TABLE OF CONTENTS
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of: March, 2008
Commission File Number: 000-50393
NEUROCHEM INC.
275 Armand-Frappier Boulevard
Laval, Québec
H7V 4A7
Indicate by check mark whether the registrant files or will file annual reports under cover of
Form 20-F or Form 40 F.
Form 20-F
¨
Form 40-F
þ
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1):
Yes
¨
No
þ
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7):
Yes
¨
No
þ
Indicate by check mark whether the registrant by furnishing the information contained in this Form
is also thereby furnishing the information to the Commission pursuant to Rule 12g-3 under the
Securities Exchange Act of 1934.
Yes
¨
No
þ
If Yes is marked, indicate below the file number assigned to the registrant in connection with
Rule 12g3-2(b):
SIGNATURES:
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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NEUROCHEM INC.
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March 14, 2008
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By:
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/s/ David Skinner
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David Skinner, Vice-President
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General Counsel and Corporate Secretary
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Neurochem
annual report
2007
[Neurochem logotype]
1
NAME OF THE CORPORATION
In light of the Companys expanded strategy now including nutraceutical
and pharmaceutical activities, on February 20, 2008, the Board of
Directors adopted a resolution authorizing the Corporation to file articles
of amendment to change its name from Neurochem Inc. to BELLUS
Health Inc.. The Board recommends that shareholders vote in favour
of the adoption of the special resolution ratifying and confirming the
change in its name from Neurochem Inc. to BELLUS Health Inc..
Provisions have been taken ahead of the vote by the shareholders to
duly protect the names BELLUS Health Inc., BELLUS Santé inc. and
the logo. Please refer to the Management Proxy Circular for more details.
[Bellus Health logo]
Certain statements contained in this document, other than statements of fact that are independently
verifiable at the date hereof, may constitute forward-looking statements. 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 Neurochem Inc.s control. Such risks
include, but are not limited to: the impact of general economic conditions, general conditions in
the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the
jurisdictions in which the Neurochem group does business, stock market volatility, fluctuations in
costs, changes to the competitive environment, 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 public filings of Neurochem Inc. 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 any forward-looking statements included in this
document. These statements speak only as of the date made and Neurochem Inc. is under no obligation
and disavows any intention to update or revise such statements as a result of any event,
circumstances or otherwise, unless required by applicable legislation or regulation. Please see the
Annual Information Form of Neurochem Inc. for further risk factors that might affect the Neurochem
group and its business.
2
MANAGEMENTS DISCUSSION AND ANALYSIS
This Managements Discussion and Analysis provides Managements perspectives on Neurochem Inc. and
its subsidiaries (Neurochem or the Company) and their performance. It also discusses the material
variations in the audited consolidated statements of operations, financial position and cash flows
of Neurochem for the years ended December 31, 2007, 2006 and 2005. This discussion and analysis
should be read in conjunction with the Companys audited consolidated financial statements for the
year ended December 31, 2007, which have been prepared in accordance with Canadian generally
accepted accounting principles (GAAP). Additional information relating to the Company, including
its Annual Report and Annual Information Form, is available on SEDAR at www.sedar.com or on EDGAR
at www.sec.gov. Also available on SEDAR and EDGAR are the Companys reconciliation to United States
(US) GAAP and the additional disclosures required for the presentation of the financial statements
in accordance with US GAAP and Securities and Exchange Commission rules and regulations.
This document contains forward-looking statements, which are qualified by reference to, and should
be read together with the Forward-Looking Statements cautionary notice, which can be found at the
end of this Managements Discussion and Analysis.
As previously reported, effective July 1, 2007, the Company adopted the US dollar as its functional
and reporting currency, as a significant portion of its revenue, expenses, assets, liabilities and
financing are denominated in US dollars. All currency figures reported in the consolidated
financial statements and in this document, including comparative figures, are reported in US
dollars, unless otherwise specified.
This discussion and analysis was performed by management with information available as of March 13,
2008.
Description of Neurochem
Neurochem is a global health company focused on the research, development and commercialization of
products to provide innovative health solutions to address critical unmet medical needs.
In November 2007, the Company announced important initiatives following key events that took place
over the past year. The Company announced the termination of the tramiprosate (ALZHEMED;
homotaurine) pharmaceutical drug development program, including the early termination of its
European Phase III clinical trial, and the advancement of its next generation prodrug of
tramiprosate (ALZHEMED) into preclinical development for the treatment of Alzheimers disease
(AD). Also, the Company announced its decision to take steps to commercialize homotaurine as a
branded nutraceutical, potentially starting as early as 2008. Furthermore, Neurochem announced that
it intends to continue to advance eprodisate programs for Amyloid A (AA) amyloidosis, as well as
for Type II Diabetes as well as certain features of metabolic syndrome. These decisions are
discussed further in the following paragraphs.
3
The current status of the Companys principal product candidates is as follows:
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Disease indication
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Product candidate
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Stage of development
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AA amyloidosis
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eprodisate (KIACTA
TM
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Clinical development
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Type II Diabetes as well as
certain features of metabolic
syndrome
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NC-503
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Phase II clinical trial
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Alzheimers Disease
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prodrug
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Pre-clinical development
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Eprodisate (KIACTA) is the Companys oral investigational product candidate for the treatment of
AA amyloidosis, a potentially fatal disease which is often associated with kidney dysfunction. The
Company was seeking marketing approval of eprodisate (KIACTA) for the treatment of AA amyloidosis.
In December 2007, the Company received an acknowledgement from the United States Food and Drug
Administration (FDA) that Neurochems response to the approvable letter received in July 2007 for
the New Drug Application (NDA) for eprodisate (KIACTA
TM
) for the treatment of AA
amyloidosis is a complete, Class 2 response. In this second approvable letter (July 2007), the FDA
indicated that an additional efficacy trial will be necessary before the FDA could approve the
investigational product candidate. The approvable letter also states that additional submissions,
filed by Neurochem as part of its response to this approvable letter, may address issues raised in
this letter. The FDA had indicated that additional submissions could persuade the agency to
eliminate the requirement for an additional trial. The FDA also asked for additional information,
including further pharmacokinetic studies, and again acknowledged that a QT clinical study should
be submitted as part of a Phase IV (post-approval) commitment. Neurochem had also submitted for
marketing approval of eprodisate (KIACTA) for the treatment of AA amyloidosis in the European
Union and Switzerland. In December 2007, the Committee for Medicinal Products for Human Use (CHMP),
the scientific committee of the European Medicines Agency (EMEA), issued a negative opinion
recommending refusal of the marketing authorization application (MAA) for eprodisate
(KIACTA
TM
) for the treatment of AA amyloidosis in the European Union and concluded that
another study would be needed to demonstrate eprodisate (KIACTA
TM
)s effectiveness. The
Company requested a re-examination of the opinion by CHMP. As provided by the European regulations,
the Company requested that the CHMP consult a Scientific Advisory Group in connection with the
re-examination. Eprodisate (KIACTA) has been granted Orphan Drug Designation in the US and
received Orphan Medicinal Product designation in Europe, which normally provide for market
exclusivity of seven years and ten years, respectively, once the drug is approved. Eprodisate
(KIACTA) has also received Orphan Drug Designation in Switzerland. On March 13, 2008, the Company
announced its decision to pursue the drug development program for eprodisate (KIACTA) for the
treatment of AA amyloidosis. The Company is taking steps to initiate a second Phase III clinical
trial and will enter into discussions with the FDA and with the EMEA to reach agreement on the
terms for an approval of eprodisate (KIACTA) for the treatment of AA amyloidosis. As part of its
decision, the Company announced that it is withdrawing its current marketing applications for
eprodisate (KIACTA) in the United States, the European Union and Switzerland.
In December 2004, the Company concluded a collaboration and distribution agreement with Centocor,
Inc. (Centocor) for eprodisate (KIACTA) for the prevention and treatment of AA amyloidosis. Under
this agreement, Neurochem granted to Centocor, a wholly-owned subsidiary of Johnson & Johnson,
Inc., worldwide exclusive distribution rights for eprodisate (KIACTA), with the
4
exception of
Canada, Switzerland, China, Japan, Taiwan and South Korea, for which the distribution rights remain
with Neurochem. The agreement includes up-front, regulatory and sales-based milestone payments
valued up to $54 million, as well as tiered distribution fees which will be based upon net annual
sales of eprodisate (KIACTA) in the applicable territories over the life of the agreement.
Neurochem will be responsible for the product approval activities in the US and in Europe, as well
as for global manufacturing activities. Centocor will manage the marketing and sales of eprodisate
(KIACTA) in the applicable territories. KIACTA is a trademark of Johnson & Johnson Corporation.
NC-503 (eprodisate) is being developed for the treatment of Type II Diabetes as well as certain
features of metabolic syndrome. A Phase II clinical trial in diabetic patients was launched in
Canada in February 2008. NC-503 has shown beneficial effects in preclinical in vivo models.
Preliminary results have shown that NC-503 protects the kidney function in obese diabetic rats. As
well, NC-503 has shown an impact on metabolic changes associated with Diabetes and obesity,
including a significant decrease of triglyceride levels and cholesterol, a significant decrease of
glycemia and an increase in insulin plasma levels.
The decision to terminate the tramiprosate (ALZHEMED) pharmaceutical drug development program
early was taken in November 2007. Tramiprosate (ALZHEMED) was the Companys investigational
product candidate for the treatment of AD. In November 2007, the Company announced the early
termination of the European Phase III clinical trial for the treatment of AD. This decision was
taken in light of the information gathered from the North American Phase III clinical trial and
from the Special Advisory Board established to assist Neurochem in reviewing and analyzing the data
from the North American Phase III clinical trial. Neurochem was faced with the decision of
completing the European Phase III clinical trial and/or initiating another Phase III study to
support the approval of tramiprosate (ALZHEMED
TM
) by regulatory agencies and/or
investing in the development of a next generation compound related to the original product
candidate. Neurochem took the decision to leverage the numerous years of accumulated knowledge and
the experience it has gained in developing tramiprosate (ALZHEMED
TM
) for AD, and to
prioritize and accelerate the development of its next generation prodrug candidate of tramiprosate
into preclinical development for the treatment of AD. Tramiprosate (ALZHEMED) completed its
18-month North American Phase III clinical trial during the first quarter of 2007. Despite some
descriptive data showing numerical differences in favor of tramiprosate (ALZHEMED), the North
American Phase III clinical trial did not demonstrate a statistically significant difference in
favor of the product candidate with respect to the primary endpoints over 18 months of treatment.
Due to significant interference from confounding factors and between-site variations that
complicated the statistical analyses beyond expectations, it was not possible to demonstrate a
statistically significant treatment effect of tramiprosate (ALZHEMED). However, a difference
observed in hippocampal volume did approach statistical significance utilizing an adjusted model
aiming to address confounding factors. All patients who completed the North American Phase III
clinical trial were eligible to receive tramiprosate (ALZHEMED) in a 12-month open-label extension
of the North American Phase III study.
In light of some encouraging results from preliminary post-hoc analysis of the data from the North
American Phase III trial which suggest an effect of homotaurine on cognition and memory and given
that homotaurine occurs naturally in certain algae, Neurochem is taking steps to commercialize
homotaurine as a branded nutraceutical product, potentially as early as mid-2008, through the
creation of subsidiaries. A large number of physicians and families have requested access to the
compound. The Companys goal is to provide innovative health solutions to address critical unmet
medical needs.
5
The Company also has ongoing research programs that are focused on the development of next
generation compounds for AD and diabetes.
The Company has an indirect equity investment in Innodia Inc. (Innodia), a private company engaged
in developing novel drugs for the treatment of Type II Diabetes and underlying diseases. As at
December 31, 2007, Neurochems indirect equity investment represented approximately 23% of equity
ownership, based on the issued and outstanding shares of Innodia.
A subsidiary of Picchio Pharma Inc. (Picchio Pharma) is the principal shareholder of the Company
with an ownership of approximately 23% as at December 31, 2007, based on the issued and outstanding
shares of the Company as of that date. Picchio Pharma Inc. is a joint venture healthcare investment
company established between FMRC Family Trust, a trust of which Dr. Francesco Bellini is a
beneficiary, and Power Technology Investment Corporation, a subsidiary of Power Corporation of
Canada.
In January 2007, the litigation with Immtech Pharmaceuticals, Inc. (formerly known as Immtech
International, Inc. (Immtech)) came to a conclusion when Immtech, the University of North Carolina
at Chapel Hill (UNC), and Georgia State University Research Foundation, Inc. filed with the Federal
District Court for the Southern District of New York, U.S.A. a Notice of Voluntary Dismissal. The
plaintiffs voluntarily dismissed their complaint against Neurochem in the Federal District Court
without any payment, license, business agreement, concession or compromise by Neurochem.
In June 2006, the International Chamber of Commerce Court of Arbitration (ICC) issued its Final
Award (the Final Award) in the arbitration dispute involving Neurochem and Immtech. The dispute
concerned an agreement entered into between Immtech and Neurochem in April 2002 (the Agreement)
under which Neurochem had the right to apply its proprietary anti-amyloid technology to test
certain compounds to be provided by Immtech. The ICC denied the majority of Immtechs claims after
an evidentiary hearing before the tribunal convened in accordance with the rules of the ICC (the
Tribunal) 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 $35,000 in damages, plus interest thereon for a disputed progress payment under the
Agreement. 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 $1.8 million. Neurochem has made
the payments required by the Final Award. The Tribunal issued an Addendum to the Final Award dated
September 21, 2006, in which it denied Immtechs July 10, 2006, request to make a further
determination with respect to ownership of the Neurochem inventions and pending patent
applications, leaving its earlier ruling intact.
The Company has significant tax losses that may be used to reduce future taxable income. See note
16 of the Consolidated Financial Statements for more details.
As at December 31, 2007, Neurochems workforce comprised 170 employees. During the year ended
December 31, 2006 and the first quarter of 2007, the Company increased its workforce in
anticipation of commercialization and completion of clinical programs. During the second quarter of
2007, the workforce was reduced due to delays encountered in the product candidate development
programs.
6
Selected Financial information
(In thousands of US dollars, except per share data)
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Years ended December 31
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2007
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2006
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2005
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(audited)
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(audited)
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(audited)
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$
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$
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$
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Revenues:
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Collaboration agreement
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1,119
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2,106
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2,793
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Reimbursable costs
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396
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712
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872
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1,515
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2,818
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3,665
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Expenses:
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Research and development (R&D)
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55,732
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51,688
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41,676
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Research tax credits and grants
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(2,161
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)
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(1,899
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)
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(3,626
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Other R&D charges
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1,127
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53,571
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50,916
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38,050
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General and administrative
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10,581
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11,522
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18,333
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Arbitral award
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1,835
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Reimbursable costs
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396
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712
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872
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Stock-based compensation
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4,275
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3,569
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3,958
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Depreciation, amortization and
patent cost write-off
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1,698
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1,556
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2,632
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70,521
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70,110
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63,845
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Loss before undernoted items
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(69,006
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(67,292
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(60,180
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Interest income
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3,341
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2,077
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1,718
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Interest and bank charges
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(202
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(133
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(381
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Accretion expense
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(15,751
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(550
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Change in fair value embedded
derivatives
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(870
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Change in fair value of third-party
asset-backed commercial paper
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(1,184
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Foreign exchange gain (loss)
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1,130
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(280
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)
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154
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Other income
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1,274
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1,348
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772
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Share of loss in a company subject
to significant influence
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(327
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)
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(2,440
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)
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(2,578
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)
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Non-controlling interest
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109
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801
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768
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(12,480
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)
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823
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453
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Net loss
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(81,486
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)
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(66,469
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)
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(59,727
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)
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Net loss per share: Basic and diluted
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(1.85
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)
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(1.72
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)
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(1.70
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)
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7
Selected Financial information (continued)
(In thousands of US dollars, except per share data)
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December 31,
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December 31,
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December 31,
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2007
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2006
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2005
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(audited)
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(audited)
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(audited)
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$
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$
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$
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Total assets
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78,431
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71,402
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83,150
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Total long-term financial liabilities
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36,700
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34,285
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178
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RESULTS OF OPERATIONS
Year ended December 31, 2007 compared to the year ended December 31, 2006
Revenue from collaboration agreement
amounted to $1,119,000 for the year ended December 31, 2007,
compared to $2,106,000 for the previous year. Revenue recognized is in respect of the
non-refundable upfront payment received from Centocor in respect of eprodisate (KIACTA), which is
being amortized over the estimated period through to the anticipated regulatory approval date of
the investigational product candidate. The estimated period is subject to change based on
additional information that the Company may receive periodically. The other portion of the upfront
payment received from Centocor ($6,000,000) has been classified as deferred revenue and is not
being amortized as earned revenue given that it is potentially refundable. In the event that the
Company receives an approval letter issued by the FDA, the amount would no longer be refundable and
would be amortized as earned revenue. As previously discussed, the Company anticipates a decision
by the FDA regarding eprodisate (KIACTA) in April 2008. The decrease in revenue from collaboration
agreement is mainly attributable to a change in the estimated period over which the non-refundable
upfront payment received from Centocor in respect of eprodisate (KIACTA) is being amortized.
Reimbursable costs revenue
amounted to $396,000 for the year ended December 31, 2007, compared to
$712,000 for the previous year, and consists of costs reimbursable by Centocor in respect of
eprodisate (KIACTA)-related activities. The Company earns no margin on these reimbursable costs.
Research and development expenses
, before research tax credits and grants, amounted to $55,732,000
for the year ended December 31, 2007, compared to $51,688,000 for the previous year. The increase
is due to expenses incurred in relation to the development of tramiprosate (ALZHEMED), primarily
in respect of the Phase III clinical trial in Europe and the North American open-label extension of
the Phase III study, as well as the conduct of a QT cardiac status Phase I study. For the year
ended December 31, 2007, research and development expenses also included costs incurred to support
the North American Phase III clinical trial for tramiprosate (ALZHEMED), the open-label extension
of the eprodisate (KIACTA) Phase II/III study, as well as drug discovery programs. The Company
expects research and development
expenses to decrease in the near future as clinical development activities will be reduced
primarily due to the termination of the tramiprosate (ALZHEMED) clinical program.
Research tax credits and grants
amounted to $2,161,000 for the year ended December 31, 2007,
compared to $1,899,000 for the previous year. Research tax credits represent refundable tax credits
earned under the Quebec Scientific Research and Experimental Development Program for
8
expenditures
incurred in Quebec. The increase is due to higher eligible expenditures in the current year and the
realization of tax credits from prior years that met the criteria for recognition in the current
year.
Other research and development charges
amounted to nil for the year ended December 31, 2007,
compared to $1,127,000 for the previous year. In 2006, the Quebec taxation authorities confirmed
their position in the application of the tax credit program that denied tax credits on research and
development taxable benefits relating to stock options for 2005 and prior years. Accordingly,
management determined at that time that the criteria for recognition of these credits were no
longer met and recorded a provision for these research tax credits.
General and administrative expenses
totalled $10,581,000 for the year ended December 31, 2007,
compared to $11,522,000 for the previous year. These costs are incurred to support the overall
activities of the Company. The decrease is mainly due to a reduction in management bonuses, and in
performance-based fees due to Picchio International Inc.
Arbitral award
amounted to nil for the year ended December 31, 2007, compared to $1,835,000 for the
previous year. This expense related to the dispute with Immtech, as described previously.
Reimbursable costs
amounted to $396,000 for the year ended December 31, 2007, compared to $712,000
for the previous year, and consist of costs incurred on behalf of Centocor in respect of eprodisate
(KIACTA)-related activities and reimbursable by Centocor.
Stock-based compensation
amounted to $4,275,000 for the year ended December 31, 2007, compared to
$3,569,000 for the previous year. This expense relates to stock options and stock-based incentives,
whereby compensation cost in relation to stock options is measured at fair value at the date of
grant and is expensed over the awards vesting period. The increase is due to new stock options
granted during the past year.
Depreciation, amortization and patent cost write-off
amounted to $1,698,000 for the year ended
December 31, 2007, compared to $1,556,000 for the previous year. The increase in 2007 is
attributable to patent cost of $239,000 written off during the year, for which no future benefit
was expected to be realized.
Interest income
amounted to $3,341,000 for the year ended December 31, 2007, compared to $2,077,000
for the previous year. The increase is mainly attributable to higher average cash balances during
the current year, compared to the previous year.
Accretion expense
amounted to $15,751,000 for the year ended December 31, 2007, compared to
$550,000 for the previous year. Accretion expense represents the imputed interest under
GAAP on the $42,085,000 aggregate principal amount of 6% convertible senior notes issued in
November 2006, as well as on the $40,000,000 6% senior convertible notes (Senior Notes) and
$40,000,000 5% senior subordinated convertible notes (Junior Notes) issued in May 2007. The Company
accretes the carrying values of the convertible notes to their face value through a charge to
earnings over their expected lives of 60 months, 54 months and 1 month, respectively. Of the total
accretion expense recorded in the year ended December 31, 2007, $10,430,000 relates to accretion
expense on the Junior Notes, which were fully converted during the second quarter of 2007. Please
refer to the Liquidity and Capital Resources section for more details on the convertible notes.
9
Change in fair value of embedded derivatives
amounted to a loss of $870,000 for the year ended
December 31, 2007 and represents the variation in the fair value of the embedded derivatives
included in the aggregate $80,000,000 Senior and Junior Notes issued in May 2007.
Change in fair value of third-party asset-backed commercial paper
amounted to a loss of $1,184,000
for the year ended December 31, 2007 and represents a provision recorded on the valuation of
asset-backed commercial paper held by the Company. See Liquidity and Capital Resources section for
more details.
Foreign exchange gain
amounted to $1,130,000 for the year ended December 31, 2007, compared to a
loss of $280,000 for the previous year. Foreign exchange gains or losses arise on the movement in
foreign exchange rates in relation to the Companys net monetary assets denominated in currencies
other than US dollars, which is its functional and reporting currency, and consists primarily of
monetary assets and liabilities denominated in Canadian dollars. Foreign exchange gains recognized
during 2007 are mainly attributable to the strengthening of the Canadian dollar compared to the US
dollar during the period.
Other income
amounted to $1,274,000 for the year ended December 31, 2007, compared to $1,348,000
for the previous year. Other income consists of non-operating revenue, primarily sub-lease revenue.
The 2006 income includes an amount of $293,000 in respect of the recovery of prior years property
taxes.
Share of loss in a company subject to significant influence
amounted to $327,000 for the year ended
December 31, 2007, compared to $2,440,000 for the previous year.
Non-controlling interest
amounted
to $109,000 for the year ended December 31, 2007, compared to $801,000 for the previous year. These
items result from the consolidation of the Companys interest in a holding company (Innodia
Holding) that owns shares of Innodia Inc., for which Neurochem is the primary beneficiary. The
share of loss recorded in the current year has reduced the Companys long-term investment in
Innodia Holding to a nominal value.
Net loss
for the year ended December 31, 2007 amounted to $81,486,000 ($1.85 per share), compared
to $66,469,000 ($1.72 per share) for the previous year.
Fourth quarter (unaudited)
For the fourth quarter ended December 31, 2007, the Company recorded a
net loss
of $16,097,000
($0.33 per share), compared to $17,011,000 ($0.44 per share) for the corresponding period in the
previous year.
Total revenues
for the quarter ended December 31, 2007, amounted to $270,000 compared to $675,000
for the corresponding period in the previous year. The decrease is mainly attributable to a change
in the estimated period over which the non-refundable upfront payment received from Centocor in
respect of eprodisate (KIACTA) is being amortized.
Research and Development expenses
, before tax credits and grants, amounted to $12,199,000 for the
quarter ended December 31, 2007, compared to $14,142,000 for the corresponding period in the
previous year. The decrease is mainly attributable to a reduction in expenses incurred in relation
to the development of tramiprosate (ALZHEMED), primarily in respect of the North American Phase
III clinical trial.
10
General and administrative expenses
totalled $1,397,000 for the quarter ended December 31, 2007,
compared to $2,819,000 for the corresponding period in the previous year. These costs are incurred
to support the overall activities of the Company. The decrease is mainly attributable to a
reduction in management bonuses, and in performance-based fees due to Picchio International Inc.
Accretion expense
amounted to $1,183,000 for the quarter ended December 31, 2007, compared to
$550,000 for the corresponding period in the previous year. The increase is due to accretion
expense recorded on the $40,000,000 6% Senior Notes issued in May 2007.
Change in fair value of third party asset-backed commercial paper
amounted to a loss of $1,184,000
for the quarter ended December 31, 2007, and represents a provision recorded on the valuation of
asset-backed commercial paper held by the Company. Refer to the Liquidity and Capital Resources
section for more details.
Year ended December 31, 2006 compared to the year ended December 31, 2005
Revenue from collaboration agreement
amounted to $2,106,000 for the year ended December 31, 2006,
compared to $2,793,000 for the previous year. Revenue recognized is in respect of the
non-refundable upfront payment received from Centocor in respect of eprodisate (KIACTA), which is
being amortized over the estimated period through to the anticipated regulatory approval date of
the investigational product candidate. The estimated period is subject to change based on
additional information that the Company may receive periodically. The other portion of the upfront
payment received from Centocor ($6,000,000) has been classified as deferred revenue and is not
being amortized as earned revenue given that it is potentially refundable. In the event that the
Company receives an approval letter issued by the FDA, the amount would no longer be refundable and
would be amortized as earned revenue.
Reimbursable costs revenue
amounted to $712,000 for the year ended December 31, 2006, compared to
$872,000 for the previous year and consists of costs reimbursable by Centocor in
respect of eprodisate (KIACTA)-related activities. The Company earns no margin on these
reimbursable costs.
Research and development expenses
, before research tax credits and grants, amounted to $51,688,000
for the year ended December 31, 2006, compared to $41,676,000 for the previous year. The increase
is due to expenses incurred in relation to the development of tramiprosate (ALZHEMED), primarily
in respect of the Phase III clinical trial in Europe and the North American open-label extension of
the Phase III study. For the year ended December 31, 2006, research and development expenses also
included costs incurred to support the North American Phase III clinical trial for tramiprosate
(ALZHEMED), the open-label extension of the eprodisate (KIACTA
) Phase II/III study, as well as
drug discovery programs.
Research tax credits and grants
amounted to $1,899,000 for the year ended December 31, 2006,
compared to $3,626,000 for the previous year. Research tax credits represent refundable tax credits
earned under the Quebec Scientific Research and Experimental Development Program for expenditures
incurred in Quebec. The decrease is mainly due to additional tax credits of $1,100,000 recorded
during 2005, claimed in respect of research and development taxable benefits on stock options for
2005 and prior years. Also, research grants for the year ended December 31, 2005, include the final
contribution of $948,000 received by the Company under the Technology Partnerships Canada Program
for the development of tramiprosate (ALZHEMED).
11
Other research and development charges
amounted to $1,127,000 for the year ended December 31, 2006.
In 2006, the Quebec taxation authorities confirmed their position in the application of the tax
credit program that denied tax credits on research and development taxable benefits relating to
stock options for 2005 and prior years. Accordingly, management determined at that time that the
criteria for recognition of these credits were no longer met and recorded a provision for these
research tax credits.
General and administrative expenses
totalled $11,522,000 for the year ended December 31, 2006,
compared to $18,333,000 for the previous year. The decrease is primarily attributable to a
reduction in legal fees incurred by the Company regarding the dispute with Immtech.
Arbitral award
amounted to $1,835,000 for the year ended December 31, 2006 and relates to the
dispute with Immtech, as discussed previously.
Reimbursable costs
amounted to $712,000 for the year ended December 31, 2006, compared to $872,000
for the previous year, and consist of costs incurred on behalf of Centocor in respect of eprodisate
(KIACTA)-related activities and reimbursable by Centocor.
Stock-based compensation
amounted to $3,569,000 for the year ended December 31, 2006, compared to
$3,958,000 for the previous year. This expense relates to stock options and stock-based incentives,
whereby compensation cost is measured at fair value at the date of grant and is expensed over the
awards vesting period. The decrease is primarily attributable to expenses of $1,189,000 recorded
in 2005 in relation to 140,000 common shares to be issued to the Chairman, President and Chief
Executive Officer, pursuant to an agreement signed in December 2004.
Depreciation, amortization and patent cost write-off
amounted to $1,556,000 for the year ended
December 31, 2006, compared to $2,632,000 for the previous year. The decrease is mainly
attributable to the write-off of patent costs of $704,000 recorded in 2005 in relation to non-core
technology patents, responsibility for which reverted to Parteq Research & Development Innovations,
the technology transfer office of Queens University. The decrease is also attributable to the
sale-leaseback transaction entered into by the Company in November 2005 in respect of its
facilities located in Laval, Quebec. As a result of the transaction, the Company had no
depreciation expense for the buildings in 2006. In 2005, depreciation expense on the buildings was
recorded up to the date of the sale-leaseback transaction.
Interest income
amounted to $2,077,000 for the year ended December 31, 2006, compared to $1,718,000
for the previous year. The increase is mainly attributable to higher interest rates and is
partially offset by lower average cash balances during the current year, compared to the previous
year.
Interest and bank charges
amounted to $133,000 for the year ended December 31, 2006, compared to
$381,000 for the previous year. The decrease is attributable to the reimbursement in November 2005,
in connection with the sale-leaseback transaction, of the long-term debt previously contracted to
finance the acquisition of facilities in 2004.
Accretion expense
amounted to $550,000 for the year ended December 31, 2006, and mainly represents
the imputed interest under GAAP on the $42,085,000 aggregate principal amount of 6% convertible
senior notes issued in November 2006. Please refer to the section Liquidity and Capital Resources
for more details on the convertible notes.
12
Foreign exchange loss
amounted to $280,000 for the year ended December 31, 2006, compared to a gain
of $154,000 for the previous year. Foreign exchange gains or losses arise on the movement in
foreign exchange rates related to the Companys net monetary assets held in currencies other than
the Canadian dollar. Foreign exchange losses recognized during 2006 are mainly attributable to the
strengthening of the Canadian dollar compared to the US dollar during the year. Prior to July 1,
2007, the Companys functional currency was the Canadian dollar.
Other income
amounted to $1,348,000 for the year ended December 31, 2006, compared to $772,000 for
the previous year. Other income consists of non-operating revenue, primarily sub-lease revenue. The
increase is mainly attributable to recovery of prior years property taxes in 2006 in the amount of
$293,000.
Share of loss in a company subject to significant influence
amounted to $2,440,000 for the year
ended December 31, 2006, compared to $2,578,000 for the previous year.
Non-controlling interest
amounted to $801,000 for the year ended December 31, 2006, compared to $768,000 for the previous
year. These items result from the consolidation of the Companys interest in a holding company that
owns shares of Innodia, for which Neurochem is the primary beneficiary.
Net loss
for the year ended December 31, 2006 amounted to $66,469,000 ($1.72 per share), compared
to $59,727,000 ($1.70 per share) for the previous year.
Quarterly results (unaudited)
(In thousands of US dollars, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
Quarter
|
|
Revenue
|
|
Net loss
|
|
Basic and diluted
|
|
|
$
|
|
$
|
|
$
|
Year ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth
|
|
|
270
|
|
|
|
(16,097
|
)
|
|
|
(0.33
|
)
|
Third
|
|
|
301
|
|
|
|
(13,889
|
)
|
|
|
(0.29
|
)
|
Second
|
|
|
443
|
|
|
|
(30,484
|
)
|
|
|
(0.75
|
)
|
First
|
|
|
501
|
|
|
|
(21,016
|
)
|
|
|
(0.54
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth
|
|
|
675
|
|
|
|
(17,011
|
)
|
|
|
(0.44
|
)
|
Third
|
|
|
694
|
|
|
|
(16,509
|
)
|
|
|
(0.43
|
)
|
Second
|
|
|
724
|
|
|
|
(18,113
|
)
|
|
|
(0.47
|
)
|
First
|
|
|
725
|
|
|
|
(14,836
|
)
|
|
|
(0.39
|
)
|
The increase in quarterly losses year over year, with the exception of the third and fourth quarter of 2007, is primarily
due to additional investments in research and development as the Company advances its product candidates through clinical
trials. The increase in the 2007 second quarter net loss is also due to accretion expense recorded on the convertible notes
issued in November 2006 and May 2007. The decrease in the 2007 third quarter net loss, compared to the corresponding period
the previous year is primarily due to a reduction in research and development expenses. The decrease in the 2007 fourth
quarter net loss, compared to the corresponding period the previous year, is primarily due to a reduction in research,
development and administrative expenses, offset by lower revenues, higher accretion expense on the convertible notes and a
write-down of third party asset-backed commercial paper.
13
Related party transactions
(In thousands of US dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
Year ended
|
|
Year ended
|
|
|
December 31,
|
|
December 31,
|
|
December 31,
|
|
|
2007
|
|
2006
|
|
2005
|
|
|
$
|
|
$
|
|
$
|
Management services expense
|
|
|
2,343
|
|
|
|
2,164
|
|
|
|
1,981
|
|
Sub-lease revenue
|
|
|
858
|
|
|
|
846
|
|
|
|
579
|
|
In March 2003, Neurochem entered into a management services agreement with Picchio International
Inc. (Picchio International) into which Picchio Pharma Inc. intervened, which has since been
amended. Picchio International is wholly-owned by Dr. Francesco Bellini and his spouse. The
management services agreement stipulates that Picchio International provides the services of Dr.
Francesco Bellini, as Chief Executive Officer of the Company and services of other members of
Picchio International and Picchio Pharma Inc. Under the agreement, Picchio International and
Picchio Pharma Inc. provide regular consulting and advisory services, including services related to
reviewing existing and potential research and development activities, and potential clinical
programs, financing activities, partnering and licensing opportunities, commercialization plans and
programs, and advising and assisting in investor relations activities. In consideration of all
services rendered under the agreement, Picchio International received in 2007 a monthly fee of
approximately CDN$208,000. Pursuant to an amendment in 2003, the agreement also provides for
performance-based fees determined at the discretion of the Board of Directors. During the year
ended December 31, 2007, the Company paid $848,000 of performance-based fees, which was accrued as
at December 31, 2006.
In 2004, the Company entered into an agreement to issue shares with the Chief Executive Officer.
Refer to the section Contractual Obligations for details.
In April 2005, the Company entered into a lease agreement with a company in which Picchio Pharma
has an equity interest. The lease is for a three-year period ending April 2008, 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 Company 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. During 2007, the lease agreement was extended to April 2011, with a
gross rent of approximately CDN$968,000 per year.
Please refer to notes 8, 14(b) and 15(b) of the Consolidated Financial Statements for transactions
with Parteq Research and Development Innovations.
FINANCIAL CONDITION
Liquidity and capital resources
As at December 31, 2007, the Company had available cash, cash equivalents and marketable securities
of $58,672,000, compared to $48,758,000 at December 31, 2006. The increase is primarily due to
proceeds received from the issue of convertible notes in May 2007 and is partially offset by funds
used in operating activities.
14
Financing activities
Proceeds from the issue of share capital
for the year ended December 31, 2007, amounted to $371,000
and are related to the issue of share capital pursuant to the exercise of stock options. Proceeds
from the issue of share capital for the year ended December 31, 2006, amounted to $8,641,000 and
are mainly related to the warrant exercised by Picchio Pharma on February 16, 2006, which was
previously issued pursuant to a February 2003 private placement and was otherwise scheduled to
expire on February 18, 2006. Proceeds from the issue of share capital for the year ended December
31, 2005, amounted to $69,829,000 and are mainly related to the issue of additional share capital
and the exercise of a warrant during that year. In March 2005, the Company completed a public
offering of its common shares in the US and in Canada. The Company issued four million common
shares at a price of $15.30 per share. Total proceeds from the offering were $61,200,000 and the
issue costs totaled $4,107,000. In July 2005, Picchio Pharma exercised a warrant, issued pursuant
to a July 2002 private placement that was otherwise scheduled to expire on that date, generating
total proceeds to the Company of $7,189,000 and resulting in the issuance of 2,800,000 common
shares from treasury.
Net proceeds from convertible notes
amounted to $74,279,000 for the year ended December 31, 2007
and are in respect of the $80,000,000 aggregate principal amount of convertible notes issued in May
2007, consisting of $40,000,000 6% senior convertible notes due in 2027 and $40,000,000 5% senior
subordinated convertible notes due in 2012. The 6% senior convertible notes have an initial
conversion price equal to the lesser of $12.68 or the 5-day weighted average trading price of the
common shares preceding any conversion, subject to adjustments in certain circumstances. The
Company will pay interest on the 6% senior convertible notes until maturity on May 2, 2027, subject
to earlier repurchase, redemption or conversion. The 5% senior subordinated convertible notes were
subject to mandatory conversion into common shares under certain circumstances. In connection with
this transaction, the Company issued warrants to purchase an aggregate of 2,250,645 common shares
until May 2, 2012, at an initial purchase price of $12.68 per share, subject to adjustments in
certain circumstances. During the year ended December 31, 2007, $35,500,000 of the 6% senior
convertible notes were converted into 5,619,321 common shares and the totality of the 5% senior
subordinated convertible notes were converted into 4,444,449 common shares. Of the net proceeds
from the offering, $34,274,000 has yet to be spent as of December 31, 2007. As at December 31,
2007, the use of proceeds has conformed in all material respects, with the expectations set forth
in the prospectus filed publicly. Net proceeds from convertible notes amounted to $40,306,000 for
the year ended December 31, 2006 and are in respect of the private placement entered into in
November 2006 of $42,085,000 aggregate principal amount of 6% convertible senior notes due in 2026,
with a conversion premium of 20%. The Company will pay interest on the notes until maturity on
November 15, 2026, subject to earlier repurchase, redemption or conversion. Refer to note 10 of the
Consolidated Financial Statements for more details.
Proceeds from sale-leaseback
amounted to $26,411,000 for the year ended December 31, 2005, and are
in respect of the Companys facilities located in Laval, Quebec. The transaction generated a net
gain of CDN$21,358,000. For accounting purposes, the net gain is deferred and amortized over the
period of the lease. The Company has leased the facilities for a period of 15 years, with an option
to buy it back at fair market value beginning December 1, 2017. In addition,
the Company has secured two five-year options to extend the lease beyond the original term. Of the
proceeds, CDN$9.8 million was used to repay the long-term debt contracted in 2004 to finance the
acquisition of the facilities from Shire BioChem.
15
In August 2006, the Company entered into a securities purchase agreement in respect of an equity
line of credit facility (ELOC) with Cityplatz Limited (Cityplatz), that provides the Company up to
$60,000,000 of funds in return for the issuance of common shares at a discount of 3.0% to market
price at the time of draw downs over term, less a placement fee equal to 2.4% of gross proceeds
payable to the placement agent, Rodman & Renshaw, LLC. The ELOC established by the securities
purchase agreement will terminate on February 9, 2009. The ELOC shall also terminate if (i) the
Companys common shares are de-listed from NASDAQ unless the common shares are listed at such time
on another trading market specified in the agreement and such de-listing is in connection with a
subsequent listing on another trading market specified in the agreement, (ii) the Company is
subject to a change of control transaction or (iii) the Company suffers a material adverse effect
which cannot be cured prior to the next drawdown notice. The Company may terminate the securities
purchase agreement (i) if Cityplatz fails to fund a properly notified drawdown within five trading
days of the end of the applicable settlement period or (ii) after it has drawn down at least
$25,000,000 under the ELOC. Either party may also terminate the securities purchase agreement if
the volume-weighted average price of the Companys common shares is below $5 per share for more
than 30 consecutive trading days. Given that the current price per share has been below the minimum
price as per the agreement, the agreement may be terminated at any time. As at December 31, 2007,
the Company had not drawn any funds under the ELOC. See subsequent event note for terms of
amendment.
Investing activities
Additions to property and equipment
for the year ended December 31, 2007, amounted to $575,000,
compared to $801,000 for the year ended December 31, 2006, and $1,126,000 for the year ended
December 31, 2005. The main additions to property and equipment for these three years were composed
of research equipment. Additions to patents for the year ended December 31, 2007, amounted to
$1,180,000, compared to $1,716,000 for the year ended December 31, 2006, and $939,000 for the year
ended December 31, 2005.
Addition to long-term investment
amounted to $1,464,000 for the year ended December 31, 2006 and
represents the Companys additional indirect equity investment in Innodia, as described above.
Other
As at January 31, 2008, the Company had 48,848,095 common shares outstanding, 220,000 common shares
issuable to the Chief Executive Officer upon the achievement of specified performance targets,
2,815,233 options granted under the stock option plan, 2,884,471 shares potentially issuable under
the convertible notes and 2,250,645 warrants outstanding, for a maximum of 57,018,444 common
shares, on a fully diluted basis.
The Company invests available cash resources, in a manner consistent with a goal of capital
preservation, liquidity and with limited credit risk, in liquid securities with varying terms to
maturity not exceeding twelve months, selected with regard to the expected timing of expenditures
to be incurred from continuing operations and prevailing interest rates.
Restricted Cash presented on the Consolidated Balance Sheet is composed of short-term investments
pledged to a bank as collateral for two letters of credit; the first in the amount of $6,000,000
was issued in connection with the potentially refundable upfront payment received under the
collaboration agreement with Centocor and the second in the amount of CDN$640,000 was granted in
favour of a landlord in relation to the lease of a building. As at December 31, 2007,
16
restricted
cash is composed of third-party asset-backed commercial paper (ABCP). These investments were due to
mature during the third quarter of 2007 but, as a result of a disruption in the credit markets,
particularly in the ABCP market, they did not settle on maturity and currently remain outstanding.
At the time these investments were acquired, the ABCP were rated R1-high by Dominion Bond Rating
Service, which is the highest credit rating for this type of investment. The ABCP are currently
subject to a restructuring proposal under a standstill agreement which is expected to result in the
conversion of the ABCP into longer-term financial instruments with maturities corresponding to the
underlying assets. A Pan-Canadian Investors Committee (the Committee) was established to oversee
the orderly restructuring of these instruments during this standstill period. A restructuring plan
was announced by the Committee on December 23, 2007, and is anticipated to be completed by the end
of March, 2008. During the quarter ended December 31, 2007, the Company recorded a provision for
losses in the amount of $1,184,000 in respect of ABCP, reflecting the Companys estimated reduction
in the fair value of these investments as at December 31, 2007. The Company estimated the fair
value of the ABCP using a probability weighted discounted cash flow approach, based on its best
estimates of the time period over which the assets are going to generate cash flows, ranging from 7
to 30 years based on the proposed restructuring, the coupon interest rate, the discount rate to
apply to the net cash flows anticipated to be received commensurate with highly rated notes and
other qualitative factors. This estimate of the fair value of the ABCP is not supported by
observable market prices or rates, therefore is subject to uncertainty, including, but not limited
to, the outcome of the restructuring plan being considered, the estimated amounts to be recovered,
the yield of the substitute financial instruments and the timing of future cash flows. The
resolution of these uncertainties could be such that the ultimate fair value of these investments
may vary from the Companys current best estimate. Changes in the near term could require changes
in the recognized amount of these assets. The Company does not expect there will be a material
adverse impact on its business as a result of the third party ABCP liquidity issue. During the
third and fourth quarter of 2007, both letters of credit were renewed upon their respective annual
expiry, with the ABCP issued as collateral.
Since its inception in 1993, Neurochem has devoted its resources principally to funding research
and development programs and the related infrastructure and support activities. As at December 31,
2007, the Company has incurred a cumulative deficit since inception of $318,254,000 of which
research and development expenditures totalled $224,622,000 before net research tax credits and
grants of $21,253,000. The Company expects operating expenses to decrease during fiscal 2008,
primarily due to the early termination of the tramiprosate (ALZHEMED) program,
however the Company intends to continue to invest in product research and development and
preparations to commercialize homotaurine as a branded nutraceutical product.
The Company signed a collaboration and distribution agreement with Centocor in respect of
eprodisate (KIACTA
) in December 2004. However, the Company has not yet generated any revenues
from the sale of products and has not been profitable to date. Neurochem has funded its operations
primarily through private and public offerings of common shares, issuance of convertible notes,
payments received under collaboration and research and development agreements, proceeds from the
sale-leaseback, interest income, tax credits and grants. While the Company continues to be in the
development phase, it expects to fund operations with proceeds from equity or debt financing,
interest income, revenues from partnership, revenue from nutraceutical product commercialization,
collaborative research, license, product development and co-marketing agreements, research tax
credits and grants.
17
The Company believes that its available cash and short-term investments, expected interest income,
potential funding from partnerships, research collaborations and licensing agreements, potential
proceeds from the equity line of credit facility, potential revenue from commercialization of
nutraceutical products, research tax credits, grants, and access to capital markets should be
sufficient to finance the Companys operations and capital needs during the ensuing fiscal year.
However, in light of the uncertainties associated with the regulatory approval process, clinical
trial results, commercialization of nutraceutical products, and the Companys ability to secure
additional licensing, partnership and/or other agreements, further financing may be required to
support the Companys operations in the future.
Disclosure of fair value of financial instruments, credit risk, foreign currency risk and interest
rate risk is presented in note 20 of the Consolidated Financial Statements.
Contractual Obligations
As at December 31, 2007, Neurochems future contractual obligations are principally for operating
leases for facilities and office equipment, clinical trial outsourcing agreements, management fees
for Picchio International, as well as payments in relation to the convertible notes. Future
contractual obligations by year of maturity are presented below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
(in thousands of US dollars)
|
Contractual
|
|
|
|
|
|
Less than 1
|
|
|
|
|
|
|
|
|
|
More than 5
|
obligations
|
|
Total
|
|
year
|
|
1-3 years
|
|
3-5 years
|
|
years
|
Operating leases
|
|
|
42,724
|
|
|
|
2,916
|
|
|
|
5,966
|
|
|
|
6,298
|
|
|
|
27,544
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trial
agreements
|
|
|
3,732
|
|
|
|
3,716
|
|
|
|
16
|
|
|
Nil
|
|
|
Nil
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Management fees
|
|
|
2,317
|
|
|
|
2,317
|
|
|
Nil
|
|
|
Nil
|
|
|
Nil
|
|
Convertible
notes (1)
|
|
|
46,585
|
|
|
Nil
|
|
|
Nil
|
|
|
|
46,585
|
|
|
Nil
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest payments
on convertible
notes (1)
|
|
|
11,180
|
|
|
|
2,795
|
|
|
|
5,590
|
|
|
|
2,795
|
|
|
Nil
|
|
|
|
|
(1)
|
|
Assumes redemption of convertible notes in November 2011.
|
|
|
|
Refer to note 10 to the Consolidated Financial Statements for terms and conditions.
|
The Company has not engaged in commodity contract trading or off-balance sheet financing, other
than in relation to operating leases and the sale-leaseback transaction, for which the contractual
obligations under the operating leases are stated above. In addition, the Company is also
responsible for operating costs and taxes under the operating leases. Furthermore, the Company
entered into a securities purchase agreement in respect of an equity line of credit facility, as
discussed previously.
The Company has letters of credit granted in favour of Centocor for $6,000,000 and a landlord for
CDN$640,000; marketable securities are pledged under these letters of credit and are presented as
restricted cash on the Consolidated Balance Sheet as at December 31, 2007.
In December 2004, the Company entered into an agreement with its Chief Executive Officer, Dr.
Francesco Bellini, to issue to him up to 220,000 common shares upon the execution of the agreement
and upon achievement of specified performance targets. In 2005, the Company recorded stock-based
compensation in relation to 140,000 common shares to be issued to the Chief Executive Officer in
connection with his execution and achievement of certain specified performance targets; these
shares will be issued by the Company upon formal notification by the Chief Executive Officer.
18
The Company has entered into a number of other agreements, which involve future commitments,
including agreements with Parteq Research and Development Innovations and the federal Ministry of
Industry (Technology Partnerships Canada Program). Please refer to note 14 of the Consolidated
Financial Statements for the year ended December 31, 2007.
DISCLOSURE CONTROLS AND PROCEDURES
Disclosure controls and procedures means controls and other procedures of an issuer that are
designed to provide reasonable assurance that information required to be disclosed by the issuer in
its annual filings, interim filings or other reports filed or submitted by it under provincial and
territorial securities legislation is recorded, processed, summarized and reported within the time
periods specified in the provincial and territorial securities legislation and includes, without
limitation, controls and procedures designed to ensure that information required to be disclosed by
an issuer in its annual filings, interim filings or other reports filed or submitted under
provincial and territorial securities legislation is accumulated and communicated to the issuers
management, including its chief executive officer and chief financial officer (or persons who
perform similar functions to a chief executive officer and chief financial officer), as
appropriate, to allow timely decisions regarding required disclosure.
The Companys Chief Executive Officer and its Chief Financial Officer are responsible for
establishing and maintaining disclosure controls and procedures. They are assisted in this
responsibility by the Companys disclosure committee, which is composed of members of senior
management. Based on an evaluation of the Companys disclosure controls and procedures, the
Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls
and procedures were effective as of December 31, 2007.
INTERNAL CONTROL OVER FINANCIAL REPORTING
Managements Annual Report on Internal Control Over Financial Reporting
Internal control over financial reporting (ICFR) is designed to provide reasonable assurance
regarding the reliability of the Companys financial reporting and the preparation of financial
statements for external purposes in accordance with GAAP. Management, including the Companys Chief
Executive Officer and its Chief Financial Officer, is responsible for establishing and maintaining
adequate ICFR. Management assessed the effectiveness of the Companys ICFR as of December 31, 2007,
based on the framework established in Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment,
management concluded that the Companys ICFR was effective as of December 31, 2007.
Attestation Report of Independent Registered Public Accounting Firm
KPMG LLP, an independent registered public accounting firm, which audited and reported on the
Companys financial statements in this Annual Report, has issued an unqualified attestation report
on the effectiveness of the Companys ICFR as of December 31, 2007.
Changes in Internal Controls Over Financial Reporting
No changes were made in the Companys ICFR during the year ended December 31, 2007, that have
materially affected, or are reasonably likely to materially affect its ICFR. The design of any
system of controls and procedures is based in part upon certain assumptions about the likelihood of
19
certain events. There can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions, regardless of how remote.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The preparation of consolidated financial statements in accordance with GAAP requires management to
adopt accounting policies and to make certain estimates and assumptions that the Company believes
are reasonable based upon the information available at the time these decisions are made. These
accounting policies, estimates and assumptions affect the reported amounts of assets and
liabilities and the disclosure of contingent liabilities at the date of the financial statements,
and the reported amounts of revenues, expenses and cash flows during the reporting periods. By
their nature, these judgments are subject to an inherent degree of uncertainty and are based upon
historical experience, trends in the industry and information available from outside sources. On an
ongoing basis, management reviews its estimates and actual results could differ from estimates. The
Companys significant accounting policies are described in Note 3 to the audited Consolidated
Financial Statements. Management considers that the following accounting policies and estimates are
the more important in assisting an understanding and evaluating the Companys consolidated
financial statements.
Revenue recognition:
Revenue from collaboration and distribution agreements that include multiple
elements is considered to be a revenue arrangement with multiple deliverables. Under this type of
arrangement, identification of separate units of accounting is required and revenue is allocated
among the separate units based on their relative fair value. Payments received under the
collaboration and distribution agreements may include upfront payments, regulatory and sales-based
milestone payments for specific achievements, as well as distribution fees. Upfront and regulatory
milestone payments, which require the Companys ongoing involvement are deferred and amortized into
income on a straight-line basis over the estimated period of service. Sales-based milestone
payments, for which the Company has no future involvement or obligations to perform related to that
specific element of the arrangement, are recognized as income upon the achievement of the specified
milestones. Distribution fee revenue is recognized when the service is performed, the amount is
determinable and collection is reasonably assured.
Research and development costs
consist of direct and indirect expenditures, including a reasonable
allocation of overhead expenses, associated with the Companys various research and development
programs. Research and development costs are expensed as incurred. Overhead expenses comprise
general and administrative support provided to the research and development programs and involve
costs associated with support activities such as facility operating costs, office services,
information technology and human resources. The Company accrues clinical trial expenses based on
work performed, which relies on estimates of total costs incurred based on completion of patient
studies and other events. The Company follows this method since reasonable dependable estimates of
the costs applicable to various stages of a research agreement or clinical trial can be made.
Accrued clinical costs are subject to revisions as trials progress to completion.
Income taxes
are accounted for under the asset and liability method. Future tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax
bases and operating loss and tax credit carry forwards. Future tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the years in which those
temporary differences are expected to be recovered or settled. The effect on future tax assets and
liabilities of a
20
change in tax rates is recognized in income in the period that includes the
enactment date. Management provides valuation allowances against the future tax asset for amounts
which are not considered more likely than not to be realized. In assessing the realizability of
tax assets,
management considers whether it is more likely than not that some portion or all of the tax assets
will not be realized. The ultimate realization of future tax assets is dependent upon the
generation of future taxable income during the periods in which those temporary differences become
deductible. Management considers the scheduled reversal of tax liabilities, projected future
taxable income, and tax planning strategies in making this assessment. The Company has determined
that a 100% tax valuation allowance is necessary at December 31, 2007. In the event the Company was
to determine that it would be able to realize its tax asset, an adjustment to the tax asset would
increase income in the period in which such determination is made.
Property, equipment and patent costs
are stated at cost and are amortized on a straight-line or
declining balance basis. The Company regularly reviews property, equipment and patent costs for
impairment, as well as whenever events or changes in business circumstances indicate that the
carrying value of the assets may not be recoverable. Impairment is assessed by comparing the
carrying amount of an asset with its expected future net undiscounted cash flows from use together
with its residual value (net recoverable value). If such assets are considered impaired, the
impairment to be recognized is measured by the amount by which the carrying amount exceeds its fair
value. Quoted market values are used whenever available to estimate fair value. When quoted market
values are unavailable, the fair value of the long-lived asset is generally based on estimates of
discounted expected net cash flows. Managements judgment regarding the existence of impairment
indicators is based on legal factors, market conditions and operating performances. Future events
could cause management to conclude that impairment indicators exist and that the carrying values of
the Companys property, equipment or patent costs are impaired. Any resulting impairment loss could
have a material adverse impact on the Companys financial position and results of operations.
Stock-based compensation
is recorded using the fair value based method for stock options issued to
employees and non-employees subsequent to July 1, 2002. Under this method, compensation cost is
measured at fair value at the date of grant and is expensed over the awards vesting period. The
Company uses the Black-Scholes options pricing model to calculate stock option values, which
requires certain assumptions, including the future stock price volatility and expected time to
exercise. Changes to any of these assumptions, or the use of a different option pricing model,
could produce different fair values for stock-based compensation, which could have a material
impact on the Companys earnings.
CHANGE IN ACCOUNTING POLICIES
Change in functional and reporting currency
Effective July 1, 2007, the Company adopted the US dollar as its functional and reporting currency,
as a significant portion of its revenues, expenses, assets, liabilities and financing are
denominated in US dollars. Prior to that date, the Companys operations were measured in Canadian
dollars and the consolidated financial statements were expressed in Canadian dollars. The Company
followed the recommendations of the Emerging Issues Committee (EIC) of the Canadian Institute of
Chartered Accountants (CICA), set out in EIC-130, Translation method when the reporting currency
differs from the measurement currency or there is a change in the reporting currency. In
accordance with EIC-130, assets and liabilities as of June 30, 2007, were translated in US dollars
using the exchange rate in effect on that date; revenues, expenses and cash flows were translated
at the average rate in
21
effect during the six-month period ended June 30, 2007, and equity
transactions were translated at historical rates.
For comparative purposes, historical financial statements have been restated into US dollars using
the current rate method. Under this method, assets and liabilities are translated at the closing
rate in effect at the end of these periods, revenues, expenses and cash flows are translated at the
average rates in effect during these periods and equity transactions are translated at historical
rates. Any exchange differences resulting from the translation are included in accumulated other
comprehensive income presented in shareholders equity.
New accounting pronouncements adopted in 2007
On January 1, 2007, the Company adopted the following new accounting standards issued by the CICA:
Section 1530, Comprehensive Income, introduces a new financial statement which shows the change in
equity of an enterprise during a period from transactions and other events arising from non-owner
sources. A new financial statement has been presented in relation to Section 1530.
Section 3251, Equity, describes standards for the presentation of equity and changes in equity for
the reporting period as a result of the application of Section 1530, Comprehensive Income. This
standard did not have an impact on the Companys consolidated financial statements for the year
ended December 31, 2007.
Section 3855, Financial Instruments Recognition and Measurement and Section 3861, Financial
Instruments Disclosure and Presentation, establish standards for recognition and presentation of
financial instruments on the balance sheet and the measurement of financial instruments according
to prescribed classifications. The Company is required to designate its financial instruments into
one of five categories, which determine the manner of evaluation of each instrument and the
presentation of related gains and losses. Depending on the financial instruments classifications,
changes in subsequent measurements are recognized in net income or comprehensive income.
The Company has designated its financial instruments as follows:
§
Cash equivalents, marketable securities and restricted cash are classified as Financial Assets
Available for Sale. These financial assets are marked-to-market at each reporting dates with all
unrealized losses recognized in comprehensive income.
§
Other receivables are classified as Loans and Receivables. Accounts payable, accrued
liabilities and convertible notes are classified as Other Financial Liabilities. After their
initial fair value measurement, these financial instruments are measured at amortized cost using
the effective interest rate method.
The new standards require derivative instruments to be recorded as either assets or liabilities
measured at their fair value unless exempted from derivative treatment as a normal purchase and
sale. Certain derivatives embedded in other contracts must also be measured at fair value. Embedded
derivatives are required to be separated from the host contract and accounted for as a derivative
financial instrument if the embedded derivative and host contract are not closely related, and the
combined contract is not held for trading or designated at fair value. The change in accounting
policy related to embedded derivatives resulted in an increase of $155,000 to the opening deficit
at the date of adoption.
22
As a result of adopting Section 3855, deferred financing costs of $1,535,000 as at January 1, 2007,
relating to convertible notes, have been reclassified from deferred financing fees to convertible
notes
on the consolidated balance sheet. These costs are being amortized using the effective interest
method over the life of the related debt.
Section 3865, Hedges, specifies the criteria under which hedge accounting may be applied, how hedge
accounting should be performed under permitted hedging strategies and the required disclosures.
This standard did not have an impact on the Companys consolidated financial statements for the
year ended December 31, 2007.
Recent accounting pronouncements to be adopted
The following accounting standards were recently issued by the CICA. The Company is currently
evaluating the impact of the adoption of these new standards on its consolidated financial
statements.
Section 1535, Capital Disclosures, establishes guidelines for disclosure of both qualitative and
quantitative information that enables users of financial statements to evaluate the entitys
objectives, policies and processes for managing capital. This new standard relates to disclosure
only and will not impact the financial results of the Company. This standard is effective January
1, 2008.
Section 3862, Financial Instruments Disclosure, describes the required disclosure for the
assessment of the significance of financial instruments for an entitys financial position and
performance and of the nature and extent of risks arising from financial instruments to which the
entity is exposed and how the entity manages those risks. Section 3863, Financial Instruments
Presentation, establishes standards for presentation of the financial instruments and non-financial
derivatives. It carries forward the presentation related requirements of Section 3861, Financial
Instruments Disclosure and Presentation. These new standards relate to disclosure only and will
not impact the financial results of the Company. These standards are effective January 1, 2008.
International Financial Reporting Standards (IFRS)
In 2005, the Accounting Standards Board of Canada (AcSB) announced that accounting standards in
Canada are to converge with IFRS. In May 2007, the CICA published an updated version of its
Implementation Plan for Incorporating IFRS into Canadian GAAP. This plan includes an outline of
the key decisions that the CICA needs to make as it implements the Strategic Plan for publicly
accountable enterprises that will converge Canadian generally accepted accounting standards with
IFRS. While IFRS uses a conceptual framework similar to Canadian GAAP, there are significant
differences in accounting policy which must be addressed. The Company is currently assessing the
future impact of these new standards on its consolidated financial statements. These standards are
effective for fiscal years beginning on January 1, 2011.
SUBSEQUENT EVENTS
On February 20, 2008, the Companys Board of Directors approved the following transactions:
(a) The issuance of 2,445,000 options to purchase common shares to be issued under the stock option
plan of the Company. The option price per share will be determined based on the weighted average
trading price of common shares for the five days preceding the date of grant during which the
common shares were traded on the Toronto Stock Exchange.
23
(b) The Company renewed the management services agreement entered into with Picchio International
Inc. to November 30, 2008.
(c) The Company entered into an amendment with respect to the ELOC facility. The term of the ELOC
facility has been extended to February 2010. The minimum draw-down obligation by the Company has
been reduced to $15,000,000 over the term. The maximum amount of each monthly draw-down is limited
to the lower of $6,000,000 or 12.5% of the volume-weighted price calculation of the common shares
at the time of draw-down. The common shares will be issued at a discount of 4.0% to market price if
the volume-weighted average price (VWAP) per share is $6 or higher, and 7% if the VWAP per share is
lower than $6 at the time of draw-down.
(d) The name-change from Neurochem to BELLUS Health
TM
, pending shareholder approval at
the next annual meeting.
RISKS AND UNCERTAINTIES
Since its inception in 1993, Neurochem has experienced operating losses and products have not yet
been marketed commercially. The Companys product candidates are in development and have not yet
been approved for commercialization by regulatory authorities in any jurisdiction. The Companys
business entails significant risks, including the costs and time involved in obtaining the required
regulatory approvals, the adequacy of patent protection, the uncertainties involved in clinical
testing, the availability of capital to continue development and commercialization of the products,
and competition from pharmaceutical, biotechnology and nutraceutical companies.
Product research and development involves a high degree of risk, and returns to investors are
dependent upon successful development and commercialization of the Companys products. A setback in
any of the Companys clinical trials may cause a drop in the Companys stock price. Difficulties
encountered in enrolling patients in the Companys clinical trials could delay or adversely affect
the trials. There can be no assurance that development of any product will be successfully
completed or that regulatory approval of any of the Companys products under development will be
obtained. Furthermore, there can be no assurance that existing products or new products developed
by competitors will not be more effective, or more effectively marketed and sold, than any that may
be developed by the Company. There can be no assurance that the Companys future potential products
will gain market acceptance among physicians, patients, healthcare payers, the medical community
and consumers.
Because of the length of time and expense associated with bringing new products through
development, obtaining regulatory approval and bringing products to market, the Company places
considerable importance on obtaining and maintaining patent protection and safeguarding trade
secret protection for significant discoveries. There can be no assurance that any pending patent
application filed by the Company will mature into an issued patent. Furthermore, there can be no
assurance that existing or pending patent claims will offer protection against competition, or will
not be designed around or infringed upon by others. Commercial success will also depend in part on
the Company not infringing patents or proprietary rights of others. Patent litigation is costly and
time consuming and may subject the Company to liabilities.
The Company is currently dependent on third parties for a variety of functions and may enter into
future collaborations for the development, manufacture and commercialization of products, including
Centocor for the commercialization of eprodisate (KIACTA
). There is no assurance that the
arrangements with these third parties will provide benefits the Company expects. There can also be
24
no assurance that the Company will be successful in manufacturing, marketing and distributing
products, or that the Company will be able to make adequate arrangements with third parties for
such purposes. There can be no assurance that the Company will generate revenue or achieve
profitability.
Significant funding is required for ongoing research and development, clinical trials, commercial
manufacturing of products and the establishment of sales and marketing teams necessary for the
launch and ongoing sales of new products. In addition, major financial resources are necessary
until such time as the products are commercialized and sold successfully, and sales are sufficient
to generate profits. The Company intends to raise additional financing, as required, through
research, partnership and licensing agreements, the exercise of stock options and warrants, and
through equity and/or debt financing. However, there can be no assurance that these financing
efforts will be successful or that the Company will continue to be able to meet its ongoing cash
requirements. It is possible that financing will not be available or, if available, may not be on
favorable terms. The availability of financing will be affected by the results of scientific
research and clinical development, the Companys ability to obtain regulatory approvals, the market
acceptance of the Companys products, the state of the capital markets generally (with particular
reference to pharmaceutical, biotechnology, nutraceutical and medical companies), the status of
strategic alliance agreements, and other relevant commercial considerations.
A detailed discussion on the Companys risks and uncertainties can be found in the Companys public
filings including the Annual Information Form and prospectuses available on SEDAR at www.sedar.com
or on EDGAR at www.sec.gov.
FORWARD-LOOKING STATEMENTS
Certain statements included in this Managements Discussion and Analysis may constitute
forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995 and Canadian securities legislation and regulations, and are subject to important
risks, uncertainties and assumptions. This forward-looking information includes amongst others,
information with respect to the Companys objectives and the strategies to achieve these
objectives, as well as information with respect to the Companys beliefs, plans, expectations,
anticipations, estimates and intentions. Forward-looking statements generally can be identified by
the use of conditional or forward-looking terminology such as may, will, expect, intend,
estimate, anticipate, plan, foresee, believe or continue or the negatives of these
terms or variations of them or similar terminology. Refer to the Companys filings with the
Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, as well
as the Risks and Uncertainties section of this Managements Discussion and Analysis, for a
discussion of the various factors that may affect the Companys future results. Such risks include
but are not limited to: the impact of general economic conditions, general conditions in the
pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the
jurisdictions in which the Neurochem group does 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.
The results or events predicted in forward-looking information may differ materially from actual
results or events. The Company believes that expectations represented by forward-looking statements
are reasonable, yet there can be no assurance that such expectations will prove to be correct.
Unless otherwise stated, the forward-looking statements contained in this report are made as of the
date of this report, and the Company does not undertake any obligation to update publicly or to
revise any of the included forward-looking statements, whether as a result of
25
new information,
future events or otherwise, unless required by applicable legislation or regulation. The
forward-looking statements contained in this report are expressly qualified by this cautionary
statement.
26
MANAGEMENTS RESPONSIBILITY FOR FINANCIAL REPORTING
The accompanying consolidated financial statements have been prepared by management and approved by
the Board of Directors of the Company. The consolidated financial statements were prepared in
accordance with accounting principles generally accepted in Canada and, where appropriate, reflect
managements best estimates and judgments. Where alternative accounting methods exist, management
has chosen those methods deemed most appropriate in the circumstances. Management is responsible
for the accuracy, integrity and objectivity of the consolidated financial statements within
reasonable limits of materiality, and for the consistency of financial data included in the text of
the Managements Discussion and Analysis with the data contained in the consolidated financial
statements.
To assist management in the discharge of these responsibilities, the Company maintains a system of
internal controls over financial reporting as described in the Managements Discussion and
Analysis.
The Companys Audit Committee is appointed by the Board of Directors annually and is comprised
exclusively of outside, independent directors. The Audit Committee meets with management as well as
with the external auditors to satisfy itself that management is properly discharging its financial
reporting responsibilities and to review the consolidated financial statements. The Audit
Committee reports its findings to the Board of Directors for consideration in approving the
consolidated financial statements for presentation to the shareholders. The Audit Committee
considers, for review by the Board of Directors and approval by the shareholders, the engagement or
reappointment of the independent auditors. The external auditors, KPMG LLP, have direct access to
the Audit Committee of the Board of Directors.
The consolidated financial statements have been independently audited by KPMG LLP, Chartered
Accountants, on behalf of the shareholders, in accordance with Canadian generally accepted auditing
standards and, with respect to the consolidated financial statements for the year ended December
31, 2007, in accordance with the standards of the Public Company Accounting Oversight Board (United
States). Their report outlines the nature of their audit and expresses their opinion on the
consolidated financial statements of the Company. In addition, the Companys auditors have issued
an attestation report on the effectiveness of the Companys internal controls over financial
reporting as of December 31, 2007.
|
|
|
[signed]
|
|
[signed]
|
|
|
|
Francesco Bellini, O.C.
|
|
Mariano Rodriguez, C.A., C.P.A.
|
Chairman, President and
|
|
Vice President, Finance and
|
Chief Executive Officer
|
|
Chief Financial Officer
|
Laval, Quebec, Canada
February 20, 2008
27
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of Neurochem Inc.
We have audited the accompanying consolidated balance sheets of Neurochem Inc. (the Company) and
subsidiaries as of December 31, 2007 and 2006 and the related consolidated statements of
operations, comprehensive loss, shareholders equity and cash flows for each of the years in the
three-year period ended December 31, 2007, and for the period from inception (June 17, 1993) to
December 31, 2007. These consolidated financial statements are the responsibility of the Companys
management. Our responsibility is to express an opinion on these consolidated financial statements
based on our audits.
We conducted our audits in accordance with Canadian generally accepted auditing standards. With
respect to the consolidated financial statements for the year ended December 31, 2007, we also
conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of the Company and subsidiaries as of December 31, 2007
and 2006 and the results of their operations and their cash flows for each of the years in the
three-year period ended December 31, 2007 and for the period from inception (June 17, 1993) to
December 31, 2007, in conformity with Canadian generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the Companys internal control over financial reporting as of December 31,
2007, based on the criteria established in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO), and our report dated
February 13, 2008 expressed an unqualified opinion on the effectiveness of the Companys internal
control over financial reporting.
[signed] KPMG LLP
Chartered Accountants
Montreal, Canada
February 13, 2008, except as to Note 21, which is as of February 20, 2008
28
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of Neurochem Inc.
We have audited Neurochem Inc.s (the Company) internal control over financial reporting as of
December 31, 2007, based on the criteria established in Internal ControlIntegrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The
Companys management is responsible for maintaining effective internal control over financial
reporting and for its assessment of the effectiveness of internal control over financial reporting
as presented in the section entitled Internal Control over Financial Reporting included in the
accompanying Managements Discussion and Analysis. Our responsibility is to express an opinion on
the Companys internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, assessing the risk that a material weakness exists, and testing
and evaluating the design and operating effectiveness of internal control based on the assessed
risk. Our audit also included performing such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed 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. A
companys internal control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and directors of the company;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or
detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, the Company maintained, in all material respects, effective internal control over
financial reporting as of December 31, 2007, based on the criteria established in Internal
ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO).
29
We also have conducted our audits on the consolidated financial statements in accordance with
Canadian generally accepted auditing standards. With respect to the consolidated financial
statements for the year ended December 31, 2007, we also have conducted our audit in accordance
with the standards of the Public Company Accounting Oversight Board (United States). Our report
dated February 13, 2008, except as to Note 21, which is as of February 20, 2008, expressed an
unqualified opinion on those consolidated financial statements.
[signed] KPMG LLP
Chartered Accountants
Montreal, Canada
February 13, 2008
30
Consolidated Balance Sheets
December 31, 2007 and 2006
(in thousands of US dollars, unless otherwise noted)
(in accordance with Canadian GAAP)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
|
|
(CDN$-
|
|
(US$)
|
|
(US$-
|
|
|
note 2 (b))
|
|
|
|
|
|
note 2 (a))
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,833
|
|
|
$
|
10,963
|
|
|
$
|
12,158
|
|
Marketable securities
|
|
|
47,141
|
|
|
|
47,709
|
|
|
|
36,600
|
|
Restricted cash (note 6)
|
|
|
|
|
|
|
|
|
|
|
6,000
|
|
Sales taxes and other receivables
|
|
|
766
|
|
|
|
775
|
|
|
|
1,043
|
|
Research tax credits receivable
|
|
|
1,785
|
|
|
|
1,807
|
|
|
|
928
|
|
Prepaid expenses
|
|
|
1,335
|
|
|
|
1,351
|
|
|
|
2,489
|
|
|
|
|
|
61,860
|
|
|
|
62,605
|
|
|
|
59,218
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash (note 6)
|
|
|
5,399
|
|
|
|
5,464
|
|
|
|
549
|
|
Deferred financing fees (notes 4 (b) and 10)
|
|
|
|
|
|
|
|
|
|
|
1,535
|
|
Long-term prepaid expenses
|
|
|
361
|
|
|
|
365
|
|
|
|
789
|
|
Long-term investment (note 4 (a))
|
|
|
1
|
|
|
|
1
|
|
|
|
319
|
|
Property and equipment (note 7)
|
|
|
3,794
|
|
|
|
3,840
|
|
|
|
3,912
|
|
Patents (note 8)
|
|
|
6,083
|
|
|
|
6,156
|
|
|
|
5,080
|
|
|
|
|
$
|
77,498
|
|
|
$
|
78,431
|
|
|
$
|
71,402
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
3,632
|
|
|
$
|
3,676
|
|
|
$
|
3,753
|
|
Accrued liabilities
|
|
|
8,988
|
|
|
|
9,096
|
|
|
|
9,834
|
|
Deferred revenue (note 5)
|
|
|
7,044
|
|
|
|
7,129
|
|
|
|
7,568
|
|
Deferred gain on sale of property (note 7)
|
|
|
1,323
|
|
|
|
1,339
|
|
|
|
1,222
|
|
|
|
|
|
20,987
|
|
|
|
21,240
|
|
|
|
22,377
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred gain on sale of property (note 7)
|
|
|
15,713
|
|
|
|
15,902
|
|
|
|
15,732
|
|
Long-term accrued liabilities (note 9)
|
|
|
1,264
|
|
|
|
1,279
|
|
|
|
635
|
|
Convertible notes (note 10)
|
|
|
35,000
|
|
|
|
35,421
|
|
|
|
33,650
|
|
|
|
|
|
72,964
|
|
|
|
73,842
|
|
|
|
72,394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-controlling interest
|
|
|
672
|
|
|
|
680
|
|
|
|
725
|
|
Shareholders equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital (note 11)
|
|
|
270,017
|
|
|
|
273,269
|
|
|
|
203,751
|
|
Equity portion of convertible notes (note 10)
|
|
|
9,724
|
|
|
|
9,841
|
|
|
|
8,620
|
|
Additional paid-in capital
|
|
|
15,214
|
|
|
|
15,397
|
|
|
|
11,396
|
|
Warrants (note 10)
|
|
|
16,656
|
|
|
|
16,857
|
|
|
|
|
|
|
|
|
|
311,611
|
|
|
|
315,364
|
|
|
|
223,767
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
(314,467
|
)
|
|
|
(318,254
|
)
|
|
|
(234,240
|
)
|
Accumulated other comprehensive income
|
|
|
6,718
|
|
|
|
6,799
|
|
|
|
8,756
|
|
|
|
|
|
(307,749
|
)
|
|
|
(311,455
|
)
|
|
|
(225,484
|
)
|
|
|
|
|
3,862
|
|
|
|
3,909
|
|
|
|
(1,717
|
)
|
Commitments and contingencies (note 14)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent events (note 21)
|
|
$
|
77,498
|
|
|
$
|
78,431
|
|
|
$
|
71,402
|
|
|
See accompanying notes to consolidated financial statements.
On behalf of the Board of Directors by:
|
|
|
[signed]
|
|
[signed]
|
Graeme K. Rutledge, Director
|
|
Colin Bier, Director
|
31
Consolidated Statements of Operations
Years ended December 31, 2007, 2006 and 2005 and period from inception (June 17, 1993) to December 31, 2007
(in thousands of US dollars, except per share data, unless otherwise noted)
(in accordance with Canadian GAAP)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
since
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
inception of
|
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
operations
|
|
|
|
|
(CDN$-
|
|
(US$)
|
|
(US$-
|
|
(US$-
|
|
(US$-
|
|
|
note 2 (b))
|
|
|
|
|
|
note 2(a))
|
|
note 2 (a))
|
|
note 2 (a))
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreement
(note 5)
|
|
$
|
1,106
|
|
|
$
|
1,119
|
|
|
$
|
2,106
|
|
|
$
|
2,793
|
|
|
$
|
6,120
|
|
Reimbursable costs
|
|
|
391
|
|
|
|
396
|
|
|
|
712
|
|
|
|
872
|
|
|
|
2,131
|
|
Research contracts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,038
|
|
License fees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
733
|
|
|
|
|
|
1,497
|
|
|
|
1,515
|
|
|
|
2,818
|
|
|
|
3,665
|
|
|
|
15,022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
55,069
|
|
|
|
55,732
|
|
|
|
51,688
|
|
|
|
41,676
|
|
|
|
224,622
|
|
Research tax credits and grants
|
|
|
(2,135
|
)
|
|
|
(2,161
|
)
|
|
|
(1,899
|
)
|
|
|
(3,626
|
)
|
|
|
(21,253
|
)
|
Other research and development
charges
|
|
|
|
|
|
|
|
|
|
|
1,127
|
|
|
|
|
|
|
|
1,127
|
|
|
|
|
|
52,934
|
|
|
|
53,571
|
|
|
|
50,916
|
|
|
|
38,050
|
|
|
|
204,496
|
|
General and administrative
|
|
|
10,455
|
|
|
|
10,581
|
|
|
|
11,522
|
|
|
|
18,333
|
|
|
|
74,584
|
|
Arbitral award (note 12)
|
|
|
|
|
|
|
|
|
|
|
1,835
|
|
|
|
|
|
|
|
1,835
|
|
Reimbursable costs
|
|
|
391
|
|
|
|
396
|
|
|
|
712
|
|
|
|
872
|
|
|
|
2,131
|
|
Stock-based compensation
|
|
|
4,224
|
|
|
|
4,275
|
|
|
|
3,569
|
|
|
|
3,958
|
|
|
|
14,904
|
|
Special charges
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,288
|
|
Depreciation of property and
equipment
|
|
|
1,022
|
|
|
|
1,034
|
|
|
|
1,129
|
|
|
|
1,674
|
|
|
|
7,646
|
|
Amortization and patent cost
write-off
|
|
|
656
|
|
|
|
664
|
|
|
|
427
|
|
|
|
958
|
|
|
|
2,738
|
|
|
|
|
|
69,682
|
|
|
|
70,521
|
|
|
|
70,110
|
|
|
|
63,845
|
|
|
|
309,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before undernoted items
|
|
|
(68,185
|
)
|
|
|
(69,006
|
)
|
|
|
(67,292
|
)
|
|
|
(60,180
|
)
|
|
|
(294,600
|
)
|
|
Interest income
|
|
|
3,301
|
|
|
|
3,341
|
|
|
|
2,077
|
|
|
|
1,718
|
|
|
|
11,589
|
|
Interest and bank charges
|
|
|
(200
|
)
|
|
|
(202
|
)
|
|
|
(133
|
)
|
|
|
(381
|
)
|
|
|
(1,543
|
)
|
Accretion expense (note 10)
|
|
|
(15,564
|
)
|
|
|
(15,751
|
)
|
|
|
(550
|
)
|
|
|
|
|
|
|
(16,301
|
)
|
Change in fair value of embedded
derivatives
|
|
|
(860
|
)
|
|
|
(870
|
)
|
|
|
|
|
|
|
|
|
|
|
(870
|
)
|
Change in fair value of third party
asset-backed commercial
paper (note 6)
|
|
|
(1,170
|
)
|
|
|
(1,184
|
)
|
|
|
|
|
|
|
|
|
|
|
(1,184
|
)
|
Gain on technology transfer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,306
|
|
Foreign exchange gain (loss)
|
|
|
1,117
|
|
|
|
1,130
|
|
|
|
(280
|
)
|
|
|
154
|
|
|
|
866
|
|
Other income
|
|
|
1,259
|
|
|
|
1,274
|
|
|
|
1,348
|
|
|
|
772
|
|
|
|
3,719
|
|
Share of loss in a company
subject to significant
influence (note 4 (a))
|
|
|
(323
|
)
|
|
|
(327
|
)
|
|
|
(2,440
|
)
|
|
|
(2,578
|
)
|
|
|
(5,346
|
)
|
Non-controlling interest (note 4 (a))
|
|
|
108
|
|
|
|
109
|
|
|
|
801
|
|
|
|
768
|
|
|
|
1,678
|
|
|
|
|
|
(12,332
|
)
|
|
|
(12,480
|
)
|
|
|
823
|
|
|
|
453
|
|
|
|
(5,086
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes
|
|
|
(80,517
|
)
|
|
|
(81,486
|
)
|
|
|
(66,469
|
)
|
|
|
(59,727
|
)
|
|
|
(299,686
|
)
|
Income taxes:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quebec credit for losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
464
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(80,517
|
)
|
|
$
|
(81,486
|
)
|
|
$
|
(66,469
|
)
|
|
$
|
(59,727
|
)
|
|
$
|
(299,222
|
)
|
|
Net loss per share (note 17):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(1.83
|
)
|
|
$
|
(1.85
|
)
|
|
$
|
(1.72
|
)
|
|
$
|
(1.70
|
)
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
32
Consolidated Statements of Comprehensive Loss
Years ended December 31, 2007, 2006 and 2005
(in thousands of US dollars)
(in accordance with Canadian GAAP)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Net loss
|
|
$
|
(81,486
|
)
|
|
$
|
(66,469
|
)
|
|
$
|
(59,727
|
)
|
Foreign exchange adjustment
on change in functional currency (note 2 (a))
|
|
|
1,957
|
|
|
|
(1,397
|
)
|
|
|
(1,219
|
)
|
|
Comprehensive loss
|
|
$
|
(79,529
|
)
|
|
$
|
(67,866
|
)
|
|
$
|
(60,946
|
)
|
|
See accompanying notes to consolidated financial statements.
33
Consolidated Statements of Shareholders Equity
Years ended December 31, 2007, 2006 and 2005
(in thousands of US dollars, unless otherwise noted)
(in accordance with Canadian GAAP)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
portion of
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
other
|
|
|
|
|
|
|
Share capital
|
|
|
convertible
|
|
|
paid-in
|
|
|
|
|
|
|
|
|
|
|
comprehensive
|
|
|
|
|
|
|
Number
|
|
|
Dollars
|
|
|
notes
|
|
|
capital
|
|
|
Warrants
|
|
|
Deficit
|
|
|
income
|
|
|
Total
|
|
|
Balance, December 31,
2004
|
|
|
30,320,419
|
|
|
$
|
125,212
|
|
|
$
|
|
|
|
$
|
4,434
|
|
|
$
|
|
|
|
$
|
(101,438
|
)
|
|
$
|
6,140
|
|
|
$
|
34,348
|
|
Adjustment to reflect
change in accounting
policy for variable
interest entities
(note 4 (a))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,079
|
)
|
|
|
|
|
|
|
(2,079
|
)
|
Issued for cash from
public offering
(note 11 (b))
|
|
|
4,000,000
|
|
|
|
61,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61,200
|
|
Share issue costs
(note 11 (b))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,107
|
)
|
|
|
|
|
|
|
(4,107
|
)
|
Exercise of warrants
(note 11 (b))
|
|
|
2,800,000
|
|
|
|
7,189
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,189
|
|
Exercise of stock options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For cash
|
|
|
300,660
|
|
|
|
1,111
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,111
|
|
Ascribed value from
additional paid-in capital
|
|
|
|
|
|
|
428
|
|
|
|
|
|
|
|
(428
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
(notes 11(d) and 13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,958
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,958
|
|
Change in foreign currency
translation adjustment
(note 2 (a))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,219
|
|
|
|
1,219
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(59,727
|
)
|
|
|
|
|
|
|
(59,727
|
)
|
|
Balance, December 31,
2005
|
|
|
37,421,079
|
|
|
|
195,140
|
|
|
|
|
|
|
|
7,964
|
|
|
|
|
|
|
|
(167,351
|
)
|
|
|
7,359
|
|
|
|
43,112
|
|
Exercise of warrants
(note 11 (b))
|
|
|
1,200,000
|
|
|
|
8,095
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,095
|
|
Equity portion of
November 2006
convertible notes
(note 10 (a))
|
|
|
|
|
|
|
|
|
|
|
8,620
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,620
|
|
Share issue costs
(note 10 (a))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(420
|
)
|
|
|
|
|
|
|
(420
|
)
|
Exercise of stock options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For cash
|
|
|
100,943
|
|
|
|
379
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
379
|
|
Ascribed value from
additional paid-in capital
|
|
|
|
|
|
|
137
|
|
|
|
|
|
|
|
(137
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
(note 13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,569
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,569
|
|
Change in foreign currency
translation adjustment
(note 2 (a))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,397
|
|
|
|
1,397
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(66,469
|
)
|
|
|
|
|
|
|
(66,469
|
)
|
|
Balance, December 31,
2006
|
|
|
38,722,022
|
|
|
|
203,751
|
|
|
|
8,620
|
|
|
|
11,396
|
|
|
|
|
|
|
|
(234,240
|
)
|
|
|
8,756
|
|
|
|
(1,717
|
)
|
|
34
Consolidated Statements of Shareholders Equity, Continued
Years ended December 31, 2007, 2006 and 2005
(in thousands of US dollars, unless otherwise noted)
(in accordance with Canadian GAAP)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
portion of
|
|
|
Additional
|
|
|
|
|
|
|
|
|
|
|
other
|
|
|
|
|
|
|
Share capital
|
|
|
convertible
|
|
|
paid-in
|
|
|
|
|
|
|
|
|
|
|
comprehensive
|
|
|
|
|
|
|
Number
|
|
|
Dollars
|
|
|
notes
|
|
|
capital
|
|
|
Warrants
|
|
|
Deficit
|
|
|
income
|
|
|
Total
|
|
|
Balance carried forward,
December 31,
2006
|
|
|
38,722,022
|
|
|
$
|
203,751
|
|
|
$
|
8,620
|
|
|
$
|
11,396
|
|
|
$
|
|
|
|
$
|
(234,240
|
)
|
|
$
|
8,756
|
|
|
$
|
(1,717
|
)
|
Adjustment to reflect change
in
accounting policy for
financial instruments
(note 4 (b))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(155
|
)
|
|
|
|
|
|
|
(155
|
)
|
Equity portion of May 2007
convertible notes
(note 10 (b))
|
|
|
|
|
|
|
|
|
|
|
11,152
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,152
|
|
Warrants issued in connection
with the May 2007
convertible notes
issuance (note 10 (b))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,857
|
|
|
|
|
|
|
|
|
|
|
|
16,857
|
|
Share issue costs (note 10 (b))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,373
|
)
|
|
|
|
|
|
|
(2,373
|
)
|
Exercise of stock options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For cash
|
|
|
60,803
|
|
|
|
371
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
371
|
|
Ascribed value from
additional paid-in capital
|
|
|
|
|
|
|
224
|
|
|
|
|
|
|
|
(224
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued on conversion of
6% senior convertible
notes due in 2027
(note 10 (b))
|
|
|
5,619,321
|
|
|
|
30,513
|
|
|
|
(9,688
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,825
|
|
Issued on conversion of 5%
junior convertible notes
due in 2012 (note 10 (b))
|
|
|
4,444,449
|
|
|
|
38,410
|
|
|
|
(243
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,167
|
|
Stock-based compensation
(note 13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,225
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,225
|
|
Change in foreign currency
translation adjustment
(note 2 (a))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,957
|
)
|
|
|
(1,957
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(81,486
|
)
|
|
|
|
|
|
|
(81,486
|
)
|
|
Balance, December 31,
2007
|
|
|
48,846,595
|
|
|
$
|
273,269
|
|
|
$
|
9,841
|
|
|
$
|
15,397
|
|
|
$
|
16,857
|
|
|
$
|
(318,254
|
)
|
|
$
|
6,799
|
|
|
$
|
3,909
|
|
|
See accompanying notes to consolidated financial statements.
35
Consolidated Statements of Cash Flows
Years ended December 31, 2007, 2006 and 2005 and period from inception (June 17, 1993) to December 31, 2007
(in thousands of US dollars, unless otherwise noted)
(in accordance with Canadian GAAP)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
since
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
inception of
|
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
operations
|
|
|
|
|
(CDN$-
|
|
|
(US$)
|
|
|
(US$-
|
|
|
(US$-
|
|
|
(US$-
|
|
|
|
note 2 (b))
|
|
|
|
|
|
|
note 2 (a))
|
|
|
note 2 (a))
|
|
|
note 2 (a))
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(80,517
|
)
|
|
$
|
(81,486
|
)
|
|
$
|
(66,469
|
)
|
|
$
|
(59,727
|
)
|
|
$
|
(299,222
|
)
|
Adjustments for:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation, amortization
and patent cost write-off
|
|
|
1,678
|
|
|
|
1,698
|
|
|
|
1,556
|
|
|
|
2,632
|
|
|
|
10,384
|
|
Unrealized foreign exchange
(gain) loss
|
|
|
(3,113
|
)
|
|
|
(3,151
|
)
|
|
|
1,384
|
|
|
|
1,450
|
|
|
|
1,299
|
|
Stock-based compensation
|
|
|
4,224
|
|
|
|
4,275
|
|
|
|
3,569
|
|
|
|
3,958
|
|
|
|
14,904
|
|
Share of loss in a company
subject to significant
influence
|
|
|
323
|
|
|
|
327
|
|
|
|
2,440
|
|
|
|
2,578
|
|
|
|
5,346
|
|
Non-controlling interest
|
|
|
(108
|
)
|
|
|
(109
|
)
|
|
|
(801
|
)
|
|
|
(768
|
)
|
|
|
(1,678
|
)
|
Accretion expense
|
|
|
15,564
|
|
|
|
15,751
|
|
|
|
550
|
|
|
|
|
|
|
|
16,301
|
|
Change in fair value of
embedded derivatives
|
|
|
860
|
|
|
|
870
|
|
|
|
|
|
|
|
|
|
|
|
870
|
|
Change in fair value of third
party asset-backed
commercial paper
|
|
|
1,170
|
|
|
|
1,184
|
|
|
|
|
|
|
|
|
|
|
|
1,184
|
|
Amortization of gain on
sale-leaseback
|
|
|
(1,282
|
)
|
|
|
(1,297
|
)
|
|
|
(1,256
|
)
|
|
|
(144
|
)
|
|
|
(2,698
|
)
|
Amortization of deferred
financing fees
|
|
|
|
|
|
|
|
|
|
|
47
|
|
|
|
|
|
|
|
47
|
|
Write-off of leasehold
improvements and other
property and equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
914
|
|
Provision for lease exit
obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
374
|
|
Gain on technology transfer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,306
|
)
|
Shares issued for services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30
|
|
Changes in operating assets
and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,519
|
)
|
|
|
(6,519
|
)
|
Amount receivable under
collaboration agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,098
|
|
|
|
|
|
Sales taxes and other
receivables
|
|
|
343
|
|
|
|
347
|
|
|
|
(430
|
)
|
|
|
45
|
|
|
|
(526
|
)
|
Research tax credits
receivable
|
|
|
(552
|
)
|
|
|
(558
|
)
|
|
|
1,166
|
|
|
|
(871
|
)
|
|
|
(1,253
|
)
|
Prepaid expenses
|
|
|
1,358
|
|
|
|
1,374
|
|
|
|
238
|
|
|
|
470
|
|
|
|
(912
|
)
|
Long-term prepaid expenses
|
|
|
480
|
|
|
|
486
|
|
|
|
384
|
|
|
|
5
|
|
|
|
3
|
|
Deferred revenue
|
|
|
(1,106
|
)
|
|
|
(1,119
|
)
|
|
|
(2,106
|
)
|
|
|
(2,793
|
)
|
|
|
5,193
|
|
Accounts payable and
accrued liabilities
|
|
|
(5,372
|
)
|
|
|
(5,437
|
)
|
|
|
3,291
|
|
|
|
2,157
|
|
|
|
7,009
|
|
|
|
|
|
(66,050
|
)
|
|
|
(66,845
|
)
|
|
|
(56,437
|
)
|
|
|
(46,429
|
)
|
|
|
(251,256
|
)
|
|
36
Consolidated Statements of Cash Flows, Continued
Years ended December 31, 2007, 2006 and 2005 and period from inception (June 17, 1993) to December 31, 2007
(in thousands of US dollars, unless otherwise noted)
(in accordance with Canadian GAAP)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
since
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
inception of
|
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
operations
|
|
|
|
|
(CDN$-
|
|
|
(US$)
|
|
|
(US$-
|
|
|
(US$-
|
|
|
(US$-
|
|
|
|
note 2 (b))
|
|
|
|
|
|
|
note 2 (a))
|
|
|
note 2 (a))
|
|
|
note 2 (a))
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issue of share
capital
|
|
|
367
|
|
|
|
371
|
|
|
|
8,641
|
|
|
|
69,829
|
|
|
|
203,616
|
|
Share issue costs
|
|
|
|
|
|
|
|
|
|
|
(418
|
)
|
|
|
(4,090
|
)
|
|
|
(12,758
|
)
|
Proceeds from convertible notes
|
|
|
79,048
|
|
|
|
80,000
|
|
|
|
41,930
|
|
|
|
|
|
|
|
121,930
|
|
Financing fees
|
|
|
(5,653)
|
|
|
|
(5,721)
|
|
|
|
(1,624
|
)
|
|
|
|
|
|
|
(7,345
|
)
|
Proceeds from sale-leaseback
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,411
|
|
|
|
27,807
|
|
Repayment of obligations under
capital lease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(343
|
)
|
|
|
(2,214
|
)
|
Proceeds from long-term debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,052
|
|
Repayment of long-term debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,773
|
)
|
|
|
(8,052
|
)
|
|
|
|
|
73,762
|
|
|
|
74,650
|
|
|
|
48,529
|
|
|
|
84,034
|
|
|
|
331,036
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions to property and
equipment
|
|
|
(568
|
)
|
|
|
(575
|
)
|
|
|
(801
|
)
|
|
|
(1,126
|
)
|
|
|
(18,703
|
)
|
Additions to patents
|
|
|
(1,166
|
)
|
|
|
(1,180
|
)
|
|
|
(1,716
|
)
|
|
|
(939
|
)
|
|
|
(7,931
|
)
|
Additions to long-term investment
|
|
|
|
|
|
|
|
|
|
|
(1,464
|
)
|
|
|
|
|
|
|
(1,855
|
)
|
Proceeds from (purchase of)
marketable securities
|
|
|
(10,005
|
)
|
|
|
(10,126
|
)
|
|
|
18,565
|
|
|
|
(34,453
|
)
|
|
|
(41,141
|
)
|
Proceeds from disposal of
property and equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56
|
|
|
|
76
|
|
|
|
|
|
(11,739
|
)
|
|
|
(11,881
|
)
|
|
|
14,584
|
|
|
|
(36,462
|
)
|
|
|
(69,554
|
)
|
|
Net (decrease) increase in cash and
cash equivalents
|
|
|
(4,027
|
)
|
|
|
(4,076
|
)
|
|
|
6,676
|
|
|
|
1,143
|
|
|
|
10,226
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning
of period
|
|
|
12,013
|
|
|
|
12,158
|
|
|
|
6,332
|
|
|
|
5,988
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of foreign exchange
on cash and cash equivalents
|
|
|
2,847
|
|
|
|
2,881
|
|
|
|
(850
|
)
|
|
|
(799
|
)
|
|
|
737
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents,
end of period
|
|
$
|
10,833
|
|
|
$
|
10,963
|
|
|
$
|
12,158
|
|
|
$
|
6,332
|
|
|
$
|
10,963
|
|
|
Supplemental disclosures to cash flow statements (note 18)
See accompanying notes to consolidated financial statements.
37
Notes to Consolidated Financial Statements
Years ended December 31, 2007, 2006 and 2005 and period from inception (June 17, 1993) to December
31, 2007
(in thousands of US dollars, except per share data, unless otherwise noted)
1. Organization and business activities:
Neurochem Inc. (the Company or Neurochem) is a global health company focused on the research,
development and commercialization of products to provide innovative health solutions to address
critical unmet medical needs.
Since inception, the business activities of the Company have been devoted principally to the
development of the Companys core technology platform, amyloid inhibitors, which focus on
chemical compounds that could have the potential to inhibit the formation, deposition and
toxicity of amyloid fibrils which are implicated or believed to be the underlying causes of
certain diseases. The diseases currently targeted by the Company include Amyloid A (AA)
amyloidosis, Alzheimers disease and Type II Diabetes as well as certain features of metabolic
syndrome.
The status of the Companys principal product candidates is as follows:
|
|
|
|
|
Disease indication
|
|
Product candidate
|
|
Stage of development
|
|
AA amyloidosis
|
|
eprodisate (KIACTA
TM
)
|
|
Clinical development
|
|
|
|
|
|
Type II Diabetes as well as
features of metabolic syndrome
|
|
NC-503
|
|
Phase II clinical trial
|
|
|
|
|
|
Alzheimers Disease
|
|
prodrug
|
|
Preclinical development
|
Neurochem is considered to be in the development stage, with clinical trials for two of its
programs. Since inception, substantially all of the Companys research and development
expenditures, capital expenditures, including costs incurred to secure patents, and all
revenues from milestone payments, collaboration agreements and research contracts, relate to
the Companys core technology platform.
In the fiscal period ended June 30, 2003, the Company licensed out intellectual property rights
on preclinical-stage technology in its Type II Diabetes program to Innodia Inc. (Innodia).
Innodia is a private development stage company engaged in developing novel drugs for the
treatment of Type II Diabetes and underlying diseases.
The Company is subject to a number of risks, including the successful development and marketing
of its technologies and product candidates. In order to achieve its business plan, the Company
anticipates the need to raise additional capital and/or achieve sales and other revenue
generating activities. As of December 31, 2007, management believes that funds from operations,
as well as existing financial resources will be sufficient to meet the Companys requirements
for the next year.
38
2. Functional and reporting currency:
|
(a)
|
|
Change in functional and reporting currency:
|
|
|
|
|
Effective July 1, 2007, the Company adopted the US dollar as its functional and reporting
currency, as a significant portion of its revenue, expenses, assets, liabilities and
financing are denominated in US dollars. Prior to that date, the Companys operations were
measured in Canadian dollars and the consolidated financial statements were expressed in
Canadian dollars.
|
|
|
|
|
The Company followed the recommendations of the Emerging Issues Committee (EIC) of the
Canadian Institute of Chartered Accountants (CICA), set out in EIC-130, Translation method
when the reporting currency differs from the measurement currency or there is a change in
the reporting currency. In accordance with EIC-130, assets and liabilities as at June 30,
2007 were translated into US dollars using the exchange rate in effect on that date;
revenues, expenses and cash flows were translated at the average rate in effect during the
six-month period ended June 30, 2007 and equity transactions were translated at historical
rates. For comparative purposes, historical financial statements have been restated in US
dollars using the current rate method. Under this method, assets and liabilities are
translated at the closing rate in effect at the end of these periods, revenues, expenses
and cash flows are translated at the average rates in effect for these periods and equity
transactions are translated at historical rates. Any exchange differences resulting from
the translation are included in accumulated other comprehensive income presented in
shareholders equity.
|
|
(b)
|
|
Translation of convenience:
|
|
|
|
|
The Companys functional currency is the US dollar. The Company also presents the
consolidated financial statements as at and for the period ended December 31, 2007, in
Canadian dollars, using the convenience translation method whereby all US dollar amounts
are converted into Canadian dollars at the noon exchange rate quoted by the Federal Reserve
Bank of New York as at December 31, 2007, which was 0.9881 Canadian dollar per US dollar.
The supplementary information in Canadian dollars is presented only for the convenience of
some readers and thus has limited usefulness. This translation should not be viewed as a
representation that such US dollar amounts actually represent such Canadian dollar amounts
or could be or would have been converted into Canadian dollars at the rate indicated.
|
3. Significant accounting policies:
The consolidated financial statements have been prepared in accordance with Canadian generally
accepted accounting principles (GAAP).
|
(a)
|
|
Principles of consolidation:
|
|
|
|
|
The consolidated financial statements include the accounts of Neurochem Inc. and its
subsidiaries. All significant intercompany balances and transactions have been eliminated
on consolidation.
|
|
(b)
|
|
Cash and cash equivalents:
|
|
|
|
|
The Company considers all investments with maturities of three months or less at inception,
that are highly liquid and readily convertible into cash, to be cash equivalents.
|
39
3. Significant accounting policies (continued):
|
(c)
|
|
Marketable securities:
|
|
|
|
|
Marketable securities are investments with maturities greater than three months and less
than a year, and consist principally of commercial paper. Interest is recognized on an
effective yield basis. Marketable securities are classified as Financial Assets Available
for Sale and are marked-to-market with all unrealized gains and losses recognized in
comprehensive loss. Realized gains and losses on sale and losses on impairment of these
securities are recognized in net loss.
|
|
(d)
|
|
Property and equipment:
|
|
|
|
|
Property and equipment are stated at cost. Depreciation is provided at the following
annual rates:
|
|
|
|
|
|
Asset
|
|
Basis
|
|
Rate/period
|
|
Building (to November 2005)
|
|
Straight-line
|
|
20 years
|
Research equipment
|
|
Declining balance
|
|
20%
|
Office equipment
|
|
Declining balance
|
|
20%
|
Computer hardware
|
|
Declining balance
|
|
30%
|
Computer software
|
|
Straight-line
|
|
1-2 years
|
|
(e)
|
|
Patents:
|
|
|
|
|
The capitalized amount with respect to patents relates to direct costs incurred in
connection with securing patents. Patents are stated at cost and are amortized using the
straight-line method over the remaining life of the patent.
|
|
(f)
|
|
Impairment and disposal of long-lived assets:
|
|
|
|
|
Long-lived assets, including property and equipment and purchased intangibles subject to
amortization, are reviewed for impairment whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be recoverable. Recoverability of
assets to be held and used is measured by a comparison of the carrying amount of an asset
to estimated undiscounted future cash flows expected to be generated by the asset. If the
carrying amount of an asset exceeds its estimated undiscounted future cash flows, an
impairment charge is recognized for the difference between the carrying amount and the fair
value. Quoted market values are used whenever available to estimate fair value. When
quoted market values are unavailable, the fair value of the long-lived asset is generally
based on estimates of discounted expected net cash flows. Assets to be disposed of would
be separately presented in the balance sheet and reported at the lower of the carrying
amount or the fair value less selling costs, and would no longer be depreciated. The
assets and liabilities of a disposed group classified as held-for-sale would be presented
separately in the appropriate asset and liability sections of the balance sheet.
|
40
3. Significant accounting policies (continued):
|
(g)
|
|
Revenue recognition:
|
|
|
|
|
Revenue from collaboration agreements that includes multiple elements is considered to be a
revenue arrangement with multiple deliverables. Under this type of arrangement, the
identification of separate units of accounting is required and revenue is allocated among
the separate units based on their relative fair values. Payments received under the
collaboration agreement may include upfront payments, regulatory and sales-based milestone
payments for specific achievements, as well as distribution fees. Upfront and regulatory
milestone payments, which require the Companys ongoing involvement, are deferred and
amortized into income on a straight-line basis over the estimated period of service.
Sales-based milestone payments, for which the Company has no future involvement or
obligations to perform related to that specified element of the arrangement, are recognized
into income upon the achievement of the specified milestones. Distribution fees are
recognized when the service has been performed, amount is determinable and collection is
reasonably assured.
|
|
|
|
|
License fees are recorded when conditions and events under the license agreement have been
met or occurred, and collectibility is reasonably assured.
|
|
|
|
|
Reimbursable costs incurred in connection with the Companys collaboration agreement with
Centocor, Inc. are included in total revenues and expenses.
|
|
|
|
|
Interest income is recognized as earned.
|
|
(h)
|
|
Research and development:
|
|
|
|
|
Research expenditures are expensed as incurred and include a reasonable allocation of
overhead expenses. Development expenditures are deferred when they meet the criteria for
capitalization in accordance with Canadian GAAP, and the future benefits could be regarded
as being reasonably certain. At December 31, 2007 and 2006, no development costs were
deferred.
|
|
(i)
|
|
Government assistance:
|
|
|
|
|
Government assistance, consisting of grants and research tax credits, is recorded as a
reduction of the related expense or the cost of the asset acquired. Grants are recorded
when there is reasonable assurance that the Company has complied with the terms and
conditions of the approved grant program. Research tax credits are recorded when there is
reasonable assurance of their recovery.
|
|
(j)
|
|
Foreign exchange:
|
|
|
|
|
Monetary assets and liabilities denominated in foreign currencies are translated at
year-end exchange rates. Non-monetary assets and liabilities denominated in foreign
currencies are translated at exchange rates in effect at the transaction date. Income and
expenses denominated in foreign currencies are translated at exchange rates in effect at
the transaction date. Translation gains and losses are included in income.
|
|
(k)
|
|
Income taxes:
|
|
|
|
|
Income taxes are provided for using the liability method. Under this method, differences
between the financial reporting bases and the income tax bases of the Companys assets and
liabilities are recorded using the substantively enacted tax rates anticipated to be in
effect when the tax differences are expected to reverse. A valuation allowance is
recorded against any future tax asset if it is more likely than not that the asset will not
be realized.
|
41
3. Significant accounting policies (continued):
|
(l)
|
|
Costs associated with lease exit activities:
|
|
|
|
|
Costs associated with lease obligations for leased premises that are no longer being used
by the Company are recognized and measured at fair value as of the cease-use date. The
fair value of the liability at the cease-use date is determined based on the remaining
lease rentals, reduced by estimated sublease rentals that could reasonably be obtained for
the property, measured using the credit-adjusted risk-free rate.
|
|
|
(m)
|
|
Earnings per share:
|
|
|
|
|
Basic earnings per share are determined using the weighted average number of common shares
outstanding during the period. Diluted earnings per share are computed in a manner
consistent with basic earnings per share, except that the weighted average shares
outstanding are increased to include additional shares from the assumed exercise of options
and warrants, if dilutive. The number of additional shares is calculated by assuming that
outstanding options and warrants were exercised, and that the proceeds from such exercises
were used to acquire common shares at the average market price during the reporting period.
The dilutive effect of the convertible notes is reflected in diluted earnings per share by
application of the if-converted method, if dilutive. Under the if-converted method,
convertible notes are assumed to have been converted at the beginning of the period (or at
time of issuance, if later) and the resulting common shares are included in the
denomination for purposes of calculating diluted earnings per share.
|
|
|
(n)
|
|
Stock-based compensation:
|
|
|
|
|
The Company follows the fair value based method to account for options granted to employees
and non-employees, whereby compensation cost is measured at fair value at the date of grant
and is expensed over the awards vesting period.
|
|
|
(o)
|
|
Use of estimates:
|
|
|
|
|
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities at the
date of the financial statements, the disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and expenses
during the reporting periods. Significant areas requiring the use of management estimates
include estimating the useful lives of long-lived assets, including property and equipment
and patent costs, estimating accruals for clinical trial expenses, estimating the timing of
regulatory approvals for revenue recognition purposes, estimating the fair value of
restricted cash, allocating the proceeds received from issuance of convertible notes
between debt and equity components as well as assessing the recoverability of research tax
credits and future tax assets. The reported amounts and note disclosures reflect the most
probable set of economic conditions and planned course of actions. Actual results could
differ from these estimates.
|
42
4. Changes in accounting policies:
|
(a)
|
|
Variable interest entities:
|
|
|
|
|
On January 1, 2005, the Company adopted the recommendations of Accounting Guideline 15,
Consolidation of Variable Interest Entities
(AcG-15), which provides guidance for
determining when an enterprise consolidates the assets, liabilities and results of
operations of entities that are subject to control on a basis other than ownership of
voting interests (a variable interest entity (VIE)). This guideline requires the Company
to identify VIEs in which it has an interest, determine whether it is the primary
beneficiary of such entities and, if so, to consolidate the VIE. A primary beneficiary is
an enterprise that will absorb a majority of the VIEs expected losses, receive a majority
of its expected residual returns, or both. It was determined that the Companys investment
in a holding company that owns Innodia Inc.s shares (Innodia Holding) meets the criteria
for being a VIE and that the Company is the primary beneficiary of Innodia Holding.
Innodia Holdings only activity is the investment in Innodia Inc., which is accounted for
using the equity method. The implementation of AcG-15 resulted in the consolidation of the
Companys interest in Innodia Holding starting January 1, 2005. The effect of the
implementation of this accounting guideline was to adjust the net carrying value of the
long-term investment and the deficit by $2,079 at January 1, 2005.
|
|
|
|
|
In March 2006, the Company invested an additional amount of $1,464 in Innodia Holding in
connection with a financing by Innodia Inc. As at December 31, 2007, the Companys indirect
equity investment in Innodia Inc. is approximately 23% of the issued and outstanding
shares. For the year ended December 31, 2007, the Company recorded its share of loss in
Innodia Holding bringing the investment to $1. The Company has since ceased to recognize
its share of Innodia Inc.s losses since it is not committed to provide further financial
support to this company or otherwise guarantee obligations of this company. The Company
continues to track the losses of Innodia Holding should it return to profitability.
|
|
|
(b)
|
|
On January 1, 2007, the Company adopted the following new accounting standards issued
by the CICA:
|
|
(i)
|
|
Comprehensive income:
|
|
|
|
|
Section 1530,
Comprehensive Income
, introduces a new financial statement which shows
the change in equity of an enterprise during a period from transactions and other
events arising from non-owner sources. A new financial statement has been presented in
relation to Section 1530.
|
43
4. Changes in accounting policies (continued):
|
(ii)
|
|
Financial instruments recognition and measurement:
|
|
|
|
|
Section 3855,
Financial Instruments Recognition and Measurement
and Section 3861,
Financial Instruments Disclosure and Presentation
, establish standards for
recognition and presentation of financial instruments on the balance sheet and the
measurement of financial instruments according to prescribed classifications. The
Company is required to designate its financial instruments into one of five categories,
which determine the manner of evaluation of each instrument and the presentation of
related gains and losses. Depending on the financial instruments classifications,
changes in subsequent measurements are recognized in net income or comprehensive
income.
|
|
|
|
|
The Company has designated its financial instruments as follows:
|
|
|
|
Cash equivalents, marketable securities and restricted cash are
classified as Financial Assets Available for Sale. These financial assets are
marked-to-market at each reporting date with all unrealized gains and losses
recognized in comprehensive income. See note 6 for restricted cash.
|
|
|
|
|
Other receivables are classified as Loans and Receivables.
Accounts payable, accrued liabilities and convertible notes are classified as
Other Financial Liabilities. After their initial fair value measurement, these
financial instruments are measured at amortized cost using the effective interest
rate method.
|
|
|
|
The new standards require derivative instruments to be recorded as either assets or
liabilities measured at their fair value each period through earnings unless exempted
from derivative treatment as a normal purchase and sale. Certain derivatives embedded
in other contracts must also be measured at fair value. Embedded derivatives are
required to be separated from the host contract and accounted for as a derivative
financial instrument if the embedded derivative and host contract are not closely
related, and the combined contract is not held for trading or designated at fair value.
The Company chose to review all contracts in place, that were entered into after
January 1, 2003, for any embedded derivatives within these contracts to determine if
any such embedded derivatives needed to be accounted for separately at fair value from
the base contract. The change in accounting policy related to embedded derivatives
resulted in an increase of $155 to the opening deficit at the date of adoption. As of
December 31, 2007, the fair value of the embedded derivative liability was $109 and was
included in accrued liabilities on the consolidated balance sheet. During the year
ended December 31, 2007, the increase in fair value of the embedded derivative
liability of $63 was recorded as an expense in the consolidated statement of
operations.
|
|
|
|
|
As a result of adopting Section 3855, deferred financing costs of $1,535 as at January
1, 2007, relating to convertible notes have been reclassified from deferred financing
fees to convertible notes on the consolidated balance sheet. These costs are being
amortized using the effective interest method over the life of the related debt.
|
|
(iii)
|
|
Equity:
|
|
|
|
|
Section 3251,
Equity
, describes standards for the presentation of equity and changes in
equity for the reporting period as a result of the application of Section 1530,
Comprehensive Income
. This standard did not have an impact on the Companys
consolidated financial statements for the year ended December 31, 2007.
|
44
4. Changes in accounting policies (continued):
|
(iv)
|
|
Hedges:
|
|
|
|
|
Section 3865,
Hedges
, specifies the criteria under which hedge accounting may be
applied, how hedge accounting should be performed under permitted hedging strategies
and the required disclosures. This standard did not have an impact on the Companys
consolidated financial statements for the year ended December 31, 2007.
|
|
(c)
|
|
Future accounting changes:
|
|
|
|
|
The following accounting standards were recently issued by the CICA. The Company is
currently evaluating the impact of the adoption of these new standards on its consolidated
financial statements.
|
|
|
|
|
Section 1535,
Capital Disclosures
, establishes guidelines for disclosure of both
qualitative and quantitative information that enables users of financial statements to
evaluate the entitys objectives, policies and processes for managing capital. This new
standard relates to disclosure only and will not impact the financial results of the
Company. This standard is effective January 1, 2008.
|
|
|
|
|
Section 3862,
Financial Instruments Disclosure
, describes the required disclosure for the
assessment of the significance of financial instruments for an entitys financial position
and performance and of the nature and extent of risks arising from financial instruments to
which the entity is exposed and how the entity manages those risks. Section 3863,
Financial
Instruments Presentation
, establishes standards for presentation of the financial
instruments and non-financial derivatives. It carries forward the presentation related
requirements of Section 3861,
Financial Instruments Disclosure and Presentation
. These
new standards relate to disclosure only and will not impact the financial results of the
Company. These standards are effective January 1, 2008.
|
|
|
|
|
International Financial Reporting Standards (IFRS)
|
|
|
|
|
In 2005, the Accounting Standards Board of Canada (AcSB) announced that accounting
standards in Canada are to converge with IFRS. In May 2007, the CICA published an updated
version of its Implementation Plan for Incorporating IFRS into Canadian GAAP. This plan
includes an outline of the key decisions that the CICA needs to make as it implements the
Strategic Plan for publicly accountable enterprises that will converge Canadian generally
accepted accounting standards with IFRS. While IFRS uses a conceptual framework similar to
Canadian GAAP, there are significant differences in accounting policy which must be
addressed. The Company is currently assessing the future impact of these new standards on
its consolidated financial statements. These standards are effective for fiscal years
beginning January 1, 2011.
|
45
5. Collaboration agreement:
In December 2004, the Company concluded a collaboration and distribution agreement with
Centocor, Inc. (Centocor) for eprodisate (KIACTA
TM
), the Companys most advanced
product candidate designed to treat AA Amyloidosis. Under this agreement, Neurochem granted to
Centocor, a wholly-owned subsidiary of Johnson & Johnson, Inc., worldwide exclusive
distribution rights for eprodisate (KIACTA
TM
), with the exception of Canada,
Switzerland, China, Japan, Taiwan and South Korea for which the distribution rights remain with
Neurochem. The agreement includes up-front, regulatory and sales-based milestone payments
valued up to $54,000, as well as tiered distribution fees which will be based upon annual sales
of eprodisate (KIACTA
TM
) in the applicable territories over the life of the
agreement. Neurochem will be responsible for the product approval activities in the United
States and in Europe, as well as for global manufacturing activities. Centocor will manage the
marketing and sales of eprodisate (KIACTA
TM
) in the applicable territories.
KIACTA
TM
is a trademark of Johnson & Johnson Corporation.
In 2004, the Company recorded a receivable for the upfront payment due from Centocor upon
signing of the agreement in the amount of $12,000, which was received in 2005. One half of the
upfront payment received by the Company is potentially refundable in specified circumstance.
All of the deferred revenue at December 31, 2007 and 2006 relates to amounts received under
this agreement.
The Company recognized $1,119 of revenue under the agreement in 2007 (2006 $2,106; 2005 -
$2,793), representing the amortization of the non-refundable upfront payment for the period
from signing the agreement, December 21, 2004, over the remaining estimated period through to
the anticipated regulatory approval date of the related investigational product candidate. The
estimated period over which revenue is being recognized is subject to change based on
additional information that the Company may receive periodically in respect of its expected
date of regulatory approvals.
6. Restricted cash:
Restricted cash is composed of short-term investments pledged to a bank as collateral for two
letters of credit; the first in the amount of $6,000 was issued in connection with the
potentially refundable upfront payment received under the collaboration agreement with Centocor
and the second in the amount of CDN$640 was granted in favour of a landlord in relation to the
lease of a building. As at December 31, 2007, restricted cash is composed of third-party
Asset-Backed Commercial Paper (ABCP). These investments were due to mature during the third
quarter of 2007 but, as a result of a disruption in the credit markets, particularly in the
ABCP market, they did not settle on maturity and currently remain outstanding. At the time
these investments were acquired, the ABCP were rated R1-high by Dominion Bond Rating Service,
which is the highest credit rating for this type of investment. The ABCP are currently subject
to a restructuring proposal under a standstill agreement which is expected to result in the
conversion of the ABCP into longer-term financial instruments with maturities corresponding to
the underlying assets. A Pan-Canadian Investors Committee (the Committee) was established to
oversea the orderly restructuring of these instruments during the standstill agreement period.
A restructuring plan was announced by the Committee on December 23, 2007, and is anticipated to
be completed by the end of March 2008.
46
6. Restricted cash (continued):
During the quarter ended December 31, 2007, the Company recorded a provision for losses in the
amount of $1,184 in respect of ABCP, reflecting the Companys estimated reduction in the fair
value of these investments as at December 31, 2007. The Company estimated the fair value of the
ABCP using a probability weighted discounted cash flow approach, based on its best estimates of
the time period over which the assets in the underlying trust are going to generate cash flows
ranging from 7 to 30 years based on the proposed restructuring, the coupon interest rate, the
discount rate to apply to the net cash flows anticipated to be received commensurate with
highly rated notes and other qualitative factors. This estimate of the fair value of the ABCP
is not supported by observable market prices or rates, therefore is subject to uncertainty,
including, but not limited to, the outcome of the restructuring plan being considered, the
estimated amounts to be recovered, the yield of the substitute financial instruments and the
timing of future cash flows. The resolution of these uncertainties could be such that the
ultimate fair value of these investments may vary from the Companys current best estimate.
Changes to the near term could require changes in the recognized amount of these assets. The
Company does not expect there will be a material adverse impact on its business as a result of
the Third Party ABCP liquidity issue.
During the third and fourth quarters of 2007, both letters of credit were renewed upon their
respective annual expiry, with the ABCP issued as collateral.
7. Property and equipment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
|
Accumulated
|
|
|
Net book
|
|
|
|
Cost
|
|
|
depreciation
|
|
|
value
|
|
|
Research equipment
|
|
$
|
7,568
|
|
|
$
|
4,648
|
|
|
$
|
2,920
|
|
Computer hardware and software
|
|
|
3,148
|
|
|
|
2,645
|
|
|
|
503
|
|
Office equipment
|
|
|
973
|
|
|
|
556
|
|
|
|
417
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
11,689
|
|
|
$
|
7,849
|
|
|
$
|
3,840
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
|
|
Accumulated
|
|
|
Net book
|
|
|
|
Cost
|
|
|
depreciation
|
|
|
value
|
|
|
Research equipment
|
|
$
|
6,450
|
|
|
$
|
3,617
|
|
|
$
|
2,833
|
|
Computer hardware and software
|
|
|
2,818
|
|
|
|
2,160
|
|
|
|
658
|
|
Office equipment
|
|
|
842
|
|
|
|
421
|
|
|
|
421
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
10,110
|
|
|
$
|
6,198
|
|
|
$
|
3,912
|
|
|
On November 17, 2005, the Company entered into a sale and leaseback transaction for its
facilities for a sale price of $26,411. The transaction generated a net gain of $20,085. The
net gain is deferred and is being amortized over the original term of the lease of 15 years as
a reduction of rent expense. The Company accounts for this lease as an operating lease. Rent
expense is calculated on a straight-line basis over the original term of the lease. The Company
has an option to purchase the property at fair market value beginning on December 1, 2017. The
Company repaid in its totality the remaining balance of the revolving decreasing term credit,
which originally financed the acquisition of the facilities. Interest on long-term debt
amounted to $282 for the year ended December 31, 2005.
47
8. Patents:
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Cost
|
|
$
|
7,686
|
|
|
$
|
6,121
|
|
Accumulated amortization
|
|
|
1,530
|
|
|
|
1,041
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
6,156
|
|
|
$
|
5,080
|
|
|
The remaining weighted average amortization period of patents at December 31, 2007 is 13.6
years (2006 14.3 years; 2005 15.6 years). The estimated amortization expense for each of
the next five years is approximately $450 per annum or $2,250 in the aggregate.
Effective January 1, 1994, the Company entered into an epilepsy license agreement (Epilepsy
Agreement), with Parteq Research and Development Innovations (Parteq), the commercialization
arm of Queens University. Pursuant to the Epilepsy Agreement, the Company was granted the
worldwide exclusive license, under certain intellectual property, including patents and patent
applications (Epilepsy Patents) belonging to Queens University to develop, make, have made,
use, sell and have sold certain products. In 2005, the Company provided Parteq with a
termination notice for the Epilepsy Agreement, pursuant to which responsibility for, and all
rights in, the Epilepsy Patents reverted to Parteq. Accordingly, the Company wrote off the net
book value of the Epilepsy Patents in the amount of $704 during the year ended December 31,
2005.
9. Long-term liabilities:
Long-term accrued liabilities consist of:
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Lease exit obligation
|
|
$
|
59
|
|
|
$
|
71
|
|
Deferred rent liability
|
|
|
1,161
|
|
|
|
564
|
|
Deferred share unit plan (note 11 (f))
|
|
|
59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,279
|
|
|
$
|
635
|
|
|
48
10. Convertible notes:
Convertible notes consist of the following:
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
6% Senior convertible notes due in 2026 (a)
|
|
$
|
33,618
|
|
|
$
|
33,650
|
|
6% Senior convertible notes due in 2027 (b)
|
|
|
2,825
|
|
|
|
|
|
Derivative-related asset (b)
|
|
|
(1,022
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
35,421
|
|
|
$
|
33,650
|
|
|
|
(a)
|
|
On November 9, 2006, the Company entered into a private placement of $42,085
aggregate principal amount of convertible senior notes (the 2006 Notes) due in 2026. The
2006 Notes bear interest at a rate of 6% per annum and are payable semi-annually on May 15
and November 15 of each year, beginning on May 15, 2007. The 2006 Notes are convertible
into common shares based on an initial conversion rate of 50.7181 shares per $1 principal
amount of 2006 Notes ($19.72 per share) which represents a conversion premium of 20% over
the Companys share price at date of issuance.
|
|
|
|
|
The 2006 Notes are convertible, at the option of the holder under the following conditions:
|
|
(i)
|
|
after December 31, 2006, if the closing sale price of the Companys common
shares for each of 20 or more trading days in a period of 30 consecutive trading days
ending on the last trading day of the preceding calendar quarter exceed 120% of the
conversion price in effect on the last trading day of the immediately preceding
calendar quarter;
|
|
|
(ii)
|
|
during the five consecutive business days immediately after any five
consecutive trading day period in which the average trading price per $1 principal
amount of 2006 Notes was equal to or less than 97% of the average conversion value of
the 2006 Notes;
|
|
|
(iii)
|
|
if the Company makes certain distributions on its common shares or engages
in certain transactions;
|
|
|
(iv)
|
|
at any time from, and including, October 15, 2009 to November 15, 2009, from
October 15, 2011 to November 15, 2011 and at any time on or after November 15, 2021.
|
|
|
|
On October 15, 2009, the conversion rate of the 2006 Notes will be adjusted to an amount
equal to a fraction whose numerator is $1 and whose denominator is the average of the
closing sale prices of the common shares during the 20 trading days immediately preceding,
and including, the third business day immediately preceding October 15, 2009. However, no
such adjustment will be made if the adjustment will reduce the conversion rate. On and
after November 15, 2009, the conversion rate will be readjusted back to the conversion rate
that was in effect prior to October 15, 2009.
|
|
|
|
|
On or after November 15, 2011, the Company may redeem the 2006 Notes, in whole or in part,
at a redemption price in cash equal to 100% of the principal amount of the 2006 Notes, plus
any accrued and unpaid interest. On November 15, 2011, November 15, 2016 and November 15,
2021, the 2006 Note holders may require the Company to purchase all or a portion of their
2006 Notes at a purchase price in cash equal to 100% of the principal amount of the 2006
Notes to be purchased, plus any accrued and unpaid interest.
|
|
|
|
|
The Company, at its discretion, may elect to settle the principal amount owing upon
redemption or conversion in cash, shares or a combination thereof.
|
49
10. Convertible notes (continued):
|
(a)
|
|
(continued):
|
|
|
|
|
In accordance with Canadian GAAP, the 2006 Notes are accounted for as a compound financial
instrument and are presented in their component parts of debt and equity. The debt
component is measured at the issue date as the present value of the cash payments of
interest and principal due under the terms at a rate which approximates the estimated
interest rate of a similar non-convertible financial instrument with comparable terms and
risk. The difference between the value as determined in this manner and the face value of
the 2006 Notes has been allocated to equity. The debt component is accreted to its face
value through a charge to earnings over its term. The effective interest rate of the 2006
Notes is 12.60%.
|
|
|
|
|
Issue costs incurred in connection with the issuance of the 2006 Notes were $1,955 and have
been presented as follows: $1,535 as financing fees and $420 as share issue costs.
|
|
|
|
|
Changes in the 2006 Notes for the years ended December 31, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
Balance, December 31, 2005
|
|
$
|
|
|
Note issuance as at November 9, 2006
|
|
|
33,465
|
|
Accretion expense
|
|
|
550
|
|
Interest paid/payable
|
|
|
(365
|
)
|
|
|
|
|
|
|
Balance, December 31, 2006
|
|
|
33,650
|
|
Adjustment to reflect change in accounting policy
for financial instruments (note 4 (b))
|
|
|
(1,535
|
)
|
Accretion expense
|
|
|
4,108
|
|
Interest paid/payable
|
|
|
(2,525
|
)
|
Foreign exchange gain
|
|
|
(80
|
)
|
|
|
|
|
|
|
Balance, December 31, 2007
|
|
$
|
33,618
|
|
|
|
(b)
|
|
On May 2, 2007, the Company issued $80,000 aggregate principal amount of convertible
notes, consisting of $40,000, 6% senior convertible notes due in 2027 (the Senior Notes)
and $40,000, 5% senior subordinated convertible notes due in 2012 (the Junior Notes). The
Senior Notes have an initial conversion price equal to the lesser of $12.68 or the 5-day
weighted average trading price of the common shares preceding any conversion, subject to
adjustments in certain circumstances. The Senior Notes are convertible at the option of
the holder at anytime after three days notice. The conversion price is the average
trading price of the Companys trading price for the period preceding the conversion,
subject to a ceiling of $12.68 and a floor of $6.00. The conversion price may be fixed,
subject to shareholders approval, for the period from October 15, 2009 to November 15,
2009. After November 1, 2011, the Senior Notes may be redeemed by the holders if the
Company fails to maintain a specified net cash position. The Company will pay interest on
the Senior Notes until maturity on May 2, 2027, subject to earlier repurchase, redemption
or conversion. The Junior Notes were subject to mandatory conversion into common shares
under certain circumstances. In connection with this transaction, the Company issued
warrants to purchase an aggregate of 2,250,645 common shares of Neurochem until May 2,
2012, at an initial purchase price of $12.68 per share, subject to adjustments in certain
circumstances.
|
50
10. Convertible notes (continued):
|
(b)
|
|
(continued):
|
|
|
|
|
In accordance with Canadian GAAP, the Senior Notes and the Junior Notes are accounted for
as a compound financial instrument and are presented in their component parts of debt and
equity. The Company initially allocated the proceeds from the Senior Notes and the Junior
Notes between its liability and equity components using the residual value method. The
Senior Notes proceeds, net of issue costs of $2,069, were allocated as follows: $23,492 to
debt, $10,909 to equity portion of the convertible notes, $5,907 to warrants and $2,377 to
derivative-related asset. The Junior Notes proceeds, net of issue costs of $2,697, were
allocated as follows: $27,753 to debt, $243 to equity portion of the convertible notes,
$9,533 to warrants and $226 to derivative-related asset. Issue costs of $2,373 in relation
to equity instruments, including $1,417 of warrants, were charged to the deficit. The fair
value of the embedded derivatives was determined using the Binomial model and the fair
value of the warrants was determined using the Black-Scholes pricing model. The models
used in the valuation of the components of the convertible notes contain certain subjective
assumptions, changes of which may cause significant variation in the estimated fair value
of the debt and equity components of the convertible notes.
|
|
|
|
|
The Company accretes the carrying value of the Senior Notes and Junior Notes to their face
values through a charge to earnings over their expected lives, which is 54 months for the
Senior Notes and was one month for the Junior Notes. The effective interest rate of the
Senior Notes is 19.97%.
|
|
|
|
|
During the year ended December 31, 2007, $35,500 of the Senior Notes were converted into
5,619,321 common shares and the totality of the Junior Notes was converted into 4,444,449
common shares.
|
|
|
|
|
Changes in the Senior Notes, Junior Notes and derivative-related asset for the year ended
December 31, 2007, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior
|
|
|
Junior
|
|
|
Derivative-
|
|
|
|
Notes
|
|
|
Notes
|
|
|
related asset
|
|
|
Balance as at December 31, 2006
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Notes issuance as at May 2, 2007
|
|
|
23,492
|
|
|
|
27,753
|
|
|
|
(2,603
|
)
|
Accretion expense
|
|
|
1,213
|
|
|
|
10,430
|
|
|
|
|
|
Interest paid/payable
|
|
|
(628
|
)
|
|
|
(174
|
)
|
|
|
|
|
Foreign exchange loss
|
|
|
32
|
|
|
|
383
|
|
|
|
90
|
|
Conversion by note holders
|
|
|
(21,284
|
)
|
|
|
(38,392
|
)
|
|
|
684
|
|
Change in fair value
|
|
|
|
|
|
|
|
|
|
|
807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at December 31, 2007
|
|
$
|
2,825
|
|
|
$
|
|
|
|
$
|
(1,022
|
)
|
|
51
11. Share capital:
|
(a)
|
|
The authorized share capital of the Company consists of:
|
|
|
|
an unlimited number of voting common shares
|
|
|
|
|
an unlimited number of non-voting preferred shares, issuable in one or more series
|
|
(b)
|
|
Common shares issued and outstanding:
|
|
|
|
|
December 31, 2005
:
|
|
(i)
|
|
On March 9, 2005, the Company completed a public offering for the issuance
and sale of 4 million common shares at a price of $15.30 for total proceeds of
$61,200. Total share issue costs of $4,107 were charged to the deficit.
|
|
|
(ii)
|
|
On July 25, 2005, a subsidiary of Picchio Pharma Inc. (Picchio Pharma)
exercised a warrant to purchase 2.8 million common shares for total proceeds of
$7,189.
|
|
(iii)
|
|
On February 16, 2006, Picchio Pharma exercised its remaining warrant
outstanding to purchase 1.2 million common shares for total proceeds of $8,095.
|
|
(iv)
|
|
In 2007, the Company issued 10,063,770 common shares in connection with the
conversion of Senior and Junior convertible notes. See note 10 (b).
|
|
|
|
Under its stock option plan, the Company may grant options to purchase common shares to
employees, directors and consultants of the Company (the Stock Option Plan). The terms,
number of common shares covered by each option, as well as the vesting period are
determined by the Board of Directors. In general, options vest over periods of up to five
years. During the year ended December 31, 2005, the shareholders approved an amendment to
the Companys Stock Option Plan to change the maximum number of shares reserved for
issuance from 4,438,767 common shares to 12.5% of the issued and outstanding common shares.
The maximum number of common shares which may be optioned in favor of any single
individual shall not exceed 5% of the issued and outstanding common shares of the Company.
The option price per share is equal to the weighted average trading price of common shares
for the five days preceding the effective date of grant during which the common shares were
traded on the Toronto Stock Exchange. In no event may the term of any option exceed ten
years from the date of the grant of the option.
|
52
11. Share capital (continued):
|
(c)
|
|
(continued):
|
|
|
|
|
Changes in outstanding options issued under the Stock Option Plan for the years ended
December 31, 2005, 2006 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
average
|
|
|
|
Number
|
|
|
exercise price
|
|
|
|
|
|
|
|
|
(CDN$)
|
Options outstanding, December 31, 2004
|
|
|
2,363,784
|
|
|
$
|
14.51
|
|
Granted
|
|
|
318,500
|
|
|
|
21.31
|
|
Exercised
|
|
|
(300,660
|
)
|
|
|
4.48
|
|
Cancelled or expired
|
|
|
(71,666
|
)
|
|
|
13.68
|
|
|
Options outstanding, December 31, 2005
|
|
|
2,309,958
|
|
|
|
16.78
|
|
Granted
|
|
|
402,000
|
|
|
|
16.53
|
|
Exercised
|
|
|
(100,943
|
)
|
|
|
4.25
|
|
Cancelled or expired
|
|
|
(33,519
|
)
|
|
|
20.84
|
|
|
Options outstanding, December 31, 2006
|
|
|
2,577,496
|
|
|
|
17.17
|
|
Granted
|
|
|
336,333
|
|
|
|
11.20
|
|
Exercised
|
|
|
(60,803
|
)
|
|
|
7.12
|
|
Cancelled or expired
|
|
|
(36,293
|
)
|
|
|
11.72
|
|
|
Options outstanding, December 31, 2007
|
|
|
2,816,733
|
|
|
$
|
16.75
|
|
|
|
|
|
The following table summarizes information about options outstanding and exercisable at
December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding
|
|
|
Options exercisable
|
|
|
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
average
|
|
|
average
|
|
|
|
|
|
|
average
|
|
|
|
|
|
|
|
exercise
|
|
|
years to
|
|
|
|
|
|
|
exercise
|
|
Exercise price/share
|
|
Number
|
|
|
price
|
|
|
expiration
|
|
|
Number
|
|
|
price
|
|
|
(CDN$)
|
|
|
|
|
|
(CDN$)
|
|
|
|
|
|
|
|
|
|
(CDN$)
|
$0.36 - $0.65
|
|
|
11,500
|
|
|
$
|
0.65
|
|
|
|
0.5
|
|
|
|
11,500
|
|
|
$
|
0.65
|
|
$2.99 - $6.93
|
|
|
513,127
|
|
|
|
4.42
|
|
|
|
5.5
|
|
|
|
341,552
|
|
|
|
4.11
|
|
$8.11 - $15.35
|
|
|
670,766
|
|
|
|
10.62
|
|
|
|
6.3
|
|
|
|
468,467
|
|
|
|
9.05
|
|
$17.40 - $23.35
|
|
|
801,507
|
|
|
|
19.76
|
|
|
|
7.3
|
|
|
|
376,533
|
|
|
|
21.10
|
|
$25.30 - $33.00
|
|
|
819,833
|
|
|
|
26.75
|
|
|
|
6.5
|
|
|
|
560,708
|
|
|
|
27.18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,816,733
|
|
|
$
|
16.75
|
|
|
|
6.5
|
|
|
|
1,758,760
|
|
|
$
|
16.39
|
|
|
53
11. Share capital (continued):
|
(d)
|
|
Agreement to issue shares:
|
|
|
|
|
The agreement with the Chief Executive Officer effective December 1, 2004, to issue to him
up to 220,000 common shares upon the execution of the agreement and upon achievement of
specified performance targets was approved by regulatory authorities and shareholders in
2005. During the year ended December 31, 2007, the Company recorded nil (2006 nil; 2005
$1,189) in stock-based compensation in relation to nil common shares (2006 nil; 2005 -
140,000) to be issued to the Chief Executive Officer in connection with his execution and
achievement of certain specified targets. As at December 31, 2007, stock-based compensation
in relation to 140,000 of the total 220,000 common shares has been recognized. The shares
will be issued by the Company upon formal notification by the Chief Executive Officer.
|
|
|
(e)
|
|
Equity line of credit:
|
|
|
|
|
On August 9, 2006, the Company entered into a securities purchase agreement in respect of
an equity line of credit facility. The facility will terminate February 9, 2009, and it
provides the Company with access to financing of up to $60,000 in return for the issuance
of common shares at a discount of 3.0% to market price at the time of drawdown less a
placement fee equal to 2.4% of gross proceeds payable to the placement agent. Under the
agreement, the Company is committed to draw down at least $25,000 over the term of the
facility. Drawdown requests are subject to the terms and conditions as specified in the
agreement. Either party may terminate the agreement if the volume-weighted average price
of the Companys common shares is below $5 per share for more than 30 consecutive days.
Given that the current price per share has been below the minimum price as per the
agreement, the agreement may be terminated at any time. As of December 31, 2007, the
Company had not drawn any funds under the equity line of credit.
|
|
|
|
|
See subsequent event note 21 (c), for terms of the amendment.
|
|
|
(f)
|
|
Deferred share unit plan:
|
|
|
|
|
On February 15, 2007, the Company adopted a deferred share unit (DSU) plan for certain
designated employees (the Designated Employees Plan), as well as a DSU plan for members of
the Board of Directors (the Board Plan). The Designated Employees Plan permits employees
to elect to take all or any portion of their annual bonus in the form of DSUs rather than
in cash, while the Board Plan permits members of the Board of Directors to elect to take
all of their annual retainer and/or all of their meeting attendance fees as DSUs rather
than in cash. The number and price of DSUs are determined by the five-day volume weighted
average trading price of the Companys common shares at the time the DSUs are issued, as
provided for under the respective plans. The DSUs are redeemable only upon the
participants resignation, termination, retirement or death, in cash, at a value equal to
the number of DSUs credited multiplied by the market value of common shares on the date a
notice of redemption is filed.
|
|
|
|
|
During the year ended December 31, 2007, the Company granted 26,567 DSUs having a weighted
average fair value per unit of CDN$11.26. For DSUs, compensation cost is measured based on
the market price of the Companys shares from the effective date of grant through to the
settlement date. The offsetting liability is marked-to-market. Any changes in the market
value of the Companys shares through to the settlement date results in a change to the
measure of compensation cost for those awards and is recorded in the consolidated statement
of operations. At December 31, 2007, the Company had a liability
of $59 with respect to issued DSUs.
|
54
12. Arbitral award:
|
|
In June 2006, the International Chamber of Commerce Court of Arbitration (ICC) issued its Final
Award (the Final Award) in the arbitration dispute involving Neurochem and Immtech
Pharmaceuticals, Inc., formerly known as Immtech International, Inc. (Immtech). The dispute
concerned an agreement entered into between Immtech and Neurochem in April 2002 (the Agreement)
under which Neurochem had the right to apply its proprietary anti-amyloid technology to test
certain compounds to be provided by Immtech. The ICC denied the majority of Immtechs claims
after an evidentiary hearing before the tribunal convened in accordance with the rules of the
ICC (the Tribunal) 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 $35 in damages, plus interest thereon for a disputed progress payment under the
Agreement. 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. In the second quarter of 2006, the
Company recorded a charge of $1,835 to account for this decision.
|
|
|
|
On January 25, 2007, Immtech, the University of North Carolina at Chapel Hill (UNC), and
Georgia State University Research Foundation, Inc. (together with UNC, the Universities) filed
with the Federal District Court for the Southern District of New York, USA (the Court) a Notice
of Voluntary Dismissal bringing to an end the litigation action described herein. The
litigation had been stayed since 2004 when the Court 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
plaintiffs voluntarily dismissed their litigation complaint against the Company without any
payment, license, business agreement, concession or compromise by the Company.
|
13. Stock-based compensation:
|
|
For the year ended December 31, 2007, the Company recorded total stock-based compensation
(excluding compensation under the deferred share unit plan) of $4,225 (2006 $3,569; 2005 -
$2,769), related to stock options granted under the Stock Option Plan after July 1, 2002.
|
|
|
|
The fair value of each option granted is estimated on the date of grant using the Black-Scholes
pricing model. The weighted average assumptions for the years ended December 31, 2007, 2006
and 2005 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Risk-free interest rate
|
|
|
4.02
|
%
|
|
|
4.18
|
%
|
|
|
3.86
|
%
|
Expected volatility
|
|
|
61
|
%
|
|
|
60
|
%
|
|
|
58
|
%
|
Expected life in years
|
|
|
7
|
|
|
|
7
|
|
|
|
7
|
|
Expected dividend yield
|
|
nil
|
|
|
nil
|
|
|
nil
|
|
55
13. Stock-based compensation (continued):
|
|
The following table summarizes the weighted average grant-date fair value per share for options
granted during the years ended December 31, 2007, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
|
|
|
|
Number of
|
|
|
grant-date
|
|
|
|
options
|
|
|
fair value
|
|
(CDN$)
|
Years ended:
|
|
|
|
|
|
|
|
|
December 31, 2007
|
|
|
336,333
|
|
|
$
|
6.94
|
|
December 31, 2006
|
|
|
402,000
|
|
|
|
10.46
|
|
December 31, 2005
|
|
|
318,500
|
|
|
|
12.77
|
|
|
|
|
Dividend yield was excluded from the calculation, since it is the present policy of the Company
to retain all earnings to finance operations and future growth.
|
14. Commitments and contingencies:
|
(a)
|
|
Operating leases:
|
|
|
|
|
Minimum annual lease payments for the next five years and thereafter under operating leases
are as follows:
|
|
|
|
|
|
2008
|
|
$
|
2,916
|
|
2009
|
|
|
2,952
|
|
2010
|
|
|
3,014
|
|
2011
|
|
|
3,103
|
|
2012
|
|
|
3,195
|
|
Thereafter
|
|
|
27,544
|
|
|
|
|
|
|
|
|
|
$
|
42,724
|
|
|
|
|
|
In addition, the Company is also responsible for operating costs and taxes under the
operating leases.
|
|
|
(b)
|
|
License agreements and research collaborations:
|
|
|
|
|
On February 1, 2006, the Company entered into an assignment agreement with Parteq
(Assignment Agreement) which terminated an amyloid license agreement. This amyloid license
agreement granted the Company an exclusive worldwide license under certain intellectual
property (Amyloid Intellectual Property). Pursuant to the Assignment Agreement, Parteq
agreed and assigned the Amyloid Intellectual Property to the Company for consideration,
comprising an upfront payment of CDN$200 and various deferred payment amounts, which are
approximately equal to the payments provided for in the amyloid license agreement. The
Assignment Agreement also provides for annual technology payments, deferred milestone
payments and deferred graduated payments based on gross revenues to be generated from
commercialized products, which approximate the payments included in the amyloid license
agreement.
|
56
14. Commitments and contingencies (continued):
|
(b)
|
|
(continued):
|
|
|
|
|
Under the terms of an agreement with the federal Ministry of Industry (Technology
Partnerships Canada Program), as amended in 2005, the Company is committed to pay the
federal government 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 Alzheimers disease until December 31, 2010. After
December 31, 2010, the Company may have to continue to pay royalties until such time as the
aggregate amount of royalties paid pursuant to the agreement reaches CDN$20,540. Under the
agreement, the Company is committed to spend a specified amount on research and development
from the date of regulatory approval to December 31, 2014.
|
|
|
|
|
The Company is party to research and license agreements under which it has obtained rights
to use certain technologies to develop certain product candidates. These agreements impose
various milestones, commercialization, sublicensing, royalty and other payment, insurance,
indemnification and other obligations and are subject to certain reservations of rights.
|
|
|
|
|
The Company is a party to a collaboration agreement with Centocor for eprodisate
(KIACTA
TM
), under which Neurochem is responsible for the regulatory activities
in the United States and in Europe up to approval, as well as for global manufacturing
activities.
|
|
|
|
|
The Company outsources clinical trials in the normal course of business. As at December
31, 2007, the Companys future obligations with respect to these clinical trial agreements
amount to $3,732 (2006 $16,615).
|
|
|
(c)
|
|
Management services agreement:
|
|
|
|
|
The payments under a management services agreement with Picchio International Inc. (Picchio
International), a company related to a shareholder, director and officer (see note 15 (a))
are $2,317 in 2008.
|
|
|
(d)
|
|
Guarantees:
|
|
|
|
|
The Company is contingently liable for letters of credit, see note 6. The Company has not
recorded a liability with respect to the guarantees, as the Company does not expect to make
any payments for these items. The Company has determined that the fair value of the
non-contingent obligations requiring performance under the guarantees in the event that
specified events or conditions occur approximate the cost of obtaining the letters of
credit.
|
57
15. Related party transactions:
|
(a)
|
|
Under the terms of a management services agreement entered into in March 2003, as
amended, with Picchio International, the Company recorded a management fee of $2,343 for
the year ended December 31, 2007 (2006 $2,164; 2005 $1,981). During the year ended
December 31, 2007, the Company paid $848 of performance based fees which was accrued as at
December 31, 2006.
|
|
|
|
|
In 2004, the Company entered into an agreement to issue shares to the Chief Executive
Officer. See note 11 (d).
|
|
|
(b)
|
|
The Company paid Parteq, a company related to a director, the following amounts in
the normal course of operations:
|
|
|
|
|
|
Years ended:
|
|
|
|
|
December 31, 2007
|
|
$
|
23
|
|
December 31, 2006
|
|
|
27
|
|
December 31, 2005
|
|
|
31
|
|
|
|
|
As indicated in note 8, the Company wrote off certain patents related to non-core
technologies that reverted back to Parteq. As indicated in note 14 (b), the Company
entered into an agreement with Parteq which terminated an amyloid license agreement and
assigned the Amyloid Intellectual Property to the Company.
|
|
|
(c)
|
|
In 2005, the Company entered into a lease agreement for a three-year period ending
April 2008 with a company in which Picchio Pharma has an equity interest. For the year
ended December 31, 2007, sub-lease revenue under the agreement amounted to $858 (2006 -
$846; 2005 $579). During 2007, the lease agreement was extended to April 2011, with
gross rent of approximately $968 per year. The Company 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. At December 31, 2007, Neurochem had an amount receivable
of $19 (2006 $19) with this company. In addition, Neurochem had amounts receivable of
$2 (2006 $22) from other companies in which Picchio Pharma has an equity interest.
|
|
|
(d)
|
|
In March 2006, as disclosed in note 4 (a), the Company invested an additional amount
of $1,464 in Innodia Holding, a company in which Picchio Pharma has an equity interest.
In addition, during 2006, the Company entered into an amendment agreement with Innodia
amending the May 2003 license agreement, which granted Innodia an exclusive worldwide
license under certain intellectual property relating to diabetes.
|
These transactions are measured at the exchange amount, which is the amount of consideration
established and agreed to by the related parties.
58
16. Income taxes:
|
(a)
|
|
Details of the components of income taxes are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Loss before income taxes:
|
|
|
|
|
|
|
|
|
|
|
|
|
Canadian operations
|
|
$
|
(22,150
|
)
|
|
$
|
(12,290
|
)
|
|
$
|
(12,702
|
)
|
Foreign operations
|
|
|
(59,336
|
)
|
|
|
(54,179
|
)
|
|
|
(47,025
|
)
|
|
|
|
|
(81,486
|
)
|
|
|
(66,469
|
)
|
|
|
(59,727
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic income tax rate
|
|
|
32.02
|
%
|
|
|
32.02
|
%
|
|
|
31.02
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Computed income tax recovery
|
|
|
(26,092
|
)
|
|
|
(21,283
|
)
|
|
|
(18,527
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments in income taxes resulting from:
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-recognition of losses and other deductions
|
|
|
6,915
|
|
|
|
2,603
|
|
|
|
12,185
|
|
Difference in tax rate of a foreign subsidiary
|
|
|
16,529
|
|
|
|
15,428
|
|
|
|
8,773
|
|
Non-deductible stock option expense
|
|
|
1,331
|
|
|
|
1,108
|
|
|
|
1,193
|
|
Non-taxable portion of gain on sale of property-
|
|
|
|
|
|
|
(2,658
|
)
|
|
|
|
|
Permanent differences and other
|
|
|
1,317
|
|
|
|
(6
|
)
|
|
|
(966
|
)
|
Impact of future changes in enacted rates:
|
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in future tax asset
|
|
|
2,856
|
|
|
|
(58
|
)
|
|
|
7,658
|
|
Increase (decrease) in valuation allowance
|
|
|
(2,856
|
)
|
|
|
2,208
|
|
|
|
(7,658
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
59
16. Income taxes (continued):
|
(b)
|
|
Net future tax assets:
|
|
|
|
|
The future tax assets and liabilities at December 31, 2007 and 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Future tax assets:
|
|
|
|
|
|
|
|
|
Patent costs
|
|
$
|
9,677
|
|
|
$
|
7,829
|
|
Unclaimed scientific research and experimental
development expenditures for tax purposes
|
|
|
21,456
|
|
|
|
13,523
|
|
Deferred gain on sale of property
|
|
|
4,638
|
|
|
|
5,239
|
|
Share issue costs
|
|
|
1,352
|
|
|
|
1,443
|
|
Net operating losses of a foreign subsidiary
|
|
|
7,910
|
|
|
|
5,051
|
|
Long-term investment
|
|
|
1,259
|
|
|
|
1,215
|
|
Convertible notes
|
|
|
|
|
|
|
225
|
|
Other
|
|
|
837
|
|
|
|
241
|
|
|
|
|
|
47,129
|
|
|
|
34,766
|
|
|
|
|
|
|
|
|
|
|
Less: valuation allowance
|
|
|
(45,382
|
)
|
|
|
(33,794
|
)
|
|
|
|
|
1,747
|
|
|
|
972
|
|
|
|
|
|
|
|
|
|
|
Future tax liabilities:
|
|
|
|
|
|
|
|
|
Property and equipment
|
|
|
(841
|
)
|
|
|
(889
|
)
|
Deferred financing fees
|
|
|
(59
|
)
|
|
|
(83
|
)
|
Convertible notes
|
|
|
(847
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net future tax assets
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
In assessing the realizability of future tax assets, management considers whether it is
more likely than not that some portion or all of the future income tax assets will be
realized. The ultimate realization of future tax assets is dependent upon the generation
of future taxable income and/or tax planning strategies. Since the Company is a
development stage enterprise, the generation of future taxable income is dependent on the
successful commercialization of its products and technologies.
|
|
|
(c)
|
|
The Company has the following unclaimed deductions available to reduce future taxable
income in Canada:
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
Quebec
|
|
|
Research expenditure pool (no expiry)
|
|
$
|
93,252
|
|
|
$
|
38,341
|
|
|
|
|
The Company also has approximately $15,207 in federal research investment tax credits that
can be used to reduce future federal taxes payable and which expire as follows:
|
|
|
|
|
|
2014
|
|
$
|
2,074
|
|
2015
|
|
|
4,145
|
|
2026
|
|
|
5,006
|
|
2027
|
|
|
3,982
|
|
|
|
|
|
|
|
|
|
$
|
15,207
|
|
|
60
16.
|
|
Income taxes (continued):
|
|
(d)
|
|
The Company has non-capital losses carried forward in a foreign subsidiary which are
available to reduce future years taxable income of that subsidiary. These expire as
follows:
|
|
|
|
|
|
2011
|
|
$
|
46,752
|
|
2012
|
|
|
51,605
|
|
2013
|
|
|
63,775
|
|
2014
|
|
|
74,875
|
|
|
|
|
|
|
|
|
|
$
|
237,007
|
|
|
|
|
The reconciliation between basic and diluted loss per share is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Basic weighted average
number of common shares
outstanding
|
|
|
44,030,474
|
|
|
|
38,654,063
|
|
|
|
35,104,342
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per share
|
|
$
|
(1.85
|
)
|
|
$
|
(1.72
|
)
|
|
$
|
(1.70
|
)
|
|
|
|
Diluted loss per share was not presented as the effect of options, warrants and Notes would
have been anti-dilutive. All outstanding options, warrants and Notes could potentially be
dilutive in the future.
|
18.
|
|
Statements of cash flows supplementary disclosure:
|
|
(a)
|
|
Cash and cash equivalents:
|
|
|
|
|
Cash and cash equivalents consist of cash balances with banks and short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Cash balances with banks
|
|
$
|
1,925
|
|
|
$
|
2,034
|
|
Short-term investments (yielding interest between
4.18% to 4.75% (December 31, 2006: 4.32% to 5.31%))
|
|
|
9,038
|
|
|
|
10,124
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
10,963
|
|
|
$
|
12,158
|
|
|
|
(b)
|
|
Interest and income taxes:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Cash paid in the year for:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
3,367
|
|
|
$
|
|
|
|
$
|
212
|
|
Income tax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61
18.
|
|
Statements of cash flows supplementary disclosure (continued):
|
|
(c)
|
|
Non-cash transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Additions to property and equipment
and patents included in
accounts payable and accrued
liabilities at year-end
|
|
$
|
404
|
|
|
$
|
332
|
|
|
$
|
1,136
|
|
|
|
(a)
|
|
Business segment:
|
|
|
|
|
The Company operates in one business segment, the research, development and
commercialization of innovative therapeutics. The Companys operations are conducted
principally in Canada and Europe.
|
|
|
(b)
|
|
Property and equipment and intangible assets (patents) by geographic area are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Canada
|
|
$
|
3,801
|
|
|
$
|
3,841
|
|
Europe
|
|
|
6,195
|
|
|
|
5,151
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
9,996
|
|
|
$
|
8,992
|
|
|
|
(c)
|
|
Major customers:
|
|
|
|
|
All revenues recognized in 2007, 2006 and 2005 were derived from one customer under the
collaboration agreement referred to in note 5.
|
62
20.
|
|
Financial instruments:
|
|
(a)
|
|
Fair value disclosure:
|
|
|
|
|
Fair value estimates are made as of a specific point in time, using available information
about the financial instrument. These estimates are subjective in nature and often cannot
be determined with precision.
|
|
|
|
|
The Company has determined that the carrying value of its short-term financial assets and
liabilities, including cash and cash equivalents, sales taxes and other receivables, as
well as accounts payable and accrued liabilities, approximates their fair value because of
the relatively short periods to maturity of these instruments. Refer to note 6 for
restricted cash. The fair value of convertible notes is estimated based on discounting
expected future cash flows at the discount rates which represent borrowing rates presently
available to the Company for instruments with similar terms and maturity. At December 31,
2007, the fair values of long-term financial liabilities were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
2006
|
|
|
|
|
Carrying
|
|
|
Fair
|
|
|
Carrying
|
|
|
Fair
|
|
|
|
amount
|
|
|
value
|
|
|
amount
|
|
|
value
|
|
|
Financial liabilities included
in long-term liabilities
|
|
$
|
118
|
|
|
$
|
118
|
|
|
$
|
71
|
|
|
$
|
71
|
|
Convertible notes
|
|
|
35,421
|
|
|
|
21,182
|
|
|
|
33,650
|
|
|
|
33,650
|
|
|
|
|
|
Marketable securities are comprised of fixed income instruments with a high credit rating
(not less than R1-mid rating) as rated by Dominion Board Rating Service (DBRS). As at
December 31, 2007, the weighted average effective interest rate of the marketable
securities is approximately 4.61% (2006 5.02%). The fair market value of the marketable
securities amounts to $47,709 as at December 31, 2007 (2006 $36,600).
|
|
|
(b)
|
|
Credit risk:
|
|
|
|
|
Credit risk results from the possibility that a loss may occur from the failure of another
party to perform according to the terms of the contract. The Company regularly monitors
the credit risk exposure and takes steps to mitigate the likelihood of these exposures from
resulting in actual loss.
|
|
|
|
|
Financial instruments that potentially subject the Company to significant concentrations of
credit risk consist principally of cash and cash equivalents, marketable securities and
restricted cash. The Company invests cash with major North American and European financial
institutions. The Company has investment policies that are designed to provide for the
safety and preservation of principal, the Companys liquidity needs and yields that are
appropriate. Authorized investments include bankers acceptances, bearer deposit notes,
corporate and government bonds, certificates of deposit, commercial paper and treasury
bills, and shall not exceed 10% per issuer, subject to certain exceptions.
|
|
|
|
|
Refer to note 6 for credit risk related to restricted cash.
|
|
|
(c)
|
|
Foreign currency risk management:
|
|
|
|
|
A portion of the Companys expenses, are denominated in Canadian dollars. This results in
financial risk due to fluctuations in the value of the US dollar relative to the Canadian
dollar. The Company does not use derivative financial instruments to reduce its foreign
exchange exposure. Fluctuations in foreign exchange rates could cause unanticipated
fluctuations in the Companys operating results.
|
63
20.
|
|
Financial instruments (continued):
|
|
(d)
|
|
Interest rate risk:
|
|
|
|
|
The Companys exposure to interest rate risk is as follows:
|
|
|
|
Cash and cash equivalents
|
|
Short-term fixed interest rate
|
Marketable securities
|
|
Short-term fixed interest rate
|
Convertible notes
|
|
Fixed interest rate
|
|
21.
|
|
Subsequent events:
|
|
|
|
On February 20, 2008, the Companys Board of Directors approved the following transactions:
|
|
(a)
|
|
The issuance of 2,445,000 options to purchase common shares to be issued under the Stock
Option Plan of the Company. The option price per share will be determined based on the
weighted average trading price of common shares for the five days preceding the date of grant
during which the common shares were traded on the Toronto Stock Exchange.
|
|
|
(b)
|
|
The Company renewed the management services agreement entered into with Picchio
International Inc., referred to in note 15 (a), to November 30, 2008.
|
|
|
(c)
|
|
The Company entered into an amendment with respect to the equity line of credit (ELOC)
facility. The term of the ELOC facility has been extended to February 2010. The minimum
draw-down obligation by the Company has been reduced to $15,000 over the term. The maximum
amount of each monthly draw-down is limited to the lower of $6,000 or 12.5% of the
volume-weighted price calculation of the common shares at the time of draw-down. The common
shares will be issued at a discount of 4.0% to market price if the volume-weighted average
price (VWAP) per share is $6 or higher, and 7% if the VWAP per share is lower than $6 at the
time of draw-down.
|
|
|
(d)
|
|
The name-change from Neurochem to BELLUS Health
TM
, pending shareholder approval
at the next annual meeting.
|
64
Shareholder information
Executive management
Dr. Francesco Bellini
Chairman, President and
Chief Executive Officer
Mr. Mariano Rodriguez
Vice President, Finance and
Chief Financial Officer
Dr. Denis Garceau
Senior Vice President,
Drug Development
Dr. Daniel Delorme
Vice President, Research
Dr. Lise Hébert
Vice President,
Corporate Communications
Dr. Shona McDiarmid
Vice President, Intellectual
Property and Compliance
Ms. Judith Paquin
Vice President, Human Resources
Mr. David Skinner
Vice President, General Counsel
and Corporate Secretary
OVOS Natural Health Inc.
Mr. Gary Schmid
Chief Executive Officer
Board of directors
Dr. Francesco Bellini
Chairman, President and
Chief Executive Officer,
Neurochem Inc.
Mr. John Bernbach
President and Founder, NTM Inc.
Dr. Colin Bier
Managing Director,
ABA BioResearch Inc.
Mr. Jean-Guy Desjardins
Chairman, President and
Chief Executive Officer, Centria Inc.
65
Mr. André Desmarais
President and Co-Chief
Executive Officer,
Power Corporation of Canada
Mr. Neil Flanzraich
Consultant
Mr. Peter Kruyt
President, Power Technology
Investment Corporation
Mr. François Legault
President and Chief Operating Officer,
ViroChem Pharma Inc.
Mr. John Molloy
President and Chief Executive Officer,
Parte q Research and Development
Innovations
Mr. Calin Rovinescu
Senior Principal,
Genuity Capital Markets
Mr. Graeme K. Rutledge
Consultant
Dr. Emil Skamene
Professor of Medicine and Director,
Centre for the Study of Host Resistance
McGill University
Corporate governance
Neurochem is committed to sound corporate
governance practices which ensure that
its affairs are managed in the best interest
of all stakeholders. The Board of Directors
undertakes a periodic review to verify that
Neurochems governance practices have kept
pace with changing regulatory environments
in the United States and Canada, to which
Neurochem is subject as a company listed
on both the Nasdaq and TSX. Please refer
to the management proxy circular for more
information on the overall structure of the
Board and its Committees and for details of
Neurochems corporate governance practices.
Auditors
KPMG LLP
600 de Maisonneuve Blvd. West
Suite 1500
Montreal, Quebec, Canada H3A 0A3
66
Transfer agents
Computershare Investor Services
100 University Avenue
9th Floor, North Tower
Toronto, Ontario, Canada M5J 2Y1
Stock Listing
Nasdaq National Market (Nasdaq)
Symbol: NRMX
Toronto Stock Exchange (TSX)
Symbol: NRM
Annual and special meeting
The Annual and Special Meeting
of shareholders will be held at 10:00 a.m.
on April 15, 2008, in the Maxwell-Cummings
Auditorium of the Michal and Renata Hornstein
Pavilion of the Montreal Museum of
Fine Arts, 1379 Sherbrooke Street West,
Montreal, Quebec, Canada.
67
Corporate profile
Neurochem is a global health company
focused on the research, development and
commercialization of products to provide
innovative health solutions to address critical
unmet medical needs.
Neurochem Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
Telephone: (450) 680-4500
Toll-Free: 1 (877) 680-4500
Fax: (450) 680-4501
E-mail:
info@neurochem.com
www.neurochem.com
68
Neurochem (NASDAQ:NRMX)
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