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0001206212-07-000073.txt : 20070327
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20070327113754
ACCESSION NUMBER: 0001206212-07-000073
CONFORMED SUBMISSION TYPE: 40-F/A
PUBLIC DOCUMENT COUNT: 5
CONFORMED PERIOD OF REPORT: 20070327
FILED AS OF DATE: 20070327
DATE AS OF CHANGE: 20070327
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: NEUROCHEM INC
CENTRAL INDEX KEY: 0001259942
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 000000000
FISCAL YEAR END: 0630
FILING VALUES:
FORM TYPE: 40-F/A
SEC ACT: 1934 Act
SEC FILE NUMBER: 000-50393
FILM NUMBER: 07720235
BUSINESS ADDRESS:
STREET 1: 275 ARMAND-FRAPPIER BLVD.
CITY: LAVAL
STATE: A8
ZIP: H7V 4A7
BUSINESS PHONE: 450-680-4500
MAIL ADDRESS:
STREET 1: 275 ARMAND-FRAPPIER BLVD.
CITY: LAVAL
STATE: A8
ZIP: H7V 4A7
40-F/A
1
m35441a3e40vfza.htm
FORM 40-F/A
e40vfza
U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
40-F/A
(Amendment
No. 3)
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REGISTRATION STATEMENT PURSUANT TO SECTION 12 OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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ANNUAL REPORT PURSUANT TO SECTION 13(a) OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2006
Commission File Number 000-50393
NEUROCHEM INC.
(Exact name of Registrant as specified in its charter)
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Canada
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2834
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Not Applicable |
(Province or other jurisdiction of
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(Primary Standard Industrial
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(I.R.S. Employer |
incorporation or organization )
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Classification Code Number)
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Identification No.) |
275 Armand-Frappier Boulevard
Laval, Quebec H7V 4A7, Canada
(450) 680-4500
(Address and telephone number of Registrants principal executive offices)
CT Corporation System
111 Eighth Avenue, 13th Floor
New York, New York 10011
(212) 894-8400
(Name, address (including zip code) and telephone number
(including area code) of agent for service in the United States)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
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Title of each class
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Name of exchange on which registered |
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Common Shares, no par value
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The NASDAQ Stock Market |
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
For annual reports, indicate by check mark the information filed with this Form:
þ Annual information form o Audited annual financial statements
Indicate the number of outstanding shares of each of the issuers classes of capital or common
stock as of the close of the period covered by the annual report:
The Registrant had 38,722,022 Common Shares
Outstanding as at December 31, 2006
Indicate by check mark whether the Registrant by filing the information contained in this Form is
also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934 (the Exchange Act). If Yes is marked, indicate the filing
number assigned to the Registrant in connection with such Rule.
Yes
o.
82-
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No
þ.
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period
that the Registrant was required to file such reports) and (2) has been subject to such filing
requirements for the past 90 days.
Yes
þ. No o.
EXPLANATORY NOTE
This Amendment No. 3 to the Annual Report on Form 40-F, including exhibits hereto (this
Amendment) is being filed by Neurochem Inc. (the Registrant) to amend its annual report on
Form 40-F for the year ended December 31, 2006, filed with the Commission on March 2, 2007 (the
Original Form 40-F) as amended by Amendment No. 1 thereto (Amendment No. 1) filed with the
Commission on March 6, 2007 and Amendment No. 2 thereto (Amendment No. 2) filed with the Commission on March 13, 2007 (the Original Form 40-F as amended by Amendment No. 1 and Amendment No. 2, the Form
40-F). The Registrant is filing this Amendment to file its Annual Information Form for the fiscal year ended December 31, 2006.
No other changes have been made to the information in the Form 40-F.
PRINCIPAL DOCUMENTS
The following documents have been filed as part of this Annual Report on Form 40-F:
A. Annual Information Form
The Annual Information Form of the Registrant for the fiscal year ended December 31, 2006 (filed herewith).
B. Consolidated Audited Annual Financial Statements
The audited consolidated balance sheets of the Registrant as at December 31, 2006 and 2005 and the
consolidated statements of operations, deficit and cash flows for the years ended December 31,
2006, December 31, 2005, and December 31, 2004, and for the period from inception (June 17, 1993)
to December 31, 2006, together with the auditors report
thereon (previously filed on Form 40-F/A on March 13, 2007).
C. Managements Discussion and Analysis
Managements Discussion and Analysis of Consolidated Financial Condition and Results of Operations
of the Registrant for the year ended December 31, 2006 compared to the year ended December 31,
2005, and for the year ended December 31, 2005 compared to the
year ended December 31, 2004 (previously filed on Form 40-F on
March 2, 2007).
D. US GAAP Reconciliation Note
A supplemental note entitled Reconciliation to United States Generally Accepted Accounting
Principles in respect of the Registrants consolidated financial statements as at December 31,
2006 and 2005 and for the years ended December 31, 2006, 2005 and 2004 and for the period from
inception (June 17, 1993) to December 31, 2006, together with the auditors report thereon (previously filed on Form 40-F/A on March 13, 2007).
DOCUMENTS FILED PURSUANT TO GENERAL INSTRUCTIONS:
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Document |
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1.
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Annual Information Form of the Registrant for the fiscal year ended December 31, 2006. |
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2.
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The audited consolidated balance sheets of the Registrant as at December 31, 2006 and 2005
and the consolidated statements of operations, deficit and cash flows for the years ended
December 31, 2006, December 31, 2005, and December 31, 2004, and for the period from inception
(June 17, 1993) to December 31, 2006, together with the auditors report thereon.* |
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3.
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Managements Discussion of Consolidated Financial Condition and Results of Operations of the
Registrant for the year ended December 31, 2006 compared to the year ended December 31, 2005,
and for the year ended December 31, 2005 compared to the year
ended December 31, 2004.** |
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4.
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A supplemental note entitled Reconciliation to United States Generally Accepted Accounting
Principles in respect of the Registrants audited consolidated financial statements as at December
31, 2006 and 2005 and for the years ended December 31, 2006, 2005 and 2004 and for the period
from inception (June 17, 1993) to December 31, 2006 together with the auditors report
thereon.* |
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* |
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Previously filed on Form 40-F/A on March 13, 2007. |
** |
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Previously filed on Form 40-F on
March 2, 2007. |
INCORPORATION BY REFERENCE
The supplemental note entitled Reconciliation to United States Generally Accepted Accounting
Principles in respect of the Registrants consolidated financial statements as at December 31,
2006 and 2005 and for the years ended December 31, 2006, 2005 and 2004 and for the period from
inception (June 17, 1993) to December 31, 2006, together with the auditors report thereon, is
hereby incorporated by reference into the prospectus included in the Registrants registration
statement on Form F-10 (SEC Reg. No. 333-140039).
The following documents included in or filed as an exhibit to this Annual Report on Form 40-F
are hereby incorporated by reference as exhibits to the Registrants registration statement on Form
F-10 (SEC Reg. No. 333-140039):
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The audited consolidated balance sheets of the Registrant as at December 31, 2006 and 2005
and the consolidated statements of operations, deficit and cash flows for the years ended
December 31, 2006, December 31, 2005, and December 31, 2004, and for the period from inception
(June 17, 1993) to December 31, 2006, together with the auditors report thereon (previously filed as
Exhibit 99.2 hereto). |
2. |
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Managements Discussion of Consolidated Financial Condition and Results of Operations of the
Registrant for the year ended December 31, 2006 compared to the year ended December 31, 2005,
and for the year ended December 31, 2005 compared to the year
ended December 31, 2004 (previously filed
as Exhibit 99.3 hereto). |
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The consent of KPMG LLP (previously filed as Exhibit 99.5 hereto). |
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A supplemental note entitled Reconciliation to United States Generally Accepted Accounting
Principles in respect of the Registrants audited consolidated financial statements as at December
31, 2006 and 2005 and for the years ended December 31, 2006, 2005 and 2004 and for the period
from inception (June 17, 1993) to December 31, 2006, together with the auditors report
thereon (previously filed as Exhibit 99.4 hereto). |
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Annual Information Form of the Registrant for the fiscal year ended December 31, 2006 (filed as Exhibit 99.1 hereto). |
UNDERTAKING AND CONSENT TO SERVICE OF PROCESS
The Registrant undertakes to make available, in person or by telephone, representatives to
respond to inquiries made by the Commission staff, and to furnish promptly, when required to do so
by the Commission staff, information relating to: the securities registered pursuant to Form 40-F;
the securities in relation to which the obligation to file an annual report on Form 40-F arises; or
transactions in said securities.
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Consent to Service of Process |
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The Registrant has previously filed with the Commission a Form F-X. |
TABLE OF CONTENTS
SIGNATURE
Pursuant to the requirements of the Exchange Act, the Registrant certifies that it meets all
of the requirements for filing on Form 40-F and has duly caused this
Amendment to the annual report to be signed on
its behalf by the undersigned, thereto duly authorized.
March 26, 2007
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NEUROCHEM INC. |
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By: |
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(signed) Dr. Francesco Bellini
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Dr. Francesco Bellini
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Chairman of the Board, President and Chief Executive Officer |
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EXHIBIT INDEX
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Number |
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Document |
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99.1
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Annual Information Form of the Registrant for the fiscal year ended December 31, 2006. |
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99.2
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The audited consolidated balance sheets of the Registrant as at December 31, 2006 and 2005
and the consolidated statements of operations, deficit and cash flows for the year ended
December 31, 2006, December 31, 2005, and December 31, 2004, and for the period from inception
(June 17, 1993) to December 31, 2006, together with the auditors report thereon.* |
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99.3
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Managements Discussion of Consolidated Financial Condition and Results of Operations of the
Registrant for the year ended December 31, 2006 compared to the year ended December 31, 2005,
and for the year ended December 31, 2005 compared to the year
ended December 31, 2004.* |
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99.4
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Supplemental note entitled Reconciliation to United States Generally Accepted Accounting
Principles in respect of the Registrants audited consolidated financial statements as at December
31, 2006 and 2005 and for the years ended December 31, 2006, 2005 and 2004 and for the period
from inception (June 17, 1993) to December 31, 2006, together with the auditors report
thereon.* |
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99.5
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Consent of KPMG
LLP.* |
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99.6
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Certification pursuant to Rule 13a-14 or 15d-14 of the Exchange Act, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (Dr. Francesco Bellini). |
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99.7
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Certification pursuant to Rule 13a-14 or 15d-14 of the Exchange Act, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (Mariano Rodriguez). |
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99.8
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Certification pursuant to Title 18, United States Code, Section 1350 as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (Dr. Francesco Bellini).* |
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99.9
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Certification pursuant to Title 18, United States Code, Section 1350 as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (Mariano Rodriguez).* |
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99.10
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Code of Ethics.* |
EX-99.1
2
m35441a3exv99w1.htm
ANNUAL INFORMATION FORM
exv99w1
TABLE OF CONTENTS
Exhibit 99.1
NEUROCHEM INC.
ANNUAL INFORMATION FORM
Fiscal year ended December 31, 2006
March 26, 2007
TABLE OF CONTENTS
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As used in this annual information form, unless the context otherwise requires, the terms we,
us, our, Neurochem or the Corporation, mean or refer to Neurochem Inc. and, unless the
context otherwise requires, its subsidiaries and its Affiliates (as such term is defined in this
annual information form). Except as otherwise stated, all dollar amounts and references to CDN$ are
to Canadian dollars and US$ refers to United States dollars.
Certain statements contained in this annual information form, other than statements of fact that
are independently verifiable at the date hereof, may constitute forward-looking statements. When
used in this annual information form the words believe, anticipate, intend, estimate and
expect and similar expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain such words. Such statements, based as they are on the
current expectations of management, inherently involve numerous risks and uncertainties, known and
unknown, many of which are beyond our control. Such risks include but are not limited to: the
impact of general economic conditions, general conditions in the pharmaceutical industry, changes
in the regulatory environment in the jurisdictions in which we do business, stock market
volatility, fluctuations in costs, and changes to the competitive environment due to consolidation,
that actual results may vary once the final and quality-controlled verification of data and
analyses has been completed, as well as other risks disclosed in our public filings. Consequently,
actual future results may differ materially from the anticipated results expressed in the
forward-looking statements. The reader should not place undue reliance, if any, on the
forward-looking statements included in this annual information form. These statements speak only as
of the date made and we are under no obligation and disavow any intention to update or revise such
statements as a result of any event, circumstances or otherwise.
Unless otherwise noted, in this annual information form, all information is presented as at
December 31, 2006.
CORPORATE STRUCTURE
Name, Address and Incorporation
Neurochem was incorporated on June 17, 1993 under the Canada Business Corporations Act in
association with Parteq Research and Development Innovations (Parteq), the technology transfer
office of Queens University, Kingston, Ontario. On June 20, 2000, the Corporation amended its
share capital (i) to change all of the then issued and outstanding Class A Shares into Common
Shares and cancel the Class A Shares as an authorized class and (ii) to create a class of
Preferred Shares, issuable in series.
Our head office is located at 275 Armand-Frappier Boulevard, Laval, Quebec H7V 4A7, Canada.
Intercorporate Relationships
Neurochem Inc. has an indirect wholly-owned subsidiary, Neurochem (International) Limited, a Swiss
corporation. Neurochem (International) Limited is wholly-owned by Neurochem Holdings Limited, a
Swiss corporation which is, in turn, wholly-owned by Neurochem Luxco II S.A.R.L., a Luxembourg
corporation. Neurochem Luxco II S.A.R.L. is wholly-owned by Neurochem Luxco I S.C.S., a Luxembourg
limited partnership whose sole limited partner is Neurochem Inc. and whose sole general partner is
Neurochem Luxco I S.A.R.L., a Luxembourg corporation wholly-owned by Neurochem Inc. Neurochem Inc.
is also the sole shareholder of Neurochem U.S. LLC, a Delaware limited liability company. All of
such entities, other than Neurochem Inc., are sometimes collectively referred to in this annual
information form as our Affiliates.
2
OUR BUSINESS
Our Product Candidates
We are a biopharmaceutical company focused on the development and commercialization of innovative
therapeutics to address critical unmet medical needs. We currently have one program for which we
have completed and submitted a new drug application (NDA) to the United States Food and Drug
Administration (the FDA) and a marketing authorization application (MAA) to the European
Medicines Agency (the EMEA), one program in Phase III clinical development with one clinical
trial recently completed and one other ongoing, and another program which has completed a Phase IIa
clinical trial. Each of these programs targets disorders for which there are currently no known
cures and limited therapies. As our drugs target what are known or believed to be the underlying
causes of disorders and potentially inhibit further disease progression, the product candidates are
referred to as disease modifiers.
As they all target amyloid-related diseases, our investigational product candidates consist of
small molecules that have been shown to interfere with amyloidosis and the associated build-up of
amyloid leading to the damage of the tissues in the body and/or their related functions. Both
eprodisate (KIACTA; formerly known as FIBRILLEX) and tramiprosate (ALZHEMED and CEREBRIL), our
most advanced product candidates, are based on this technology.
Eprodisate (KIACTA) completed a Phase II/III clinical trial in December 2004. Eprodisate (KIACTA)
is targeted to treat Amyloid A amyloidosis (AA amyloidosis), usually a fatal disease, which is
often associated with kidney dysfunction. In December 2004, through our wholly-owned subsidiary,
Neurochem (International) Limited, we entered into a definitive collaboration and distribution
agreement with Centocor, Inc. (Centocor), a subsidiary of Johnson & Johnson, for the exclusive
distribution rights for eprodisate (KIACTA) for the prevention and treatment of AA amyloidosis,
with the exception of Canada, Switzerland, Japan, China, Taiwan and South Korea, for which the
distribution rights remain with Neurochem. We submitted to the FDA the final modules of our NDA for
eprodisate (KIACTA) in February 2006 and are now seeking marketing approval of eprodisate
(KIACTA) for the treatment of AA amyloidosis. That submission completed the rolling NDA that was
initiated in August 2005 under the Continuous Marketing Application (CMA) Pilot 1 program. The FDA
agreed in June 2005 to file and review the NDA. See Recent developments. In August 2006, we
received an approvable letter from the FDA with respect to the eprodisate (KIACTA) NDA. In
September 2006, we were advised by the EMEA that our MAA for eprodisate (KIACTA) is valid and that
the regulatory review had started, and in October 2006, we announced that we had submitted a
complete response to the FDA approvable letter for eprodisate (KIACTA). Having been subsequently
awarded a Class II review by the FDA, a decision on eprodisate (KIACTA) is expected on or about
April 16, 2007. A decision on eprodisate (KIACTA) by the EMEA is expected in the second half of
2007. See Recent developments. KIACTA is a trademark of Centocor.
Tramiprosate (ALZHEMED) is being developed for the treatment of Alzheimers disease (AD).
Tramiprosate (ALZHEMED) is currently in advanced clinical development. The Phase III clinical
trials, designed to assess the safety, efficacy and disease-modifying effect of tramiprosate
(ALZHEMED) in mild-to-moderate AD patients, began in North America and Europe in June 2004 and
September 2005, respectively. The North American Phase III clinical trial was recently completed.
Enrolment of patients participating in the European clinical trial is scheduled to be completed in
the first half of 2007. We are in discussions with various potential partners with respect to a
partnership agreement for tramiprosate (ALZHEMED).
Tramiprosate (CEREBRIL) is designed for the treatment of Hemorrhagic Stroke due to Cerebral
Amyloid Angiopathy (CAA). A Phase IIa clinical trial was completed in January 2004. We are
currently prioritizing our human and financial resources on the development of our eprodisate
(KIACTA) and tramiprosate (ALZHEMED) programs. Accordingly, we plan to await the outcome of one
or both of these programs before advancing our CAA program any further.
We also have ongoing discovery programs that are focused on the development of next generation AD
compounds and a vaccine for the prevention and/or treatment of AD.
3
Eprodisate (KIACTA) for AA amyloidosis
Eprodisate (KIACTA) is our product candidate for the treatment of AA amyloidosis, a chronic,
systemic disorder. AA amyloidosis is characterized by the over-expression of Serum Amyloid A
(SAA), a protein found in the blood that is produced in response to inflammation. SAA is a
precursor of an amyloid protein known as the Amyloid A (AA) protein. In AA amyloidosis, the AA
protein forms fibrils that accumulate in the kidney, gastrointestinal tract, spleen, liver and
other internal organs, compromising their function. As AA amyloidosis progresses, it results in
serious illness, organ failure and, potentially, death. There is at present no known cure for the
disorder, and patients with AA amyloidosis normally have a life expectancy of five to 15 years. It
is estimated that approximately 40,000 patients are presently diagnosed with AA amyloidosis in the
United States and Europe.
Eprodisate (KIACTA) has been granted Orphan Drug Designation in the United States and received
Orphan Medicinal Product designation in Europe, which normally provide a drug seven and ten years
of market exclusivity, respectively, once approved. Eprodisate (KIACTA) has also received Orphan
Drug Designation in Switzerland.
In April 2006, the NDA for eprodisate (KIACTA) was filed and granted priority review by the FDA.
Priority review status of the application normally reduces the standard review time for an
application to six months. On August 11, 2006, Neurochem announced that it had received an
approvable letter from the FDA for eprodisate (KIACTA) for the treatment of AA amyloidosis. In its
letter, the FDA requested additional efficacy information, as well as a safety update. The FDA
asked for further manufacturing and pharmacokinetic information, and stated that a QT cardiac
status clinical study should be submitted as part of a Phase 4 (post approval) commitment. The FDA
stated that the efficacy information would probably need to be addressed by one or more additional
clinical trials. As an alternative, the FDA also stated that significant findings obtained from a
complete follow-up of patients in the existing study could be persuasive.
In September 2006, we were advised by the EMEA that our MAA for eprodisate (KIACTA) is valid and
that the regulatory review had started. We are seeking marketing approval of our investigational
product candidate, eprodisate (KIACTA) in the European Union (EU).
The MAA for eprodisate (KIACTA) is being reviewed under the Centralized Procedure, where marketing
authorization is applied for all EU Member States (numbering 27 countries today), plus Norway and
Iceland. Eprodisate (KIACTA) has been designated as an Orphan Medicinal Product in the EU, which
normally provides ten years of market exclusivity upon regulatory approval.
On October 16, 2006, we announced that we had submitted a complete response to the FDAs August
2006 approvable letter to eprodisate (KIACTA).
Tramiprosate (ALZHEMED) for AD
Tramiprosate (ALZHEMED) is our product candidate for AD, a degenerative neurological disorder that
progressively impairs a persons cognitive functions and gradually destroys the brain. According to
the American Alzheimers Association, it is estimated that over four and a half million North
Americans are currently afflicted with AD. There is no cure currently known or available for AD,
and existing drugs only treat symptoms such as cognitive function deficit. In its early stages, AD
may cause only minor incidences of memory loss or forgetfulness. However, as it progresses, the
symptoms multiply and intensify and the patient experiences the deterioration of both cognitive and
motor functions, leading ultimately to death within an average of seven to 10 years. There is an
increased prevalence with aging, and AD is increasingly being diagnosed in individuals in their 50s
and 60s.
The pathogenesis of AD is still somewhat ill-defined. Although it is well recognized in the
scientific literature that there is an early onset form of the disease that is genetically
inherited, the vast majority of cases have no known genetic cause and occur later in life. Common
to all cases of AD is the deposition of amyloid fibrils in the brain. Tramiprosate (ALZHEMED) is a
small molecule that binds to soluble Amyloid b (Ab) peptide and has been shown in
vivo to reduce amyloid deposition in a mouse model of brain amyloidosis or in vitro to reduce the
toxic effects of Ab peptide in neuronal cells and brain cultures. Tramiprosate (ALZHEMED) is
being developed to slow or arrest the progression of the disease in symptomatic patients.
4
In April 2006, data was presented from the open-label extension study of the Phase II clinical
trial for tramiprosate (ALZHEMED), involving mild-to-moderate AD patients, and the results were
consistent with the stabilization of the disease, particularly in the mild AD subgroup on study
medication. The data were presented by Paul S. Aisen, M.D., Professor of Neurology and Medicine at
Georgetown University Medical Center, and principal investigator in the United States of the
ongoing Phase III clinical trial for tramiprosate (ALZHEMED). The presentation was given at the
9th international Geneva/Springfield Symposium on advances in Alzheimer Therapy (Geneva,
Switzerland).
Additional efficacy results on tramiprosate (ALZHEMED) were also presented at recent scientific
and medical conferences. Due to the ability of tramiprosate (ALZHEMED) to bind to soluble amyloid
b (Ab) peptide and interfere with the amyloid cascade, data from in vitro studies
suggest that tramiprosate (ALZHEMED) exhibits neuroprotective effects against Ab-induced
neurotoxicity. The exact molecular mechanism underlying these effects is currently under
investigation.
Tramiprosate (ALZHEMED) recently completed a multicentre, randomized, double-blind,
placebo-controlled, three-armed, parallel-designed Phase III clinical trial in North America. A
total of 1,052 patients at 67 clinical sites across the United States and Canada were randomized to
receive study medication over a period of 18 months. All patients who completed the North American
Phase III clinical trial were eligible to receive tramiprosate (ALZHEMED) in an 18-month extension
study.
The Corporation also launched its Phase III clinical trial in Europe in September 2005. Similar to
the North American trial, the European international, multicentre, randomized, double-blind,
placebo-controlled, three-armed, parallel-designed Phase III clinical trial will investigate the
safety, efficacy and the potential to arrest or slow the progression of AD with tramiprosate
(ALZHEMED) in some 930 mild-to-moderate AD patients. Enrolment is advancing well and is expected
to be completed in the first half of 2007.
The safety profile of tramiprosates (ALZHEMED) is well characterized. In relation to the North
American Phase III clinical trial, the Corporation received five consecutive recommendations from
its North American Independent Safety Review Board (DSMB) for tramiprosate (ALZHEMED) to
continue that clinical trial for the treatment of AD. In November 2006, the Corporation announced
that it had received a recommendation from its European DSMB to continue its European Phase III
clinical trial for tramiprosate (ALZHEMED). Subsequent to the year end, Neurochem announced that
it had received a second recommendation from the European DSMB to continue the ongoing European
Phase III clinical trial for tramiprosate (ALZHEMED).
Tramiprosate (CEREBRIL) for Hemorrhagic Stroke due to CAA
Tramiprosate (CEREBRIL) is our product candidate to treat Hemorrhagic Stroke due to CAA, a
potentially fatal neurological disorder that is characterized by recurrent brain hemorrhage.
Hemorrhagic Stroke due to CAA is a syndrome of recurrent strokes resulting from amyloid deposits
that cause blood vessels in the brain to rupture or otherwise malfunction.
Hemorrhagic Stroke due to CAA remains a largely untreated disorder which is often undiagnosed
unless it is confirmed by an autopsy. No effective therapy has yet been developed. Tramiprosate
(CEREBRIL) is designed to prevent the recurrence of Hemorrhagic Stroke due to CAA by reducing the
deposit of amyloid fibrils within the microvasculature of the brain. The active ingredient in
tramiprosate (CEREBRIL) is the same compound as tramiprosate (ALZHEMED) and therefore has the
same chemical properties as tramiprosate (ALZHEMED). Tramiprosate (CEREBRIL) has been found to
markedly reduce CAA in an animal model of brain amyloidosis.
We are currently prioritizing our efforts on the development of our eprodisate (KIACTA) and
tramiprosate (ALZHEMED) programs in which we are investing our human and financial resources.
Accordingly, we await the outcome of one or both of our most advanced programs before advancing our
CAA program further at this time.
5
Research and Development Programs
In addition to our clinical and developmental stage drug candidates, we have an ongoing discovery
effort that is focused on the development of next generation compounds for the treatment of AD and
development of a vaccine for the prevention and/or treatment of AD.
Our approach to AD has been to focus on targeting the Ab protein before it aggregates. One
approach to blocking the development of AD is to intervene early using either a small molecule that
can prevent Ab aggregation or a vaccine strategy that could generate antibodies against this
protein. Our vaccine approach consists of a peptide conjugate derived from a defined Ab
protein segment that can elicit a humoral immune response and thus produce antibodies which target
soluble Ab protein (prior to any structural change which leads to unwanted fibril formation).
Recent Developments
Equity line of credit facility
In August 2006, Neurochem entered into a securities purchase agreement with Cityplatz Limited
(Cityplatz) for an equity line of credit facility (the ELOC) with a 24-month term that provides
the Corporation with the right to issue and sell up to US$60 million worth of the Corporations
Common Shares to Cityplatz, subject to certain terms and conditions, at a discount of 3% of the
market price of the Common Shares. The agreement provides for an obligation on the part of
Neurochem, subject to certain conditions, to sell at least US$25 million worth of Common Shares
over the term of the facility. Rodman & Renshaw, LLC, a registered broker/dealer in the United
States, is acting as placement agent in connection with the ELOC, and is entitled to a placement
fee equal to 2.4% of the gross proceeds paid to us pursuant to each drawdown. We also signed a
registration rights agreement whereby we agreed to file a registration statement covering the
resale of the Common Shares issued under the facility.
Change to board of directors
On August 18, 2006, Neurochem announced that Mr. Ronald Nordmann had resigned from the
Corporations board of directors.
On January 12, 2007 we appointed Mr. John Bernbach to our board of directors. Mr. Bernbach brings
vast experience and expertise in advertising, marketing and branding strategies to Neurochem. He
is President and Founder of NTM (Not Traditional Media) Inc., has served as Chairman and CEO of The
Bernbach Group, as Director and then as CEO and Chairman of North American Television, as Chairman
and Director of Avenue China and as President/COO of DDB Needham Worldwide. He currently serves on
several other boards, including the boards of a number of non-profit organizations.
Private placement of US$42.085 million aggregate principal amount of 6% convertible senior notes
due 2026
We announced on November 9, 2006 the initial closing of a private placement with UBS Securities LLC
as initial purchaser, of US$40 million aggregate principal amount of 6% convertible senior notes
due in 2026 (the Notes), with a conversion premium of 20%. Neurochem had granted the initial
purchaser a 30-day option to purchase up to an additional US$2.085 million aggregate principal
amount of the Notes, which was exercised in full by UBS Securities LLC on November 15, 2006, and
closed on November 17, 2006. Neurochem will pay interest on the Notes until maturity on November
15, 2026, subject to earlier repurchase, redemption or conversion.
Neurochem has been advised that the FMRC Family Trust (of which Dr. Francesco Bellini, the
Chairman, President and CEO of Neurochem, is a beneficiary) and Power Technology Investment
Corporation (a subsidiary of Power Corporation of Canada), the shareholders of Picchio Pharma Inc.,
the indirect principal shareholder of Neurochem, and certain officers and directors of Neurochem
and/or such entities have purchased approximately US$17.585 million aggregate principal amount of
Notes in the private placement.
6
Filing of a Shelf Prospectus
On January 17, 2007, we announced that, in accordance with agreements entered into at the time of
the establishment, in August 2006, of the ELOC and the issuance, in November 2006, of US$42.085
million aggregate principal amount of Notes, we filed a preliminary short form base shelf
prospectus with the Canadian securities regulators and a registration statement with the U.S.
Securities and Exchange Commission. This prospectus is in connection with the resale of up to US$60
million of Common Shares which may be issued under the ELOC, as well as the resale of Notes and of
the Common Shares issuable upon conversion thereof. An aggregate amount not exceeding US$102.085
million of securities has been registered under the shelf prospectus and registration statement.
Sales and Marketing
Neurochem intends to pursue different commercialization strategies for our products in different
parts of the world. We intend to retain full commercialization rights for products in markets that
we can adequately reach on our own. In other markets, we intend to partner with third parties
through collaborative arrangements, including distribution and/or co-promotion agreements. In
addition, in various designated markets, we intend to enter into out-licensing arrangements and
eventually, perhaps, also in-licensing arrangements.
Eprodisate (KIACTA): In December 2004, we signed a definitive collaboration and distribution
agreement, granting Centocor exclusive distribution rights for eprodisate (KIACTA) worldwide, with
the exception of Canada, Switzerland, Japan, China, South Korea and Taiwan.
Tramiprosate (ALZHEMED): AD is characterized by a large and growing patient population and a
broad prescriber base composed mostly of general practitioners and specialists. We therefore intend
to partner with one or possibly more leading biotech or pharmaceutical companies possessing
complementary marketing and commercial networks for the commercialization, marketing and sale of
tramiprosate (ALZHEMED), while retaining rights to commercialize the product ourselves in selected
territories and/or to certain types of specialists in some of the partnered markets.
Tramiprosate (CEREBRIL): tramiprosate (CEREBRIL) targets a small and well-defined population
primarily treated by specialists. Since tramiprosate (CEREBRIL) and tramiprosate (ALZHEMED) are
made up of the same compound, potential commercialization synergies between the two products will
be evaluated as we explore partnership arrangements for tramiprosate (ALZHEMED).
Other Product Candidates
In addition to our ongoing clinical work, we have an active research and development program aimed
at feeding our product pipeline.
Next Generation Anti-Amyloid Compounds for AD
Know-how acquired through the development of tramiprosate (ALZHEMED) has led to the design and
synthesis of a next generation of anti-amyloid compounds for AD. We have already conducted
preliminary studies in both in vitro and in vivo assays on a variety of new compounds that have
been designed with improved physicochemical and pharmacodynamic properties. So far, key compounds
have been identified and are currently being evaluated by our research scientists with a view to
lead optimization as the next step.
Vaccine
Our approach has been to focus on targeting the Ab protein before it organizes into fibrils
and causes neuronal damage. One approach to block the development of AD is to prevent the damage
caused by Ab by intervening early in the process using a vaccine strategy. Our vaccine
approach consists of a peptide conjugate derived from a defined Ab protein segment that can
elicit a humoral immune response and thus produce antibodies which target soluble Ab protein
(prior to any structural change which leads to fibril formation).
7
Preliminary in vivo studies have identified vaccine peptides from the Ab protein that
effectively block amyloidogenesis in vitro. We have used these peptides as antigens to promote the
formation of antibodies against Ab. Blocking this epitope on the Ab peptide by binding
with antibodies could prevent fibrillogenesis and raise the potential for an in vivo effect.
Library of Product Candidates
To date, we have produced a library of molecules that we use for compound screening. The library
comprises several different classes of potential pharmacophores, sulfates, sulphonates,
phosphonates, carboxylates and a number of other functional chemical groups.
Through our portfolio of in vitro and in vivo screening assays, including pharmacokinetic analysis,
we have identified lead drug molecules with potent anti-amyloid activity, the most promising of
which are undergoing further lead optimization through ongoing research and development.
Our Product Technology Platform
Our therapeutic approach to amyloid-related disorders aims at preventing the onset and arresting
the progression of the targeted disorders. We have identified small molecules which can reduce
amyloid deposits in vivo.
Government Funding Agreements
In 1999, Neurochem entered into an agreement with the federal Ministry of Industry (Technology
Partnerships Canada (TPC) program) regarding financial assistance to be provided by the
Government of Canada for the development of one or more oral therapeutic products for the treatment
of AD. Under the terms of this agreement, as amended in 2005, we are committed to pay to TPC
royalties equal to 7.24% of certain milestone revenue and 0.724% of end-product sales realized from
the commercialization of effective orally-administered therapeutics for the treatment of AD until
December 31, 2010. After December 31, 2010, we may have to continue to pay royalties until such
time as the aggregate amount of royalties paid pursuant to the agreement reaches CDN$20.54 million.
Under the agreement, we are committed to spend a specified amount on research and development from
the date of regulatory approval to December 31, 2014.
Intellectual Property
It is an important part of our business to obtain intellectual property protection for our
technology, products and processes. Our success will depend, in part, on our ability to obtain,
license and enforce patents, protect our proprietary information and maintain trade secret
protection without infringing the proprietary rights of third parties. Our strategic approach is
to file and/or license patent applications whenever possible to obtain patent protection in at
least the major pharmaceutical markets, including the United States, major European countries,
Japan and Canada. We also rely on trade secrets, proprietary unpatented information, trade marks
and contractual arrangements to protect our technology and enhance our competitive position.
We currently have over 60 issued patents, including over 10 issued US patents and more than 250
pending applications. The patent portfolio includes numerous patents and patent applications
claiming compounds, pharmaceutical compositions, peptides, vaccines, processes and methods of
treating diseases, including amyloid- related disorders. A number of these patents and patent
applications are owned by the Corporation. Other patent applications are co-owned with Queens
University or the University of British Columbia.
We have four issued US patents for our product candidates tramiprosate (ALZHEMED) and tramiprosate
(CEREBRIL) and we have a fifth issued US patent for our product candidate tramiprosate
(CEREBRIL). We also have been granted patents in other jurisdictions for tramiprosate (ALZHEMED)
and tramiprosate (CEREBRIL), including Japan and Europe and pending applications in a number of
countries.
8
We have three issued US patents for our product candidate eprodisate (KIACTA). We also have been
granted patents or pending patent applications for eprodisate (KIACTA) in selected countries,
including the United States, Europe and Japan.
We are a party to license agreements and assignment agreements under which we have obtained rights
to use certain technologies to develop our product candidates. The licenses to which we are a party
impose various milestones, commercialization, sublicensing, royalty and other payment, insurance,
indemnification and other obligations on us and are subject to certain reservations of rights.
Effective January 1, 1994, we entered into an amyloid license agreement with Parteq. That initial
amyloid agreement was subsequently replaced when, effective January 1, 1999, we entered into a new
amyloid license agreement (the Amyloid Agreement) with Parteq. Pursuant to the Amyloid
Agreement, we were granted the worldwide exclusive license under certain intellectual property,
including patents and patent applications (Amyloid Intellectual Property) to develop, make, have
made, use, and sell certain products.
Effective February 1, 2006, we entered into assignment agreements with Queens University and its
technology transfer entity Parteq (collectively, the Assignment Agreements) which terminate the
Amyloid Agreement and assign the Amyloid Intellectual Property to us for consideration including an
upfront payment of CDN$200,000. The Assignment Agreements also provide for annual technology
payments, deferred milestone payments and deferred graduated payments based on revenues to be
generated from net sales of commercial products, which payment amounts approximate the payments
included in the Amyloid Agreement.
Pursuant to a settlement agreement dated October 3, 2005, with Alza Corporation, relative to their
opposition to our trademark application for ALZHEMED in the United States, we agreed not to
register ALZHEMED in the United States and elsewhere except for Canada, Switzerland, China, Japan
and South Korea.
All of our intellectual property, with the exception of the commercialization rights for our
products in Canada and the applications for our Canadian trademarks (which are owned by Neurochem
Inc.), is owned by Neurochem (International) Limited, a Swiss corporation and an indirect
wholly-owned subsidiary of Neurochem Inc. See Corporate Structure Intercorporate
Relationships.
Human Resources
As at December 31, 2006, we employed 218 people, the majority of which are involved in research and
drug development. Of these 218 people, 45 are scientists with Ph.D degrees and 79 are scientists
with M.Sc. degrees.
Facilities
On May 11, 2004, we completed the acquisition of facilities located in the Parc Scientifique de la
Haute Technologie in Laval, Quebec, Canada, for a purchase price of approximately CDN$10.5 million.
The acquisition was financed by entering into a CDN$10.5 million five-year revolving decreasing
term credit. Following such acquisition, our headquarters and corporate and scientific employees
were transferred to this site.
On November 8, 2005, we announced that we had entered into a sale and leaseback transaction with an
affiliate of Alexandria Real Estate Equities, Inc. The transaction involved the Neurochem
facilities referred to above located in Laval, Quebec, Canada, including its head office and
research facility, for total proceeds to us of CDN$32 million. The closing occurred on November 17,
2005. We are leasing the facilities for a 15 year initial term, expiring in 2020, with two
additional 5 year renewal options and a buy-back option after 12 years.
Risk Factors
Investing in our securities involves a significant amount of risk. You should carefully consider
the risks described below, together with all of the other information in our publicly filed
documents, before making an investment decision. If any of the following risks actually occurs, our
business, financial condition or results of operations could be adversely affected. In such an
event, the trading price of our Common Shares could decline and you may
9
lose part or all of your investment in our securities. Any reference in this section to our
products includes a reference to our product candidates and future products we may develop.
We have a history of losses, and we have not generated any product sales revenue to date. We may
never achieve or maintain profitability.
Our potential product candidates are still only in development, and as a result we have not to date
generated any revenues from product sales. We have incurred substantial expenses in our efforts to
develop products. Consequently, we have generated operating losses each year since our inception,
and as of December 31, 2006, we had an accumulated deficit of approximately CDN $296.6 million or
US$254.5 million. Our losses have adversely impacted, and will continue to adversely impact our
working capital, total assets and shareholders equity. We do not expect to generate any
significant revenues from product sales in the immediate future, and our expenses are likely to
increase as we continue to expand our research and development and clinical study programs and our
sales and marketing activities and seek regulatory approval for our product candidates. We may
never commercialize any products. Even if we succeed in developing commercial products, we expect
to incur additional operating losses for at least the next several years. If we do not ultimately
commercialize products and achieve or maintain profitability, an investment in our shares could
result in a significant or total loss.
We do not have the required approvals to market any of our product candidates, and we do not know
if we will ever receive such approvals.
None of our product candidates has received regulatory approval for commercial sale. We cannot
market a pharmaceutical product in any jurisdiction until it has completed rigorous pre-clinical
testing and clinical trials and such jurisdictions extensive regulatory approval process. In
general, significant research and development and clinical studies are required to demonstrate the
safety and efficacy of our product candidates before we can submit regulatory applications.
Preparing, submitting and advancing applications for regulatory approval is complex, expensive and
time consuming and entails significant uncertainty. The NDA filing process for the first of our
product candidates was completed in April, 2006, and only in relation to the FDA. See Our Business
Recent Developments Even if a product candidate is approved by the FDA or any other regulatory
authority, we may not obtain approval for an indication whose market is large enough to recoup our
investment in that product candidate. We may never obtain the required regulatory approvals for any
of our product candidates.
Our clinical trials may not yield results which will enable us to obtain regulatory approval for
our products.
We will only receive regulatory approval for a product candidate if we can demonstrate in carefully
designed and conducted clinical trials that the product candidate is safe and effective. We do not
know whether our pending or any future clinical trials will demonstrate sufficient safety and
efficacy to obtain the requisite regulatory approvals or will result in marketable products. The
FDA has indicated to us that if it grants marketing approval for eprodisate (KIACTA), such
approval will need to be supplemented by complementary clinical studies aimed at specific matters,
including QT cardiac status clinical studies. Unfavourable data from those studies could result in
withdrawal of marketing approval. In addition, the FDA has requested additional supporting
information, including clinical data, in connection with the approval process for eprodisate
(KIACTA). See Our Business Recent Developments Clinical trials are lengthy, complex,
expensive and uncertain processes. It takes several years to complete testing, and failure can
occur at any stage of testing. Results attained in pre-clinical testing and early clinical studies,
or trials, may not be indicative of results that are obtained in later studies. We may suffer
significant setbacks in advanced clinical trials, even after promising results in earlier studies.
Based on results at any stage of clinical trials, we may decide to repeat or redesign a trial or
discontinue development of one or more of our product candidates. Further, actual results may vary
once the final and quality-controlled verification of data and analyses has been completed. If we
fail to adequately demonstrate the safety and efficacy of our products under development, we will
not be able to obtain the required regulatory approvals to commercialize our product candidates.
Clinical trials are subject to continuing oversight by governmental regulatory authorities and
institutional review boards and:
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4 must meet the requirements of these authorities; |
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4 must meet requirements for informed consent; and |
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4 must meet requirements for good clinical practices. |
We may not be able to comply with these requirements in respect of one or more of our product
candidates.
We rely on third parties, including contract research organizations and outside consultants, to
assist us in managing and monitoring clinical trials. Our reliance on these third parties may
result in delays in completing, or in failing to complete, these trials if one or more third
parties fails to perform with the speed and level of competence we expect.
If clinical trials for a product candidate are unsuccessful, we will be unable to commercialize
such product candidate. If one or more of our clinical trials is delayed, we will be unable to meet
our anticipated development or commercialization timelines. Either circumstance could cause the
price of the Common Shares to decline.
If we encounter difficulties enrolling patients in our clinical trials, our trials could be delayed
or otherwise adversely affected.
Clinical trials for our product candidates require that we identify and enrol a large number of
patients with the disorder under investigation. We may not be able to enrol a sufficient number of
patients to complete our clinical trials in a timely manner. Patient enrolment is a function of
many factors including:
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4 design of the protocol; |
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4 the size of the patient population; |
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4 eligibility criteria for the study in question; |
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4 perceived risks and benefits of the drug under study; |
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4 availability of competing therapies; |
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4 efforts to facilitate timely enrolment in clinical trials; |
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4 patient referral practices of physicians; and |
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4 availability of clinical trial sites. |
If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as
planned, we may need to delay or terminate ongoing clinical trials.
A setback in any of our clinical trials would likely cause a drop in the price of the Common
Shares.
We have completed a Phase II/III clinical trial of eprodisate (KIACTA) and have initiated two
Phase III clinical trials of tramiprosate (ALZHEMED). Study data for the Phase II/III clinical
trial of eprodisate (KIACTA) was released in the second quarter of 2005. With respect to the
results of the Phase II/III clinical trial, the primary efficacy analysis consisted of a stringent
pre-specified p-value of 0.01, which was not met. Setbacks in any phase of the clinical development
of our product candidates would have an adverse financial impact (including with respect to our
collaboration agreement and distribution agreement with Centocor) could jeopardize FDA or EMEA
approval and would likely cause a drop in the price of our Common Shares. The FDA issued an
approvable letter for eprodisate (KIACTA) in August, 2006. See Our Business Recent
Developments Moreover, because tramiprosate (ALZHEMED) and tramiprosate (CEREBRIL) are the same
compound targeted at different indications, a failure in the development of either of these product
candidates could have a negative impact on the development of the other.
11
Even if we obtain regulatory approvals for our product candidates, we will be subject to stringent
ongoing government regulation.
Even if regulatory authorities approve any of our product candidates, the manufacture, marketing
and sale of such products will be subject to strict and ongoing regulation. Compliance with such
regulation will be expensive and consume substantial financial and management resources. For
example, an approval for a product may be conditioned on our conducting costly post-marketing
follow-up studies. For example, the FDA has indicated to us that if it grants marketing approval
for eprodisate (KIACTA), such approval will need to be supplemented by complementary clinical
studies aimed at specific matters, including QT cardiac status clinical studies. In addition, if
based on these studies, a regulatory authority does not believe that the product demonstrates a
benefit to patients, such authority could limit the indications for which the product may be sold
or revoke the products regulatory approval.
We and our contract manufacturers will be required to comply with applicable current Good
Manufacturing Practice regulations for the manufacture of our products. These regulations include
requirements relating to quality assurance, as well as the corresponding maintenance of records and
documentation. Manufacturing facilities must be approved before we can use them in commercial
manufacturing of our products and are subject to subsequent periodic inspection by regulatory
authorities. In addition, material changes in the methods of manufacturing or changes in the
suppliers of raw materials are subject to further regulatory review and approval.
If we or any future marketing collaborators or contract manufacturers fail to comply with
applicable regulatory requirements, we may be subject to sanctions including fines, product recalls
or seizures, injunctions, total or partial suspension of production, civil penalties, withdrawals
of previously granted regulatory approvals and criminal prosecution. Any of these penalties could
delay or prevent the promotion, marketing or sale of our products.
If our products do not gain market acceptance, we may be unable to generate significant revenues.
Even if our products are approved for sale, they may not be successful in the marketplace. Market
acceptance of any of our products will depend on a number of factors including:
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4 demonstration of clinical effectiveness and safety; |
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4 the advantages and disadvantages of our products relative to alternative treatments; |
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4 the availability of acceptable pricing and adequate third-party reimbursement; and |
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4 the effectiveness of marketing and distribution methods for the products. |
If our products do not gain market acceptance among physicians, patients and others in the medical
community, our ability to generate significant revenues from our products would be limited.
We may not achieve our projected development goals in the time frames we announce and expect.
We set goals for and make public statements regarding timing of the accomplishment of objectives
material to our success, such as the commencement and completion of clinical trials, anticipated
regulatory submission and approval dates and time of product launch. The actual timing of these
events can vary dramatically due to factors such as delays or failures in our clinical trials, the
uncertainties inherent in the regulatory approval process and delays in achieving manufacturing or
marketing arrangements sufficient to commercialize our products. There can be no assurance that our
clinical trials will be completed, that we will make regulatory submissions or receive regulatory
approvals as planned or that we will be able to adhere to our current schedule for the launch of
any of our products. If we fail to achieve one or more of these milestones as planned, the price of
the Common Shares would likely decline.
12
If we fail to obtain acceptable prices or adequate reimbursement for our products, our ability to
generate revenues will be diminished.
Our ability to successfully commercialize our products will depend significantly on our ability to
obtain acceptable prices and the availability of reimbursement to the patient from third-party
payers, such as government and private insurance plans. While we have not commenced discussions
with any such parties, these third-party payers frequently require companies to provide
predetermined discounts from list prices, and they are increasingly challenging the prices charged
for pharmaceuticals and other medical products. Our products may not be considered cost-effective,
and reimbursement to the patient may not be available or sufficient to allow us to sell our
products on a competitive basis. We may not be able to negotiate favourable reimbursement rates for
our products.
In addition, the continuing efforts of third-party payers to contain or reduce the costs of
healthcare through various means may limit our commercial opportunity and reduce any associated
revenue and profits. We expect proposals to implement similar government control to continue. In
addition, increasing emphasis on managed care will continue to put pressure on the pricing of
pharmaceutical and biopharmaceutical products. Cost control initiatives could decrease the price
that we or any current or potential collaborators could receive for any of our products and could
adversely affect our profitability. In addition, in Canada and in many other countries, pricing
and/or profitability of some or all prescription pharmaceuticals and biopharmaceuticals are subject
to government control.
If we fail to obtain acceptable prices or an adequate level of reimbursement for our products, the
sales of our products would be adversely affected or there may be no commercially viable market for
our products.
Competition in our targeted markets is intense, and development by other companies could render our
products or technologies non-competitive.
The biopharmaceutical industry is highly competitive. New products developed by other companies in
the industry could render our products or technologies non-competitive. Competitors are developing
and testing products and technologies that would compete with the products that we are developing.
Some of these products may be more effective or have an entirely different approach or means of
accomplishing the desired effect than our products. We expect competition from biopharmaceutical
and pharmaceutical companies and academic research institutions to increase over time. Many of our
competitors and potential competitors have substantially greater product development capabilities
and financial, scientific, marketing and human resources than we do. Our competitors may succeed in
developing products earlier and in obtaining regulatory approvals and patent protection for such
products more rapidly than we can or at a lower price.
We may not obtain adequate protection for our products through our intellectual property.
Our success depends, in large part, on our ability to protect our competitive position through
patents, trade secrets, trademarks and other intellectual property rights. The patent positions of
pharmaceutical and biopharmaceutical firms, including Neurochem, are uncertain and involve complex
questions of law and fact for which important legal issues remain unresolved. The patents issued or
to be issued to us may not provide us with any competitive advantage. Our patents may be challenged
by third parties in patent litigation, which is becoming widespread in the biopharmaceutical
industry. In addition, it is possible that third parties with products that are very similar to
ours will circumvent our patents by means of alternate designs or processes. We may have to rely on
method of use protection for our compounds in development and any resulting products, which may not
confer the same protection as compounds per se. We may be required to disclaim part of the term of
certain patents. There may be prior art of which we are not aware that may affect the validity or
enforceability of a patent claim. There also may be prior art of which we are aware, but which we
do not believe affects the validity or enforceability of a claim, which may, nonetheless ultimately
be found to affect the validity or enforceability of a claim. No assurance can be given that our
patents would, if challenged, be held by a court to be valid or enforceable or that a competitors
technology or product would be found by a court to infringe our patents. Applications for patents
and trademarks in Canada, the United States and in foreign markets have been filed and are being
actively pursued by us. Pending patent applications may not result in the issuance of patents, and
we may not develop additional proprietary products which are patentable.
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Patent applications relating to or affecting our business have been filed by a number of
pharmaceutical and biopharmaceutical companies and academic institutions. A number of the
technologies in these applications or patents may conflict with our technologies, patents or patent
applications, and such conflict could reduce the scope of patent protection which we could
otherwise obtain. We could become involved in interference proceedings in the United States in
connection with one or more of our patents or patent applications to determine priority of
invention. Our granted patents could also be challenged and revoked in opposition proceedings in
certain countries outside the United States.
In addition to patents, we rely on trade secrets and proprietary know-how to protect our
intellectual property. We generally require our employees, consultants, outside scientific
collaborators and sponsored researchers and other advisors to enter into confidentiality
agreements. These agreements provide that all confidential information developed or made known to
the individual during the course of the individuals relationship with us is to be kept
confidential and not disclosed to third parties except in specific circumstances. In the case of
our employees, the agreements provide that all of the technology which is conceived by the
individual during the course of employment is our exclusive property. These agreements may not
provide meaningful protection or adequate remedies in the event of unauthorized use or disclosure
of our proprietary information. In addition, it is possible that third parties could independently
develop proprietary information and techniques substantially similar to ours or otherwise gain
access to our trade secrets.
We currently have the right to use certain technology under license agreements with third parties.
Our failure to comply with the requirements of material license agreements could result in the
termination of such agreements, which could cause us to terminate the related development program
and cause a complete loss of our investment in that program.
As a result of the foregoing factors, we may not be able to rely on our intellectual property to
protect our products in the marketplace.
We may infringe the intellectual property rights of others.
Our commercial success depends significantly on our ability to operate without infringing the
patents and other intellectual property rights of third parties. There could be issued patents of
which we are not aware that our products infringe or patents, that we believe we do not infringe,
but that we may ultimately be found to infringe. Moreover, patent applications are in some cases
maintained in secrecy until patents are issued. The publication of discoveries in the scientific or
patent literature frequently occurs substantially later than the date on which the underlying
discoveries were made and patent applications were filed. Because patents can take many years to
issue, there may be currently pending applications of which we are unaware that may later result in
issued patents that our products infringe. For example, pending applications may exist that provide
support or can be amended to provide support for a claim that results in an issued patent that our
product infringes.
The biopharmaceutical industry has produced a proliferation of patents, and it is not always clear
to industry participants, including us, which patents cover various types of products. The coverage
of patents is subject to interpretation by the courts, and the interpretation is not always
uniform. We are aware of, and have reviewed, third party patents relating to the treatment of
amyloid related diseases, and we believe that our product candidates do not infringe any valid
claim of these patents, although there can be no assurances of this. In the event of infringement
or violation of another partys patent, we may not be able to enter into licensing arrangements or
make other arrangements at a reasonable cost. Any inability to secure licenses or alternative
technology could result in delays in the introduction of our products or lead to prohibition of the
manufacture or sale of products by us.
Patent litigation is costly and time consuming and may subject us to liabilities.
Our involvement in any patent litigation, interference, opposition or other administrative
proceedings will likely cause us to incur substantial expenses, and the efforts of our technical
and management personnel will be significantly diverted. In addition, an adverse determination in
litigation could subject us to significant liabilities.
14
We may not obtain trademark registrations.
The Corporation has filed applications for trademark registrations in connection with our product
candidates in various jurisdictions, including the United States. KIACTATM is a
trademark of Centocor. We do not believe that any of these current trademarks is critical to the
success of the product candidate to which it relates, and we intend to file applications for other
possible trademarks for our product candidates. No assurance can be given that any of our
trademarks will be registered in the United States or elsewhere or that the use of any trademark
will confer a competitive advantage in the marketplace. Furthermore, even if we are successful in
our trademark registrations, the FDA has its own process for drug nomenclature and its own views
concerning appropriate proprietary names. It also has the power, even after granting market
approval, to request a company to reconsider the name for a product because of evidence of
confusion in the market place. No assurance can be given that the FDA or any other regulatory
authority will approve of any of our trademarks or will not request reconsideration of one of our
trademarks at some time in the future. During the summer of 2006, the trademark KIACTA and not
FIBRILLEX was accepted by the FDA thus far. In addition, pursuant to a settlement agreement dated
October 3, 2005, with Alza Corporation, relative to their opposition to our trademark application
for ALZHEMED in the United States, we agreed not to register ALZHEMED in the United States and
elsewhere except for Canada, Switzerland, China, Japan, South Korea and Taiwan.
We will require significant additional financing, and we may not have access to sufficient capital.
We will require additional capital to pursue planned clinical trials, regulatory approvals, as well
as further research and development and marketing efforts for our product candidates. Except as
expressly described in this annual information form, we do not anticipate generating significant
revenues from operations in the near future, and we have no committed sources of capital, except
pursuant to the ELOC facility.
Although the ELOC facility provides that we can require the counterparty to purchase, at our
election and subject to certain terms and conditions, up to US$60 million of Common Shares, there
can be no assurances that we will be able to satisfy the closing conditions applicable to us under
the facility. In addition, each advance under the ELOC is limited in that we cannot issue more than
4.9% of our issued and outstanding Common Shares in any one drawdown. The ELOC will terminate on
February 9, 2009. The ELOC shall also terminate if (i) the Common Shares are de-listed from NASDAQ
unless the Common Shares are listed at such time on a trading market and such de-listing is in
connection with a subsequent listing on another trading market, (ii) the Corporation is subject to
a change of control transaction, (iii) the Corporation suffers a material adverse effect which
cannot be cured prior to the next drawdown notice, or (iv) the registration statement does not
become effective by the 12-month anniversary of the date of the securities purchase agreement. The
Corporation may terminate the securities purchase agreement upon five trading days notice (i) if
Cityplatz shall fail to fund a properly noticed drawdown within five trading days of the end of the
applicable settlement period or (ii) after it has drawn down at least US$25,000,000 under the ELOC.
Either party may also terminate the securities purchase agreement upon five trading days notice if
the volume-weighted average price of the Common Shares is below US$5 for more than 30 consecutive
trading days, as adjusted.
We intend to raise additional funds through public or private financing, collaborations with other
pharmaceutical companies or financing from other sources. Additional funding may not be available
on terms which are acceptable to us. If adequate funding is not available on reasonable terms, we
may need to delay, reduce or eliminate one or more of our product development programs or obtain
funds on terms less favourable than we would otherwise accept. To the extent that additional
capital is raised through the sale of equity or convertible debt securities, the issuance of those
securities could result in dilution to our shareholders. Moreover, the incurrence of debt financing
could result in a substantial portion of our future operating cash flow, if any, being dedicated to
the payment of principal and interest on such indebtedness and could impose restrictions on our
operations. This could render us more vulnerable to competitive pressures and economic downturns.
We anticipate that our existing working capital, access to the ELOC facility and anticipated
revenues will be sufficient to fund our development programs, clinical trials and other operating
expenses into fiscal 2008. However, our future capital requirements are substantial and may
increase beyond our current expectations depending on many factors including:
15
|
|
4 |
the duration and results of our clinical trials for eprodisate (KIACTA), tramiprosate (ALZHEMED) and tramiprosate
(CEREBRIL); |
|
|
4 |
unexpected delays or developments in seeking regulatory approvals; |
|
|
4 |
the time and cost in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
|
|
4 |
other unexpected developments encountered in implementing our business development and commercialization strategies; |
|
|
4 |
the outcome of litigation; if any; and |
|
|
4 |
further arrangements, if any, with collaborators. |
Our revenues and expenses may fluctuate significantly, and any failure to meet financial
expectations may disappoint securities analysts or investors and result in a decline in the price
of the Common Shares.
Our revenues and expenses have fluctuated in the past and are likely to do so in the future. These
fluctuations could cause our share price to decline. Some of the factors that could cause our
revenues and expenses to fluctuate include:
|
|
4 |
the inability to complete product development in a timely manner that results in a failure or delay in receiving the
required regulatory approvals to commercialize our product candidates; |
|
|
4 |
the timing of regulatory submissions and approvals; |
|
|
4 |
the timing and willingness of any current or future collaborators to invest the resources necessary to commercialize
our product candidates; |
|
|
4 |
the outcome of litigation, if any; |
|
|
4 |
the timing of achievement and the receipt of milestone payments from current or future collaborators; and |
|
|
4 |
failure to enter into new or the expiration or termination of current agreements with collaborators. |
Due to fluctuations in our revenues and expenses, we believe that period-to-period comparisons of
our results of operation are not indicative of our future performance. It is possible that in some
future quarter or quarters, our revenues and expenses will be below the expectations of securities
analysts or investors. In this case, the price of the Common Shares could fluctuate significantly
or decline.
We may invest or spend the proceeds of an Offering in ways with which investors may not agree and
in ways that may not earn a profit.
We intend to use the proceeds from any Offering primarily for general corporate purposes, which may
include but are not limited to, our current clinical development programs. However, we will retain
broad discretion over the use of the proceeds from such Offering. Investors may not agree with the
ways we decide to use these proceeds, and our use of the proceeds may not yield any profits. We
will not receive any proceeds from the sale of any Securities by a selling securityholder.
We are dependent on Centocor for the commercialization of eprodisate (KIACTA).
We are dependent on Centocor for the further development and commercialization of eprodisate
(KIACTA) in most jurisdictions. Risks that we face in connection with this collaboration include
the following:
16
|
|
4 |
while Centocor is contractually prohibited from developing or
commercializing, either alone or with others, products and
services that are similar to or competitive with eprodisate
(KIACTA), this restriction does not apply to its affiliates; |
|
|
4 |
Centocor may underfund or not commit sufficient resources to
marketing, distribution or other development of eprodisate
(KIACTA); |
|
|
4 |
Centocor may not properly maintain or defend certain intellectual
property rights that may be important to the commercialization of
eprodisate (KIACTA); |
|
|
4 |
Centocor may encounter conflicts of interest, changes in business
strategy or other issues which could adversely affect its
willingness or ability to fulfill its obligations to us (for
example, pharmaceutical companies historically have re-evaluated
their priorities following mergers and consolidations, which have
been common in recent years in this industry); and |
|
|
4 |
disputes may arise between us and Centocor delaying or terminating
the development or commercialization of eprodisate (KIACTA),
resulting in litigation or arbitration that could be
time-consuming and expensive, or causing Centocor to act in its
own self-interest and not in our interest or those of our
shareholders. |
Centocor can terminate our collaboration with them for a number of reasons, including without cause
upon one-years notice, upon a change of control of Neurochem and upon short notice if the FDA
takes certain adverse actions with respect to an NDA filing. If this collaboration were to be
terminated, we would be required to devote additional resources to developing and commercializing
eprodisate (KIACTA) or seek a new collaborator or abandon this product candidate.
As we are seeking a collaboration with respect to tramiprosate (ALZHEMED), we would likely be
subject to the same general types of risks as those described above.
There can be no assurances that we will conclude a collaboration with respect to tramiprosate
(ALZHEMED)
While we are seeking a collaboration with respect to tramiprosate (ALZHEMED), there can be no
assurances that we will be able to conclude such a collaboration successfully or on favourable
terms. This could adversely affect our ability to commercialize tramiprosate (ALZHEMED).
We are currently dependent on third parties for a variety of functions and may enter into future
collaborations for the manufacture of our products. Our arrangements with these third parties may
not provide us with the benefits we expect.
We currently rely upon third parties to perform functions related to the research, development and
clinical trials of our product candidates. In addition, because we do not have the resources,
facilities or experience to manufacture our product candidates on our own, we currently rely, and
will continue to rely, on contract manufacturers to produce our product candidates for clinical
trials, and, if our products are approved, in quantities for commercial sales. Our reliance on
these relationships poses a number of risks, including the following:
|
|
4 |
disagreements with third parties could delay or terminate the research, development or manufacturing of product
candidates, or result in litigation or arbitration; |
|
|
4 |
we cannot effectively control the resources our third-party partners will devote to our programs or products; |
|
|
4 |
there can be no assurances that we will be able to renew such arrangements, especially with respect to product supply; |
|
|
4 |
contracts with our third parties may fail to provide sufficient protection or we may have difficulty enforcing the
contracts if one of these partners fails to perform; |
17
|
|
4 |
the third parties with whom we contract may fail to comply with regulatory requirements; |
|
|
4 |
conflicts of interest may arise between their work for us and their work for another entity, and we may lose their
services; |
|
|
4 |
with respect to our contract manufacturers: |
|
|
4 |
third parties may not be able to manufacture our product candidates in a cost-effective
or timely manner or in quantities needed for clinical trials or commercial sales; |
|
|
4 |
delays in, or failures to achieve, scale-up to commercial quantities, or changes to
current raw material suppliers or product manufacturers (whether the change is attributable
to us or the supplier or manufacturer) could delay clinical studies, regulatory submissions
and commercialization of our product candidates; and |
|
|
4 |
we may not have all of the required intellectual property rights to the manufacturing
processes for our product candidates. |
Given these risks, our current and future collaborative efforts with third parties may not be
successful. Failure of these efforts could require us to devote additional internal resources to
the activities currently performed, or to be performed, by third parties, to seek alternative
third-party collaborators, or to delay our product development or commercialization.
We will not be able to successfully commercialize our product candidates if we are unable to create
sales, marketing and distribution capabilities or make adequate arrangements with third parties for
such purposes.
In order to commercialize our product candidates successfully, we intend, on a product-by-product
basis, either to develop internal sales, marketing and distribution capabilities or make
arrangements with third parties to perform some or all of these services. We currently have limited
marketing capabilities and no sales force. We have limited experience in developing, training or
managing a marketing or sales force. To the extent we internally develop a sales force, the cost of
establishing and maintaining a sales force would be substantial and may exceed its cost
effectiveness. In addition, in marketing our products, we would likely compete with many companies
that currently have extensive and well-funded marketing and sales operations. Despite our marketing
and sales efforts, we may be unable to compete successfully against these companies. For example,
we are seeking a co-development and co-promotion partner to assist us in completing the development
and undertaking the commercialization of tramiprosate (ALZHEMED). We may not be able to do so on
favourable terms. We do not currently have any arrangements in place with third parties for the
sale, marketing or distribution of any of our products, except for the distribution rights granted
to Centocor. We may rely on additional third parties to market and sell our products in certain
territories, rather than establish our own sales force. If we contract with third parties for the
sales and marketing of our products, our revenues will depend upon the efforts of these third
parties, whose efforts may not be successful. If we fail to establish successful marketing and
sales capabilities or to make arrangements with third parties for such purposes, our business,
financial condition and results of operations will be materially adversely affected.
We are subject to intense competition for our skilled personnel, and the loss of key personnel or
the inability to attract additional personnel could impair our ability to conduct our operations.
We are highly dependent on our management and our clinical, regulatory and scientific staff, the
loss of whose services might adversely impact our ability to achieve our objectives. Recruiting and
retaining qualified management and clinical, scientific and regulatory personnel is critical to our
success. Competition for skilled personnel is intense, and our ability to attract and retain
qualified personnel may be affected by such competition.
Our Management Agreement with Picchio International Inc., pursuant to which Dr. Francesco Bellini,
our Chairman, President and Chief Executive Officer, provides management services to the
Corporation, expires on November 30, 2007. There can be no assurances that we will be able to renew
the agreement or retain the services of Dr. Bellini.
18
We are subject to the risk of product liability claims, for which we may not have or be able to
obtain adequate insurance coverage.
Human therapeutic products involve the risk of product liability claims and associated adverse
publicity. Currently, our principal risks relate to participants in our clinical trials, who may
suffer unintended consequences. If we ultimately are successful in commercializing a product,
claims might be made directly by patients, healthcare providers or pharmaceutical companies or
others selling our products. We may not have or be able to obtain or maintain sufficient and
affordable insurance coverage, including coverage for potentially very significant legal expenses,
and without sufficient coverage any claim brought against us could have a materially adverse effect
on our business, financial condition or results of operations.
Our business involves the use of hazardous materials which requires us to comply with environmental
regulation.
Our discovery and development processes 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. 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 may not be adequately insured against this type of
liability. We may be required to incur significant costs to comply with environmental laws and
regulations in the future, and our operations, business or assets may be materially adversely
affected by current or future environmental laws or regulations.
Legislative actions, potential new accounting pronouncements and higher insurance costs are likely
to impact our future financial position or results of operations.
Future changes in financial accounting standards may cause adverse, unexpected revenue fluctuations
and affect our financial position or results of operations. New pronouncements and varying
interpretations of pronouncements have occurred with greater frequency and are expected to occur in
the future, and we may make or be required to make changes in our accounting policies in the
future. Compliance with changing regulations of corporate governance and public disclosure, notably
with respect to internal controls over financial reporting, may result in additional expenses.
Changing laws, regulations and standards relating to corporate governance and public disclosure are
creating uncertainty for companies such as ours, and insurance costs are increasing as a result of
this uncertainty.
We may incur losses associated with foreign currency fluctuations.
Our operations are in many instances conducted in currencies other than the Canadian dollar
(principally in US dollars and Euros) and we hold cash, cash equivalents and debt in other
currencies (principally in US dollars), and fluctuations in the value of foreign currencies
relative to the Canadian dollar could cause us to incur currency exchange losses.
Our largest shareholder has influence over our business and corporate matters, including those
requiring shareholder approval. This could delay or prevent a change in control. Sales of Common
Shares by such shareholders could have an impact on the market price of the Common Shares.
Picchio Pharma Inc. and its shareholders, Power Technology Investment Corporation, the FMRC Family
Trust and certain persons related to such entities own an aggregate of approximately 33% of our
outstanding Common Shares. In addition, three of our 12 directors are nominees of Picchio Pharma
Inc. Picchio Pharma Inc. has the ability to exercise some degree of influence over our business and
the outcome of various corporate matters, including those requiring shareholder approval. In
particular, this concentration of ownership may have the effect of delaying or deferring a change
in control of us and may adversely affect the price of our Common Shares. Dr. Francesco Bellini,
O.C., our Chairman, President and Chief Executive Officer, is a beneficiary of a trust which owns
50% of the voting shares of Picchio Pharma Inc. Pursuant to an agreement between Power Technology
Investment Corporation and the FMRC Family Trust, each has agreed to use commercially reasonable
efforts to cause the sale of up to half of Common Shares owned indirectly by Picchio Pharma Inc.
from time to time upon request by the other.
19
DIVIDENDS
We have not declared any dividends since our incorporation. Any future determination to pay
dividends will remain at the discretion of our Board of Directors and will depend on our financial
condition, results of operations, capital requirements and such other factors as our Board of
Directors deems relevant.
DESCRIPTION OF CAPITAL STRUCTURE
Our authorized share capital consists of an unlimited number of Common Shares and an unlimited
number of preferred shares (Preferred Shares), all without nominal or par value. Excluding
options issued under and outside of our Stock Option Plan, as at December 31, 2006, 38,722,022
Common Shares and no Preferred Shares were issued and outstanding. We have no current intention to
issue Preferred Shares.
Common Shares. Each Common Share entitles the holder thereof to one vote at any meeting of the
shareholders of the Corporation, except meetings at which only holders of a specified class of
shares are entitled to vote. Subject to the rights of holders of the Preferred Shares, the Common
Shares are entitled to receive, as and when declared by our Board of Directors, dividends in such
amounts as shall be determined by our Board of Directors. The holders of Common Shares have the
right, subject to the rights of the holders of Preferred Shares, to receive the remaining property
of the Corporation in the event of liquidation, dissolution or winding-up of the Corporation,
whether voluntary or involuntary.
Preferred Shares. The Preferred Shares may be issued from time to time in one or more series, the
terms of each series, including the number of shares, the designation, rights, preferences,
privileges, priorities, restrictions, conditions and limitations, to be determined at the time of
creation of each such series by our Board of Directors without shareholder approval, provided that
all Preferred Shares will rank, with respect to dividends and return of capital in the event of
liquidation, dissolution, winding-up or other distribution of our assets for the purpose of
winding-up its affairs, pari passu among themselves and in priority to all Common Shares or shares
of any class ranking junior to the Preferred Shares. Except as provided for in our articles of
incorporation (as amended), the holders of Preferred Shares shall not be entitled to receive notice
of meetings of our shareholders nor to attend thereat and shall not be entitled to vote at any such
meeting.
MARKET FOR SECURITIES
Our Common Shares are quoted on NASDAQ (NRMX) and listed and posted for trading on the TSX (NRM).
The following table sets forth, for the periods indicated, the reported high and low sales prices
and the aggregate volume of trading of our Common Shares on NASDAQ and the TSX.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NASDAQ (US$) |
|
|
TSX (CDN$) |
|
Period |
|
High |
|
|
Low |
|
|
Volume |
|
|
High |
|
|
Low |
|
|
Volume |
|
January 2006 |
|
|
15.82 |
|
|
|
14.06 |
|
|
|
1,231,718 |
|
|
|
18.45 |
|
|
|
16.28 |
|
|
|
1,775,779 |
|
February 2006 |
|
|
16.47 |
|
|
|
13.56 |
|
|
|
2,210,326 |
|
|
|
18.99 |
|
|
|
15.57 |
|
|
|
1,144,106 |
|
March 2006 |
|
|
15.29 |
|
|
|
13.76 |
|
|
|
1,221,903 |
|
|
|
17.65 |
|
|
|
16.03 |
|
|
|
1,030,398 |
|
April 2006 |
|
|
15.09 |
|
|
|
12.20 |
|
|
|
1,960,178 |
|
|
|
17.10 |
|
|
|
13.95 |
|
|
|
1,106,267 |
|
May 2006 |
|
|
15.03 |
|
|
|
12.49 |
|
|
|
2,202,816 |
|
|
|
16.75 |
|
|
|
14.05 |
|
|
|
1,155,876 |
|
June 2006 |
|
|
13.15 |
|
|
|
10.09 |
|
|
|
2,156,075 |
|
|
|
14.45 |
|
|
|
11.20 |
|
|
|
938,437 |
|
July 2006 |
|
|
12.20 |
|
|
|
9.73 |
|
|
|
2,055,222 |
|
|
|
12.68 |
|
|
|
10.95 |
|
|
|
1,201,424 |
|
August 2006 |
|
|
18.40 |
|
|
|
9.23 |
|
|
|
8,975,751 |
|
|
|
20.38 |
|
|
|
10.40 |
|
|
|
3,588,926 |
|
September 2006 |
|
|
20.36 |
|
|
|
14.81 |
|
|
|
5,704,693 |
|
|
|
22.69 |
|
|
|
16.40 |
|
|
|
2,789,455 |
|
October 2006 |
|
|
19.33 |
|
|
|
15.58 |
|
|
|
5,236,931 |
|
|
|
22.00 |
|
|
|
17.78 |
|
|
|
1,922,635 |
|
November 2006 |
|
|
26.51 |
|
|
|
15.56 |
|
|
|
5,691,296 |
|
|
|
22.99 |
|
|
|
18.11 |
|
|
|
2,369,423 |
|
December 2006 |
|
|
26.25 |
|
|
|
20.81 |
|
|
|
7,115,329 |
|
|
|
29.50 |
|
|
|
24.23 |
|
|
|
2,481,561 |
|
DIRECTORS AND OFFICERS
The following table lists our directors and executive officers. All members of the Board of
Directors will hold their positions until the next annual meeting of shareholders of the
Corporation scheduled for May 8, 2007.
20
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|
|
|
|
|
|
|
|
|
|
Period during |
|
|
|
Age |
|
|
|
|
|
which |
|
Name and Municipality |
|
(at March 12, |
|
|
|
|
|
served as a |
|
of Residence |
|
2007) |
|
Principal Occupation |
|
Office |
|
Director |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr.
Francesco Bellini,
O.C.(1),
(2)
Calgary, Alberta, Canada
|
|
|
59 |
|
|
Chairman, President and Chief Executive Officer of the
Corporation(3)
|
|
Chairman, President and
Chief Executive Officer
|
|
2002-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mr. John Bernbach(4), (5)
New York, New York, United States
|
|
|
63 |
|
|
President of NTM (Not Traditional
Media) Inc. (a
marketing advisory company)(6)
|
|
Director
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Colin Bier(7)
Montreal, Quebec, Canada
|
|
|
61 |
|
|
Consultant
|
|
Director
|
|
1996-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Jean-Guy Desjardins(7)
Montreal, Quebec, Canada
|
|
|
62 |
|
|
President and Chief Executive Officer, Centria Inc. (a
holding company)(8)
|
|
Director
|
|
2004-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
André R. Desmarais(2), (5)
Montreal, Quebec, Canada
|
|
|
50 |
|
|
Co-Chief Executive Officer,
Power Corporation of Canada (a diversified management
and holding company)
|
|
Director
|
|
2006-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Neil Flanzraich(2), (9), (10)
Miami, Florida, United States
|
|
|
63 |
|
|
Consultant
|
|
Director
|
|
2006-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Peter Kruyt(5)
Montreal, Quebec, Canada
|
|
|
51 |
|
|
President, Power Technology
Investment Corporation (a technology holding company)
|
|
Director
|
|
2002-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
François Legault(5)
Montreal, Quebec, Canada
|
|
|
50 |
|
|
President and Chief Operating Officer, ViroChem Pharma
Inc. (a biopharmaceutical company)(11)
|
|
Director
|
|
2004-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Frederick H. Lowy(9)
Montreal, Quebec, Canada
|
|
|
74 |
|
|
Consultant(12)
|
|
Director
|
|
2003-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
John Molloy(7)
Kingston, Ontario, Canada
|
|
|
53 |
|
|
President and Chief Executive Officer, Parteq Research
and Development Innovations, Queens University (a university technology transfer organization)
|
|
Director
|
|
1994-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Calin Rovinescu(2), (9)
Montreal, Quebec, Canada
|
|
|
51 |
|
|
Senior Principal of Genuity Capital Markets (an
independent investment dealer) (13)
|
|
Director
|
|
2006-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Graeme K. Rutledge(7)
Perth, Ontario, Canada
|
|
|
65 |
|
|
Consultant(14)
|
|
Director
|
|
2003-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Emil Skamene(9)
Montreal, Quebec, Canada
|
|
|
65 |
|
|
Scientific Director,
Research Institute of the McGill University Health
Centre (an academic health centre)
|
|
Director
|
|
2002-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period during |
|
|
|
Age |
|
|
|
|
|
which |
|
Name and Municipality |
|
(at March 12, |
|
|
|
|
|
served as a |
|
of Residence |
|
2007) |
|
Principal Occupation |
|
Office |
|
Director |
|
|
Dr. Andreas Orfanos
Montreal, Quebec, Canada
|
|
|
48 |
|
|
Executive Vice President, Strategic Planning and
Scientific Affairs (15)
|
|
Executive Vice President,
Strategic Planning and
Scientific Affairs
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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Mariano Rodriguez
Montreal, Quebec, Canada
|
|
|
37 |
|
|
Vice President,
Finance and Chief Financial Officer(16)
|
|
Vice President,
Finance and Chief
Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dr. Denis Garceau
Montreal, Quebec, Canada
|
|
|
50 |
|
|
Senior Vice President,
Drug Development
|
|
Senior Vice President,
Drug Development
|
|
|
|
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|
|
|
|
|
|
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|
Dr. Philippe Calais
Hudson, Quebec, Canada
|
|
|
48 |
|
|
President, Global Business(17)
|
|
President, Global Business
|
|
|
|
|
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|
|
|
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|
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|
Dr. Daniel Delorme
Montreal, Quebec, Canada
|
|
|
49 |
|
|
Vice President, Research(18)
|
|
Vice President,
Research
|
|
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|
|
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|
|
|
|
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|
Dr. Lise Hébert
Montreal, Quebec, Canada
|
|
|
45 |
|
|
Vice President, Corporate Communications(19)
|
|
Vice President, Corporate
Communications
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christine Lennon
Montreal, Quebec, Canada
|
|
|
42 |
|
|
Vice President,
Business Development(20)
|
|
Vice President, Business
Development
|
|
|
|
|
|
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|
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|
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|
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Dr. Shona McDiarmid
Montreal, Quebec, Canada
|
|
|
52 |
|
|
Vice President,
Intellectual Property(21)
|
|
Vice President,
Intellectual Property
|
|
|
|
|
|
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|
|
|
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|
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|
Judith Paquin
Montreal, Quebec, Canada
|
|
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39 |
|
|
Vice President,
Human Resources(22)
|
|
Vice President,
Human Resources
|
|
|
|
|
|
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|
|
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|
David Skinner
Montreal, Quebec, Canada
|
|
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42 |
|
|
Vice-President, General Counsel and Corporate
Secretary(23)
|
|
Vice-President, General
Counsel and Corporate
Secretary
|
|
|
|
NOTES:
|
|
|
(1) |
|
Pursuant to a subscription agreement dated July 25, 2002, by and between Picchio Pharma, P.P.
Luxco Holdings II S.A.R.L. and the Corporation, the Corporation covenanted to cause a total of
three nominees of Picchio Pharma to be included in the list of management nominees to be
proposed for election to the Board at each shareholders meeting occurring following the date
thereof. Picchio Pharmas right shall terminate on the date it ceases to beneficially hold at
least 15% of the issued and outstanding Common Shares (including Common Shares issuable upon
exercise of the warrants issued to them concurrently). Dr. Bellini and Messrs. Kruyt and
Legault are the current nominees of Picchio Pharma. |
|
(2) |
|
Member of the Executive Committee. |
|
(3) |
|
Prior to his appointment as Chief Executive Officer of the Corporation on December 11, 2002,
Dr. Bellinis principal occupation was Chairman of Picchio Pharma, a biopharmaceutical
investment company, a position he continues to hold. Prior to 2001, Dr. Bellini was Chairman
and Chief Executive Officer of BioChem Pharma Inc., a specialty biopharmaceutical company
which he co-founded in 1986 (now a member of the Shire plc group of companies). |
|
(4) |
|
Mr. Bernbach was appointed to the Board on January 12, 2007, to fill the vacancy left by the
departure of Mr. Ronald M. Nordmann effective August 18, 2006. |
|
(5) |
|
Member of the Nominating and Corporate Governance Committee. |
|
(6) |
|
Between August 2000 and June 2003, Mr. Berbach was a partner at Barnet-Bernbach-Carduner LLC,
a venture capital company. |
22
|
|
|
(7) |
|
Member of the Audit Committee. |
|
(8) |
|
Mr. Desjardins is also the President and Chief Executive Officer of Fiera Corporation Inc., a
holding company. Prior to October 2001, Mr. Desjardins was President and Chief Executive
Officer of TAL Global Asset Management Inc., a holding and management company. |
|
(9) |
|
Member of the Compensation Committee. |
|
(10) |
|
Mr. Flanzraich is the Lead Director of the Corporation. |
|
(11) |
|
Prior to May 2001, Mr. Legault was Executive Vice President Corporate Development of BioChem
Pharma Inc., a specialty biopharmaceutical company (now a member of the Shire plc group of
companies). |
|
(12) |
|
Prior to June 2005, Dr. Lowy was President and Vice-Chancellor of Concordia University. He is
now President Emeritus. |
|
(13) |
|
Mr. Rovinescu served as Executive Vice-President of Air Canada between April 2000 and April
2004, in addition to serving as its Chief Restructuring Officer from April, 2003. |
|
(14) |
|
Prior to June 2002, Mr. Rutledge was a Senior Partner at Deloitte & Touche LLP, Canada, an
accounting firm. |
|
(15) |
|
Prior to 2004, Dr. Orfanos was Vice President of Picchio Pharma. Prior to this, Dr. Orfanos
was Vice President of the Immunology Transplantation Business Unit of Novartis Canada Inc. |
|
(16) |
|
Prior to 2004, Mr. Rodriguez was Vice President, Finance and Chief Financial Officer of
Galileo Genomics Inc., a biopharmaceutical company. |
|
(17) |
|
Prior to January 2003, Dr. Calais served between 2000 and 2002 as General Manager at Servier
Canada Inc., part of the French private pharmaceutical group and from 1990 to 2000 Dr. Calais
held several management positions at Hoffmann La Roche in several countries, the last
position being Global Business Unit Head in Switzerland. |
|
(18) |
|
Prior to 2005, Dr. Delorme served between 2003 and 2005 as Vice President, Research and
Development, at the Canadian biopharmaceutical company Phagetech Inc. and from 1998 to 2003,
Dr. Delorme was Vice President Medicinal Chemistry at Methylgene Inc. |
|
(19) |
|
Dr. Hébert was promoted to Vice President, Corporate Communications on December 12, 2002.
Prior to that date, she was Director, Communications and Investor Relations. |
|
(20) |
|
Prior to January 2004, Ms. Lennon was Venture Advisor for the Biotechnology and Life Sciences
investment sector of CDP Capital Inc, a division of one of Canadas largest pension funds.
Prior to this, Ms. Lennon was Vice President, Global Commercial Development Oncology of
Shire, plc and from 1994 to 2001, Ms. Lennon held senior level positions within BioChem Pharma
Inc., a specialty biopharmaceutical company (now a member of the Shire plc group of
companies). |
|
(21) |
|
Prior to 2005, Dr. McDiarmid served as Vice President of Global Intellectual Property for
the Shire Pharmaceuticals Group. |
|
(22) |
|
Prior to January 2004, Ms. Paquin was Vice President, Human Resources of Schering Canada
Inc., a biopharmaceutical company. |
|
(23) |
|
Prior to April 2003, Mr. Skinner served as Commercial Counsel and Deputy to the Director of
Commercial and Legal Affairs in the London, England, office of Antfactory Limited, a global
venture capital firm. Mr. Skinner also served in the corporate commercial departments of the
law firms Freshfields Bruckhaus Deringer in London, England, and Stikeman Elliott in Montreal,
Budapest and London. |
In our Management Proxy Circular dated March 13, 2007, all of the above listed directors were
nominated by management for re-election as directors, except for Dr. Frederick H. Lowy who is
retiring from the Board in accordance with our Boards Mandatory retirement policy.
As of March 12, 2007, the directors and executive officers, as a group, beneficially owned or
exercised control or direction over approximately 6,910,200 of the Common Shares
outstanding.1
The following is a description of the current committees of the Board:
Committees of the Board
Executive Committee
The Board has established an Executive Committee, whose mandate includes assisting the Board in
responding to matters, including (but not limited to) reviewing and approving matters on behalf of
the Board, when (i) it is impractical to call a full Board meeting in a timely fashion, (ii)
specific transactions or actions have previously been approved in principle by the full Board and
subsequently require a specific resolution for formal approval, or (iii) management requires timely
input from the Board on particular matters, whether of an operational or other nature.
|
|
|
1 |
|
Included in this amount are 166,666
Common Shares owned directly by Dr. Bellini, the 5,534,184 Common Shares
beneficially owned indirectly by the FMRC Family Trust (FMRC)
through its 50% ownership of Picchio Pharma as well as the 250,000 Common
Shares purchased, directly, by FMRC as part of a public offering of the
Corporations Common Shares in the United States and Canada. |
23
The Executive Committee has been delegated all powers of the Board in respect of the business and
affairs of the Corporation, during the intervals between meetings of the Board, except for those
powers which, under the laws governing the Corporation, or the by-laws of the Corporation, may not
be exercised by such a committee, in all cases in which specific directions shall not previously
have been given by the Board. In delegating to the Executive
Committee authority to act between meetings of the Board, the Board recognizes the need for
flexibility for the Executive Committee to act on matters where action may be necessary between
Board meetings and the calling of a special Board meeting is not warranted. The current members of
the Executive Committee are Dr. Francesco Bellini (Chair), Mr. André R. Desmarais, Mr. Neil
Flanzraich and Mr. Calin Rovinescu.
Audit Committee
The mandate of the Audit Committee includes assisting the Board in its oversight of (i) the
integrity of the Corporations financial statements, accounting and financial reporting processes,
system of internal controls over financial reporting and audit process, (ii) the Corporations
compliance with, and process for monitoring compliance with, legal and regulatory requirements so
far as they may relate to matters of financial reporting, (iii) the independent auditors
qualifications, independence and performance, and (iv) the performance of the Corporations
internal audit function (if any). The current members of the Audit Committee are Mr. Graeme K.
Rutledge (Chair), Dr. Colin Bier, Mr. Jean-Guy Desjardins and Mr. John Molloy.
Compensation Committee
The mandate of the Compensation Committee includes reviewing the compensation arrangements for the
Corporations employees, including executive officers and directors, and making recommendations to
the Board with respect to such compensation arrangements, as well as making recommendations to the
Board with respect to the Corporations incentive compensation plans and equity-based plans and
overseeing succession planning. The Compensation Committee is also
responsible for reviewing an
annual report on executive compensation for purposes of disclosure to shareholders. That report can
be found above under the heading Report on Executive Compensation in our management proxy
circular for meeting to be held on May 8, 2007. The current members of the Compensation Committee
are Mr. Calin Rovinescu (Chair), Mr. Neil Flanzraich, Dr. Frederick H. Lowy and Dr. Emil Skamene.
Nominating and Corporate Governance Committee
The mandate of the Nominating and Corporate Governance Committee is to develop and recommend to the
Board a set of corporate governance principles and to prepare and review the disclosure with
respect to, and the operation of, the Corporations system of corporate governance, before such
disclosure is submitted to the Board for its approval. The Nominating and Corporate Governance
Committee is responsible for the review and periodic update of the Corporations corporate
governance mandates, charters, policies and procedures, including its Code of Ethics which governs
the conduct of the Corporations directors, officers and other employees. Moreover, the Nominating
and Corporate Governance Committee is mandated to examine, on an annual basis, the size and
composition of the Board and, if appropriate, recommend to the Board a program to establish a Board
comprised of members who facilitate effective decision-making. Finally, the Nominating and
Corporate Governance Committee shall identify individuals qualified to become members of the Board,
recommend to the Board nominees to be put before shareholders at each annual meeting and recommend
to the Board a process for board, committee and director assessment. The current members of the
Nominating and Corporate Governance Committee are Mr. Peter Kruyt (Chair), Mr. John Bernbach, Mr.
André Desmarais and Mr. François Legault.
LEGAL PROCEEDINGS AND REGULATORY ACTIONS
In June 2006 the International Chamber of Commerce Court of Arbitration (the ICC) issued its
Final Award (the Final Award) in the arbitration dispute involving Neurochem Inc. and Neurochem
(International) Limited (in this section of this annual information form, collectively referred to
as Neurochem) and Immtech Pharmaceuticals, Inc. (formerly known as Immtech International, Inc. or
Immtech). The dispute concerns an agreement entered into between Immtech and Neurochem Inc. in
April 2002 (the Agreement) under which Neurochem Inc. had the right
24
to apply its proprietary anti-amyloid technology to test certain compounds to be provided by
Immtech. The ICC denied the majority of Immtechs claims.
Immtech brought claims against Neurochem Inc. in legal proceedings filed on August 12, 2003, with
the Federal District Court for the Southern District of New York, USA (the Court). An amended
complaint was filed in January 2004 adding the University of North Carolina at Chapel Hill (UNC)
and Georgia State University, Research Foundation, Inc. (together with UNC, the Universities) as
plaintiffs and Neurochem (International) Limited as defendant. The dispute was presented to a
tribunal (the Tribunal) convened in accordance with the rules of the ICC. An evidentiary hearing
before the Tribunal was held in September 2005. In the Final Award, the Tribunal held that
Neurochem did not misappropriate any of Immtechs compounds, information or trade secrets and that
Immtech was not entitled to any interest in, or ownership or assignment of, Neurochems patent
applications.
The Tribunal found that Neurochem had breached certain sections of the Agreement, and Immtech was
awarded US$35,000 in damages, plus interest thereon. Immtech was awarded only a portion of the
ICCs administrative charges and arbitral fees and costs incurred by the Tribunal which had been
previously advanced by Immtech, as well as a portion of Immtechs arbitration-related legal fees.
Those charges, fees and costs amounted to approximately US$1.83 million.
On July 10, 2006, Immtech submitted an application in the form of a letter to the Tribunal and the
ICC seeking determination by the Tribunal of an issue Immtech asserted the Tribunal did not decide;
specifically, Immtech claimed that certain Neurochem inventions, and pending patent applications
relating thereto, should be assigned to, and therefore be owned by Immtech and that the Final Award
failed to distinguish between the issue of ownership, as distinct from the issue of inventorship.
On July 28, 2006, we filed a response opposing Immtechs request for a further determination with
respect to ownership of the Neurochem inventions and pending patent applications.
The Tribunal issued an Addendum to the Final Award dated September 21, 2006, in which it denied
Immtechs request to make a further determination.
On January 25, 2007, Immtech and the Universities filed a Notice of Voluntary Dismissal with the
Court, bringing to an end the litigation action described herein. The litigation had been stayed
since 2004 when the Court had ordered Immtech to submit its claims to arbitration as provided for
in the underlying agreement between Immtech and Neurochem, leaving the claims of the Universities
to be decided after the conclusion of the arbitration.
The voluntary dismissal occurred after a January 16, 2007, status conference where the Court
granted Neurochem permission to take discovery of the plaintiffs as to the extent to which the
Universities controlled Immtechs involvement in the ICC arbitration between Neurochem and Immtech
completed last year and described herein. In the litigation, the Universities asserted that they
had claims against Neurochem that were independent of the claims asserted by Immtech in the
arbitration. Neurochems position is that the Universities had no claims. The discovery ordered by
the Court in a January 17, 2007 order would have been in aid of Neurochems motion for summary
judgment as to any claims made by the Universities. The plaintiffs voluntarily dismissed their
complaint against Neurochem without any payment, license, business agreement, concession or
compromise by Neurochem.
INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS
Management Services Agreement
On March 1, 2003, we entered into a management services agreement (the Management Services
Agreement) with Picchio International Inc. (Picchio International) into which Picchio Pharma
intervened (Picchio Pharma and Picchio International are sometimes referred to collectively in this
annual information form as the Picchio Group). All of the shares of Picchio International are
owned by Dr. Francesco Bellini, O.C., and his spouse. The Management Services Agreement was amended
as of the 30th day of October, 2003 to permit the grant of performance based fees at the
discretion of the Board. The Management Services Agreement currently runs until November 30, 2007.
25
The Management Services Agreement provides that Picchio International shall provide to the
Corporation the services of Dr. Francesco Bellini as Chief Executive Officer of the Corporation and
provide the services of other members of the Picchio Group. Under the agreement, the Picchio Group
is currently providing, and will continue to provide, on-going regular consulting, advisory and
administrative services, including consulting on research and development activities, clinical
programs, financing activities, partnering and licensing opportunities, commercialization plans and
programs, and investor relations.
In consideration of the services rendered under the Management Services Agreement, Picchio
International receives a monthly fee of CDN$208,114 (the monthly fee as at January 1, 2007, which
fee is adjusted on a yearly basis, with the approval of the Compensation Committee, to take
increases in the consumer price index for Montreal into account). This amount includes all direct
and indirect costs and expenses, including travel and all other out-of-pocket expenses, incurred by
Dr. Bellini and the Picchio Group relating to the services provided pursuant to such agreement.
During the fiscal periods ended December 31, 2006, 2005 and 2004, Picchio International received
aggregate amounts of CDN$2,453,688, CDN$2,400,000, CDN$1,080,000 (CDN$200,000 of which was received
in 2005), respectively, under the Management Services Agreement. The Management Services Agreement
also provides for the payment, from time to time, to Picchio International of a discretionary
amount as a performance based fee for services rendered. The amount of such performance based fee,
if any, will be determined by the Board at its sole discretion. As of December 31, 2006, the
Corporation had accrued $1,000,000 for performance-based fees which were paid in January 2007 to
Picchio International. Each party has the right to terminate the Management Services Agreement at
any time upon sending a written prior notice of 180 days. The Management Services Agreement
provides that it shall be automatically renewed for successive one year terms unless either party
sends a prior written notice of non-renewal to the other party at least 90 days prior to the then
current termination date.
The Management Services Agreement provides that the Picchio Group shall not, without the
Corporations written consent, during the term of such agreement and for the 24 months following
the termination of the Management Services Agreement, carry on or be engaged in any business which
is the same or similar to or in competition in any material way with any of the businesses which
the Corporation now or which the Corporation shall, during the term of such agreement, carry on
anywhere in the world. The Picchio Group also agreed not to hire any of the Corporations employees
during the term of the Management Services Agreement and for the twelve months following its
expiration.
Performance Target Agreement
Pursuant to an agreement between Neurochem and Dr. Francesco Bellini dated December 1, 2004, (the
Performance Target Agreement), Neurochem agreed to issue up to 220,000 Common Shares to Dr.
Bellini in consideration of his services and subject to the accomplishment of certain performance
targets. In particular, we agreed to issue 60,000 Common Shares to Dr. Bellini upon execution of
the Performance Target Agreement, 55,000 Common Shares upon the execution of a collaboration
agreement in respect of tramiprosate (ALZHEMED), 55,000 Common Shares upon the execution of a
collaboration agreement in respect of eprodisate (KIACTA), 25,000 Common Shares upon the
completion of a third-party equity and/or debt financing and 25,000 Common Shares upon the
restructuring of the Corporations management structure, including formalizing a succession plan.
The issuance of the shares pursuant to the Performance Target Agreement was approved by the
shareholders of the Corporation and regulators in 2005 and provides that the Corporation may, at
its option, purchase Common Shares in the open market to satisfy its obligations under the
Performance Target Agreement. Dr. Bellini has met the performance targets in respect of the
eprodisate (KIACTA) transaction and in respect of the financing.
If Dr. Bellini ceases to be an officer and director of the Corporation and no longer provides us
with management services, directly or through a formal agreement such as the Management Services
Agreement described herein, for any reason other than termination without cause or death or
incapacity, all rights granted under the Performance Target Agreement shall be immediately
forfeited as of the first date on which Dr. Bellini is no longer an officer, director or management
service provider and Dr. Bellini shall not be entitled to receive any Common Shares pursuant to the
Performance Target Agreement. In the event of the death or incapacity of Dr. Bellini or
termination of such management services without cause, Dr. Bellini or his heirs or other legal
representatives, as the case may be, shall be entitled to receive, within 90 days of the death,
determination of incapacity or termination, the Common Shares which are issuable or deliverable, as
the case may be, by Neurochem upon the execution of the Performance Target Agreement and in respect
of which the relevant performance target has been achieved.
26
All rights, and the payment obligations relating thereto, are for the benefit of Dr. Bellini or, in
the event of his death, his heirs or other legal representatives. Dr. Bellini shall not be entitled
to transfer, assign, charge, pledge or hypothecate, or otherwise alienate, whether by operation of
law or otherwise, any such rights and they shall not be subject to execution, attachment or similar
process.
Lease with a Related Party
In April 2005, the Corporation entered into a lease agreement with a company in which Picchio
Pharma has an equity interest. The lease is for a three-year period, with a gross rent of
approximately CDN$960,000 per year. In connection with the sale-leaseback transaction of November
2005 for its Laval facilities, the Corporation provided an indemnification to that company should
it be required to vacate its subleased premises by the landlord prior to the expiration of the
lease referred to above.
Parteq Assignment Agreements
The Corporation wrote off certain patents related to non-core technologies that reverted back to
Parteq, a company related to a director, and entered into the Assignment Agreements which terminate
the Amyloid Agreement and assigned the Amyloid Intellectual Property to us. In the normal course of
operations, we paid Parteq CDN$31,000, CDN$37,000 and CDN$10,000 in the years ended December 31,
2006, 2005 and 2004, respectively. See Our Business Intellectual Property.
AUDIT COMMITTEE FINANCIAL EXPERT
Our Board of Directors has determined that Mr. Graeme K. Rutledge is an audit committee financial
expert.
AUDIT COMMITTEE AND PRINCIPAL ACCOUNTANTS FEES AND SERVICES
Charter of the Audit Committee
The Charter of the Audit Committee is attached hereto as Schedule A.
Composition of the Audit Committee
The Audit Committee is composed of Mr. Graeme K. Rutledge (Chair), Dr. Colin Bier, Mr. Jean-Guy
Desjardins and Mr. John Molloy. Each of the members of the Audit Committee is financially literate
and Mr. Rutledge, Dr. Bier and Mr. Desjardins are independent.
Under the listing requirements of NASDAQ, no director who is not independent, may be appointed to
the audit committee of a company, except under limited circumstances. For the year ended December
31, 2006, Mr. Molloy was not independent under such requirements, as he is the President and Chief
Executive Officer of Parteq, a former licensor of the Corporation. However, in accordance with such
requirements, the Board resolved, for the year ended December 31, 2006, that the continued
membership of Mr. Molloy on the Audit Committee was required in the best interests of the
Corporation and its shareholders because of his knowledge of the Corporation and experience in such
matters. It is intended that Mr. Molloy no longer serve on the Audit Committee after the meeting of
shareholders of Neurochem to be held on May 8, 2007.
Relevant Education and Experience
Up to 2002, Mr. Rutledge was a senior partner at Deloitte & Touche, LLP, Canada, an accounting
firm. Mr. Rutledge is a chartered accountant. Since 1990, Dr. Colin Bier has been a consultant
toxicologist, as well as managing and scientific director of ABA BioResearch, an independent
bioregulatory consulting company. Dr. Bier has extensive management experience in the biomedical
sector, having held senior scientific and executive management positions in the contract research
industry. Mr. Jean-Guy Desjardins is the President and Chief Executive Officer of Centria Inc., has
30 years of investment expertise, holds a Masters in Business Administration
27
degree and is a Certified Financial Analyst. Mr. John Molloy is the President and Chief Executive
Officer of Parteq and holds a Masters in Business Administration degree.
As such, all members of the Corporations Audit Committee understand the accounting principles the
Corporation uses to prepare its financial statements and have the ability to assess the general
application of such accounting principles in connection with the accounting for estimates, accruals
and reserves. Mr. Rutledge, specifically, has experience in preparing, auditing, analyzing and
evaluating financial statements that present a breadth and level of complexity of accounting issues
that are generally comparable to the breadth and complexity of issues that can reasonably be
expected to be raised by the Corporations financial statements. Mr. Rutledge, formerly a senior
partner in a global accounting firm, has significant experience in preparing such audits and
supervising persons engaged in such activities.
Mr. Rutledge, Dr. Bier, Mr. Desjardins and Mr. Molloy have an understanding of internal controls
and procedures for financial reporting.
External Auditor Services Fees
The Corporation has paid KPMG LLP (KPMG), its external auditors, the following fees in each of
the last three fiscal periods.
Annual Audit and Interim Financial Statements review fees
The following sets forth the aggregate fees for each of the last two fiscal periods for
professional fees to KPMG for the audit of the annual financial statements or for services normally
provided by KPMG in connection with statutory and regulatory filings or engagements for those
fiscal periods.
|
|
|
|
|
Fiscal year ended December 31, 2006 |
|
CDN$158,500 |
Fiscal year ended December 31, 2005 |
|
CDN$147,175 |
Audit-Related Fees
The following sets forth additional aggregate fees to those reported under Audit Fees in each of
the last two fiscal periods for assurance and related services by KPMG that are reasonably related
to the performance of the audit or review of the financial statements:
|
|
|
|
|
Fiscal year
ended December 31, 2006 |
Public offering |
|
CDN$74,000 |
Sundry consultations |
|
CDN$47,500 |
Translation services |
|
CDN$18,800 |
Fiscal year
ended December 31, 2005 |
Public offering |
|
CDN$80,000 |
Sundry accounting |
|
CDN$37,250 |
Translation services |
|
CDN$17,585 |
Tax Fees
The following sets forth the aggregate fees in each of last two fiscal periods for professional
services rendered by KPMG for tax compliance, tax advice and tax planning:
|
|
|
|
|
Fiscal year ended December 31, 2006 |
|
CDN$20,940 |
Fiscal year ended December 31, 2005 |
|
CDN$48,587 |
28
All Other Fees
The following sets forth the aggregate fees in each of the last two fiscal periods for products and
services provided by the principal accountant not described above:
|
|
|
|
|
Fiscal year ended December 31, 2006 |
|
None |
Fiscal year ended December 31, 2005 |
|
None |
Our Audit Committee pre-approves every significant engagement by KPMG to render audit or non-audit
services. All of the services described above were approved by the Audit Committee.
TRANSFER AGENT AND REGISTRAR
Computershare Investor Services Inc. is the Canadian transfer agent and registrar for our Common
Shares and Computershare Trust Company, Inc. is the US transfer agent and registrar for our Common
Shares.
INTEREST OF EXPERTS
KPMG has audited our consolidated balance sheets as at December 31, 2006 and 2005, and the
consolidated statements of operations, deficit and cash flows for the year ended December 31, 2006,
December 31, 2005, and December 31, 2004, and for the period from inception (June 17, 1993) to
December 31, 2006. The partners and associates of KPMG, as a group, do not own, beneficially or of
record, any of the outstanding Common Shares.
ADDITIONAL INFORMATION
Additional information regarding Neurochem may be found on SEDAR at www.sedar.com, and on EDGAR at
www.sec.gov.
Additional information, including directors and officers remuneration and indebtedness, principal
holders of our securities, options to purchase securities and interests of informed persons in
material transactions, if applicable, is contained in our information circular for our most recent
meeting of shareholders that involved the election of directors. Additional financial information
is provided in our comparative financial statements for the most recently completed financial year.
We shall provide to any person, upon written request to the Secretary of the Corporation:
when our securities are in the course of a distribution under a preliminary short form prospectus
or a short form prospectus,
|
(i) |
|
one copy of our annual information form, together with one copy of any
document, or the pertinent pages of any document, incorporated by reference in the
annual information form, |
|
(ii) |
|
one copy of our comparative financial statements for our most recently
completed financial year for which financial statements have been filed together with
the accompanying report of the auditor and one copy of our most recent interim
financial statements that have been filed, if any, for any period after the end of our
most recently completed financial year, |
|
(iii) |
|
one copy of our information circular in respect of our most recent annual
meeting of shareholders that involved the election of directors or one copy of any
annual filing prepared instead of that information circular, as appropriate, and |
29
|
(iv) |
|
one copy of any other documents that are incorporated by reference into the
preliminary short form prospectus or the short form prospectus and are not required to
be provided under clauses (i), (ii) or (iii) above; or |
at any other time, one copy of any documents referred to in clauses (i), (ii) and (iii), provided
that we may require the payment of a reasonable charge if the request is made by a person or
company who is not one of our security holders.
The foregoing documents may be obtained by contacting the office of the Corporate Secretary at our
head office, 275 Armand-Frappier Boulevard, Laval, Quebec H7V 4A7, Canada.
30
Schedule A
NEUROCHEM INC.
AUDIT COMMITTEE CHARTER
ESTABLISHMENT OF COMMITTEE
The establishment of the Audit Committee of the Board of Directors of the Neurochem Inc. (the
Corporation) is hereby confirmed with the purpose, constitution and responsibilities described
below.
THE PURPOSE OF THE AUDIT COMMITTEE
The purpose of the Audit Committee is to assist the Board of Directors in its oversight of (i)
the integrity of the Corporations financial statements, accounting and financial reporting
processes, system of internal controls over financial reporting and audit process, (ii) the
Corporations compliance with, and process for monitoring compliance with, legal and regulatory
requirements so far as they relate to matters of financial reporting, (iii) the independent
auditors qualifications, independence and performance and (iv) the performance of the
Corporations internal audit function (if any). Management is responsible for (a) the preparation,
presentation and integrity of the Corporations financial statements, (b) accounting and financial
reporting principles and (c) the Corporations internal controls and procedures designed to promote
compliance with accounting standards and applicable laws and regulations. The Corporations
independent auditing firm is responsible for performing an independent audit of the consolidated
financial statements in accordance with generally accepted auditing standards.
The Audit Committee members are not necessarily professional accountants or auditors and their
functions are not intended to duplicate or to certify the activities of management and the
independent auditor. The Audit Committee is not expected to certify that the independent auditor
is independent under applicable rules. The Audit Committee serves a Board level oversight role
where it oversees the relationship with the independent auditor, as set forth in this charter, and
provides advice, counsel and general direction, as it deems appropriate, to management and the
independent auditor on the basis of the information it receives, discussions with the auditor and
the experience of the Audit Committees members in business, financial and accounting matters.
MEMBERSHIP
The Committee shall consist of no fewer than three members of the Board of Directors, all of
whom shall be appointed by the Board. Except as otherwise permitted by applicable law and the
rules of the relevant regulatory authorities and stock exchanges, the members of the Committee
shall meet the independence and financial literacy requirements of The NASDAQ Stock Market, Inc.
(NASDAQ) and applicable law and no Committee member may have participated in the preparation of
the financial statements of the Corporation or any of its subsidiaries at any time in the previous
three years. Appointment to the Committee, and the designation of any Committee members as audit
committee financial experts, shall be made on an annual basis by the full Board upon
recommendation of the Nominating and Corporate Governance Committee.
COMPENSATION OF COMMITTEE MEMBERS
No member of the Committee may receive any compensation from the Corporation other than (i)
directors fees, which may be received in cash, common stock, equity-based awards or other in-kind
consideration ordinarily available to directors, (ii) a pension or other deferred compensation for
prior service that is not contingent on future
1
service, and (iii) any other regular benefits that directors of peer companies may receive,
all as determined from time to time by the Compensation Committee and the Board of Directors.
COMMITTEE STRUCTURE AND OPERATIONS
The Board shall designate one member of the Committee as its chairperson. The Committee shall
meet at least once during each fiscal quarter, with further meetings to occur, or actions to be
taken by unanimous written consent, when deemed necessary or desirable by the Committee or its
chairperson.
The Audit Committee shall meet at such times and places as it shall determine. The Committee
may invite such members of management, the independent auditor and other persons to its meetings as
it may deem desirable or appropriate. Periodically, the Audit Committee shall meet in executive
session with the independent auditor, the internal auditor, if any, and management. The Chairman
of the Audit Committee shall report on Audit Committee activities to the full Board of Directors.
RESPONSIBILITIES
The Audit Committee:
|
|
|
is directly responsible for the appointment (and recommends to the Corporations
Board of Directors and shareholders the appointment/ratification of the appointment of)
and replacement, compensation and oversight of the work of the Corporations
independent auditor; the independent auditor shall report directly to the Audit
Committee. |
|
|
|
reviews and discusses the written statement from the independent auditor concerning
any relationship between the independent auditor and the Corporation or any other
relationships that may adversely affect the independence of the auditor, and, based on
such review, assesses the independence of the auditor. |
|
|
|
reviews and evaluates the qualifications, performance and independence of the
independent auditor. |
|
|
|
establishes policies and procedures for the review and pre-approval by the Committee
of all auditing services and permissible non-audit services (including the fees and
terms thereof) to be performed by the independent auditor, with exceptions provided for
de minimis amounts under certain circumstances as described by law. |
|
|
|
reviews and discusses with the independent auditor: (a) its audit plans and audit
procedures, including the scope, fees and timing of the audit, (b) the results of the
annual audit examination and accompanying management letters and (c) the results of the
independent auditors procedures with respect to interim audit periods. |
|
|
|
reviews and discusses reports from the independent auditor on (a) all critical
accounting policies and practices used by the Corporation, (b) alternative accounting
treatments within generally accepted accounting principles related to material items
that have been discussed with management, including the ramifications of the use of the
alternative treatments and the treatment preferred by the independent auditor and (c)
other material written communications between the independent auditor and management. |
|
|
|
reviews with the independent auditor its judgment as to the quality, not just the
acceptability, of the Corporations accounting principles and such matters as are
required to be discussed with the Committee under generally accepted auditing
standards. |
|
|
|
discusses and reviews with management and the independent auditor quarterly
financial statements, the year-end audited financial statements, the Managements
Discussion and Analysis of Financial Condition and Results of Operations and related
press releases, and recommends to the Board of |
2
|
|
|
Directors that the audited financial statements be included in the annual report to
shareholders, the Annual Information Form (in Canada) and the Annual Report on the US
Securities and Exchange Commission (SEC) Form 40-F (or other relevant SEC Form) for
the financial year. |
|
|
|
reviews and discusses with management the Corporations principal risks affecting
financial reporting and the steps management has taken to monitor and control such
risks. |
|
|
|
reviews and has prior-approval authority for related-party transactions (as defined
in the relevant NASDAQ requirements). |
|
|
|
reviews and discusses with management, the independent auditor, the Chief Financial
Officer and the internal auditor, if any: (a) the adequacy and effectiveness of the
Corporations internal controls (including any significant deficiencies and significant
changes in internal controls reported to the Committee by the independent auditor or
management), (b) the Corporations internal audit procedures, where applicable, and (c)
the adequacy and effectiveness of the Corporations disclosures controls and
procedures, and management reports thereon. |
|
|
|
reviews and concurs in the appointment, replacement, reassignment or dismissal of
the internal auditor, if any. |
|
|
|
establishes procedures for the receipt, retention and treatment by the Corporation
of complaints regarding accounting, internal accounting controls, or auditing matters,
and the confidential, anonymous submission by employees of concerns regarding
questionable accounting or auditing matters. |
|
|
|
establishes policies for the hiring of employees and former employees of the
independent auditor. |
|
|
|
when appropriate, designates one or more of its members to perform certain of its
duties on its behalf, subject to such reporting to or ratification by the Committee as
the Committee shall direct. |
PERFORMANCE EVALUATION
The Audit Committee will engage in an annual self-assessment with the goal of continuing
improvement, and will annually review and reassess the adequacy of its charter, and recommend any
changes to the full Board of Directors.
RESOURCES AVAILABLE TO THE COMMITTEE
The Audit Committee shall have the authority to engage independent legal, accounting and other
advisers, as it determines necessary to carry out its duties. The Audit Committee shall have sole
authority to approve related fees and retention terms.
DIRECT COMMUNICATION WITH THE COMMITTEE
The Chairman of the Audit Committee is to be contacted directly by the Chief Financial
Officer, the internal auditor, if any, or the independent auditor: (1) to review items of a
sensitive nature that can impact the accuracy of financial reporting, or (2) to discuss significant
issues relative to the overall Board of Directors responsibility that have been communicated to
management but, in their judgment, may warrant follow-up by the Audit Committee.
3
EX-99.6
3
m35441a3exv99w6.htm
CERTIFICATION (DR. FRANCESCO BELLINI)
exv99w6
Exhibit 99.6
Certification of Chairman of the Board, President and Chief Executive Officer
pursuant to Rule 13a-14 or 15d-14 of the Exchange Act,
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Dr. Francesco Bellini, certify that:
|
1. |
|
I have reviewed this annual report on Form 40-F of Neurochem Inc.; |
|
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
|
|
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the issuer as of, and for, the periods presented in
this report; |
|
|
4. |
|
The issuers other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the issuer and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the issuer, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which
this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the issuers disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on
such evaluation; and |
|
|
d) |
|
Disclosed in this report any change in the issuers internal control over
financial reporting that occurred during the period covered by the annual report that
has materially affected, or is reasonably likely to materially affect, the issuers
internal control over financial reporting; and |
|
5. |
|
The issuers other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the issuers auditors and the
audit committee of the issuers board of directors (or persons performing the equivalent
functions): |
|
a) |
|
All significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to adversely
affect the issuers ability to record, process, summarize and report financial
information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or other employees
who have a significant role in the issuers internal control over financial reporting. |
Date:
March 26, 2007.
|
|
|
|
|
|
(signed)
Dr. Francesco
Bellini
Dr. Francesco Bellini
|
|
|
Chairman of the Board, President and Chief Executive Officer |
|
|
|
|
|
EX-99.7
4
m35441a3exv99w7.htm
CERTIFICATION (MARIANO RODRIGUEZ)
exv99w7
Exhibit 99.7
Certification of Vice President, Finance and Chief Financial Officer pursuant to
Rule 13a-14 or 15d-14 of the Exchange Act, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Mariano Rodriguez, certify that:
|
1. |
|
I have reviewed this annual report on Form 40-F of Neurochem Inc.; |
|
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
|
|
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the issuer as of, and for, the periods presented in
this report; |
|
|
4. |
|
The issuers other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the issuer and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the issuer, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which
this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the issuers disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on
such evaluation; and |
|
|
d) |
|
Disclosed in this report any change in the issuers internal control over
financial reporting that occurred during the period covered by the annual report that
has materially affected, or is reasonably likely to materially affect, the issuers
internal control over financial reporting; and |
|
5. |
|
The issuers other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the issuers auditors and the
audit committee of the issuers board of directors (or persons performing the equivalent
functions): |
|
a) |
|
All significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to adversely
affect the issuers ability to record, process, summarize and report financial
information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or other employees
who have a significant role in the issuers internal control over financial reporting. |
Date:
March 26, 2007.
|
|
|
|
|
|
(signed)
Mariano Rodriguez
Mariano Rodriguez
|
|
|
Vice President, Finance and Chief Financial Officer |
|
|
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B/;0#I#H9HUU`2_%+6LIH.IP9NUJK%J@31H%2TOQ#0```.S\_
`
end
-----END PRIVACY-ENHANCED MESSAGE-----
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