traded on a qualified exchange. Our common
shares are currently traded on the AMEX, however, on
August 21, 2006 the NASDAQ Stock Market Inc. approved the
listing of our common shares on the NASDAQ, and our common
shares will begin trading on the NASDAQ upon completion of
certain final regulatory requirements, which we expect to occur
prior to the end of September 2006. Upon our shares becoming
listed on the NASDAQ, our common shares will be de-listed from
the AMEX. Both the
18
AMEX and NASDAQ are qualified exchanges. We cannot
assure U.S. taxpayers that our common shares will be treated as
regularly traded stock. If the mark-to-market election is
available and validly made, the electing U.S. taxpayer generally
would (i) include in gross income, entirely as ordinary
income, an amount equal to the excess, if any, of the fair
market value of the PFIC stock as of the close of such taxable
year and its adjusted tax basis in the stock, and
(ii) deduct as an ordinary loss the excess, if any, of the
adjusted tax basis of the PFIC stock over its fair market value
at the end of the taxable year, but only to the extent of the
amount previously included in gross income as a result of the
mark-to-market election.
A U.S. taxpayer considering investing in our common shares
should consult its own tax advisor concerning the United States
federal income tax consequences of holding our common shares if
we are treated as a PFIC for any taxable year during which the
U.S. shareholder holds, or is treated as holding, our common
shares (including the advisability and availability of making
any of the foregoing elections).
U.S. investors may not be able to obtain enforcement of civil
liabilities against us, certain of our directors and officers,
and the experts named in this prospectus.
The enforcement by investors of civil liabilities under the
United States federal or state securities laws may be affected
adversely by the fact that we are organized under and governed
by the federal laws of Canada, and that certain of our directors
are not U.S. residents and a majority of our officers and the
experts named in this prospectus are residents of Canada, and
that a substantial portion of our are located outside the United
States. It may not be possible for investors to effect service
of process within the United States on us, certain of our
directors and officers, and the experts named in this
prospectus, or enforce judgments obtained in U.S. courts against
us, certain of our directors and officers, and the experts named
in this prospectus based upon the civil liability provisions of
U.S. federal or state securities laws.
There is some doubt as to whether a judgment of a U.S. court
based solely upon the civil liability provisions of U.S. federal
or state securities laws would be enforceable in Canada against
us and our directors and officers. There is also doubt as to
whether an original action could be brought in Canada against us
or our directors and officers to enforce liabilities based
solely upon U.S. federal or state securities laws.
OUR COMPANY
We are a chemistry-based biopharmaceutical company focused on
the discovery, development and commercialization of new
therapeutic drugs in the areas of hematology, human
immunodeficiency virus, or HIV, and oncology, based on our
research into chemokine receptors. Our lead drug candidate,
MOZOBIL, is in pivotal Phase III clinical trials for stem
cell mobilization. We believe MOZOBIL has the potential to
increase the proportion of patients achieving an optimal
collection of stem cells more rapidly and predictably than
currently approved drugs thus making current stem cell
transplantation procedures more safe, effective and accessible
to patients.
Our programs are focused on a new class of drugs that target
chemokine receptors, specifically CXCR4 and CCR5 receptors.
Chemokines are a class of naturally occurring proteins that are
involved in cellular signalling, adhesion and migration. These
processes play a critical role in bone marrow function, immune
responses as well the pathogenesis of diseases such as cancer
and HIV infection.
While significant advances in drug discovery have generated
breakthroughs in the treatment and management of hematology, HIV
and oncology, individual responses to treatments remain
19
highly variable with a significant proportion of patients
deriving little or no benefit from the therapy. For example,
exposure to chemotherapeutic drugs is associated with toxic side
effects and adaptation within the tumor micro environment can
rapidly trigger drug resistance. In the HIV setting, mutations
of the HIV virus generate drug resistance. As a result,
treatments for cancer and HIV often involve drug
cocktails whereby physicians employ a strategy of
combining drugs with different mechanisms of action to maximize
tumor response and infection control, respectively.
Our product candidates in HIV and oncology have the potential to
improve patient outcomes by working additively or
synergistically with common drugs used to manage and treat
cancer and HIV. In conditions where the underlying pathology of
the disease is mediated by chemokines, our product candidates
have the potential to serve as primary therapeutic compounds.
The following table summarizes our preclinical and clinical
product candidates and programs:
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Program |
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Indication |
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Status |
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Marketing Rights |
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MOZOBIL
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Stem Cell Transplant |
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Phase III |
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AnorMED |
AMD070
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HIV Entry Inhibitor |
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Phase Ib/IIa |
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AnorMED |
MOZOBIL
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Oncology |
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Preclinical |
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AnorMED |
CCR5
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HIV |
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Preclinical |
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AnorMED |
CXCR4
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Oncology |
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Preclinical |
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AnorMED |
CAPITALIZATION
Since June 30, 2006, there have been no material changes in
our consolidated share and loan capital.
USE OF PROCEEDS
Unless otherwise specified in a prospectus supplement, any net
proceeds that we receive from the issue of our common shares
will be used for working capital and general corporate purposes,
which may include, but is not limited to, conducting clinical
trials and other research and development and, if and when
approved, commercialization of our product candidates.
DESCRIPTION OF SHARE CAPITAL
Our authorized share capital consists of an unlimited number of
common shares without par value and an unlimited number of
preferred shares issuable in one or more series, without par
value. As at August 25, 2006, 41,660,411 of our common
shares, and none of our preferred shares, were issued and
outstanding.
The modification, amendment or variation of the rights attached
to our common shares or preferred shares is governed by the
Canada Business Corporations Act, the legislation under
which we are incorporated. This legislation provides that such a
modification, amendment or variation requires the approval of
our shareholders by special resolution, being a majority of not
less than 2/3 of the votes cast by our shareholders.
Common Shares
The holders of our common shares are entitled to receive notice
of any meeting of our shareholders, except those meetings at
which only the holders of shares of another class or of a
particular series are entitled to vote, and to attend and vote
thereat. Each of our common shares
20
entitles its holder to one vote on any poll that may be
conducted. Subject to the rights of the holders of our preferred
shares, the holders of our common shares are entitled to receive
on a pro-rata basis such dividends as our board of directors may
declare out of funds legally available for this purpose. In the
event of the dissolution, liquidation, winding-up or other
distribution of our assets, holders of our common shares are
entitled to receive on a pro-rata basis all of our assets
remaining after payment of all of our liabilities, subject to
the rights of holders of our preferred shares. The common shares
carry no pre-emptive or conversion rights and no provisions for
redemption, retraction, purchase for cancellation or surrender,
sinking or purchase funds, or requiring a shareholder to
contribute additional capital.
Preferred Shares
Our preferred shares are issuable from time to time in one or
more series, each series comprising the number of shares,
designation, rights, privileges, restrictions and conditions
determined by our board of directors. Our preferred shares will
be entitled to priority over our common shares with respect to
the payment of dividends and distributions in the event of our
dissolution, liquidation or winding-up. The holders of our
preferred shares are entitled to receive notice of any meeting
of our shareholders and to attend and vote thereat, except as
otherwise provided in the rights and restrictions attached to a
series of preferred shares by our board or directors.
PLAN OF DISTRIBUTION
We may issue the common shares offered by this prospectus for
cash or other consideration;
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to or through underwriters, dealers, placement agents or other
intermediaries; |
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directly to one or more purchasers; or |
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in connection with acquisitions by us. |
Each prospectus supplement will set forth the terms of the
offering of the common shares, including:
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the name or names of any underwriters, dealers or other
placement agents; |
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the purchase price of, and form of consideration for, the common
shares; |
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any proceeds to us; and |
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any underwriting commissions, fees, discounts and other items
constituting underwriters compensation. |
The common shares may be sold, from time to time in one or more
transactions at a fixed price or prices which may be changed or
at market prices prevailing at the time of sale, at prices
related to such prevailing market price or at negotiated prices.
Under agreements which may be entered into by us, underwriters,
dealers and agents who participate in the distribution of common
shares may be entitled to indemnification by us against certain
liabilities, including liabilities under the United States
Securities Act of 1933, as amended, and applicable Canadian
provincial securities legislation, or to contribution with
respect to payments which such underwriters, dealers or agents
may be required to make in respect thereof. The underwriters,
dealers and agents with whom we enter into agreements may be
customers of, engage in transactions with, or perform services
for, us in the ordinary course of business.
21
In connection with any offering of common shares, the
underwriters may over-allot or effect transactions which
stabilize or maintain the market price of the common shares
offered at a level above that which might otherwise prevail in
the open market. Such transactions, if commenced, may be
discontinued at any time.
LEGAL MATTERS
Certain legal matters relating to the common shares offered by
this short form base shelf prospectus will be passed upon for us
by Farris, Vaughan, Wills & Murphy LLP, Vancouver,
British Columbia, Canada, with respect to matters of Canadian
law, and Dorsey & Whitney LLP, Vancouver, British Columbia,
Canada, with respect to matters of United States law.
DOCUMENTS FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION
The following documents have been filed with the SEC as part of
the Registration Statement of which this prospectus forms a
part: the documents referred to under the heading
documents incorporated by reference; consent of KPMG
LLP; and powers of attorney from our directors and officers.
22
PART II
INFORMATION NOT REQUIRED TO BE DELIVERED TO
OFFEREES OR PURCHASERS
Indemnification of Directors and Officers.
Canada Business Corporations Act
Under the Canada Business Corporations Act (the
CBCA), which governs the Registrant, the Registrant
may indemnify a present or former director or officer of the
Registrant or a person who acts or acted at the
Registrants request as a director or officer, or an
individual acting in a similar capacity, of another entity (the
Individual), against all costs, charges and
expenses, including an amount paid to settle an action or
satisfy a judgment, reasonably incurred by the Individual in
respect of any civil, criminal, administrative, investigative or
other proceeding in which the Individual is involved because of
that association with the Registrant or other entity. The
Registrant may advance monies to the Individual for the costs,
charges and expenses of a proceeding referred to in the
preceding sentence.
However, the indemnification referred to in the preceding
paragraph is prohibited under the CBCA, and all moneys advanced
to the Individual pursuant to the preceding paragraph must be
repaid, unless the Individual:
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(a) acted honestly and in good faith with a view to the best
interests of the Registrant, or, as the case may be, to the best
interests of the other entity for which the Individual acted as
director or officer or in a similar capacity at the
Registrants request; and |
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(b) in the case of a criminal or administrative action or
proceeding that is enforced by a monetary penalty, had
reasonable grounds for believing that the Individuals
conduct was lawful. |
In addition, such indemnification or the advance of monies may
only be made in respect of an action by or on behalf of the
Registrant or other entity to procure a judgment in its favour
with the prior approval of the court.
Notwithstanding the foregoing, the CBCA provides that an
Individual is entitled to indemnity from the Registrant in
respect of all costs, charges and expenses reasonably incurred
by the Individual in connection with the defence of any civil,
criminal, administrative, investigative or other proceeding to
which the Individual is subject because of the Individuals
association with the Registrant or other entity, if the
Individual was not judged by the court or other competent
authority to have committed any fault or omitted to do anything
that the individual ought to have done and has fulfilled the
conditions set forth in (a) and (b) of the preceding
paragraph.
Bylaws of the Registrant
The bylaws of the Registrant provide that, subject to the
limitations contained in the CBCA, but without limiting the
right of the Registrant to indemnify any individual under the
CBCA or otherwise to the full extent permitted by law, the
Registrant:
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(a) shall indemnify each director or officer or former director
or officer and each other individual who acts or has acted at
the Registrants request as a director or officer, or in a
similar capacity, of another entity (and each such
individuals respective heirs and personal
representatives), against all costs, charges and expenses,
including an amount paid to settle an |
II-1
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action or satisfy a judgment, reasonably incurred in respect of
any civil, criminal, administrative, investigative or other
proceeding in which the individual is involved because of that
association with the Registrant or other entity, provided: |
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(i) the individual acted honestly and in good faith with a view
to the best interests of the Registrant or, as the case may be,
to the best interests of the other entity for which the
individual acted as a director or officer or in a similar
capacity at the Registrants request; and |
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(ii) in the case of a criminal or administrative action or
proceeding that is enforced by a monetary penalty, the
individual had reasonable grounds for believing that the
individuals conduct was lawful; and |
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(b) shall advance monies to a director, officer or other
individual for the costs, charges and expenses of a proceeding
referred to in subparagraph (a) above in accordance with
and subject to the CBCA. |
Notwithstanding the foregoing, the bylaws of the Registrant
provide that any such indemnity or advance of monies in respect
of an action referred to in (a) of the preceding paragraph
by or on behalf of the Registrant or other entity in respect of
which an individual has acted as director or officer or in a
similar capacity at the request of the Registrant to procure
judgment in its favour shall be subject to approval of a court.
Indemnification Agreements
The Registrant has entered into an indemnification agreement
with each of its directors and officers which provides, among
other things, that the Registrant will, to the fullest extent
not prohibited by law, indemnify such person against costs,
charges and expenses reasonably incurred by such person in
respect of any civil, criminal, administrative, investigative or
other proceeding in which such person is involved because of his
or her association as a present or former director or officer of
the Registrant, or an individual who acts or acted at the
Registrants request as a director or officer, or an
individual acting in a similar capacity, of another entity,
whether brought by or on behalf of the Registrant or otherwise.
The indemnification agreements also provide that, to the fullest
extent not prohibited by law, or by a finding of an arbitrator
or a court of first instance, the Registrant will advance, as
they are incurred in advance of the final disposition of an
eligible proceeding, the litigation expenses actually and
reasonably incurred by such person in connection with the
eligible proceeding, and upon it being ultimately determined
whether or not indemnification of such person for all or part of
the advanced litigation expenses is prohibited by the CBCA:
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(a) to the extent that indemnification for the advanced
litigation expenses is not prohibited, the Registrant will
indemnify such person against them, and such person will not be
required to repay them; or |
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(b) to the extent that indemnification for the advanced
litigation expenses is prohibited, such person will repay them
to the Registrant. |
Directors and Officers Insurance
The Registrant maintains a directors and officers
insurance and registrant reimbursement policy. The policy:
(a) insures directors and officers against losses for which
the Registrant does not indemnify and which losses arise from
certain wrongful acts in the indemnified parties
capacities as directors and officers; and, (b) reimburses
the Registrant for those losses for which the Registrant has
lawfully indemnified the directors and officers.
II-2
United States Securities and Exchange Commission Opinion on
Indemnification Under the Securities Act
Insofar as indemnification for liabilities arising under the
Securities Act of 1933, as amended (the Securities
Act), may be permitted to directors, officers or persons
controlling the Registrant pursuant to the foregoing provisions,
the Registrant has been informed that in the opinion of the
United States Securities and Exchange Commission such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
II-3
EXHIBITS
See the Exhibit Index hereto.
II-4
PART III
UNDERTAKING AND CONSENT TO SERVICE OF PROCESS
Item 1. Undertaking.
The Registrant undertakes to make available, in person or by
telephone, representatives to respond to inquiries made by the
United States Securities and Exchange Commission staff, and to
furnish promptly, when requested to do so by the United States
Securities and Exchange Commission staff, information relating
to the securities registered pursuant to this Form F-10 or
to transactions in said securities.
Item 2. Consent to Service
of Process.
Concurrently with the filing of this Registration Statement, the
Registrant has filed with the Commission a written Appointment
of Agent for Service of Process and Undertaking on Form F-X.
Any change to the name or address of the agent for service of
the Registrant shall be communicated promptly to the United
States Securities and Exchange Commission by an amendment to
Form F-X referencing the file number of the relevant
registration statement.
III-1
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe
that it meets all of the requirements for filing on
Form F-10 and has duly caused this Registration Statement
to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Langley, Province of British
Columbia, Canada, on this 28th day of August, 2006.
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By: |
/s/ Kenneth H. Galbraith
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Name: Kenneth H. Galbraith |
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Title: |
Interim Chief Executive Officer,
Chairman and Director |
POWERS OF ATTORNEY
Each person whose signature appears below constitutes and
appoints Kenneth H. Galbraith and William J. Adams, and each of
them, either of whom may act without the joinder of the other,
as his true and lawful attorneys-in-fact and agents, with full
power of substitution and resubstitution, for him and in his
name, place and stead, in any and all capacities, to sign any or
all amendments (including post-effective amendments) to this
Registration Statement, and to file the same, with all exhibits
thereto and other documents in connection therewith, with the
United States Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents full power and authority to do
and perform each and every act and thing requisite and necessary
to be done, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that
said attorneys-in-fact and agents or their substitute or
substitutes may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons
in the capacities indicated on August 28, 2006:
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Signature |
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Title |
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/s/ Kenneth H.
Galbraith
Kenneth
H. Galbraith |
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Interim Chief Executive Officer, Chairman and Director
(Principal Executive Officer) |
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/s/ William J. Adams
William
J. Adams |
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Vice President, Finance, Chief Financial Officer, Secretary and
Treasurer (Principal Financial Officer and Principal Accounting
Officer) |
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/s/ Paul A. Brennan
Paul
A. Brennan |
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Acting President, Vice President, Business Development and
Director |
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/s/ Joseph P. Dougherty
Joseph
P. Dougherty |
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Director |
III-2
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Signature |
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Title |
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/s/ Henry J. Fuchs
Henry
J. Fuchs |
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Director |
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/s/ Jacques R. Lapointe
Jacques
R. Lapointe |
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Director |
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/s/ I. Berl Nadler
I.
Berl Nadler |
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Director |
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/s/ Kelvin M. Neu
Kelvin
M. Neu |
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Director |
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/s/ Klaus R. Veitinger
Klaus
R. Veitinger |
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Director |
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/s/ Felix Baker
Felix
Baker |
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Director |
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/s/ William L. Hunter
William
L. Hunter |
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Director |
III-3
AUTHORIZED REPRESENTATIVE
Pursuant to the requirements of Section 6(a) of the
Securities Act of 1933, as amended, the undersigned has signed
this Registration Statement, solely in its capacity as the duly
authorized representative of AnorMED Inc. in the United States,
on August 28, 2006.
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/s/ Klaus R. Veitinger
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Klaus R. Veitinger |
III-4
EXHIBIT INDEX
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Exhibit |
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Description |
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4 |
.1 |
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Annual information Form for the financial year ended
March 31, 2006, dated June 27, 2006 (incorporated by
reference to AnorMED Inc.s Annual Report on Form 40-F
for the financial year ended March 31, 2006, filed with the
SEC on June 30, 2006 (File No. 0-51803)). |
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4 |
.2 |
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Audited consolidated balance sheets as at March 31, 2006
and 2005 and the consolidated statements of operations, changes
in shareholders equity, and cash flows for each of the
years in the three year period ended March 31, 2006,
together with the notes thereto and the auditors report
thereon (incorporated by reference to AnorMED Inc.s Annual
Report on Form 40-F for the financial year ended
March 31, 2006, filed with the SEC on June 30, 2006
(File No. 0-51803)). |
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4 |
.3 |
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Managements discussion and analysis for the financial year
ended March 31, 2006 (incorporated by reference to AnorMED
Inc.s Annual Report on Form 40-F for the financial
year ended March 31, 2006, filed with the SEC on
June 30, 2006 (File No. 0-51803)). |
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4 |
.4 |
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Unaudited consolidated balance sheet as at June 30, 2006
and consolidated statements of operations, changes in
shareholders equity, and cash flows for the three month
periods ended June 30, 2006 and 2005 (incorporated by
reference to AnorMED Inc.s Report on Form 6-K,
furnished to the SEC on August 14, 2006 (File
No. 0-51803)). |
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4 |
.5 |
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Managements discussion and analysis for the three month
period ended June 30, 2006 (incorporated by reference to
AnorMED Inc.s Report on Form 6-K, furnished to the
SEC on July 31, 2006 (File No. 0-51803)). |
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4 |
.6 |
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Material change report dated April 28, 2006 (incorporated
by reference to AnorMED Inc.s Report on Form 6-K,
furnished to the SEC on June 6, 2006 (File
No. 0-51803)). |
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4 |
.7 |
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Material change report dated May 26, 2006 (incorporated by
reference to AnorMED Inc.s Report on Form 6-K,
furnished to the SEC on May 30, 2006 (File
No. 0-51803)). |
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4 |
.8 |
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Material change report dated June 14, 2006 (incorporated by
reference to AnorMED Inc.s Report on Form 6-K,
furnished to the SEC on June 19, 2006 (File
No. 0-51803)). |
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4 |
.9 |
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Management proxy circular dated August 10, 2006 prepared in
connection with the annual and special meeting of our
shareholders to be held on September 19, 2006 (incorporated
by reference to AnorMED Inc.s Report on Form 6-K,
furnished to the SEC on August 28, 2006 (File
No. 0-51803)). |
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5 |
.1 |
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Consent of KPMG LLP. |
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6 |
.1 |
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Powers of Attorney (included on the signature page of this
registration statement). |